0000950170-24-124668 | 10-Q | XBRL Viewer

Payroll Liabilities

9 Months Ended

Sep. 30, 2024

NOTE 7: PAYROLL LIABILITIES

Payroll liabilities consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Accrued bonuses	$	748	$	1,134
Accrued vacation		194		236
Accrued payroll and benefits		119		284
Total payroll liabilities	$	1,061	$	1,654

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. They do not include all information and notes required by GAAP for complete financial statements. However, except as disclosed herein, there has been no material changes in the information disclosed in the Notes to Consolidated Financial Statements included in the Annual Report on Form 10-K of the Company for the year ended December 31, 2023. The year-end Condensed Consolidated Balance Sheet presented in this report was derived from audited consolidated financial statements but does not include all annual disclosures required by GAAP. All amounts in the Condensed Consolidated Financial Statements and the notes thereto have been presented in thousands, except for par value, share and per share data or as otherwise indicated. In the opinion of management, all adjustments (including normal recurring accruals) considered necessary for a fair presentation have been included and have been prepared on the same basis as the annual consolidated financial statements. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
Reclassification	Reclassification Certain reclassifications have been made to prior period financial information to conform to the current year presentation.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include the valuation of the investment in non-marketable equity securities, stock-based compensation expense, and prepaid or accrued clinical trial balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates.
Segments	Segments The Company operates as a single segment. Operating segments are identified as the components of an enterprise of which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and in assessing performance. To date, the Company's chief operating decision maker has made such decisions and assessed performance at the Company-level as a single segment.
Cash and Cash Equivalents	Cash and Cash Equivalents Cash and cash equivalents include unrestricted cash and all highly liquid instruments with original maturities of three months or less at the date of purchase. Cash equivalents consist primarily of amounts invested in money market accounts.
Restricted Cash	Restricted Cash The Company’s restricted cash balance as of September 30, 2024 and December 31, 2023 consisted entirely of cash pledged as security for the Company’s issued commercial credit cards.
Concentration of Credit Risk	Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of deposits of cash and cash equivalents, including those deposited in money market deposit accounts. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any material losses in such accounts and believes it is not exposed to significant risk. The Company has invested its excess cash primarily in money market funds.
Prepaid Materials	Prepaid Materials The Company capitalizes its purchase of certain raw materials, active pharmaceutical ingredients and related supplies for use in the manufacturing of drug products for use in our preclinical and clinical development programs, as it has determined that these materials have alternative future use. The Company can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. The Company expenses the cost of materials when used. The Company periodically reviews these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. Prepaid materials not expected to be used within 12 months of the balance sheet date are presented in Other assets on the Condensed Consolidated Balance Sheets.
Valuation of Other Investments	Entities The Company reviews agreements it enters into with third-party entities, pursuant to which the Company may have a variable interest in the entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, the Company assesses whether or not it is the primary beneficiary of that entity. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If the Company determines it is the primary beneficiary of a VIE, it consolidates that VIE into the Company’s Condensed Consolidated Financial Statements. The Company’s determination about whether it should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. The Company currently does not consolidate any VIEs.
Investments in Equity Securities	Investments in Equity Securities The Company has one investment in non-marketable equity securities. This investment does not have a readily determinable fair value, so the Company has elected to measure the investment at cost less any impairment, adjusted to fair value if there are observable price changes in orderly transactions for an identical or similar investment of the same issuer, in accordance with Accounting Standards Codification (ASC) 321, Investments – Equity Securities. At each reporting period, the Company performs an assessment to determine if it still qualifies for this measurement alternative. At each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. If a qualitative assessment indicates the investment is impaired, the Company estimates the investment's fair value. If the fair value is less than the investment's carrying value, an impairment charge is recorded in the Condensed Consolidated Statements of Operations equal to the difference between the carrying value and fair value and a new basis in the investment is established. Refer to Note 4.
Other Assets	Other Assets Other assets consist of property and equipment, noncurrent prepaid materials and clinical deposits.
Fair Value Measurements	Fair Value Measurements The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. The fair value hierarchy is broken down into the three input levels summarized below: • Level 1: Quoted market prices in active markets for identical assets or liabilities; • Level 2: Other observable market-based inputs or unobservable inputs that are corroborated by market data; and • Level 3: Unobservable inputs that cannot be corroborated by market data that reflects the reporting entity's own assumptions. The carrying amounts reflected in the accompanying Condensed Consolidated Balance Sheets for cash and cash equivalents, restricted cash, and accounts payable approximate their fair values due to their short-term nature. Refer to Note 9.
Research and Development	Research and Development Research and development (R&D) costs are generally expensed as incurred. R&D expenses include, for example, manufacturing expenses for the Company's drugs under development, expenses associated with preclinical studies, clinical trials and associated salaries, bonuses, stock-based compensation and benefits. The Company has entered into various research and development contracts with research institutions, clinical research organizations (CROs), clinical manufacturing organizations (CMOs) and other third parties. Payments for these activities are based on the terms of the individual agreements, which may differ from the timing of costs incurred. The Company records accruals for estimated costs incurred for ongoing research and development activities as reflected in the Condensed Consolidated Balance Sheets as accrued expenses. Payments made in advance of incurring costs are reflected in the Condensed Consolidated Balance Sheets as prepaid expenses. When evaluating the adequacy of the accrued expenses and prepaid expenses, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. R&D expenses also include an allocation of the CEO's salary and related benefits, including bonus and non-cash stock-based compensation expense, based on an estimate of his total hours spent on R&D activities. The Company's CEO is involved in the development of the Company's drug candidates and oversight of the related clinical trial activities and also acts as the Company's Chief Medical Officer.
Stock-based Compensation	Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees, officers, non-employee directors, and other key persons providing services to the Company, currently limited to stock options. Stock-based compensation is measured using the estimated grant date fair value and is recognized as an expense over the requisite service period, generally the vesting period. The Company has made a policy election to recognize forfeitures when they occur. The fair value of each stock option grant is estimated using the Black-Scholes option-pricing model, which requires assumptions regarding the expected volatility of the price of the Company's common stock, the expected life of the options, an expectation regarding future dividends on the Company’s common stock, and a risk-free interest rate. The Company’s expected common stock price volatility assumption is based upon the historical volatility of its stock price. The Company has elected the simplified method for the expected life assumption for stock option grants, which averages the contractual term of the options of 10 years with the vesting term, typically one to four years, as the Company does not have sufficient option exercise experience. The dividend yield assumption of zero is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends in the future. The risk-free interest rate assumption is based upon prevailing short-term interest rates over the expected life of the options as of the grant date.
Income Taxes	Income Taxes The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. The Company records any interest or penalties related to income taxes in income tax benefit in the Condensed Consolidated Statements of Operations.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This standard requires disclosure of significant segment expenses and other segment items by reportable segment. This ASU becomes effective for annual periods beginning in 2024 and interim periods in 2025. The Company is assessing the potential impact of this ASU. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU becomes effective on January 1, 2025. The Company is assessing the potential impact of this ASU. The Company does not expect adoption of any other recently issued accounting pronouncements to have a material impact on its financial statements.

