0001558370-25-003386 | 10-K | XBRL Viewer

As of December 31,

Office equipment

Less accumulated depreciation

Property and equipment, net

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2024	Mar. 17, 2025	Jun. 30, 2024
Cover [Abstract]
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2024
Document Transition Report	false
Entity File Number	001-37809
Entity Registrant Name	METAVIA INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-2389984
Entity Address, Address Line One	545 Concord Avenue, Suite 210
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02138
City Area Code	857
Local Phone Number	702-9600
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	MTVA
Security Exchange Name	NASDAQ
Entity Voluntary Filers	No
Entity Well-known Seasoned Issuer	No
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
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Entity Public Float			$ 13.8
Entity Common Stock, Shares Outstanding		8,654,869
Auditor Firm ID	243
Auditor Name	BDO USA, P.C.
Auditor Location	Boston Massachusetts
Entity Central Index Key	0001638287
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	FY
Amendment Flag	false

Related party

12 Months Ended

Dec. 31, 2024

Related party

Related party

5.Related party

License agreement with Dong-A for DA-1241 and DA-1726

In September 2022, we entered into the 2022 License Agreement with Dong-A pursuant to which we received an exclusive global license (except for the territory of the Republic of Korea) for two proprietary compounds for specified indications upon meeting certain financing milestones. The 2022 License Agreement covers the rights to DA-1241 for treatment of MASH and DA-1726 for treatment of obesity and MASH. The 2022 License Agreement also provides that we may develop DA-1241 for the treatment of T2DM.

In connection with the 2022 License Agreement, we entered into a shared services agreement with Dong-A (the “Shared Services Agreement”), relating to DA-1241 and DA-1726, pursuant to which Dong-A may provide technical support, preclinical development, and clinical trial support services on terms and conditions acceptable to both parties. In addition, the Shared Services Agreement provides that Dong-A will manufacture all of our clinical requirements of DA-1241 and DA-1726 under the terms provided in the Shared Services Agreement.

Under the terms of the 2022 License Agreement, we had previously expensed $8.2 million of IPR&D in 2022 as the 2022 License Agreement did not include any processes or activities constituting a “business” acquired since none of the rights underlying the Dong-A License Agreement had alternative future uses or had reached a stage of technological feasibility. Also, Dong-A will be eligible to receive (i) regulatory milestone payments of up to $178 million for DA-1726 and $138 million for DA-1241, dependent upon the achievement of specific regulatory developments; (ii) commercial-based milestone payments, dependent upon the achievement of specific commercial developments; and (iii) single digit royalties on net sales received by us from the commercial sale of products covering DA-1241 or DA-1726. The term of the 2022 License Agreement continues on a product-by-product and country-by country basis until the later of (i) the fifth anniversary of the first commercial sale of such product in such country, (ii) the expiration or termination of the last valid patent claim that covers a product in such country and (iii) the loss of regulatory exclusivity for such product in such jurisdiction. Either Dong-A or MetaVia may terminate the 2022 License Agreement (i) if the other party is in material breach of the agreement and has not cured or started to cure the breach within 60 days of notice of such breach; provided that if the breach cannot be cured within the 60-day period and the breaching party started to remedy the breach, if such breach is not cured within 90 days of receipt of written notice, or (ii) if the other party is subject to a bankruptcy or insolvency event (subject to a 30-day cure period in the case of a petition for bankruptcy).

As of December 31, 2024, there were no potential milestones under the 2022 License Agreement that were yet considered probable; therefore, no liabilities were recorded.

As of December 31, 2024, Dong-A owns approximately 62% of our outstanding common stock.

Shared services agreement with Dong-A

In September 2022, in conjunction with the 2022 License Agreement, we entered into the Shared Services Agreement with Dong-A, relating to DA-1241 and DA-1726. The Shared Services Agreement provides that Dong-A may provide technical support, preclinical development, and clinical trial support services on terms and conditions acceptable to both parties. In addition, the Shared Services Agreement provides that Dong-A will manufacture all of our clinical requirements of DA-1241 and DA-1726 under the terms provided in the Shared Services Agreement.

Either party may terminate the Shared Services Agreement for the other party’s material breach that is not cured within 30 days of notice. Dong-A may also terminate the Shared Services Agreement in part on a service-by-service or product-by-product basis upon a breach by us which is not cured within 30 days.

We incurred R&D expenses of $4.9 million and $2.4 million for 2024 and 2023, respectively, under the Shared Services Agreement, which are included in operating expenses in the accompanying consolidated statement of operations. As of December 31, 2024 and 2023, we have amounts payable to Dong-A of $1.5 million and $0.8 million, respectively, under the Shared Services Agreement, which is included in related party payable in the accompanying consolidated balance sheets. We did not incur any expenses or liabilities under the Shared Services Agreement in 2022.

License agreement with Dong-A for NB-01 (a legacy therapeutic program)

In January 2018, we entered into an exclusive license agreement with Dong-A, (the “2018 License Agreement”) which agreement was amended in April 2018 and July 2019. Under the terms of the 2018 License Agreement, we obtained an exclusive, royalty-bearing, worldwide (except for the Republic of Korea) license to make, use, offer to sell, sell and import products covered by certain Dong-A intellectual property rights in its proprietary compound designated as DA-9801 (NB-01). Our license rights cover any and all applications and markets for the therapeutic, health, nutrition or well-being of humans. We may grant sublicenses to any affiliate or third party. We are responsible for all future patent prosecution costs.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

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+ Details

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

Commitments and Contingencies - Contingent payments and license agreements (Details) $ in Thousands	Dec. 31, 2024 USD ($)
Commitments and contingencies
Contingent liabilities recorded	$ 0
Contingent assets recorded	$ 0

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (27,592)	$ (12,470)

- 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

Commitments and contingencies - Operating Leases - (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Aug. 31, 2023
Commitments and Contingencies
Lease asset liability	$ 136
New Corporate Headquarters Lease
Commitments and Contingencies
Term of contract			3 years
Renewal term			2 years
Rental expense	100	$ 29
Operating lease cash payments	$ 100	$ 28
Operating lease discount rate	11.00%	11.00%
Former Corporate Headquarters Lease
Commitments and Contingencies
Rental expense	$ 0	$ 22
Operating lease cash payments	$ 0	$ 22

Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Prepaid expenses and other current assets
Insurance	$ 5
Deposits	16	$ 39
Other prepaid expenses	34	38
Total	$ 55	$ 77

Current liabilities -Warrant liabilities (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Current liabilities
As of beginning balance	$ 658	$ 10,796
Reclassification of warrant liabilities upon exercise of warrants		(7,183)
Change in fair value of warrant liabilities	$ (297)	$ (2,955)
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Fair Value Adjustment of Warrants	Fair Value Adjustment of Warrants
As of ending balance	$ 361	$ 658

Stockholders' equity (Tables)

12 Months Ended

Dec. 31, 2024

Stockholders' equity

Schedule of outstanding warrants


	Shares of Common Stock Issuable
	for Outstanding Warrants
	As of December 31,		Exercise		Expiration
Warrant Issuance	2024	2023	Price		Date
July 2018 ⁽¹⁾	6	6	$	44,820.00	July 2028
April 2020 ⁽¹⁾	159	159	$	3,000.00	April 2025
January 2021 ⁽¹⁾	10,421	10,421	$	1,447.20	July 2026
October 2021 ⁽¹⁾	15,390	15,390	$	900.00	April 2025
November 2022 Series B ⁽²⁾	177,938	177,938	$	0.00	December 2027
June 2024 Placement Agent⁽³⁾	127,227	—	$	4.91	July 2026
June 2024 Pre-Funded ⁽⁴⁾	1,430,000	—	$	0.00	no expiration date
June 2024 Series A ⁽⁵⁾	5,089,060	—	$	3.93	September 2025 (latest date)
June 2024 Series B ⁽⁶⁾	7,633,591	—	$	3.93	September 2029 (latest date)
Total	14,483,792	203,914

(1)

The number of outstanding and exercisable warrants is equal to the number of shares of common stock issuable for outstanding warrants.

(2)

The number of outstanding and exercisable warrants of 1,423,504 represent eight times the number of shares of common stock issuable for these warrants. These warrants have a cashless exercise provision whereby eight warrants can be exercised for one share of common stock for no additional consideration, which renders the $3.00 per warrant exercise price to be zero. In 2023, 6,843,666 Series B warrants issued in November 2022 were exercised for 855,458 shares of our common stock.

(3)

These warrants are exercisable at any time from the Stockholder Approval Date and expire two years after a resale registration statement covering the shares of common stock issuable upon the exercise of the warrants hereunder becomes effective with the SEC. In July 2024, a resale registration statement was filed with the SEC and became effective.

(4)

These warrants are exercisable immediately upon their issuance in June 2024 and are considered to be perpetual warrants without any expiration date. Additionally, in the third quarter of 2024, 351,171 Pre-Funded Warrants were exercised for an equivalent number of shares of our common stock.

(5)

These warrants are exercisable at any time from the Stockholder Approval Date and expire earlier of (i) the twelve months anniversary of the Stockholder Approval Date, and (ii) the 60th day following the date on which the Company publicly announces the receiving of positive Phase 1 MAD data readout for DA-1726.

(6)

These warrants are exercisable at any time from the Stockholder Approval Date and expire on the earlier of (i) the five-year anniversary of the Stockholder Approval Date and (ii) the six months anniversary following the date on which the Company publicly announce the receiving of positive Phase 1, Part 3 data readout for DA-1726.

Schedule of stock-based compensation expense

Stock-based compensation expense was included in general and administrative and research and development as follows (in thousands):


	Year Ended December 31,
	2024		2023
General and administrative	$	366	$	178
Research and development		172		44
Total stock-based compensation	$	538	$	222

Schedule of outstanding awards issued pursuant to our stock-based award plans and inducement grants


			Remaining shares of
	Stock		common stock available
Plan Name	Options	RSUs	for future issuance
2019 Plan	1,575	—	—
2022 Plan	3,125	175,086	356,992
2021 Inducement Plan	—	—	4,166
Total	4,700	175,086	361,158

Schedule of RSUs and related transactions

The following table summarizes the status of our RSUs and related transactions for the period presented (in thousands, except share and per share amounts):


	Outstanding					Vested and Deferred Release
	Shares of	Average				Shares of	Average
	Common Stock	Grant Date		Aggregate		Common Stock	Grant Date		Aggregate
	Issuable	Fair Value		Fair		Issuable	Fair Value		Intrinsic
	for RSUs	Price		Value		for RSUs	Price		Value
As of January 1, 2023	—	$	—	$	—	—	$	—	$	—
Granted	173,395		4.45
Forfeited/cancelled	(7,032)		4.04
Vested and released	(25,002)		3.99		100
Vested and deferred release						5,469		4.02
As of December 31, 2023	141,361		4.55		523	5,469		4.02		20
Granted	120,129		4.56
Vested and released	(86,404)		4.31		284
Vested and deferred release						7,554		4.44
As of December 31, 2024	175,086	$	4.68	$	355	13,023	$	4.26	$	26

Schedule of the status of outstanding and exercisable options and related transactions

The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):


	Outstanding				Exercisable
	Shares of			Weighted	Shares of			Weighted
	Common	Weighted		Average	Common	Weighted		Average
	Stock	Average		Remaining	Stock	Average		Remaining
	Issuable	Exercise		Contractual	Issuable	Exercise		Contractual
	for Options	Price		Term (years)	for Options	Price		Term (years)
As of January 1, 2023	4,560	$	796.96	8.5	2,238	$	1,173.60	8.1
Granted	3,125		5.36
Forfeited and cancelled	(2,985)		596.32
As of December 31, 2023	4,700		398.30	8.6	4,577		391.04	8.6
As of December 31, 2024	4,700	$	398.30	7.5	4,695	$	398.46	7.5

