0001193125-26-331574 | 10-Q | XBRL Viewer | Palvella Therapeutics INC

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Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Jun. 30, 2026
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
George Jenkins
Trading Arrangements, by Individual
Material Terms of Trading Arrangement	Sale of up to 55,000 shares of Common Stock
Name	George Jenkins
Title	Director
Rule 10b5-1 Arrangement Adopted	true
Adoption Date	June 12, 2026
Expiration Date	May 12, 2027 or such earlier date upon completion of all trades under the plan (or expiration of the orders relating to such trades without execution) or the occurrence of such other termination events as specified in the plan.

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended				6 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Jun. 30, 2026	Mar. 31, 2026	Jun. 30, 2025	Mar. 31, 2025	Jun. 30, 2026	Jun. 30, 2025
Pay vs Performance Disclosure
Net Income (Loss)	$ (21,870)	$ (15,767)	$ (9,471)	$ (8,185)	$ (37,637)	$ (17,656)

- 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

Accrued Expenses and Other Current Liabilities

6 Months Ended

Jun. 30, 2026

Payables and Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

Note 5. Accrued Expenses and Other Current Liabilities

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


	June 30, 2026		December 31, 2025
Research and development expenses	$	1,635	$	1,200
Compensation expense		1,469		1,915
Professional fees		597		531
Other		1,244		705
Total accrued expenses and other current liabilities	$	4,945	$	4,351

Description of Business, Organization and Liquidity - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended				6 Months Ended
	Jun. 30, 2026	Mar. 31, 2026	Jun. 30, 2025	Mar. 31, 2025	Jun. 30, 2026	Jun. 30, 2025	Dec. 31, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Merger agreement closing date					Dec. 13, 2024
Net Income (Loss)	$ (21,870)	$ (15,767)	$ (9,471)	$ (8,185)	$ (37,637)	$ (17,656)
Net cash used in operating activities					(23,709)	$ (12,202)
Accumulated deficit	(173,087)				(173,087)		$ (135,450)
Cash and cash equivalents and short-term investments	$ 250,600				$ 250,600

- Definition

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

+ References

+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Fair Value Measurements - Schedule of Fair Value Measurement Key Assumptions (Details)	Jun. 30, 2026 yr	Dec. 31, 2025 yr
Discount rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative, assumption	0.16	0.18
Probability rate of achieving FDA approval of a product
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative, assumption	0.566	0.566
Expected term to FDA regulatory approval of a product
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative, assumption	1	1.5

Equity Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended		6 Months Ended
	Jun. 10, 2026	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025	Dec. 31, 2025
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares, issued (in shares)		14,395,705		14,395,705		12,380,933
Common stock, shares outstanding (in shares)		14,395,705		14,395,705		12,380,933
Vesting period				4 years
Options expiration period				10 years
Aggregate intrinsic value of options outstanding		$ 396,800		$ 396,800
Aggregate intrinsic value of options exercisable		155,800		155,800
Unrecognized compensation cost		55,200		$ 55,200
Expected to be recognized over a remaining weighted-average service period				2 years 9 months
Share-based compensation arrangement by share-based payment award, options, vested, weighted average grant date fair value (in dollars per share)				$ 60.61
Stock-based compensation expense		5,155	$ 1,433	$ 8,531	$ 2,527
General and Administrative Expense [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense		3,410	923	5,329	1,627
Research and Development Expense [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense		1,745	$ 510	$ 3,202	$ 900
Minimum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Percent of option exercise price				100.00%
RSUs
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period				4 years
PSUs
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period				1 year
RSU and PSU \| General and Administrative Expense [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense		$ 800		$ 5
2019 Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares outstanding (in shares)		477,811		477,811
Share-based compensation arrangement by share-based payment award, options, grants in period, gross (in shares)				548,686
2024 Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, shares, issued (in shares)		2,794,172		2,794,172
Shares available for future grants		4,205,433		4,205,433
Increase in number of shares reserved for future issuance	750,000

Equity Incentive Plans - Summary of Restricted Stock Units activities (Parenthetical) (Details) - PSUs	6 Months Ended
	Jun. 30, 2026 shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Awards vested	3,250
Awards vested net of employee tax withholdings	2,293