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended				9 Months Ended		12 Months Ended
	Sep. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (7,230)	$ (5,878)	$ (6,229)	$ (6,281)	$ (19,157)	$ (22,340)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation					1,518	4,102
Impairment charge on investment in equity securities	1,710		0		1,710	2,990	$ 2,990
Depreciation					13	9
Loss on disposal of assets					3	0
Changes in operating assets and liabilities:
Prepaid materials					202	3,148
Prepaid expenses and other current assets					1,212	542
Other assets					(40)	(1,697)
Accounts payable					755	(2,247)
Accrued expenses					721	202
Payroll liabilities					(593)	(81)
Other current liabilities					(323)	2
Net cash used in operating activities					(13,979)	(15,370)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment					(19)	(14)
Net cash used in investing activities					(19)	(14)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercise of warrants					304	0
Common stock repurchased						(1,475)
Net cash provided by (used in) financing activities					304	(1,475)
NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH					(13,694)	(16,859)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING BALANCE		$ 88,570		$ 111,000	88,570	111,000	111,000
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, ENDING BALANCE	74,876		94,141		74,876	94,141	88,570
RECONCILIATION OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
Cash and cash equivalents	74,766		94,031		74,766	94,031	88,460
Restricted cash	110		110		110	110
Total cash, cash equivalents and restricted cash	$ 74,876		$ 94,141		74,876	94,141	$ 88,570
NON CASH INVESTING AND FINANCING ACTIVITIES
Common stock issued upon cashless exercise of stock options					$ 273	$ 0

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

NOTE 13: COMMITMENTS AND CONTINGENCIES

Litigation and Contingencies

On August 18, 2023, Intas Pharmaceuticals LTD. filed a Petition for Post Grant Review (PGR) with the U.S. Patent and Trademark Office (the PGR Petition), seeking to invalidate one of the Company's issued patents (U.S. Patent No. 11,572,334) titled “Methods for Making and Using Endoxifen” (the Patent) on the grounds of anticipation and obviousness. The Company is actively contesting the PGR Petition and believes that the Patent was properly granted and is valid and enforceable. However, there can be no assurance that the Company will prevail in contesting the PGR Petition.

The Company is subject to other legal proceedings and claims that arise in the ordinary course of its business. The Company believes that these matters do not have a material effect, individually or in the aggregate, on its financial position, results of operations, or cash flows.

Contractual Obligations

Contractual obligations represent the Company’s future cash commitments and liabilities under agreements with third party clinical trial service providers. Apart from contracts with one third party clinical trial service provider, such agreements are cancellable upon written notice by the Company. The non-cancellable contracts expire upon completion of the clinical trial and release of the final report, or the contracts may be terminated by the clinical trial service provider, by the FDA or another governmental agency. As of September 30, 2024, the Company's estimated non-cancellable commitment was $10.5 million.

Summary of Significant Accounting Policies - Additional Information (Detail)	9 Months Ended
	Sep. 30, 2024 Unit
Summary of Accounting Policies [Line Items]
Number of operating segments	1
Assumption of dividend yield	0.00%
Maximum [Member]
Summary of Accounting Policies [Line Items]
Contractual term	10 years
Vesting term	4 years
Minimum [Member]
Summary of Accounting Policies [Line Items]
Vesting term	1 year

Stockholders' Equity

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Stockholders' Equity

NOTE 10: STOCKHOLDERS’ EQUITY

Common Stock

On June 27, 2024, the Company’s stockholders approved an amendment of the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, par value $0.18 per share, from 175,000,000 to 350,000,000. As of September 30, 2024, the Company is authorized to issue 350,000,000 shares of common stock, par value $0.18 per share.

Share Repurchases

On June 27, 2023, the Board of Directors (the Board) authorized a program to repurchase shares of common stock, par value $0.18 per share, up to an aggregate market value of $10.0 million. On December 18, 2023, the Board authorized an extension of the program through December 31, 2024. The Board may suspend, modify, or terminate the share repurchase program at any time. During the three and nine months ended September 30, 2024, no shares were repurchased. During the three and nine months ended September 30, 2023, 1,200,664 shares and 1,320,046 shares were purchased for a cost of $1.3 million and $1.5 million, respectively.

Preferred Stock

The Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.001 per share. The Company has designated 750,000 shares of Series A junior participating preferred stock, par value $0.001 per share, 4,000 shares of Series A convertible preferred stock, par value $0.001 per share, 25,000 shares of Series B convertible preferred stock, par value $0.001 per share, and 20,000 shares of Series C convertible preferred stock, par value $0.001 per share, through the filings of certificates of designation with the Delaware Secretary of State. No shares of Series A junior participating preferred stock, Series A convertible preferred stock, or Series C convertible preferred stock, were outstanding as of September 30, 2024 and December 31, 2023.

Series B Convertible Preferred Stock

Conversion. Each share of Series B convertible preferred stock is convertible at the Company’s option at any time, or at the option of the holder at any time, into the number of shares of the Company’s common stock determined by dividing the $1,000 stated value per share of the Series B convertible preferred stock by a conversion price of $3.52 per share. In addition, the conversion price per share is subject to adjustment for stock dividends, distributions, subdivisions, combinations, or reclassifications. Subject to limited exceptions, a holder of the Series B convertible preferred stock will not have the right to convert any portion of the Series B convertible preferred stock to the extent that, after giving effect to the conversion, the holder, together with its affiliates, would

beneficially own in excess of 9.99% of the number of shares of the Company's common stock outstanding immediately after giving effect to its conversion.

During the three and nine months ended September 30, 2024 and 2023, there were no conversions of Series B convertible preferred stock.

Fundamental Transactions. In the event the Company effects certain mergers, consolidations, sales of substantially all of its assets, tender or exchange offers, reclassifications, or share exchanges in which its common stock is effectively converted into or exchanged for other securities, cash or property, the Company consummates a business combination in which another person acquires 50% of the outstanding shares of its common stock, or any person or group becomes the beneficial owner of 50% of the aggregate ordinary voting power represented by its issued and outstanding common stock, then, upon any subsequent conversion of the Series B convertible preferred stock, the holders of the Series B convertible preferred stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series B convertible preferred stock.

Dividends. Holders of Series B convertible preferred stock shall be entitled to receive dividends (on an as-if-converted-to-common-stock basis) in the same form as dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of common stock. The Company’s preferred stock contractually entitles the holders of such securities to participate in dividends but do not contractually require the holders of such securities to participate in losses of the Company.

Voting Rights. Except as otherwise provided in the certificate of designation or as otherwise required by law, the Series B convertible preferred stock has no voting rights.

Liquidation Preference. Upon the Company’s liquidation, dissolution or winding-up, whether voluntary or involuntary, holders of Series B convertible preferred stock will be entitled to receive out of the Company’s assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Series B convertible preferred stock were fully converted (disregarding for such purpose any conversion limitations under the certificate of designation) to common stock, which amounts shall be paid pari passu with all holders of common stock.

Redemption Rights. The Company is not obligated to redeem or repurchase any shares of Series B convertible preferred stock. Shares of Series B convertible preferred stock are not otherwise entitled to any redemption rights, or mandatory sinking fund or analogous provisions.

2021 and 2020 Warrants

The warrants were issued to institutional and accredited investors as a part of the financing transactions, which closed on December 11, 2020, December 21, 2020, December 28, 2020, January 8, 2021, and March 23, 2021. The terms and conditions of the warrants are as follows:

Exercisability. Each warrant is exercisable at any time and will expire between 4 and 4.5 years from the date of issuance. The warrants are exercisable, at the option of each holder, in whole or in part by delivering to the Company a duly executed exercise notice and payment in full for the number of shares of the Company’s common stock purchased upon such exercise, except in the case of a cashless exercise as discussed below. The number of shares of common stock issuable upon exercise of the warrants is subject to adjustment in certain circumstances, including a stock split or, stock dividend on, or a subdivision, combination or recapitalization of the common stock. Upon the merger, consolidation, sale of substantially all of the Company’s assets, or other similar transaction, the holders of warrants shall, at the option of the Company, be required to exercise the warrants immediately prior to the closing of the transaction, or such warrants shall automatically expire. Upon such exercise, the holders of warrants shall participate on the same basis as the holders of common stock in connection with the transaction.

