0001193125-25-277793 | 10-Q | XBRL Viewer

Subsequent Events	9 Months Ended
Sep. 30, 2025
SUBSEQUENT EVENTS
Subsequent Events	NOTE 7. SUBSEQUENT EVENTS Subsequent to September 30, 2025, the Company received a total of $1.2 million from the exercise of pre-funded warrants for 115,244 shares of common stock and warrants for 221,098 shares of common stock.

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Current assets
Cash and cash equivalents	$ 99,369	$ 94,851
Prepaid expenses and other current assets	3,441	1,835
Total current assets	102,810	96,686
Total assets	102,810	96,686
Current liabilities
Accounts payable	5,608	3,157
Accrued liabilities	991	1,536
Total current liabilities	6,599	4,693
Total liabilities	6,599	4,693
Commitments and contingencies; see Note 4
Stockholders' equity
Series A Preferred stock, par value $0.0001, authorized 5,181,346 shares; issued and outstanding 210, as of September 30, 2025 and December 31, 2024	0	0
Common stock, par value $0.0001 per share; authorized 400,000,000 shares; issued and outstanding 5,907,233 as of September 30, 2025 and 3,420,906 as of December 31, 2024, respectively	1	0
Additional paid-in capital	448,124	406,848
Accumulated deficit	(351,914)	(314,855)
Total stockholders' equity	96,211	91,993
Total liabilities and stockholders' equity	$ 102,810	$ 96,686

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2025	Dec. 31, 2024
Common Stock, Par Value	$ 0.0001	$ 0.0001
Common Stock, Shares Authorized	400,000,000	400,000,000
Common Stock, Shares Issued	5,907,233	3,420,906
Common Stock, Shares Outstanding	5,907,233	3,420,906
Preferred Stock, Undesignated Shares Authorized	4,818,654	4,818,654
Prefered Stock, Shares Issued	10,000,000
Series A Preferred Stock [Member]
Preferred Stock, Par Value	$ 0.0001	$ 0.0001
Preferred Stock, Shares Authorized	5,181,346	5,181,346
Prefered Stock, Shares Issued	210	210
Prefered Stock ,Shares Outstanding	210	210

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2025

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles ("GAAP") for interim financial information and the instructions to Form 10‑Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period.

The accompanying unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Form 10-K, which was filed with the United States Securities and Exchange Commission (“SEC”) on March 25, 2025, from which the Company derived the balance sheet data on December 31, 2024.

The condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation.

Use of Estimates

The preparation of the accompanying unaudited condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.

Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024, other than the following:

Cash Concentration Risk

The Federal Deposit Insurance Corporation (the “FDIC”) insurance limits are $250,000 per depositor per insured bank. The Company had cash balances of $98.8 million and $1.0 million uninsured by the FDIC as of September 30, 2025 and December 31, 2024, respectively. At December 31, 2024, the Company utilized the IntraFi network of commercial banks which deposits $250,000 in each of its member banks to maintain the FDIC insurance limit.

Loss Per Share

Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock, and warrants.

The following outstanding options, restricted stock grants, convertible preferred shares and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.


	Nine months ended September 30,
	2025		2024

Warrants to purchase common stock		19,079,777		19,886,360
Options to purchase common stock		6,706,747		1,731
Convertible preferred shares outstanding		210		210

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified. These reclassifications had no effect on the financial position or reported results of operations for the periods presented. In the Condensed Consolidated Statements of Stockholders' Equity for the three months ended March 31, 2024, the presentation of the public offering sale of common stock, warrants, and pre-funded warrants was presented as proceeds, net of offering costs, of $6.2 million in additional paid-in capital and $1.8 million attributed to the exercise of pre-funded warrants. In the current presentation, this is now presented as $8.0 million, net of offering costs of $1.0 million for the public offering of common stock, warrants, and pre-funded warrants and $1 thousand attributed to the exercise of pre-funded warrants.

- Definition

Disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles.

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+ Details

Segments - Summary of Significant Expense and Asset Categories (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2025	Sep. 30, 2024	Dec. 31, 2024	Dec. 31, 2023
Operating expenses:
Research and development	$ 10,328			$ 3,112			$ 22,132	$ 8,115
General and administrative	6,478			1,507			17,804	4,084
Total operating expenses	16,806			4,619			39,936	12,199
Net operating loss	(16,806)			(4,619)			(39,936)	(12,199)
Other segment items
Interest income	1,017			665			2,901	887
Interest expense				(7)				(24)
Other income (expense), net	(15)			(0)			(24)
Net loss	(15,804)	$ (10,847)	$ (10,408)	(3,961)	$ (3,575)	$ (3,799)	(37,059)	(11,335)
Assets:
Cash and cash equivalents	$ 99,369			$ 98,311			$ 99,369	$ 98,311	$ 94,851	$ 9,792

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2025	Sep. 30, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ (15,804)	$ (10,847)	$ (10,408)	$ (3,961)	$ (3,575)	$ (3,799)	$ (37,059)	$ (11,335)

- Definition

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

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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

Segments (Tables)

9 Months Ended

Sep. 30, 2025

Segment Reporting [Abstract]

Summary of Significant Expense and Asset Categories

The table below summarizes the significant expense categories regularly reviewed by the CODM for the three and nine months ended September 30, 2025 and 2024 (in thousands).