Schedule of assumptions used in the Black Scholes option-pricing model


	Placement Agent
				Contingent			Stock
	Warrants			Warrants			Options
	Granted in			Granted in			Granted in
	June 2024			June 2024			March 2023
Weighted average fair value	$	2.73		$	3.43		$	3.63
Expected stock price volatility		140.0	%		127.0	%		82.9	%
Expected term (years)		2.1			5.7			5.0
Expected dividend yield		—	%		—	%		—	%
Risk-free interest rate		4.63	%		4.31	%		3.54	%

Current liabilities - Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Current liabilities
Employee related costs	$ 713	$ 118
Professional service fees	17	308
Other	55	166
Total	$ 785	$ 592

Stockholders' equity - Award plans and inducement grants (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Stock-based compensation
Stock options	4,700	4,700	4,560
RSUs	175,086	141,361
Remaining shares of common stock available for future issuance	361,158
2022 Plan
Stock-based compensation
Remaining shares of common stock available for future issuance	356,992
2021 Inducement Plan
Stock-based compensation
Remaining shares of common stock available for future issuance	4,166
Stock Plan 2019, 2022 And Inducement Plan
Stock-based compensation
Unrecognized share-based compensation cost	$ 0.6
Unrecognized share-based compensation - Weighted average period	1 year 8 months 12 days
Employee Stock Option
Stock-based compensation
Stock options	4,700
Employee Stock Option \| 2019 Plan
Stock-based compensation
Stock options	1,575
Employee Stock Option \| 2022 Plan
Stock-based compensation
Stock options	3,125
Restricted stock units
Stock-based compensation
RSUs	175,086
Restricted stock units \| 2022 Plan
Stock-based compensation
RSUs	175,086

Income taxes - Loss before income taxes and Components (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Loss before Income taxes:
United States	$ (27,592)	$ (12,468)
Foreign		(2)
Loss before income taxes	(27,592)	(12,470)
Deferred
United States	(8,401)	(3,424)
Foreign		176
Total deferred income tax (benefit) expense	(8,401)	(3,248)
Change in valuation allowance - United States	8,401	3,424
Change in valuation allowance - Foreign		(176)
Provision for income taxes	$ 0	$ 0

Income taxes (Tables)

12 Months Ended

Dec. 31, 2024

Income taxes

Schedule of loss before income taxes

Our loss before income taxes is as follows (in thousands):


	Year Ended December 31,
	2024		2023
United States	$	(27,592)	$	(12,468)
Foreign		—		(2)
Loss before income taxes	$	(27,592)	$	(12,470)

Schedule of components of income tax provision


	Year Ended December 31,
	2024		2023
United States	$	(27,592)	$	(12,468)
Foreign		—		(2)
Loss before income taxes	$	(27,592)	$	(12,470)

Schedule of reconciliation between income tax computed at the statutory U.S. federal statutory rate and the consolidated effective tax rate


	Year Ended December 31,
	2024		2023
Income taxes at federal statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	6.0		3.0
Change in state tax rate	2.5		(1.4)
Change in fair value of warrant liabilities	0.3		5.7
Other	0.6		(0.8)
Valuation allowance	(30.4)		(27.5)
Effective tax rate	—	%	—	%

Schedule of deferred tax assets and liabilities


	Year Ended December 31,
	2024		2023
Income taxes at federal statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	6.0		3.0
Change in state tax rate	2.5		(1.4)
Change in fair value of warrant liabilities	0.3		5.7
Other	0.6		(0.8)
Valuation allowance	(30.4)		(27.5)
Effective tax rate	—	%	—	%

The significant components of our deferred tax assets and liabilities are as follows (in thousands):


	As of December 31,
	2024		2023
Gross deferred income tax assets:
Federal and state operating loss carryforwards	$	4,959	$	2,107
Acquired intangibles		3,000		2,803
Stock-based compensation		458		392
Lease liability		37		49
Capitalized R&D expenses		7,516		2,315
Other		118		34
R&D credit carryforwards		26		26
Total gross deferred income tax assets		16,114		7,726
Valuation allowance - U.S. federal		(16,077)		(7,676)
Gross deferred tax assets, net of valuation allowance		37		50
Gross deferred tax liabilities:
ROU asset		(36)		(49)
Other		(1)		(1)
Gross deferred income tax liabilities		(37)		(50)
Deferred income tax assets, net	$	—	$	—

Property and equipment, net (Tables)

12 Months Ended

Dec. 31, 2024

Property and equipment, net

Schedule of property and equipment, net

Property and equipment, net consist of the following (in thousands):

Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands	Dec. 31, 2024	Dec. 31, 2023
Consolidated Balance Sheets
Preferred stock, par value (in dollar per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000	10,000
Common stock, par value (in dollar per share)	$ 0.001	$ 0.001
Common stock, shares authorized	100,000	100,000
Common stock, shares issued	8,637	4,906
Common stock, shares outstanding	8,637	4,906

Stockholders' equity

12 Months Ended

Dec. 31, 2024

Stockholders' equity

Stockholders' equity

7.Stockholders’ equity

Common stock

The voting, dividend, and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers, and preferences of the holders of the preferred stock when outstanding. The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. Common stockholders are entitled to receive dividends at the sole discretion of our Board. There have been no dividends declared on common stock to date as of December 31, 2024. In the event of any liquidation, dissolution, or winding-up of MetaVia, the holders of common stock shall be entitled to share in the remaining assets of MetaVia available for distribution post preferential distributions made to any holders of our preferred stock.

The Offering

Securities purchase agreements

In June 2024, we entered into and closed on two securities purchase agreements (the “Offering”) with an institutional investor and Dong-A, and received aggregate gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A. The Offering was comprised of (i) 3,307,889 shares of common stock at a purchase price of $3.93 per share, (ii) pre-funded warrants to purchase up to 1,781,171 shares of common (the “Pre-Funded Warrants”) at a purchase price of $3.929 per warrant, (iii) Series A warrants to purchase 5,089,060 shares of common stock (the “Series A Warrants”), and (iv) Series B warrants to purchase up to 7,633,591 shares of common stock (the “Series B Warrants”). Collectively, the Series A Warrants and the Series B Warrants are referred to as “PIPE Common Warrants.” Of the total shares of common stock issued in the Offering, 763,359 shares were sold to an institutional investor.

The Pre-Funded Warrants have an exercise price of $0.001 per share and are immediately exercisable and will expire when exercised in full and the PIPE Common Warrants have an exercise price of $3.93 per share and are exercisable as of September 18, 2024, which is the effective date of the stockholder approval received at the Special Meeting of Stockholders for the issuance of the shares upon exercise of the warrants (the “Stockholder Approval Date”).

The Series A Warrants will expire on the earlier of the twelve month anniversary of the Stockholder Approval Date and within 60 days following the public announcement of the Company receiving positive Phase 1 multiple ascending dose (“MAD”) data readout for DA-1726, and the Series B Warrants will expire on the earlier of the five-year anniversary of the Stockholder Approval Date and within six months following the public announcement of the Company receiving positive Phase 1 Part 3 data readout for DA-1726. Based on the terms of the PIPE Common Warrants, we have concluded that the accounting classification of the PIPE Common Warrants is to be stockholders’ equity.

Under the terms of the Pre-Funded Warrants and the PIPE Common Warrants issued to the institutional investor, we may not affect the exercise of any such Pre-Funded Warrants or PIPE Common Warrants, and the holder will not be entitled to exercise any portion of any Pre-Funded Warrants or PIPE Common Warrants, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates, other persons acting or who could be deemed to be acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with the holder’s or any of the holder’s affiliates) would exceed 9.99% (in the case of the Pre-Funded Warrants) or 4.99% (in the case of the PIPE Common Warrants) of the number of shares of the Company’s outstanding common stock immediately after giving effect to the exercise (the “Beneficial

Ownership Limitation”), as such percentage ownership is calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the SEC. A holder of the Pre-Funded Warrants or PIPE Common Warrants that were issued to the institutional investor may increase or decrease the Beneficial Ownership Limitation to a higher or lower percentage (not to exceed 9.99%), effective 61 days after written notice to us. Any such increase or decrease will apply only to that holder and not to any other holder of the Pre-Funded Warrants or PIPE Common Warrants.

Placement agent

We paid the placement agent a cash fee equal to 7.0% of the gross proceeds of the Offering received from a certain institutional investor and $0.1 million for non-accountable expenses and clearing costs. In addition, we issued warrants to the placement agent’s designees (“Placement Agent Warrants”) to purchase up to 127,227 shares of common stock (which represents 5% of the sum of the shares of common stock and Pre-Funded Warrants sold to the institutional investor in the Offering) at an exercise price of $4.9125 per share (which represents a premium of 125% of the offering price per share of common stock in the Offering). The Placement Agent Warrants will be exercisable beginning on the effective date of the Stockholder Approval Date and will expire on the earlier of (i) two years after the date that the shares of common stock underlying the Placement Agent Warrants are registered pursuant to an effective registration statement filed pursuant to the Securities Act of 1933, as amended, which occurred on July 24, 2024, and (ii) June 23, 2029. The grant date fair value of the Placement Agent Warrants was $0.3 million, which represents a non-cash issuance cost. The weighted average grant date fair value per share of these Placement Agent Warrants was $2.73, which was determined using the Black-Scholes option pricing model. Based on the terms of the Placement Agreement Warrants, we have concluded that the accounting classification of the Placement Agent Warrants is stockholders’ equity in the accompanying consolidated balance sheets.

Upon the exercise for cash of any PIPE Common Warrants issued to a certain institutional investor, we shall pay the placement agent (i) a cash fee of 7.0% of the aggregate gross exercise price paid in cash with respect thereto and (ii) a non-cash fee in the form of additional warrants to purchase the number of shares of common stock equal to 5.0% of the aggregate number of such shares of common stock underlying such warrants. The cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as a contingent commitment and will be recorded as an offset to any gross proceeds received from any future exercises of PIPE Common Warrants by the institutional investor. The non-cash fee payable to the placement agent for any PIPE Common Warrants exercised by the institutional investor is accounted for as contingent warrants (“Placement Agent Contingent Warrants”) to purchase up to 318,067 shares of common stock, which is subject to performance criteria of the institutional investor regarding any exercise for cash of any PIPE Common Warrants with an assumed grant date of the Offering closing date, and an exercise price of $4.9125 per share. The weighted average grant date fair value per share of these Placement Agent Contingent Warrants was $3.43, which was determined using the Black-Scholes option pricing model. Based on the terms of the placement agent engagement letter, we have concluded that the accounting classification of the Placement Agent Contingent Warrants is to be stockholders’ equity. On each balance sheet reporting date, we will need to assess whether it is probable for us to issue warrants to the placement agent based on whether it is probable for any PIPE Common Warrants to be exercised by the institutional investor. As of December 31, 2024, we determined that the issuance of additional warrants to the placement agent is not yet probable; accordingly, the Placement Agent Contingent Warrants had no impact on the consolidated balance sheets.

