As filed with the Securities and Exchange Commission on March 29, 2024
No. 333-
Delaware | | | 11-3430072 |
(State or other jurisdiction of incorporation or organization) | | | (IRS Employer Identification No.) |
Large accelerated filer ☐ | | | Accelerated filer ☐ |
Non-accelerated filer ☒ | | | Smaller reporting company ☒ |
| | Emerging growth company ☒ |
• | our financial condition, including our ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, our ability to continue as a going concern and our cash runway; |
• | the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
• | our ability to utilize our platform to develop a pipeline of product candidates to address unmet needs in cancer and infectious disease; |
• | the timing, progress and results of clinical trials for ELI-002, and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and research and development programs; |
• | the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs (as defined below) and U.S. Food and Drug Administration (“FDA”) approval of ELI-002 and any future product candidates; |
• | the timing, scope or likelihood of foreign regulatory filings and approvals; |
• | our ability to develop and advance current product candidates and programs into, and successfully complete, clinical studies; |
• | our manufacturing, commercialization, and marketing capabilities and strategy; |
• | the need to hire additional personnel and our ability to attract and retain such personnel; |
• | the size of the market opportunity for our product candidates, including estimates of the number of patients who suffer from the diseases we are targeting; |
• | expectations regarding the approval and use of our product candidates in combination with other drugs; |
• | expectations regarding potential for accelerated approval or other expedited regulatory designation; |
• | our competitive position and the success of competing therapies that are or may become available; |
• | our anticipated research and development activities and projected expenditures; |
• | existing regulations and regulatory developments in the United States, Europe and other jurisdictions; |
• | the extent to which global economic and political developments, including the ongoing conflict between Ukraine and Russia, the conflicts in the Middle East, geopolitical tensions with China, and other geopolitical events, will affect our business operations, clinical trials, or financial condition; |
• | our expectations regarding other macroeconomic trends; |
• | our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ELI-002, other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
• | our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for clinical trials; |
• | our ability to have manufactured sufficient supplies of drug product for clinical testing and commercialization; |
• | our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
• | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
• | our projected financial performance; |
• | the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our planned operating expenses and capital expenditure requirements; and |
• | the impact of laws and regulations. |
| | Shares of Common Stock Beneficially Owned Before this Offering | | | Number of Shares of Common Stock Being Offered(3) | | | Shares of Common Stock Beneficially Owned Upon Completion of this Offering | |||||||
| | Number | | | Percentage(2) | | | Number(4) | | | Percentage(2)(4) | ||||
Selling Stockholder(1) | | | | | | | | | | | |||||
GKCC, LLC(4) | | | 2,038,655 | | | 19.95% | | | 1,213,000 | | | 825,655 | | | 8.08% |
(1) | All information regarding the selling stockholder was provided by the selling stockholder as of March 19, 2024. |
(2) | Percentage ownership is based on 10,221,014 shares of common stock of the Company outstanding as of March 18, 2024. |
(3) | The number of shares of Common Stock in the column “Number of Shares of Common Stock Being Offered” represents all of the shares of Common Stock that a selling stockholder may offer and sell from time to time under this prospectus, including all shares of our Common Stock purchased by such selling stockholder in the Private Placement and shares of our Common Stock underlying pre-funded warrants exercisable by the selling stockholder within 60 days of March 19, 2024. |
(4) | The shares are held of record by GKCC, LLC. Yekaterina Chudnovsky, a director of the Company, has sole voting and investment control over the shares held by GKCC, LLC and may be deemed to beneficially own such shares. Yekaterina Chudnovsky does not directly own any securities of the Company. |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares 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; |
