Agile Therapeutics (AGXRW) 10-Q9 Nov 232023 Q3 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2023	Nov. 07, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
Entity File Number	001-36464
Entity Registrant Name	AGILE THERAPEUTICS INC
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	23-2936302
Entity Address, Address Line One	500 College Road East, Suite 300
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	609
Local Phone Number	683-1880
Title of 12(b) Security	Common stock
Trading Symbol	AGRX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		2,511,657
Entity Central Index Key	0001261249
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Amendment Flag	false

Balance Sheets

Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 2,873	$ 5,246
Accounts receivable, net	3,521	3,377
Inventory, net	2,411	1,332
Prepaid expenses and other current assets	1,259	1,403
Total current assets	10,064	11,358
Property and equipment, net	101	177
Right of use asset	486	695
Other non-current assets	238	2,012
Total assets	10,889	14,242
Current liabilities:
Long-term debt, current portion	1,589	1,426
Notes payable, current portion	379
Accounts payable	6,879	7,734
Accrued expenses	8,338	3,908
Lease liability, current portion	353	319
Total current liabilities	17,538	13,387
Lease liabilities, long-term	196	466
Warrant liability	5,566	5,934
Total liabilities	23,300	19,787
Commitments and contingencies (Note 10)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively	0	0
Additional paid-in capital	406,288	403,157
Accumulated deficit	(418,699)	(408,702)
Total stockholders' deficit	(12,411)	(5,545)
Total liabilities and stockholders' deficit	$ 10,889	$ 14,242

Balance Sheets (Parenthetical)

Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, authorized (in shares)	10,000,000	10,000,000
Preferred stock, issued (in shares)	4,850	0
Preferred stock, outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, authorized (in shares)	300,000,000	300,000,000
Common stock, issued (in shares)	2,277,657	859,402
Common stock, outstanding (in shares)	2,277,657	859,402

Statements of Operations and Co

Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Statements of Operations and Comprehensive Loss
Revenues, net	$ 6,662	$ 3,002	$ 15,979	$ 6,888
Cost of product revenues	2,477	1,425	6,787	5,183
Gross profit	4,185	1,577	9,192	1,705
Operating expenses:
Research and development	705	788	2,171	2,901
Selling and marketing	4,800	5,560	14,040	23,523
General and administrative	2,680	2,815	8,813	9,837
Loss on disposition of assets		11,122		11,122
Total operating expenses	8,185	20,285	25,024	47,383
Loss from operations	(4,000)	(18,708)	(15,832)	(45,678)
Other income (expense)
Interest income	13	46	61	50
Interest expense	(341)	(1,004)	(1,114)	(2,699)
Unrealized gain on warrant liability	3,529	13,736	6,890	22,171
Total other income, net	3,201	12,778	5,837	19,522
Loss before benefit from income taxes	(799)	(5,930)	(9,995)	(26,156)
Benefit from income taxes				4,675
Net loss and comprehensive loss	$ (799)	$ (5,930)	$ (9,995)	$ (21,481)
Net loss per share (basic) (in dollars per share)	$ (0.27)	$ (8.01)	$ (5.30)	$ (71.61)
Net loss per share (diluted) (in dollars per share)	$ (0.27)	$ (8.01)	$ (5.30)	$ (71.61)
Weighted-average common shares (basic) (in shares)	2,950,136	739,957	1,884,793	299,970
Weighted-average common shares (diluted) (in shares)	2,950,136	739,957	1,884,793	299,970

Statements of Changes in Stockh

Statements of Changes in Stockholders' Deficit - USD ($)	Preferred Stock Series B Convertible Preferred Stock	Preferred Stock Series A and B Convertible Preferred Stock	Preferred Stock	Common stock Public offering	Common stock At-the-market sales	Common stock Series A Convertible Preferred Stock	Common stock Series B Convertible Preferred Stock	Common stock	Additional Paid-in Capital. At-the-market sales	Additional Paid-in Capital.	Accumulated Deficit	At-the-market sales	Total
Balance at Dec. 31, 2021										$ 387,205,000	$ (383,290,000)		$ 3,915,000
Balance (in shares) at Dec. 31, 2021								60,698
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										764,000			764,000
Issuance of common stock									$ 348,000			$ 348,000
Issuance of common stock (in shares)					512
Issuance of common stock upon exercise of options (in shares)		4,850
Conversion of convertible preferred stock (in shares)						6,063
Vesting of RSUs			$ (2,425)
Vesting of RSUs (in shares)								35
Net loss											(10,385,000)		(10,385,000)
Balance at Mar. 31, 2022										388,317,000	(393,675,000)		(5,358,000)
Balance (in shares) at Mar. 31, 2022			2,425					67,308
Balance at Dec. 31, 2021										387,205,000	(383,290,000)		3,915,000
Balance (in shares) at Dec. 31, 2021								60,698
Increase (decrease) in stockholders' equity
Net loss													(21,481,000)
Balance at Sep. 30, 2022										401,748,000	(404,773,000)		(3,025,000)
Balance (in shares) at Sep. 30, 2022								780,535
Balance at Dec. 31, 2021										387,205,000	(383,290,000)		3,915,000
Balance (in shares) at Dec. 31, 2021								60,698
Balance at Dec. 31, 2022										403,157,000	(408,702,000)		(5,545,000)
Balance (in shares) at Dec. 31, 2022								859,402
Balance at Mar. 31, 2022										388,317,000	(393,675,000)		(5,358,000)
Balance (in shares) at Mar. 31, 2022			2,425					67,308
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										669,000			669,000
Issuance of common stock									12,226,000			12,226,000
Issuance of common stock (in shares)					173,750
Conversion of convertible preferred stock (in shares)	(2,425)						6,062
Vesting of RSUs (in shares)								82
Net loss											(5,168,000)		(5,168,000)
Balance at Jun. 30, 2022										401,212,000	(398,843,000)		2,369,000
Balance (in shares) at Jun. 30, 2022								247,202
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										536,000			536,000
Issuance of common stock (in shares)								533,333
Net loss											(5,930,000)		(5,930,000)
Balance at Sep. 30, 2022										401,748,000	(404,773,000)		(3,025,000)
Balance (in shares) at Sep. 30, 2022								780,535
Balance at Dec. 31, 2022										403,157,000	(408,702,000)		(5,545,000)
Balance (in shares) at Dec. 31, 2022								859,402
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										498,000			498,000
Issuance of common stock									1,003,000			1,003,000
Issuance of common stock (in shares)					72,699
Net loss											(5,389,000)		(5,389,000)
Balance at Mar. 31, 2023										404,658,000	(414,091,000)		(9,433,000)
Balance (in shares) at Mar. 31, 2023								932,101
Balance at Dec. 31, 2022										403,157,000	(408,702,000)		(5,545,000)
Balance (in shares) at Dec. 31, 2022								859,402
Increase (decrease) in stockholders' equity
Net loss													(9,995,000)
Balance at Sep. 30, 2023										406,288,000	(418,699,000)		(12,411,000)
Balance (in shares) at Sep. 30, 2023								2,277,657
Balance at Mar. 31, 2023										404,658,000	(414,091,000)		(9,433,000)
Balance (in shares) at Mar. 31, 2023								932,101
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										$ 482,000			$ 482,000
Fractional shares retired as a result of reverse split										13,000			13,000
Issuance of common stock									$ 652,000			$ 652,000
Issuance of common stock (in shares)				95,000	105,342
Exercise of pre-funded warrants (in shares)								508,286
Vesting of RSUs (in shares)								76
Net loss											(3,809,000)		$ (3,809,000)
Balance at Jun. 30, 2023										$ 405,779,000	(417,900,000)		(12,121,000)
Balance (in shares) at Jun. 30, 2023								1,640,805
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs										439,000			439,000
Issuance of common stock										70,000			70,000
Issuance of common stock (in shares)								29,842
Exercise of pre-funded warrants (in shares)								607,000
Vesting of RSUs (in shares)								10
Net loss											(799,000)		(799,000)
Balance at Sep. 30, 2023										$ 406,288,000	$ (418,699,000)		$ (12,411,000)
Balance (in shares) at Sep. 30, 2023								2,277,657