Warrants

The following warrants were outstanding as of December 31, 2024 and 2023:


	Shares of Common Stock Issuable
	for Outstanding Warrants
	As of December 31,		Exercise		Expiration
Warrant Issuance	2024	2023	Price		Date
July 2018 ⁽¹⁾	6	6	$	44,820.00	July 2028
April 2020 ⁽¹⁾	159	159	$	3,000.00	April 2025
January 2021 ⁽¹⁾	10,421	10,421	$	1,447.20	July 2026
October 2021 ⁽¹⁾	15,390	15,390	$	900.00	April 2025
November 2022 Series B ⁽²⁾	177,938	177,938	$	0.00	December 2027
June 2024 Placement Agent⁽³⁾	127,227	—	$	4.91	July 2026
June 2024 Pre-Funded ⁽⁴⁾	1,430,000	—	$	0.00	no expiration date
June 2024 Series A ⁽⁵⁾	5,089,060	—	$	3.93	September 2025 (latest date)
June 2024 Series B ⁽⁶⁾	7,633,591	—	$	3.93	September 2029 (latest date)
Total	14,483,792	203,914

(1)

The number of outstanding and exercisable warrants is equal to the number of shares of common stock issuable for outstanding warrants.

(2)

(3)

(4)

(5)

(6)

Additionally, on a cashless basis, 6,768,837 Series A warrants issued in November 2022 were exercised in 2023 for 846,105 shares of our common stock. As of December 31, 2023, all Series A warrants were fully exercised for shares of our common stock.

Stock-based compensation

Stock-based compensation expense was included in general and administrative and research and development as follows (in thousands):


	Year Ended December 31,
	2024		2023
General and administrative	$	366	$	178
Research and development		172		44
Total stock-based compensation	$	538	$	222

Stock-based award plans

In December 2019, in connection with a merger, we adopted the 2019 Equity Incentive Plan (the “2019 Plan”). Additionally, we adopted the 2021 Inducement Plan in November 2021 and the Amended and Restated 2022 Equity Incentive Plan (the “2022 Plan”) in December 2022. The 2019 Plan, 2021 Inducement Plan and 2022 Plan provide for the grant of stock options, restricted stock, RSUs and other equity awards of our common stock to employees, officers, consultants, and directors. Stock options granted under any of these plans expire within a period of not more than ten years from the date of grant.

With the adoption of the 2022 Plan, no additional shares may be added to or granted from the 2019 Plan, and any shares related to forfeited awards are carryover to the 2022 Plan. In June 2024, in connection with the 2024 Annual Meeting of Stockholders, our stockholders approved an amendment (the “Amendment”) to our 2022 Plan. Pursuant to the terms and conditions of the Amendment, the 2022 Plan was amended to:

●

automatically increase on January 1st of each year for a period of eight years commencing on January 1, 2025 and ending on (and including) January 1, 2032, the aggregate number of shares of common stock that may be issued pursuant to Awards (as defined in the 2022 Plan) to an amount equal to 10% of the Fully Diluted Shares (as defined in the 2022 Plan) as of the last day of the preceding calendar year, provided, however that the Board may act prior to the effective date of any such annual increase to provide that the increase for such year will be a lesser number of shares of common stock; and

●

increase the aggregate maximum number of shares of common stock that may be issued pursuant to the exercise of

Incentive Stock Options (as defined in the 2022 Plan) to 1 million shares of the common stock plus the amount of any increase in the number of shares that may be available for issuance pursuant to the annual increase described above, but in no event more than 15 million shares of the common stock issued as incentive stock options.

The following table summarizes the outstanding awards issued pursuant to our stock-based award plans and inducement grants as of December 31, 2024 and the remaining shares of common stock available for future issuance:


			Remaining shares of
	Stock		common stock available
Plan Name	Options	RSUs	for future issuance
2019 Plan	1,575	—	—
2022 Plan	3,125	175,086	356,992
2021 Inducement Plan	—	—	4,166
Total	4,700	175,086	361,158

For stock options and RSUs granted under the 2019 Plan and 2022 Plan as of December 31, 2024, unrecognized stock-based compensation costs totaled $0.6 million. The unrecognized stock-based costs are expected to be recognized as an expense over a weighted average period of 1.7 years.

RSUs

The following table summarizes the status of our RSUs and related transactions for the period presented (in thousands, except share and per share amounts):


	Outstanding					Vested and Deferred Release
	Shares of	Average				Shares of	Average
	Common Stock	Grant Date		Aggregate		Common Stock	Grant Date		Aggregate
	Issuable	Fair Value		Fair		Issuable	Fair Value		Intrinsic
	for RSUs	Price		Value		for RSUs	Price		Value
As of January 1, 2023	—	$	—	$	—	—	$	—	$	—
Granted	173,395		4.45
Forfeited/cancelled	(7,032)		4.04
Vested and released	(25,002)		3.99		100
Vested and deferred release						5,469		4.02
As of December 31, 2023	141,361		4.55		523	5,469		4.02		20
Granted	120,129		4.56
Vested and released	(86,404)		4.31		284
Vested and deferred release						7,554		4.44
As of December 31, 2024	175,086	$	4.68	$	355	13,023	$	4.26	$	26

Stock options

The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):


	Outstanding				Exercisable
	Shares of			Weighted	Shares of			Weighted
	Common	Weighted		Average	Common	Weighted		Average
	Stock	Average		Remaining	Stock	Average		Remaining
	Issuable	Exercise		Contractual	Issuable	Exercise		Contractual
	for Options	Price		Term (years)	for Options	Price		Term (years)
As of January 1, 2023	4,560	$	796.96	8.5	2,238	$	1,173.60	8.1
Granted	3,125		5.36
Forfeited and cancelled	(2,985)		596.32
As of December 31, 2023	4,700		398.30	8.6	4,577		391.04	8.6
As of December 31, 2024	4,700	$	398.30	7.5	4,695	$	398.46	7.5

The aggregate intrinsic value of our outstanding and exercisable options was zero as of January 1, 2023 and December 31,

2023 and 2024.

Grant date fair value of RSUs, stock options and warrants

We estimated the grant date fair value of RSUs granted to employees, consultants, and directors based on the closing sales price of our common stock as reported on Nasdaq on the date of grant. We estimated the grant date fair value of stock options and warrants granted to employees, consultants, and directors using the Black-Scholes option pricing model.

The following table sets forth the fair value per share of Placement Agent Warrants granted in 2024 and the weighted average fair value per share of stock options granted in 2023 and the assumptions used in the Black-Scholes option-pricing model:


	Placement Agent
				Contingent			Stock
	Warrants			Warrants			Options
	Granted in			Granted in			Granted in
	June 2024			June 2024			March 2023
Weighted average fair value	$	2.73		$	3.43		$	3.63
Expected stock price volatility		140.0	%		127.0	%		82.9	%
Expected term (years)		2.1			5.7			5.0
Expected dividend yield		—	%		—	%		—	%
Risk-free interest rate		4.63	%		4.31	%		3.54	%

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478448/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

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-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
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+ Details

Current liabilities (Tables)

12 Months Ended

Dec. 31, 2024

Current liabilities

Schedule of accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):


	As of December 31,
	2024			2023
Employee related costs	$	713	$	118
Professional service fees		17		308
Other		55		166
Total	$	785	$	592

Schedule of warrant liabilities

Changes to our warrant liabilities are summarized as follows (in thousands):


	Total
As of January 1, 2023	$	10,796
Reclassification of warrant liabilities upon exercise of warrants		(7,183)
Change in fair value of warrant liabilities		(2,955)
As of December 31, 2023		658
Change in fair value of warrant liabilities		(297)
As of December 31, 2024	$	361

- Definition

Tabular disclosure of the nature and terms of the financial instruments and the rights and obligations embodied in those instruments, information about settlement alternatives, if any, in the contract and identification of the entity that controls the settlement alternatives including: a. The amount that would be paid, or the number of shares that would be issued and their fair value, determined under the conditions specified in the contract if the settlement were to occur at the reporting date b. How changes in the fair value of the issuer's equity shares would affect those settlement amounts (for example, "the issuer is obligated to issue an additional x shares or pay an additional y dollars in cash for each $1 decrease in the fair value of one share") c. The maximum amount that the issuer could be required to pay to redeem the instrument by physical settlement, if applicable d. The maximum number of shares that could be required to be issued, if applicable e. That a contract does not limit the amount that the issuer could be required to pay or the number of shares that the issuer could be required to issue, if applicable f. For a forward contract or an option indexed to the issuer's equity shares, the forward price or option strike price, the number of issuer's shares to which the contract is indexed, and the settlement date or dates of the contract, as applicable. g. The components of the liability that would otherwise be related to shareholders' interest and other comprehensive income (if any) subject to the redemption feature (for example, par value and other paid in amounts of mandatorily redeemable instruments are disclosed separately from the amount of retained earnings or accumulated deficit).

+ References + Details

Stockholders equity - Warrants - Narrative (Details) - USD ($)		1 Months Ended		3 Months Ended	12 Months Ended
	Nov. 30, 2022	Jun. 30, 2024	Nov. 30, 2022	Sep. 30, 2024	Dec. 31, 2024	Oct. 31, 2022
Proceeds from exercise of warrants					$ 1,000
Warrants term					2 years
November 2022 Series A and B
Outstanding and exercisable warrants					1,423,504
Proceeds from exercise of warrants			$ 0
Exercise Price	$ 0		$ 0
June 2024 Series A
Exercise Price					$ 3.93
Expired terms					12 months
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants					60 days
June 2024 Series B
Exercise Price					$ 3.93
Expired terms					5 years
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants					6 months
Series A warrant
Number of warrants exchanged					6,768,837
Warrants to purchase shares of common stock					846,105
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants		60 days
November 2022 Series B
Number of warrants exchanged					8
Exercised warrants					8
Proceeds from exercise of warrants					$ 0
Exercise Price	$ 0		$ 0		$ 0	$ 3
Number of warrants	6,843,666
Warrants to purchase shares of common stock	855,458		855,458
Pre-Funded Warrants
Pre-Funded warrants issued				351,171

Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
Consolidated Statements of Stockholders' Equity
Stock and warrants issuance costs	$ 1,960

Significant segment expenses

12 Months Ended

Dec. 31, 2024

Significant segment expenses

Significant segment expenses

8.Significant segment expenses

The following table sets forth the significant segment expenses that are regularly provided to our CODM:


	Year Ended December 31,
	2024		2023
Operating expenses
Research and development
Clinical trial	$	14,441	$	5,100
Costs under the Shared Services Agreement with Dong-A (related party)		4,930		2,438
Employee compensation and benefits		1,606		461
Consulting		288		483
Other ⁽¹⁾		288		676
Total research and development		21,553		9,158
General and administrative
Legal and professional fees		2,864		3,007
Consulting		1,533		1,961
Employee compensation and benefits		1,659		620
Other ⁽²⁾		1,200		1,140
Total general and administrative		7,256		6,728
Total operating expenses	$	28,809	$	15,886

(1)

Other R&D expenses include non-clinical and preclinical services and other R&D expenditures.

(2)

Other G&A expenses include insurance, software license fees, non-income state taxes, lease rental expenses and other G&A expenditures.

- 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

Current liabilities - Warrant liabilities - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended	12 Months Ended
	Nov. 30, 2022	Dec. 31, 2024
Warrant liabilities
Proceeds from exercise of warrants		$ 1
November 2022 Series A and B
Warrant liabilities
Number of warrants per unit	8
Proceeds from exercise of warrants	$ 0
Warrants exercise price	$ 0

Significant segment expenses (Tables)

12 Months Ended

Dec. 31, 2024

Significant segment expenses

Schedule of significant segment expenses


	Year Ended December 31,
	2024		2023
Operating expenses
Research and development
Clinical trial	$	14,441	$	5,100
Costs under the Shared Services Agreement with Dong-A (related party)		4,930		2,438
Employee compensation and benefits		1,606		461
Consulting		288		483
Other ⁽¹⁾		288		676
Total research and development		21,553		9,158
General and administrative
Legal and professional fees		2,864		3,007
Consulting		1,533		1,961
Employee compensation and benefits		1,659		620
Other ⁽²⁾		1,200		1,140
Total general and administrative		7,256		6,728
Total operating expenses	$	28,809	$	15,886

(1)

Other R&D expenses include non-clinical and preclinical services and other R&D expenditures.