Cashless Exercise. If at any time there is no effective registration statement registering, or the prospectus contained therein is not available for issuance of, the shares issuable upon exercise of the warrant, the holder may exercise the warrant on a cashless basis. When exercised on a cashless basis, a portion of the warrant is cancelled in payment of the purchase price payable in respect of the number of shares of the Company’s common stock purchasable upon such exercise.

Exercise Price. Each warrant represents the right to purchase one share of common stock. In addition, the exercise price per share is subject to adjustment for stock dividends, distributions, subdivisions, combinations or reclassifications, and for certain dilutive issuances. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of the warrant to the extent that, after giving effect to the exercise, the holder, together with its affiliates, and any other person acting as a group together with the holder or any of its affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to its exercise. The holder, upon notice to the Company, may increase or decrease the

beneficial ownership limitation provisions of the warrant, provided that in no event shall the limitation exceed 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise of the warrant.

Transferability. Subject to applicable laws and restrictions, a holder may transfer a warrant upon surrender of the warrant to us with a completed and signed assignment in the form attached to the warrant. The transferring holder will be responsible for any tax liability that may arise as a result of the transfer.

Exchange Listing. The Company does not intend to apply to list the warrants on any securities exchange or recognized trading system.

Rights as Stockholder. Except as set forth in the warrant, the holder of a warrant, solely in such holder’s capacity as a holder of a warrant, will not be entitled to vote, to receive dividends or to any of the other rights of the Company's stockholders. The Company’s warrants contractually entitle the holders of such securities to participate in dividends but do not contractually require the holders of such securities to participate in losses of the Company.

Warrants Outstanding

As of September 30, 2024, the following warrants to purchase shares of the Company’s common stock were outstanding:


	Outstanding Warrants to Purchase Shares		Exercise Price Per Warrant		Expiration Date
December 2020 warrants		6,185,750	$	1.00	December 11, 2024-June 21, 2025
January 2021 warrants		4,500,000	$	1.055	July 8, 2025
March 2021 warrants		10,525,000	$	2.88	September 22, 2025
		21,210,750

Warrant Activity

During the nine months ended September 30, 2024, the Company received approximately $0.3 million from the exercises of warrants resulting in the issuance of 303,750 shares of common stock. There were no warrant exercises during the nine months ended September 30, 2023.

- Definition

The entire disclosure for equity.

+ References

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+ Details

Fair Value of Financial Instruments - Schedule of Assets and Liabilities Measured on Recurring Basis (Details) - Fair Value, Recurring [Member] - Money Market Funds [Member] - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market account	$ 74,220	$ 88,029
Fair Value, Inputs, Level 1 [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market account	74,220	88,029
Fair Value, Inputs, Level 2 [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market account	0	0
Fair Value, Inputs, Level 3 [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Money market account	$ 0	$ 0

Accrued Expenses

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Accrued Expenses

NOTE 6: ACCRUED EXPENSES

Accrued expenses consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Accrued clinical trial costs	$	1,207	$	608
Accrued professional services and other		487		365
Total accrued expenses	$	1,694	$	973

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Schedule of Stockholders' Equity Note, Warrants or Rights

As of September 30, 2024, the following warrants to purchase shares of the Company’s common stock were outstanding:


	Outstanding Warrants to Purchase Shares		Exercise Price Per Warrant		Expiration Date
December 2020 warrants		6,185,750	$	1.00	December 11, 2024-June 21, 2025
January 2021 warrants		4,500,000	$	1.055	July 8, 2025
March 2021 warrants		10,525,000	$	2.88	September 22, 2025
		21,210,750

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Summary of Accrued Expenses

Accrued expenses consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Accrued clinical trial costs	$	1,207	$	608
Accrued professional services and other		487		365
Total accrued expenses	$	1,694	$	973

Nature of Operations

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Nature of Operations

NOTE 1: NATURE OF OPERATIONS

Atossa Therapeutics, Inc. (the Company) was incorporated on April 30, 2009, in the State of Delaware to develop and market medical devices, laboratory tests and therapeutics to address breast health conditions. The Company is focused on developing proprietary innovative medicines in areas of significant unmet medical need in oncology, with a focus on breast cancer and other breast conditions.

Net Loss Per Share - Schedule of Antidilutive Securities (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of potential common shares excluded (in shares)	41,781,667	42,272,875	39,690,813	39,422,654
Options to Purchase Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of potential common shares excluded (in shares)	20,405,579	20,593,037	18,216,874	17,742,816
Series B Convertible Preferred Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of potential common shares excluded (in shares)	165,338	165,338,000	165,338	165,338
Warrants to Purchase Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of potential common shares excluded (in shares)	21,210,750	21,514,500,000	21,308,601,000	21,514,500,000

Investment in Equity Securities - Additional Information (Details) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2023 USD ($)	Jun. 30, 2023
Schedule of Equity Method Investments [Line Items]
Equity securities without readily determinable fair Value, impairment loss, annual amount	$ 1,710	$ 0	$ 1,710	$ 2,990	$ 2,990
Measurement Input Probability [Member] \| Valuation Dynamic Options Approach [Member]
Schedule of Equity Method Investments [Line Items]
Equity securities without readily determinable fair value, measurement input	0.05		0.05			0.50
Measurement Input Probability [Member] \| Valuation, Cost Approach [Member]
Schedule of Equity Method Investments [Line Items]
Equity securities without readily determinable fair value, measurement input	0.95		0.95			0.50
Measurement Input, Expected Term [Member]
Schedule of Equity Method Investments [Line Items]
Equity securities without readily determinable fair value, measurement input	3		3			3.5