Statements of Changes in Stoc_2

Statements of Changes in Stockholders' Deficit (Parenthetical)	Apr. 10, 2023
Statements of Changes in Stockholders' Deficit
Stockholders' Equity Note, Stock Split, Conversion Ratio	0.02

Statements of Cash Flows

Statements of Cash Flows - USD ($)	9 Months Ended
Statements of Cash Flows - USD ($)	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (9,995,000)	$ (21,481,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	77,000	1,255,000
Amortization	209,000	188,000
Loss on disposition of assets		11,122,000
Noncash stock-based compensation	1,418,000	1,969,000
Noncash amortization of deferred financing costs	838,000	1,635,000
Unrealized gain on warrants	(6,890,000)	(22,171,000)
Changes in operating assets and liabilities:
Accounts receivable	(144,000)	(2,178,000)
Inventory	(1,079,000)	(831,000)
Prepaid expenses and other assets	2,480,000	(1,551,000)
Accounts payable and accrued expenses	3,572,000	(2,213,000)
Lease liability	(235,000)	(132,000)
Net cash used in operating activities	(9,749,000)	(34,388,000)
Cash flows from investing activities:
Acquisition of property and equipment		(133,000)
Net cash used in investing activities		(133,000)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs	6,509,000	21,971,000
Repayments of long-term debt	(675,000)	(17,150,000)
Repayments of note payable	(184,000)
Net cash provided by financing activities	7,375,000	21,523,000
Net decrease in cash and cash equivalents	(2,374,000)	(12,998,000)
Cash and cash equivalents, beginning of period	5,246,000	19,143,000
Cash and cash equivalents, end of period	2,873,000	6,145,000
Supplemental disclosure of noncash financing activities
Warrants issued in connection with preferred stock offering		2,101,000
Supplemental cash flow information
Interest paid	276,000	1,078,000
Series A Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		897,000
Series B Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		887,000
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129,000
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs	$ 1,725,000	$ 12,573,000

Organization and Description of

Organization and Description of Business	9 Months Ended
Organization and Description of Business	Sep. 30, 2023
Organization and Description of Business
Organization and Description of Business	1. Organization and Description of Business Nature of Operations Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla ® The Company’s sole approved product, Twirla, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA, in February 2020 and was commercially launched in early December 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has generated minimal product revenue to date and is subject to a number of risks similar to those of other early stage commercial companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the need to obtain additional capital necessary to fund the development of its products, reliance on a consistent supply chain both for Twirla and in general, macroeconomic factors such as inflation, competition from larger companies, and compliance with FDA and other government regulations. If the Company does not continue to successfully commercialize Twirla, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of September 30, 2023, the Company had an accumulated deficit of approximately million. The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company: ● maintains a sales and marketing infrastructure and contract manufacturing arrangement to support the continued commercialization of Twirla in the United States; ● continues to commercialize Twirla and seek increased uptake of Twirla in the United States; ● continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla; ● maintains, leverages, and expands the Company’s intellectual property portfolio; and ● maintains operational, financial, and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts. The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 8), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. Going Concern As of September 30, 2023, the Company had cash and cash equivalents of $2.9 million and a $7.5 million working capital deficit. The Company’s current liquidity is sufficient to fund operations into December 2023. The Company closely monitors its cash and cash equivalents and will need to raise additional funds to meet its projected operating requirements, including the continued commercialization of Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities. The Company has generated losses since inception, used substantial cash in operations, has a working capital deficit as of September 30, 2023, and anticipates it will continue to incur net losses for the foreseeable future. The Company’s future success depends on its ability to obtain additional capital and/or implement various strategic alternatives, and there can be no assurance that any financing can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern through the 12 months following the date on which this Quarterly Report on Form 10-Q is filed. The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives, or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities. The unaudited financial statements as of September 30, 2023 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan and successfully commercialize Twirla. The unaudited financial statements as of September 30, 2023 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements. Basis of Presentation The accompanying unaudited interim financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for Quarterly Reports on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP has been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 23, 2023. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods presented. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the operating results for the full fiscal year or any future period. The Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations .

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
Summary of Significant Accounting Policies	Sep. 30, 2023
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	2 The Company’s complete listing of significant accounting policies is described in Note 2 to the Company’s audited financial statements as of December 31, 2022 included in its Annual Report on Form 10-K filed with the SEC on March 23, 2023. Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, costs of product revenues, inventory reserves, the accounting for common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Risks and Uncertainties While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed, or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations. It should be noted that the possibility of continued public health threats could adversely affect the Company’s ongoing or planned business operations. For example, the coronavirus (“COVID-19”) pandemic previously resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The most significant impacts to the Company’s business were encountered by sales representatives promoting Twirla in the field, as some offices limited opportunities for face-to-face interactions with healthcare providers. Re-implementation of COVID-19 restrictions, if necessary in the future, may disrupt the Company’s business and/or could adversely affect the Company’s commercialization plans and results. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom the Company engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. Another shutdown necessitating work in a completely remote environment could result in delays to its business activities and commercialization plan. The Company will continue to closely monitor events as they develop, and plan for alternative and mitigating measures that can be implemented if needed. Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. Trade Accounts Receivable and Allowances Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward-looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of September 30, 2023 and December 31, 2022. Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. Inventory Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of September 30, 2023 and December 31, 2022, inventory reserves approximated $1.4 million and $0.6 million, respectively. Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment Research and Development Expenses Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees, and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. Advertising Costs Deferred Financing Costs Costs directly attributable to the Company’s senior secured term loan (see Note 7) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $44,000 and $146,000 for the three months ended September 30, 2023 and 2022, respectively and was approximately $146,000 and $284,000 for the nine months ended September 30, 2023 and 2022, respectively. Concentrations of Credit Risk Financial instruments, which potentially subject the Company to credit risk consist principally of cash, cash equivalents, and accounts receivable. The Company invests its cash and cash equivalents in interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity, and have a high credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three months ended September 30, 2023, the Company had sales to five customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.7 million, $1.3 million, $1.1 million, $1.1 million, and $1.1 million, respectively, which represented 93% of total revenues in the three months ended September 30, 2023. In the nine months ended September 30, 2023, the Company had sales to five customers that individually accounted for more than 10% of its total revenue. These customers had sales of $3.2 million, $3.2 million, $3.2 million, $3.0 million and $2.1 million, respectively, which represented 92% of total revenue for the nine months ended September 30, 2023. Accounts receivable related to these five customers comprised 36%, 26%, 18%, 15%, and 0%, of the Company’s total accounts receivable, respectively, as of September 30, 2023. In the three months ended September 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $0.7 million, $0.6 million, and $0.6 million, respectively, which represented 30% of total revenues in the three months ended September 30, 2022. In the nine months ended September 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.9 million, $1.8 million and $1.7 million, respectively, which represented 33% of total revenue for the nine months ended September 30, 2022. Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable and Allowance policy. The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Twirla is sold to customers at the wholesale acquisition cost (“WAC”). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: ● Distribution services fees; ● Prompt pay and other discounts; ● Product returns; ● Chargebacks; ● Rebates; and ● Co-payment assistance. An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period. In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data continues to become available, the Company will incorporate that data into its estimates of variable consideration. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows: Distribution services fees – The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra trade accounts receivable on the balance sheet. Prompt pay and other discount The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded. Product returns Chargebacks Rebates Co-payment assistance Provisions for the revenue reserves described above totaled $8.5 million and $3.2 million for the three months ended September 30, 2023 and 2022, respectively, and $19.3 million and $6.1 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, reserves on the balance sheet associated with variable consideration were $7.4 million. Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . In connection with entering into a senior secured term loan facility in February 2020 (the “Perceptive Credit Agreement”), the Company issued warrants to purchase Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 6,660 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statements of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information. In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information. In connection with a letter agreement and waiver entered into with an investor on April 2022, the Company issued warrants to purchase shares of common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. See Note 8 for additional information. In connection with a public offering completed in July 2022, the Company issued warrants to purchase In connection with a public offering completed in May 2023, the Company issued warrants to purchase Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of September 30, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to no less than the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, respectively, because to do so would be anti-dilutive (in common equivalent shares): September 30, 2023 2022 Common stock warrants 4,484,077 36,691 Unvested restricted stock units 135,037 142 Common stock options 43,510 5,778 Total 4,662,624 42,611 Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its financial statements.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
Fair Value Measurements	Sep. 30, 2023
Fair Value Measurements
Fair Value Measurements	3. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities. ● Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities. ● Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company has no Level 3 assets. Level 3 liabilities consist of warrant liability. The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands): Level 1 Level 2 Level 3 September 30, 2023 Assets: Cash and cash equivalents $ 2,873 $ — $ — Total assets at fair value $ 2,873 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,566 Total assets at fair value $ — $ — $ 5,566 Level 1 Level 2 Level 3 December 31, 2022 Assets: Cash and cash equivalents $ 5,246 $ — $ — Total assets at fair value $ 5,246 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,934 Total assets at fair value $ — $ — $ 5,934 The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of September 30, 2023 include (i) volatility 86.06% - 123.42%, (ii) risk-free interest rate 4.62% - 5.46%, (iii) strike price for the common warrants of $3.69, $45.00 and $1,700.00, (iv) fair value of common stock $2.40 and (v) expected life 1.15 - 4.65 years. The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2022 include (i) volatility 136.8% - 137.4%, (ii) risk-free interest rate 4.2% - 4.7%, (iii) strike price for the common warrants $45.00 and $1,700, (iv) strike price for the preferred warrants of $520.00, (v) fair value of common stock $11.50 and (vi) expected life 0.7 - 4.5 years. The following is a roll forward of the fair value of Level 3 warrants: Beginning balance at December 31, 2022 $ 5,934 Warrants issued 10,615 Change in fair value (10,983) Ending Balance September 30, 2023 $ 5,566 There were no transfers between Level 1, 2 or 3 during the nine months ended September 30, 2023 or 2022.