	For the three months ended September 30,						For the nine months ended September 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	10,328		$	3,112		$	22,132		$	8,115
General and administrative		6,478			1,507			17,804			4,084
Total operating expenses	$	16,806		$	4,619		$	39,936		$	12,199

Net operating loss		(16,806	)		(4,619	)		(39,936	)		(12,199	)
Other segment items (a)
Interest income		1,017			665			2,901			887
Interest expense		-			(7	)		-			(24	)
Other income (expense), net		(15	)		-			(24	)		1
Net loss (b)	$	(15,804	)	$	(3,961	)	$	(37,059	)	$	(11,335	)

(a)

Other segment items included in segment loss includes interest income and interest expense.

(b)

The Company is a single operating segment and therefore the measure of segment net loss is the same as consolidated net loss and does not require reconciliation.

The table below summarizes the significant asset categories regularly reviewed by the CODM at September 30, 2025 and September 30, 2024 (in thousands).


	September 30, 2025		September 30, 2024
Assets:
Cash and cash equivalents	$	99,369	$	98,311

Segments

9 Months Ended

Sep. 30, 2025

Segment Reporting [Abstract]

Segments

NOTE 6. SEGMENTS

Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the Chief Operating Decision Maker ("CODM"), or decision-making group, in making decisions on how to allocate resources and assess performance. The Company's CODM, the President and Chief Executive Officer, views the Company's operations as one operating segment, which is focused on identifying and developing therapeutics that address cardiovascular and pulmonary diseases with high unmet medical need, with an initial therapeutic focus on pulmonary hypertension. The Company does not have revenue in the current comparative period, incurs expenses primarily in the United States and manages the business activities on a consolidated basis.

The accounting policies of the cardiovascular and pulmonary therapeutics segment are the same as those described in the summary of significant accounting policies.

The CODM assesses performance for the cardiovascular and pulmonary therapeutics segment and decides how to allocate resources based on net loss that also is reported on the income statement as consolidated net loss. The measure of segment assets is reported on the balance sheet as cash and cash equivalents.

The Company has not generated any product revenue in the current period and expects to continue to incur significant expenses and operating losses for the foreseeable future as the Company advances its product candidates through all stages of development and clinical trials.

As such, the CODM uses cash forecast models in deciding how to invest into the cardiovascular and pulmonary therapeutics segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results, net cash used in operating activities for the period and cash on hand are used in assessing performance of the segment.

The table below summarizes the significant expense categories regularly reviewed by the CODM for the three and nine months ended September 30, 2025 and 2024 (in thousands).


	For the three months ended September 30,						For the nine months ended September 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	10,328		$	3,112		$	22,132		$	8,115
General and administrative		6,478			1,507			17,804			4,084
Total operating expenses	$	16,806		$	4,619		$	39,936		$	12,199

Net operating loss		(16,806	)		(4,619	)		(39,936	)		(12,199	)
Other segment items (a)
Interest income		1,017			665			2,901			887
Interest expense		-			(7	)		-			(24	)
Other income (expense), net		(15	)		-			(24	)		1
Net loss (b)	$	(15,804	)	$	(3,961	)	$	(37,059	)	$	(11,335	)

(a)

Other segment items included in segment loss includes interest income and interest expense.

(b)

The Company is a single operating segment and therefore the measure of segment net loss is the same as consolidated net loss and does not require reconciliation.

For the nine months ended September 30, 2025 and 2024, the net cash used in operating activities was $22.4 million and $11.3 million, respectively. The table below summarizes the significant asset categories regularly reviewed by the CODM at September 30, 2025 and September 30, 2024 (in thousands).


	September 30, 2025		September 30, 2024
Assets:
Cash and cash equivalents	$	99,369	$	98,311

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

Segments - Additional Information (Details)	9 Months Ended
Segments - Additional Information (Details)	Sep. 30, 2025 USD ($) Segment	Sep. 30, 2024 USD ($)
Segment Reporting [Abstract]
Number of operating segment \| Segment	1
Segment Reporting, Expense Information Used by CODM, Description	The CODM assesses performance for the cardiovascular and pulmonary therapeutics segment and decides how to allocate resources based on net loss that also is reported on the income statement as consolidated net loss.
Segment Reporting, CODM, Individual Title and Position or Group Name [Extensible Enumeration]	srt:ChiefExecutiveOfficerMember, srt:PresidentMember
Product revenue	$ 0
Net cash used in operating activities	$ (22,385,000)	$ (11,284,000)

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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+ Details