Stockholders' Equity - Additional Information (Details) - USD ($)	3 Months Ended			9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Jun. 27, 2024	Jun. 26, 2024	Dec. 31, 2023	Jun. 27, 2023
Stockholders' Equity [Line Items]
Common stock, shares authorized	350,000,000			350,000,000		350,000,000	175,000,000	175,000,000
Common stock, par or stated value per share	$ 0.18			$ 0.18		$ 0.18		$ 0.18
Common stock repurchased		$ 1,323,000	$ 152,000
Preferred stock, shares authorized	10,000,000			10,000,000				10,000,000
Preferred stock, par or stated value per share	$ 0.001			$ 0.001				$ 0.001
Preferred stock, shares issued	582			582				582
Consummate a business combination, percentage of acquired outstanding shares	50.00%			50.00%
Consummate a business combination, percentage of aggregate ordinary voting power	50.00%			50.00%
Class of warrant or right, outstanding	21,210,750			21,210,750
Class of warrant or right, exercised during period					0
Exercises of warrants				$ 304,000	$ 0
Common stock, issued (in shares)	125,801,254			125,801,254				125,801,254
Share Repurchases [Member]
Stockholders' Equity [Line Items]
Common stock, par or stated value per share									$ 0.18
Stock repurchase program, authorized amount									$ 10,000,000
Common stock repurchased, shares	0	1,200,664		0	1,320,046
Common stock repurchased		$ 1,300,000			$ 1,500,000
The 2020 Liability Warrants [Member]
Stockholders' Equity [Line Items]
Warrants and rights outstanding, term	4 years			4 years
Warrants Associated with 2020 Offering Consisting of Common Stock and Warrants [Member]
Stockholders' Equity [Line Items]
Warrants and rights outstanding, term	4 years 6 months			4 years 6 months
The 2020 Warrants [Member]
Stockholders' Equity [Line Items]
Class of warrant or right, number of securities called by each warrant or right	1			1
Warrants exercisable, ownership percentage of shares allowed	4.99%			4.99%
Common stock, convertible, ownership percentage of shares allowed	9.99%			9.99%
2021 and 2020 Warrants [Member]
Stockholders' Equity [Line Items]
Common stock, issued (in shares)	303,750			303,750
Series A Junior Participating Preferred Stock [Member]
Stockholders' Equity [Line Items]
Preferred stock, shares authorized	750,000			750,000
Preferred stock, par or stated value per share	$ 0.001			$ 0.001
Series A Convertible Preferred Stock [Member]
Stockholders' Equity [Line Items]
Preferred stock, shares authorized	4,000			4,000
Preferred stock, par or stated value per share	$ 0.001			$ 0.001
Series B Convertible Preferred Stock [Member]
Stockholders' Equity [Line Items]
Preferred stock, shares authorized	25,000			25,000
Preferred stock, par or stated value per share	$ 0.001			$ 0.001
Stated value per share	$ 1,000			$ 1,000
Preferred stock, convertible, conversion price	$ 3.52			$ 3.52
Series C Convertible Preferred Stock [Member]
Stockholders' Equity [Line Items]
Preferred stock, shares authorized	20,000			20,000
Preferred stock, par or stated value per share	$ 0.001			$ 0.001
Preferred stock, shares issued	0			0				0
Preferred stock, convertible, ownership percentage of shares allowed	9.99%			9.99%

Payroll Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Schedule of Payroll Liabilities

Payroll liabilities consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Accrued bonuses	$	748	$	1,134
Accrued vacation		194		236
Accrued payroll and benefits		119		284
Total payroll liabilities	$	1,061	$	1,654

Investment in Equity Securities

9 Months Ended

Sep. 30, 2024

Equity Method Investments and Joint Ventures [Abstract]

Investment in Equity Securities

NOTE 4: INVESTMENT IN EQUITY SECURITIES

The Company holds an investment in Dynamic Cell Therapies, Inc. (DCT), a U.S. private company that is in the pre-clinical stage of developing novel Chimeric Antigen Receptor (CAR) T-cell therapies based on technology licensed from a leading U.S. cancer treatment and research institution. The Company determined that DCT is a VIE however, the Company does not consolidate DCT because it does not have the power to direct economically significant activities. The Company has no obligation to provide any future funding to DCT and its maximum exposure to loss is its investment value, which is recorded in the Condensed Consolidated Balance Sheets as an Investment in equity securities.

The Company considered qualitative and quantitative impairment factors in determining if there were any signs of impairment of this investment as of September 30, 2024. Specifically, the Company considered continued concerns about the investee's ability to continue as a going concern, due to negative cash flows from operations and its inability to raise additional funding during the three and nine months ended September 30, 2024. Based on these impairment indicators, the Company performed a quantitative fair value measurement as of September 30, 2024. The impairment of the Company's Investment in equity securities required the estimation of fair value using unobservable inputs (a level 3 fair value measurement). The Company used the dynamic options approach, which required the assumptions regarding the expected average volatility of comparable companies the expected term of the Company's investment, and an estimation of an appropriate risk-free interest rate over the term of the Company's investment. The expected stock price volatility assumption was based upon the average historic volatility of comparable public clinical stage immunotherapy or CAR-T companies. The expected term of the Company's investment was 3.0 years and the risk-free interest rate used was based upon prevailing short term interest rates over the expected term of the investment. The dynamic options approach was weighted at a 5% outcome probability. An adjusted book value approach was also considered and weighted at a 95% probability due to DCT's limited cash on hand, status of current fundraising efforts and the subsequent decision by DCT to lay off all employees and wind down operations. Based on the valuation, the Company concluded that the investment was impaired, and accordingly, an impairment charge of $1.7 million was recorded in the Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024.

On June 30, 2023, the Company considered adverse changes in the general market condition of the industry in which DCT operates and concerns about DCT's ability to continue as a going concern. Based on these impairment indicators, the Company performed a quantitative fair value measurement in the second quarter of 2023. The impairment of the Company's Investment in equity securities required the estimation of fair value using unobservable inputs (a level 3 fair value measurement). The Company used the dynamic options approach, which required assumptions regarding the expected average volatility of comparable companies, the expected term of the Company's investment, and an estimation of an appropriate risk-free interest rate over the term of the Company's investment. The expected stock price volatility assumption was based upon the average historic volatility of comparable public clinical stage immunotherapy or CAR-T companies. The expected term of the Company's investment as of June 30, 2023 was 3.5 years and the risk-free interest rate used was based upon prevailing short-term interest rates over the expected term of the investment. The dynamic options approach was weighted at a 50% outcome probability. An adjusted book value approach was

also considered and also weighted at a 50% probability due to DCT's limited cash on hand, status of then-current fundraising efforts and the estimated timing of a deemed liquidation event occurring as of June 30, 2023. The Company recorded an impairment charge of $3.0 million for the nine months ended September 30, 2023.

The following table summarizes the changes in the Company's fair value estimate of its Investment in equity securities (in thousands):




Beginning balance as of January 1, 2023 of Investment in equity securities	$	4,700
Impairment charge on Investment in equity securities		(2,990	)
Balance as of December 31, 2023 Investment in equity securities		1,710
Impairment charge on Investment in equity securities		(1,710	)
Balance as of September 30, 2024 Investment in equity securities	$	-

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Schedule of Antidilutive Securities

The following table sets forth the weighted average number of common shares excluded from the calculation of diluted net loss per share, because including them would be anti-dilutive:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Options to purchase common stock		20,405,579		20,593,037		18,216,874		17,742,816
Series B convertible preferred stock		165,338		165,338		165,338		165,338
Warrants to purchase common stock		21,210,750		21,514,500		21,308,601		21,514,500
		41,781,667		42,272,875		39,690,813		39,422,654

Stock Based Compensation - Schedule of Share-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock compensation expense	$ 749	$ 926	$ 1,518	$ 4,102
General and administrative
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock compensation expense	545	602	1,078	2,813
Research and development
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock compensation expense	$ 204	$ 324	$ 440	$ 1,289

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Name Accounting Standards Codification
-Section 35
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Stock Based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Share-Based Payment Arrangement

NOTE 14: STOCK BASED COMPENSATION

On May 15, 2020, the stockholders of the Company approved the 2020 Stock Incentive Plan (the 2020 Plan) to provide for the grants of equity-based awards to employees, officers, non-employee directors and other key persons providing services to the Company. On June 27, 2024, the stockholders of the Company approved an amendment and restatement of the 2020 Plan which increased the shares available for issuance by 12,000,000 shares, to a total of 30,000,000 shares available for grant. The 2020 Plan was also extended through June 27, 2034. As of September 30, 2024, 13,484,925 shares were available for future grants under the 2020 Plan.

