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S-1 Filing
Cidara Therapeutics (CDTX) S-1IPO registration
Filed: 23 Dec 24, 4:39pm
Delaware | 46-1537286 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification Number) |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||
Emerging growth company | ☐ |
The information in this prospectus is not complete and may be changed. The selling stockholders may not sell these securities or accept an offer to buy these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting offers to buy these securities in any state where such offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED DECEMBER 23, 2024
PROSPECTUS
7,041,309 shares of Common Stock
This prospectus covers the offer and resale from time to time of up to an aggregate of 7,041,309 shares (the “Resale Shares”) of our common stock, par value $0.0001 per share (the “Common Stock”), of which 3,892,274 are issued and outstanding (the “Shares”) and 3,149,035 shares (the “Warrant Shares”) are issuable upon the exercise of pre-funded warrants to purchase shares of Common Stock by the selling stockholders named herein, together with any additional selling stockholders listed in a prospectus supplement (together with any of such stockholders’ transferees, pledgees, donees or successors).
We are registering the offer and sale of the Resale Shares from time to time by the selling stockholders to satisfy the registration rights they were granted in connection with the issuance of the Resale Shares and pre-funded warrants to purchase Resale Shares (the “Pre-Funded Warrants”) which were sold to the selling stockholders in a private placement (the “Private Placement”) which closed on November 26, 2024 (the “Closing Date”). We are not selling any Resale Shares and will not receive any proceeds from the sale of the Resale Shares by the selling stockholders.
Sales of the Resale Shares by the selling stockholders may occur at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. The selling stockholders may sell the Resale Shares to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions from the selling stockholders, the purchasers of the Resale Shares, or both.
We are paying the cost of registering the Resale Shares as well as various related expenses. The selling stockholders are responsible for all selling commissions, transfer taxes and other costs related to the offer and sale of their Resale Shares. See “Plan of Distribution” for more information about how the selling stockholders may sell or dispose of their Resale Shares.
Our Common Stock is listed on The Nasdaq Capital Market under the symbol “CDTX.” On December 20, 2024, the last reported sale price of our Common Stock was $23.22 per share.
Investing in our Common Stock involves a high degree of risk. Before making an investment decision, please read the information under “Risk Factors” on page 4 of this prospectus and under similar headings in any amendment or supplement to this prospectus or in any filing with the Securities and Exchange Commission that is incorporated by reference herein.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2024.
EXPLANATORY NOTE
On April 24, 2024, us and Napp Pharmaceutical Group Limited (“Napp”), an affiliate of Mundipharma Medical Company (“Mundipharma”), entered into an Asset Purchase Agreement (the “Napp Purchase Agreement”) pursuant to which we sold to Napp all of our rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations. Due to such determination, we have included in this Registration Statement on Form S-1, recast financial statements for the years ended December 31, 2023 and 2022 as well as for the nine month periods ending September 30, 2024 and 2023 and an updated Management’s Discussion and Analysis of Financial Condition and Result of Operations. In addition, on April 23, 2024, effected the approved 1-for-20 reverse stock split of our shares of common stock (the “Reverse Stock Split”). All references in this Registration Statement on Form S-1 to number of common shares, price per share and weighted average number of shares outstanding have been adjusted to reflect the Reverse Stock Split on a retroactive basis.
TABLE OF CONTENTS
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 7 | |||
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 32 | |||
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F-1 |
i
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission (the “SEC”). Under this registration statement, the selling stockholders may sell from time to time in one or more offerings the shares of Common Stock described in this prospectus or otherwise as described under “Plan of Distribution”.
We have not, and the selling stockholders have not, authorized anyone to provide you with information other than the information that we have provided or incorporated by reference in this prospectus and your reliance on any unauthorized information or representation is at your own risk. This prospectus may be used only in jurisdictions where offers and sales of these securities are permitted. You should assume that the information appearing in this prospectus is accurate only as of the date of this prospectus and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus, or any sale of our Common Stock. Our business, financial condition and results of operations may have changed since those dates.
Unless otherwise stated, all references in this prospectus to “we,” “us,” “our,” “Cidara,” the “Company” and similar designations refer to Cidara Therapeutics, Inc. This prospectus contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and any applicable prospectus supplement or free writing prospectus, including the documents that we incorporate by reference herein and therein, contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions (including their use in the negative) intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. As such, our actual results may differ significantly from those expressed in any forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
We discuss many of these risks in greater detail under the “Risk Factors”, “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections in this prospectus and/or incorporated by reference into this prospectus from our most recent Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q for the quarterly periods ended subsequent to our filing of such Annual Report on Form 10-K, as well as any amendments thereto reflected in subsequent filings with the SEC.
Also, these forward-looking statements represent our estimates and assumptions only as of the date of the document containing the applicable statement. Unless required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should read this prospectus, any applicable prospectus supplement, together with the documents that we have filed with the SEC that are incorporated by reference and any free writing prospectus we have authorized for use in connection with this offering, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in the foregoing documents by these cautionary statements.
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INDUSTRY, MARKET AND OTHER DATA
Certain industry, market and competitive position data contained in this prospectus supplement and the information incorporated by reference herein relate to or are based on industry studies, research, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, research, publications, surveys and other data to be reliable as of the date of this prospectus supplement and based on reasonable assumptions, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources, and all such data involve risks and uncertainties and are subject to change based on various factors. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable.
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PROSPECTUS SUMMARY
This summary highlights certain information about us, the Private Placement (as defined below) and selected information contained elsewhere in or incorporated by reference into this prospectus. This summary is not complete and does not contain all of the information that you should consider before making an investment decision. For a more complete understanding of our company, you should read and consider carefully the more detailed information included or incorporated by reference in this prospectus and any applicable prospectus supplement, including the factors described under the heading “Risk Factors” on page 4 of this prospectus, as well as the information incorporated herein by reference, before making an investment decision.
Overview
We are a biotechnology company using our proprietary Cloudbreak® platform to develop drug-Fc conjugate (“DFC”) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases.
Our lead clinical-stage asset is CD388, a DFC intended for influenza prophylaxis, which we discovered and advanced to the clinic under a partnership with J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”). To date, we have completed two Phase 1 studies and one Phase 2a study of CD388 under our prior license and collaboration agreement we entered into with Janssen in March 2021 (the “Janssen Collaboration Agreement”). In 2023, as part of a prioritization of its research and development (“R&D”) business, Janssen disclosed its intention to discontinue internal development of multiple product candidates in its infectious disease pipeline, including CD388. Through a competitive process, we reacquired all rights to develop and commercialize CD388 by executing a license and technology transfer agreement with Janssen (the “Janssen License Agreement”), in April 2024. Under the terms of the Janssen License Agreement, we received an exclusive, worldwide, fee-bearing but royalty-free license under certain Janssen-controlled technology to develop, manufacture and commercialize compounds, including CD388.
Our sole R&D focus has now shifted to our proprietary Cloudbreak platform, which enables the development of novel DFCs that inhibit specific disease targets while simultaneously engaging the immune system. With the reacquisition of CD388, it is now our most advanced DFC program. CD388 is a highly potent antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza.
Private Placement
On November 20, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) with the selling stockholders named in this prospectus, pursuant to which we sold and issued to the selling stockholders in a private placement (the “Private Placement”) (i) an aggregate of 3,892,274 shares of Common Stock, at a purchase price of $14.912 per share, and (ii) in lieu of shares of Common Stock to certain selling stockholders, Pre-Funded Warrants to purchase up to an aggregate of 3,149,035 shares of Common Stock at a purchase price of $14.9119 per Pre-Funded Warrant (representing the $14.912 per share purchase price less the exercise price of $0.0001 per Warrant Share). The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.
RBC Capital Markets, LLC acted as the sole placement agent for the Private Placement. Guggenheim Securities, LLC acted as our financial advisor.
The Private Placement closed on November 26, 2024 (the “Closing Date”). We received aggregate gross proceeds from the Private Placement of approximately $105.0 million, before deducting estimated offering expenses payable by us.
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The Pre-Funded Warrants issued in the Private Placement provide that the holder of the Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving 61 days’ notice to us, but not to any percentage in excess of 19.99%.
In connection with the Private Placement, we entered into a registration rights agreement (the “Registration Rights Agreement”) with the selling stockholders named in this prospectus, pursuant to which we agreed to file a registration statement covering the resale of the Shares and the Warrant Shares by no later than December 23, 2024 (the “Filing Deadline”). We agreed to use commercially reasonable efforts to cause such registration statement to become effective as soon as practicable, but in any event no later than the earlier of (i) the 90th calendar day following the Closing Date (or the 120th calendar day following the Closing Date if the SEC notifies us that it will “review” the registration statement) and (ii) the 5th business day after we are notified by the SEC that the registration statement will not be “reviewed” or will not be subject to further review. We also agreed to use commercially reasonable efforts to keep such registration statement effective until the date the Shares and the Warrant Shares covered by such registration statement have been sold or may be resold pursuant to Rule 144 without restriction.
For more information regarding the Private Placement, see our Current Report on Form 8-K filed with the SEC on November 26, 2024 and incorporated herein by reference.
Corporate Information
We were incorporated in Delaware as K2 Therapeutics, Inc. in December 2012. In July 2014, we changed our name to Cidara Therapeutics, Inc. Our principal executive offices are located at 6310 Nancy Ridge Drive, Suite 101, San Diego, California 92121, and our telephone number is (858) 752-6170.
We formed wholly-owned subsidiaries, Cidara Therapeutics UK Limited, in England, and Cidara Therapeutics (Ireland) Limited, in Ireland, in March 2016 and October 2018, respectively, for the purpose of developing our product candidates in Europe. Our corporate website address is www.cidara.com. Information contained on or accessible through our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.
Implications of Being a Smaller Reporting Company
We qualify as a “smaller reporting company” and accordingly may provide less public disclosure than larger public companies, including the inclusion of only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations disclosure. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.
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The Offering
Common Stock offered by the selling stockholders | 7,041,309 shares of Common Stock, consisting of (i) 3,892,274 Shares and (ii) 3,149,035 Warrant Shares issuable upon the exercise of the Pre-Funded Warrants, all of which were issued by us in the Private Placement pursuant to the Purchase Agreement. |
Terms of the offering | Each selling stockholder will determine when and how it will sell the Common Stock offered in this prospectus, as described in “Plan of Distribution.” |
Use of proceeds | We will not receive any proceeds from the sale of the shares of Common Stock covered by this prospectus. |
Risk Factors | See “Risk Factors” on page 4 for a discussion of factors you should carefully consider before deciding to invest in our Common Stock. |
Nasdaq Capital Market symbol | CDTX |
The selling stockholders named in this prospectus may offer and sell up to 7,041,309 shares of Common Stock. Our Common Stock is currently listed on The Nasdaq Capital Market under the symbol “CDTX.” Shares of our Common Stock that may be offered under this prospectus will be fully paid and non-assessable. We will not receive any of the proceeds of sales by the selling stockholders of any of the Common Stock covered by this prospectus. We will, however, receive the exercise price of $0.0001 per share of the Pre-Funded Warrants exercised for cash. Throughout this prospectus, when we refer to the shares of our Common Stock being registered on behalf of the selling stockholders for offer and resale, we are referring to the Shares and Warrant Shares issuable upon exercise of the Pre-Funded Warrants that were issued to the selling stockholders in the Private Placement as described above. When we refer to the selling stockholders in this prospectus, we are referring to the selling stockholders identified in this prospectus and, as applicable, their permitted transferees or other successors-in-interest that may be identified in a supplement to this prospectus or, if required, a post-effective amendment to the registration statement of which this prospectus is a part.
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RISK FACTORS
Investing in our Common Stock involves a high degree of risk. Before making an investment decision, you should carefully consider the risks described in the sections entitled “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as filed with the SEC, which are incorporated herein by reference, as well any amendment or updates to our risk factors reflected in subsequent filings with the SEC, including any applicable prospectus supplement. Our business, financial condition, results of operations or prospects could be materially adversely affected by any of these risks. The trading price of our common stock could decline due to any of these risks, and you may lose all or part of your investment. This prospectus and the documents incorporated herein by reference also contain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks mentioned elsewhere in this prospectus. For more information, see the section entitled “Where You Can Find More Information.” Please also read carefully the section entitled “Special Note Regarding Forward-Looking Statements.”
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USE OF PROCEEDS
We will not receive any of the proceeds from the sale or other disposition of shares of our Common Stock held by the selling stockholders pursuant to this prospectus. The selling stockholders will receive all of the proceeds from the sale of shares of Common Stock hereunder. Upon any exercise of the Pre-Funded Warrants for cash, the applicable selling stockholder would pay us the nominal $0.0001 per share exercise price set forth in the Pre-Funded Warrants.
We will bear the out-of-pocket costs, expenses and fees incurred in connection with the registration of shares of our Common Stock to be sold by the selling stockholders pursuant to this prospectus. Other than registration expenses, the selling stockholders will bear underwriting discounts, commissions, placement agent fees or other similar expenses payable with respect to sales of shares of our Common Stock.
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DIVIDEND POLICY
We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future. In addition, any future debt instruments may materially restrict our ability to pay dividends on our common stock. Any future determination related to dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, tax considerations, legal or contractual restrictions, business prospects, the requirements of current or then-existing debt instruments, general economic conditions and other factors our board of directors may deem relevant.
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our audited consolidated financial statements and unaudited interim condensed consolidated financial statements and related notes included elsewhere in this prospectus. The results of operations for the years ended December 31, 2023 and 2022 have been derived from our audited consolidated financial statements included elsewhere in this prospectus. The results of operations for the nine months ended September 30, 2024 and 2023 have been derived from our unaudited interim condensed consolidated financial statements included elsewhere in this prospectus. In addition to our historical consolidated financial information, this discussion contains forward-looking statements based upon current expectations that involve risks, uncertainties, and assumptions. Our actual results could differ materially from those described in or implied by these forward-looking statements as a result of various factors, including those set forth under the section titled “Risk factors” and elsewhere in this prospectus.
OVERVIEW
We are a biotechnology company using our proprietary Cloudbreak platform to develop DFC immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases.
Our lead clinical-stage asset is CD388, a DFC intended for influenza prophylaxis, which we discovered and advanced to the clinic under a partnership with Janssen. To date, we have completed two Phase 1 studies and one Phase 2a study of CD388 under the Janssen Collaboration Agreement. In 2023, as part of a prioritization of its R&D business, Janssen disclosed its intention to discontinue internal development of multiple product candidates in its infectious disease pipeline, including CD388. Through a competitive process, we reacquired all rights to develop and commercialize CD388 by executing the Janssen License Agreement, in April 2024. Under the terms of the Janssen License Agreement, we received an exclusive, worldwide, fee-bearing but royalty-free license under certain Janssen-controlled technology to develop, manufacture and commercialize compounds, including CD388.
Concurrent with the CD388 reacquisition, we closed a private placement (the “Series A Private Placement”), led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (“BVF”) and Canaan Partners. The Series A Private Placement provided $240.0 million in gross proceeds, of which we used $85.0 million to fund the upfront payment under the Janssen License Agreement. The remainder of the gross proceeds of $155.0 million will be utilized to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with the CD388 Phase 2b NAVIGATE study that we initiated in September 2024. We believe the reacquisition of CD388 is transformational for Cidara and potentially for those who could benefit from a long-acting, universal preventative against known forms of influenza.
In addition, in April 2024 we simultaneously divested rezafungin, our sole non-Cloudbreak asset, to enable us to focus our resources on our core technology. We entered into the Napp Purchase Agreement with Napp, an affiliate of Mundipharma, our licensee for the asset in all territories other than the U.S. and Japan, pursuant to which we sold to Napp all of our rezafungin assets, including our right to receive future milestones and royalties under the Melinta License Agreement, and the Mundipharma Collaboration Agreement. We estimate that we will achieve approximately $128.0 million in cost savings over the patent life of rezafungin.
Following these transactions, our sole research and development (“R&D”) focus has now shifted to our proprietary Cloudbreak platform, which enables the development of novel DFCs that inhibit specific disease targets while simultaneously engaging the immune system. With the reacquisition of CD388, it is now our most advanced DFC program. CD388 is a highly potent antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza.
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Private Placement
On November 20, 2024, we entered into the Purchase Agreement with the selling stockholders named in this prospectus, pursuant to which we sold and issued to the selling stockholders in the Private Placement (i) an aggregate of 3,892,274 shares of Common Stock, at a purchase price of $14.912 per share, and (ii) in lieu of shares of Common Stock to certain selling stockholders, Pre-Funded Warrants to purchase up to an aggregate of 3,149,035 shares of Common Stock at a purchase price of $14.9119 per Pre-Funded Warrant (representing the $14.912 per share purchase price less the exercise price of $0.0001 per Warrant Share). The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.
We received aggregate gross proceeds from the Private Placement of approximately $105.0 million, before deducting estimated offering expenses payable by us.
Cloudbreak Platform
We believe our Cloudbreak platform has the potential to offer a fundamentally new approach to treat and prevent serious diseases such as viral infections and solid tumors, by developing product candidates designed to provide potent disease targeting activity and immune system engagement in a single long-acting molecule. Because serious disease often results when a pathogen or cancer cell evades or overcomes the host immune system, our Cloudbreak DFC candidates are designed to counter diseases in two ways: prevention of disease proliferation and immune evasion by directly targeting and, where applicable, by focusing the immune system on a pathogen or infected cell. We believe this is a potentially transformative approach, distinct from current therapies, including antibody drug conjugates (“ADCs”) monoclonal or multi-specific antibodies and vaccines.
In addition, DFCs are designed to have several advantages, including:
• | Multivalent binding which has the potential to increase potency; |
• | Ability to engage different targets to serve as a “drug cocktail” in a single molecule, which may improve response to treatment and prevention; and |
• | Potential advantages over vaccines irrespective of the immune status of patients. |
DFCs are fundamentally different from ADCs: DFCs are biologically stable drug-Fc conjugates designed to engage extracellular targets, while ADCs are designed to enter target cells to deliver and release cytotoxic small molecule drugs. In contrast to ADCs and monoclonal antibodies, DFCs are smaller, providing the potential for better tissue penetration and targeting multiple sites. Unlike small molecules, we believe DFC optimization can be focused primarily on potency.
Our lead Cloudbreak candidate for the prevention of influenza is CD388, a highly potent antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza. Our lead oncology DFC is CBO421, a development candidate targeting CD73 for the treatment of solid tumors, which received investigational new drug application (“IND”) clearance in July 2024. We do not plan to initiate clinical trials for any oncology product candidates at this time but continue business development discussions for our oncology DFC programs, including CBO421.
Cloudbreak Influenza Program
We have completed two Phase 1 studies and one Phase 2a study of CD388, our influenza DFC:
• | A randomized, double-blind, dose-escalation Phase 1 study to determine the safety, tolerability and pharmacokinetics of intramuscular and subcutaneous administration of CD388 in healthy subjects (NCT05285137); |
• | A separate Phase 1 Japanese bridging study (NCT05619536); and |
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• | A Phase 2a study (NCT05523089) to evaluate the pre-exposure prophylactic activity of CD388 against influenza. |
We initiated the CD388 Phase 2b NAVIGATE study in September 2024.
In December 2022, we received the first U.S. patent for CD388. The patent includes claims directed to the composition of matter of CD388. The patent is projected to expire in 2039 plus any available patent term extension.
In June 2023, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation to CD388 for the prevention of influenza A and B infection in adults who are at high risk of influenza complications due to underlying immunodeficiency and may not mount an adequate response to influenza vaccine or are at high risk of severe influenza despite influenza vaccination, including those for whom vaccines are contraindicated. Fast Track designation aims to facilitate the development and expedite the review of drugs to treat serious conditions with unmet medical needs. The purpose is to get important new drugs to patients earlier. Companies that are granted this designation are given the opportunity for more frequent interactions with the FDA, and, if relevant criteria are met, eligibility for Priority Review.
Final CD388 Phase 1 and Phase 2a Results
On September 21, 2023, we announced efficacy and safety data from our Phase 1 and Phase 2a studies evaluating the pre-exposure prophylactic activity of CD388 against an H3N2 influenza A virus strain.
CD388 was well-tolerated up to 900 milligrams (“mg”) (maximum dose tested):
In total, 108 subjects were dosed in our Phase 1 and Phase 2a studies, 84 of which were dosed subcutaneously (“SQ”) and 24 were dosed intramuscularly (“IM”).
Percent of SQ CD388 or Placebo Treatment Related Adverse Events in Phase 1 and Phase 2a studies
| ||||||
First in Human Study (Phase 1) | Japanese Bridging Study (Phase 1) | Human Challenge Study (Phase 2a) | ||||
Dose | CD388 N=8/dose; Placebo N=12 | CD388 N=7*/dose; Placebo N=6 | 50mg N=2; 150mg N=28; Placebo N=29 | |||
Placebo | 33.3 | 16.7 | — | |||
50 mg | 62.5 | 28.6 | — | |||
150 mg | 12.5 | 12.5 | — | |||
450 mg | — | — | N/A | |||
900 mg | 25.0 | N/A | N/A |
Safety Summary:
• | No treatment-emergent serious adverse events (“SAEs”) and no discontinuation of study drug or withdrawals due to safety findings. |
• | No consistent adverse event (“AE”) patterns. |
• | No hypersensitivity reactions. |
• | Most treatment-emergent adverse events (“TEAEs”) were Grade 1 (90%), few Grade 2, all resolved. |
• | Incidence of TEAE not dose-dependent. |
• | Few injection site events (pain, IM, route mainly), Grade 1, all resolved spontaneously. |
• | No clinically relevant electrocardiogram (“ECG”) vital signs or physical exam abnormalities. |
* 150mg N=8
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First in Human - single CD388 dose of 150 mg to 450 mg potentially provides seasonal coverage:
CD388 demonstrated protection in Phase 2a Human Challenge Model:
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The Phase 2a prophylactic efficacy results are based on 56 subjects enrolled in the trial, with 28 subjects receiving a single dose of CD388 (150 mg) and 28 subjects receiving a placebo.
Placebo (n=28) | CD388 150 mg (n=28) | P-value | ||||||||||
Quantitative reverse transcriptase polymerase chain reaction (“qRT-PCR”) confirmed influenza infection * | 14 | (50%) | 6 | (21%) | 0.0248 | |||||||
qRT-PCR confirmed symptomatic influenza infection ** | 9 | (32%) | 4 | (14%) | 0.1023 | |||||||
qRT-PCR confirmed moderately to severe symptomatic influenza infection *** | 7 | (25%) | 3 | (11%) | 0.1477 |
*RT-PCR-confirmed influenza infection: two quantifiable (≥ lower limit of quantification (“LLOQ”)) qRT-PCR measurements (reported on two or more independent samples over two days), from Day 1 (pm) up to Day 8 (am).
**RT-PCR-confirmed symptomatic influenza infection: RT-PCR-confirmed influenza infection (two quantifiable (≥LLOQ) qRT-PCR measurements (reported on two or more independent samples over two days)), from Day 1 (pm) up to Day 8 (am), and symptoms ≥2 at a single time point.
***RT-PCR-confirmed moderate to severe symptomatic influenza infection: RT-PCR confirmed influenza infection (two quantifiable (≥LLOQ) qRT-PCR measurements (reported on two or more independent samples over two days)), from Day 1 (pm) up to Day 8 (am), and any symptoms of grade ≥2 at a single time point.
As shown above, despite the small sample size in this analysis, a decrease in viral replication in the upper respiratory tract and influenza infection was observed in participants receiving a single dose of CD388 when compared to placebo. No treatment emergent adverse events leading to study discontinuation or SAEs were reported in the analysis. All participants included in the analysis received either CD388 or placebo and were then challenged with influenza five days later.
Viral culture data from Phase 2a Human Challenge Study confirmed efficacy seen in early analyses:
CD388 Phase 2a and Phase 1 Data Presentations at 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference:
In April 2024, we presented data from the Phase 2a study of CD388 in various poster presentations at the 34th ESCMID conference. The first presentation showed CD388 was well-tolerated and demonstrated
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statistically significant antiviral effects when administered as a single subcutaneous dose in healthy volunteers challenged with influenza. The second presentation highlighted data from a Phase 1 single ascending dose study of CD388 which showed the drug has an extended half-life of 6-8 weeks. These data underscore the potential of CD388 to provide patients with seasonal influenza prevention.
CD388 Phase 2a and Phase 1 Data Presentations at the Options XII conference:
In October 2024, we presented data from the Phase 2a study and the two Phase 1 studies. The first presentation was an oral presentation and showed the comprehensive safety data from all completed studies in the CD388 development program, demonstrating that CD388 appears to be well-tolerated at single doses up to 900 mg and repeat doses up to 450 mg. The second presentation was a poster presentation of the Phase 1 Japanese Bridging study that demonstrated that the pharmacokinetics of CD388 were similar between Japanese and Western participants and required no dose changes.