Description of Business - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2025	Sep. 30, 2024
DESCRIPTION OF BUSINESS
Accumulated deficit	$ 351,900						$ 351,900
Net loss	15,804	$ 10,847	$ 10,408	$ 3,961	$ 3,575	$ 3,799	37,059	$ 11,335
Cash and cash equivalents	$ 99,400						$ 99,400

- Definition

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

+ References

+ Details

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2025

Schedule of Warrants Activity

The following table summarizes the Company’s warrant activity for the nine months ended September 30, 2025, not including pre-funded warrants:


	Warrants			Weighted Average Exercise Price
Outstanding at December 31, 2024		19,874,360		$	5.77
Exercised		(792,699	)		4.64
Canceled/Expired		(1,884	)		1,249.17
Outstanding at September 30, 2025		19,079,777		$	5.69

Schedule of outstanding stock options

Transactions during the nine months ended September 30, 2025 related to stock options granted to employees and directors under Company option plans were as follows:


	Shares			Weighted average exercise price per Share		Weighted average remaining contractual life (years)		Aggregate intrinsic value (in thousands)
Options outstanding as of December 31, 2024		3,126,436		$	6.66		9.95	$	783
Granted		3,330,000		5.87
Forfeited		(3	)		109,440.00
Options outstanding as of September 30, 2025		6,456,433		$	6.21		9.43	$	11,000
Options exercisable at September 30, 2025		755		$	2,461.98		6.32	$	1

Pre-Funded Warrants [Member]

Schedule of Warrants Activity

Pre-Funded Warrants Activity

The following table summarizes the Company’s pre-funded warrant activity for the nine months ended September 30, 2025:


	Prefunded Warrants			Weighted Average Exercise Price
Outstanding at December 31, 2024		31,882,671		$	0.01
Issued		3,760,726			0.01
Exercised		(1,315,282	)		0.01
Canceled/Expired		(1,343	)		0.01
Outstanding at September 30, 2025		34,326,772		$	0.01

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Deficit
Balance, shares at Dec. 31, 2023		210	298,281
Balance, amount at Dec. 31, 2023	$ 8,098			$ 305,351	$ (297,253)
Public offering sale of common stock, warrants, and prefunded warrants, net of offering costs, shares			421,260
Public offering sale of common stock, warrants and prefunded warrants, net of offering costs, amount	8,010			8,010
Exercise of pre-funded warrants for cash, shares			973,240
Exercise of pre-funded warrants for cash, amount	1			1
Exercise of pre-funded warrants, cashless, shares			205,467
Exercise of pre-funded warrants, amount	1,800
Stock split and fractional shares issued, shares			59,997
Stock-based compensation expense	119			119
Net loss	(3,799)				(3,799)
Balance, shares at Mar. 31, 2024		210	1,958,245
Balance, amount at Mar. 31, 2024	12,429			313,481	(301,052)
Balance, shares at Dec. 31, 2023		210	298,281
Balance, amount at Dec. 31, 2023	8,098			305,351	(297,253)
Net loss	(11,335)
Balance, shares at Sep. 30, 2024		210	3,408,906
Balance, amount at Sep. 30, 2024	97,223			405,811	(308,588)
Balance, shares at Mar. 31, 2024		210	1,958,245
Balance, amount at Mar. 31, 2024	12,429			313,481	(301,052)
Stock-based compensation expense	22			22
Net loss	(3,575)				(3,575)
Balance, shares at Jun. 30, 2024		210	1,958,245
Balance, amount at Jun. 30, 2024	8,876			313,503	(304,627)
Public offering sale of common stock, warrants, and prefunded warrants, net of offering costs, shares			1,450,661
Public offering sale of common stock, warrants and prefunded warrants, net of offering costs, amount	92,293			92,293
Stock-based compensation expense	15			15	(3,961)
Net loss	(3,961)
Balance, shares at Sep. 30, 2024		210	3,408,906
Balance, amount at Sep. 30, 2024	97,223			405,811	(308,588)
Balance, shares at Dec. 31, 2024		210	3,420,906
Balance, amount at Dec. 31, 2024	91,993			406,848	(314,855)
Public offering sale of common stock, warrants, and prefunded warrants, net of offering costs, shares			378,346
Public offering sale of common stock, warrants and prefunded warrants, net of offering costs, amount	23,216			23,216
Exercise of pre-funded warrants, shares			99,189
Exercise of pre-funded warrants, amount	1			1
Exercise of warrants, shares			71,944
Exercise of warrants, amount	347			347
Stock-based compensation expense	4,142			4,142
Net loss	(10,408)				(10,408)
Balance, shares at Mar. 31, 2025		210	3,970,385
Balance, amount at Mar. 31, 2025	109,291			434,554	(325,263)
Balance, shares at Dec. 31, 2024		210	3,420,906
Balance, amount at Dec. 31, 2024	91,993			406,848	(314,855)
Net loss	(37,059)
Balance, shares at Sep. 30, 2025		210	5,907,233
Balance, amount at Sep. 30, 2025	96,211		$ 1	448,124	(351,914)
Balance, shares at Mar. 31, 2025		210	3,970,385
Balance, amount at Mar. 31, 2025	109,291			434,554	(325,263)
Exercise of pre-funded warrants, shares			116,693
Exercise of pre-funded warrants, amount	1			1
Exercise of warrants, shares			61,417
Exercise of warrants, amount	276			276
Stock-based compensation expense	4,609			4,609
Net loss	(10,847)				(10,847)
Balance, shares at Jun. 30, 2025		210	4,148,495
Balance, amount at Jun. 30, 2025	103,330			439,440	(336,110)
Exercise of pre-funded warrants, shares			1,099,400
Exercise of pre-funded warrants, amount	4		$ 1	3
Exercise of warrants, shares			659,338
Exercise of warrants, amount	3,059			3,059
Stock-based compensation expense	5,622			5,622
Net loss	(15,804)				(15,804)
Balance, shares at Sep. 30, 2025		210	5,907,233
Balance, amount at Sep. 30, 2025	$ 96,211		$ 1	$ 448,124	$ (351,914)