The Company recognized stock-based compensation expense in the Condensed Consolidated Statements of Operations as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	204	$	324	$	440	$	1,289
General and administrative		545		602		1,078		2,813
Total stock-based compensation expense	$	749	$	926	$	1,518	$	4,102

The following table shows a summary of all stock option activity for the nine months ended September 30, 2024:


	Number of Underlying Shares			Weighted- Average Exercise Price Per Share		Weighted- Average Contractual Life Remaining in Years		Aggregate Intrinsic Value
Outstanding as of January 1, 2024		17,506,345		$	1.79			$	554,525
Granted		4,208,334			1.06
Forfeited		(1,167,504	)		1.60
Exercised		(343,998	)		0.79
Expired		(4,606	)		258.08
Outstanding as of September 30, 2024		20,198,571		$	1.61		7.13	$	6,090,201
Exercisable as of September 30, 2024		16,069,778		$	1.76		6.53	$	3,966,111
Vested and expected to vest		20,198,571		$	1.61		7.13	$	6,090,201

No options were granted during the three months ended September 30, 2024. The weighted average grant date fair value of options granted during the nine months ended September 30, 2024 was $0.84.

As of September 30, 2024, the unrecognized compensation cost associated with unvested options was $3.1 million. This expense is expected to be recognized over a weighted-average period of 1.49 years.

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, authorized (in shares)	10,000,000	10,000,000
Preferred stock, issued (in shares)	582	582
Preferred stock, outstanding (in shares)	582	582
Common stock, par value (in dollars per share)	$ 0.18	$ 0.18
Common stock, authorized (in shares)	350,000,000	175,000,000
Common stock, issued (in shares)	125,801,254	125,801,254
Common stock, outstanding (in shares)	125,304,064	125,304,064
Treasury stock, shares (in shares)	1,320,046	1,320,046

Consolidated Consolidated Statements of Operations (Current Period Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating expenses
Research and development	$ 3,412	$ 4,467	$ 10,714	$ 11,680
General and administrative	2,973	3,001	9,756	10,678
Total operating expenses	6,385	7,468	20,470	22,358
Operating loss	(6,385)	(7,468)	(20,470)	(22,358)
Impairment charge on investment in equity securities	(1,710)	0	(1,710)	(2,990)
Interest income	1,001	1,274	3,213	3,107
Other expense, net	(136)	(35)	(190)	(99)
Loss before income taxes	(7,230)	(6,229)	(19,157)	(22,340)
Income taxes benefit	0	0	0	0
Net loss	$ (7,230)	$ (6,229)	$ (19,157)	$ (22,340)
Net loss per share of common stock - basic (in dollars per share)	$ (0.06)	$ (0.05)	$ (0.15)	$ (0.18)
Net loss per share of common stock - diluted (in dollars per share)	$ (0.06)	$ (0.05)	$ (0.15)	$ (0.18)
Weighted average shares outstanding used to compute net loss per share- basic (in shares)	125,772,664	125,793,112	125,608,794	126,343,629
Weighted average shares outstanding used to compute net loss per share - diluted (in shares)	125,772,664	125,793,112	125,608,794	126,343,629

Stock Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions		3 Months Ended	9 Months Ended
	Jun. 27, 2024	Sep. 30, 2024	Sep. 30, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)			4,208,334
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares)			343,998
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price (in dollars per share)			$ 0.79
Employee Stock Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount		$ 3.1	$ 3.1
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)			1 year 5 months 26 days
The 2020 Stock Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares)	12,000,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)		0
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share)			$ 0.84
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant	30,000,000
The 2020 Stock Incentive Plan [Member] \| Employee Stock Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)		13,484,925	13,484,925

Stock Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Share-Based Compensation Expense

The Company recognized stock-based compensation expense in the Condensed Consolidated Statements of Operations as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	204	$	324	$	440	$	1,289
General and administrative		545		602		1,078		2,813
Total stock-based compensation expense	$	749	$	926	$	1,518	$	4,102

Schedule of Option Activity for Share-Based Payment Arrangement

The following table shows a summary of all stock option activity for the nine months ended September 30, 2024:


	Number of Underlying Shares			Weighted- Average Exercise Price Per Share		Weighted- Average Contractual Life Remaining in Years		Aggregate Intrinsic Value
Outstanding as of January 1, 2024		17,506,345		$	1.79			$	554,525
Granted		4,208,334			1.06
Forfeited		(1,167,504	)		1.60
Exercised		(343,998	)		0.79
Expired		(4,606	)		258.08
Outstanding as of September 30, 2024		20,198,571		$	1.61		7.13	$	6,090,201
Exercisable as of September 30, 2024		16,069,778		$	1.76		6.53	$	3,966,111
Vested and expected to vest		20,198,571		$	1.61		7.13	$	6,090,201

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Prepaid clinical trial deposits	$ 552	$ 805
Prepaid insurance	119	794
Professional services	131	501
Other	148	62
Total prepaid expenses	$ 950	$ 2,162

Defined Contribution Plan - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Defined Contribution Plan [Abstract]
Defined contribution plan, employer matching contribution, percent of match			6.00%
Defined contribution plan, cost	$ 39	$ 31	$ 153	$ 137

Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2024	Nov. 08, 2024
Document Information [Line Items]
Entity Central Index Key	0001488039
Entity Registrant Name	ATOSSA THERAPEUTICS, INC.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-35610
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-4753208
Entity Address, Address Line One	10202 5th Avenue NE
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Seattle
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98125
City Area Code	206
Local Phone Number	588-0256
Title of 12(b) Security	Common Stock, $0.18 par value
Trading Symbol	ATOS
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		125,801,254

Income Taxes

9 Months Ended

Sep. 30, 2024

Income Tax Disclosure [Abstract]

Income Tax Disclosure

NOTE 12: INCOME TAXES

Deferred income tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided for the amount of deferred tax assets that, based on available evidence, are not expected to be realized.

As a result of the Company’s cumulative losses, management has concluded that a full valuation allowance against the Company’s net deferred tax assets is appropriate. Therefore, no income tax provision was recorded for the three and nine months ended September 30, 2024 and 2023.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Research and Development Rebate Liability

9 Months Ended

Sep. 30, 2024

Other Liabilities Disclosure [Abstract]

Research and Development Rebate Liability

NOTE 8: RESEARCH AND DEVELOPMENT REBATE LIABILITY

In 2017, the Company formed a wholly owned subsidiary in Australia called Atossa Genetics AUS Pty Ltd. The purpose of this subsidiary is to perform R&D activities, including some of the Company's clinical trials. Australia offers R&D cash rebates on qualified R&D activities incurred in the country. The Australian R&D tax incentive program is a self-assessment program, and as such, the Australian Taxation Office (ATO) has the right to review the Company’s program and related expenditures for a period of four years following the tax return filing date. If a review were to occur, a qualified program and related expenditures could be disqualified by the ATO with interest and penalties. Based on the Company's evaluation of the ATO's taxpayer alert in December 2023, the Company believes that it is not reasonably assured that the full tax position would be sustained under audit. Accordingly, as of September 30, 2024 and December 31 2023 a liability of $1.5 million and $1.8 million was included in Other current liabilities in the Condensed Consolidated Balance Sheets.

Defined Contribution Plan

9 Months Ended

Sep. 30, 2024

Defined Contribution Plan [Abstract]

Defined Contribution Plan

NOTE 15: DEFINED CONTRIBUTION PLAN

The Company has a defined contribution plan to which employees of the Company may defer contributions for income tax purposes. Participants are eligible to receive employer matching contributions up to 6% of deferrals. Employees may also be eligible for a discretionary match over 6%. Defined contribution plan employer matching contributions for the three and nine months ended September 30, 2024 were $39 thousand and $153 thousand, respectively, and $31 thousand and $137 thousand for the same periods in 2023, respectively.