CD388 Phase 2a and Phase 1 Data Presentations at the ID Week conference:
In October 2024, we presented additional data from the Phase 2a study and the Phase 1 First-in-Human study. The first presentation was an oral presentation that showed that among those participants who had serology confirmation of influenza infection in the Phase 2a study that the rates of symptomatic clinical influenza and viral load AUC were significantly lower for CD388 participants versus placebo participants. The second presentation was a poster presentation that showed comprehensive safety and pharmacokinetic data from the First-in-Human Phase 1 study. This poster demonstrated that a single dose of CD388 should be sufficient to last through an entire influenza season and the lack of hypersensitivity or anti-drug antibodies with repeat dosing of CD388.
CD388 Phase 2b NAVIGATE Study Timeline
We initiated the CD388 Phase 2b NAVIGATE study during the current Northern Hemisphere influenza season, with dosing of the first subjects on September 20, 2024. The CD388 Phase 2b NAVIGATE study is a randomized, double-blinded, controlled trial with single doses of CD388 or placebo administered at the beginning of the influenza season with subjects followed for the influenza season to monitor for breakthrough cases of influenza. The primary endpoint of this study will compare the rates of laboratory-confirmed clinical influenza between different single dose levels of CD388 and placebo over an influenza season. The patient population in this study will be healthy adults who have not received an influenza vaccination for the upcoming season. In December 2024, we announced that we had reached full planned enrollment of at least 5,000 subjects across clinical trial sites in the United States and United Kingdom. Topline data is expected in the third quarter of 2025.
Cloudbreak Oncology Programs
We have expanded the Cloudbreak platform beyond infectious diseases, to discover and develop highly potent DFCs that can target single or multiple immune checkpoint pathways for the treatment of solid tumors.
Immune checkpoint antagonists have generated durable responses in cancers with improved side effect profiles compared to conventional chemotherapy. However, improved outcomes from existing therapies have been limited to a small subset of patients. To broaden the response rate to more patients, targeting additional mechanisms of tumor immune evasion will be critical.
Using Cloudbreak, we seek to develop a new generation of immunotherapies targeting the tumor microenvironment. Our lead oncology DFC candidate, CBO421, is a highly differentiated CD73 inhibitor that combines the strengths of small molecules and monoclonal antibodies targeting CD73. CBO421 targets CD73 in the adenosine pathway, which contributes to immune evasion in solid cancers by flooding the tumor microenvironment with adenosine, a potent immune cell suppressor. The CD73 pathway is clinically validated in
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early/mid-stage clinical studies to reduce tumor growth in combination with PD-1/ PD-L1 inhibitors in disease areas that do not historically respond to checkpoint inhibition alone, such as triple negative breast cancer (“TNBC”) and other solid tumors. As a monotherapy and in combination with PD-1 inhibitors, CBO421 has demonstrated activity and formation of immunologic memory in multiple murine tumor models, along with differentiated activity in T-cell reactivation assays and tumor penetration compared with the most advanced CD73 antibody therapeutics in clinical development. CBO421 received IND clearance in July 2024.
Cloudbreak Oncology Pipeline:
We do not plan to initiate clinical trials for any oncology product candidates at this time but continue business development discussions for our oncology DFC programs, including CBO421.
Compliance with Nasdaq Listing Requirements and Reverse Stock Split
Our common stock is listed on The Nasdaq Capital Market, which has as one of its continued listing requirements a minimum bid price of at least $1.00 per share (the “Minimum Bid Price Requirement”). On November 9, 2023, we received a notification letter (the “Notice”), from the Listing Qualification Staff (the “Staff”), of The Nasdaq Stock Market LLC (“Nasdaq”), advising us that for 30 consecutive trading days preceding November 6, 2023, the bid price of our common stock had closed below the Minimum Bid Price Requirement. As a result of the Nasdaq Hearings Panel (“the Panel”), imposing the previously disclosed Panel Monitor on us until November 9, 2023 pursuant to the February 9, 2023 Hearings Decision of the Panel, we were not eligible for a compliance period and the Staff notified us that this matter served as a basis for delisting our securities from The Nasdaq Capital Market.
On November 16, 2023, we requested a hearing before the Panel, which stayed any delisting action in connection with the Notice and allowed the continued listing of our common stock on The Nasdaq Capital Market until the Panel renders a decision subsequent to the hearing. On January 12, 2024, we submitted a pre-hearing submission in which we presented a plan to regain compliance with the Minimum Bid Price Requirement and request that the Panel allow us additional time within which to regain compliance.
The hearing was conducted on February 1, 2024, and on February 8, 2024, the Panel granted our request for continued listing on The Nasdaq Capital Market, pursuant to an extension, through May 7, 2024, to regain compliance with the Minimum Bid Price Requirement. The extension is subject to certain specified conditions and our submission of certain interim updates to the Panel.
At our special meeting of stockholders held on April 4, 2024, our stockholders approved a proposal to (i) amend our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our
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outstanding common stock at a ratio in the range of 1-for-10 to 1-for-30, inclusive; and (ii) if and only if the reverse stock split is approved and implemented, a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the reverse stock split ratio, with such ratio to be determined in the discretion of our board of directors and with such reverse stock split to be effected at such time and date, if at all, as determined by our board of directors in its sole discretion.
On April 12, 2024, our board of directors approved a reverse stock split of all outstanding shares of our common stock at a ratio of 1-for-20 (the “Reverse Stock Split”). Our board of directors also approved a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the Reverse Stock Split ratio. On April 22, 2024, we filed with the Secretary of State of the State of Delaware a Certificate of Amendment of our Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect the Reverse Stock Split. The Charter Amendment became effective at 5:00 p.m. Eastern Time on April 23, 2024. Our common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on April 24, 2024 under a new CUSIP number (171757206).
On May 14, 2024, we received a letter from the Staff notifying us that we had regained compliance with Nasdaq’s requirements for continued listing. In addition, the Panel imposed a discretionary Panel monitor until May 14, 2025, such that if we fail to maintain compliance with any continued listing requirement during such period, the Staff will issue a delist determination letter and we will promptly schedule a new hearing before the Panel to address such noncompliance.
Impact of Macroeconomic Conditions
Our business is subject to various trends, events or uncertainties that are reasonably likely to cause our reported financial information not to be necessarily indicative of future operating results or of future financial condition. We may be impacted by broader macroeconomic conditions, including global pandemics, high inflation, bank failures, labor shortages, supply chain disruptions, recession risks, the recent presidential election in the U.S. and potential disruptions from the ongoing Russia-Ukraine conflict and related sanctions and the active conflicts in the Middle East. The stock market, and in particular the market for pharmaceutical and biotechnology company stocks, has recently experienced significant decreases in value. This volatility and valuation decline have affected the market prices of securities issued by many companies, often for reasons unrelated to their operating performance.
Common Stock Equivalents Outstanding
As of September 30, 2024, we had 7,046,633 shares of common stock outstanding, 204,725 shares of Series A Convertible Voting Preferred Stock outstanding, which are convertible into 14,330,750 shares of common stock, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock, for a total of 22,429,619 shares of common stock equivalents outstanding.
Liquidity Overview
We have a limited operating history and the sales and income potential of our business and market are unproven. We have experienced net losses and negative cash flows from operating activities since our inception. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $559.0 million and $441.4 million, respectively. We expect to continue to incur net losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support our cost structure.
At September 30, 2024, we had cash and cash equivalents of $127.4 million, which we expect, together with the $105.0 million gross proceeds from the Private Placement, will provide sufficient liquidity for a period of at least one year following the date that our audited consolidated financial statements and unaudited interim condensed consolidated financial statements are issued as part of this Registration Statement on Form S-1.
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Our ability to execute our current business plan depends on our ability to obtain additional funding through equity offerings, debt financings, other third-party funding, or potential licensing or collaboration arrangements. We may not be able to raise additional funding on terms acceptable to us, or at all, and any failure to raise funds as and when needed will compromise our ability to execute on our business plan.
We plan to continue to fund our losses from operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third-party funding, or potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to us. Even if we raise additional capital, we may also be required to modify, delay or abandon some of our plans which could have a material adverse effect on our business, operating results and financial condition and our ability to achieve our intended business objectives. Any of these actions could materially harm our business, results of operations and future prospects.
FINANCIAL OPERATIONS OVERVIEW
Revenues
We have generated all of our revenues from our strategic partnership with Janssen. In the future, we may generate revenue from a combination of license fees and other upfront payments, other funded R&D agreements, milestone payments, product sales, government and other third-party funding and royalties in connection with strategic alliances. We expect that any revenue we generate will fluctuate from quarter-to-quarter as a result of the timing of our achievement of nonclinical, clinical, regulatory and commercialization milestones, the timing and amount of payments relating to such milestones and the extent to which our products are approved and successfully commercialized.
If we are unable to fund our development costs or we are unable to develop product candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenues and our results of operations and financial position would be adversely affected.
Acquired In-process Research and Development Expenses
Acquired in-process research and development (“IPR&D”), expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones.
We evaluate license agreements for IPR&D projects to determine if it meets the definition of a business and thus should be accounted for as a business combination. If the license agreement for IPR&D does not meet the definition of a business and the assets have not reached technological feasibility and have no alternative future use, we expense payments made under such license agreements as acquired IPR&D expense in our consolidated statements of operations and comprehensive loss. In those cases, payments for milestones achieved and payments for a product license prior to regulatory approval of the product are expensed in the period incurred. Payments made in connection with regulatory and sales-based milestones will be capitalized and amortized to cost of revenue.
Research and development expenses
Our R&D expenses have related primarily to nonclinical development of our Cloudbreak platform. R&D expenses consist of wages, benefits and stock-based compensation for R&D employees, as well as the cost of scientific consultants, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, and nonclinical and clinical trial costs. We accrue clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies or other activities within studies and other events.
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R&D costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed. We accrue for costs incurred as the services are being provided by monitoring the status of the study or project and the invoices received from our external service providers. We adjust our accruals as actual costs become known.
We may receive potential R&D funding through a partnership from the National Institute of Allergy and Infectious Diseases. We have evaluated the terms of the grants to assess our obligations and the classification of funding received. Amounts received for funded R&D are recognized in the consolidated statements of operations and comprehensive loss as a reduction to R&D expenses over the grant period as the related costs are incurred to meet our obligations.
R&D activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of development, primarily due to the increased size and duration of later-stage clinical trials. However, it is difficult to determine with certainty the duration, costs and timing to complete our current or future nonclinical programs and clinical trials of our product candidates.
The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
• | per patient trial costs; |
• | the number of patients that participate in the trials; |
• | the number of sites included in the trials; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible patients; |
• | the number of doses that patients receive; |
• | the drop-out or discontinuation rates of patients; |
• | potential additional safety monitoring or other studies requested by regulatory authorities; |
• | the duration of patient follow-up; |
• | the phase of development of the product candidate; and |
• | the efficacy and safety profile of the product candidates. |
R&D expenses by major program or category for the nine months ended September 30, 2024 and 2023, were as follows (in thousands):
Nine Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Cloudbreak platform | $ | 13,227 | $ | 20,370 | ||||
Personnel costs | 9,758 | 6,642 | ||||||
Other research and development expenses | 2,020 | 1,741 | ||||||
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Total research and development expenses | $ | 25,005 | $ | 28,753 | ||||
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R&D expenses by major program or category for the years ended December 31, 2023 and 2022, were as follows (in thousands):
Year ended December 31, | ||||||||
2023 | 2022 | |||||||
(As Restated) | ||||||||
Cloudbreak platform | 25,936 | 20,271 | ||||||
Personnel costs | 8,568 | 7,675 | ||||||
Other research and development expenses | 2,259 | 2,222 | ||||||
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Total research and development expenses | $ | 36,763 | $ | 30,168 | ||||
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We typically deploy our employees, consultants and infrastructure resources across our programs. Thus, some of our R&D expenses are not attributable to an individual program but are included in other R&D expenses as shown above.
In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.
Selling, general and administrative expenses
Selling, general and administrative (“SG&A”) expenses relate to selling, finance, human resources, legal and other administrative activities. SG&A expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, legal, business development, commercial planning, and support functions. Other SG&A expenses include facility and overhead costs not otherwise included in R&D expenses, consultant expenses, travel expenses, professional fees for auditing, tax, legal, and other services.
Other income, net
Other income, net consists primarily of interest income and expense, and various income or expense items of a non-recurring nature. We earn interest income from interest-bearing accounts and money market accounts for cash and cash equivalents. Interest expense represents interest paid related to term loans, the amortization of debt issuance costs, and interest on finance lease liabilities.
Discontinued Operations
On April 24, 2024, we entered into the Napp Purchase Agreement with Napp, pursuant to which we sold to Napp all of our rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations.
We present discontinued operations when there is a disposal of a component or a group of components that represents a strategic shift that will have a major effect on operations and financial results. The results from discontinued operations of the rezafungin assets prior and subsequent to its sale are presented as net income (loss) from discontinued operations, net of income taxes, in the consolidated statements of operations and comprehensive loss for all periods presented, including the $1.8 million loss on disposal of discontinued operations recognized during the second quarter of 2024. The assets and liabilities for the rezafungin operations related activities prior and subsequent to its sale have been classified as discontinued operations and segregated for all periods presented in the consolidated balance sheets. See Note 11 to the audited consolidated financial statements and Note 9 to the unaudited interim condensed consolidated financial statements, included elsewhere in this prospectus, for additional information.
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CRITICAL ACCOUNTING ESTIMATES
Our discussion and analysis of our financial condition and results of operations is based upon financial statements that we have prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities as of the date of the financial statements, and the revenues and expenses incurred during the reporting periods. We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made. To the extent there are material differences between these estimates, judgments or assumptions and actual results, our financial statements will be affected. Historically, revisions to our estimates have not resulted in a material change to our financial statements. While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements contained in our Annual Report on Form 10-K, the significant accounting estimates that we believe are important to aid in fully understanding and evaluating our reported financial results include the following:
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”), which applies to all contracts with customers, except for elements of certain contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or service we transfer to a customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and identify those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
In a contract with multiple performance obligations, we must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
Collaboration Revenue
If a license to our intellectual property is determined to be distinct from the other performance obligations identified in a contract, we recognize revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from the allocated transaction price. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue or expense recognition as a change in estimate.
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At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being reached. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or a collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of milestones that are within our or a collaboration partner’s control, such as operational development milestones and any related constraint, and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which will affect collaboration revenues and earnings in the period of adjustment. Revisions to our estimate of the transaction price may also result in negative collaboration revenues and earnings in the period of adjustment.
For arrangements that include sales-based royalties, including commercial milestone payments based on the level of sales, and a license is deemed to be the predominant item to which the royalties relate, we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied, or partially satisfied.
See Note 8 and Note 11 to the audited consolidated financial statements and Note 6 and Note 9 to the unaudited interim condensed consolidated financial statements, included elsewhere in this prospectus, for additional information.
Preclinical and Clinical Trial Accruals
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on the facts and circumstances known at that time. Our accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations (“CROs”) clinical trial investigational sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be required to estimate these services based on other information available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time, adjustments to R&D expenses may be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals.
RESULTS OF OPERATIONS
Comparison of the nine months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):
Nine Months Ended September 30, | Change | |||||||||||
2024 | 2023 | |||||||||||
Collaboration revenue | $ | 1,275 | $ | 20,527 | $ | (19,252 | ) | |||||
Acquired in-process research and development | 84,883 | — | 84,883 | |||||||||
Research and development expenses | 25,005 | 28,753 | (3,748 | ) | ||||||||
Selling, general and administrative expenses | 13,307 | 10,133 | 3,174 | |||||||||
Other income, net | 3,998 | 1,468 | 2,530 | |||||||||
Income tax expense | — | (8 | ) | 8 | ||||||||
Income (loss) from discontinued operations, net of income taxes | 402 | (2,819 | ) | 3,221 |
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Collaboration revenue
Collaboration revenue was $1.3 million for the nine months ended September 30, 2024 and $20.5 million for the nine months ended September 30, 2023. Collaboration revenue for the nine months ended September 30, 2024 and 2023 related to R&D and clinical supply services provided to Janssen under the Janssen Collaboration Agreement. The Janssen Collaboration Agreement was terminated upon the effectiveness of the Janssen License Agreement on April 24, 2024.
Acquired in-process research and development expenses
Acquired IPR&D expenses were $84.9 million for the nine months ended September 30, 2024 and related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement, on April 24, 2024, plus $0.4 million in direct transaction costs, offset by a settlement gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
Research and development expenses
R&D expenses were $25.0 million for the nine months ended September 30, 2024 and $28.8 million for the nine months ended September 30, 2023. The decrease in R&D expenses is primarily due to lower nonclinical expenses associated with our Cloudbreak platform, offset by higher expenses associated with our CD388 Phase 2b NAVIGATE study and higher personnel costs, including $1.2 million for severance and employee benefits incurred related to a reduction in force.
Selling, general and administrative expenses
SG&A expenses were $13.3 million for the nine months ended September 30, 2024 and $10.1 million for the nine months ended September 30, 2023. The increase in SG&A expenses is primarily due to higher audit fees, legal costs, and personnel costs.
Other income, net
Other income, net during the nine months ended September 30, 2024 and 2023 related primarily to interest income generated from cash held in interest-bearing accounts, offset by interest expense on finance lease liabilities.
Income tax expense
We estimate an annual effective income tax rate based on projected results for the applicable year and apply the rate to net loss before taxes to calculate income tax expense. When applicable, the income tax provision also includes adjustments for discrete tax items. Any refinements made due to subsequent information that affects the estimated annual effective income tax rate are reflected as adjustments in the current period.
Income (loss) from discontinued operations
On April 24, 2024, we entered into the Napp Purchase Agreement with Napp, pursuant to which we sold to Napp all of our rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations.
Income from discontinued operations was $0.4 million for the nine months ended September 30, 2024 and primarily consisted of revenue of $29.3 million related to sale of rezafungin assets, including sale of IP and inventory, product revenue related to shipments of REZZAYO naked vials to Mundipharma, as well as R&D and clinical supply services provided to Mundipharma and Melinta, offset by (i) cost of product revenue of
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$9.0 million, (ii) R&D expenses of $10.6 million associated with the rezafungin clinical trial and development costs, (iii) SG&A expenses of $7.5 million primarily associated with rezafungin-related patent costs, accrued interest and penalties for indirect taxes for rezafungin-related shipments and accrued indirect tax penalties on disposal of rezafungin, and (iv) loss on disposal of discontinued operations of $1.8 million.
Loss from discontinued operations was $2.8 million for the nine months ended September 30, 2023 and primarily consisted of revenue of $25.8 million related to the achievement of a milestone and R&D and clinical supply services provided to Mundipharma and Melinta, as well as product revenue related to shipments of REZZAYO naked vials to Mundipharma, offset by (i) cost of product revenue of $0.4 million, (ii) R&D expenses of $25.1 million associated with the rezafungin clinical trial and development costs, (iii) SG&A expenses of $2.8 million primarily associated with rezafungin-related patent costs and accrued interest and penalties for indirect taxes for rezafungin-related shipments, and (iv) income tax expense of $0.4 million.
Comparison of the years ended December 31, 2023 and 2022
The following table summarizes our results of operations for the years ended December 31, 2023 and 2022 (in thousands):
Year ended December 31, | Change | |||||||||||
2023 | 2022 | |||||||||||
(As Restated) | ||||||||||||
Collaboration revenue | $ | 23,283 | $ | 23,496 | $ | (213 | ) | |||||
Research and development | 36,763 | 30,168 | 6,595 | |||||||||
Selling, general and administrative | 13,580 | 15,227 | (1,647 | ) | ||||||||
Other income, net | 1,995 | 191 | 1,804 | |||||||||
Income tax expense | (15 | ) | (14 | ) | (1 | ) | ||||||
Income (loss) from discontinued operations, net of income taxes | 2,149 | (11,862 | ) | 14,011 |
Collaboration revenue
Collaboration revenue was $23.3 million and $23.5 million for the years ended December 31, 2023 and 2022, respectively, and related to the achievement of milestones and ongoing research and development and clinical supply services provided to Janssen. The Janssen Collaboration Agreement was terminated upon the effectiveness of the Janssen License Agreement on April 24, 2024.
Research and development expenses
Research and development expenses were $36.8 million for the year ended December 31, 2023 compared to $30.2 million for the year ended December 31, 2022. The increase in research and development expenses is primarily due to higher chemistry, manufacturing and controls (“CMC”) expenses associated with our Cloudbreak platform.
Selling, general and administrative expenses
SG&A expenses were $13.6 million for the year ended December 31, 2023 compared to $15.2 million for the year ended December 31, 2022. The decrease in SG&A expenses is primarily due to lower consulting, personnel and legal costs.
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Other income, net
Other income, net during the year ended December 31, 2023 related primarily to interest income generated from cash held in interest-bearing accounts, offset by interest expense on finance lease liabilities. Other income, net during the year ended December 31, 2022 related primarily to interest income generated from cash held in interest-bearing accounts, offset by interest expense in connection with our loan from Pacific Western Bank.
Income tax expense
Income tax expense for the years ended December 31, 2023 and 2022 is primarily the result of capitalized Internal Revenue Code (“IRC”) Section 174 research and development expenditures, effective January 1, 2022, creating taxable income which can be offset with net operating losses and credits that are limited in use by IRC Sections 382 and 383. For the years ended December 31, 2023 and 2022 the tax provision for income taxes from continuing operations consisted primarily of state minimum taxes.
Income (loss) from discontinued operations
On April 24, 2024, we entered into the Napp Purchase Agreement with Napp, pursuant to which we sold to Napp all of our rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations.
Income from discontinued operations was $2.1 million for the year ended December 31, 2023 and primarily consisted of revenue of $40.6 million related to the achievement of milestones and R&D and clinical supply services provided to Mundipharma and Melinta, as well as product revenue related to shipments of REZZAYO naked vials to Mundipharma and Melinta, offset by (i) cost of product revenue of $1.5 million, (ii) R&D expenses of $31.8 million associated with the rezafungin clinical trial and development costs, (iii) SG&A expenses of $4.8 million primarily associated with amortization of contract costs related to obtaining the Melinta License Agreement, rezafungin-related patent costs and accrued interest and penalties for indirect taxes for rezafungin-related shipments, and (iv) income tax expense of $0.4 million.
Loss from discontinued operations was $11.9 million for the year ended December 31, 2022 and primarily consisted of revenue of $41.0 million related to the achievement of milestones and R&D and clinical supply services provided to Mundipharma and Melinta, offset by (i) R&D expenses of $47.2 million associated with the rezafungin clinical trial and development costs, (ii) SG&A expenses of $5.3 million primarily associated with amortization of contract costs related to obtaining the Melinta License Agreement, rezafungin-related patent costs and accrued interest and penalties for indirect taxes for rezafungin-related shipments, and (iii) income tax expense of $0.3 million.
LIQUIDITY AND CAPITAL RESOURCES
Our primary sources of liquidity are our cash and cash equivalents, as well as equity financings. We have devoted our resources to funding R&D programs, including research, preclinical and clinical development activities.
Our ability to fund future operating needs will depend on a combination of equity, debt or other financing structures, potentially entering into collaborations, strategic alliances or licensing arrangements with third parties or receiving government and/or charitable grants or contracts. Our ability to raise additional capital may also be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the U.S. and worldwide from geopolitical and macroeconomic events, including global pandemics, the recent presidential election in the U.S., the ongoing Russia-Ukraine conflict and related sanctions, the active conflicts in the Middle East, and bank failures. As a result of our failure to timely file our
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Annual Report on Form 10-K for the year ended December 31, 2023, we lost our Form S-3 eligibility for primary and secondary offerings for at least 12 months following the date our Annual Report on Form 10-K filing was first delinquent, or through April 16, 2025.
On November 8, 2018, we entered into the controlled equity offering sales agreement with Cantor Fitzgerald & Co. (“the Sales Agreement”) pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million. As of September 30, 2024 and December 31, 2023, the remaining capacity under the Sales Agreement was $37.1 million. We have not sold shares of our common stock under the Sales Agreement since July 2023. We will not be able to sell shares of our common stock under the Sales Agreement until April 16, 2025, due to the loss of our Form S-3 eligibility for primary and secondary offerings.
In March 2023, we issued shares of our common stock and Series X Convertible Preferred Stock upon the closing of concurrent but separate public offerings, for gross proceeds of approximately $19.5 million.