(2)

Other G&A expenses include insurance, software license fees, non-income state taxes, lease rental expenses and other G&A expenditures.

Income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
Income taxes (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Operating loss carryforwards:
Valuation allowance	$ 16,100	$ 7,700
Foreign operating loss carryforwards	0
Income tax:
Uncertain tax positions	0	0
Interest or penalties	0	0
Federal
Operating loss carryforwards:
Valuation allowance	16,077	7,676
Operating loss carryforwards	18,500	8,800
State
Operating loss carryforwards:
Research credit carry forward	2	2
Operating loss carryforwards	$ 17,400	$ 4,400

Stockholders' equity - Stock-based award plans (Details)	12 Months Ended
	Dec. 31, 2024 shares
2022 Plan
Stock-based compensation
Number of shares added (In shares)	0
Period of automatic increase in shares reserved	8 years
Percentage of the common shares outstanding (as a percent)	10.00%
Number of shares authorized	1,000,000
2022 Plan \| Maximum
Stock-based compensation
Number of shares authorized	15,000,000
2019 Plan \| Employee Stock Option \| Maximum
Stock-based compensation
Expiration period	10 years

Stockholders' equity - Common stock (Details)	12 Months Ended
Stockholders' equity - Common stock (Details)	Dec. 31, 2024 USD ($) Vote / shares
Common Stock
Common stock, vote per share \| Vote / shares	1
Dividends Rights
Dividends declared \| $	$ 0

Stockholders equity - Warrants (Details) - $ / shares	Dec. 31, 2024	Dec. 31, 2023	Nov. 30, 2022	Oct. 31, 2022
Warrants
Number of Warrants	14,483,792	203,914
Warrants Exercise Price 44,820.00
Warrants
Number of Warrants	6	6
Exercise Price	$ 44,820
Warrants Exercise Price 3,000.00
Warrants
Number of Warrants	159	159
Exercise Price	$ 3,000
Warrants Exercise Price 1,447.20
Warrants
Number of Warrants	10,421	10,421
Exercise Price	$ 1,447.2
Warrants Exercise Price 900.00
Warrants
Number of Warrants	15,390	15,390
Exercise Price	$ 900
November 2022 Series B
Warrants
Number of Warrants	177,938	177,938
Exercise Price	$ 0		$ 0	$ 3
June 2024 Placement Agent
Warrants
Number of Warrants	127,227
Exercise Price	$ 4.91
June 2024 Pre-funded
Warrants
Number of Warrants	1,430,000
Exercise Price	$ 0
June 2024 Series A
Warrants
Number of Warrants	5,089,060
Exercise Price	$ 3.93
June 2024 Series B
Warrants
Number of Warrants	7,633,591
Exercise Price	$ 3.93

Prepaid expenses and other current assets (Tables)

12 Months Ended

Dec. 31, 2024

Prepaid expenses and other current assets

Schedule of prepaid expenses and other current assets

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


	As of December 31,
	2024			2023
Insurance	$	5	$	—
Deposits		16		39
Other prepaid expenses		34		38
Total	$	55	$	77

Commitments and Contingencies (Tables)

12 Months Ended

Dec. 31, 2024

Commitments and contingencies

Schedule of reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet

The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2024 (in thousands):


	Operating
	Lease
2025	$	89
2026		60
Total lease payments		149
Less effect of discounting		(13)
Total		136
Short-term portion		78
Long-term portion	$	58

Stockholders' equity - Stock - Assumptions (Details)	12 Months Ended
Stockholders' equity - Stock - Assumptions (Details)	Dec. 31, 2024 $ / shares
Placement agent warrants \| June 2024 Offering
Stock-based compensation
Weighted average fair value	$ 2.73
Expected stock price volatility	140.00%
Expected term (years)	2 years 1 month 6 days
Risk free interest rate	4.63%
Placement agent contingent warrants \| June 2024 Offering
Stock-based compensation
Weighted average fair value	$ 3.43
Expected stock price volatility	127.00%
Expected term (years)	5 years 8 months 12 days
Risk free interest rate	4.31%
Employee Stock Option
Stock-based compensation
Weighted average fair value	$ 3.63
Expected stock price volatility	82.90%
Expected term (years)	5 years
Risk free interest rate	3.54%

- 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.

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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
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Reference 23: http://www.xbrl.org/2003/role/disclosureRef
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
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Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

+ Details

Loss per share of common stock - Antidilutive Securities (Details) - shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Employee Stock Option
Loss per share of common stock
Outstanding securities not included in the calculation of diluted earnings per share of common stock (in shares)	4,700	4,700
RSUs
Loss per share of common stock
Outstanding securities not included in the calculation of diluted earnings per share of common stock (in shares)	162,063	141,361
Warrants
Loss per share of common stock
Outstanding securities not included in the calculation of diluted earnings per share of common stock (in shares)	12,875,854	25,976

Commitments and Contingencies - Employment agreements and Employee benefit plan (Details) - USD ($)	1 Months Ended	12 Months Ended
	Jan. 31, 2019	Dec. 31, 2024	Dec. 31, 2023
License Agreements
Minimum age of employee to cover under the plan	21 years
Employer matches vesting period	6 years
Percentage of employee contribution vested on their contribution	100.00%
Amount of discretionary matching contributions on employee deferrals		$ 0	$ 0
Maximum
License Agreements
Employee compensation deferred percentage	90.00%

Stockholders' equity - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Stock Options, Additional Disclosures
Outstanding, Number, Beginning Balance (in shares)	4,700	4,560
Granted (in shares)		3,125
Forfeited and cancelled (in shares)		(2,985)
Outstanding, Number, Ending Balance (in shares)	4,700	4,700	4,560
Options Exercisable, Number, Beginning	4,577	2,238
Options Exercisable, Number, Ending	4,695	4,577	2,238
Outstanding, Weighted Average Exercise Price, Beginning Balance (in dollars per share)	$ 398.3	$ 796.96
Granted (in dollars per share)		5.36
Forfeited and cancelled (in dollars per share)		596.32
Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share)	398.3	398.3	$ 796.96
Options Exercisable, Exercise price, beginning (in dollars per share)	391.04	1,173.6
Options Exercisable, Exercise price, ending (in dollars per share)	$ 398.46	$ 391.04	$ 1,173.6
Options, Outstanding, Remaining Contractual Term	7 years 6 months	8 years 7 months 6 days	8 years 6 months
Vested and exercisable (years)	7 years 6 months	8 years 7 months 6 days	8 years 1 month 6 days
Options Exercisable, Intrinsic value	$ 0	$ 0

Commitments and contingencies

12 Months Ended

Dec. 31, 2024

Commitments and contingencies

Commitments and contingencies

6. Commitments and contingencies

Operating lease

In August 2023, we entered into a non-cancelable operating lease for our corporate headquarters in Cambridge, Massachusetts. The initial lease term is for three years with an option to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2026. We recorded lease rental expenses of $0.1 million and $29 thousand for 2024 and 2023, respectively, and made lease cash payments of $0.1 million and $28 thousand for 2024 and 2023, respectively.

The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2024 (in thousands):


	Operating
	Lease
2025	$	89
2026		60
Total lease payments		149
Less effect of discounting		(13)
Total		136
Short-term portion		78
Long-term portion	$	58

As of December 31, 2024 and 2023, our lease liability, which represents the net present value of future lease payments, was calculated utilizing a discount rate of 11%, which corresponds to our estimated incremental borrowing rate.

Additionally, in January 2024, we terminated a short-term operating lease for our former corporate headquarters located in Boston, Massachusetts. There were no lease rental expense or lease cash payment for 2024 for our former corporate headquarters and we recorded a lease rental expense and made lease cash payments of $22 thousand for 2023.

Contingent payments and license agreements

We have certain contractual contingent payments under various merger or license agreements executed between 2019 and 2020 for our legacy therapeutic programs. Since we have discontinued the clinical development of our legacy therapeutic programs, we believe any contractual payments to be paid by us or to be received by us under these agreements are remote. Therefore, as of December 31, 2024, no liabilities or assets were recorded in the accompanying consolidated financial statements for our legacy therapeutic programs.

Legal proceedings

From time to time, we may be involved in various claims and legal proceedings arising out of our ordinary course of business. We are not currently a party to any claims or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business and consolidated financial statements. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Purchase commitments

We enter into contracts in the normal course of business with various third parties for clinical trials, preclinical research studies, and testing, manufacturing, and other services and products for operating purposes. These contracts provide for termination upon notice. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation. There are no minimum purchase requirements under these contracts.

Employment agreements

We have entered into employment agreements with certain of our executives that provide for compensation and certain other benefits. Under certain circumstances, including a change in control, some of these agreements provide for severance or other payments, if those circumstances occur during the term of the employment agreement.

Employee benefit plan

We adopted a 401(k) defined contribution plan in November 2018, which became effective in January 2019, for all employees over age 21. Employees can defer up to 90% of their compensation through payroll withholdings into the plan subject to federal law limits. Discretionary employer matches vest over a six-year period beginning on the second anniversary of an employee’s date of hire. Employee contributions and any employer matching contributions made to satisfy certain non-discrimination tests required by the Internal Revenue Code are 100% vested upon contribution. No matching contributions were made for 2024 and 2023.

Income taxes - Reconciliation of income tax (Details)	12 Months Ended
Income taxes - Reconciliation of income tax (Details)	Dec. 31, 2024	Dec. 31, 2023
Reconciliation of income tax:
Income taxes at federal statutory rate (as a percent)	21.00%	21.00%
State income tax, net of federal benefit (as a percent)	6.00%	3.00%
Change in state tax rate (as a percent)	2.50%	(1.40%)
Change in fair value of warrant liabilities (as percent)	0.30%	5.70%
Other (as a percent)	0.60%	(0.80%)
Valuation allowance (as a percent)	30.40%	27.50%
Effective tax rate (as a percent)	0.00%	0.00%

Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at beginning of period at Dec. 31, 2022	$ 3	$ 117,542	$ (95,795)	$ 21,750
Balance at beginning of period (shares) at Dec. 31, 2022	3,179
Increase (Decrease) in Stockholders' Equity
Issuance of stock from exercise of warrants	$ 2	7,181		7,183
Issuance of stock from exercise of warrants (in shares)	1,702
Stock-based compensation		222		222
Issuance of stock for vested restricted stock units (in shares)	25
Net loss			(12,470)	(12,470)
Balance at end of period at Dec. 31, 2023	$ 5	124,945	(108,265)	16,685
Balance at end of period (shares) at Dec. 31, 2023	4,906
Increase (Decrease) in Stockholders' Equity
Issuance of stock from exercise of warrants	$ 1			1
Issuance of stock from exercise of warrants (in shares)	351
Stock-based compensation		538		538
Issuance of common stock and warrants under the securities purchase agreements, net of issuance costs	$ 3	18,035		18,038
Issuance of common stock and warrants under the securities purchase agreements, net of issuance costs (in shares)	3,308
Issuance of placement agent warrants		309		309
Issuance of stock for vested restricted stock units, net of shares withheld for withholding taxes		(48)		(48)
Issuance of stock for vested restricted stock units, net of shares withheld for withholding taxes (in shares)	72
Net loss			(27,592)	(27,592)
Balance at end of period at Dec. 31, 2024	$ 9	$ 143,779	$ (135,857)	$ 7,931
Balance at end of period (shares) at Dec. 31, 2024	8,637