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (7,230)	$ (6,049)	$ (5,878)	$ (6,229)	$ (9,830)	$ (6,281)	$ (19,157)	$ (22,340)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Stock Based Compensation - Schedule of Option Activity for Share-Based Payment Arrangement (Details)	9 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($)
Share-Based Payment Arrangement [Abstract]
Outstanding, shares (in shares) \| shares	17,506,345
Outstanding, weighted average exercise price per share (in dollars per share) \| $ / shares	$ 1.79
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross \| shares	4,208,334
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price \| $ / shares	$ 1.06
Forfeited (in shares) \| shares	(1,167,504)
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Forfeitures in Period, Weighted Average Exercise Price \| $ / shares	$ 1.6
Exercised (in shares) \| shares	(343,998)
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price \| $ / shares	$ 0.79
Expired (in shares) \| shares	(4,606)
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price \| $ / shares	$ 258.08
Outstanding, shares (in shares) \| shares	20,198,571
Outstanding, weighted average exercise price per share (in dollars per share) \| $ / shares	$ 1.61
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term	7 years 1 month 17 days
Outstanding, aggregate intrinsic value \| $	$ 6,090,201	$ 554,525
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number \| shares	16,069,778
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Exercise Price \| $ / shares	$ 1.76
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term	6 years 6 months 10 days
Exercisable, aggregate intrinsic value \| $	$ 3,966,111
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number \| shares	20,198,571
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price \| $ / shares	$ 1.61
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term	7 years 1 month 17 days
Vested and expected to vest, aggregate intrinsic value \| $	$ 6,090,201

Income Taxes - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating Loss Carryforwards [Line Items]
Income tax expense (benefit), total	$ 0	$ 0	$ 0	$ 0
Deferred income tax provision	$ 0	$ 0	$ 0	$ 0

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (ee)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 4: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 6.I.7)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-8

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-10

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(9))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477250/944-220-S99-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
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-Paragraph 2
-Subparagraph (a)
-SubTopic 20
-Topic 740
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482659/740-20-45-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h))
-SubTopic 10
-Topic 235
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

+ Details

Investment in Equity Securities - Summary of Changes in Fair Value Estimate of Investment in Equity Securities (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Equity Method Investments and Joint Ventures [Abstract]
Beginning balance Investment in equity securities			$ 1,710	$ 4,700	$ 4,700
Impairment charge on investment in equity securities	$ (1,710)	$ 0	(1,710)	$ (2,990)	(2,990)
Ending balance Investment in equity securities	$ 0		$ 0		$ 1,710

Liquidity and Capital Resources - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Net loss	$ (7,230)	$ (6,049)	$ (5,878)	$ (6,229)	$ (9,830)	$ (6,281)	$ (19,157)	$ (22,340)
Cash in operating activities							(13,979)	(15,370)
Cash and cash equivalents	74,766			$ 94,031			74,766	$ 94,031	$ 88,460
Working capital	$ 71,300						$ 71,300

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets
Cash and cash equivalents	$ 74,766	$ 88,460
Restricted cash	110	110
Prepaid materials	1,285	1,487
Prepaid expenses and other current assets	950	2,162
Total current assets	77,111	92,219
Investment in equity securities	0	1,710
Other assets	2,366	2,323
Total Assets	79,477	96,252
Current liabilities
Accounts payable	1,561	806
Accrued expenses	1,694	973
Payroll liabilities	1,061	1,654
Other current liabilities	1,480	1,803
Total current liabilities	5,796	5,236
Total Liabilities	5,796	5,236
Commitments and contingencies (Note 13)
Stockholders' equity
Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized; 582 shares issued and outstanding as of September 30, 2024 and December 31, 2023	0	0
Common stock - $0.18 par value; 350,000,000 and 175,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 125,801,254 and 125,304,064 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	22,882	22,792
Additional paid-in capital	257,719	255,987
Treasury stock, at cost; 1,320,046 shares of common stock at September 30, 2024 and December 31, 2023	(1,475)	(1,475)
Accumulated deficit	(205,445)	(186,288)
Total Stockholders' Equity	73,681	91,016
Total Liabilities and Stockholders' Equity	$ 79,477	$ 96,252

Stockholders' Equity - Outstanding Warrants (Details)	Sep. 30, 2024 $ / shares shares
Stockholders' Equity [Line Items]
Outstanding Warrants to Purchase Shares	21,210,750
December 2020 Warrants [Member]
Stockholders' Equity [Line Items]
Outstanding Warrants to Purchase Shares	6,185,750
Exercise Price Per Warrant \| $ / shares	$ 1
December 2020 Warrants [Member] \| Maximum [Member]
Stockholders' Equity [Line Items]
Expiration Date	Jun. 21, 2025
December 2020 Warrants [Member] \| Minimum [Member]
Stockholders' Equity [Line Items]
Expiration Date	Dec. 11, 2024
March 2021 Warrants [Member]
Stockholders' Equity [Line Items]
Outstanding Warrants to Purchase Shares	10,525,000
Exercise Price Per Warrant \| $ / shares	$ 2.88
Expiration Date	Sep. 22, 2025
The January 2021 Warrants [Member]
Stockholders' Equity [Line Items]
Outstanding Warrants to Purchase Shares	4,500,000
Exercise Price Per Warrant \| $ / shares	$ 1.055
Expiration Date	Jul. 08, 2025

Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued clinical trial costs	$ 1,207	$ 608
Accrued professional services and other	487	365
Total accrued expenses	$ 1,694	$ 973

Commitments and Contingencies - Additional Information (Details) $ in Millions	Sep. 30, 2024 USD ($)
Research and Development Arrangement [Member]
Unrecorded Unconditional Purchase Obligation [Line Items]
Estimated non-cancellable commitment	$ 10.5

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2024

Notes to Financial Statements

Prepaid Expenses and Other Current Assets

NOTE 5: PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Prepaid clinical trial deposits	$	552	$	805
Prepaid insurance		119		794
Prepaid professional services		131		501
Other		148		62
Total prepaid expenses and other current assets	$	950	$	2,162

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2024

Notes Tables

Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Prepaid clinical trial deposits	$	552	$	805
Prepaid insurance		119		794
Prepaid professional services		131		501
Other		148		62
Total prepaid expenses and other current assets	$	950	$	2,162

Payroll Liabilities - Schedule of Payroll Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued bonuses	$ 748	$ 1,134
Accrued vacation	194	236
Accrued payroll and benefits	119	284
Total payroll liabilities	$ 1,061	$ 1,654

Research and Development Rebate Liability - Additional Information (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Other Liabilities Disclosure [Abstract]
Other current liabilities	$ 1,480	$ 1,803

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Investment in Equity Securities (Tables)

9 Months Ended

Sep. 30, 2024

Equity Method Investments and Joint Ventures [Abstract]

Summary of Changes in Fair Value Estimate of Investment in Equity Securities

The following table summarizes the changes in the Company's fair value estimate of its Investment in equity securities (in thousands):




Beginning balance as of January 1, 2023 of Investment in equity securities	$	4,700
Impairment charge on Investment in equity securities		(2,990	)
Balance as of December 31, 2023 Investment in equity securities		1,710
Impairment charge on Investment in equity securities		(1,710	)
Balance as of September 30, 2024 Investment in equity securities	$	-

Net Loss Per Share

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Net Loss Per Share

NOTE 11: NET LOSS PER SHARE

Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding. Diluted net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock that would have been outstanding during the period assuming the issuance of shares of common stock for all potentially dilutive shares of common stock outstanding. Potentially dilutive shares of common stock consist of outstanding stock options, convertible preferred stock and common stock warrants. Because the inclusion of potential shares of common stock would be anti-dilutive for all periods presented, they have been excluded from the calculation.