- 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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+ Details

Equity Incentive Plans - Schedule of Stock-based Compensation Expense Recognized (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense	$ 5,155	$ 1,433	$ 8,531	$ 2,527
Research and development
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense	1,745	510	3,202	900
General and administrative
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation expense	$ 3,410	$ 923	$ 5,329	$ 1,627

- Definition

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

+ References

+ Details

Equity Incentive Plans - Schedule of Stock Options Activity (Details) - 2019 Equity Incentive Plan	6 Months Ended	12 Months Ended
	Jun. 30, 2026 $ / shares shares	Dec. 31, 2025 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common Shares Underlying Stock Options, Outstanding balance \| shares	2,917,143
Common Shares Underlying Stock Options, Granted \| shares	548,686
Common Shares Underlying Stock Options, Exercised \| shares	(172,479)
Common Shares Underlying Stock Options, Forfeited / Cancelled \| shares	(21,367)
Common Shares Underlying Stock Options, Outstanding balance \| shares	3,271,983	2,917,143
Common Shares Underlying Stock Options, Exercisable \| shares	1,135,878
Weighted Average Exercise Price Per Share, Outstanding balance \| $ / shares	$ 20.69
Weighted Average Exercise Price Per Share, Granted \| $ / shares	88.39
Weighted average exercise price per share, Exercised \| $ / shares	12.96
Weighted Average Exercise Price Per Share, Forfeited / Cancelled \| $ / shares	140.03
Weighted Average Exercise Price Per Share, Outstanding balance \| $ / shares	31.67	$ 20.69
Weighted Average Exercise Price Per Share, Exercisable \| $ / shares	$ 16.01
Weighted Average Remaining Contractual Life (in years)	8 years 6 months	8 years 6 months
Weighted Average Remaining Contractual Life (in years), Exercisable	7 years 8 months 12 days

Description of Business, Organization and Liquidity

6 Months Ended

Jun. 30, 2026

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business, Organization and Liquidity

Note 1. Description of Business, Organization and Liquidity

Business

Palvella Therapeutics, Inc. (the “Company,” or “Palvella”) (previously named Pieris Pharmaceuticals, Inc. (“Pieris”)), a Nevada corporation, is a late clinical-stage biopharmaceutical company committed to serving individuals suffering from serious, rare skin diseases and vascular malformations without approved therapies. The Company’s lead product candidate, QTORIN 3.9% rapamycin anhydrous gel (“QTORIN rapamycin”), is based on the Company’s patented QTORIN platform. QTORIN rapamycin is in clinical development for microcystic lymphatic malformations (“microcystic LMs”), cutaneous venous malformations (“cutaneous VMs”) and angiokeratomas. The Company is conducting IND-enabling development for QTORIN pitavastatin for disseminated superficial actinic porokeratosis (“DSAP”). Since inception, the Company has devoted substantially all of its resources to identifying, researching and conducting preclinical and clinical activities for its product candidates, and developing its platform technology, organizing and staffing the Company, business planning, raising capital and establishing its intellectual property portfolio. The Company’s principal executive offices are located in Wayne, Pennsylvania.

Reverse Merger

On December 13, 2024 (the “Closing Date”), the Company consummated the previously announced merger pursuant to the terms of that certain Agreement and Plan of Merger, dated as of July 23, 2024 (the “Merger Agreement”), by and among the Company, Polo Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Pieris (the “Merger Sub”), and Palvella Therapeutics, Inc., a Delaware corporation (“Legacy Palvella”). Pursuant to the Merger Agreement, on the Closing Date, (i) Merger Sub merged with and into Legacy Palvella, with Legacy Palvella as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of the Company (the “Reverse Merger”) and (ii) the Company’s name was changed from Pieris Pharmaceuticals, Inc. to Palvella Therapeutics, Inc. (the “Reverse Merger” and, together with the other transactions contemplated by the Merger Agreement, the “Business Combination”).

Liquidity

The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements—Going Concern, which requires management to assess the Company’s ability to continue as a going concern within one year after the date the financial statements are issued.