• | short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the SEC; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | broker-dealers may agree with the selling stockholder to sell a specified number of such shares at a stipulated price per share; |
• | a combination of any such methods of sale; and |
• | any other method permitted by applicable law. |
• | our Annual Report on Form 10-K for the year ended December 31, 2023 that we filed with the SEC on March 29, 2024; |
• | our Current Reports on Form 8-K filed with the SEC on January 9, 2024, January 16, 2024, January 17, 2024, February 2, 2024, March 18, 2024 and March 29, 2024, to the extent information therein is filed and not furnished; and |
• | the description of our common stock contained in our Registration Statement on Form 8-A filed with the SEC on February 2, 2021, including any amendments or reports filed for the purposes of updating this description. |
Item 14. | Other Expenses of Issuance and Distribution. |
Expense | | | Amount |
SEC Registration Fee | | | $1,244 |
Accounting Fees and Expenses | | | $10,000 |
Legal Fees and Expenses | | | $30,000 |
Miscellaneous Fees and Expenses | | | $5,000 |
Total | | | $46,244 |
Item 15. | Indemnification of Directors and Officers. |
Item 16. | Exhibits and Financial Statements Schedules. |
Item 17. | Undertakings. |
(a) | The undersigned registrant hereby undertakes: |
(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 Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% 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; |
(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: |
(i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. 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, |
(b) | The undersigned 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 section 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. |
(c) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant, 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 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 Act and will be governed by the final adjudication of such issue. |
Exhibit Number | | | Item |
| | Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-39990) filed on February 9, 2021). | |
| | Certificate of Amendment (Reverse Stock Split) to the Amended and Restated Certificate of Incorporation, dated June 1, 2023 (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K (File No. 001-39990) filed on June 2, 2023). | |
| | Certificate of Amendment (Officer Exculpation) to the Amended and Restated Certificate of Incorporation, dated June 1, 2023 (incorporated by reference to Exhibit 3.4 to the Company’s Current Report on Form 8-K (File No. 001-39990) filed on June 2, 2023). | |
| | Certificate of Amendment (Name Change) to the Amended and Restated Certificate of Incorporation, dated June 1, 2023 (incorporated by reference to Exhibit 3.5 to the Company’s Current Report on Form 8-K (File No. 001-39990) filed on June 2, 2023). | |
| | Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K (File No. 001-39990) filed on February 9, 2021). | |
| | Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. | |
| | Subscription Agreement, dated December 22, 2023, by and between Elicio Therapeutics, Inc. and GKCC, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-39990), filed on December 22, 2023). | |
| | Consent of Baker Tilly US, LLP. | |
| | Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (contained in Exhibit 5.1). | |
| | Powers of Attorney (included in the signature page of this registration statement). | |
| | Filing fee table. |
* | Filed herewith. |
| | ELICIO THERAPEUTICS, INC. | ||||
| | | | |||
| | By: | | | /s/ Robert Connelly | |
| | | | Robert Connelly | ||
| | | | Chief Executive Officer |
Name | | | Title | | | Date |
| | | | |||
/s/ Robert Connelly | | | Chief Executive Officer, President and Director (Principal Executive Officer) | | | March 29, 2024 |
Robert Connelly | | |||||
| | | | |||
/s/ Brian Piekos | | | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) | | | March 29, 2024 |
Brian Piekos | | |||||
| | | | |||
/s/ Jay Venkatesan, M.D. | | | Director | | | March 29, 2024 |
Jay Venkatesan, M.D. | | |||||
| | | | |||
/s/ Julian Adams, Ph.D. | | | Director | | | March 29, 2024 |
Julian Adams, Ph.D. | | |||||
| | | | |||
/s/ Carol Ashe | | | Director | | | March 29, 2024 |
Carol Ashe | | |||||
| | | | |||
/s/ Yekaterina (Katie) Chudnovsky | | | Director | | | March 29, 2024 |
Yekaterina (Katie) Chudnovsky | | |||||
| | | | |||
/s/ Robert R. Ruffolo, Jr., Ph.D. | | | Director | | | March 29, 2024 |
Robert R. Ruffolo, Jr., Ph.D. | | |||||
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