The following table sets forth the weighted average number of common shares excluded from the calculation of diluted net loss per share, because including them would be anti-dilutive:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Options to purchase common stock		20,405,579		20,593,037		18,216,874		17,742,816
Series B convertible preferred stock		165,338		165,338		165,338		165,338
Warrants to purchase common stock		21,210,750		21,514,500		21,308,601		21,514,500
		41,781,667		42,272,875		39,690,813		39,422,654

Fair Value of Financial Instruments (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of Assets and Liabilities Measured on Recurring Basis

The following tables present the Company’s fair value hierarchy for all its financial assets and liabilities, by major security type, measured at fair value on a recurring basis (in thousands):


September 30, 2024	Estimated Fair Value		Level 1		Level 2		Level 3
Assets:
Money market fund	$	74,220	$	74,220	$	—	$	—


December 31, 2023	Estimated Fair Value		Level 1		Level 2		Level 3
Assets:
Money market fund	$	88,029	$	88,029	$	—	$	—

Condensed Consolidated Statements of Stockholders' Equity (Current Period Unaudited) - USD ($)	Total	Common Stock [Member]	Preferred Stock [Member] Convertible Preferred Stock	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Treasury Stock, Common [Member]
Balance (in shares) at Dec. 31, 2022		126,624,110	582
Balance at Dec. 31, 2022	$ 117,964,000	$ 22,792,000	$ 0	$ 251,366,000	$ (156,194,000)	$ 0
Stock-based compensation	1,573,000	0	0	1,573,000	0	0
Net loss	(6,281,000)	$ 0	$ 0	0	(6,281,000)	0
Balance (in shares) at Mar. 31, 2023		126,624,110	582
Balance at Mar. 31, 2023	113,256,000	$ 22,792,000	$ 0	252,939,000	(162,475,000)	0
Balance (in shares) at Dec. 31, 2022		126,624,110	582
Balance at Dec. 31, 2022	117,964,000	$ 22,792,000	$ 0	251,366,000	(156,194,000)	0
Net loss	(22,340,000)
Balance (in shares) at Sep. 30, 2023		125,304,064	582
Balance at Sep. 30, 2023	98,251,000	$ 22,792,000	$ 0	255,468,000	(178,534,000)	(1,475,000)
Balance (in shares) at Mar. 31, 2023		126,624,110	582
Balance at Mar. 31, 2023	113,256,000	$ 22,792,000	$ 0	252,939,000	(162,475,000)	0
Stock-based compensation	1,603,000	0	0	1,603,000	0	0
Common stock repurchased	(152,000)	$ 0	0	0	0	(152,000)
Common stock repurchased, shares		(119,382)
Net loss	(9,830,000)	$ 0	$ 0	0	(9,830,000)	0
Balance (in shares) at Jun. 30, 2023		126,504,728	582
Balance at Jun. 30, 2023	104,877,000	$ 22,792,000	$ 0	254,542,000	(172,305,000)	(152,000)
Stock-based compensation	926,000	0	0	926,000	0	0
Common stock repurchased	(1,323,000)	$ 0	0	0	0	(1,323,000)
Common stock repurchased, shares		(1,200,664)
Net loss	(6,229,000)	$ 0	$ 0	0	(6,229,000)	0
Balance (in shares) at Sep. 30, 2023		125,304,064	582
Balance at Sep. 30, 2023	98,251,000	$ 22,792,000	$ 0	255,468,000	(178,534,000)	(1,475,000)
Balance (in shares) at Dec. 31, 2023		125,304,064	582
Balance at Dec. 31, 2023	91,016,000	$ 22,792,000	$ 0	255,987,000	(186,288,000)	(1,475,000)
Stock-based compensation	417,000	0	0	417,000	0	0
Issuance of common stock upon warrant exercise	204,000	$ 37,000	0	167,000	0	0
Issuance of common stock upon warrant exercise, shares		203,750
Net loss	(5,878,000)	$ 0	$ 0	0	(5,878,000)	0
Balance (in shares) at Mar. 31, 2024		125,507,814	582
Balance at Mar. 31, 2024	85,759,000	$ 22,829,000	$ 0	256,571,000	(192,166,000)	(1,475,000)
Balance (in shares) at Dec. 31, 2023		125,304,064	582
Balance at Dec. 31, 2023	91,016,000	$ 22,792,000	$ 0	255,987,000	(186,288,000)	(1,475,000)
Net loss	(19,157,000)
Balance (in shares) at Sep. 30, 2024		125,801,254	582
Balance at Sep. 30, 2024	73,681,000	$ 22,882,000	$ 0	257,719,000	(205,445,000)	(1,475,000)
Balance (in shares) at Mar. 31, 2024		125,507,814	582
Balance at Mar. 31, 2024	85,759,000	$ 22,829,000	$ 0	256,571,000	(192,166,000)	(1,475,000)
Stock-based compensation	352,000	0	0	352,000	0	0
Issuance of common stock upon warrant exercise	100,000	$ 18,000	0	82,000	0	0
Issuance of common stock upon warrant exercise, shares		100,000
Issuance of common stock upon option exercise (in Shares)		268,998
Issuance of common stock upon option exercise	228,000	$ 48,000	0	180,000	0	0
Shares withheld related to cashless exercise of options and taxes (in shares)		(119,396)
Shares withheld related to cashless exercise of options and taxes	(228,000)	$ (21,000)	0	(207,000)	0	0
Net loss	(6,049,000)	$ 0	$ 0	0	(6,049,000)	0
Balance (in shares) at Jun. 30, 2024		125,757,416	582
Balance at Jun. 30, 2024	80,162,000	$ 22,874,000	$ 0	256,978,000	(198,215,000)	(1,475,000)
Stock-based compensation	749,000	$ 0	0	749,000	0	0
Issuance of common stock upon option exercise (in Shares)		75,000
Issuance of common stock upon option exercise	45,000	$ 14,000	0	31,000	0	0
Shares withheld related to cashless exercise of options and taxes (in shares)		(31,162)
Shares withheld related to cashless exercise of options and taxes	(45,000)	$ (6,000)	0	(39,000)	0	0
Net loss	(7,230,000)	$ 0	$ 0	0	(7,230,000)	0
Balance (in shares) at Sep. 30, 2024		125,801,254	582
Balance at Sep. 30, 2024	$ 73,681,000	$ 22,882,000	$ 0	$ 257,719,000	$ (205,445,000)	$ (1,475,000)

Liquidity and Capital Resources

9 Months Ended

Sep. 30, 2024

Notes to Financial Statements

Liquidity and Capital Resources

NOTE 2: LIQUIDITY AND CAPITAL RESOURCES

The Company has incurred net losses and negative operating cash flows since inception. For the nine months ended September 30, 2024, the Company recorded a net loss of $19.2 million and used $14.0 million of cash in operating activities. As of September 30, 2024, the Company had $74.8 million in cash and cash equivalents and working capital of $71.3 million. The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs, and it believes it will need to continue to raise substantial additional capital to accomplish its business plan over the next several years. Management believes its currently available cash and cash equivalents will be sufficient to finance the Company’s operations for at least one year from the date these Condensed Consolidated Financial Statements are issued. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of public or private equity offerings, debt financings or other sources, including potential corporate collaborations, licenses and other similar arrangements. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure additional funding, it may be forced to curtail or suspend its business plans.