Stockholders' equity - RSU (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Stockholders' equity
RSU's Fair value, Beginning balance (in shares)	141,361
RSU's, Number grants (in shares)	120,129	173,395
RSU's, Number Forfeited/Cancelled (in shares)		(7,032)
RSU's, Number Vested and Released (in shares)	(86,404)	(25,002)
RSU's Fair value, Ending balance (in shares)	175,086	141,361
RSU's Fair value, Opening balance (per share)	$ 4.55
RSU's Fair value, grants in period (per share)	4.56	$ 4.45
RSU's Fair value, Forfeited/Cancelled in period (per share)		4.04
RSU's Fair value, vested in period (per share)	4.31	3.99
RSU's Fair value, Ending balance (per share)	$ 4.68	$ 4.55
Outstanding, Aggregate Fair Value, beginning balance	$ 523
Outstanding, Aggregate Fair Value, Vested and released	284	$ 100
Outstanding, Aggregate Fair Value, ending balance	$ 355	$ 523
RSU's Vested and Deferred Release, Beginning balance (in shares)	5,469
RSUs, Vested and Deferred Release (in shares)	7,554	5,469
RSU's Vested and Deferred Release, Ending balance (in shares)	13,023	5,469
RSU's Vested Fair value, Opening balance (per share)	$ 4.02
RSUs, Vested and Deferred Release (per share)	4.44	$ 4.02
RSU's Vested Fair value, Ending balance (per share)	$ 4.26	$ 4.02
Intrinsic value, opening balance	$ 20
Intrinsic value, ending balance	$ 26	$ 20

Commitments and Contingencies - Operating Lease - Lease liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Maturity of the lease liability was as follows (in thousands):
2025	$ 89
2026	60
Total lease payments	149
Less effect of discounting	(13)
Total	136
Short-term portion	78	$ 67
Long-term portion	$ 58	$ 136

Significant segment expenses - Schedule of significant segment expenses (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
General and administrative
Total general and administrative	$ 7,256	$ 6,728
Single reportable segment
Research and development
Clinical trials	14,441	5,100
Employee compensation and benefits	1,606	461
Consulting	288	483
Other	288	676
Total research and development	21,553	9,158
General and administrative
Legal and professional fees	2,864	3,007
Consulting	1,533	1,961
Employee compensation and benefits	1,659	620
Other	1,200	1,140
Total general and administrative	7,256	6,728
Total operating expenses	28,809	15,886
Single reportable segment \| Related party
Research and development
Costs under the Shared Services Agreement with Dong-A (related party)	$ 4,930	$ 2,438

Related party (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
Related party (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2024	Dec. 31, 2023
Related party
Research and development		$ 21,553	$ 9,158
Related party payable		$ 1,472	$ 789
Other Liability, Current, Related Party [Extensible Enumeration]		Related party	Related party
2022 License Agreements
Related party
R&D expenses	$ 8,200
Period for failing to cure the beach, the agreement may get terminated	60 days
Cure period for beaching party if cannot be cured within the 60-day period	60 days
Period for termination notice when material breach not cured	90 days
Cure period for petition for bankruptcy	30 days
Amount of milestones accrued		$ 0
DA-1726
Related party
Developmental and regulatory milestone payment eligible to be received	$ 178,000
DA-1241
Related party
Developmental and regulatory milestone payment eligible to be received	$ 138,000
Shared Services Agreement
Related party
Period for failing to cure the beach, the agreement may get terminated	30 days
Research and development		4,900	$ 2,400
Related party payable		$ 1,500	$ 800
Other Liability, Current, Related Party [Extensible Enumeration]		Related party	Related party
Other Liability, Current, Related Party, Name [Extensible Enumeration]		Dong-A	Dong-A
Related party \| Dong-A
Related party
Percentage of common stock outstanding		62.00%

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Current assets:
Cash	$ 16,017	$ 22,435
Prepaid expenses and other current assets	55	77
Total current assets	16,072	22,512
Property and equipment, net	34	46
Right-of-use asset	133	202
Other assets	21	21
Total assets	16,260	22,781
Current liabilities:
Accounts payable	3,879	821
Clinical trial accrued liabilities	1,696	3,033
Accrued expenses and other current liabilities	785	592
Warrant liabilities	361	658
Related party payable	$ 1,472	$ 789
Other Liability, Current, Related Party [Extensible Enumeration]	Related Party [Member]	Related Party [Member]
Lease liability, short-term	$ 78	$ 67
Total current liabilities	8,271	5,960
Lease liability, long-term	58	136
Total liabilities	8,329	6,096
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value per share; 10,000 shares authorized and no shares issued or outstanding as of December 31, 2024 and 2023
Common stock, $0.001 par value per share, 100,000 shares authorized as of December 31, 2024 and 2023; 8,637 and 4,906 shares issued and outstanding as of December 31, 2024 and 2023, respectively	9	5
Additional paid-in capital	143,779	124,945
Accumulated deficit	(135,857)	(108,265)
Total stockholders' equity	7,931	16,685
Total liabilities and stockholders' equity	$ 16,260	$ 22,781

Consolidated Statements of Operations - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Operating expenses
Research and development	$ 21,553	$ 9,158
General and administrative	7,256	6,728
Total operating expenses	28,809	15,886
Loss from operations	(28,809)	(15,886)
Other income
Change in fair value of warrant liabilities	297	2,955
Interest income	920	461
Total other income	1,217	3,416
Loss before income taxes	(27,592)	(12,470)
Provision for income taxes	0	0
Net loss and comprehensive net loss	$ (27,592)	$ (12,470)
Loss per share:
Loss per share of common stock, basic (in dollars per share)	$ (3.56)	$ (2.46)
Loss per share of common stock, diluted (in dollars per share)	$ (3.56)	$ (2.46)
Weighted average shares of common stock outstanding:
Weighted average shares of common stock outstanding, basic (in shares)	7,757,128	5,071,101
Weighted average shares of common stock outstanding, diluted (in shares)	7,757,128	5,071,101

Stockholders' equity - June 2024 registered direct offering and private placement (Details) $ / shares in Units, $ in Millions	1 Months Ended
	Jun. 30, 2024 USD ($) security $ / shares shares	Dec. 31, 2024 shares
Series A warrant
Shares of common stock issuable for Issued and outstanding warrants \| shares		846,105
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants	60 days
June 2024 Offering
Number of Securities \| security	2
Consideration received \| $	$ 20.0
Shares issued (in shares) \| shares	3,307,889
Offering shares (Per share) \| $ / shares	$ 3.93
Percentage of placement agent fee	7.00%
Non-accountable expenses and clearing costs \| $	$ 0.1
Percentage of common stock sold	5.00%
June 2024 Offering \| Pre-Funded Warrants
Offering shares (Per share) \| $ / shares	$ 3.929
Shares of common stock issuable for Issued and outstanding warrants \| shares	1,781,171
Exercise Price \| $ / shares	$ 0.001
Maximum percentage of outstanding common stock	9.99%
Number of days written notice	61 days
June 2024 Offering \| Series A warrant
Shares of common stock issuable for Issued and outstanding warrants \| shares	5,089,060
Expired terms	12 months
June 2024 Offering \| Series B warrants
Shares of common stock issuable for Issued and outstanding warrants \| shares	7,633,591
Expired terms	5 years
Threshold period following the public announcement of receiving positive phase 1 multiple ascending dose data for expiry of warrants	6 months
June 2024 Offering \| PIPE common warrants
Shares issued (in shares) \| shares	763,359
Exercise Price \| $ / shares	$ 3.93
Maximum percentage of outstanding common stock	4.99%
June 2024 Offering \| Placement agent warrants
Shares of common stock issuable for Issued and outstanding warrants \| shares	127,227
Exercise Price \| $ / shares	$ 4.9125
Premium of offering price per share (as a percent)	125.00%
Weighted average fair value of warrants \| $ / shares	$ 2.73
Terminate of common stock	2 years
Non-cash issuance cost \| $	$ 0.3
June 2024 Offering \| Placement Agent Contingent Warrants
Shares of common stock issuable for Issued and outstanding warrants \| shares	318,067
Exercise Price \| $ / shares	$ 4.9125
Weighted average fair value of warrants \| $ / shares	$ 3.43
June 2024 Offering \| Dong-A
Consideration received \| $	$ 10.0

Property and equipment, net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Property and equipment, net
Office equipment	$ 88	$ 80
Less accumulated depreciation	(54)	(34)
Property and equipment, net	34	46
Depreciation	$ 20	$ 6

Current liabilities

12 Months Ended

Dec. 31, 2024

Current liabilities

Current liabilities

4. Current liabilities

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):


	As of December 31,
	2024			2023
Employee related costs	$	713	$	118
Professional service fees		17		308
Other		55		166
Total	$	785	$	592

Warrant liabilities

Changes to our warrant liabilities are summarized as follows (in thousands):


	Total
As of January 1, 2023	$	10,796
Reclassification of warrant liabilities upon exercise of warrants		(7,183)
Change in fair value of warrant liabilities		(2,955)
As of December 31, 2023		658
Change in fair value of warrant liabilities		(297)
As of December 31, 2024	$	361

Our warrant liabilities relate to the 2022 Series A warrants and 2022 Series B warrants, both of which were issued in November 2022. These warrants are considered to be derivative instruments; accordingly, we recorded their estimated fair value as warrant

liabilities. We estimated the fair value of these warrants using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby eight warrants can be exercised for one share of common stock for no additional consideration, which results in the warrant exercise price to be zero.

Property and equipment, net

12 Months Ended

Dec. 31, 2024

Property and equipment, net

Property and equipment, net

3. Property and equipment, net

Property and equipment, net consist of the following (in thousands):

We recorded depreciation expense of $20 thousand and $6 thousand for 2024 and 2023, respectively, which was included in general and administrative operating expenses in the accompanying consolidated statements of operations.

Fair value measurements

12 Months Ended

Dec. 31, 2024

Fair value measurements

Fair value measurements

11.Fair value measurements

Fair value is a market-based measurement, not an entity specific measurement and is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy:

Level 1:

Unadjusted quoted prices for identical assets or liabilities in active markets;

Level 2:

Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy (in thousands):


	As of December 31, 2024								As of December 31, 2023
Description	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Liabilities:
Warrant liabilities	$	361	$	—	$	361	$	—	$	658	$	—	$	658	$	—
Total	$	361	$	—	$	361	$	—	$	658	$	—	$	658	$	—

We estimated the fair value of our warrant liabilities using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby eight warrants can be exercised for one share of common stock for no additional consideration, which results in the warrant exercise price to be zero. Accordingly, our warrant liabilities were considered to be Level 2 of the fair value hierarchy.

- 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
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

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

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2E
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2E

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

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (f)
-Publisher FASB
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-Subparagraph (e)
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+ Details

Insider Trading Arrangements	12 Months Ended
Insider Trading Arrangements	Dec. 31, 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

Business, basis of presentation, new accounting standards and summary of significant accounting policies

12 Months Ended

Dec. 31, 2024

Business, basis of presentation, new accounting standards and summary of significant accounting policies

Business, basis of presentation, new accounting standards and summary of significant accounting policies

1. Business, basis of presentation, new accounting standards and summary of significant accounting policies

General

MetaVia Inc. (the “Company”), a Delaware corporation, and its subsidiaries are referred to collectively in these notes to the financial statements of the Company as “MetaVia,” “we,” “our” and “us.” Prior to the Company’s legal name change in November 2024, the Company was formerly known as NeuroBo Pharmaceuticals, Inc. We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. MetaVia has two programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity, DA-1241 and DA-1726.