On April 23, 2024, we entered into a securities purchase agreement with certain institutional and other accredited investors, pursuant to which we issued and sold, in the Series A Private Placement, 240,000 shares of Series A Convertible Voting Preferred Stock, par value $0.0001 per share, at a purchase price of $1,000 per share. The closing of the Series A Private Placement took place on April 24, 2024, and we received total gross proceeds of $240.0 million. As a condition to the effectiveness of the Janssen License Agreement, we paid Janssen an upfront payment of $85.0 million on April 24, 2024.
On September 9, 2024, our management, as authorized by our board of directors, approved a reduction in our workforce of 20 employees, which represented approximately 30% of our workforce (the “Reduction”). The Reduction was substantially completed by November 1, 2024 and is expected to substantially reduce our capital needs related to recurring personnel costs going forward.
On November 20, 2024, we entered into the Purchase Agreement with the selling stockholders named in this prospectus, pursuant to which we sold and issued to the selling stockholders in the Private Placement (i) an aggregate of 3,892,274 shares of Common Stock, at a purchase price of $14.912 per share, and (ii) in lieu of shares of Common Stock to certain selling stockholders, Pre-Funded Warrants to purchase up to an aggregate of 3,149,035 shares of Common Stock at a purchase price of $14.9119 per Pre-Funded Warrant (representing the $14.912 per share purchase price less the exercise price of $0.0001 per Warrant Share). The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire. We received aggregate gross proceeds from the Private Placement of approximately $105.0 million, before deducting estimated offering expenses payable by us.
As of September 30, 2024 and December 31, 2023, we have no outstanding loan balances.
Our finance lease for lab equipment expires in January 2027. Total undiscounted finance lease payments are $0.7 million as of September 30, 2024.
Our lease with Nancy Ridge Technology Center, L.P. expires on December 31, 2026 with options for two individual two-year extensions, which have not been exercised, and remain in effect and available to us. As of September 30, 2024, and December 31, 2023, we were not reasonably certain that we would exercise the extension options, and therefore did not include these options in the determination of the total lease term for accounting purposes. Total undiscounted operating lease payments are $3.8 million as of September 30, 2024 and $5.0 million as of December 31, 2023.
We are mindful that conditions in the current macroeconomic environment could affect our ability to achieve our goals. Sustained weakness or further deterioration of the local economies and currencies and adverse effects of the impact of pandemics, sanctions, or other macroeconomic events may pose operational challenges in
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those countries. We will continue to monitor these conditions and will attempt to adjust our business plans, as appropriate, to mitigate macroeconomic risks.
We enter into contracts in the normal course of business with vendors for R&D activities, manufacturing, and professional services that generally provide for termination either on notice or after a notice period. Our material cash requirements include costs to conduct R&D activities associated with our Cloudbreak platform, as well as personnel and SG&A support costs.
Comparison of cash flows for the nine months ended September 30, 2024 and 2023
The following table shows a summary of our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
Nine Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Net cash (used in) provided by: | ||||||||
Operating activities | $ | (147,119 | ) | $ | (9,710 | ) | ||
Investing activities | (129 | ) | (327 | ) | ||||
Financing activities | 238,856 | 25,976 | ||||||
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Net increase in cash and cash equivalents | 91,608 | 15,939 | ||||||
Cash and cash equivalents at beginning of period | 35,778 | 32,731 | ||||||
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Cash and cash equivalents at end of period | $ | 127,386 | $ | 48,670 | ||||
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Operating activities
Net cash used in operating activities was $147.1 million for the nine months ended September 30, 2024, compared to net cash used in operating activities of $9.7 million for the nine months ended September 30, 2023. Cash used in operating activities for the nine months ended September 30, 2024 was primarily attributable to (i) a net loss of $117.5 million which included an upfront payment of $85.0 million paid to Janssen under to the Janssen License Agreement, on April 24, 2024, plus $0.4 million in direct transaction costs, and (ii) a $26.8 million increase in prepaid expenses, other current assets, and other assets primarily associated with prepayments and deposits paid to a contract research organization at the start of our CD388 Phase 2b NAVIGATE study, offset by a loss on disposal of discontinued operations of $1.8 million. Cash used in operating activities for the nine months ended September 30, 2023 was primarily attributable to a net loss of $19.7 million which included $20.0 million for a milestone achieved in March 2023 under the Melinta License Agreement, which was received in April 2023.
For all periods presented, the primary use of cash was to fund R&D activities for our product candidates, which activities and uses of cash we expect to continue to increase for the foreseeable future.
Investing activities
Our investing activities during the nine months ended September 30, 2024 and 2023 consisted of purchases of property and equipment.
Financing activities
Net cash provided by financing activities of $238.9 million during the nine months ended September 30, 2024 primarily consisted of net proceeds of $239.1 million, from the sale of 240,000 shares of Series A Convertible Voting Preferred Stock, at a purchase price of $1,000 per share, pursuant to the Series A Private Placement, after deducting expenses payable by us, offset by payment of finance lease liabilities of $0.2 million.
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Net cash provided by financing activities of $26.0 million during the nine months ended September 30, 2023 primarily consisted of (i) net proceeds of $17.3 million from the sale of 554,300 shares of common stock and 286,000 shares of Series X Convertible Preferred Stock pursuant to concurrent but separate underwritten public offerings and (ii) net proceeds of $8.7 million from the sale of 310,983 shares of common stock under the Sales Agreement, after deducting placement agent fees.
Discontinued Operations
The cash flows related to discontinued operations have not been segregated and are included in the condensed consolidated statements of cash flows. The total net cash used in operating activities from discontinued operations was $18.1 million and $9.3 million for the nine months ended September 30, 2024 and 2023, respectively. There were no investing or financing activities from discontinued operations for the nine months ended September 30, 2024 and 2023.
The increase in cash used in operating activities from discontinued operations primarily related to lower milestone payments received offset by decreased clinical, development, and manufacturing activities related to the rezafungin program during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023.
The absence of cash outflows from discontinued operations is expected to reduce our operating cash outflows from continuing operations given that we no longer have any future obligations related to rezafungin. The expected cash outflows for these obligations to complete the ongoing clinical trials, development activities, and manufacturing activities would have been offset by any near-term future milestones and royalties.
Comparison of cash flows for the years ended December 31, 2023 and 2022
The following table shows a summary of our cash flows for the years ended December 31, 2023 and 2022 (in thousands):
Year ended December 31, | ||||||||
2023 | 2022 | |||||||
Net cash (used in) provided by: | ||||||||
Operating activities | $ | (22,432 | ) | $ | (28,473 | ) | ||
Investing activities | (505 | ) | (118 | ) | ||||
Financing activities | 25,984 | (951 | ) | |||||
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Net increase (decrease) in cash and cash equivalents | 3,047 | (29,542 | ) | |||||
Cash and cash equivalents at beginning of year | 32,731 | 62,273 | ||||||
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Cash and cash equivalents at end of year | $ | 35,778 | $ | 32,731 | ||||
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Operating activities
Net cash used in operating activities was $22.4 million for the year ended December 31, 2023, compared to $28.5 million for the year ended December 31, 2022. Cash used in operating activities for the year ended December 31, 2023 was primarily attributable to a net loss of $22.9 million, and included $20.0 million for a milestone achieved in March 2023 under the Melinta License Agreement, which was received in April 2023, and $7.0 million for a milestone achieved in September 2023 under the Janssen Collaboration Agreement, which was received in September 2023.
Cash used in operating activities for the year ended December 31, 2022 was primarily attributable to a net loss of $33.6 million, and included $2.8 million for a milestone achieved in December 2021 under the Mundipharma Collaboration Agreement, which was received in January 2022, $3.0 million for a milestone
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achieved in March 2022 under the Janssen Collaboration Agreement, which was received in May 2022, $11.1 million for a milestone achieved in August 2022 under the Mundipharma Collaboration Agreement, which was received in September 2022, and the $30.0 million upfront payment received in August 2022 pursuant to the Melinta License Agreement.
For all periods presented, the primary use of cash was to fund research and development activities for our product candidates, which activities and uses of cash we expect to continue to increase for the foreseeable future.
Investing activities
Our investing activities during the years ended December 31, 2023 and 2022 consist of purchases of property and equipment.
Financing activities
Net cash provided by financing activities during the year ended December 31, 2023 consisted primarily of (i) net proceeds of $17.3 million from the sale of 554,300 shares of common stock and 286,000 shares of Series X Convertible Preferred Stock pursuant to concurrent but separate underwritten public offerings and (ii) net proceeds of $8.7 million from the sale of 311,583 shares of common stock under the Sales Agreement, after deducting placement agent fees.
Net cash used in financing activities during the year ended December 31, 2022 consisted primarily of net proceeds of $2.4 million, after deducting placement agent fees, from the sale of 170,123 shares of common stock under our Sales Agreement, offset by principal payments of $2.6 million made in connection with our loan from Pacific Western Bank and $0.7 million related to issuance costs for our 2021 underwritten public offering.
Discontinued Operations
The cash flows related to discontinued operations have not been segregated and are included in the consolidated statements of cash flows. The total net cash used in operating activities from discontinued operations was $10.5 million and $3.9 million for the years ended December 31, 2023 and 2022, respectively. There were no investing or financing activities from discontinued operations for the years ended December 31, 2023 and 2022.
The increase in cash used in operating activities from discontinued operations primarily related to lower milestone payments received offset by decreased clinical, development, and manufacturing activities related to the rezafungin program during the year ended December 31, 2023 as compared to the year ended December 31, 2022.
The absence of cash outflows from discontinued operations is expected to reduce our operating cash outflows from continuing operations given that we no longer have any future obligations related to rezafungin. The expected cash outflows for these obligations to complete the ongoing clinical trials, development activities, and manufacturing activities would have been offset by any near-term future milestones and royalties.
Operating Capital Requirements
Our ability to execute our operating plan depends on our ability to obtain additional funding through equity offerings, debt financings, other third-party funding, or potential licensing or collaboration arrangements. We plan to continue to fund our losses from operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third party funding, or potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to us. Even if we raise additional capital, we may also
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be required to modify, delay or abandon some of our plans which could have a material adverse effect on our business, operating results and financial condition and our ability to achieve our intended business objectives. Any of these actions could materially harm our business, results of operations and future prospects.
Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide information typically disclosed under this item.
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BUSINESS
Please see Item 1 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of our business.
Properties
Please see Item 2 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of our properties.
Legal Proceedings
Please see Item 3 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of legal proceedings.
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MANAGEMENT
Please see Item 10 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of our management.
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EXECUTIVE COMPENSATION
Please see Item 11 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of our executive compensation.
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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Please see Item 13 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of certain relationships and related transactions.
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Please see Item 12 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024, which is incorporated herein by reference, for a discussion of the security ownership of certain beneficial owners and management and related stockholder matters.
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SELLING STOCKHOLDERS
The shares of Common Stock being offered by the selling stockholders are those (i) issued to the selling stockholders in the Private Placement and (ii) issuable to the selling stockholders upon exercise of the Pre-Funded Warrants issued in the Private Placement. For additional information regarding the issuances of those shares of Common Stock and the Pre-Funded Warrants, see “Prospectus Summary—Private Placement” above. We are registering the resale of shares of Common Stock issued to the selling stockholders and issuable upon exercise of the Pre-Funded Warrants in order to permit the selling stockholders to offer the shares for resale from time to time.
Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to our Common Stock. Generally, a person “beneficially owns” shares of our Common Stock if the person has or shares with others the right to vote those shares or to dispose of them, or if the person has the right to acquire voting or disposition rights within 60 days.
The table below lists the selling stockholders and other information regarding the beneficial ownership of the shares of Common Stock by each of the selling stockholders. This information has been obtained from the selling stockholders or in Schedules 13G or 13D and other public documents filed with the SEC. The second column lists the number of shares of Common Stock beneficially owned by each selling stockholder, based on its ownership of the shares of Common Stock and Pre-Funded Warrants, as of December 20, 2024, assuming exercise of the Pre-Funded Warrants held by the selling stockholders on that date, subject to any limitations on exercises. The percentage of shares owned prior to and after the offering in the third and sixth columns are based on 10,945,235 shares of Common Stock outstanding as of December 20, 2024. The fifth and sixth columns assume the sale of all of the shares offered by the selling stockholders pursuant to this prospectus.
In accordance with the terms of the Registration Rights Agreement, this prospectus generally covers the resale of the sum of (i) the number of shares of Common Stock issued to the selling stockholders in the Private Placement and (ii) the maximum number of shares of Common Stock issuable upon exercise of the Pre-Funded Warrants issued in the Private Placement. This maximum amount is determined as if the outstanding Pre-Funded Warrants were exercised in full as of the trading day immediately preceding the date this registration statement was initially filed with the SEC, subject to adjustment as provided in the Registration Rights Agreement and without regard to any limitations on the exercise of the warrants. Under the terms of the Pre-Funded Warrants, a selling stockholder may not exercise the Pre-Funded Warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of Common Stock which would exceed 9.99% of the number of shares of our Common Stock outstanding following such exercise (for purposes of the denominator, immediately after giving effect to the issuance of shares of Common Stock to be issued upon the applicable exercise of such Pre-Funded Warrant). The number of shares in the second column reflect this limitation. The selling stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
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Unless otherwise indicated, the address for the persons and entities listed in the table below is c/o Cidara Therapeutics, Inc., 6310 Nancy Ridge Drive, Suite 101, San Diego, California 92121.
Before Offering | After Offering | |||||||||||||||
Name of Selling Stockholder | Number of Shares Beneficially Owned | Maximum Number of Shares Offered | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | ||||||||||||
Adage Capital Partners LP (1) | 243,935 | 201,180 | 42,755 | * | ||||||||||||
Entities Affiliated with BVF Partners L.P.(2) | 1,094,382 | 670,600 | 1,487,141 | 9.99 | % | |||||||||||
Checkpoint Capital L.P. (3) | 287,408 | 134,123 | 153,285 | 1.09 | % | |||||||||||
RA Capital Healthcare Fund, L.P. (4) | 1,093,499 | 1,676,502 | 1,486,240 | 9.99 | % | |||||||||||
Entities Affiliated with Spruce Street (5) | 441,670 | 335,300 | 106,370 | * | ||||||||||||
TCG Crossover Fund II, LP (6) | 1,005,901 | 1,005,901 | 0 | * | ||||||||||||
Entities Affiliated with Venrock Healthcare Capital Partners (7) | 1,129,800 | 2,347,103 | 0 | * | ||||||||||||
Entities Affiliated with Vivo (8) | 670,600 | 670,600 | 0 | * |
* | Beneficial ownership is less than 1%. |
(1) | Bob Atchinson and Phillip Gross are the managing members of Adage Capital Advisors, L.L.C., which is the managing member of Adage Capital Partners GP, L.L.C., which is the general partner of Adage, and each such person or entity, as the case may be, has shared voting and/or investment power over the securities held by Adage Capital Partners, LP and may be deemed the beneficial owner of such shares, and each such person or entity, as the case may be, disclaims beneficial ownership of such securities except to the extent of their respective pecuniary interest therein. The principal business address of the persons and entities listed above is 200 Clarendon Street, 52nd Floor, Boston, Massachusetts 02116. |
(2) | Consists of (i) 494,471 shares of Common Stock and 9,543 Warrant Shares underlying Pre-Funded Warrants held by Biotechnology Value Fund, L.P. (“BVF”), (ii) 489,056 shares of Common Stock held by Biotechnology Value Fund II, L.P. (“BVF II”), (iii) 63,450 shares of Common Stock held by Biotechnology Value Trading Fund OS LP (“BV Trading Fund”), and (iv) 37,862 shares of Common Stock held by MSI BVF SPV, LLC (“MSI BVF”, and together with BVF, BVF II, and BV Trading Fund, the “BVF Funds”). Due to the Beneficial Ownership Limitation, the beneficial ownership in the “Before Offering” column excludes an aggregate of (i) (a) 116,289 Warrant Shares underlying Pre-Funded Warrants, (b) 1,210,543 shares of our Series X Convertible Preferred Stock, $0.0001 par value per share (“Series X Preferred Stock”) which are convertible into 605,272 shares of Common Stock, and (c) 7,870 shares of our Series A Convertible Voting Preferred Stock, $0.0001 par value per share (“Series A Preferred Stock”) which are convertible into 550,900 shares of Common Stock, each held by BVF, (ii) (a) 120,246 Warrant Shares underlying Pre-Funded Warrants, (b) 773,927 shares of Series X Preferred Stock which are convertible into 386,963 shares of Common Stock, and (c) 6,252 shares of Series A Preferred Stock which are convertible into 437,640 shares of Common Stock, each held by BVF II, (iii) (a) 25,279 Warrant Shares underlying Pre-Funded Warrants, (b) 110,738 shares of Series X Preferred Stock which are convertible into 55,369 shares of Common Stock, and (c) 514 shares of Series A Preferred Stock which are convertible into 35,980 shares of Common Stock, each held by BV Trading Fund and (iv) (a) 9,512 Warrant Shares underlying Pre-Funded Warrants, (b) 9,264 shares of Series X Preferred Stock which are convertible into 4,632 shares of Common Stock, and (c) 221 shares of Series A Preferred Stock which are convertible into 15,470 shares of Common Stock, each held by MSI BVF. Any Pre-Funded Warrants held by the BVF Funds may not be exercised to the extent such exercise would cause the BVF Funds, together with their affiliates, to beneficially own in excess of 9.99% of the number of shares of our Common Stock outstanding immediately after giving effect to such exercise. The number in the column “Maximum Number of Shares Offered” consists of (i) 174,603 shares of Common Stock and 125,832 Warrant Shares underlying Pre-Funded Warrants held by BVF, (ii) 166,852 shares of Common Stock and 120,246 Warrant Shares underlying Pre-Funded Warrants held by BVF II, (iii) 35,077 shares of Common Stock and 25,279 Warrant Shares underlying Pre-Funded Warrants held by BV Trading Fund and (iv) 13,199 shares of Common Stock and 9,512 Warrant Shares underlying Pre-Funded Warrants held by MSI BVF. The number in |
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the column “After Offering” consists of (i) (a) 319,868 shares of Common Stock and (b) 1,210,543 shares of our Series X Preferred Stock which are convertible into 605,272 shares of Common Stock held by BVF, (ii) (a) 322,204 shares of Common Stock and (b) 373,523 shares of our Series X Preferred Stock which are convertible into 186,761 shares of Common Stock held by BVF II, (iii) 28,373 shares of Common Stock held by BV Trading Fund, and (iv) 24,663 shares of Common Stock held by MSI BVF. Due to the beneficial ownership limitations on the exercise of Series X Preferred Stock and Series A Preferred Stock as detailed below in the section titled “Description of Capital Stock”, the beneficial ownership in the “After Offering” column excludes an aggregate of (i) 7,870 shares of our Series A Preferred Stock which are convertible into 550,900 shares of Common Stock held by BVF, (ii) (a) 400,404 shares of Series X Preferred Stock which are convertible into 200,202 shares of Common Stock and (b) 6,252 shares of Series A Preferred Stock which are convertible into 437,640 shares of Common Stock, each held by BVF II, (iii) (a) 110,738 shares of Series X Preferred Stock which are convertible into 55,369 shares of Common Stock and (b) 514 shares of Series A Preferred Stock which are convertible into 35,980 shares of Common Stock, each held by BV Trading Fund and (iv) (a) 9,264 shares of Series X Preferred Stock which are convertible into 4,632 shares of Common Stock and (b) 221 shares of Series A Preferred Stock which are convertible into 15,470 shares of Common Stock, each held by MSI BVF. Based upon a Schedule 13G/A filed with the SEC on November 14, 2024 by Biotechnology Value Fund, L.P., on behalf of itself, BVF I GP LLC, Biotechnology Value Fund II, L.P., BVF II GP LLC, Biotechnology Value Trading Fund OS LP, BVF Partners OS Ltd., BVF GP Holdings, LLC, BVF Partners L.P., BVF Inc., and Mark N. Lampert. Biotechnology Value Fund, L.P., BVF I GP LLC, Biotechnology Value Fund II, L.P., BVF II GP LLC, Biotechnology Value Trading Fund OS LP, BVF Partners OS Ltd., BVF GP Holdings, LLC, BVF Partners L.P., BVF Inc., and Mark N. Lampert have shared voting and investment power over the shares. The address for Biotechnology Value Fund, L.P. and its affiliates is 44 Montgomery Street, 40th Floor, San Francisco, California 94104. |
(3) | Consists of 322,499 shares of Common Stock held by Checkpoint Capital L.P. (“Checkpoint”). The number in the column “Maximum Number of Shares Offered” consists of 134,123 shares of Common Stock held by Checkpoint. Kung-Tao Samuel Huang is the control person of Checkpoint and may be deemed to have voting, investment and dispositive power over the shares. Mr. Huang disclaims beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The principal business address of Checkpoint and Mr. Huang is 611 Washington Street, San Francisco, California 94111. |
(4) | Consists of 1,092,796 shares of Common Stock and 703 Warrant Shares underlying Pre-Funded Warrants held by RA Capital Healthcare Fund (“RACHF”). Due to the Beneficial Ownership Limitation, the beneficial ownership in the “Before Offering” column excludes an aggregate of (i) 1,286,083 Warrant Shares underlying Pre-Funded Warrants and (ii) 89,956 shares of Series A Preferred Stock which are convertible into 6,296,920 shares of Common Stock. Any Pre-Funded Warrants held by RACHF may not be exercised to the extent such exercise would cause RACHF, together with their affiliates, to beneficially own in excess of 9.99% of the number of shares of our Common Stock outstanding immediately after giving effect to such exercise. The number in the column “Maximum Number of Shares Offered” consists of (i) 389,716 shares of Common Stock held by RACHF and (ii) 1,286,786 Warrant Shares underlying Pre-Funded Warrants held by RACHF. The number in the column “After Offering” consists of 703,080 shares of Common Stock and 11,188 shares of Series A Preferred which are convertible into 783,160 shares of Common Stock. Due to the beneficial ownership limitations on the exercise of Series A Preferred Stock as detailed below in the section titled “Description of Capital Stock”, the beneficial ownership in the “After Offering” column excludes an aggregate of 78,768 shares of Series A Preferred Stock which are convertible into 5,513,760 shares of Common Stock. Based upon a Schedule 13D/A filed with the SEC on November 26, 2024, RA Capital Healthcare Fund GP, LLC is the general partner of RACHF. RA Capital Management, L.P. is the investment manager for RACHF. The general partner of RA Capital Management, L.P. is RA Capital Management GP, LLC, of which Peter Kolchinsky and Rajeev Shah are the controlling persons. Each of RA Capital Management, L.P., RA Capital Management GP, LLC, Dr. Kolchinsky and Mr. Shah may be deemed to have voting and investment power over the shares held by RACHF. RA Capital Management, L.P., RA Capital Management GP, LLC, Dr. Kolchinsky and Mr. Shah disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The principal business address of the persons and entities listed above is 200 Berkeley Street, 18th Floor, Boston, Massachusetts 02116. |
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(5) | Consists of (i) 83,992 shares of Common Stock held by MAP 852 SP, a segregated portfolio of MAP Institutional SPC (“MAP”), and (ii) 357,678 shares of Common Stock held by Spruce Street Capital Master Fund LP (“Master Fund”, and together with MAP, the “Spruce Funds”). The number in the column “Maximum Number of Shares Offered” consists of (i) 63,717 shares of Common Stock held by MAP and (ii) 271,583 shares of Common Stock held by Master Fund. Alex Ryan Rosen and Simon Basseyn are the controlling persons of the Spruce Funds and may be deemed to share voting, investment and dispositive power over the shares held by the Spruce Funds. Messrs. Rosen and Basseyn disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The principal business address of the Spruce Funds and Messrs. Rosen and Basseyn is 777 Third Avenue, Suite 1704, New York, New York 10017. |
(6) | Consists of 1,005,901 shares of Common Stock held by TCG Crossover Fund II, LP (“TCGX II”). Chen Yu is the sole managing member of TCG Crossover GP II, LLC (“TCGX II GP”), the general partner of TCGX II. Each of Mr. Yu and TCGX II GP may be deemed to have voting, investment, and dispositive power with respect to these securities. Mr. Yu and TCGX II GP disclaim beneficial ownership over the shares held by TCGX II, except to the extent of any pecuniary interest therein. The principal business address of TCGX II is 705 High St. Palo Alto, California 94301. |
(7) | Consists of (i) 132,317 shares of Common Stock and 273,262 Warrant Shares underlying Pre-Funded Warrants held by Venrock Healthcare Capital Partners III, L.P. (“VHCP III”), (ii) 13,247 shares of Common Stock and 27,358 Warrant Shares underlying Pre-Funded Warrants held by VHCP Co-Investment Holdings III, LLC (“VHCP Co-Investment”), and (iii) 620,159 shares of Common Stock and 63,457 Warrant Shares underlying Pre-Funded Warrants held by Venrock Healthcare Capital Partners EG, L.P. (“VHCP EG”, and together with VHCP III and VHCP Co-Investment, the “Venrock Funds”). Due to the Beneficial Ownership Limitation, the beneficial ownership in the “Before Offering” columns excludes 1,217,303 Warrant Shares underlying Pre-Funded Warrants held by VHCP EG. Any Pre-Funded Warrants held by the Venrock Funds may not be exercised to the extent such exercise would cause the Venrock Funds, together with their affiliates, to beneficially own in excess of 9.99% of the number of shares of our Common Stock outstanding immediately after giving effect to such exercise. The number in the column “Maximum Number of Shares Offered” consists of (i) 132,317 shares of Common Stock and 273,262 Warrant Shares underlying Pre-Funded Warrants held by VHCP III, (ii) 13,247 shares of Common Stock and 27,358 Warrant Shares underlying Pre-Funded Warrants held by VHCP Co-Investment, and (iii) 620,159 shares of Common Stock and 1,280,760 Warrant Shares underlying Pre-Funded Warrants held by VHCP EG. Based on a Schedule 13G filed with the SEC on November 26, 2024 by the Venrock Funds, VHCP Management III, LLC is the general partner of VHCP III and the manager of VHCP Co-Investment. VHCP Management EG, LLC is the general partner of VHCP EG. Nimish Shah and Bong Koh are the voting members of VHCP Management III, LLC and VHCP Management EG, LLC. Each of VHCP Management III, LLC, VHCP Management EG, LLC and Messrs. Shah and Koh may be deemed to share voting, investment and dispositive power over the shares held by the Venrock Funds. The principal business address of the above entities and persons is 7 Bryant Park, 23rd Floor, New York, New York 10018. |
(8) | Consists of (i) 600,157 shares of Common Stock held by Vivo Opportunity Fund Holdings, L.P. (“VOFH”) and (ii) 70,443 shares of Common Stock held by Vivo Asia Opportunity Fund Holdings, L.P (“VAOFH” and, together with VOFH, the “Vivo Funds”). The number in the column “Maximum Number of Shares Offered” consists of (i) 600,157 shares of Common Stock held by VOFH and (ii) 70,443 shares of Common Stock held by VAOFH. Based on a Schedule 13G filed with the SEC on December 9, 2024, Vivo Opportunity, LLC is the general partner of VOFH and Vivo Opportunity Cayman, LLC is the general partner of VAOFH. The voting members of Vivo Opportunity Cayman, LLC are Kevin Dai, Gaurav Aggarwal, Frank Kung and Shan Fu. Each of Mr. Dai, Mr. Aggarwal, Mr. Kung, Mr. Fu, Vivo Opportunity, LLC and Vivo Opportunity Cayman, LLC may be deemed to share voting, investment and dispositive power over the shares held by the Vivo Funds. Each of Mr. Dai, Mr. Aggarwal, Mr. Kung, Mr. Fu, disclaim beneficial ownership of such shares, except to the extent of any pecuniary interest therein. The principal business address of the Vivo Funds, Vivo Opportunity, LLC and Vivo Opportunity Cayman, LLC is 192 Lytton Avenue, Palo Alto, California 94301. |
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Relationships with Selling Stockholders
Board of Directors and Executive Officers
RA Capital Healthcare Fund, L.P. is an affiliate of Laura Tadvalkar, Ph.D., a member of our board of directors since April 2024.