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss	$ (37,059)	$ (11,335)
Adjustments to reconcile net loss to net cash used in operating activities
Interest on debt instrument	0	24
Stock-based compensation	14,373	155
Changes in operating assets and liabilities
Prepaid expenses and other current assets	(1,606)	419
Accounts payable	2,452	(513)
Accrued liabilities	(545)	(34)
Net cash used in operating activities	(22,385)	(11,284)
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash provided by investing activities	0	0
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of warrants and pre-funded warrants, net of issuance costs	23,216	98,477
Proceeds from the exercise of warrants and pre-funded warrants	3,687	1,827
Payments on short-term note	0	(501)
Net cash provided by financing activities	26,903	99,803
Net change in cash and cash equivalents	4,518	88,519
Cash and cash equivalents, beginning of period	94,851	9,792
Cash and cash equivalents, end of period	99,369	98,311
Supplemental Disclosures:
Cash paid for interest	$ 0	$ 23

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Operating expenses
Research and development	$ 10,328	$ 3,112	$ 22,132	$ 8,115
General and administrative	6,478	1,507	17,804	4,084
Total operating expenses	16,806	4,619	39,936	12,199
Net operating loss	(16,806)	(4,619)	(39,936)	(12,199)
Interest income	1,017	665	2,901	887
Interest expense		(7)		(24)
Other income (expense), net	(15)	(0)	(24)
Net loss	$ (15,804)	$ (3,961)	$ (37,059)	$ (11,335)
Net loss per share, basic	$ (0.4)	$ (0.19)	$ (0.96)	$ (1.37)
Net loss per share, diluted	$ (0.4)	$ (0.19)	$ (0.96)	$ (1.37)
Weighted average number of common shares and prefunded warrants outstanding, basic	39,741,404	21,161,143	38,644,395	8,282,118
Weighted average number of common shares and prefunded warrants outstanding, diluted	39,741,404	21,161,143	38,644,395	8,282,118