While we primarily focus our financial resources and management’s attention on the development of DA-1241 and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases which we are not planning to advance development on and have, or continue to consider for, out-licensing and divestiture opportunities. In July 2024, we entered into an exclusive out-license agreement with MThera Pharma Co., LTD. (“MThera”) to provide MThera with the rights to NB-01 for the treatment of painful diabetic neuropathy.

Our operations have consisted principally of performing research and development (“R&D”) activities, which include preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

Going concern

As reflected in the consolidated financial statements, we had $16.0 million in cash as of December 31, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $135.9 million as of December 31, 2024. We have incurred a net loss of $27.6 million and net cash used in operating activities of $24.7 million for the year ended December 31, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of these consolidated financial statements.

We plan to continue to fund our operations from equity offerings, debt financing, or other sources, potentially including collaborations, out-licensing and other similar arrangements. However, there can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.

The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.

A.Basis of presentation

Our consolidated financial statements include a South Korean wholly owned subsidiary, which was dissolved and liquidated in June 2023. The accompanying financial statements were prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Our fiscal year-end is as of and for the year ended December 31st for each year presented. All significant intercompany accounts and transactions have been eliminated in the preparation of the financial statements.

B.New accounting standards

Adoption of new accounting standards

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to improve disclosure requirements

about reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. This ASU requires that a public entity that has a single reportable segment provide all the disclosures required by the amendments in this ASU and all existing segment disclosures in Topic 280. Additionally, this ASU requires disclosures of significant segment expenses provided to the Chief Operating Decision Maker ("CODM") and included in reported measures of segment profit and loss. Disclosure of the title and position of the CODM is required. This ASU requires interim and annual disclosures about a reportable segment's profit or loss and assets. Furthermore, this ASU requires disclosure of other segment items by reportable segment including a description of its composition. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis. We adopted ASU 2023-07 in 2024. See below I. Segment reporting and Note 8. Significant segment expenses for additional information.

Other new accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our consolidated financial statements or processes.

Accounting standards issued but not yet adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures to improve the transparency of income tax disclosures by amending the required rate reconciliation disclosures as well as requiring disclosure of income taxes paid disaggregated by jurisdiction. As amended, the rate reconciliation disclosure will be required to be presented in both percentages and reporting currency amounts, with consistent categories and greater disaggregation of information. This ASU also includes amendments intended to improve the effectiveness of income tax disclosures and eliminate certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. This ASU is effective for fiscal years beginning after December 15, 2024 and should be applied prospectively. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements; however, the amendments affect where such information appears in the notes to financial statements because entities are required to include certain current disclosures in the same tabular format disclosure as the other disaggregation requirements in the amendments. In January 2025, the FASB issued ASU 225-01, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. This ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting period beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes.

Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on our consolidated financial statements.

C.Estimates and assumptions

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our consolidated financial statements relate to clinical trial costs and accruals, classification of warrants as derivative liability or equity, and the fair value of stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.

D.Cash

We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $0.25 million per bank. Our cash balance includes liquid insured deposits, which are obligations of the banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.

E.Property and equipment, net

Property and equipment are recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for property and equipment ranges from three to five years. Tangible assets acquired for R&D activities and that have an alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.

F.Leases

We assess our contracts at inception to determine whether the contract contains a lease, including evaluation of whether the contract conveys the right to control an explicitly or implicitly identified asset for a period of time. We have recognized right-of-use assets and lease liabilities that represent the net present value of future operating lease payments utilizing a discount rate corresponding to our incremental borrowing rate and amortized over the remaining terms of the leases. For operating leases of a short-term nature, i.e., those with a term of less than twelve months, we recognize lease payments as an expense on a straight-line basis over the remaining lease term.

G.Warrant liabilities

Warrants are accounted for as liabilities at their fair value if equity accounting treatment is precluded due to provisions existing within the warrant agreements. The change in fair value of the warrant liabilities is recognized as a fair value change in warrant liabilities in the consolidated statements of operations and as an operating item in the statement of cash flows. Additionally, issuance costs associated with warrants initially classified as liabilities are expensed as incurred and reflected as financing costs in the accompanying consolidated statements of operations.

H.Fair value of financial instruments

Our financial instruments principally include cash, prepaid expenses, right of use assets, accounts payable, accrued liabilities, lease liabilities and warrant liabilities. The carrying amounts of cash, prepaid expenses and other current assets, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.

I.Segment reporting

We manage and operate as one reportable segment, which is principally the business of development of pharmaceutical products, with one geographic location. We do not operate separate lines of business with respect each pharmaceutical product being studied in a clinical environment, and we do not prepare discrete financial information with respect to our pharmaceutical products. Our CODM is our chief executive officer. The measure of performance used by the CODM to assess segment performance is reported on the consolidated statements of operations as loss from operations and net loss. Since the Company only have one reportable segment, our CODM does not need to decide on how to allocate resources between segments. The measure of segment assets is reported on the consolidated balance sheets as total assets.

J.Research and development costs

R&D expenditures for clinical development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the United States Food and Drug Administration, are charged to R&D expense as incurred. These expenses consist of costs incurred in performing development activities, including salaries and benefits, equity-based compensation expense, preclinical expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses.

Expenses incurred for certain R&D activities, including expenses associated with particular activities performed by contract research organizations, investigative sites in connection with clinical trials and contract manufacturing organizations, are recognized based on an evaluation of the progress or completion of specific tasks using either time-based measures or data such as information provided to us by our vendors on actual activities completed or costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of expense recognition. Expenses for R&D activities incurred that have yet to be invoiced by the vendors that perform the related activities are reflected as clinical trial accrued liabilities in the accompanying consolidated financial statements. Advance payments, if any, for goods or services to be received in the future for R&D activities are deferred and capitalized as prepaid expenses and other current assets in the

accompanying consolidated balance sheets. The capitalized amounts are expensed as the related goods are delivered or the services are performed.

K.Acquired in-process research and development

We include costs to acquire or in-license product candidates in acquired in-process R&D (“IPR&D”). When we acquire the right to develop and commercialize a new product candidate, any up-front payments, or any future milestone payments that relate to the acquisition or licensing of such a right are immediately expensed as acquired IPR&D in the period in which they are incurred. These costs are immediately expensed provided that the payments do not also represent processes or activities that would constitute a “business” as defined under GAAP, or provided that the product candidate has not achieved regulatory approval for marketing and absent obtaining such approval, has no alternative future use. Royalties owed on future sales of any licensed product will be expensed in the period the related revenues are recognized.

L.General and administrative expenses

General and administrative expenses consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with R&D activities. Other significant costs include legal fees related to intellectual property and corporate matters and professional fees for accounting and other services.

M.Patent costs

Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.

N.Stock-based compensation

Compensation costs related to equity instruments granted are recognized at the grant-date fair value, which is amortized as compensation expense on a straight-line basis over the requisite service period (generally, the vesting period) for both graded and cliff vesting awards. We have elected to account for forfeitures as they occur.

O.Income taxes

Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and income tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in income tax rates is recorded as a component of the income tax provision in the period that includes the enactment date.

Regular assessments are made on the likelihood that our deferred tax assets will be recovered from our future taxable income. Our evaluation is based on estimates, assumptions, and includes an analysis of available positive and negative evidence, giving weight based on the evidence’s relative objectivity. Sources of positive evidence include estimates of future taxable income, future reversal of existing taxable temporary differences, taxable income in carryback years, and available tax planning strategies. Sources of negative evidence include current and cumulative losses in recent years, losses expected in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that, if unfavorably resolved, would adversely affect future profit levels.

The remaining carrying value of our deferred tax assets, after recording the valuation allowance on our deferred tax assets, is based on our present belief that it is more likely than not that we will be able to generate sufficient future taxable income to utilize such deferred tax assets. The amount of the remaining deferred tax assets considered recoverable could be adjusted if our estimates of future taxable income during the carryforward period change favorably or unfavorably. To the extent we believe that it is more likely than not that some or all the remaining deferred tax assets will not be realized, we must establish a valuation allowance against those deferred tax assets, resulting in additional income tax expense in the period such determination is made. To the extent a valuation allowance currently exists, we will continue to monitor all positive and negative evidence until we believe it is more likely than not that it is no longer necessary, resulting in an income tax benefit in the period such determination is made.

Our policy is to recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. A significant judgment is required in evaluating our tax positions, and in determining our provisions for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets. We establish reserves when,

despite our belief that the income tax return positions are fully supportable, certain positions are likely to be challenged and we may ultimately not prevail in defending those positions.

P.Foreign currency translation

Our foreign subsidiary, dissolved and liquidated in June 2023, used the South Korean Won (KRW) as its functional currency. We translated the assets and liabilities of our foreign operation into United States (“U.S.”) dollars based on the rates of exchange in effect as of the transaction date. The resulting adjustments from the translation process are included in accumulated other comprehensive (loss) income in the accompanying consolidated balance sheets.

Certain transactions are settled in foreign currency and are thus translated to U.S. dollars at the rate of exchange in effect at the end of each month. Gains and losses resulting from the translation are included in other income or expense in the accompanying consolidated statements of operations.

Q.Comprehensive loss

Comprehensive loss is comprised of net loss and other comprehensive income or loss. Comprehensive loss includes net loss as well as other changes in stockholders' equity that result from transactions and economic events other than those with stockholders. Comprehensive loss currently consists of net loss and changes in foreign currency translation adjustments.

R.Loss per share of common stock

Basic earnings or loss per share of common stock is computed by dividing net income or loss available to stockholders of common stock by the weighted average number of shares of common stock. Diluted earnings per share of common stock is computed by dividing net income or loss available to stockholders of common stock by the sum of the weighted average number of shares of common stock and the number of additional shares of common stock that would have been outstanding if our outstanding potentially dilutive securities had been issued. Potentially dilutive securities include convertible preferred stock, outstanding stock options, non-vested restricted stock units (“RSUs”) and outstanding warrants. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per share of common stock by application of the treasury stock method, except if its impact is anti-dilutive. Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities. For additional information, see Note 10. Loss per share of common stock.

S.Concentrations

Credit Risk

Financial instruments that potentially subject us to concentration of credit risk consist of cash. As of December 31, 2024, our cash is held by one financial institution in the U.S., and we believe that the financial institution is financially sound. Accordingly, minimal credit risk exists with the financial institution.

Supplier Risk

In 2022, we entered into an exclusive license agreement (the “2022 License Agreement”) with Dong-A ST Co., Ltd. (“Dong-A”), a related party, which requires Dong-A to be the sole manufacturer for the production of DA-1241 and DA-1726. If any issues arise in the manufacturing and we are unable to arrange for alternative third-party manufacturing sources, or unable to find an alternative third party capable of reproducing the existing manufacturing method or unable to do so on commercially reasonable terms or in a timely manner, we may not be able to complete the development of DA-1241 or DA-1726.

T.Loss contingencies

In determining whether an accrual for a loss contingency is required, we first assess the likelihood of occurrence of the future event or events that will confirm the loss. When a loss is probable (the future event or events are likely to occur) and the amount of the loss can be reasonably estimated, the estimated loss is accrued. If the reasonable estimate of the loss is a range and an amount within the range appears to be a better estimate than any other amount within the range, that amount should be accrued. However, if no amount within the range is a better estimate, the minimum amount in the range should be accrued.

When a loss is reasonably possible (the chance of the future event or events occurring is more than remote but less than likely), no accrual is recognized.