Private Placement
The description set forth above under “Prospectus Summary—Private Placement” is incorporated herein by reference.
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PLAN OF DISTRIBUTION
We are registering the Resale Shares issued to the selling stockholders to permit the sale, transfer or other disposition of these shares by the selling stockholders or their donees, pledgees, transferees or other successors-in-interest from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the selling stockholders of the Resale Shares. We will bear all fees and expenses incident to our obligation to register such shares of Common Stock.
The term “selling securityholders” includes donees, pledgees, transferees or other successors in interest selling securities received after the date of this prospectus from a selling securityholder as a gift, pledge, partnership distribution or other transfer. The selling securityholders will act independently of us in making decisions with respect to the timing, manner and size of each sale. Such sales may be made on the principal trading market for our Common Stock or any other stock exchange, market or trading facility on which our Common Stock is traded or in private transactions. These sales may be at fixed or negotiated prices. A selling stockholder may use any one or more of the following methods when selling such securities:
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | settlement of short sales; |
• | in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities at a stipulated price per security; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | by pledge to secured debts and other obligations; |
• | delayed delivery arrangements; |
• | to or through underwriters or broker-dealers; |
• | in “at the market” offerings, as defined in Rule 415 under the Securities Act, at negotiated prices, at prices prevailing at the time of sale or at prices related to such prevailing market prices, including sales made directly on a national securities exchange or sales made through a market maker other than on an exchange or other similar offerings through sales agents; |
• | in options transactions; |
• | a combination of any such methods of sale; or |
• | any other method permitted pursuant to applicable law. |
The selling stockholders may also sell the securities under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.
In addition, a selling securityholder that is an entity may elect to make a pro rata in-kind distribution of securities to its members, partners or stockholders pursuant to the registration statement of which this prospectus is a part by delivering a prospectus with a plan of distribution. Such members, partners or stockholders would thereby receive freely tradeable securities pursuant to the distribution through a registration statement. To the
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extent a distributee is our affiliate (or to the extent otherwise required by law), we may, at our option, file a prospectus supplement in order to permit the distributees to use the prospectus to resell the securities acquired in the distribution. Broker-dealers engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with Financial Industry Regulatory Authority (“FINRA”) Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.
In connection with the sale of the securities or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The selling stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The selling stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each selling stockholder has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.
We are required to pay certain fees and expenses incurred by us incident to the registration of the securities. We have agreed to indemnify the selling stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to use commercially reasonable efforts to keep this prospectus effective until the date the Resale Shares have been sold or may be resold pursuant to Rule 144 without restriction, subject to our right to suspend pursuant to Section 2(d) of the Registration Rights Agreement. The securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the securities covered hereby may not simultaneously engage in market making activities with respect to the Common Stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the Common Stock by the selling stockholders or any other person. We will make copies of this prospectus available to the selling stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
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DESCRIPTION OF CAPITAL STOCK
General
The following summary description of our capital stock is based on the material provisions of our amended and restated certificate of incorporation, as amended, and amended and restated bylaws, and the applicable provisions of the General Corporation Law of the State of Delaware (the “DGCL”). This information may not be complete in all respects and is qualified entirely by reference to the provisions of our certificate of incorporation and bylaws, and the DGCL. For information on how to obtain copies of our certificate of incorporation, bylaws and such agreements, which are exhibits to the registration statement of which this prospectus is a part, see the section entitled “Where You Can Find More Information.”
As of the date of this registration statement, our authorized capital stock consists of 50,000,000 shares of Common Stock, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 par value per share (“Preferred Stock”), of which 204,725 shares have been designated as Series A Convertible Voting Preferred Stock, $0.0001 par value per share, and 4,947,759 shares have been designated as Series X Convertible Preferred Stock, $0.0001 par value per share.
As of December 20, 2024, there were 10,945,235 shares of our Common Stock outstanding, 204,725 shares of Series A Convertible Voting Preferred Stock outstanding, which are convertible into 14,330,750 shares of Common Stock, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of Common Stock.
Common Stock
Voting Rights. Our Common Stock is entitled to one vote for each share held of record on all matters submitted to a vote of the stockholders, including the election of directors, and does not have cumulative voting rights. Accordingly, the holders of a majority of the shares of our Common Stock entitled to vote in any election of directors can elect all of the directors standing for election. For most other matters, the approval of a majority of the shares voting at an annual or special meeting of stockholders will be required. Exceptions to this include removing directors for cause and amending our certificate of incorporation and bylaws, each of which will require the approval of the holders of at least 66 2/3% of the voting power of all of our then outstanding Common Stock.
Dividends and Distributions. Subject to preferences that may be applicable to any then outstanding Preferred Stock, the holders of outstanding shares of Common Stock may receive dividends, if any, as may be declared from time to time by the Board of Directors out of legally available funds. We have never issued a dividend on shares of our Common Stock and have no intention to do so in the future.
Liquidation, Dissolution or Winding Up. In the event of our liquidation, dissolution or winding up, the assets legally available for distribution shall be distributed ratably to the holders of shares of Common Stock and Preferred Stock, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of Preferred Stock.
Other Rights and Preferences. Holders of Common Stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of Preferred Stock that our board of directors may designate and issue in the future.
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Preferred Stock
General Description
Our board of directors is authorized, subject to limitations prescribed by Delaware law, to issue up to 10,000,000 shares of Preferred Stock in one or more series, to establish from time to time the number of shares to be included in each series and to fix the designation, powers, preferences and rights of the shares of each series and any of its qualifications, limitations or restrictions. Our board of directors can also increase or decrease the number of shares of any series, but not below the number of shares of that series then outstanding, without any further vote or action by our stockholders. Our board of directors may authorize the issuance of Preferred Stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the Common Stock. The issuance of Preferred Stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring, discouraging or preventing a change in control of us and may adversely affect the market price of our Common Stock and the voting and other rights of the holders of Common Stock.
Series X Convertible Preferred Stock
Pursuant to our Certificate of Designation of Preferences, Rights and Limitations of Series X Convertible Preferred Stock (the “Series X Certificate of Designation”), we designated 4,947,759 shares of our authorized and unissued Preferred Stock as Series X Convertible Preferred Stock (the “Series X Preferred Stock”), and established the rights, preferences and privileges of the Series X Preferred Stock, which are summarized below.
Conversion. Each share of Series X Preferred Stock is convertible at the option of the holder into 0.5 shares of Common Stock; provided that holders are not permitted to convert Series X Preferred Stock into Common Stock if, after conversion, the holder, its affiliates, and any other person whose beneficial ownership of Common Stock would be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Exchange Act, would beneficially own more than 9.99% of the number of shares of Common Stock outstanding immediately after the conversion.
Dividends and Distributions. Holders of Series X Preferred Stock are not entitled to receive any dividends except to the extent that dividends are paid on our Common Stock. If dividends are paid on shares of Common Stock, holders of Series X Preferred Stock are entitled to participate in such dividends on an as-converted basis.
Liquidation, Dissolution or Winding Up. Upon the liquidation, dissolution, or winding up of us, each holder of Series X Preferred Stock will participate pari passu with any distribution of proceeds to holders of Common Stock.
Voting Rights. Shares of Series X Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series X Preferred Stock will be required to amend the terms of the Series X Preferred Stock, if such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series X Preferred Stock, or to increase or decrease (other than by conversion) the number of authorized shares of Series X Preferred Stock.
The Series X Certificate of Designation and our certificate of incorporation do not provide for the repurchase or redemption of shares by us.
Series A Convertible Voting Preferred Stock
Pursuant to our Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”), we currently have designated 204,725 shares of our authorized and unissued Preferred Stock as Series A Convertible Voting Preferred Stock (the “Series A Preferred
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Stock”), and established the rights, preferences and privileges of the Series A Preferred Stock, which are summarized below.
Conversion. Each share of Series A Preferred Stock is convertible at the option of the holder into 70 shares of Common Stock; provided that holders are not permitted to convert Series A Preferred Stock into Common Stock if, after conversion, the holder, its affiliates, and any other person whose beneficial ownership of Common Stock would be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Exchange Act, would beneficially own more than 9.99% of the number of shares of Common Stock outstanding immediately after the conversion.
Dividends and Distributions. Holders of Series A Preferred Stock are not entitled to receive any dividends except to the extent that dividends are paid on our Common Stock. If dividends are paid on shares of Common Stock, holders of Series A Preferred Stock are entitled to participate in such dividends on an as-if-converted basis.
Liquidation, Dissolution or Winding Up. Upon the liquidation, dissolution, or winding up of us, each holder of Series A Preferred Stock will participate pari passu with any distribution of proceeds to holders of Series X Preferred Stock and Common Stock.
Voting Rights. Holders of the Series A Convertible Preferred Stock are entitled to vote together with the holders of Common Stock on an as-if-converted basis on all matters submitted to a vote of stockholders.
The Series A Certificate of Designation and our certificate of incorporation do not provide for the repurchase or redemption of shares by us.
Anti-takeover effects of provisions of our certificate of incorporation and bylaws and Delaware law
Certificate of Incorporation and Bylaws
Provisions of our amended and restated certificate of incorporation, as amended, and amended and restated bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our Common Stock. Among other things, our amended and restated certificate of incorporation and amended and restated bylaws:
• | permit our board of directors to issue up to 10,000,000 shares of Preferred Stock, with any rights, preferences and privileges as they may designate; |
• | provide that the authorized number of directors may be changed only by resolution adopted by a majority of the board of directors; |
• | provide that the board of directors or any individual director may only be removed with cause and the affirmative vote of the holders of at least 66 2/3% of the voting power of all of our then outstanding Common Stock; |
• | provide that all vacancies, including newly created directorships, may, except as otherwise required by law or subject to the rights of holders of Preferred Stock as designated from time to time, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum; |
• | divide our board of directors into three classes; |
• | require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent or electronic transmission; |
• | provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner and also specify requirements as to the form and content of a stockholder’s notice; |
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• | do not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of Common Stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose); |
• | provide that special meetings of our stockholders may be called only by the chairman of the board, our Chief Executive Officer or by the board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exists any vacancies); and |
• | provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors or officers to us or our stockholders, (iii) any action asserting a claim against the us arising pursuant to any provision of the DGCL or our certificate of incorporation or bylaws, or (iv) any action asserting a claim against us governed by the internal affairs doctrine. |
Delaware Anti-Takeover Law
We are subject to Section 203 of the Delaware General Corporation Law (“Section 203”). Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:
• | prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder; |
• | the interested stockholder owned at least 85% of the voting stock of the corporation outstanding upon consummation of the transaction, excluding for purposes of determining the number of shares outstanding (a) shares owned by persons who are directors and also officers and (b) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
• | on or subsequent to the consummation of the transaction, the business combination is approved by the board and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder. |
Section 203 defines a business combination to include:
• | any merger or consolidation involving the corporation and the interested stockholder; |
• | any sale, transfer, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation; |
• | subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; |
• | subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; and |
• | the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.
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Transfer Agent and Registrar
The transfer agent and registrar for our Common Stock is Equiniti Trust Company, LLC (f/k/a American Stock Transfer & Trust Company, LLC). The transfer agent and registrar’s address is 55 Challenger Road, Ridgefield Park, New Jersey 07660.
Listing on the Nasdaq Global Market
Our Common Stock is listed on the Nasdaq Capital Market under the symbol “CDTX”.
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LEGAL MATTERS
Certain legal matters, including the validity of the shares of Common Stock offered pursuant to this registration statement, will be passed upon for us by Cooley LLP, San Diego, California.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated financial statements at December 31, 2023 and 2022, and for each of the two years in the period ended December 31, 2023, as set forth in their report (which contains an explanatory paragraph describing the 2022 consolidated financial statements have been restated to correct misstatements as described in Note 1 to the consolidated financial statements). We have included our financial statements in the prospectus and elsewhere in the registration statement in reliance on Ernst & Young LLP’s report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement we filed with the SEC. This prospectus does not contain all of the information set forth in the registration statement and the exhibits to the registration statement. For further information with respect to us and the securities we are offering under this prospectus, we refer you to the registration statement and the exhibits and schedules filed as a part of the registration statement. Neither we nor any agent, underwriter or dealer has authorized any person to provide you with information that is different from that contained in this prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We are not making an offer of these securities in any state where the offer is not permitted. You should not assume that the information in this prospectus is accurate as of any date other than the date on the front page of this prospectus, regardless of the time of delivery of this prospectus or any sale of the securities offered by this prospectus.
We file annual, quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC, including us. The address of the SEC website is www.sec.gov.
We maintain a website at www.cidara.com. Information contained in or accessible through our website does not constitute a part of this prospectus.
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to “incorporate by reference” information from other documents that we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the SEC prior to the date of this prospectus.
We incorporate by reference into this prospectus and the registration statement of which this prospectus is a part the information or documents listed below that we have filed with the SEC (Commission File No. 001-36912), including portions that are furnished and not filed or otherwise not incorporated into registration statements pursuant to SEC rules:
• | our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 22, 2024; |
• | our Definitive Proxy Statements on Schedule 14A, filed with the SEC on March 4, 2024 and June 3, 2024; |
• | our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2024, June 30, 2024 and September 30, 2024, filed with the SEC on May 15, 2024, August 13, 2024 and November 7, 2024, respectively; and |
• | our Current Reports on Form 8-K filed with the SEC on February 9, 2024, April 5, 2024, April 16, 2024, April 22, 2024, April 24, 2024, April 24, 2024, as amended by the Form 8-K/A filed with the SEC on April 29, 2024, May 3, 2024, May 20, 2024, July 18, 2024, September 12, 2024, September 23, 2024 and November 26, 2024 (other than the portions thereof which are furnished and not filed). |
In addition, all documents subsequently filed by us (excluding any information furnished rather than filed) pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the termination of the offering shall be deemed to be incorporated by reference into this prospectus.
We will furnish without charge to each person, including any beneficial owner, to whom this prospectus is delivered, upon written or oral request, a copy of any document incorporated by reference. Requests should be addressed to 6310 Nancy Ridge Drive, Suite 101, San Diego, California 92121, Attn: Corporate Secretary or may be made telephonically at (858) 752-6170.
You also may access these filings on our website at www.cidara.com. We do not incorporate the information on our website into this prospectus and you should not consider any information on, or that can be accessed through, our website as part of this prospectus (other than those filings with the SEC that we specifically incorporate by reference into this prospectus).
In accordance with Rule 412 of the Securities Act, any statement contained in a document incorporated by reference herein shall be deemed modified or superseded to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein modifies or supersedes such statement.