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2025	Nov. 11, 2025
Cover [Abstract]
Entity Registrant Name	TENAX THERAPEUTICS, INC.
Entity Central Index Key	0000034956
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Sep. 30, 2025
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2025
Entity Common Stock Shares Outstanding		6,243,575
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-34600
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	26-2593535
Entity Address Address Line 1	101 Glen Lennox Drive
Entity Address Address Line 2	Suite 300
Entity Address City Or Town	Chapel Hill
Entity Address State Or Province	NC
Entity Address Postal Zip Code	27517
City Area Code	919
Local Phone Number	855-2100
Security 12b Title	Common Stock, $0.0001 par value per share
Trading Symbol	TENX
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Jun. 30, 2025	Sep. 30, 2025	Sep. 30, 2024	Dec. 31, 2024
Common Stock, Shares Authorized	400,000,000			400,000,000		400,000,000
Common Stock, Par Value	$ 0.0001			$ 0.0001		$ 0.0001
Common Stock, Shares Outstanding	5,907,233			5,907,233		3,420,906
Common Stock, Shares issued	5,907,233			5,907,233		3,420,906
Issuance of preferred shares	10,000,000			10,000,000
Preferred Stock, Undesignated Shares Authorized	4,818,654			4,818,654		4,818,654
Preferred stock, par value	$ 0.0001			$ 0.0001
Preferred Stock convertible into share of common stock	1			1		1
Weighted average remaining contractual life options exercisable				6 years 3 months 25 days
Unrecognized Compensation Costs	$ 18,400			$ 18,400
Weighted average remaining vesting period				1 year 6 months 18 days
Compensation Expense	$ 5,500	$ 9		$ 14,000	$ 35
August 2024 Private Placement Financing [Member] \| Pre-Funded Warrants [Member]
Exercise price	$ 0.01			$ 0.01
Warrant to purchase share of common stock				1,450,661
Common stock shares				31,882,671
Warrant purchase				16,666,666
Offering Price				$ 3
Common stock warrant				$ 2.99
Gross proceeds form warrant				$ 99,700
Agent fees and direct offering expenses				92,300
fair value allocated				3,200
Pre-funded warrants				69,400
Warrant				$ 27,100
March 2025 Private Placement Financing \| Pre-Funded Warrants [Member]
Exercise price	$ 0.01			$ 0.01
Warrant to purchase share of common stock				378,346
Common stock shares				3,760,726
Offering Price				$ 6.04
Common stock warrant				$ 6.03
Gross proceeds form warrant				$ 25,000
Agent fees and direct offering expenses				23,200
fair value allocated				2,300
Pre-funded warrants				$ 22,700
February 2024 Offering 1 [Member]
Common stock shares				1,178,740
Warrant purchase				3,200,000
Offering Price				$ 5.65
Common stock warrant				$ 5.649
Gross proceeds form warrant				$ 9,000
Agent fees and direct offering expenses				8,000
fair value allocated				900
Pre-funded warrants				2,400
Warrant				$ 5,700
February 2024 Offering 1 [Member] \| Pre-Funded Warrants [Member]
Warrant to purchase share of common stock				421,260
February 2024 [Member]
Warrant to purchase share of common stock				3,200,000
Offering Price				$ 5.65
Weighted average remaining contractual life options exercisable				5 years
fair value allocated				$ 5,700
Risk-free interest rate				4.12%
Expected dividend yield				0.00%
Dividend Yield				131.87%
August 2024 Warrants [Member]
Issued unregistered warrants to purchase shares of common stock				16,666,666
Offering Price				$ 4.5
Weighted average remaining contractual life options exercisable				1 year 9 months 18 days
fair value allocated				$ 27,100
Risk-free interest rate				3.83%
Expected dividend yield				0.00%
Dividend Yield				177.27%
2022 Stock Incentive Plan
Shares remained available for issuance	1,881,121			1,881,121
Series A Stock Plan
Issuance of preferred shares	5,181,346			5,181,346
Prefered Stock ,Shares Outstanding	210			210		210
First Inducement Stock Options
Number of shares of common stock authorized for issuance				250,000
Stock Option Award Granted				1,400,000
Stock Options Description				The option award will vest in four equal annual installments beginning on the first anniversary of the date of issuance, subject to the employee's continued employment with the Company through each applicable vesting date. The option has a 10-year term and an exercise price of $6.45 per share, the January 21, 2025 closing price of the Company’s common stock.
Risk-free interest rate				4.49%
Dividend Yield				0.00%
Volatility Factor Rate				123.41%
Expected Life				6 years
Inducement Stock Options [Member]
Unrecognized Compensation Costs	$ 1,400			$ 1,400
Compensation Expense	$ 89	$ 6		$ 326	$ 121
Inducement Stock Options [Member] \| President and Chief Executive Officer [Member]
Number of shares of common stock authorized for issuance				157
Stock Option Award Granted			403,000
Stock Options Description				This award vested as follows: 25% on the one-year anniversary of the Chief Executive Officer's employment start date and an additional 25% on each of the following three anniversaries of the Chief Executive Officer's employment start date, subject to continued employment. The option has a 10-year term and an exercise price of $3,152 per share, the July 6, 2021 closing price of our common stock.
Risk-free interest rate			1.13%
Dividend Yield			0.00%
Volatility Factor Rate			99.36%
Expected Life			7 years
Vesting milestone achieved percentage			75.00%
Inducement Stock Options [Member] \| Chief Medical Officer [Member]
Stock Option Award Granted				157
Stock Options Description				This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by Nasdaq Listing Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an investigational NDA; and 25% upon approval. The options have a 10-year term and an exercise price of $2,848 per share, the January 15, 2021 closing price of our common stock.
Estimated Fair Value Of The Inducement Stock Option Award Granted			$ 403
Risk-free interest rate			11.00%
Dividend Yield			0.00%
Volatility Factor Rate			103.94%
Expected Life			10 years

Stockholders' Equity

9 Months Ended

Sep. 30, 2025

Stockholders' Equity Note [Abstract]

Stockholders' Equity

NOTE 5. STOCKHOLDERS’ EQUITY

Common Stock and Preferred Stock

Common Stock

The Company’s Certificate of Incorporation, as amended, authorizes the issuance of 400,000,000 shares of $0.0001 par value common stock. As of September 30, 2025 and December 31, 2024, there were 5,907,233 and 3,420,906 shares of common stock issued and outstanding, respectively.

Preferred Stock

Under the Company’s Certificate of Incorporation, as amended, the Board is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. Of the potential 10,000,000 shares of preferred stock, 5,181,346 are designated as Series A Stock and 4,818,654 remain undesignated. As of September 30, 2025 and December 31, 2024, there were 210 shares of Series A Stock outstanding, convertible in the aggregate into one share of common stock.