Fair Value of Financial Instruments

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Fair Value of Financial Instruments

NOTE 9: FAIR VALUE OF FINANCIAL INSTRUMENTS

The following tables present the Company’s fair value hierarchy for all its financial assets and liabilities, by major security type, measured at fair value on a recurring basis (in thousands):


September 30, 2024	Estimated Fair Value		Level 1		Level 2		Level 3
Assets:
Money market fund	$	74,220	$	74,220	$	—	$	—


December 31, 2023	Estimated Fair Value		Level 1		Level 2		Level 3
Assets:
Money market fund	$	88,029	$	88,029	$	—	$	—

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 107
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 2: http://www.xbrl.org/2003/role/exampleRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 940
-SubTopic 820
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

NOTE 3: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. They do not include all information and notes required by GAAP for complete financial statements. However, except as disclosed herein, there has been no material changes in the information disclosed in the Notes to Consolidated Financial Statements included in the Annual Report on Form 10-K of the Company for the year ended December 31, 2023. The year-end Condensed Consolidated Balance Sheet presented in this report was derived from audited consolidated financial statements but does not include all annual disclosures required by GAAP. All amounts in the Condensed Consolidated Financial Statements and the notes thereto have been presented in thousands, except for par value, share and per share data or as otherwise indicated.

In the opinion of management, all adjustments (including normal recurring accruals) considered necessary for a fair presentation have been included and have been prepared on the same basis as the annual consolidated financial statements. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.

Reclassification

Certain reclassifications have been made to prior period financial information to conform to the current year presentation.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include the valuation of the investment in non-marketable equity securities, stock-based compensation expense, and prepaid or accrued clinical trial balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates.

Segments

The Company operates as a single segment. Operating segments are identified as the components of an enterprise of which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and in assessing performance. To date, the Company's chief operating decision maker has made such decisions and assessed performance at the Company-level as a single segment.

Cash and Cash Equivalents

Cash and cash equivalents include unrestricted cash and all highly liquid instruments with original maturities of three months or less at the date of purchase. Cash equivalents consist primarily of amounts invested in money market accounts.

Restricted Cash

The Company’s restricted cash balance as of September 30, 2024 and December 31, 2023 consisted entirely of cash pledged as security for the Company’s issued commercial credit cards.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of deposits of cash and cash equivalents, including those deposited in money market deposit accounts. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any material losses in such accounts and believes it is not exposed to significant risk. The Company has invested its excess cash primarily in money market funds.

Prepaid Materials

The Company capitalizes its purchase of certain raw materials, active pharmaceutical ingredients and related supplies for use in the manufacturing of drug products for use in our preclinical and clinical development programs, as it has determined that these materials have alternative future use. The Company can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. The Company expenses the cost of materials when used. The Company periodically reviews these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. Prepaid materials not expected to be used within 12 months of the balance sheet date are presented in Other assets on the Condensed Consolidated Balance Sheets.

Investments in Equity Securities

The Company has one investment in non-marketable equity securities. This investment does not have a readily determinable fair value, so the Company has elected to measure the investment at cost less any impairment, adjusted to fair value if there are observable price changes in orderly transactions for an identical or similar investment of the same issuer, in accordance with Accounting Standards Codification (ASC) 321, Investments – Equity Securities. At each reporting period, the Company performs an assessment to determine if it still qualifies for this measurement alternative.

At each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. If a qualitative assessment indicates the investment is impaired, the Company estimates the investment's fair value. If the fair value is less than the investment's carrying value, an impairment charge is recorded in the Condensed Consolidated Statements of Operations equal to the difference between the carrying value and fair value and a new basis in the investment is established. Refer to Note 4.

Other Assets

Other assets consist of property and equipment, noncurrent prepaid materials and clinical deposits.

Fair Value Measurements

The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements.

The fair value hierarchy is broken down into the three input levels summarized below:

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Level 1: Quoted market prices in active markets for identical assets or liabilities;

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Level 2: Other observable market-based inputs or unobservable inputs that are corroborated by market data; and

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Level 3: Unobservable inputs that cannot be corroborated by market data that reflects the reporting entity's own assumptions.

The carrying amounts reflected in the accompanying Condensed Consolidated Balance Sheets for cash and cash equivalents, restricted cash, and accounts payable approximate their fair values due to their short-term nature. Refer to Note 9.

Research and Development

Research and development (R&D) costs are generally expensed as incurred. R&D expenses include, for example, manufacturing expenses for the Company's drugs under development, expenses associated with preclinical studies, clinical trials and associated salaries, bonuses, stock-based compensation and benefits. The Company has entered into various research and development contracts with research institutions, clinical research organizations (CROs), clinical manufacturing organizations (CMOs) and other third parties. Payments for these activities are based on the terms of the individual agreements, which may differ from the timing of costs incurred. The Company records accruals for estimated costs incurred for ongoing research and development activities as reflected in the Condensed Consolidated Balance Sheets as accrued expenses. Payments made in advance of incurring costs are reflected in the Condensed Consolidated Balance Sheets as prepaid expenses. When evaluating the adequacy of the accrued expenses and prepaid expenses, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs.

R&D expenses also include an allocation of the CEO's salary and related benefits, including bonus and non-cash stock-based compensation expense, based on an estimate of his total hours spent on R&D activities. The Company's CEO is involved in the development of the Company's drug candidates and oversight of the related clinical trial activities and also acts as the Company's Chief Medical Officer.

Stock-based Compensation

The Company measures and recognizes compensation expense for all stock-based awards made to employees, officers, non-employee directors, and other key persons providing services to the Company, currently limited to stock options. Stock-based compensation is measured using the estimated grant date fair value and is recognized as an expense over the requisite service period, generally the vesting period. The Company has made a policy election to recognize forfeitures when they occur.

The fair value of each stock option grant is estimated using the Black-Scholes option-pricing model, which requires assumptions regarding the expected volatility of the price of the Company's common stock, the expected life of the options, an expectation regarding future dividends on the Company’s common stock, and a risk-free interest rate. The Company’s expected common stock price volatility assumption is based upon the historical volatility of its stock price. The Company has elected the simplified method for the expected life assumption for stock option grants, which averages the contractual term of the options of 10 years with the vesting term, typically one to four years, as the Company does not have sufficient option exercise experience. The dividend yield assumption of zero is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends in the future. The risk-free interest rate assumption is based upon prevailing short-term interest rates over the expected life of the options as of the grant date.

Income Taxes

The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. The Company records any interest or penalties related to income taxes in income tax benefit in the Condensed Consolidated Statements of Operations.

Variable Interest Entities

The Company reviews agreements it enters into with third-party entities, pursuant to which the Company may have a variable interest in the entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, the Company assesses whether or not it is the primary beneficiary of that entity. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If the Company determines it is the primary beneficiary of a VIE, it consolidates that VIE into the Company’s Condensed Consolidated Financial Statements. The Company’s determination about whether it should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. The Company currently does not consolidate any VIEs.

Recently Issued Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This standard requires disclosure of significant segment expenses and other segment items by reportable segment. This ASU becomes effective for annual periods beginning in 2024 and interim periods in 2025. The Company is assessing the potential impact of this ASU.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU becomes effective on January 1, 2025. The Company is assessing the potential impact of this ASU.

The Company does not expect adoption of any other recently issued accounting pronouncements to have a material impact on its financial statements.