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Page | ||||
Years Ended December 31, 2023 and 2022 | ||||
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F-8 | ||||
F-9 |
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Nine Months Ended September 30, 2024 and 2023 | ||||
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F-68 |
Estimated total costs expected to be incurred under the Mundipharma and Melinta Collaboration and License Agreements | ||
Description of the Matter | As more fully described in Note 11 to the consolidated financial statements, the Company entered into collaboration and license agreements with Mundipharma Medical Company (“Mundipharma”) and Melinta Therapeutics, LLC (“Melinta”) for strategic collaborations to develop and commercialize rezafungin. For the collaboration and license agreements, the Company determined the license and intellectual property, research and development services, and clinical supply services represent the distinct performance obligations. Revenue related to research and development services and clinical supply services are recognized over the estimated period of time to conduct the research and development services and clinical supply services based on actual costs incurred compared to the estimated total costs expected to be incurred. Collaboration revenue was significant to our audit because the revenue recognition assessment process involved inherent uncertainty, uses subjective assumptions, and the amounts involved are material to the financial statements taken as a whole. The subjective assumption relates to the estimated total costs expected to be incurred under the collaboration and license agreements. | |
How We Addressed the Matter in Our Audit | To test revenue recognized we performed audit procedures that included, among others, testing the assumption and underlying data used by the Company in its computation of the total estimated research and development services and clinical supply services budget expenses and testing the accuracy of the computations. We inspected evidence supporting the amount of actual costs incurred and assessed whether they were appropriate costs according to the terms of the contract by category. We performed corroborative inquiries of individuals outside of the finance department and inspected updated budget and change in estimated costs as approved by management. We assessed the reasonableness of the estimated costs to be incurred as of the reporting date based on current factors. | |
Accrued indirect tax liabilities | ||
Description of the Matter | As discussed in Notes 1 and 2 to the consolidated financial statements, the Company’s purchases of clinical drug supplies and raw materials, inventory transfers, and sales of commercial drug product are subject to accrued indirect tax liabilities in various jurisdictions outside of the United States. The Company evaluated the indirect taxation consequences upon the first commercial sale of REZZAYO in 2023 and determined that it has a liability for indirect taxation in various tax jurisdictions outside of the United States based on its supply chain activities in 2023 and prior years. As of December 31, 2023, the Company recorded $18.0 million of accrued indirect tax liabilities. |
Auditing the Company’s accrued indirect tax liabilities was challenging because the indirect tax liabilities was dependent upon an accumulation of a high volume of historical information related to the Company’s supply chain and clinical supply activities and the application of various international indirect tax laws and regulations, which varied between countries. | ||
How We Addressed the Matter in Our Audit | To test the accrued indirect tax liabilities, we performed audit procedures to test the completeness of the Company’s accrued indirect tax liabilities that included, among other procedures, inspecting evidence of supply chain activities for clinical and commercial drug supplies. With the assistance of our indirect tax specialists, we also performed testing of management’s determination of transactions subject to indirect taxes and the indirect tax rates applied to those transactions. In addition, we performed testing of the mathematical accuracy of the underlying computation of accrued indirect tax liabilities. |
December 31, 2023 | December 31, 2022 | |||||||
(In thousands, except share and per share data) | (As Restated) | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 35,778 | $ | 32,731 | ||||
Accounts receivable | 14,075 | 5,718 | ||||||
Prepaid expenses and other current assets | 1,712 | 5,577 | ||||||
Current assets from discontinued operations | 9,290 | 1,068 | ||||||
Total current assets | 60,855 | 45,094 | ||||||
Property and equipment, net | 557 | 222 | ||||||
Finance lease right-of-use | 782 | — | ||||||
Operating lease right-of-use | 3,788 | 1,099 | ||||||
Other assets | 114 | 114 | ||||||
Noncurrent assets from discontinued operations | 934 | 958 | ||||||
Total assets | $ | 67,030 | $ | 47,487 | ||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,772 | $ | 1,447 | ||||
Accrued liabilities | 14,177 | 7,672 | ||||||
Accrued indirect tax liabilities | 18,040 | 11,534 | ||||||
Accrued compensation and benefits | 5,034 | 4,922 | ||||||
Current contract liabilities | 430 | 1,004 | ||||||
Current portion of finance lease liability | 218 | — | ||||||
Current portion of operating lease liability | 1,082 | 1,211 | ||||||
Current liabilities from discontinued operations | 24,665 | 13,610 | ||||||
Total current liabilities | 67,418 | 41,400 | ||||||
Long-term finance lease liability | 575 | — | ||||||
Long-term operating lease liability | 3,002 | — | ||||||
Noncurrent liabilities from discontinued operations | 4,245 | 20,525 | ||||||
Total liabilities | 75,240 | 61,925 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ deficit: | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at December 31, 2023 and December 31, 2022: | ||||||||
Series X Convertible Preferred stock, $0.0001 par value; 4,947,759 shares authorized at December 31, 2023 and 2022; 2,156,713 shares issued and 2,104,472 shares outstanding at December 31, 2023 and 1,870,713 shares issued and 1,818,472 shares outstanding at December 31, 2022 | — | — | ||||||
Common stock, $0.0001 par value; 20,000,000 shares authorized at December 31, 2023 and 2022; 4,530,113 shares issued and outstanding at December 31, 2023; 3,623,591 shares issued and outstanding at December 31, 2022 | 1 | 1 | ||||||
Additional paid-in capital | 433,220 | 404,061 | ||||||
Accumulated deficit | (441,431 | ) | (418,500 | ) | ||||
Total stockholders’ deficit | (8,210 | ) | (14,438 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 67,030 | $ | 47,487 | ||||
Years ended December 31, | ||||||||
(In thousands, except share and per share data) | 2023 | 2022 | ||||||
(As Restated) | ||||||||
Revenues: | ||||||||
Collaboration revenue | $ | 23,283 | $ | 23,496 | ||||
Total revenues | 23,283 | 23,496 | ||||||
Operating expenses: | ||||||||
Research and development | 36,763 | 30,168 | ||||||
Selling, general and administrative | 13,580 | 15,227 | ||||||
Total operating expenses | 50,343 | 45,395 | ||||||
Loss from operations | (27,060 | ) | (21,899 | ) | ||||
Other income, net: | ||||||||
Interest income, net | 1,995 | 191 | ||||||
Total other income, net | 1,995 | 191 | ||||||
Net loss from continuing operations before income tax expense | (25,065 | ) | (21,708 | ) | ||||
Income tax expense | (15 | ) | (14 | ) | ||||
Net loss from continuing operations | (25,080 | ) | (21,722 | ) | ||||
Income (loss) from discontinued operations, net of income taxes | 2,149 | (11,862 | ) | |||||
Net loss and comprehensive loss | $ | (22,931 | ) | $ | (33,584 | ) | ||
Basic and diluted net loss per common share from continuing operations | $ | (5.74 | ) | $ | (6.22 | ) | ||
Basic and diluted net earnings (loss) per common share from discontinued operations | 0.49 | (3.39 | ) | |||||
Basic and diluted net loss per common share | $ | (5.25 | ) | $ | (9.61 | ) | ||
Shares used to compute basic and diluted net earnings (loss) per common share | 4,371,375 | 3,492,925 | ||||||
Series X Convertible Preferred Stock | Common Stock | Additional Paid-In Capital (As Restated) | Accumulated Deficit (As Restated) | Total Stockholders’ Equity (Deficit) (As Restated) | ||||||||||||||||||||||||
(In thousands, except share data) | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||
Balance, December 31, 2021 (As Restated) | 1,818,472 | $ | — | 3,393,320 | $ | 1 | $ | 398,019 | $ | (384,916 | ) | $ | 13,104 | |||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 170,723 | — | 2,370 | — | 2,370 | |||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 41,380 | — | — | — | — | |||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | — | — | 18,168 | — | 140 | — | 140 | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 3,532 | — | 3,532 | |||||||||||||||||||||
Issuance costs for underwritten public offering (As Restated) | — | — | — | — | — | — | — | |||||||||||||||||||||
Net loss (As Restated) | — | — | — | — | — | (33,584 | ) | (33,584 | ) | |||||||||||||||||||
Balance, December 31, 2022 (As Restated) | 1,818,472 | — | 3,623,591 | 1 | 404,061 | (418,500 | ) | (14,438 | ) | |||||||||||||||||||
Underwritten public offering, net of issuance costs | 286,000 | — | 554,300 | — | 17,256 | — | 17,256 | |||||||||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 310,983 | — | 8,699 | — | 8,699 | |||||||||||||||||||||
Issuance of common stock for exercise of stock options | — | — | 1,287 | — | 21 | — | 21 | |||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 24,487 | — | — | — | — | |||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | — | — | 15,465 | — | 122 | — | 122 | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 3,061 | — | 3,061 | |||||||||||||||||||||
Net loss | — | — | — | — | — | (22,931 | ) | (22,931 | ) | |||||||||||||||||||
Balance, December 31, 2023 | 2,104,472 | $ | — | 4,530,113 | $ | 1 | $ | 433,220 | $ | (441,431 | ) | $ | (8,210 | ) | ||||||||||||||
Years ended December 31, | ||||||||
(In thousands) | 2023 | 2022 | ||||||
(As Restated) | ||||||||
Operating activities: | ||||||||
Net loss | $ | (22,931 | ) | $ | (33,584 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 3,061 | 3,532 | ||||||
Non-cash operating lease expense | 1,158 | 981 | ||||||
Depreciation and amortization | 112 | 143 | ||||||
Amortization of costs to obtain a contract with a customer | 77 | — | ||||||
Amortization of finance lease right-of-use | 6 | — | ||||||
Non-cash interest expense | 5 | 1 | ||||||
Changes in assets and liabilities: | ||||||||
Accounts receivable | (10,413 | ) | (477 | ) | ||||
Inventory | (6,097 | ) | — | |||||
Prepaid expenses, other current assets, and other assets | 3,735 | (2,440 | ) | |||||
Accounts payable and accrued liabilities | 8,886 | (2,371 | ) | |||||
Accrued indirect tax liabilities | 6,506 | 3,945 | ||||||
Accrued compensation and benefits | 235 | 203 | ||||||
Contract liabilities | (5,799 | ) | 2,646 | |||||
Operating lease liabilities | (973 | ) | (1,052 | ) | ||||
Net cash used in operating activities | (22,432 | ) | (28,473 | ) | ||||
Investing activities: | ||||||||
Purchases of property and equipment | (505 | ) | (118 | ) | ||||
Net cash used in investing activities | (505 | ) | (118 | ) | ||||
Financing activities: | ||||||||
Proceeds from underwritten public offering, net of issuance costs | 17,256 | — | ||||||
Proceeds from public offering of common stock, net of issuance costs | 8,707 | 2,362 | ||||||
Proceeds from exercise of stock options | 21 | — | ||||||
Issuance costs for underwritten public offering | — | (720 | ) | |||||
Principal repayments of Term Loan | — | (2,593 | ) | |||||
Net cash provided by (used in) financing activities | 25,984 | (951 | ) | |||||
Net increase (decrease) in cash and cash equivalents | 3,047 | (29,542 | ) | |||||
Cash and cash equivalents at beginning of year | 32,731 | 62,273 | ||||||
Cash and cash equivalents at end of year | $ | 35,778 | $ | 32,731 | ||||
Supplemental disclosure of cash flows: | ||||||||
Interest paid | $ | — | $ | 40 | ||||
Income taxes paid | $ | 797 | $ | — | ||||
Non-cash investing activity: | ||||||||
Purchases of property and equipment, included in accounts payable and accrued liabilities | $ | 11 | $ | 69 | ||||
Finance lease right-of-use | $ | 788 | $ | — | ||||
Operating lease right-of-use | $ | 3,847 | $ | — | ||||
Non-cash financing activities: | ||||||||
Purchase of shares pursuant to Employee Stock Purchase Plan | $ | 122 | $ | 140 | ||||
Proceeds from public offering of common stock, net of issuance costs, included in prepaid expenses, other current assets, and other assets | $ | — | $ | 8 |
Year Ended December 31, 2022 | ||||||||||||
Corrected Consolidated Balance Sheet | As Previously Reported | Restatement Adjustment | As Restated | |||||||||
Operating lease right-of-use | $ | 1,205 | $ | (106 | ) | $ | 1,099 | |||||
Total assets | 47,593 | (106 | ) | 47,487 | ||||||||
Accrued indirect tax liabilities | — | 11,534 | 11,534 | |||||||||
Current portion of operating lease liability | 1,317 | (106 | ) | 1,211 | ||||||||
Total current liabilities | 29,972 | 11,428 | 41,400 | |||||||||
Total liabilities | 50,497 | 11,428 | 61,925 | |||||||||
Accumulated deficit | (406,966 | ) | (11,534 | ) | (418,500 | ) | ||||||
Total stockholders’ deficit | (2,904 | ) | (11,534 | ) | (14,438 | ) | ||||||
Total liabilities and stockholders’ deficit | 47,593 | (106 | ) | 47,487 |
Year Ended December 31, 2022 | ||||||||||||
Corrected Consolidated Statement of Operations and Comprehensive Loss | As Previously Reported | Restatement Adjustment | As Restated | |||||||||
Revenues: | ||||||||||||
Collaboration revenue | $ | 23,336 | $ | 160 | $ | 23,496 | ||||||
Total revenues | 23,336 | 160 | 23,496 | |||||||||
Loss from operations | (22,059 | ) | 160 | (21,899 | ) | |||||||
Net loss from continuing operations before income tax expense | (21,868 | ) | 160 | (21,708 | ) | |||||||
Net loss from continuing operations | (21,882 | ) | 160 | (21,722 | ) | |||||||
Loss from discontinued operations | (7,917 | ) | (3,945 | ) | (11,862 | ) | ||||||
Net loss and comprehensive loss | (29,799 | ) | (3,785 | ) | (33,584 | ) | ||||||
Basic and diluted net loss per common share from continuing operations | (6.26 | ) | (6.22 | ) | ||||||||
Basic and diluted net loss per common share from discontinued operations | (2.27 | ) | (3.39 | ) | ||||||||
Basic and diluted net loss per common share | (8.53 | ) | (9.61 | ) | ||||||||
Shares used to compute basic and diluted net loss per common share | 3,492,925 | 3,492,925 |
Additional Paid-In Capital | ||||||||||||
Corrected Consolidated Statement of Convertible Preferred Stock and Stockholders’ Equity (Deficit) | As Previously Reported | Restatement Adjustment | As Restated | |||||||||
Balance, December 31, 2021 | $ | 398,739 | $ | (720 | ) | $ | 398,019 | |||||
Issuance costs for underwritten public offering | (720 | ) | 720 | — | ||||||||
Balance, December 31, 2022 | 404,061 | — | 404,061 | |||||||||
Accumulated Deficit | ||||||||||||
As Previously Reported | Restatement Adjustment | As Restated | ||||||||||
Balance, December 31, 2021 | $ | (377,167 | ) | $ | (7,749 | ) | $ | (384,916 | ) | |||
Net loss | (29,799 | ) | (3,785 | ) | (33,584 | ) | ||||||
Balance, December 31, 2022 | (406,966 | ) | (11,534 | ) | (418,500 | ) | ||||||
Total Stockholders’ Equity (Deficit) | ||||||||||||
As Previously Reported | Restatement Adjustment | As Restated | ||||||||||
Balance, December 31, 2021 | $ | 21,573 | $ | (8,469 | ) | $ | 13,104 | |||||
Issuance costs for underwritten public offering | (720 | ) | 720 | — | ||||||||
Net loss | (29,799 | ) | (3,785 | ) | (33,584 | ) | ||||||
Balance, December 31, 2022 | (2,904 | ) | (11,534 | ) | (14,438 | ) |
Year Ended December 31, 2022 | ||||||||||||
Corrected Consolidated Statement of Cash Flows | As Previously Reported | Restatement Adjustment | As Restated | |||||||||
Operating activities: | ||||||||||||
Net loss | $ | (29,799 | ) | $ | (3,785 | ) | $ | (33,584 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Non-cash operating lease expense | 1,082 | (101 | ) | 981 | ||||||||
Changes in assets and liabilities: | ||||||||||||
Accrued indirect tax liabilities | — | 3,945 | 3,945 | |||||||||
Contract liabilities | 2,806 | (160 | ) | 2,646 | ||||||||
Operating lease liabilities | (1,153 | ) | 101 | (1,052 | ) |
December 31, | ||||||||
2023 | 2022 | |||||||
Common stock warrants | 866 | 625,859 | ||||||
Series X Convertible Preferred Stock | 1,052,236 | 909,236 | ||||||
Common stock options, RSUs and PRSUs issued and outstanding | 638,037 | 465,965 | ||||||
Total | 1,691,139 | 2,001,060 | ||||||
TOTAL | LEVEL 1 | LEVEL 2 | LEVEL 3 | |||||||||||||
December 31, 2023 | ||||||||||||||||
Assets: | ||||||||||||||||
Cash and money market accounts | $ | 35,778 | $ | 35,778 | $ | — | $ | — | ||||||||
Total assets at fair value | $ | 35,778 | $ | 35,778 | $ | — | $ | — | ||||||||
December 31, 2022 | ||||||||||||||||
Assets: | ||||||||||||||||
Cash and money market accounts | $ | 32,731 | $ | 32,731 | $ | — | $ | — | ||||||||
Total assets at fair value | $ | 32,731 | $ | 32,731 | $ | — | $ | — |
December 31, | ||||||||
2023 | 2022 | |||||||
Laboratory equipment | $ | 2,817 | $ | 2,415 | ||||
Leasehold improvements | 425 | 425 | ||||||
Computer hardware and software | 327 | 305 | ||||||
Office equipment | 36 | 93 | ||||||
Furniture and fixtures | 142 | 142 | ||||||
3,747 | 3,380 | |||||||
Less accumulated depreciation and amortization | (3,190 | ) | (3,158 | ) | ||||
Total | $ | 557 | $ | 222 | ||||
December 31, | ||||||||
2023 | 2022 | |||||||
Common stock warrants | 866 | 625,859 | ||||||
Series X Convertible Preferred Stock | 1,052,236 | 909,236 | ||||||
Common stock options, RSUs and PRSUs issued and outstanding | 638,037 | 465,965 | ||||||
Authorized for future stock awards | 170,783 | 223,713 | ||||||
Awards available under the ESPP | 49,623 | 40,572 | ||||||
Total | 1,911,545 | 2,265,345 | ||||||
Number of RSUs and PRSUs | Weighted Average Grant Date Fair Value | |||||||
Outstanding at December 31, 2022 | 61,149 | $ | 29.36 | |||||
RSUs and PRSUs granted | 75,778 | 20.04 | ||||||
RSUs and PRSUs vested | (24,487 | ) | 29.64 | |||||
RSUs and PRSUs canceled | (7,554 | ) | 25.76 | |||||
Outstanding at December 31, 2023 | 104,886 | $ | 22.83 | |||||
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Total Aggregate Intrinsic Value (in thousands) | |||||||||||||
Outstanding at December 31, 2022 | 404,816 | $ | 55.60 | 6.65 | $ | 48 | ||||||||||
Options granted | 161,666 | 20.40 | ||||||||||||||
Options exercised | (1,287 | ) | 16.65 | |||||||||||||
Options canceled | (32,044 | ) | 62.40 | |||||||||||||
Outstanding at December 31, 2023 | 533,151 | $ | 44.61 | 6.72 | $ | 57 | ||||||||||
Vested and expected to vest at December 31, 2023 | 533,151 | $ | 44.61 | 6.72 | $ | 57 | ||||||||||
Exercisable at December 31, 2023 | 361,644 | $ | 55.04 | 5.71 | $ | 54 | ||||||||||
For the years ended December 31, | ||||||||
2023 | 2022 | |||||||
2015 EIP and 2020 IIP | ||||||||
Risk-free interest rate | 3.58% - 4.61% | 1.39% - 4.02% | ||||||
Expected dividend yield | 0% | 0% | ||||||
Expected volatility | 82% - 83% | 70% - 75% | ||||||
Expected term (years) | 5.50 - 6.08 | 5.50 - 6.08 | ||||||
2015 ESPP | ||||||||
Risk-free interest rate | 4.29% - 5.43% | 1.57% - 2.65% | ||||||
Expected dividend yield | 0% | 0% | ||||||
Expected volatility | 64% - 147% | 75% - 98% | ||||||
Expected term (years) | 0.50 - 2.00 | 0.50 - 2.00 |
Years ended December 31, | ||||||||
2023 | 2022 | |||||||
Stock compensation expense: | ||||||||
Research and development | $ | 839 | $ | 809 | ||||
Selling, general and administrative | 1,469 | 1,945 | ||||||
Stock compensation expense recorded in continuing operations | 2,308 | 2,754 | ||||||
Stock compensation expense recorded in discontinued operations | 753 | 951 | ||||||
Total stock compensation expense | $ | 3,061 | $ | 3,705 | ||||
Opening balance, December 31, 2022 | $ | 1,004 | ||
Payments received in advance | 292 | |||
Revenue from performance obligations satisfied during reporting period | (866 | ) | ||
Closing balance, December 31, 2023 | $ | 430 | ||
Current portion of contract liabilities | $ | 430 | ||
Long-term portion of contract liabilities | — | |||
Total contract liabilities, December 31, 2023 | $ | 430 |
Year Ended December 31, 2023 | Year Ended December 31, 2022 | |||||||
(As Restated) | ||||||||
Revenue from Janssen Collaboration Agreement: | ||||||||
Point in Time: | ||||||||
License of Intellectual Property - upon milestones achieved | $ | 2,347 | $ | 976 | ||||
Over Time: | ||||||||
Research and Development Services | 19,011 | 18,814 | ||||||
Clinical Supply Services | 1,925 | 3,706 | ||||||
Total Revenue from Janssen Collaboration Agreement | $ | 23,283 | $ | 23,496 | ||||
December 31, | ||||||||
2023 | 2022 | |||||||
Current tax (benefit) provision: | ||||||||
Federal | $ | (1 | ) | $ | — | |||
State | 16 | 14 | ||||||
Total current tax provision | 15 | 14 | ||||||
Deferred tax provision: | ||||||||
Federal | — | — | ||||||
State | — | — | ||||||
Total deferred tax provision | — | — | ||||||
Total tax provision | $ | 15 | $ | 14 | ||||
Years Ended December 31, | ||||||||
2023 | 2022 | |||||||
(As Restated) | ||||||||
Federal income taxes at 21% for 2023 and 2022 | $ | (5,264 | ) | $ | (4,559 | ) | ||
State income tax, net of federal benefit | (241 | ) | (158 | ) | ||||
Nondeductible expenses | 234 | 365 | ||||||
Tax credits | (1,096 | ) | (1,092 | ) | ||||
Rate change | (54 | ) | 491 | |||||
Change in valuation allowance | 5,861 | (22,218 | ) | |||||
Reserve for uncertain tax positions | 273 | (10,346 | ) | |||||
162m deferred tax asset limitation | 128 | 82 | ||||||
382 NOL and tax credit limitation | — | 37,513 | ||||||
Expired stock awards | 174 | 1,052 | ||||||
Other | — | (1,116 | ) | |||||
Income tax expense | $ | 15 | $ | 14 | ||||
December 31, | ||||||||
2023 | 2022 | |||||||
(As Restated) | ||||||||
Deferred tax assets: | ||||||||
Net operating losses | $ | 35,506 | $ | 42,043 | ||||
Tax credits | 9,747 | 9,327 | ||||||
Intangibles | 136 | 160 | ||||||
Capitalized R&D | 25,871 | 14,706 | ||||||
Stock compensation | 1,424 | 1,385 | ||||||
Lease liabilities | 1,112 | 275 | ||||||
Deferred revenue | 5,951 | 5,620 | ||||||
Accrued indirect tax liabilities | 4,114 | 2,617 | ||||||
Other | 725 | 1,018 | ||||||
Total deferred tax assets | 84,586 | 77,151 | ||||||
Less valuation allowance | (83,086 | ) | (76,713 | ) | ||||
Deferred tax assets, net of valuation allowance | 1,500 | 438 | ||||||
Deferred tax liabilities: | ||||||||
Prepaid expenses | (214 | ) | (189 | ) | ||||
Capitalized inventory costs | (244 | ) | — | |||||
Right-of-use | (1,042 | ) | (249 | ) | ||||
Total deferred tax liabilities | (1,500 | ) | (438 | ) | ||||
Net deferred tax assets | $ | — | $ | — | ||||
Years Ended December 31, | ||||||||
2023 | 2022 | |||||||
(As Restated) | ||||||||
Balance as of the beginning of the year | $ | 11,015 | $ | 23,990 | ||||
Increases related to current year tax positions | 552 | 497 | ||||||
Decreases related to prior year tax positions | (47 | ) | (13,472 | ) | ||||
Balance as of the end of the year | $ | 11,520 | $ | 11,015 | ||||
2024 | $ | 275 | ||
2025 | 300 | |||
2026 | 300 | |||
2027 | 25 | |||
Total undiscounted finance lease payments | 900 | |||
Less: Imputed interest | (107 | ) | ||
Present value of finance lease payments | $ | 793 | ||
Balance Sheet Classification: | ||||
Finance lease right-of-use | $ | 788 | ||
Accumulated amortization | (6 | ) | ||
Net finance lease right-of-use | $ | 782 | ||
Current portion of finance lease liability | $ | 218 | ||
Long-term finance lease liability | 575 | |||
Total finance lease liabilities | $ | 793 | ||
2024 | $ | 1,600 | ||
2025 | 1,665 | |||
2026 | 1,731 | |||
Total undiscounted operating lease payments | 4,996 | |||
Less: Imputed interest | (912 | ) | ||
Present value of operating lease payments | $ | 4,084 | ||
Balance Sheet Classification: | ||||
Operating lease right-of-use | $ | 3,788 | ||
Current portion of operating lease liability | $ | 1,082 | ||
Long-term operating lease liability | 3,002 | |||
Total operating lease liabilities | $ | 4,084 | ||
• | all of the Company’s rezafungin assets, including all of the Company’s right to receive future milestones and royalties under the Melinta License Agreement and the Mundipharma Collaboration Agreement, |