Common Stock and Pre-Funded Warrants

March 2025 Private Placement Financing (the “March 2025 Offering”)

On March 4, 2025, the Company entered into a securities purchase agreement with certain accredited investors for the purchase and sale, in a private placement financing by the Company, of (i) an aggregate of 378,346 shares of its common stock, and pre-funded warrants to purchase an aggregate of 3,760,726 shares of common stock at an offering price of $6.04 per share of common stock and $6.03 per pre-funded warrant, resulting in gross proceeds of $25.0 million. The pre-funded warrants do not expire and have an exercise price of $0.01. The net proceeds of the March 2025 Offering, after deducting placement agent fees and direct offering expenses were $23.2 million. The relative fair value allocated to the common stock and pre-funded warrants was $2.3 million and $22.7 million, respectively.

Also, on March 5, 2025 and in connection with the March 2025 Offering, the Company entered into a registration rights agreement (the “March 2025 Registration Rights Agreement”) with the purchasers, pursuant to which the Company agreed to register for resale the shares of common stock issued in the March 2025 Offering and the shares of common stock issuable upon exercise of the pre-funded warrants issued in the March 2025 Offering within 45 days of the closing date. Pursuant to the March 2025 Registration Rights Agreement, on April 15, 2025, the Company filed a resale registration statement on Form S-3 with the SEC, which went effective on April 23, 2025.

The March 2025 Registration Rights Agreement includes liquidated damages provisions that meet the definition of a registration payment arrangement that is within the scope of ASC 825-20. The Company determined at the initial issuance of the pre-funded warrants that it is not probable that a payment would be required as it has both the intent and ability to satisfy the March 2025 Registration Rights Agreement. Therefore, the Company did not record a liability at inception but will evaluate the contingency at each reporting period. As of September 30, 2025, no events had occurred that would change our initial assessment of this provision.

August 2024 Private Placement Financing (the “August 2024 Offering”)

On August 6, 2024, the Company entered into a securities purchase agreement with certain accredited investors for the purchase and sale, in a private placement financing by the Company, of (i) an aggregate of 1,450,661 shares of its common stock, and pre-funded warrants to purchase an aggregate of 31,882,671 shares of common stock and (ii) accompanying warrants to purchase up to an aggregate of 16,666,666 shares of its common stock (or, in lieu thereof, additional pre-funded warrants) at a combined offering price of $3.00 per share of common stock and accompanying warrant, or $2.99 per pre-funded warrant and accompanying warrant, resulting in gross proceeds of $99.7 million. The pre-funded warrants do not expire and have an exercise price of $0.01. The net proceeds of the August 2024 Offering after deducting placement agent fees and direct offering expenses were $92.3 million. The relative fair value allocated to the common stock, pre-funded warrants, and accompanying warrants was $3.2 million, $69.4 million, and $27.1 million, respectively.

Also, on August 6, 2024 and in connection with the August 2024 Offering, the Company entered into a registration rights agreement (the “August 2024 Registration Rights Agreement”) with the purchasers, pursuant to which the Company agreed to register for resale the shares of common stock issued in the August 2024 Offering and the shares of common stock issuable upon exercise of the warrants issued in the August 2024 Offering within 60 days following the effective date of the August 2024 Registration Rights Agreement. Pursuant to the August 2024 Registration Rights Agreement, on August 30, 2024, the Company filed a resale registration statement on Form S-3 with the SEC, which went effective on September 12, 2024.

The August 2024 Registration Rights Agreement includes liquidated damages provisions that meet the definition of a registration payment arrangement that is within the scope of ASC 825-20. The Company determined at the initial issuance of the pre-funded warrants and accompanying warrant that it is not probable that a payment would be required as it has both the intent and ability to satisfy the August 2024 Registration Rights Agreement. Therefore, the Company did not record a liability at inception but

will evaluate the contingency at each reporting period. As of September 30, 2025, no events have occurred that would change our initial assessment of this provision.

February 2024 Registered Public Offering (the “February 2024 Offering”)

On February 8, 2024, the Company entered into a securities purchase agreement with certain purchasers for the purchase and sale, in a registered public offering by the Company, of (i) an aggregate of 421,260 shares of its common stock, and pre-funded warrants to purchase an aggregate of 1,178,740 shares of common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,000 shares of its common stock at a combined offering price of $5.65 per share of common stock and associated warrant, or $5.649 per pre-funded warrant and accompanying warrant, resulting in gross proceeds of $9.0 million. The net proceeds of the February 2024 Offering after deducting placement agent fees and direct offering expenses were $8.0 million. The relative fair value allocated to the common stock, pre-funded warrants and warrants was $0.9 million, $2.4 million, and $5.7 million, respectively.