Prepaid Expenses and Other Curr

Prepaid Expenses and Other Current Assets	9 Months Ended
Prepaid Expenses and Other Current Assets	Sep. 30, 2023
Prepaid Expenses and Other Current Assets
Prepaid Expenses and Other Current Assets	4. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, 2023 2022 Prepaid insurance $ 697 $ 628 Other 562 775 Total prepaid expenses and other current assets $ 1,259 $ 1,403

Accrued Liabilities

Accrued Liabilities	9 Months Ended
Accrued Liabilities	Sep. 30, 2023
Accrued Liabilities
Accrued Liabilities	5. Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, 2023 2022 Gross to net accruals $ 3,933 $ 2,332 Accrued compensation 2,721 833 Accrued professional fees and other 1,684 743 Total accrued liabilities $ 8,338 $ 3,908

Leases

Leases	9 Months Ended
Leases	Sep. 30, 2023
Leases
Leases	6. Leases The Company has no finance leases and one operating lease for its corporate headquarters in Princeton, NJ. The current lease commenced on December 1, 2021 and terminates on March 31, 2025. The lease provides the Company with an option to extend the lease for an additional five years. Under the terms of the lease, the Company pays base annual rent subject to a fixed dollar amount increase each year, a fixed monthly charge for electricity, and other normal operating expenses such as taxes, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The lease does not require variable lease payments, residual value guarantees, or restrictive covenants. The lease does not provide an implicit rate, therefore the Company used its incremental borrowing rate as the discount rate when measuring the operating lease liability. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease. Operating lease expense was $89,000 and $90,000 for the three months ended September 30, 2023 and 2022, respectively. Operating lease expense was $267,000 and $271,000 for the nine months ended September 30, 2023 and 2022, respectively. Operating cash flows used for operating leases during the nine months ended September 30, 2023 and 2022 were approximately $235,000 and $132,000 respectively. As of September 30, 2023, the weighted average remaining lease term was 1.50 years, and the weighted average discount rate was 11.8%. Future minimum lease payments under non-cancellable leases as of September 30, 2023 were as follows (in thousands): 2023 $ 98 2024 397 2025 101 Total $ 596 Less: Interest (47) Present value of lease liability $ 549

Credit Agreement and Guaranty

Credit Agreement and Guaranty	9 Months Ended
Credit Agreement and Guaranty	Sep. 30, 2023
Credit Agreement and Guaranty
Credit Agreement and Guaranty	7. Credit Agreement and Guaranty On February 10, 2020, the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP (“Perceptive”) for a senior secured term loan credit facility of up to The facility will mature on February 10, 2024 (“Maturity Date”). Pursuant to the Perceptive Credit Agreement, beginning August 31, 2022, the Company began making monthly principal payments in an amount equal to Borrowings under the Perceptive Credit Agreement will accrue interest at an annual rate equal to the London Interbank Offered Rate for one-month deposits (“LIBOR”) plus The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment premium of All of the Company’s obligations under the Perceptive Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property. The Perceptive Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customary for similar financings. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain investments or restricted payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, as amended by the Seventh Amendment, the Company must (i) at all times for the period from June 30, 2023 to October 31, 2023 maintain a minimum cash balance of In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 700 shares of the Company’s common stock (together, the “2020 Perceptive Warrants”). The first warrant is exercisable for 350 shares of common stock at an exercise price of $7,480 per share. The second warrant is exercisable for 350 shares of common stock at an exercise price of $9,340 per share. The 2020 Perceptive Warrants expire on February 10, 2027. In connection with the Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 225 shares of the Company’s common stock (the “2021 Perceptive Warrant” and, together with the 2020 Perceptive Warrants, the “Perceptive Warrants”) at an exercise price of $5,740 per share. The 2021 Perceptive Warrant expires on February 26, 2028. In connection with the Sixth Amendment, the Company amended the Perceptive Warrants to reset the exercise price to $10.50 per warrant. In connection with the Seventh Amendment, the Company further amended the Perceptive Warrants to reset the exercise price to As a result of the public offering of the Company’s common stock completed in October 2021 (see Note 8), the antidilution provision of the Perceptive Warrants was triggered, resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $9,340 per share were reduced to $7,080 per share, warrants to purchase 350 shares of common stock that had an exercise price of $7,480 per share were reduced to $5,760 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $5,740 per share were reduced to $4,540 per share. As a result of the registered direct offering completed in March 2022 (see Note 8), the anti-dilution provision of the Perceptive Warrants was again triggered resulting in a further reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an adjusted exercise price of $7,080 per share were reduced to $5,276 per share, warrants to purchase 350 shares of common stock that had an adjusted exercise price of $5,760 per share were reduced to $4,330.50 per share, and warrants to purchase 225 shares of common stock that had an adjusted exercise price of $4,540 per share were reduced to $3,456.50 per share. As a result of the public offering of the Company’s common stock completed in July 2022 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $5,276 per share were reduced to $745 per share, warrants to purchase 350 shares of common stock that had an exercise price of $4,330.50 per share were reduced to $618.50 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $3,456.50 per share were reduced to $501.50 per share. As a result of the public offering of the Company’s common stock completed in May 2023 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $745 per share were reduced to $3.69 per share, warrants to purchase 350 shares of common stock that had an exercise price of $618.50 per share were reduced to $3.69 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $501.50 per share were reduced to $3.69 per share. The Company allocated the proceeds of September 30, December 31, 2023 2022 Notes payable $ 1,950 $ 2,625 Debt issuance costs (63) (209) Warrant discount (298) (990) Total debt $ 1,589 $ 1,426 Less, current portion 1,589 1,426 Long-term debt, less current portion $ — $ — The fair value of the warrants and the debt issue costs are being amortized utilizing the effective interest method over the term of the loan. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of