• | all rezafungin intellectual property rights, including patents and know-how, all product data, regulatory approvals and documentation, |
• | rezafungin and comparator inventory, |
• | specified prepaid assets and specified contracts, in exchange for Napp’s assumption of certain liabilities of the rezafungin business, including the ongoing costs of the ReSPECT Phase 3 clinical trial and the ReSTORE Phase 3 clinical trial in China and the Company’s obligations from and after closing under the Melinta License Agreement, |
• | the Commercial Supply Agreement dated January 23, 2023 between the Company and Melinta, and |
• | the Commercial Supply Agreement, dated December 12, 2022 between the Company and Mundipharma, or the Mundipharma Commercial Supply Agreement. |
December 31, 2023 | December 31, 2022 | |||||||
(In thousands) | (As Restated) | |||||||
Carrying amount of major assets included as part of discontinued operations: | ||||||||
Current assets: | ||||||||
Accounts receivable | $ | 2,171 | $ | 116 | ||||
Inventory | 6,097 | — | ||||||
Prepaid expenses and other current assets | 1,022 | 952 | ||||||
Current assets from discontinued operations | 9,290 | 1,068 | ||||||
Noncurrent assets: | ||||||||
Other assets | 934 | 958 | ||||||
Noncurrent assets from discontinued operations | 934 | 958 | ||||||
Total assets from discontinued operations | $ | 10,224 | $ | 2,026 | ||||
Carrying amount of major liabilities included as part of discontinued operations: | ||||||||
Current liabilities: | ||||||||
Current contract liabilities | $ | 24,665 | $ | 13,610 | ||||
Current liabilities from discontinued operations | 24,665 | 13,610 | ||||||
Noncurrent liabilities: | — | |||||||
Long-term contract liabilities | 4,245 | 20,525 | ||||||
Noncurrent liabilities from discontinued operations | 4,245 | 20,525 | ||||||
Total liabilities from discontinued operations | $ | 28,910 | $ | 34,135 | ||||
December 31, | ||||||||
2023 | 2022 | |||||||
Raw materials | $ | 2,691 | $ | — | ||||
Work-in-process | 3,406 | — | ||||||
Total inventory | $ | 6,097 | $ | — | ||||
Years ended December 31, | ||||||||
(In thousands) | 2023 | 2022 | ||||||
(As Restated) | ||||||||
Major line items constituting pretax income (loss) of discontinued operations | ||||||||
Revenues: | ||||||||
Total revenues | $ | 40,622 | $ | 40,952 | ||||
Operating expenses: | ||||||||
Cost of product revenue | 1,523 | — | ||||||
Research and development | 31,769 | 47,237 | ||||||
Selling, general and administrative | 4,753 | 5,319 | ||||||
Total operating expenses | 38,045 | 52,556 | ||||||
Income (loss) from discontinued operations before income tax expense | 2,577 | (11,604 | ) | |||||
Income tax expense | (428 | ) | (258 | ) | ||||
Income (loss) from discontinued operations, net of income taxes | $ | 2,149 | $ | (11,862 | ) | |||
Opening balance, December 31, 2022 | $ | 34,135 | ||
Payments received in advance | 1,463 | |||
Payments receivable | 1,488 | |||
Revenue from performance obligations satisfied during reporting period | (8,176 | ) | ||
Closing balance, December 31, 2023 | $ | 28,910 | ||
Current portion of contract liabilities | $ | 24,665 | ||
Long-term portion of contract liabilities | 4,245 | |||
Total contract liabilities, December 31, 2023 | $ | 28,910 | ||
Year Ended December 31, 2023 | ||||||||
Mundipharma | Melinta | |||||||
Revenue from Collaboration, License and Purchase Agreements: | ||||||||
Point in Time: | ||||||||
License of Intellectual Property - upon milestones achieved | $ | 3,252 | $ | 17,257 | ||||
Clinical Drug Supply | 26 | — | ||||||
Product Revenue | 2,867 | 1,468 | ||||||
Royalty Revenue | — | 168 | ||||||
Over Time: | ||||||||
Research and Development Services | 12,303 | 2,441 | ||||||
Clinical Supply Services | 840 | — | ||||||
Total Revenue from Collaboration, License and Purchase Agreements | $ | 19,288 | $ | 21,334 | ||||
Year Ended December 31, 2022 | ||||||||
Mundipharma | Melinta | |||||||
Revenue from Collaboration and License Agreements: | ||||||||
Point in Time: | ||||||||
License of Intellectual Property - upon transfer of license | $ | — | $ | 25,885 | ||||
License of Intellectual Property - upon milestones achieved | 3,252 | — | ||||||
Clinical Drug Supply | 484 | — | ||||||
Over Time: | ||||||||
Research and Development Services | 9,595 | 811 | ||||||
Clinical Supply Services | 925 | — | ||||||
Total Revenue from Collaboration and License Agreements | $ | 14,256 | $ | 26,696 | ||||
March 31, 2023 | March 31, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Balance Sheets (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
ASSETS | ||||||||||||||||||||||||
Current assets: | ||||||||||||||||||||||||
Cash and cash equivalents | $ | 47,976 | $ | — | $ | 47,976 | $ | 36,488 | $ | — | $ | 36,488 | ||||||||||||
Restricted Cash | — | — | — | 1,482 | — | 1,482 | ||||||||||||||||||
Accounts receivable | 25,703 | 295 | 25,998 | 8,649 | — | 8,649 | ||||||||||||||||||
Prepaid expenses and other current assets | 5,245 | (143 | ) | 5,102 | 4,038 | — | 4,038 | |||||||||||||||||
Current assets from discontinued operations | 564 | 168 | 732 | 1,350 | — | 1,350 | ||||||||||||||||||
Total current assets | 79,488 | 320 | 79,808 | 52,007 | — | 52,007 | ||||||||||||||||||
Property and equipment, net | 270 | — | 270 | 239 | — | 239 | ||||||||||||||||||
Operating lease right-of-use | 917 | (81 | ) | 836 | 2,030 | (184 | ) | 1,846 | ||||||||||||||||
Other assets | 102 | — | 102 | 155 | — | 155 | ||||||||||||||||||
Noncurrent assets from discontinued operations | 959 | — | 959 | 864 | — | 864 | ||||||||||||||||||
Total assets | $ | 81,736 | $ | 239 | $ | 81,975 | $ | 55,295 | $ | (184 | ) | $ | 55,111 | |||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||||||
Accounts payable | 3,980 | 46 | 4,026 | 2,861 | — | 2,861 | ||||||||||||||||||
Accrued liabilities | 9,078 | 30 | 9,108 | 9,234 | 720 | 9,954 | ||||||||||||||||||
Accrued indirect tax liabilities | — | 11,795 | 11,795 | — | 7,942 | 7,942 | ||||||||||||||||||
Accrued compensation and benefits | 5,843 | — | 5,843 | 3,079 | — | 3,079 | ||||||||||||||||||
Current contract liabilities | 699 | — | 699 | 4,514 | — | 4,514 | ||||||||||||||||||
Current portion of operating lease liability | 1,001 | (81 | ) | 920 | 1,190 | (100 | ) | 1,090 | ||||||||||||||||
Current portion of term loan | — | — | — | 1,481 | — | 1,481 | ||||||||||||||||||
Current liabilities from discontinued operations | 15,062 | 29 | 15,091 | 9,746 | — | 9,746 | ||||||||||||||||||
Total current liabilities | 35,663 | 11,819 | 47,482 | 32,105 | 8,562 | 40,667 | ||||||||||||||||||
Long-term contract liabilities | 92 | (9 | ) | 83 | 337 | — | 337 | |||||||||||||||||
Long-term operating lease liability | — | — | — | 1,004 | (84 | ) | 920 | |||||||||||||||||
Noncurrent liabilities from discontinued operations | 19,144 | 159 | 19,303 | 16,892 | — | 16,892 | ||||||||||||||||||
Total liabilities | 54,899 | 11,969 | 66,868 | 50,338 | 8,478 | 58,816 |
March 31, 2023 | March 31, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Balance Sheets (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||||||||
Stockholders’ equity (deficit): | ||||||||||||||||||||||||
Preferred stock (1) | ||||||||||||||||||||||||
Series X Convertible Preferred stock (2) | — | — | — | — | — | — | ||||||||||||||||||
Common stock (3) | 1 | — | 1 | 1 | — | 1 | ||||||||||||||||||
Additional paid-in capital | 430,593 | — | 430,593 | 400,404 | (720 | ) | 399,684 | |||||||||||||||||
Accumulated deficit | (403,757 | ) | (11,730 | ) | (415,487 | ) | (395,448 | ) | (7,942 | ) | (403,390 | ) | ||||||||||||
Total stockholders’ equity (deficit) | 26,837 | (11,730 | ) | 15,107 | 4,957 | (8,662 | ) | (3,705 | ) | |||||||||||||||
Total liabilities and stockholders’ equity (deficit) | $ | 81,736 | $ | 239 | $ | 81,975 | $ | 55,295 | $ | (184 | ) | $ | 55,111 | |||||||||||
(1) | Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2023 and March 31, 2022 |
(2) | Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at March 31, 2023 and March 31, 2022; 2,156,713 shares issued and 2,104,472 shares outstanding at March 31, 2023; 1,870,713 shares issued and 1,818,472 shares outstanding at March 31, 2022 |
(3) | Common stock, $0.0001 par value; 20,000,000 shares authorized at March 31, 2023 and March 31, 2022; 4,501,256 shares issued and outstanding at March 31, 2023 and 3,452,567 shares issued and outstanding at March 31, 2022 |
June 30, 2023 | June 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Balance Sheets (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
ASSETS | ||||||||||||||||||||||||
Current assets: | ||||||||||||||||||||||||
Cash and cash equivalents | $ | 50,430 | $ | — | $ | 50,430 | $ | 24,637 | $ | — | $ | 24,637 | ||||||||||||
Restricted cash | — | — | — | 370 | — | 370 | ||||||||||||||||||
Accounts receivable | 5,310 | — | 5,310 | 4,113 | — | 4,113 | ||||||||||||||||||
Prepaid expenses and other current assets | 3,230 | — | 3,230 | 5,909 | — | 5,909 | ||||||||||||||||||
Current assets from discontinued operations | 3,270 | 434 | 3,704 | 1,517 | — | 1,517 | ||||||||||||||||||
Total current assets | 62,240 | 434 | 62,674 | 36,546 | — | 36,546 | ||||||||||||||||||
Property and equipment, net | 297 | — | 297 | 201 | — | 201 | ||||||||||||||||||
Operating lease right-of-use | 4,388 | (81 | ) | 4,307 | 1,765 | (162 | ) | 1,603 | ||||||||||||||||
Other assets | 101 | — | 101 | 150 | — | 150 | ||||||||||||||||||
Noncurrent assets from discontinued operations | 960 | — | 960 | 862 | — | 862 | ||||||||||||||||||
Total assets | $ | 67,986 | $ | 353 | $ | 68,339 | $ | 39,524 | $ | (162 | ) | $ | 39,362 | |||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||||||
Accounts payable | 1,899 | — | 1,899 | 3,091 | — | 3,091 | ||||||||||||||||||
Accrued liabilities | 10,022 | — | 10,022 | 8,567 | — | 8,567 | ||||||||||||||||||
Accrued indirect tax liabilities | — | 13,431 | 13,431 | — | 10,582 | 10,582 | ||||||||||||||||||
Accrued compensation and benefits | 3,582 | — | 3,582 | 3,464 | — | 3,464 | ||||||||||||||||||
Current contract liabilities | 369 | — | 369 | 4,444 | — | 4,444 | ||||||||||||||||||
Current portion of operating lease liability | 942 | (81 | ) | 861 | 1,233 | (104 | ) | 1,129 | ||||||||||||||||
Current portion of term loan | — | — | — | 370 | — | 370 | ||||||||||||||||||
Current liabilities from discontinued operations | 14,606 | — | 14,606 | 10,286 | — | 10,286 | ||||||||||||||||||
Total current liabilities | 31,420 | 13,350 | 44,770 | 31,455 | 10,478 | 41,933 | ||||||||||||||||||
Long-term contract liabilities | — | — | — | 195 | — | 195 | ||||||||||||||||||
Long-term operating lease liability | 3,601 | — | 3,601 | 679 | (58 | ) | 621 | |||||||||||||||||
Noncurrent liabilities from discontinued operations | 17,551 | — | 17,551 | 15,156 | — | 15,156 | ||||||||||||||||||
Total liabilities | 52,572 | 13,350 | 65,922 | 47,485 | 10,420 | 57,905 |
June 30, 2023 | June 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Balance Sheets (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||||||||
Stockholders’ equity (deficit): | ||||||||||||||||||||||||
Preferred stock (4) | ||||||||||||||||||||||||
Series X Convertible Preferred stock (5) | — | — | — | — | — | — | ||||||||||||||||||
Common stock (6) | 1 | — | 1 | 1 | — | 1 | ||||||||||||||||||
Additional paid-in capital | 431,527 | — | 431,527 | 400,605 | — | 400,605 | ||||||||||||||||||
Accumulated deficit | (416,114 | ) | (12,997 | ) | (429,111 | ) | (408,567 | ) | (10,582 | ) | (419,149 | ) | ||||||||||||
Total stockholders’ equity (deficit) | 15,414 | (12,997 | ) | 2,417 | (7,961 | ) | (10,582 | ) | (18,543 | ) | ||||||||||||||
Total liabilities and stockholders’ equity (deficit) | $ | 67,986 | $ | 353 | $ | 68,339 | $ | 39,524 | $ | (162 | ) | $ | 39,362 | |||||||||||
(4) | Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2023 and June 30, 2022 |
(5) | Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at June 30, 2023 and June 30, 2022; 2,156,713 shares issued and 2,104,472 shares outstanding at June 30, 2023; 1,870,713 shares issued and 1,818,472 shares outstanding at June 30, 2022 |
(6) | Common stock, $0.0001 par value; 20,000,000 shares authorized at June 30, 2023 and June 30, 2022; 4,512,595 shares issued and outstanding at June 30, 2023 and 3,462,024 shares issued and outstanding at June 30, 2022 |
September 30, 2023 | September 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Balance Sheets (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
ASSETS | ||||||||||||||||||||||||
Current assets: | ||||||||||||||||||||||||
Cash and cash equivalents | $ | 48,670 | $ | — | $ | 48,670 | $ | 53,078 | $ | — | $ | 53,078 | ||||||||||||
Accounts receivable | 2,670 | — | 2,670 | 4,917 | — | 4,917 | ||||||||||||||||||
Prepaid expenses and other current assets | 2,794 | — | 2,794 | 3,932 | — | 3,932 | ||||||||||||||||||
Current assets from discontinued operations | 3,570 | 757 | 4,327 | 1,972 | — | 1,972 | ||||||||||||||||||
Total current assets | 57,704 | 757 | 58,461 | 63,899 | — | 63,899 | ||||||||||||||||||
Property and equipment, net | 580 | — | 580 | 173 | — | 173 | ||||||||||||||||||
Operating lease right-of-use | 4,131 | (81 | ) | 4,050 | 1,491 | (137 | ) | 1,354 | ||||||||||||||||
Other assets | 103 | — | 103 | 132 | — | 132 | ||||||||||||||||||
Noncurrent assets from discontinued operations | 950 | — | 950 | 1,163 | — | 1,163 | ||||||||||||||||||
Total assets | $ | 63,468 | $ | 676 | $ | 64,144 | $ | 66,858 | $ | (137 | ) | $ | 66,721 | |||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||||||
Accounts payable | 3,661 | — | 3,661 | 4,244 | — | 4,244 | ||||||||||||||||||
Accrued liabilities | 11,772 | — | 11,772 | 8,162 | — | 8,162 | ||||||||||||||||||
Accrued indirect tax liabilities | — | 14,689 | 14,689 | — | 11,314 | 11,314 | ||||||||||||||||||
Accrued compensation and benefits | 4,457 | — | 4,457 | 4,117 | — | 4,117 | ||||||||||||||||||
Current contract liabilities | 750 | — | 750 | 3,254 | — | 3,254 | ||||||||||||||||||
Current portion of operating lease liability | 1,051 | (81 | ) | 970 | 1,277 | (108 | ) | 1,169 | ||||||||||||||||
Current liabilities from discontinued operations | 13,929 | — | 13,929 | 11,995 | — | 11,995 | ||||||||||||||||||
Total current liabilities | 35,620 | 14,608 | 50,228 | 33,049 | 11,206 | 44,255 | ||||||||||||||||||
Long-term contract liabilities | — | — | — | 98 | — | 98 | ||||||||||||||||||
Long-term operating lease liability | 3,306 | — | 3,306 | 344 | (29 | ) | 315 | |||||||||||||||||
Noncurrent liabilities from discontinued operations | 16,504 | — | 16,504 | 24,300 | — | 24,300 | ||||||||||||||||||
Total liabilities | 55,430 | 14,608 | 70,038 | 57,791 | 11,177 | 68,968 |
September 30, 2023 | September 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Balance Sheets (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||||||||
Stockholders’ equity (deficit): | ||||||||||||||||||||||||
Preferred stock (7) | ||||||||||||||||||||||||
Series X Convertible Preferred stock (8) | — | — | — | — | — | — | ||||||||||||||||||
Common stock (9) | 1 | — | 1 | 1 | — | 1 | ||||||||||||||||||
Additional paid-in capital | 432,323 | — | 432,323 | 402,655 | — | 402,655 | ||||||||||||||||||
Accumulated deficit | (424,286 | ) | (13,932 | ) | (438,218 | ) | (393,589 | ) | (11,314 | ) | (404,903 | ) | ||||||||||||
Total stockholders’ equity (deficit) | 8,038 | (13,932 | ) | (5,894 | ) | 9,067 | (11,314 | ) | (2,247 | ) | ||||||||||||||
Total liabilities and stockholders’ equity (deficit) | $ | 63,468 | $ | 676 | $ | 64,144 | $ | 66,858 | $ | (137 | ) | $ | 66,721 | |||||||||||
(7) | Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2023 and September 30, 2022 |
(8) | Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at September 30, 2023 and September 30, 2022; 2,156,713 shares issued and 2,104,472 shares outstanding at September 30, 2023; 1,870,713 shares issued and 1,818,472 shares outstanding at September 30, 2022 |
(9) | Common stock, $0.0001 par value; 20,000,000 shares authorized at September 30, 2023 and September 30, 2022; 4,520,814 shares issued and outstanding at September 30, 2023 and 3,559,141 shares issued and outstanding at September 30, 2022 |
Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Revenues: | ||||||||||||||||||||||||
Collaboration revenue | $ | 5,915 | $ | 305 | $ | 6,220 | $ | 4,583 | $ | 160 | $ | 4,743 | ||||||||||||
Total revenues | 5,915 | 305 | 6,220 | 4,583 | 160 | 4,743 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | 9,415 | 295 | 9,710 | 5,545 | — | 5,545 | ||||||||||||||||||
General and administrative | 3,653 | — | 3,653 | 4,675 | — | 4,675 | ||||||||||||||||||
Total operating expenses | 13,068 | 295 | 13,363 | 10,220 | — | 10,220 | ||||||||||||||||||
Income (loss) from operations | (7,153 | ) | 10 | (7,143 | ) | (5,637 | ) | 160 | (5,477 | ) | ||||||||||||||
Other income (expense), net: | ||||||||||||||||||||||||
Interest income (expense), net | 232 | — | 232 | (20 | ) | — | (20 | ) | ||||||||||||||||
Total other income (expense), net | 232 | — | 232 | (20 | ) | — | (20 | ) | ||||||||||||||||
Net income (loss) from continuing operations | (6,921 | ) | 10 | (6,911 | ) | (5,657 | ) | 160 | (5,497 | ) | ||||||||||||||
Income (loss) from discontinued operations | 10,130 | (206 | ) | 9,924 | (12,624 | ) | (353 | ) | (12,977 | ) | ||||||||||||||
Net income (loss) and comprehensive income (loss) | 3,209 | (196 | ) | 3,013 | (18,281 | ) | (193 | ) | (18,474 | ) | ||||||||||||||
Allocation of earnings to participating securities | (677 | ) | 41 | (636 | ) | — | — | — | ||||||||||||||||
Net income (loss) attributable to common stockholders | $ | 2,532 | $ | (155 | ) | $ | 2,377 | $ | (18,281 | ) | $ | (193 | ) | $ | (18,474 | ) | ||||||||
Basic and diluted net earnings (loss) per common share from continuing operations (10) | $ | (1.39 | ) | $ | (1.39 | ) | $ | (1.66 | ) | $ | (1.61 | ) | ||||||||||||
Basic and diluted net earnings (loss) per common share from discontinued operations (10) | $ | 2.03 | $ | 1.99 | $ | (3.71 | ) | $ | (3.81 | ) | ||||||||||||||
Basic and diluted net earnings (loss) per common share (10) | $ | 0.64 | $ | 0.60 | $ | (5.37 | ) | $ | (5.42 | ) | ||||||||||||||
Shares used to compute basic and diluted net earnings (loss) per common share | 3,932,050 | 3,932,050 | 3,406,994 | 3,406,994 | ||||||||||||||||||||
(10) | As the Company had a discontinued operation, the company used income (loss) from continuing operations as its control number to determine whether potential common shares are dilutive or anti-dilutive for purposes of reporting basic and diluted net earnings (loss) per common share from discontinued operations. Because there is a loss from continuing operations, the potentially dilutive shares are antidilutive and diluted net earnings (loss) per share is the same as basic net earnings (loss) per share. |
Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Operations and Comprehensive Loss (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Revenues: | ||||||||||||||||||||||||
Collaboration revenue | $ | 5,395 | $ | (305 | ) | $ | 5,090 | $ | 4,293 | $ | — | $ | 4,293 | |||||||||||
Total revenues | 5,395 | (305 | ) | 5,090 | 4,293 | — | 4,293 | |||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | 8,952 | (295 | ) | 8,657 | 6,276 | — | 6,276 | |||||||||||||||||
General and administrative | 3,181 | — | 3,181 | 3,645 | — | 3,645 | ||||||||||||||||||
Total operating expenses | 12,133 | (295 | ) | 11,838 | 9,921 | — | 9,921 | |||||||||||||||||
Loss from operations | (6,738 | ) | (10 | ) | (6,748 | ) | (5,628 | ) | — | (5,628 | ) | |||||||||||||
Other income (expense), net: | ||||||||||||||||||||||||
Interest income (expense), net | 623 | — | 623 | (6 | ) | — | (6 | ) | ||||||||||||||||
Total other income (expense), net | 623 | — | 623 | (6 | ) | — | (6 | ) | ||||||||||||||||
Net loss before income tax expense | (6,115 | ) | (10 | ) | (6,125 | ) | (5,634 | ) | — | (5,634 | ) | |||||||||||||
Income tax expense | (40 | ) | — | (40 | ) | — | — | — | ||||||||||||||||
Net income (loss) from continuing operations | (6,155 | ) | (10 | ) | (6,165 | ) | (5,634 | ) | — | (5,634 | ) | |||||||||||||
Income (loss) from discontinued operations | (6,202 | ) | (1,257 | ) | (7,459 | ) | (7,485 | ) | (2,640 | ) | (10,125 | ) | ||||||||||||
Net loss and comprehensive loss | $ | (12,357 | ) | $ | (1,267 | ) | $ | (13,624 | ) | $ | (13,119 | ) | $ | (2,640 | ) | $ | (15,759 | ) | ||||||
Basic and diluted net earnings (loss) per common share from continuing operations (11) | $ | (1.37 | ) | $ | (1.37 | ) | $ | (1.63 | ) | $ | (1.63 | ) | ||||||||||||
Basic and diluted net earnings (loss) per common share from discontinued operations (11) | $ | (1.38 | ) | $ | (1.65 | ) | $ | (2.17 | ) | $ | (2.93 | ) | ||||||||||||
Basic and diluted net earnings (loss) per common share (11) | $ | (2.75 | ) | $ | (3.02 | ) | $ | (3.80 | ) | $ | (4.56 | ) | ||||||||||||
Shares used to compute basic and diluted net earnings (loss) per common share | 4,505,813 | 4,505,813 | 3,456,786 | 3,456,786 | ||||||||||||||||||||
(11) | As the Company had a discontinued operation, the company used income (loss) from continuing operations as its control number to determine whether potential common shares are dilutive or anti-dilutive for purposes of reporting basic and diluted net earnings (loss) per common share from discontinued operations. Because there is a loss from continuing operations, the potentially dilutive shares are antidilutive and diluted net earnings (loss) per share is the same as basic net earnings (loss) per share. |
Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Operations and Comprehensive Loss (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Revenues: | ||||||||||||||||||||||||
Collaboration revenue | $ | 11,310 | $ | — | $ | 11,310 | $ | 8,876 | $ | 160 | $ | 9,036 | ||||||||||||
Total revenues | 11,310 | — | 11,310 | 8,876 | 160 | 9,036 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | 18,367 | — | 18,367 | 11,821 | — | 11,821 | ||||||||||||||||||
General and administrative | 6,834 | — | 6,834 | 8,320 | — | 8,320 | ||||||||||||||||||
Total operating expenses | 25,201 | — | 25,201 | 20,141 | — | 20,141 | ||||||||||||||||||
Loss from operations | (13,891 | ) | — | (13,891 | ) | (11,265 | ) | 160 | (11,105 | ) | ||||||||||||||
Other income (expense), net: | ||||||||||||||||||||||||
Interest income (expense), net | 855 | — | 855 | (26 | ) | — | (26 | ) | ||||||||||||||||
Total other income (expense), net | 855 | — | 855 | (26 | ) | — | (26 | ) | ||||||||||||||||
Loss before income tax expense | (13,036 | ) | — | (13,036 | ) | (11,291 | ) | 160 | (11,131 | ) | ||||||||||||||
Income tax expense | (40 | ) | — | (40 | ) | — | — | — | ||||||||||||||||
Net income (loss) from continuing operations | $ | (13,076 | ) | $ | — | $ | (13,076 | ) | $ | (11,291 | ) | $ | 160 | $ | (11,131 | ) | ||||||||
Income (loss) from discontinued operations | 3,928 | (1,463 | ) | 2,465 | (20,109 | ) | (2,993 | ) | (23,102 | ) | ||||||||||||||
Net loss and comprehensive loss | $ | (9,148 | ) | $ | (1,463 | ) | $ | (10,611 | ) | $ | (31,400 | ) | $ | (2,833 | ) | $ | (34,233 | ) | ||||||
Basic and diluted net earnings (loss) per common share from continuing operations (12) | $ | (3.10 | ) | $ | (3.10 | ) | $ | (3.29 | ) | $ | (3.24 | ) | ||||||||||||
Basic and diluted net earnings (loss) per common share from discontinued operations (12) | $ | 0.93 | $ | 0.59 | $ | (5.86 | ) | $ | (6.73 | ) | ||||||||||||||
Basic and diluted net earnings (loss) per common share (12) | $ | (2.17 | ) | $ | (2.51 | ) | $ | (9.15 | ) | $ | (9.97 | ) | ||||||||||||
Shares used to compute basic and diluted net earnings (loss) per common share | 4,220,511 | 4,220,511 | 3,432,017 | 3,432,017 | ||||||||||||||||||||
(12) | As the Company had a discontinued operation, the company used income (loss) from continuing operations as its control number to determine whether potential common shares are dilutive or anti-dilutive for purposes of reporting basic and diluted net earnings (loss) per common share from discontinued operations. Because there is a loss from continuing operations, the potentially dilutive shares are antidilutive and diluted net earnings (loss) per share is the same as basic net earnings (loss) per share. |
Three Months Ended September 30, 2023 | Three Months Ended September 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Revenues: | ||||||||||||||||||||||||
Collaboration revenue | $ | 9,217 | $ | — | $ | 9,217 | $ | 6,512 | $ | — | $ | 6,512 | ||||||||||||
Total revenues | 9,217 | — | 9,217 | 6,512 | — | 6,512 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | 10,386 | — | 10,386 | 8,581 | — | 8,581 | ||||||||||||||||||