U.Reclassification of prior year presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. Adjustments have been made to the consolidated balance sheets to reclassify the presentation of certain current liabilities related to clinical trial accrued liabilities of $3.0 million and related party payable of $0.8 million from accrued expenses and other current liabilities. These reclassifications had no effect on the reported total current liabilities in the consolidated balance sheets.

Fair value measurements - Recurring basis (Details) - USD ($)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Nov. 30, 2022	Oct. 31, 2022
Fair value of financial instruments
Common stock for no additional consideration	$ 1,000
November 2022 Series B
Fair value of financial instruments
Exercised warrants	8
Common stock for no additional consideration	$ 0
Warrants exercise price	$ 0		$ 0	$ 3
Recurring
Fair value of financial instruments
Warrant liabilities	$ 361,000	$ 658,000
Total	361,000	658,000
Recurring \| Level 2
Fair value of financial instruments
Warrant liabilities	361,000	658,000
Total	$ 361,000	$ 658,000

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Operating activities
Net loss	$ (27,592)	$ (12,470)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	538	222
Non-cash lease expense	4	1
Depreciation	20	6
Change in fair value of warrant liabilities	(297)	(2,955)
Change in operating assets and liabilities:
Prepaid expenses and other assets	20	70
Accounts payable	3,058	113
Accrued and other liabilities	(461)	4,214
Net cash used in operating activities	(24,710)	(10,799)
Investing activities
Purchases of property and equipment	(8)	(50)
Net cash used in investing activities	(8)	(50)
Financing activities
Proceeds from the issuance of common stock and warrants under the securities purchase agreements	19,998
Proceeds from exercise of warrants	1
Payments of issuance costs in connection with the securities purchase agreements	(1,651)	(80)
Payment of employee withholding taxes related to shares withheld from issuance for vested restricted stock units	(48)
Net cash provided by (used in) financing activities	18,300	(80)
Net decrease in cash	(6,418)	(10,929)
Cash at beginning of period	22,435	33,364
Cash at end of period	16,017	22,435
Supplemental non-cash investing and financing transactions:
Fair value of warrants issued to placement agent	309
Right-of-use assets obtained in exchange for operating lease liabilities		223
Reclassification of warrant liabilities upon exercise of warrants	$ 1	$ 7,183

Business, basis of presentation, new accounting standards and summary of significant accounting policies (Details) - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Business, basis of presentation, new accounting standards and summary of significant accounting policies
Common stock, shares authorized	100,000	100,000
Cash	$ 16,017	$ 22,435
Accumulated deficit	135,857	108,265
Net loss	(27,592)	(12,470)
Net cash used in operating activities	24,710	10,799
Clinical trial accrued liabilities	1,696	3,033
Accrued expenses and other current liabilities	785	$ 592
Common stock for no additional consideration	$ 1
Minimum
Business, basis of presentation, new accounting standards and summary of significant accounting policies
Estimated useful life	3 years
Maximum
Business, basis of presentation, new accounting standards and summary of significant accounting policies
Estimated useful life	5 years
Revision of Prior Period, Reclassification, Adjustment [Member]
Business, basis of presentation, new accounting standards and summary of significant accounting policies
Clinical trial accrued liabilities	$ 3,000
Accrued expenses and other current liabilities	$ 800

Fair value measurements (Tables)

12 Months Ended

Dec. 31, 2024

Fair value measurements

Schedule of fair value measurements on a recurring basis

The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy (in thousands):


	As of December 31, 2024								As of December 31, 2023
Description	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Liabilities:
Warrant liabilities	$	361	$	—	$	361	$	—	$	658	$	—	$	658	$	—
Total	$	361	$	—	$	361	$	—	$	658	$	—	$	658	$	—

Loss per share of common stock

12 Months Ended

Dec. 31, 2024

Loss per share of common stock

Loss per share of common stock

10.Loss per share of common stock

The following table sets forth the computation of basic and diluted loss per share of common stock (in thousands, except share and per share amounts):


	Year Ended December 31,
	2024		2023
Numerator:
Net loss	$	(27,592)	$	(12,470)
Denominator:
Weighted average shares of common stock, basic		7,757,128		5,071,101
Effect of dilutive securities		—		—
Weighted average shares of common stock, diluted		7,757,128		5,071,101
Loss per share of common stock, basic and diluted	$	(3.56)	$	(2.46)

For each of the periods presented in the above table, our basic weighted average shares of common stock include any outstanding (i) November 2022 Series A warrants, (ii) November 2022 Series B warrants, (ii) June 2024 Pre-Funded Warrants and (iii) vested RSUs in which their release was deferred in accordance with the respective award agreement during the respective period.

Since we reported a net loss for 2024 and 2023, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per share of common stock and our basic and diluted weighted average shares of common stock are the same for 2024 and 2023.

The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per share of common stock for 2024 and 2023:


	As of December 31,
	2024	2023
Stock options	4,700	4,700
RSUs	162,063	141,361
Warrants	12,875,854	25,976

Loss per share of common stock - Computation of basic and diluted loss per share of common stock (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Loss per share of common stock
Net loss	$ (27,592)	$ (12,470)
Weighted average shares of common stock, basic (in shares)	7,757,128	5,071,101
Weighted average shares of common stock, diluted (in shares)	7,757,128	5,071,101
Loss per share of common stock, basic (in dollars per share)	$ (3.56)	$ (2.46)
Loss per share of common stock, diluted (in dollars per share)	$ (3.56)	$ (2.46)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

+ Details

- Definition

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

+ References

+ Details

Income taxes - Significant components of deferred tax assets and liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Gross deferred income tax assets:
Federal and state operating loss carryforwards	$ 4,959	$ 2,107
Acquired intangibles	3,000	2,803
Stock-based compensation	458	392
Lease liability	37	49
Capitalized R&D expenses	7,516	2,315
Other	118	34
R&D credit carryforwards	26	26
Total gross deferred income tax assets	16,114	7,726
Valuation allowance	(16,100)	(7,700)
Gross deferred tax assets, net of valuation allowance	37	50
Gross deferred tax liabilities:
ROU asset	(36)	(49)
Other	(1)	(1)
Gross deferred income tax liabilities	(37)	(50)
Deferred income tax assets, net	0	0
Domestic
Gross deferred income tax assets:
Valuation allowance	$ (16,077)	$ (7,676)