Stockholders Deficit

Stockholders Deficit	9 Months Ended
Stockholders Deficit	Sep. 30, 2023
Stockholders' Deficit
Stockholders Deficit	8. Stockholders’ Deficit On January 7, 2022, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of shares of common stock authorized for issuance from 150,000,000 shares to 300,000,000 shares. Reverse Stock Split On April 10, 2023, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment, or the Certificate of Amendment, to the Company’s Amended and Restated Certificate of Incorporation, which became effective on April 10, 2023 . The Certificate of Amendment implemented a 1 issued outstanding Shelf Registration Statement On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices, and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. Public Offerings In October 2021, the Company completed a public offering of 13,333 shares of its common stock and warrants to purchase 6,660 shares of its common stock at a combined price of $1,700 per share of common stock and one-half of a warrant to purchase one share of common stock. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $21.1 million. In July 2022, the Company completed a best efforts public offering (the “2022 Offering”) in which the Company raised net proceeds of $22.0 million through the sale of 382,966 shares of common stock and 150,366 pre-funded warrants (“Series B pre-funded warrants”) to purchase 150,366 shares of common stock at a combined price of $45.00 per share of common stock and warrants. Both the sales of shares of common stock and pre-funded warrants were accompanied by Series A-1 and Series A-2 warrants (together the “Series A warrants”) to purchase shares of common stock. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants expired unexercised in August 2023. H.C. Wainwright acted as the exclusive placement agent in connection with the 2022 Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the 2022 Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 26,666 shares of common stock with an exercise price of $56.25 per share. In May 2023, the Company completed a best efforts public offering of an aggregate of 95,000 shares of common stock and 1,801,286 pre-funded warrants in lieu of shares of common stock and warrants to purchase a total of 3,792,572 shares of common stock at combined public offering price of $3.9551 per share. Proceeds from the public offering, net of underwriting discounts, commissions, and offering expenses were approximately $6.5 million. Through September 30, 2023 at total of 1,115,286 pre-funded warrants have been exercised and 686,000 pre-funded warrants remain available for exercise as of September 30, 2023. H.C. Wainwright acted as the exclusive placement agent in connection with the Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 94,814 shares of commons stock with an exercise price of $4.9439 per share. The Company has accounted for the warrants as liabilities, while the pre-funded warrants are classified as a component of permanent equity within additional paid-in capital because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The Company also determined that the pre-funded warrants should be included in the determination of basic earnings per share in accordance with ASC 260, Earnings per Share ATM Sales Agreement In March 2021, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $50.0 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the year ended December 31, 2021, the Company issued and sold 3,457 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $9.3 million. On January 10, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering an at-the-market offering program (the “2022 ATM”) the Company entered into for the sale of up to $50.0 million of shares of its common stock. The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the three months ended March 31, 2022, the Company issued and sold 512 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $0.3 million. On April 26, 2022, the Company terminated the 2022 ATM. On April 27, 2022, the Company entered into a new at-the-market offering program (the “April 2022 ATM Agreement”) with H.C. Wainwright LLC and Co. (the “Sales Agent”) under which the Company is authorized to sell up to an aggregate of $12.8 million in gross proceeds through the sale of shares of common stock from time to time. The Company agreed to pay a commission of up to 3.0% of the gross proceeds of any common stock sold under the April 2022 ATM Agreement. Through September 30, 2022, the Company issued and sold a total of 173,750 shares of common stock under the April 2022 ATM Agreement, representing the entire capacity of the April 2022 ATM, resulting in net proceeds of approximately $12.2 million. On August 22, 2022, the Company increased the April 2022 ATM (“August 2022 ATM”). As increased, the Company was eligible to offer and sell, from time to time through the Sales Agent, shares of its common stock having an aggregate offering price of up to $75.0 million. During the year ended December 31, 2022, the Company issued and sold 78,852 shares of common stock under the August 2022 ATM resulting in net proceeds of approximately $0.9 million. During the nine months ended September 30, 2023, the Company issued and sold 207,883 shares for net proceeds of approximately $1.7 million. On April 12, 2023, the Company filed a prospectus supplement to its registration statement on Form S-3 for the August 2022 ATM verifying that it is now eligible to sell up to $4.5 million worth of shares through its ATM. Registered Direct Offering On March 14, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering a direct offering (the “2022 Preferred Stock Offering”) of 2,425 shares of Series A convertible preferred stock (the “Series A Preferred Stock”) and 2,425 shares of Series B convertible preferred stock (the “Series B Preferred Stock”) and Series A warrants (the “Series A Warrants”) to purchase up to an aggregate of 12,125 shares of the common stock of the Company and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 12,125 shares of common stock. Each share of Series A Preferred Stock and Series B Preferred Stock has a stated value of $1,000 per share and a conversion price of $400.00 per share. The shares of preferred stock issued in the 2022 Preferred Stock Offering are convertible into an aggregate of 12,125 shares of common stock. The Series A Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The Series B Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire one and one -half years following the initial exercise date. On March 15, 2022, 2,425 shares of the Series A Preferred Stock were converted into 6,025 shares of the Company’s common stock. On April 4, 2022, 2,425 shares of the Series B Preferred Stock were converted into 6,025 shares of the Company’s common stock. On April 25, 2022, the Company entered into a letter agreement and waiver (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), pursuant to which Armistice consented to the Company entering into and effecting an at-the-market (“ATM”) offering facility. On March 14, 2022, the Company entered into the 2022 Preferred Stock Offering with Armistice, under which agreement, the Company was restricted from entering into and effecting an ATM offering facility until the 180-day Stock-Based Compensation Expense Stock-based compensation expense was allocated as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Cost of goods sold $ 12 $ 29 $ 69 $ 104 Research and development 94 90 261 284 Selling and marketing 10 40 73 120 General and administrative 323 377 1,015 1,461 Total $ 439 $ 536 $ 1,418 $ 1,969