General and administrative | 3,299 | — | 3,299 | 3,783 | — | 3,783 | ||||||||||||||||||
Total operating expenses | 13,685 | — | 13,685 | 12,364 | — | 12,364 | ||||||||||||||||||
Income (loss) from operations | (4,468 | ) | — | (4,468 | ) | (5,852 | ) | — | (5,852 | ) | ||||||||||||||
Other income, net: | ||||||||||||||||||||||||
Interest income, net | 613 | — | 613 | 55 | — | 55 | ||||||||||||||||||
Total other income, net | 613 | — | 613 | 55 | — | 55 | ||||||||||||||||||
Net income (loss) before income tax expense | (3,855 | ) | — | (3,855 | ) | (5,797 | ) | — | (5,797 | ) | ||||||||||||||
Income tax expense | 32 | — | 32 | — | — | — | ||||||||||||||||||
Net income (loss) from continuing operations | (3,823 | ) | — | (3,823 | ) | (5,797 | ) | — | (5,797 | ) | ||||||||||||||
Income (loss) from discontinued operations | (4,349 | ) | (935 | ) | (5,284 | ) | 20,775 | (732 | ) | 20,043 | ||||||||||||||
Net income (loss) and comprehensive income (loss) | (8,172 | ) | (935 | ) | (9,107 | ) | 14,978 | (732 | ) | 14,246 | ||||||||||||||
Allocation of earnings to participating securities | — | — | — | (3,081 | ) | 150 | (2,931 | ) | ||||||||||||||||
Net income (loss) attributable to common stockholders | $ | (8,172 | ) | $ | (935 | ) | $ | (9,107 | ) | $ | 11,897 | $ | (582 | ) | $ | 11,315 | ||||||||
Basic and diluted net earnings (loss) per common share from continuing operations (13) | $ | (0.85 | ) | $ | (0.85 | ) | $ | (1.31 | ) | $ | (1.31 | ) | ||||||||||||
Basic and diluted net earnings (loss) per common share from discontinued operations (13) | $ | (0.96 | ) | $ | (1.17 | ) | $ | 4.70 | $ | 4.53 | ||||||||||||||
Basic and diluted net earnings (loss) per common share (13) | $ | (1.81 | ) | $ | (2.02 | ) | $ | 3.39 | $ | 3.22 | ||||||||||||||
Shares used to compute basic and diluted net earnings (loss) per common share | 4,514,381 | 4,514,381 | 3,510,974 | 3,510,974 | ||||||||||||||||||||
(13) | As the Company had a discontinued operation, the company used income (loss) from continuing operations as its control number to determine whether potential common shares are dilutive or anti-dilutive for purposes of reporting basic and diluted net earnings (loss) per common share from discontinued operations. Because there is a loss from continuing operations, the potentially dilutive shares are antidilutive and diluted net earnings (loss) per share is the same as basic net earnings (loss) per share. |
Nine Months Ended September 30, 2023 | Nine Months Ended September 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Operations and Comprehensive Loss (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Revenues: | ||||||||||||||||||||||||
Collaboration revenue | $ | 20,527 | $ | — | $ | 20,527 | $ | 15,388 | $ | 160 | $ | 15,548 | ||||||||||||
Product revenue | — | — | — | — | — | — | ||||||||||||||||||
Total revenues | 20,527 | — | 20,527 | 15,388 | 160 | 15,548 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Cost of product revenue | — | — | — | — | — | — | ||||||||||||||||||
Research and development | 28,753 | — | 28,753 | 20,402 | — | 20,402 | ||||||||||||||||||
General and administrative | 10,133 | — | 10,133 | 12,103 | — | 12,103 | ||||||||||||||||||
Total operating expenses | 38,886 | — | 38,886 | 32,505 | — | 32,505 | ||||||||||||||||||
Loss from operations | (18,359 | ) | — | (18,359 | ) | (17,117 | ) | 160 | (16,957 | ) | ||||||||||||||
Other income, net: | ||||||||||||||||||||||||
Interest income, net | 1,468 | — | 1,468 | 29 | — | 29 | ||||||||||||||||||
Total other income, net | 1,468 | — | 1,468 | 29 | — | 29 | ||||||||||||||||||
Net loss before income tax expense | (16,891 | ) | — | (16,891 | ) | (17,088 | ) | 160 | (16,928 | ) | ||||||||||||||
Income tax expense | (8 | ) | — | (8 | ) | — | — | — | ||||||||||||||||
Net income (loss) from continuing operations | (16,899 | ) | — | (16,899 | ) | (17,088 | ) | 160 | (16,928 | ) | ||||||||||||||
Income (loss) from discontinued operations | (421 | ) | (2,398 | ) | (2,819 | ) | 666 | (3,725 | ) | (3,059 | ) | |||||||||||||
Net income (loss) and comprehensive income (loss) | $ | (17,320 | ) | $ | (2,398 | ) | $ | (19,718 | ) | $ | (16,422 | ) | $ | (3,565 | ) | $ | (19,987 | ) | ||||||
Basic and diluted net earnings (loss) per common share from continuing operations (14) | $ | (3.91 | ) | $ | (3.91 | ) | $ | (4.94 | ) | $ | (4.89 | ) | ||||||||||||
Basic and diluted net earnings (loss) per common share from discontinued operations (14) | $ | (0.10 | ) | $ | (0.65 | ) | $ | 0.19 | $ | (0.89 | ) | |||||||||||||
Basic and diluted net earnings (loss) per common share (14) | $ | (4.01 | ) | $ | (4.56 | ) | $ | (4.75 | ) | $ | (5.78 | ) | ||||||||||||
Shares used to compute basic and diluted net earnings (loss) per common share | 4,319,536 | 4,319,536 | 3,458,608 | 3,458,608 | ||||||||||||||||||||
(14) | As the Company had a discontinued operation, the company used income (loss) from continuing operations as its control number to determine whether potential common shares are dilutive or anti-dilutive for purposes of reporting basic and diluted net earnings (loss) per common share from discontinued operations. Because there is a loss from continuing operations, the potentially dilutive shares are antidilutive and diluted net earnings (loss) per share is the same as basic net earnings (loss) per share. |
Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Cash Flows (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Operating activities: | ||||||||||||||||||||||||
Net income (loss) | $ | 3,209 | $ | (196 | ) | $ | 3,013 | $ | (18,281 | ) | $ | (193 | ) | $ | (18,474 | ) | ||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||||||
Stock-based compensation | 640 | — | 640 | 1,338 | — | 1,338 | ||||||||||||||||||
Non-cash operating lease expense | 288 | (26 | ) | 262 | 258 | (24 | ) | 234 | ||||||||||||||||
Depreciation and amortization | 32 | — | 32 | 39 | — | 39 | ||||||||||||||||||
Amortization of costs to obtain a contract with a customer | 475 | — | 475 | — | — | — | ||||||||||||||||||
Non-cash interest expense | — | — | — | 1 | — | 1 | ||||||||||||||||||
Changes in assets and liabilities: | ||||||||||||||||||||||||
Accounts receivable | (19,993 | ) | (295 | ) | (20,288 | ) | (3,427 | ) | — | (3,427 | ) | |||||||||||||
Prepaid expenses, other current assets, and other assets | 872 | (24 | ) | 848 | (1,120 | ) | — | (1,120 | ) | |||||||||||||||
Accounts payable and accrued liabilities | 3,116 | 76 | 3,192 | 657 | — | 657 | ||||||||||||||||||
Accrued indirect tax liabilities | — | 261 | 261 | — | 353 | 353 | ||||||||||||||||||
Accrued compensation and benefits | 921 | — | 921 | (1,953 | ) | — | (1,953 | ) | ||||||||||||||||
Contract liabilities | (142 | ) | 178 | 36 | (844 | ) | (160 | ) | (1,004 | ) | ||||||||||||||
Operating lease liabilities | (316 | ) | 26 | (290 | ) | (276 | ) | 24 | (252 | ) | ||||||||||||||
Net cash used in operating activities | (10,898 | ) | — | (10,898 | ) | (23,608 | ) | — | (23,608 | ) | ||||||||||||||
Investing activities: | ||||||||||||||||||||||||
Purchases of property and equipment | (94 | ) | — | (94 | ) | (84 | ) | — | (84 | ) | ||||||||||||||
Net cash used in investing activities | (94 | ) | — | (94 | ) | (84 | ) | — | (84 | ) | ||||||||||||||
Financing activities: | ||||||||||||||||||||||||
Proceeds from underwritten public offering, net of issuance costs | 17,593 | — | 17,593 | — | — | — | ||||||||||||||||||
Proceeds from public offering of common stock, net of issuance costs | 8,630 | — | 8,630 | 500 | — | 500 | ||||||||||||||||||
Proceeds from exercise of stock options | 14 | — | 14 | — | — | — | ||||||||||||||||||
Principal repayments of Term Loan | — | — | — | (1,111 | ) | — | (1,111 | ) | ||||||||||||||||
Net cash provided by (used in) financing activities | 26,237 | — | 26,237 | (611 | ) | — | (611 | ) | ||||||||||||||||
Net increase (decrease) in cash and cash equivalents | 15,245 | — | 15,245 | (24,303 | ) | — | (24,303 | ) | ||||||||||||||||
Cash and cash equivalents at beginning of period | 32,731 | — | 32,731 | 62,273 | — | 62,273 | ||||||||||||||||||
Cash and cash equivalents at end of period | $ | 47,976 | $ | — | $ | 47,976 | $ | 37,970 | $ | — | $ | 37,970 | ||||||||||||
Supplemental disclosure of cash flows: | ||||||||||||||||||||||||
Interest paid | $ | — | $ | — | $ | — | $ | 25 | $ | — | $ | 25 | ||||||||||||
Non-cash investing activity: | ||||||||||||||||||||||||
Purchases of property and equipment, included in accounts payable and accrued liabilities | $ | 55 | $ | — | $ | 55 | $ | 16 | $ | — | $ | 16 | ||||||||||||
Non-cash financing activities: | ||||||||||||||||||||||||
Issuance costs incurred but not yet paid, included in accounts payable and accrued liabilities | $ | 337 | $ | — | $ | 337 | $ | — | $ | 720 | $ | 720 |
Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Cash Flows (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Operating activities: | ||||||||||||||||||||||||
Net loss | $ | (9,148 | ) | $ | (1,463 | ) | $ | (10,611 | ) | $ | (31,400 | ) | $ | (2,833 | ) | $ | (34,233 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||||||
Stock-based compensation | 1,435 | — | 1,435 | 2,016 | — | 2,016 | ||||||||||||||||||
Non-cash operating lease expense | 664 | (25 | ) | 639 | 523 | (47 | ) | 476 | ||||||||||||||||
Depreciation and amortization | 57 | — | 57 | 77 | — | 77 | ||||||||||||||||||
Amortization of costs to obtain a contract with a customer | 40 | — | 40 | — | — | — | ||||||||||||||||||
Non-cash interest expense | — | — | — | 1 | — | 1 | ||||||||||||||||||
Changes in assets and liabilities: | ||||||||||||||||||||||||
Accounts receivable | 350 | — | 350 | 524 | — | 524 | ||||||||||||||||||
Inventory | (1,954 | ) | (434 | ) | (2,388 | ) | — | — | — | |||||||||||||||
Prepaid expenses, other current assets, and other assets | 2,120 | — | 2,120 | (2,567 | ) | — | (2,567 | ) | ||||||||||||||||
Accounts payable and accrued liabilities | 2,870 | — | 2,870 | (483 | ) | — | (483 | ) | ||||||||||||||||
Accrued indirect tax liabilities | — | 1,897 | 1,897 | — | 2,993 | 2,993 | ||||||||||||||||||
Accrued compensation and benefits | (1,277 | ) | — | (1,277 | ) | (1,324 | ) | — | (1,324 | ) | ||||||||||||||
Contract liabilities | (2,613 | ) | — | (2,613 | ) | (2,252 | ) | (160 | ) | (2,412 | ) | |||||||||||||
Operating lease liabilities | (620 | ) | 25 | (595 | ) | (559 | ) | 47 | (512 | ) | ||||||||||||||
Net cash used in operating activities | (8,076 | ) | — | (8,076 | ) | (35,444 | ) | — | (35,444 | ) | ||||||||||||||
Investing activities: | ||||||||||||||||||||||||
Purchases of property and equipment | (201 | ) | — | (201 | ) | (100 | ) | — | (100 | ) | ||||||||||||||
Net cash used in investing activities | (201 | ) | — | (201 | ) | (100 | ) | — | (100 | ) | ||||||||||||||
Financing activities: | ||||||||||||||||||||||||
Proceeds from underwritten public offering, net of issuance costs | 17,256 | — | 17,256 | — | — | — | ||||||||||||||||||
Proceeds from public offering of common stock, net of issuance costs | 8,706 | — | 8,706 | 500 | — | 500 | ||||||||||||||||||
Proceeds from exercise of stock options | 14 | — | 14 | — | — | — | ||||||||||||||||||
Principal repayments of Term Loan | — | — | — | (2,222 | ) | — | (2,222 | ) | ||||||||||||||||
Net cash provided by (used in) financing activities | 25,976 | — | 25,976 | (1,722 | ) | — | (1,722 | ) | ||||||||||||||||
Net increase (decrease) in cash and cash equivalents | 17,699 | — | 17,699 | (37,266 | ) | — | (37,266 | ) | ||||||||||||||||
Cash and cash equivalents at beginning of period | 32,731 | — | 32,731 | 62,273 | — | 62,273 | ||||||||||||||||||
Cash and cash equivalents at end of period | $ | 50,430 | $ | — | $ | 50,430 | $ | 25,007 | $ | — | $ | 25,007 | ||||||||||||
Supplemental disclosure of cash flows: | ||||||||||||||||||||||||
Interest paid | $ | — | $ | — | $ | — | $ | 38 | $ | — | $ | 38 | ||||||||||||
Income taxes paid | $ | 588 | $ | — | $ | 588 | $ | — | $ | — | $ | — | ||||||||||||
Non-cash investing activity: | ||||||||||||||||||||||||
Operating lease right-of-use | $ | 3,847 | $ | — | $ | 3,847 | $ | — | $ | — | $ | — | ||||||||||||
Non-cash financing activities: | ||||||||||||||||||||||||
Purchase of shares pursuant to Employee Stock Purchase Plan | $ | 63 | $ | — | $ | 63 | $ | 69 | $ | — | $ | 69 | ||||||||||||
Issuance costs incurred but not yet paid, included in accounts payable and accrued liabilities | $ | — | $ | — | $ | — | $ | 720 | $ | — | $ | 720 |
Nine Months Ended September 30, 2023 | Nine Months Ended September 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Cash Flows (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Operating activities: | ||||||||||||||||||||||||
Net loss | $ | (17,320 | ) | $ | (2,398 | ) | $ | (19,718 | ) | $ | (16,422 | ) | $ | (3,565 | ) | $ | (19,987 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||||||
Stock-based compensation | 2,231 | — | 2,231 | 2,859 | — | 2,859 | ||||||||||||||||||
Non-cash operating lease expense | 921 | (26 | ) | 895 | 796 | (72 | ) | 724 | ||||||||||||||||
Depreciation and amortization | 79 | — | 79 | 114 | — | 114 | ||||||||||||||||||
Amortization of costs to obtain a contract with a customer | 53 | — | 53 | 1,772 | — | 1,772 | ||||||||||||||||||
Non-cash interest expense | — | — | — | 1 | — | 1 | ||||||||||||||||||
Changes in assets and liabilities: | ||||||||||||||||||||||||
Accounts receivable | 2,978 | (323 | ) | 2,655 | 314 | — | 314 | |||||||||||||||||
Inventory | (2,467 | ) | (434 | ) | (2,901 | ) | — | — | — | |||||||||||||||
Prepaid expenses, other current assets, and other assets | 2,776 | — | 2,776 | (1,662 | ) | — | (1,662 | ) | ||||||||||||||||
Accounts payable and accrued liabilities | 6,204 | — | 6,204 | (1,037 | ) | — | (1,037 | ) | ||||||||||||||||
Accrued indirect tax liabilities | — | 3,155 | 3,155 | — | 3,725 | 3,725 | ||||||||||||||||||
Accrued compensation and benefits | (402 | ) | — | (402 | ) | (670 | ) | — | (670 | ) | ||||||||||||||
Contract liabilities | (3,956 | ) | — | (3,956 | ) | 7,314 | (160 | ) | 7,154 | |||||||||||||||
Operating lease liabilities | (807 | ) | 26 | (781 | ) | (850 | ) | 72 | (778 | ) | ||||||||||||||
Net cash used in operating activities | (9,710 | ) | — | (9,710 | ) | (7,471 | ) | — | (7,471 | ) | ||||||||||||||
Investing activities: | ||||||||||||||||||||||||
Purchases of property and equipment | (327 | ) | — | (327 | ) | (109 | ) | — | (109 | ) | ||||||||||||||
Net cash used in investing activities | (327 | ) | — | (327 | ) | (109 | ) | — | (109 | ) | ||||||||||||||
Financing activities: | ||||||||||||||||||||||||
Proceeds from underwritten public offering, net of issuance costs | 17,256 | — | 17,256 | — | — | — | ||||||||||||||||||
Proceeds from public offering of common stock, net of issuance costs | 8,706 | — | 8,706 | 1,698 | — | 1,698 | ||||||||||||||||||
Proceeds from exercise of stock options | 14 | — | 14 | — | — | — | ||||||||||||||||||
Issuance costs for underwritten public offering | — | — | — | (720 | ) | — | (720 | ) | ||||||||||||||||
Principal repayments of Term Loan | — | — | — | (2,593 | ) | — | (2,593 | ) | ||||||||||||||||
Net cash provided by (used in) financing activities | 25,976 | — | 25,976 | (1,615 | ) | — | (1,615 | ) | ||||||||||||||||
Net increase (decrease) in cash and cash equivalents | 15,939 | — | 15,939 | (9,195 | ) | — | (9,195 | ) | ||||||||||||||||
Cash and cash equivalents at beginning of period | 32,731 | — | 32,731 | 62,273 | — | 62,273 | ||||||||||||||||||
Cash and cash equivalents at end of period | $ | 48,670 | $ | — | $ | 48,670 | $ | 53,078 | $ | — | $ | 53,078 | ||||||||||||
Nine Months Ended September 30, 2023 | Nine Months Ended September 30, 2022 | |||||||||||||||||||||||
Corrected Condensed Consolidated Statement of Cash Flows (unaudited) | As Previously Reported | Restatement Adjustment | As Restated | As Previously Reported | Restatement Adjustment | As Restated | ||||||||||||||||||
Supplemental disclosure of cash flows: | ||||||||||||||||||||||||
Interest paid | $ | — | $ | — | $ | — | $ | 40 | $ | — | $ | 40 | ||||||||||||
Income taxes paid | $ | 651 | $ | — | $ | 651 | $ | — | $ | — | $ | — | ||||||||||||
Non-cash investing activity: | ||||||||||||||||||||||||
Purchases of property and equipment, included in accounts payable and accrued liabilities | $ | 178 | $ | — | $ | 178 | $ | — | $ | — | $ | — | ||||||||||||
Operating lease right-of-use | $ | 3,847 | $ | — | $ | 3,847 | $ | — | $ | — | $ | — | ||||||||||||
Non-cash financing activities: | ||||||||||||||||||||||||
Purchase of shares pursuant to Employee Stock Purchase Plan | $ | 63 | $ | — | $ | 63 | $ | 69 | $ | — | $ | 69 | ||||||||||||
Proceeds from public offering of common stock, net of issuance costs, included in prepaid expenses, other current assets, and other assets | $ | — | $ | — | $ | — | $ | 10 | $ | — | $ | 10 |
Corrected Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||||||||||||||||||||||
Series X Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit (As Restated) | Total Stockholders’ Equity (Deficit) (As Restated) | ||||||||||||||||||||||||
(In thousands, except share data) | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||
Balance, December 31, 2022 (As Restated) | 1,818,472 | $ | — | 3,623,591 | $ | 1 | $ | 404,061 | $ | (418,500 | ) | $ | (14,438 | ) | ||||||||||||||
Underwritten public offering, net of issuance costs | 286,000 | — | 554,300 | — | 17,256 | — | 17,256 | |||||||||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 307,936 | — | 8,622 | — | 8,622 | |||||||||||||||||||||
Issuance of common stock for exercise of options | — | — | 812 | — | 14 | — | 14 | |||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 14,617 | — | — | — | — | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 640 | — | 640 | |||||||||||||||||||||
Net income (As Restated) | — | — | — | — | — | 3,013 | 3,013 | |||||||||||||||||||||
Balance, March 31, 2023 (As Restated) | 2,104,472 | — | 4,501,256 | 1 | 430,593 | (415,487 | ) | 15,107 | ||||||||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 3,047 | — | 76 | — | 76 | |||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 232 | — | — | — | — | |||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | — | — | 8,060 | — | 63 | — | 63 | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 795 | — | 795 | |||||||||||||||||||||
Net loss (As Restated) | — | — | — | — | — | (13,624 | ) | (13,624 | ) | |||||||||||||||||||
Balance, June 30, 2023 (As Restated) | 2,104,472 | — | 4,512,595 | 1 | 431,527 | (429,111 | ) | 2,417 | ||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 8,219 | — | — | — | — | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 796 | — | 796 | |||||||||||||||||||||
Net loss (As Restated) | — | — | — | — | — | (9,107 | ) | (9,107 | ) | |||||||||||||||||||
Balance, September 30, 2023 (As Restated) | 2,104,472 | $ | — | 4,520,814 | $ | 1 | $ | 432,323 | $ | (438,218 | ) | $ | (5,894 | ) | ||||||||||||||
Corrected Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||||||||||||||||||||||
Series X Convertible Preferred Stock | Common Stock | Additional Paid-In Capital (As Restated) | Accumulated Deficit (As Restated) | Total Stockholders’ Equity (Deficit) (As Restated) | ||||||||||||||||||||||||
(In thousands, except share data) | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||
Balance, December 31, 2021 (As Restated) | 1,818,472 | $ | — | 3,393,320 | $ | 1 | $ | 398,019 | $ | (384,916 | ) | $ | 13,104 | |||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 32,208 | — | 500 | — | 500 | |||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 27,039 | — | — | — | — | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 1,165 | — | 1,165 | |||||||||||||||||||||
Net loss (As Restated) | — | — | — | — | — | (18,474 | ) | (18,474 | ) | |||||||||||||||||||
Balance, March 31, 2022 (As Restated) | 1,818,472 | — | 3,452,567 | 1 | 399,684 | (403,390 | ) | (3,705 | ) | |||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 252 | — | — | — | — | |||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | — | — | 9,205 | — | 69 | — | 69 | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 852 | — | 852 | |||||||||||||||||||||
Issuance costs for underwritten public offering (As Restated) | — | — | — | — | — | — | — | |||||||||||||||||||||
Net loss (As Restated) | — | — | — | — | — | (15,759 | ) | (15,759 | ) | |||||||||||||||||||
Balance, June 30, 2022 (As Restated) | 1,818,472 | — | 3,462,024 | 1 | 400,605 | (419,149 | ) | (18,543 | ) | |||||||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 83,197 | — | 1,208 | — | 1,208 | |||||||||||||||||||||
Issuance of common stock for restricted share units vested | — | — | 13,920 | — | — | — | — | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 842 | — | 842 | |||||||||||||||||||||
Net income (As Restated) | — | — | — | — | — | 14,246 | 14,246 | |||||||||||||||||||||
Balance, September 30, 2022 (As Restated) | 1,818,472 | $ | — | 3,559,141 | $ | 1 | $ | 402,655 | $ | (404,903 | ) | $ | (2,247 | ) | ||||||||||||||
(In thousands, except share and per share data) | September 30, 2024 | December 31, 2023 | ||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 127,386 | $ | 35,778 | ||||
Accounts receivable | 1,699 | 14,075 | ||||||
Prepaid expenses and other current assets | 27,686 | 1,712 | ||||||
Current assets from discontinued operations | — | 9,290 | ||||||
Total current assets | 156,771 | 60,855 | ||||||
Property and equipment, net | 561 | 557 | ||||||
Finance lease right-of-use | 722 | 782 | ||||||
Operating lease right-of-use | 3,035 | 3,788 | ||||||
Other assets | 1,242 | 114 | ||||||
Noncurrent assets from discontinued operations | — | 934 | ||||||
Total assets | $ | 162,331 | $ | 67,030 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,967 | $ | 3,772 | ||||
Accrued liabilities | 8,569 | 14,177 | ||||||
Accrued indirect tax liabilities | 26,289 | 18,040 | ||||||
Accrued compensation and benefits | 4,933 | 5,034 | ||||||
Current contract liabilities | — | 430 | ||||||
Current portion of finance lease liability | 259 | 218 | ||||||
Current portion of operating lease liability | 1,322 | 1,082 | ||||||
Current liabilities from discontinued operations | — | 24,665 | ||||||
Total current liabilities | 44,339 | 67,418 | ||||||
Long-term finance lease liability | 378 | 575 | ||||||
Long-term operating lease liability | 1,984 | 3,002 | ||||||
Noncurrent liabilities from discontinued operations | — | 4,245 | ||||||
Total liabilities | 46,701 | 75,240 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity (deficit): | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2024 and December 31, 2023: | ||||||||
Series A Convertible Voting Preferred Stock, $0.0001 par value; 204,725 shares authorized at September 30, 2024; 240,000 shares issued and 204,725 shares outstanding at September 30, 2024; no shares authorized, issued and outstanding at December 31, 2023 | — | — | ||||||
Series X Convertible Preferred Stock, $0.0001 par value; 4,947,759 shares authorized at September 30, 2024 and December 31, 2023; 2,156,713 shares issued and 2,104,472 shares outstanding at September 30, 2024 and December 31, 2023 | — | — | ||||||
Common stock, $0.0001 par value; 50,000,000 shares authorized at September 30, 2024 and 20,000,000 shares authorized at December 31, 2023; 7,046,633 shares issued and outstanding at September 30, 2024 and 4,530,113 shares issued and outstanding at December 31, 2023 | 1 | 1 | ||||||
Additional paid-in capital | 674,580 | 433,220 | ||||||
Accumulated deficit | (558,951 | ) | (441,431 | ) | ||||
Total stockholders’ equity (deficit) | 115,630 | (8,210 | ) | |||||
Total liabilities and stockholders’ equity (deficit) | $ | 162,331 | $ | 67,030 | ||||
Nine Months Ended September 30, | ||||||||
(In thousands, except share and per share data) | 2024 | 2023 | ||||||
Revenues: | ||||||||
Collaboration revenue | $ | 1,275 | $ | 20,527 | ||||
Total revenues | 1,275 | 20,527 | ||||||
Operating expenses: | ||||||||
Acquired in-process research and development | 84,883 | — | ||||||
Research and development | 25,005 | 28,753 | ||||||
Selling, general and administrative | 13,307 | 10,133 | ||||||
Total operating expenses | 123,195 | 38,886 | ||||||
Loss from operations | (121,920 | ) | (18,359 | ) | ||||
Other income, net: | ||||||||
Interest income, net | 3,998 | 1,468 | ||||||
Total other income, net | 3,998 | 1,468 | ||||||
Net loss from continuing operations before income tax expense | (117,922 | ) | (16,891 | ) | ||||
Income tax benefit (expense) | — | (8 | ) | |||||