Since inception, the Company has incurred net losses and negative cash flows from operations. During the six months ended June 30, 2026 and 2025, the Company reported a net loss of $37.6 million and $17.7 million, respectively, and net cash used in operating activities of $23.7 million and $12.2 million, respectively. At June 30, 2026, the Company had an accumulated deficit of $173.1 million and cash and cash equivalents and short-term investments of $250.6 million.

Management does not expect to generate commercial revenue or operating cash flows in the near-term. The Company’s ability to continue as a going concern in the near term is largely dependent on its existing cash and cash equivalents balance and ability to obtain additional sources of financing in order to fund operating expenses, complete development of its product candidates, obtain regulatory approvals, launch, and commercialize its product candidates, and continue research and development programs. Assuming no additional fund raising, the Company’s forecasted cash required to fund operations indicates that the Company has sufficient funds to support operations through at least the one-year period from the issuance date of these condensed consolidated financial statements.

Strategic Agreements - Additional Information (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended		6 Months Ended		12 Months Ended
	Dec. 31, 2018	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025	Dec. 31, 2025
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Derivative liabilities - royalty agreement		$ 2,271		$ 2,271		$ 2,041
Ligand Development Funding Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payments totalling to fund development	$ 15,000
Maximum payments to receive upon achievement of milestones	$ 8,000
Agreement royalty term period from first sale	15 years
Agreement termination notice period	90 days
Aggregate potential future milestone payments remaining under arrangement		5,000		5,000
Derivative liabilities - royalty agreement		2,300		2,300		2,000
Long-term liability		22,100		$ 22,100		$ 17,800
Effective interest rate percentage of potential future royalty payments				45.10%		44.90%
Non-cash interest expense		$ 2,300	$ 1,400	$ 4,300	$ 2,600
Ligand Development Funding Agreement [Member] \| Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Royalty percentage	9.80%
Ligand Development Funding Agreement [Member] \| Minimum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Royalty percentage	8.00%

Segment Information - Additional Information (Details)	6 Months Ended
Segment Information - Additional Information (Details)	Jun. 30, 2026 Segment
Segment Reporting [Abstract]
Number of operating segments	1
Number of reportable segments	1
Segment Reporting, Factors Used to Identify Entity's Reportable Segments	The Company expects to primarily generate revenue in North America, with its long-lived assets also concentrated in this region, and manages its business activities on a consolidated basis.
Segment Reporting, CODM, Profit (Loss) Measure, How Used, Description	The CODM assesses performance for the Company operations segment and decides how to allocate resources based on net income or loss that is also reported on the income statement as consolidated net income or loss and the measure of segment assets as reported on the balance sheet as total consolidated assets.

Fair Value Measurements - Schedule of Amortized Cost, Gross Unrealized Gains and Losses, and Fair Value of Investments in Fixed Maturity Securities (Details) $ in Thousands	Jun. 30, 2026 USD ($)
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost	$ 62,807
Gross Unrealized Gains	195
Gross Unrealized Losses	(221)
Fair Value	62,781
U.S. Treasury [Member]
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost	62,807
Gross Unrealized Gains	195
Gross Unrealized Losses	(221)
Fair Value	$ 62,781

- Definition

Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

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- Definition

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+ Details

Segment Information (Tables)

6 Months Ended

Jun. 30, 2026

Segment Reporting [Abstract]

Schedule of Reconciles Segment Direct Profit or Loss

The following table reconciles segment direct profit or loss to the Company’s consolidated results:


	Three Months Ended June 30,						Six Months Ended June 30,
(in thousands)	2026			2025			2026			2025
Research and development:
QTORIN CMC	$	3,308		$	1,517		$	5,135		$	2,289
QTORIN rapamycin for microcystic LM		865			1,235			2,400			2,389
QTORIN rapamycin for angiokeratomas		749			—			1,201			—
QTORIN rapamycin for cutaneous VM		712			354			1,157			700
QTORIN rapamycin for microcystic LM - Government grant income		—			(212	)		—			(339	)
Non-program specific and unallocated research and development expenses:
Salaries and stock-based compensation		3,697			1,501			6,887			2,823
Consultants		2,081			385			3,434			632
Other		1,061			338			1,593			698
Total research and development	$	12,473		$	5,118		$	21,807		$	9,192
General and administrative:
Salaries and stock-based compensation	$	5,147		$	1,744		$	8,429		$	3,197
Consultants		1,977			914			2,693			1,910
Other		1,808			1,474			3,331			2,822
Total general and administrative	$	8,932		$	4,132		$	14,453		$	7,929
Loss from operations	$	(21,405	)	$	(9,250	)	$	(36,260	)	$	(17,121	)

Equity Incentive Plans - Summary of Restricted Stock Units activities (Details)	6 Months Ended
	Jun. 30, 2026 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares Outstanding PSU and RSU Grants at June 30, 2026 \| shares	12,041
Weighted Average Grant Date Fair Value (per share) at June 30, 2026 \| $ / shares	$ 118.48
PSUs
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares Granted \| shares	13,000
Shares Released \| shares	(3,250)
Weighted Average Grant Date Fair Value (per share) Granted \| $ / shares	$ 119.86
Weighted Average Grant Date Fair Value (per share) Released \| $ / shares	$ 119.86
RSUs
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares Granted \| shares	2,291
Weighted Average Grant Date Fair Value (per share) Granted \| $ / shares	$ 112.59

- Definition

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

+ References

+ Details

Commitments and Contingencies

6 Months Ended

Jun. 30, 2026

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Note 8. Commitments and Contingencies

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.

Legal Proceedings

From time to time, the Company may face legal claims or actions in the normal course of business. The Company is not currently subject to any material legal proceedings.

Equity Incentive Plans

6 Months Ended

Jun. 30, 2026

Share-Based Payment Arrangement [Abstract]

Equity Incentive Plans

Note 7. Equity Incentive Plans

In connection with the Reverse Merger, the Company stockholders approved the 2024 Equity Incentive Plan (the “2024 Plan”) on December 13, 2024. The 2024 Plan provides for the grant of incentive stock options, nonqualified stock options, and stock awards, any of which may be performance-based, and for incentive bonuses, which may be paid in cash, Common Stock or a combination thereof.

On June 10, 2026, the Company stockholders approved Amendment No. 1 to the 2024 Plan, which increased the number of shares reserved for issuance under the 2024 Plan by 750,000 shares. Accordingly, the number of shares reserved for issuance under the 2024 Plan is equal to 4,205,433 shares of Common Stock as of June 30, 2026.

As of June 30, 2026, 2,794,172 options were outstanding under the 2024 Plan.

In connection with the Reverse Merger, all of the options outstanding under the Company’s 2019 Equity Incentive Plan (the “2019 Plan”) were adjusted with respect to the number of shares and exercise price to reflect the Exchange Ratio. As of June 30, 2026, 477,811 shares of Common Stock were outstanding under the 2019 Plan and no further grants will be made under the 2019 Plan.

For incentive stock options and non-statutory stock options, the option exercise price may not be less than 100% of the estimated fair value on the date of grant. Options granted to employees typically vest over a four-year period but may be granted with different vesting terms. The options expire ten years from the grant date.

The following table summarizes stock option activity for the Company’s equity incentive plans for the six months ended June 30, 2026:


	Common			Weighted		Weighted
	Shares			Average		Average
	Underlying			Exercise		Remaining
	Stock			Price per		Contractual
	Options			Share		Life (in years)
Outstanding at December 31, 2025		2,917,143		$	20.69		8.5
Granted		548,686		$	88.39
Exercised		(172,479	)	$	12.96
Forfeited / Cancelled		(21,367	)	$	140.03
Outstanding at June 30, 2026		3,271,983		$	31.67		8.5

Exercisable at June 30, 2026		1,135,878		$	16.01		7.7

The aggregate intrinsic value of options outstanding and options exercisable as of June 30, 2026 was $396.8 million and $155.8 million, respectively.