Income Taxes

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2023
Income Taxes
Income Taxes	9. Income Taxes Sale of New Jersey Net Operating Losses The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. The Company had previously reached the maximum lifetime benefit of $15.0 million under the historical Program; however, in January 2021 the Program was amended to extend the maximum lifetime benefit to $20.0 million. The Company received final approval in March 2022 for $4.7 million of additional cash benefit that was received in April 2022.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 2023
Commitments and Contingencies
Commitments and Contingencies	10. Commitments and Contingencies The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2033, total $230.1 million. This amount does not represent all of the Company’s anticipated purchases in the future, but instead represents only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend in 2023 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment. In April 2020, the Company entered into a manufacturing and commercialization agreement with Corium (the “Corium Agreement”). Under the Corium Agreement, the Company has a requirement to order quarterly minimum volumes of approximately $5.6 million of product. In the event that the Company does not order the minimum volume, the Company is required to pay an additional fee equal to twenty-five percent (25%) per unit of the transfer price for all units ordered in that quarter. The Company did not meet the minimum volume order in the first or second quarter of 2022, and has, therefore, paid the additional 25% per unit fee as a penalty for all units ordered during the period. Based on then-current demand expectations for Twirla, the Company did not expect to meet the minimum volume order for the balance of 2022 and would be subject to the additional fee on future purchases. On July 25, 2022 the Company and Corium entered into Amendment No. 1 to the Corium Agreement (the “Amendment”) that is designed to restructure the contract minimums applicable to the purchase of manufactured Twirla and other services provided by Corium, transfer equipment ownership to Corium to support the manufacture of Twirla, and extend the term of the Corium Agreement. Pursuant to the Amendment, the parties agreed to adjust the process for the Company providing Corium certain binding and non-binding forecasts required under the Corium Agreement. Additionally, Corium will not enforce the original quantity minimums in the Corium Agreement, which are waived and replaced by new minimums that are based on Corium’s revenue for product purchased by the Company, expiring raw materials, and other services billed by Corium to support batch production and release. The guaranteed minimum revenue requirement for 2023 is $7.0 million, and is $22.5 million for 2024 and each year thereafter. In the event that the Company does not meet the guaranteed minimum revenue requirements in any given year, the Company will be required to make additional payments to Corium for the shortfall. The Company agreed to make certain monthly supplemental payments to Corium through December 2023, which payments are eligible to be retroactively reduced based upon product orders placed by the Company during 2023 meeting certain designated thresholds. In connection with the supplemental payments, Corium will retain the proceeds for the sale of certain raw materials to which the Company would otherwise have economic right to offset such supplemental payments. Further, the Company agreed to reimburse Corium for any unused raw materials in the event the Company’s actual product requirements are lower than initially forecasted. Pursuant to the Amendment, the term of the Corium Agreement was extended to December 31, 2033. Pursuant to the Amendment, the parties agreed to transfer ownership of certain manufacturing equipment used in the manufacture of Twirla from the Company to Corium under a Bill of Sale dated July 25, 2022. The Company records a provision for contingent losses when it is both probable that a liability has been incurred, and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company's operations or its financial position. As of September 30, 2023, the Company has not recorded a provision for any contingent losses.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2023
Summary of Significant Accounting Policies
Basis of Presentation	Basis of Presentation The accompanying unaudited interim financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for Quarterly Reports on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP has been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 23, 2023. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods presented. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the operating results for the full fiscal year or any future period. The Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations .
Use of Estimates	Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, costs of product revenues, inventory reserves, the accounting for common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates.
Risks and Uncertainties	Risks and Uncertainties While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed, or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations. It should be noted that the possibility of continued public health threats could adversely affect the Company’s ongoing or planned business operations. For example, the coronavirus (“COVID-19”) pandemic previously resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The most significant impacts to the Company’s business were encountered by sales representatives promoting Twirla in the field, as some offices limited opportunities for face-to-face interactions with healthcare providers. Re-implementation of COVID-19 restrictions, if necessary in the future, may disrupt the Company’s business and/or could adversely affect the Company’s commercialization plans and results. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom the Company engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. Another shutdown necessitating work in a completely remote environment could result in delays to its business activities and commercialization plan. The Company will continue to closely monitor events as they develop, and plan for alternative and mitigating measures that can be implemented if needed.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.
Trade Accounts Receivable and Allowances	Trade Accounts Receivable and Allowances Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward-looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of September 30, 2023 and December 31, 2022. Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists.
Fair Value of Financial Instruments	Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.
Inventory	Inventory Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of September 30, 2023 and December 31, 2022, inventory reserves approximated $1.4 million and $0.6 million, respectively.
Long-Lived Assets	Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment
Research and Development Expense	Research and Development Expenses Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees, and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received.
Advertising Costs	Advertising Costs
Deferred Financing Costs	Deferred Financing Costs Costs directly attributable to the Company’s senior secured term loan (see Note 7) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $44,000 and $146,000 for the three months ended September 30, 2023 and 2022, respectively and was approximately $146,000 and $284,000 for the nine months ended September 30, 2023 and 2022, respectively.
Concentrations of Credit Risk	Concentrations of Credit Risk Financial instruments, which potentially subject the Company to credit risk consist principally of cash, cash equivalents, and accounts receivable. The Company invests its cash and cash equivalents in interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity, and have a high credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three months ended September 30, 2023, the Company had sales to five customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.7 million, $1.3 million, $1.1 million, $1.1 million, and $1.1 million, respectively, which represented 93% of total revenues in the three months ended September 30, 2023. In the nine months ended September 30, 2023, the Company had sales to five customers that individually accounted for more than 10% of its total revenue. These customers had sales of $3.2 million, $3.2 million, $3.2 million, $3.0 million and $2.1 million, respectively, which represented 92% of total revenue for the nine months ended September 30, 2023. Accounts receivable related to these five customers comprised 36%, 26%, 18%, 15%, and 0%, of the Company’s total accounts receivable, respectively, as of September 30, 2023. In the three months ended September 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $0.7 million, $0.6 million, and $0.6 million, respectively, which represented 30% of total revenues in the three months ended September 30, 2022. In the nine months ended September 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.9 million, $1.8 million and $1.7 million, respectively, which represented 33% of total revenue for the nine months ended September 30, 2022.
Revenue Recognition	Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable and Allowance policy. The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Twirla is sold to customers at the wholesale acquisition cost (“WAC”). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: ● Distribution services fees; ● Prompt pay and other discounts; ● Product returns; ● Chargebacks; ● Rebates; and ● Co-payment assistance. An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period. In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data continues to become available, the Company will incorporate that data into its estimates of variable consideration. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows: Distribution services fees – The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra trade accounts receivable on the balance sheet. Prompt pay and other discount The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded. Product returns Chargebacks Rebates Co-payment assistance Provisions for the revenue reserves described above totaled $8.5 million and $3.2 million for the three months ended September 30, 2023 and 2022, respectively, and $19.3 million and $6.1 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, reserves on the balance sheet associated with variable consideration were $7.4 million.
Warrants	Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . In connection with entering into a senior secured term loan facility in February 2020 (the “Perceptive Credit Agreement”), the Company issued warrants to purchase Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 6,660 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statements of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information. In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information. In connection with a letter agreement and waiver entered into with an investor on April 2022, the Company issued warrants to purchase shares of common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. See Note 8 for additional information. In connection with a public offering completed in July 2022, the Company issued warrants to purchase In connection with a public offering completed in May 2023, the Company issued warrants to purchase
Income Taxes	Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of September 30, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance.
Stock-Based Compensation	Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to no less than the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse.
Net Loss Per Share	Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, respectively, because to do so would be anti-dilutive (in common equivalent shares): September 30, 2023 2022 Common stock warrants 4,484,077 36,691 Unvested restricted stock units 135,037 142 Common stock options 43,510 5,778 Total 4,662,624 42,611
Recent Accounting Pronouncements	Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its financial statements.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	9 Months Ended
Summary of Significant Accounting Policies (Tables)	Sep. 30, 2023
Summary of Significant Accounting Policies
Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share	The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, respectively, because to do so would be anti-dilutive (in common equivalent shares): September 30, 2023 2022 Common stock warrants 4,484,077 36,691 Unvested restricted stock units 135,037 142 Common stock options 43,510 5,778 Total 4,662,624 42,611