Net loss from continuing operations | (117,922 | ) | (16,899 | ) | ||||
Income (loss) from discontinued operations (including loss on disposal of discontinued operations of $1,799 during the nine months ended September 30, 2024), net of income taxes | 402 | (2,819 | ) | |||||
Net loss and comprehensive loss | $ | (117,520 | ) | $ | (19,718 | ) | ||
Basic and diluted net loss per common share from continuing operations | $ | (22.61 | ) | $ | (3.91 | ) | ||
Basic and diluted net earnings (loss) per common share from discontinued operations | 0.08 | (0.65 | ) | |||||
Basic and diluted net loss per common share | $ | (22.53 | ) | $ | (4.56 | ) | ||
Shares used to compute basic and diluted net earnings (loss) per common share | 5,215,365 | 4,319,536 |
Nine Months Ended September 30, | ||||||||
(In thousands) | 2024 | 2023 | ||||||
Operating activities: | ||||||||
Net loss | $ | (117,520) | $ | (19,718) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Loss on disposal of discontinued operations | 1,799 | — | ||||||
Stock-based compensation | 2,249 | 2,231 | ||||||
Non-cash operating lease expense | 753 | 895 | ||||||
Depreciation and amortization | 114 | 79 | ||||||
Amortization of costs to obtain a contract with a customer | 184 | 53 | ||||||
Amortization of finance lease right-of-use | 60 | — | ||||||
Non-cash interest expense | 44 | — | ||||||
Changes in assets and liabilities: | ||||||||
Accounts receivable | 14,270 | 2,655 | ||||||
Inventory | 6,097 | (2,901 | ) | |||||
Prepaid expenses, other current assets, and other assets | (26,832 | ) | 2,776 | |||||
Accounts payable and accrued liabilities | (6,422 | ) | 6,204 | |||||
Accrued indirect tax liabilities | 8,249 | 3,155 | ||||||
Accrued compensation and benefits | (46 | ) | (402 | ) | ||||
Contract liabilities | (29,340 | ) | (3,956 | ) | ||||
Operating lease liabilities | (778 | ) | (781 | ) | ||||
Net cash used in operating activities | (147,119 | ) | (9,710 | ) | ||||
Investing activities: | ||||||||
Purchases of property and equipment | (129 | ) | (327 | ) | ||||
Net cash used in investing activities | (129 | ) | (327 | ) | ||||
Financing activities: | ||||||||
Proceeds from private placement, net of issuance costs | 239,095 | — | ||||||
Proceeds from underwritten public offering, net of issuance costs | — | 17,256 | ||||||
Proceeds from public offering of common stock, net of issuance costs | — | 8,706 | ||||||
Proceeds from exercise of stock options | — | 14 | ||||||
Payment of finance lease liabilities | (200 | ) | — | |||||
Payment for shares withheld to fund payroll taxes | (39 | ) | — | |||||
Net cash provided by financing activities | 238,856 | 25,976 | ||||||
Net increase in cash and cash equivalents | 91,608 | 15,939 | ||||||
Cash and cash equivalents at beginning of period | 35,778 | 32,731 | ||||||
Cash and cash equivalents at end of period | $ | 127,386 | $ | 48,670 | ||||
Supplemental disclosure of cash flows: | ||||||||
Income taxes paid | $ | 95 | $ | 651 | ||||
Non-cash investing activities: | ||||||||
Purchases of property and equipment, included in accounts payable and accrued liabilities | $ | — | $ | 178 | ||||
Right-of-use | $ | — | $ | 3,847 | ||||
Non-cash financing activities: | ||||||||
Purchase of shares pursuant to Employee Stock Purchase Plan | $ | 55 | $ | 63 |
Nine Months Ended September 30, 2024 | ||||||||||||||||||||||||||||||||||||
Series A Convertible Voting Preferred Stock | Series X Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||
(In thousands, except share data) | Shares | Amount | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||
Balance, December 31, 2023 | — | $ | — | 2,104,472 | $ | — | 4,530,113 | $ | 1 | $ | 433,220 | $ | (441,431 | ) | $ | (8,210 | ) | |||||||||||||||||||
Private placement, net of issuance costs | 240,000 | — | — | — | — | — | 239,095 | — | 239,095 | |||||||||||||||||||||||||||
Issuance of common stock upon conversion of Series A Convertible Voting Preferred Stock | (35,275 | ) | — | — | — | 2,469,250 | — | — | — | — | ||||||||||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units | — | — | — | — | 40,220 | — | — | — | — | |||||||||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | — | — | — | — | 7,050 | — | 55 | — | 55 | |||||||||||||||||||||||||||
Value of shares withheld to fund payroll taxes | — | — | — | — | — | — | (39 | ) | — | (39 | ) | |||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 2,249 | — | 2,249 | |||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (117,520 | ) | (117,520 | ) | |||||||||||||||||||||||||
Balance, September 30, 2024 | 204,725 | $ | — | 2,104,472 | $ | — | 7,046,633 | $ | 1 | $ | 674,580 | $ | (558,951 | ) | $ | 115,630 | ||||||||||||||||||||
Nine Months Ended September 30, 2023 | ||||||||||||||||||||||||||||
Series X Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders’ Equity (Deficit) | ||||||||||||||||||||||||
(In thousands, except share data) | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||
Balance, December 31, 2022 | 1,818,472 | $ | — | 3,623,591 | $ | 1 | $ | 404,061 | $ | (418,500 | ) | $ | (14,438 | ) | ||||||||||||||
Underwritten public offering, net of issuance costs | 286,000 | — | 554,300 | — | 17,256 | — | 17,256 | |||||||||||||||||||||
Public offering of common stock, net of issuance costs | — | — | 310,983 | — | 8,698 | — | 8,698 | |||||||||||||||||||||
Issuance of common stock for exercise of options | — | — | 812 | — | 14 | — | 14 | |||||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units | — | — | 23,068 | — | — | — | — | |||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | — | — | 8,060 | — | 63 | — | 63 | |||||||||||||||||||||
Stock-based compensation | — | — | — | — | 2,231 | — | 2,231 | |||||||||||||||||||||
Net income | — | — | — | — | — | (19,718 | ) | (19,718 | ) | |||||||||||||||||||
Balance, September 30, 2023 | 2,104,472 | $ | — | 4,520,814 | $ | 1 | $ | 432,323 | $ | (438,218 | ) | $ | (5,894 | ) | ||||||||||||||
Nine Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Common stock warrants | 866 | 866 | ||||||
Series A Convertible Voting Preferred Stock | 14,330,750 | — | ||||||
Series X Convertible Preferred Stock | 1,052,236 | 1,052,236 | ||||||
Common stock options, RSUs and PRSUs issued and outstanding | 2,454,822 | 646,233 | ||||||
Total | 17,838,674 | 1,699,335 | ||||||
TOTAL | LEVEL 1 | LEVEL 2 | LEVEL 3 | |||||||||||||
September 30, 2024 | ||||||||||||||||
Assets: | ||||||||||||||||
Cash and money market accounts | $ | 127,386 | $ | 127,386 | $ | — | $ | — | ||||||||
Total assets at fair value | $ | 127,386 | $ | 127,386 | $ | — | $ | — | ||||||||
December 31, 2023 | ||||||||||||||||
Assets: | ||||||||||||||||
Cash and money market accounts | $ | 35,778 | $ | 35,778 | $ | — | $ | — | ||||||||
Total assets at fair value | $ | 35,778 | $ | 35,778 | $ | — | $ | — | ||||||||
September 30, 2024 | December 31, 2023 | |||||||
Common stock warrants | 866 | 866 | ||||||
Series A Convertible Preferred Stock | 14,330,750 | — | ||||||
Series X Convertible Preferred Stock | 1,052,236 | 1,052,236 | ||||||
Common stock options, RSUs and PRSUs issued and outstanding | 2,454,822 | 638,037 | ||||||
Authorized for future stock awards | 1,052,406 | 170,783 | ||||||
Awards available under the ESPP | 67,089 | 49,623 | ||||||
Total | 18,958,169 | 1,911,545 | ||||||
Number of RSUs and PRSUs | Weighted Average Grant Date Fair Value | |||||||
Outstanding at December 31, 2023 | 104,886 | $ | 22.83 | |||||
RSUs and PRSUs granted | 153,012 | 12.30 | ||||||
RSUs and PRSUs vested | (43,053 | ) | 24.24 | |||||
RSUs and PRSUs canceled | (17,705 | ) | 24.68 | |||||
Outstanding at September 30, 2024 | 197,140 | $ | 14.18 | |||||
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Total Aggregate Intrinsic Value (in thousands) | |||||||||||||
Outstanding at December 31, 2023 | 533,151 | $ | 44.61 | 6.72 | $ | 57 | ||||||||||
Options granted | 1,796,401 | 11.14 | ||||||||||||||
Options exercised | — | — | ||||||||||||||
Options canceled | (71,870 | ) | 31.68 | |||||||||||||
Outstanding at September 30, 2024 | 2,257,682 | $ | 18.39 | 9.10 | $ | 1 | ||||||||||
Vested and expected to vest at September 30, 2024 | 2,257,682 | $ | 18.39 | 9.10 | $ | 1 | ||||||||||
Exercisable at September 30, 2024 | 420,941 | $ | 48.19 | 5.74 | $ | 1 | ||||||||||
Nine Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Stock compensation expense: | ||||||||
Research and development | $ | 868 | $ | 629 | ||||
Selling, general and administrative | 1,150 | 1,038 | ||||||
Stock compensation expense recorded in continuing operations | 2,018 | 1,667 | ||||||
Stock compensation expense recorded in discontinued operations | 231 | 564 | ||||||
Total stock compensation expense | $ | 2,249 | $ | 2,231 | ||||
Opening balance, December 31, 2023 | $ | 430 | ||
Revenue from performance obligations satisfied during reporting period | (370 | ) | ||
Gain on settlement of unsatisfied performance obligations | (60 | ) | ||
Closing balance, September 30, 2024 | $ | — | ||
Nine Months Ended September 30, | ||||||||
2024 | 2023 | |||||||
Revenue from Janssen Collaboration Agreement: | ||||||||
Point in Time: | ||||||||
License of Intellectual Property - upon milestone achieved | $ | — | $ | 2,347 | ||||
Over Time: | ||||||||
Research and Development Services | $ | 1,273 | $ | 16,324 | ||||
Clinical Supply Services | 2 | 1,856 | ||||||
Total Revenue from Janssen Collaboration Agreement | $ | 1,275 | $ | 20,527 | ||||
2024 | $ | 75 | ||
2025 | 300 | |||
2026 | 300 | |||
2027 | 25 | |||
Total undiscounted finance lease payments | 700 | |||
Less: Imputed interest | (63 | ) | ||
Present value of finance lease payments | $ | 637 | ||
Balance Sheet Classification: | ||||
Finance lease right-of-use | $ | 788 | ||
Accumulated amortization | (66 | ) | ||
Net finance lease right-of-use | $ | 722 | ||
Current portion of finance lease liability | $ | 259 | ||
Long-term finance lease liability | 378 | |||
Total finance lease liabilities | $ | 637 | ||
2024 | $ | 400 | ||
2025 | 1,664 | |||
2026 | 1,731 | |||
Total undiscounted operating lease payments | 3,795 | |||
Less: Imputed interest | (489 | ) | ||
Present value of operating lease payments | $ | 3,306 | ||
Balance Sheet Classification: | ||||
Operating lease right-of-use | $ | 3,035 | ||
Current portion of operating lease liability | $ | 1,322 | ||
Long-term operating lease liability | 1,984 | |||
Total operating lease liabilities | $ | 3,306 | ||
• | all of the Company’s rezafungin assets, including all of the Company’s right to receive future milestones and royalties under the Melinta License Agreement and the Mundipharma Collaboration Agreement, |
• | all rezafungin intellectual property rights, including patents and know-how, all product data, regulatory approvals and documentation, |
• | rezafungin and comparator inventory, |
• | specified prepaid assets and specified contracts, in exchange for Napp’s assumption of certain liabilities of the rezafungin business, including the ongoing costs of the ReSPECT Phase 3 clinical trial and the ReSTORE Phase 3 clinical trial in China and the Company’s obligations from and after closing under the Melinta License Agreement, |
• | the Commercial Supply Agreement dated January 23, 2023 between the Company and Melinta, and |
• | the Commercial Supply Agreement, dated December 12, 2022 between the Company and Mundipharma, or the Mundipharma Commercial Supply Agreement. |
(In thousands) | September 30, 2024 | December 31, 2023 | ||||||
Carrying amount of major assets included as part of discontinued operations: | ||||||||
Current assets: | ||||||||
Accounts receivable | $ | — | $ | 2,171 | ||||
Inventory | — | 6,097 | ||||||
Prepaid expenses and other current assets | — | 1,022 | ||||||
Current assets from discontinued operations | — | 9,290 | ||||||
Noncurrent assets: | ||||||||
Other assets | — | 934 | ||||||
Noncurrent assets from discontinued operations | — | 934 | ||||||
Total assets from discontinued operations | $ | — | $ | 10,224 | ||||
Carrying amount of major liabilities included as part of discontinued operations: | ||||||||
Current liabilities: | ||||||||
Current contract liabilities | — | 24,665 | ||||||
Current liabilities from discontinued operations | — | 24,665 | ||||||
Noncurrent liabilities: | ||||||||
Long-term contract liabilities | — | 4,245 | ||||||
Noncurrent liabilities from discontinued operations | — | 4,245 | ||||||
Total liabilities from discontinued operations | $ | — | $ | 28,910 | ||||
September 30, 2024 | December 31, 2023 | |||||||
Raw materials | $ | — | $ | 2,691 | ||||
Work-in-process | — | 3,406 | ||||||
Total inventory | $ | — | $ | 6,097 | ||||
Nine Months Ended September 30, | ||||||||
(In thousands) | 2024 | 2023 | ||||||
Major line items constituting pretax income (loss) of discontinued operations | ||||||||
Revenues: | ||||||||
Total revenues | $ | 29,263 | $ | 25,795 | ||||
Operating expenses: | ||||||||
Cost of product revenue | 9,030 | 387 | ||||||
Research and development | 10,572 | 25,061 | ||||||
Selling, general and administrative | 7,460 | 2,795 | ||||||
Total operating expenses | 27,062 | 28,243 | ||||||
Income (loss) from operations | 2,201 | (2,448 | ) | |||||
Other expense, net: | ||||||||
Loss on disposal of discontinued operations | (1,799 | ) | — | |||||
Total other expense, net | (1,799 | ) | — | |||||
Income (loss) from discontinued operations before income tax expense | 402 | (2,448 | ) | |||||
Income tax expense | — | (371 | ) | |||||
Income (loss) from discontinued operations, net of income taxes | $ | 402 | $ | (2,819 | ) | |||
Opening balance, December 31, 2023 | $ | 28,910 | ||
Revenue from performance obligations satisfied during reporting period | (28,910 | ) | ||
Closing balance, September 30, 2024 | $ | — | ||
Current portion of contract liabilities | $ | — | ||
Long-term portion of contract liabilities | — | |||
Total contract liabilities, September 30, 2024 | $ | — | ||
Nine Months Ended September 30, 2024 | ||||||||
Mundipharma | Melinta | |||||||
Revenue from Collaboration, License and Purchase Agreements: | ||||||||
Point in Time: | ||||||||
Rezafungin Assets, including Sale of IP and Inventory | $ | 20,833 | $ | — | ||||
License of Intellectual Property - upon milestone achieved | 813 | — | ||||||
Product Revenue | 2,826 | — | ||||||
Royalty Revenue | 37 | 125 | ||||||
Over Time: | ||||||||
Research and Development Services | 3,895 | 457 | ||||||
Clinical Supply Services | 175 | — | ||||||
Transition Services | 102 | — | ||||||
Total Revenue from Collaboration, License and Purchase Agreements | $ | 28,681 | $ | 582 | ||||
Nine Months Ended September 30, 2023 | ||||||||
Mundipharma | Melinta | |||||||
Revenue from Collaboration, License and Purchase Agreements: | ||||||||
Point in Time: | ||||||||
License of Intellectual Property - upon milestone achieved | $ | — | $ | 17,257 | ||||
Clinical Drug Supply | 26 | — | ||||||
Product Revenue | — | 1,468 | ||||||
Royalty Revenue | — | 70 | ||||||
Over Time: | ||||||||
Research and Development Services | 4,870 | 1,859 | ||||||
Clinical Supply Services | 245 | — | ||||||
Total Revenue from Collaboration, License and Purchase Agreements | $ | 5,141 | $ | 20,654 | ||||
Cidara Therapeutics, Inc.
7,041,309 Shares of Common Stock
PROSPECTUS
, 2024
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forth the fees and expenses, other than any placement agent fees, payable by Cidara Therapeutics, Inc. (the “Registrant,” “we,” “our” or “us”) in connection with the issuance and distribution of the securities being registered. Each item listed is estimated, except for the SEC registration fee:
Amount | ||||
SEC registration fee | $ | 22,650 | ||
Accounting fees and expenses | 300,000 | |||
Legal fees and expenses | 150,000 | |||
Other miscellaneous fees and expenses | 39,350 | |||
|
| |||
Total | $ | 512,000 |
Item 14. Indemnification of Directors and Officers
Section 145 of the Delaware General Corporation Law authorizes a court to award, or a corporation’s board of directors to grant indemnity to directors and officers under certain circumstances and subject to certain limitations. The terms of Section 145 of the Delaware General Corporation Law are sufficiently broad to permit indemnification under certain circumstances for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended (the “Securities Act”).
As permitted by the Delaware General Corporation Law, the Registrant’s amended and restated certificate of incorporation contains provisions that eliminate the personal liability of its directors for monetary damages for any breach of fiduciary duties as a director, except liability for the following:
• | any breach of the director’s duty of loyalty to the Registrant or its stockholders; |
• | acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; |
• | under Section 174 of the Delaware General Corporation Law (regarding unlawful dividends and stock purchases); or |
• | any transaction from which the director derived an improper personal benefit. |
As permitted by the Delaware General Corporation Law, the Registrant’s amended and restated bylaws provide that:
• | the Registrant is required to indemnify its directors and executive officers to the fullest extent permitted by the Delaware General Corporation Law, subject to very limited exceptions; |
• | the Registrant may indemnify its other employees and agents as set forth in the Delaware General Corporation Law; |
• | the Registrant is required to advance expenses, as incurred, to its directors and executive officers in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to very limited exceptions; and |
• | the rights conferred in the amended and restated bylaws are not exclusive. |
The Registrant has entered, and intends to continue to enter, into separate indemnification agreements with its directors and executive officers to provide these directors and executive officers additional contractual assurances regarding the scope of the indemnification set forth in the Registrant’s amended and restated
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certificate of incorporation and amended and restated bylaws and to provide additional procedural protections. At present, there is no pending litigation or proceeding involving a director or executive officer of the Registrant regarding which indemnification is sought. The indemnification provisions in the Registrant’s amended and restated certificate of incorporation, amended and restated bylaws and the indemnification agreements entered into or to be entered into between the Registrant and each of its directors and executive officers may be sufficiently broad to permit indemnification of the Registrant’s directors and executive officers for liabilities arising under the Securities Act. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
The Registrant currently carries liability insurance for its directors and officers.
Item 15. Recent Sales of Unregistered Securities
Series A Private Placement
On April 23, 2024, we entered into a securities purchase agreement (the “Series A Purchase Agreement”) with certain institutional and other accredited investors, pursuant to which we issued and sold, in a private placement (the “Series A Private Placement”), 240,000 shares of Series A Convertible Voting Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”), at a purchase price of $1,000 per share. The closing of the Series A Private Placement took place on April 24, 2024, and we received total gross proceeds of $240 million. The shares of common stock issuable upon conversion of the Series A Preferred Stock issued pursuant to the Series A Purchase Agreement were registered pursuant to a registration statement on Form S-1 (File No. 333-280919) filed with the Securities and Exchange Commission on July 19, 2024 and deemed effective on July 31, 2024.
The sales and issuances of securities in the transaction described above were not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) thereof or Regulation D promulgated thereunder. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed upon the stock certificates issued in these transactions. All recipients had adequate access, through their relationships with us, to information about us.
Private Placement (Common Stock and Prefunded Warrants)
On November 20, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) with the selling stockholders named in this prospectus, pursuant to which we sold and issued to the selling stockholders in a private placement (the “Private Placement”) (i) an aggregate of 3,892,274 shares of our common stock, par value $0.0001 per share (the “Common Stock”), at a purchase price of $14.912 per share, and (ii) in lieu of shares of Common Stock to certain selling stockholders, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 3,149,035 shares of Common Stock (the “Warrant Shares”) at a purchase price of $14.9119 per Pre-Funded Warrant (representing the $14.912 per share purchase price less the exercise price of $0.0001 per Warrant Share). The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.
The sales and issuances of securities in the transaction described above were not registered under the Securities Act in reliance upon the exemption from registration provided by Section 4(a)(2) thereof. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed upon the stock certificates and Pre-Funded Warrants issued in these transactions. All recipients had adequate access, through their relationships with us, to information about us.
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Item 16. Exhibits and Financial Statement Schedules
(a) Exhibit Index
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+ | Indicates management contract or compensatory plan. |
* | Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission. |
** | Certain portions of this exhibit are omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. |
‡ | Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC. |
(b) Financial Statement Schedules
All financial statement schedules are omitted because the information called for is not required or is shown either in the financial statements or in the notes thereto incorporated by reference herein.
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Item 17. Undertakings
The undersigned registrant hereby undertakes:
(a) (1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
Provided, however, That:
(B) Paragraphs (a)(1)(i), (ii) and (iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are incorporated by reference in this registration statement.
(2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.
(b) The registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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(c) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Diego, State of California, on December 23, 2024.
CIDARA THERAPEUTICS, INC. | ||
By: | /s/ Jeffrey Stein, Ph.D. | |
Jeffrey Stein, Ph.D. | ||
President and Chief Executive Officer |
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jeffrey Stein, Ph.D. and Preetam Shah, Ph.D., MBA, and each of them, as his/her true and lawful attorney-in-fact and agent, each acting alone, with full power of substitution and resubstitution, for him/her and in his/her name, place and stead, in any and all capacities, to sign any or all amendments (including post-effective amendments) to this Registration Statement, and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or his/her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed below by the following persons in the capacities and on the dates indicated.
Name | Title | Date | ||
/s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D. | President, Chief Executive Officer and Director (principal executive officer) | December 23, 2024 | ||
/s/ Preetam Shah, Ph.D., MBA Preetam Shah, Ph.D., MBA | Chief Financial Officer (principal financial and accounting officer) | December 23, 2024 | ||
/s/ Daniel D. Burgess Daniel D. Burgess | Chairman of the Board of Directors | December 23, 2024 | ||
/s/ Bonnie Bassler, Ph.D. Bonnie Bassler, Ph.D. | Director | December 23, 2024 | ||
/s/ Carin Canale-Theakston Carin Canale-Theakston | Director | December 23, 2024 | ||
/s/ James Merson, Ph.D. James Merson, Ph.D. | Director | December 23, 2024 | ||
/s/ Chrysa Mineo Chrysa Mineo | Director | December 23, 2024 |
Name | Title | Date | ||
/s/ Theodore R. Schroeder Theodore R. Schroeder | Director | December 23, 2024 | ||
/s/ Ryan Spencer Ryan Spencer | Director | December 23, 2024 | ||
/s/ Laura Tadvalkar, Ph.D. Laura Tadvalkar, Ph.D. | Director | December 23, 2024 |