Business, basis of presentation, new accounting standards and summary of significant accounting policies (Policies)	12 Months Ended
	Dec. 31, 2024
Business, basis of presentation, new accounting standards and summary of significant accounting policies
Basis of presentation	A.Basis of presentation Our consolidated financial statements include a South Korean wholly owned subsidiary, which was dissolved and liquidated in June 2023. The accompanying financial statements were prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Our fiscal year-end is as of and for the year ended December 31st for each year presented. All significant intercompany accounts and transactions have been eliminated in the preparation of the financial statements.
New accounting standards	B.New accounting standards Adoption of new accounting standards In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures to improve disclosure requirements about reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. This ASU requires that a public entity that has a single reportable segment provide all the disclosures required by the amendments in this ASU and all existing segment disclosures in Topic 280. Additionally, this ASU requires disclosures of significant segment expenses provided to the Chief Operating Decision Maker ("CODM") and included in reported measures of segment profit and loss. Disclosure of the title and position of the CODM is required. This ASU requires interim and annual disclosures about a reportable segment's profit or loss and assets. Furthermore, this ASU requires disclosure of other segment items by reportable segment including a description of its composition. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis. We adopted ASU 2023-07 in 2024. See below I. Segment reporting and Note 8. Significant segment expenses for additional information. Other new accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our consolidated financial statements or processes. Accounting standards issued but not yet adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures to improve the transparency of income tax disclosures by amending the required rate reconciliation disclosures as well as requiring disclosure of income taxes paid disaggregated by jurisdiction. As amended, the rate reconciliation disclosure will be required to be presented in both percentages and reporting currency amounts, with consistent categories and greater disaggregation of information. This ASU also includes amendments intended to improve the effectiveness of income tax disclosures and eliminate certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. This ASU is effective for fiscal years beginning after December 15, 2024 and should be applied prospectively. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes. In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements; however, the amendments affect where such information appears in the notes to financial statements because entities are required to include certain current disclosures in the same tabular format disclosure as the other disaggregation requirements in the amendments. In January 2025, the FASB issued ASU 225-01, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. This ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting period beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes. Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on our consolidated financial statements.
Estimates and assumptions	C.Estimates and assumptions The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our consolidated financial statements relate to clinical trial costs and accruals, classification of warrants as derivative liability or equity, and the fair value of stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.
Cash	D.Cash We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $0.25 million per bank. Our cash balance includes liquid insured deposits, which are obligations of the banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.
Property and equipment	E.Property and equipment, net Property and equipment are recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for property and equipment ranges from three to five years. Tangible assets acquired for R&D activities and that have an alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.
Leases	F.Leases We assess our contracts at inception to determine whether the contract contains a lease, including evaluation of whether the contract conveys the right to control an explicitly or implicitly identified asset for a period of time. We have recognized right-of-use assets and lease liabilities that represent the net present value of future operating lease payments utilizing a discount rate corresponding to our incremental borrowing rate and amortized over the remaining terms of the leases. For operating leases of a short-term nature, i.e., those with a term of less than twelve months, we recognize lease payments as an expense on a straight-line basis over the remaining lease term.
Warrant liabilities	G.Warrant liabilities Warrants are accounted for as liabilities at their fair value if equity accounting treatment is precluded due to provisions existing within the warrant agreements. The change in fair value of the warrant liabilities is recognized as a fair value change in warrant liabilities in the consolidated statements of operations and as an operating item in the statement of cash flows. Additionally, issuance costs associated with warrants initially classified as liabilities are expensed as incurred and reflected as financing costs in the accompanying consolidated statements of operations.
Fair value of financial instruments	H.Fair value of financial instruments Our financial instruments principally include cash, prepaid expenses, right of use assets, accounts payable, accrued liabilities, lease liabilities and warrant liabilities. The carrying amounts of cash, prepaid expenses and other current assets, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.
Segment reporting	I.Segment reporting We manage and operate as one reportable segment, which is principally the business of development of pharmaceutical products, with one geographic location. We do not operate separate lines of business with respect each pharmaceutical product being studied in a clinical environment, and we do not prepare discrete financial information with respect to our pharmaceutical products. Our CODM is our chief executive officer. The measure of performance used by the CODM to assess segment performance is reported on the consolidated statements of operations as loss from operations and net loss. Since the Company only have one reportable segment, our CODM does not need to decide on how to allocate resources between segments. The measure of segment assets is reported on the consolidated balance sheets as total assets.
Research and development costs	J.Research and development costs R&D expenditures for clinical development, including upfront licensing fees and milestone payments associated with products that have not yet been approved by the United States Food and Drug Administration, are charged to R&D expense as incurred. These expenses consist of costs incurred in performing development activities, including salaries and benefits, equity-based compensation expense, preclinical expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses. Expenses incurred for certain R&D activities, including expenses associated with particular activities performed by contract research organizations, investigative sites in connection with clinical trials and contract manufacturing organizations, are recognized based on an evaluation of the progress or completion of specific tasks using either time-based measures or data such as information provided to us by our vendors on actual activities completed or costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of expense recognition. Expenses for R&D activities incurred that have yet to be invoiced by the vendors that perform the related activities are reflected as clinical trial accrued liabilities in the accompanying consolidated financial statements. Advance payments, if any, for goods or services to be received in the future for R&D activities are deferred and capitalized as prepaid expenses and other current assets in the accompanying consolidated balance sheets. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
Acquired in-process research and development	K.Acquired in-process research and development We include costs to acquire or in-license product candidates in acquired in-process R&D (“IPR&D”). When we acquire the right to develop and commercialize a new product candidate, any up-front payments, or any future milestone payments that relate to the acquisition or licensing of such a right are immediately expensed as acquired IPR&D in the period in which they are incurred. These costs are immediately expensed provided that the payments do not also represent processes or activities that would constitute a “business” as defined under GAAP, or provided that the product candidate has not achieved regulatory approval for marketing and absent obtaining such approval, has no alternative future use. Royalties owed on future sales of any licensed product will be expensed in the period the related revenues are recognized.
General and administrative expenses	L.General and administrative expenses General and administrative expenses consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with R&D activities. Other significant costs include legal fees related to intellectual property and corporate matters and professional fees for accounting and other services.
Patent costs	M.Patent costs Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.
Stock-based compensation	N.Stock-based compensation Compensation costs related to equity instruments granted are recognized at the grant-date fair value, which is amortized as compensation expense on a straight-line basis over the requisite service period (generally, the vesting period) for both graded and cliff vesting awards. We have elected to account for forfeitures as they occur.
Income taxes	O.Income taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and income tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in income tax rates is recorded as a component of the income tax provision in the period that includes the enactment date. Regular assessments are made on the likelihood that our deferred tax assets will be recovered from our future taxable income. Our evaluation is based on estimates, assumptions, and includes an analysis of available positive and negative evidence, giving weight based on the evidence’s relative objectivity. Sources of positive evidence include estimates of future taxable income, future reversal of existing taxable temporary differences, taxable income in carryback years, and available tax planning strategies. Sources of negative evidence include current and cumulative losses in recent years, losses expected in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that, if unfavorably resolved, would adversely affect future profit levels. The remaining carrying value of our deferred tax assets, after recording the valuation allowance on our deferred tax assets, is based on our present belief that it is more likely than not that we will be able to generate sufficient future taxable income to utilize such deferred tax assets. The amount of the remaining deferred tax assets considered recoverable could be adjusted if our estimates of future taxable income during the carryforward period change favorably or unfavorably. To the extent we believe that it is more likely than not that some or all the remaining deferred tax assets will not be realized, we must establish a valuation allowance against those deferred tax assets, resulting in additional income tax expense in the period such determination is made. To the extent a valuation allowance currently exists, we will continue to monitor all positive and negative evidence until we believe it is more likely than not that it is no longer necessary, resulting in an income tax benefit in the period such determination is made. Our policy is to recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. A significant judgment is required in evaluating our tax positions, and in determining our provisions for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets. We establish reserves when, despite our belief that the income tax return positions are fully supportable, certain positions are likely to be challenged and we may ultimately not prevail in defending those positions.
Foreign currency translation	P.Foreign currency translation Our foreign subsidiary, dissolved and liquidated in June 2023, used the South Korean Won (KRW) as its functional currency. We translated the assets and liabilities of our foreign operation into United States (“U.S.”) dollars based on the rates of exchange in effect as of the transaction date. The resulting adjustments from the translation process are included in accumulated other comprehensive (loss) income in the accompanying consolidated balance sheets. Certain transactions are settled in foreign currency and are thus translated to U.S. dollars at the rate of exchange in effect at the end of each month. Gains and losses resulting from the translation are included in other income or expense in the accompanying consolidated statements of operations.
Comprehensive loss	Q.Comprehensive loss Comprehensive loss is comprised of net loss and other comprehensive income or loss. Comprehensive loss includes net loss as well as other changes in stockholders' equity that result from transactions and economic events other than those with stockholders. Comprehensive loss currently consists of net loss and changes in foreign currency translation adjustments.
Loss per share of common stock	R.Loss per share of common stock Basic earnings or loss per share of common stock is computed by dividing net income or loss available to stockholders of common stock by the weighted average number of shares of common stock. Diluted earnings per share of common stock is computed by dividing net income or loss available to stockholders of common stock by the sum of the weighted average number of shares of common stock and the number of additional shares of common stock that would have been outstanding if our outstanding potentially dilutive securities had been issued. Potentially dilutive securities include convertible preferred stock, outstanding stock options, non-vested restricted stock units (“RSUs”) and outstanding warrants. The dilutive effect of potentially dilutive securities is reflected in diluted earnings per share of common stock by application of the treasury stock method, except if its impact is anti-dilutive. Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities. For additional information, see Note 10. Loss per share of common stock.
Concentrations	S.Concentrations Credit Risk Financial instruments that potentially subject us to concentration of credit risk consist of cash. As of December 31, 2024, our cash is held by one financial institution in the U.S., and we believe that the financial institution is financially sound. Accordingly, minimal credit risk exists with the financial institution. Supplier Risk In 2022, we entered into an exclusive license agreement (the “2022 License Agreement”) with Dong-A ST Co., Ltd. (“Dong-A”), a related party, which requires Dong-A to be the sole manufacturer for the production of DA-1241 and DA-1726. If any issues arise in the manufacturing and we are unable to arrange for alternative third-party manufacturing sources, or unable to find an alternative third party capable of reproducing the existing manufacturing method or unable to do so on commercially reasonable terms or in a timely manner, we may not be able to complete the development of DA-1241 or DA-1726.
Loss contingencies	T.Loss contingencies In determining whether an accrual for a loss contingency is required, we first assess the likelihood of occurrence of the future event or events that will confirm the loss. When a loss is probable (the future event or events are likely to occur) and the amount of the loss can be reasonably estimated, the estimated loss is accrued. If the reasonable estimate of the loss is a range and an amount within the range appears to be a better estimate than any other amount within the range, that amount should be accrued. However, if no amount within the range is a better estimate, the minimum amount in the range should be accrued. When a loss is reasonably possible (the chance of the future event or events occurring is more than remote but less than likely), no accrual is recognized.
Reclassification of prior year presentation	U.Reclassification of prior year presentation Certain prior year amounts have been reclassified for consistency with the current year presentation. Adjustments have been made to the consolidated balance sheets to reclassify the presentation of certain current liabilities related to clinical trial accrued liabilities of $3.0 million and related party payable of $0.8 million from accrued expenses and other current liabilities. These reclassifications had no effect on the reported total current liabilities in the consolidated balance sheets.

Stockholders' equity - Stock-based compensation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Number of Options
Stock-based compensation	$ 538	$ 222
General and administrative
Number of Options
Stock-based compensation	366	178
Research and development
Number of Options
Stock-based compensation	$ 172	$ 44

Prepaid expenses and other current assets

12 Months Ended

Dec. 31, 2024

Prepaid expenses and other current assets

Prepaid expenses and other current assets

2. Prepaid expenses and other current assets

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


	As of December 31,
	2024			2023
Insurance	$	5	$	—
Deposits		16		39
Other prepaid expenses		34		38
Total	$	55	$	77

Income taxes

12 Months Ended

Dec. 31, 2024

Income taxes

Income taxes

9.Income taxes

Our loss before income taxes is as follows (in thousands):


	Year Ended December 31,
	2024		2023
United States	$	(27,592)	$	(12,468)
Foreign		—		(2)
Loss before income taxes	$	(27,592)	$	(12,470)

The components of our income tax provision are as follows (in thousands):


	Year Ended December 31,
	2024		2023
Income tax (benefit) expense:
Current
United States	$	—	$	—
Foreign		—		—
Total current income tax (benefit) expense		—		—
Deferred
United States		(8,401)		(3,424)
Foreign		—		176
Total deferred income tax (benefit) expense		(8,401)		(3,248)
Change in valuation allowance - United States		8,401		3,424
Change in valuation allowance - Foreign		—		(176)
Provision for income taxes	$	—	$	—

Our effective tax rate for 2024 and 2023 was zero percent. A reconciliation between income tax computed at the statutory U.S. federal statutory rate and the consolidated effective tax rate is as follows:


	Year Ended December 31,
	2024		2023
Income taxes at federal statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	6.0		3.0
Change in state tax rate	2.5		(1.4)
Change in fair value of warrant liabilities	0.3		5.7
Other	0.6		(0.8)
Valuation allowance	(30.4)		(27.5)
Effective tax rate	—	%	—	%

The significant components of our deferred tax assets and liabilities are as follows (in thousands):


	As of December 31,
	2024		2023
Gross deferred income tax assets:
Federal and state operating loss carryforwards	$	4,959	$	2,107
Acquired intangibles		3,000		2,803
Stock-based compensation		458		392
Lease liability		37		49
Capitalized R&D expenses		7,516		2,315
Other		118		34
R&D credit carryforwards		26		26
Total gross deferred income tax assets		16,114		7,726
Valuation allowance - U.S. federal		(16,077)		(7,676)
Gross deferred tax assets, net of valuation allowance		37		50
Gross deferred tax liabilities:
ROU asset		(36)		(49)
Other		(1)		(1)
Gross deferred income tax liabilities		(37)		(50)
Deferred income tax assets, net	$	—	$	—

The realization of our deferred income tax assets is primarily dependent upon future taxable income, if any, and such income is uncertain in both amount and timing. We have had significant pre-tax losses since our inception, and we have not yet generated revenues and face significant challenges to becoming profitable. Accordingly, we have recorded a valuation allowance of $16.1 million and $7.7 million as of December 31, 2024 and 2023, respectively. U.S. federal deferred income tax assets will continue to require a valuation allowance until we can demonstrate their realizability through sustained profitability or another source of income.

As of December 31, 2024 and 2023, our U.S. federal net operating loss (“NOL”) carryforwards were $18.5 million and $8.8 million, respectively. We had $24 thousand of U.S. federal R&D credit carryforwards as of December 31, 2024 and 2023. As of December 31, 2024 and 2023, we had state NOL carryforwards of $17.4 million and $4.4 million. We had $2 thousand of state R&D credit carryforwards as of December 31, 2024 and 2023. Since our U.S. federal net operating losses were incurred after December 31, 2017, our U.S NOL will not expire. Our state NOL and U.S federal and R&D credit carryforwards will begin to expire in 2042, if not utilized. Lastly, since the foreign subsidiary that generated the foreign losses was dissolved and liquidated in June 2023, the recorded value of foreign NOL and related deferred tax asset have been reduced to zero as of December 31, 2023.

Our ability to utilize our NOL and R&D credit carryforwards have been and may be substantially limited due to the ownership changes that have occurred or that could occur in the future, as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups.

We recognize interest and/or penalties related to uncertain tax positions in income tax expense. There were no uncertain tax positions as of December 31, 2024 and 2023, and as such, no interest or penalties were recorded to income tax expense.

Our U.S. corporate tax returns are subject to examination beginning with the 2019 tax year for U.S. federal and state jurisdictions, and beginning with the 2019 tax year for one foreign jurisdiction.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: 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 2: 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 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-13

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/740/tableOfContent

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-14

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-21

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-17

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

Loss per share of common stock (Tables)

12 Months Ended

Dec. 31, 2024

Loss per share of common stock

Schedule of computation of basic and diluted loss per share of common stock

The following table sets forth the computation of basic and diluted loss per share of common stock (in thousands, except share and per share amounts):


	Year Ended December 31,
	2024		2023
Numerator:
Net loss	$	(27,592)	$	(12,470)
Denominator:
Weighted average shares of common stock, basic		7,757,128		5,071,101
Effect of dilutive securities		—		—
Weighted average shares of common stock, diluted		7,757,128		5,071,101
Loss per share of common stock, basic and diluted	$	(3.56)	$	(2.46)

Schedule of outstanding securities which were not included in the calculation of diluted earnings per share of common stock


	As of December 31,
	2024	2023
Stock options	4,700	4,700
RSUs	162,063	141,361
Warrants	12,875,854	25,976