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
Fair Value Measurements (Tables)	Sep. 30, 2023
Fair Value Measurements
Schedule of financial instruments measured at fair value by level within the fair value hierarchy	The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands): Level 1 Level 2 Level 3 September 30, 2023 Assets: Cash and cash equivalents $ 2,873 $ — $ — Total assets at fair value $ 2,873 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,566 Total assets at fair value $ — $ — $ 5,566 Level 1 Level 2 Level 3 December 31, 2022 Assets: Cash and cash equivalents $ 5,246 $ — $ — Total assets at fair value $ 5,246 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,934 Total assets at fair value $ — $ — $ 5,934
Schedule of rollforward of the fair value of Level 3 warrants	Beginning balance at December 31, 2022 $ 5,934 Warrants issued 10,615 Change in fair value (10,983) Ending Balance September 30, 2023 $ 5,566

Prepaid Expenses and Other Cu_2

Prepaid Expenses and Other Current Assets (Tables)	9 Months Ended
Prepaid Expenses and Other Current Assets (Tables)	Sep. 30, 2023
Prepaid Expenses and Other Current Assets
Schedule of prepaid expenses and other current assets	Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, 2023 2022 Prepaid insurance $ 697 $ 628 Other 562 775 Total prepaid expenses and other current assets $ 1,259 $ 1,403

Accrued Liabilities (Tables)

Accrued Liabilities (Tables)	9 Months Ended
Accrued Liabilities (Tables)	Sep. 30, 2023
Accrued Liabilities
Schedule of accrued liabilities	Accrued liabilities consist of the following (in thousands): September 30, December 31, 2023 2022 Gross to net accruals $ 3,933 $ 2,332 Accrued compensation 2,721 833 Accrued professional fees and other 1,684 743 Total accrued liabilities $ 8,338 $ 3,908

Leases (Tables)

Leases (Tables)	9 Months Ended
Leases (Tables)	Sep. 30, 2023
Leases
Maturity of lease liabilities	Future minimum lease payments under non-cancellable leases as of September 30, 2023 were as follows (in thousands): 2023 $ 98 2024 397 2025 101 Total $ 596 Less: Interest (47) Present value of lease liability $ 549

Credit Agreement and Guaranty (

Credit Agreement and Guaranty (Tables)	9 Months Ended
Credit Agreement and Guaranty (Tables)	Sep. 30, 2023
Credit Agreement and Guaranty
Schedule of carrying amount of term loan	September 30, December 31, 2023 2022 Notes payable $ 1,950 $ 2,625 Debt issuance costs (63) (209) Warrant discount (298) (990) Total debt $ 1,589 $ 1,426 Less, current portion 1,589 1,426 Long-term debt, less current portion $ — $ —

Stockholders Deficit (Tables)

Stockholders Deficit (Tables)	9 Months Ended
Stockholders Deficit (Tables)	Sep. 30, 2023
Stockholders' Deficit
Schedule of allocation of stock-based compensation expense	Stock-based compensation expense was allocated as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Cost of goods sold $ 12 $ 29 $ 69 $ 104 Research and development 94 90 261 284 Selling and marketing 10 40 73 120 General and administrative 323 377 1,015 1,461 Total $ 439 $ 536 $ 1,418 $ 1,969

Organization and Description _2

Organization and Description of Business (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Nature of Operations
Accumulated deficit	$ 418,699	$ 408,702
Cash, cash equivalents and marketable securities	2,900
Working capital deficit	$ 7,500

Summary of Significant Accoun_4

Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Millions	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Summary of Significant Accounting Policies
Inventory reserve	$ 1.4	$ 0.6

Summary of Significant Accoun_5

Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Summary of Significant Accounting Policies
Advertising costs	$ 0	$ 0.9	$ 0	$ 6.1

Summary of Significant Accoun_6

Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Interest expense [Member]
Deferred Financing Costs
Amortization of deferred financing costs	$ 44,000	$ 146,000	$ 146,000	$ 284,000

Summary of Significant Accoun_7

Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2023 USD ($) customer	Sep. 30, 2022 USD ($) customer	Sep. 30, 2023 USD ($) customer	Sep. 30, 2022 USD ($) customer
Concentration risk, financial liabilities
Financial instruments with off-balance sheet risk of accounting loss, liabilities	$ 0		$ 0
Total revenue	6,662,000	$ 3,002,000	15,979,000	$ 6,888,000
Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer		3
Customer Concentration Risk \| Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer				3
Customer Concentration Risk \| Sales Revenue \| Customer One
Concentration risk, financial liabilities
Total revenue	1,700,000	$ 700,000	3,200,000	$ 1,900,000
Customer Concentration Risk \| Sales Revenue \| Customer Two
Concentration risk, financial liabilities
Total revenue	1,300,000	600,000	3,200,000	1,800,000
Customer Concentration Risk \| Sales Revenue \| Customer Three
Concentration risk, financial liabilities
Total revenue	1,100,000	$ 600,000	3,200,000	$ 1,700,000
Customer Concentration Risk \| Sales Revenue \| Customer Four
Concentration risk, financial liabilities
Total revenue	1,100,000		3,000,000
Customer Concentration Risk \| Sales Revenue \| Customer Five
Concentration risk, financial liabilities
Total revenue	$ 1,100,000		$ 2,100,000
Customer Concentration Risk \| Sales Revenue \| Three Customers
Concentration risk, financial liabilities
Concentration risk, percentage		30%		33%
Customer Concentration Risk \| Sales Revenue \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer	5		5
Total revenue			$ 92
Concentration risk, percentage	93%
Customer Concentration Risk \| Accounts Receivable \| Customer One
Concentration risk, financial liabilities
Concentration risk, percentage			36%
Customer Concentration Risk \| Accounts Receivable \| Customer Two
Concentration risk, financial liabilities
Concentration risk, percentage			26%
Customer Concentration Risk \| Accounts Receivable \| Customer Three
Concentration risk, financial liabilities
Concentration risk, percentage			18%
Customer Concentration Risk \| Accounts Receivable \| Customer Four
Concentration risk, financial liabilities
Concentration risk, percentage			15%
Customer Concentration Risk \| Accounts Receivable \| Customer Five
Concentration risk, financial liabilities
Concentration risk, percentage			0%
Customer Concentration Risk \| Accounts Receivable \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer				5

Summary of Significant Accoun_8

Summary of Significant Accounting Policies - Co-Payment Assistance (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Receivables [Abstract]
Provision for revenue reserve	$ 8.5	$ 3.2	$ 19.3	$ 6.1
Reserve for variable consideration	$ 7.4		$ 7.4

Summary of Significant Accoun_9

Summary of Significant Accounting Policies - Warrants (Details) - shares	May 31, 2023	Jul. 31, 2022	Apr. 30, 2022	Mar. 31, 2022	Oct. 31, 2021	Feb. 28, 2021	Feb. 26, 2021	Feb. 29, 2020	Feb. 10, 2020
Warrants
Common stock that can be purchased with warrants (in shares)			4,243
Common stock that can be purchased with warrants (in shares)				24,856	6,660
Public offering
Warrants
Common stock that can be purchased with warrants (in shares)	3,792,572	1,093,333
Common stock that can be purchased with warrants (in shares)					6,660
Common stock warrants \| Public offering
Warrants
Common stock that can be purchased with warrants (in shares)		533,333
Warrants
Warrants
Common stock that can be purchased with warrants (in shares)				225
Perceptive Credit Agreement \| Warrants
Warrants
Common stock that can be purchased with warrants (in shares)	225	225			225
Perceptive Credit Agreement \| Perceptive Warrants
Warrants
Common stock that can be purchased with warrants (in shares)						225		700
Common stock that can be purchased with warrants (in shares)							225		700

Summary of Significant Accou_10

Summary of Significant Accounting Policies - Income Taxes (Details)	Sep. 30, 2023 USD ($)
Uncertainty in tax positions
Uncertain tax positions	$ 0