Pre-Funded Warrants Activity

The following table summarizes the Company’s pre-funded warrant activity for the nine months ended September 30, 2025:


	Prefunded Warrants			Weighted Average Exercise Price
Outstanding at December 31, 2024		31,882,671		$	0.01
Issued		3,760,726			0.01
Exercised		(1,315,282	)		0.01
Canceled/Expired		(1,343	)		0.01
Outstanding at September 30, 2025		34,326,772		$	0.01

Warrants

The following table summarizes the Company’s warrant activity for the nine months ended September 30, 2025, not including pre-funded warrants:


	Warrants			Weighted Average Exercise Price
Outstanding at December 31, 2024		19,874,360		$	5.77
Exercised		(792,699	)		4.64
Canceled/Expired		(1,884	)		1,249.17
Outstanding at September 30, 2025		19,079,777		$	5.69

August 2024 Warrants

As described above, as part of the August 2024 Offering, the Company issued unregistered warrants to purchase 16,666,666 shares of its common stock at an exercise price of $4.50 per share. The warrants expire at the earlier of (i) 30 trading days following the date of the Company’s initial public announcement of topline data from its Phase 3 LEVEL trial (the “Topline Data Announcement”), (ii) immediately upon the exercise of the August 2024 pre-funded warrants if such exercise is prior to the Topline Data Announcement, provided that if the pre-funded warrant is not exercised in full, the warrant expires proportionally to the extent the pre-funded warrant is exercised, and (iii) August 8, 2029. The warrants have an estimated term of 1.8 years. The unregistered warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. In accordance with ASC 815, Derivatives and Hedging, these warrants are classified as equity and their relative fair value of $27.1 million was recognized as additional paid in capital. The estimated fair value is determined using the Black-Scholes option pricing model using the following assumptions: remaining estimated term of 1.8 years, risk free interest rate of 3.83%, expected dividends of zero, and expected volatility of 177.27%.

February 2024 Warrants

As described above, as a part of the February 2024 Offering, the Company issued registered warrants to purchase 3,200,000 shares of its common stock at an exercise price of $5.65 per share and contractual term of five years. In accordance with ASC 815, Derivatives and Hedging, these warrants are classified as equity and their relative fair value of $5.7 million was recognized as additional paid in capital. The estimated fair value was determined using the Black-Scholes option pricing model using the following assumptions: remaining estimated term of 5.0 years, risk free interest rate of 4.12%, expected dividends of zero, and expected volatility of 131.87%.

Stock-Based Compensation

Stock Incentive Plans

In June 2022, the Company adopted the 2022 Stock Incentive Plan, as amended on June 7, 2024 and October 25, 2024, (the “2022 Plan”), with the outstanding shares available for future grants under prior plans, as well as outstanding awards under prior plans that subsequently expire, terminate or are surrendered or forfeited, generally being assumed by the 2022 Plan. Unexpired awards granted under certain prior plans may be subject to the terms of such prior plans.

Under the 2022 Plan, with the approval of the Board’s Compensation Committee, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares, performance units, cash-based awards or other stock-based awards. Stock options granted under the 2022 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the 2022 Plan may be granted with a term of up to ten years and at prices no less than fair market value at the time of grant. Stock options granted generally vest over one to four years.

A total of 1,881,121 shares remained available for issuance under the 2022 Plan as of September 30, 2025.

Summary of Stock Option Activity

Transactions during the nine months ended September 30, 2025 related to stock options granted to employees and directors under Company option plans were as follows:


	Shares			Weighted average exercise price per Share		Weighted average remaining contractual life (years)		Aggregate intrinsic value (in thousands)
Options outstanding as of December 31, 2024		3,126,436		$	6.66		9.95	$	783
Granted		3,330,000		5.87
Forfeited		(3	)		109,440.00
Options outstanding as of September 30, 2025		6,456,433		$	6.21		9.43	$	11,000
Options exercisable at September 30, 2025		755		$	2,461.98		6.32	$	1

The Company recorded compensation expense for stock options granted under Company stock incentive plans of $5.5 million and $14.0 million for the three and nine months ended September 30, 2025, respectively, and $9 thousand and $35 thousand for the three and nine months ended September 30, 2024, respectively.

As of September 30, 2025, there were unrecognized compensation costs of $18.4 million related to non-vested stock option awards that will be recognized on a straight-line basis over the weighted average remaining vesting period of 1.55 years.

Inducement Stock Options

The Company granted an employment inducement stock option award for 250,000 shares of common stock to a new employee on January 21, 2025. This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by Nasdaq Listing Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest in four equal annual installments beginning on the first anniversary of the date of issuance, subject to the employee's continued employment with the Company through each applicable vesting date. The option has a 10-year term and an exercise price of $6.45 per share, the January 21, 2025 closing price of the Company’s common stock. The estimated fair value of the inducement stock option award was $1.4 million using the Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 4.49%, dividend yield of 0%, volatility factor for our common stock of 123.41% and an expected life of 6 years.