Summary of Significant Accou_11

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	4,662,624	42,611
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	4,484,077	36,691
Unvested restricted stock units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	135,037	142
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	43,510	5,778

Fair Value Measurements - Finan

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Level 1
Assets:
Cash and cash equivalents	$ 2,873	$ 5,246
Total assets at fair value	2,873	5,246
Level 3
Liabilities:
Warrant Liability	5,566	5,934
Total liabilities at fair value	$ 5,566	$ 5,934

Fair Value Measurements - Warra

Fair Value Measurements - Warrant Valuation Assumptions (Details) - Option pricing model	Sep. 30, 2023 USD ($) Y	Dec. 31, 2022 USD ($) Y
Fair value
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	2.40	11.50
Preferred Warrants [Member] \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		520
Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	3.69
Maximum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	123.42	137.4
Maximum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	5.46	4.7
Maximum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	4.65	4.5
Maximum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	1,700	1,700
Minimum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	86.06	136.8
Minimum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	4.62	4.2
Minimum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	1.15	0.7
Minimum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	45	45

Fair Value Measurements - Level

Fair Value Measurements - Level 3 Warrants (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Transfers between fair value levels	$ 0	$ 0
Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	5,934
Warrants issued	10,615
Change in fair value	(10,983)
Ending balance	$ 5,566

Prepaid Expenses and Other Cu_3

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Prepaid Expenses and Other Current Assets
Prepaid insurance	$ 697	$ 628
Other	562	775
Total prepaid expenses and other current assets	$ 1,259	$ 1,403

Accrued Liabilities (Details)

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Accrued Liabilities
Gross to net accruals	$ 3,933	$ 2,332
Accrued compensation	2,721	833
Accrued professional fees and other	1,684	743
Total accrued liabilities	$ 8,338	$ 3,908

Leases - Summary (Details)

Leases - Summary (Details)	3 Months Ended		9 Months Ended
Leases - Summary (Details)	Sep. 30, 2023 USD ($) lease	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($) lease	Sep. 30, 2022 USD ($)
Leases
Number of finance leases \| lease	0		0
Number of operating leases \| lease	1		1
Lessee, Operating Lease, Existence of Option to Extend [true false]			true
Renewal term	5 years		5 years
Operating lease expense \| $	$ 89,000	$ 90,000	$ 267,000	$ 271,000
Operating lease expense information:
Cash paid for amounts included in measurement of lease liabilities \| $			$ 235,000	$ 132,000
Weighted-average remaining lease term (years)	1 year 6 months		1 year 6 months
Weighted-average discount rate	11.80%		11.80%

Leases - Maturity of lease liab

Leases - Maturity of lease liabilities (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Operating Leases
2023	$ 98
2024	397
2025	101
Total	596
Less: Interest	(47)
Present value of lease liability	$ 549

Credit Agreement and Guaranty_2

Credit Agreement and Guaranty (Details)						1 Months Ended	2 Months Ended	3 Months Ended	4 Months Ended	9 Months Ended
Credit Agreement and Guaranty (Details)	Oct. 31, 2023 USD ($)	Jul. 25, 2022 USD ($)	Jul. 08, 2022 USD ($)	Jan. 07, 2022 USD ($)	Feb. 10, 2020 USD ($) Y item $ / shares shares	Feb. 10, 2024 USD ($)	Dec. 31, 2023 USD ($)	Sep. 30, 2023 USD ($) Y $ / shares	Oct. 31, 2023 USD ($)	Sep. 30, 2023 USD ($) Y $ / shares	Sep. 30, 2022 USD ($)	May 31, 2023 $ / shares shares	Dec. 31, 2022 USD ($) Y	Jul. 31, 2022 $ / shares shares	Mar. 31, 2022 $ / shares shares	Oct. 31, 2021 $ / shares shares	Feb. 26, 2021 $ / shares shares	Feb. 10, 2021 $ / shares
Credit Agreement and Guaranty
Repayments of debt										$ 675,000	$ 17,150,000
Interest rate (as a percent)								15.58%		15.58%
Percentage of annual interest rate					3%
Common stock that can be purchased with warrants (in shares) \| shares															24,856	6,660
Proceeds from warrant exercises					$ 20,000,000
Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares															225
Perceptive Credit Agreement
Credit Agreement and Guaranty
Repayments of debt			$ 5,000,000	$ 5,000,000
Principal payments on its outstanding	$ 150,000								$ 150,000
Prepayment of outstanding principal		$ 7,000,000
Monthly principal payments		$ 75,000
Periodic Payment Principal	$ 150,000
Variable interest rate margin (as a percent)					10.25%
Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares																	$ 5,740
Common stock that can be purchased with warrants (in shares) \| shares					700												225
Number of warrants issued \| item					2
Facility fee percentage					1%
Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares					$ 7,480							$ 3.69		$ 745	$ 5,276	$ 7,080		$ 7,480
Common stock that can be purchased with warrants (in shares) \| shares					350							350		350	350	350
Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares					$ 9,340							$ 3.69		$ 618.50	$ 4,330.50	$ 5,760		$ 9,340
Common stock that can be purchased with warrants (in shares) \| shares					350							350		350	350	350
Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares												$ 3.69		$ 501.50	$ 3,456.50	$ 4,540	$ 5,740
Common stock that can be purchased with warrants (in shares) \| shares												225		225		225
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Maximum borrowing capacity					$ 35,000,000
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche One
Credit Agreement and Guaranty
Amount borrowed					5,000,000
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche Two
Credit Agreement and Guaranty
Amount borrowed					$ 15,000,000
Minimum London Interbank Offered Rate (LIBOR) [Member] \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Interest rate for the base rate					1.50%
Prepayment Occur on or Before February, 10, 2024 \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Prepayment premium percentage					2%
Minimum cash covenants						$ 3,000,000	$ 1,000,000		$ 500,000
Revenue generated under debt								$ 5,000,000
Two Thousand Twenty Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants					$ 3,600,000
Two Thousand Twenty One Perceptive Warrants [Member]
Credit Agreement and Guaranty
Beneficial ownership percentage										19.99%
Fair value of warrants					$ 1,100,000
Two Thousand Twenty One Perceptive Warrants Sixth Amendment [Member]
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares								$ 10.50		$ 10.50
Two Thousand Twenty One Perceptive Warrants Seventh Amendment [Member]
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares								$ 1.82		$ 1.82
Option pricing model \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input								2.40		2.40			11.50
Option pricing model \| Maximum \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input								5.46		5.46			4.7
Option pricing model \| Maximum \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y								4.65		4.65			4.5
Option pricing model \| Minimum \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input								4.62		4.62			4.2
Option pricing model \| Minimum \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y								1.15		1.15			0.7
Option pricing model \| Common stock warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input								3.69		3.69
Option pricing model \| Common stock warrants \| Maximum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input								1,700		1,700			1,700
Option pricing model \| Common stock warrants \| Minimum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input								45		45			45
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Volatility
Credit Agreement and Guaranty
Warrants, Measurement Input					70
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input \| item					1.47
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y					7
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input					8,020
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Maximum \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input					9,340
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Minimum \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input					7,480
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Volatility
Credit Agreement and Guaranty
Warrants, Measurement Input					103.5
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input \| item					1.15
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y					7
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input					5,740
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Credit Agreement \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y					7

Credit Agreement and Guaranty -

Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Credit Agreement and Guaranty
Notes payable	$ 1,950,000		$ 1,950,000		$ 2,625,000
Debt issuance costs	(63,000)		(63,000)		(209,000)
Warrant discount	(298,000)		(298,000)		(990,000)
Total debt	1,589,000		1,589,000		1,426,000
Less, current portion	1,589,000		1,589,000		$ 1,426,000
Amortization and debt issue costs	$ 252,000	$ 838,000	$ 838,000	$ 1,635,000