The Company granted an employment inducement stock option award for 157 shares of common stock, to its then-new President and Chief Executive Officer on July 6, 2021. The employment inducement stock option award was granted in accordance with the employment inducement award exemption provided by Nasdaq Listing Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. This award vested as follows: 25% on the one-year anniversary of the Chief Executive Officer's employment start date and an additional 25% on each of the following three anniversaries of the Chief Executive Officer's employment start date, subject to continued employment. The option has a 10-year term and an exercise price of $3,152 per share, the July 6, 2021 closing price of our common stock. As of September 30, 2025, 75% of the vesting milestones had been achieved. The estimated fair value of this inducement stock option award was $403 thousand using the Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 1.13%, dividend yield of 0%, volatility factor for our common stock of 99.36% and an expected life of 7 years.

The Company also granted an employment inducement stock option award for 157 shares of common stock to its then-new Chief Medical Officer on January 15, 2021. This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by Nasdaq Listing Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an investigational NDA; and 25% upon approval. The options have a 10-year term and an exercise price of $2,848 per share, the January 15, 2021 closing price of our common stock. As of September 30, 2025, two of the vesting milestones had been achieved. The estimated fair value of the inducement stock option award granted was $403 thousand using the Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 11%, dividend yield of 0%, volatility factor for our common stock of 103.94% and an expected life of 10 years.

Inducement stock option compensation expense totaled $89 thousand and $326 thousand for the three and nine months ended September 30, 2025, respectively, and $6 thousand and $121 thousand for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, there was $1.4 million of remaining unrecognized compensation expense related to these inducement stock options.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

+ Details

Stockholders' Equity - Schedule of Warrants Activity (Details)	9 Months Ended
	Sep. 30, 2025 $ / shares shares
Class of Warrant or Right [Line Items]
Warrants outstanding beginning \| shares	19,874,360
Exercised \| shares	(792,699)
Canceled/Expired \| shares	(1,884)
Warrants outstanding ending \| shares	19,079,777
Warrants,Weighted average exercise price beginning \| $ / shares	$ 5.77
Weighted average exercise price, excercised \| $ / shares	4.64
Weighted average exercise price, Canceled/Expired \| $ / shares	1,249.17
Warrants, weighted average exercise price, ending \| $ / shares	$ 5.69
Pre-Funded Warrants [Member]
Class of Warrant or Right [Line Items]
Warrants outstanding beginning \| shares	31,882,671
Warrants issued \| shares	3,760,726
Exercised \| shares	(1,315,282)
Canceled/Expired \| shares	(1,343)
Warrants outstanding ending \| shares	34,326,772
Warrants,Weighted average exercise price beginning \| $ / shares	$ 0.01
Weighted average exercise price, issued \| $ / shares	0.01
Weighted average exercise price, excercised \| $ / shares	0.01
Weighted average exercise price, Canceled/Expired \| $ / shares	0.01
Warrants, weighted average exercise price, ending \| $ / shares	$ 0.01

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
Public offering sale of common stock, warrants, and prefunded warrants, offering costs	$ 1,746	$ 1,028

Stockholders' Equity - Schedule of outstanding stock options (Details) - USD ($)	9 Months Ended
	Sep. 30, 2025	Dec. 31, 2024
Number of shares options outstanding, beginning	3,126,436
Number of shares options outstanding, granted	3,330,000
Number of shares options outstanding, forfeited	(3)
Number of shares options outstanding, ending	6,456,433
Options exercisable	755
Weighted average exercise price per Share, beginning balance	$ 6.66
Weighted average exercise price per share, granted	5.87
Weighted average exercise price per share, forfeited	109,440
Weighted average exercise price per share, ending balance	6.21
Weighted average exercise price per share, options exercisable	$ 2,461.98
Weighted average remaining contractual life options execised	9 years 5 months 4 days	9 years 11 months 12 days
Weighted average remaining contractual life options exercisable	6 years 3 months 25 days
Aggregate intrinsic value, beginning balance	$ 783
Aggregate intrinsic value, ending balance	11,000,000
Aggregate intrinsic value, options exercisable.	$ 1,000

Accrued Liabilities - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Payables and Accruals [Abstract]
Operating costs	$ 133	$ 200
Employee related	858	1,336
Total	$ 991	$ 1,536

Commitments and Contingencies - Additional Information (Details) - Simdax License Agreement [Member] $ in Millions	9 Months Ended
	Sep. 30, 2025 USD ($)
Grant paid to canadian authority	$ 10.0
Grant paid to authority	$ 5.0
Lease Term Period	10 years
Non-refundable commercialization milestone payment	$ 45.0

Subsequent Events - Additional Information (Details)	1 Months Ended
Subsequent Events - Additional Information (Details)	Nov. 12, 2025 shares
Subsequent Events [Member]
Exercise of pre-funded warrants	115,244

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2025
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

Summary of Significant Accounting Policies (Details) - shares	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
Warrants To Purchase Common Stock[Member]
Anti- Securities Dilutive	19,079,777	19,886,360
Options To Purchase Common Stock[Member]
Anti- Securities Dilutive	6,706,747	1,731
Covertible Preferred Shares Outstanding [Member]
Anti- Securities Dilutive	210	210