Stockholders Deficit - Amended

Stockholders Deficit - Amended and Restated Certificate of Incorporation (Details)	Apr. 10, 2023 shares	Sep. 30, 2023 shares	Apr. 09, 2023 shares	Dec. 31, 2022 shares	Jan. 07, 2022 shares	Jan. 06, 2022 shares
Stockholders' Deficit
Common stock, authorized (in shares)		300,000,000		300,000,000	300,000,000	150,000,000
Reverse stock split conversion ratio	0.02
Common stock, issued (in shares)	932,101	2,277,657	46,605,134	859,402
Common Stock, Shares, Outstanding	932,101	2,277,657	46,605,134	859,402

Stockholders Deficit - Common S

Stockholders Deficit - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions

1 Months Ended

3 Months Ended

5 Months Ended

9 Months Ended

12 Months Ended

Aug. 22, 2022

Apr. 27, 2022

Apr. 25, 2022

Apr. 04, 2022

Mar. 15, 2022

Mar. 14, 2022

Jan. 10, 2022

May 31, 2023

Jul. 31, 2022

Oct. 31, 2021

Mar. 31, 2021

Sep. 30, 2023

Jun. 30, 2023

Mar. 31, 2023

Sep. 30, 2022

Jun. 30, 2022

Mar. 31, 2022

Sep. 30, 2023

Sep. 30, 2022

Sep. 30, 2023

Dec. 31, 2022

Dec. 31, 2021

Apr. 12, 2023

Oct. 02, 2020

Sale of stock

Common stock that can be purchased with warrants (in shares)

6,660

24,856

Stock stated value

$ 0.0001

Maximum

Sale of stock

Proceeds from issuance of common stock in public offering, net of offering costs

$ 75

Common stock

Sale of stock

Issuance of common stock (in shares)

29,842

533,333

Stock Issued During Period, Shares, Warrants Exercised

607,000

508,286

Conversion of stock shares converted

6,025

Conversion of convertible preferred stock (in shares)

6,025

Series B Warrants

Sale of stock

Issuance of common stock (in shares)

2,425

Warrants and rights outstanding, term

5 years

2020 Shelf Registration Statement

Sale of stock

Aggregate amount of securities issuable

$ 200

2022 Preferred Stock Offering

Sale of stock

Common stock that can be purchased with warrants (in shares)

606

Proceeds from issuance of common stock in public offering, net of offering costs

$ 4.1

Exercise price of warrants (in dollars per share)

$ 500

Conversion price

$ 400

Preferred Stock, convertible, shares issuable

12,125

Exercisable term

6 months

Stock stated value

$ 1,000

Duration From Offering To Anniversary Of Closing

180 days

2022 Preferred Stock Offering | Series A Warrants

Sale of stock

Common stock that can be purchased with warrants (in shares)

4,243

12,125

Exercise price of warrants (in dollars per share)

$ 520

Exercisable term

6 months

Warrants and rights outstanding, term

5 years

Warrant Exercisable Term

5 years

2022 Preferred Stock Offering | Series B Warrants

Sale of stock

Common stock that can be purchased with warrants (in shares)

12,125

Exercisable term

6 months

Warrants and rights outstanding, term

1 year 6 months

At-the-market sales | Common stock

Sale of stock

Issuance of common stock (in shares)

105,342

72,699

173,750

512

3,457

Proceeds from issuance of common stock in public offering, net of offering costs

$ 9.3

At-the-market sales | Common stock | Maximum

Sale of stock

Commission percentage

Authorized value for shares issuance

$ 12.8

$ 50

Public offering

Sale of stock

Issuance of common stock (in shares)

3,792,572

150,366

Common stock that can be purchased with warrants (in shares)

6,660

Share price (in dollars per share)

$ 3.9551

$ 45

Proceeds from issuance of common stock in public offering, net of offering costs

$ 22

Public offering | Common stock

Sale of stock

Issuance of common stock (in shares)

95,000

382,966

13,333

95,000

Common stock that can be purchased with one-half of warrant (in shares)

Share price (in dollars per share)

$ 1,700

Proceeds from issuance of common stock in public offering, net of offering costs

$ 6.5

$ 21.1

Public offering | Series A-1 warrants

Sale of stock

Warrant Exercisable Term

5 years

Public offering | Pre-funded warrants

Sale of stock

Common stock that can be purchased with warrants (in shares)

1,801,286

Stock Issued During Period, Shares, Warrants Exercised

1,115,286

Class of Warrant or Right, Exercisable

686,000

Public offering | Series B Pre-funded Warrants

Sale of stock

Common stock that can be purchased with warrants (in shares)

150,366

2022 ATM

Sale of stock

Issuance of common stock (in shares)

173,750

207,883

78,852

Proceeds from issuance of common stock in public offering, net of offering costs

$ 12.2

$ 1.7

$ 0.9

Eligible Amount Authorized To Sell

$ 4.5

2022 ATM | Common stock

Sale of stock

Issuance of common stock (in shares)

512

Proceeds from issuance of common stock in public offering, net of offering costs

$ 0.3

2022 ATM | Common stock | Maximum

Sale of stock

Commission percentage

Authorized value for shares issuance

$ 50

2022 ATM | New Warrant [Member]

Sale of stock

Warrant Exercisable Term

6 months

H.C. Wainwright & Co., LLC, Sales Agent [Member]

Sale of stock

Common stock that can be purchased with warrants (in shares)

94,814

26,666

Commission percentage

Exercise price of warrants (in dollars per share)

$ 4.9439

$ 56.25

Series A Preferred Stock

Sale of stock

Conversion of stock shares converted

2,425

Series A Preferred Stock | 2022 Preferred Stock Offering

Sale of stock

Issuance of common stock (in shares)

2,425

Exercise price of warrants (in dollars per share)

$ 520

Series B Preferred Stock | 2022 Preferred Stock Offering

Sale of stock

Issuance of common stock (in shares)

2,425

Exercise price of warrants (in dollars per share)

$ 520

Stockholders Deficit - Stock-Ba

Stockholders Deficit - Stock-Based Compensation Expense (Details) - Common stock options - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 439	$ 536	$ 1,418	$ 1,969
Cost of goods sold
Stock-Based Compensation Expense
Total stock-based compensation expense	12	29	69	104
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	94	90	261	284
Selling and marketing
Stock-Based Compensation Expense
Total stock-based compensation expense	10	40	73	120
General and administrative
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 323	$ 377	$ 1,015	$ 1,461

Income Taxes - Sale of New Jers

Income Taxes - Sale of New Jersey Net Operating Losses (Details) - USD ($) $ in Millions	1 Months Ended
	Apr. 30, 2022	Jan. 31, 2021	Jan. 31, 2018
Sale of New Jersey Net Operating Losses
Additional cash benefit received	$ 4.7
Sale of unused NOLs \| New Jersey
Sale of New Jersey Net Operating Losses
Maximum lifetime benefit under the Program		$ 20	$ 15
Sale of unused NOLs \| New Jersey \| Minimum
Sale of New Jersey Net Operating Losses
Allowable sale of unused tax benefits as a percentage of total value			80%

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Apr. 30, 2020	Dec. 31, 2022	Sep. 30, 2023
Commitments and Contingencies
Future purchase commitments			$ 230.1
Corium Agreement [Member]
Commitments and Contingencies
Quarterly minimum volume amount of product to be ordered	$ 5.6
Additional fee payable as a percentage of transfer price for units ordered	(25.00%)
Percentage of additional fee as penalty percent		25%
Reminder 2023			7
2024 and Each Year Thereafter			$ 22.5