Total stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2026 and 2025 is as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2026		2025		2026		2025
Research and development	$	1,745	$	510	$	3,202	$	900
General and administrative		3,410		923		5,329		1,627
Total stock-based compensation expense	$	5,155	$	1,433	$	8,531	$	2,527

As of June 30, 2026, there was approximately $55.2 million of unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over a remaining weighted-average service period of 2.75 years.

The weighted average fair value of stock options granted during the six months ended June 30, 2026 was $60.61 per share which was estimated using the Black-Scholes option pricing model with the following weighted average assumptions:


Expected volatility	72.43% - 76.17%
Risk-free interest rate	3.05% - 4.36%
Expected term (years)	5.50 - 6.08
Expected dividend yield		—

Performance Stock Unit and Restricted Stock Unit Activity

The Company grants time-based restricted stock unit (“RSU”) awards and performance-based restricted stock unit (“PSU”) awards to certain employees. RSU awards vest over a four-year period subject to the employee’s continued employment or service with the Company through the vesting date. PSU awards have a performance period of one year and vest depending on the Company’s achievement of predetermined performance goals. For the three and six months ended June 30, 2026, the Company recorded $0.8 million and $5 thousand of stock compensation expense for PSUs and RSUs, respectively, included in general and administrative expense in the statement of operations.

The following table summarizes the activities related to the Company’s unvested RSUs and PSUs:


				Weighted
				Average
				Grant Date
				Fair Value
	Shares			(per share)
Outstanding PSU and RSU Grants at December 31, 2025		-		$	-
PSUs Granted		13,000		$	119.86
RSUs Granted		2,291		$	112.59
PSUs Released (1)		(3,250	)	$	119.86
PSUs Cancelled		-		$	-
RSUs Cancelled		-		$	-
Outstanding PSU and RSU Grants at June 30, 2026		12,041		$	118.48

(1)Amount includes 3,250 PSU awards (2,293 shares, net of employee tax withholdings, paid in shares) that vested based on the achievement of performance goals during the performance period ended June 30, 2026.

Document And Entity Information - shares	6 Months Ended
Document And Entity Information - shares	Jun. 30, 2026	Jul. 31, 2026
Document Information [Line Items]
Entity Central Index Key	0001583648
Entity Registrant Name	Palvella Therapeutics, Inc.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2026
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2026
Document Transition Report	false
Entity File Number	001-37471
Entity Incorporation, State or Country Code	NV
Entity Tax Identification Number	30-0784346
Entity Address, Address Line One	353 W. Lancaster Ave
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Wayne
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19087
City Area Code	484
Local Phone Number	253-1461
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	PVLA
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		14,408,407

Subsequent Events

6 Months Ended

Jun. 30, 2026

Subsequent Events [Abstract]

Subsequent Events

Note 10. Subsequent Events

Subsequent events have been evaluated through August 4, 2026, which is the date the accompanying condensed consolidated financial statements were issued.

Equity Incentive Plans (Tables)

6 Months Ended

Jun. 30, 2026

Share-Based Payment Arrangement [Abstract]

Schedule of Stock Option Activity

The following table summarizes stock option activity for the Company’s equity incentive plans for the six months ended June 30, 2026:


	Common			Weighted		Weighted
	Shares			Average		Average
	Underlying			Exercise		Remaining
	Stock			Price per		Contractual
	Options			Share		Life (in years)
Outstanding at December 31, 2025		2,917,143		$	20.69		8.5
Granted		548,686		$	88.39
Exercised		(172,479	)	$	12.96
Forfeited / Cancelled		(21,367	)	$	140.03
Outstanding at June 30, 2026		3,271,983		$	31.67		8.5

Exercisable at June 30, 2026		1,135,878		$	16.01		7.7

Schedule of Stock-based Compensation Expense Recognized

Total stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2026 and 2025 is as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2026		2025		2026		2025
Research and development	$	1,745	$	510	$	3,202	$	900
General and administrative		3,410		923		5,329		1,627
Total stock-based compensation expense	$	5,155	$	1,433	$	8,531	$	2,527

Schedule of Weighted Average Fair Value of Stock Options Granted


Expected volatility	72.43% - 76.17%
Risk-free interest rate	3.05% - 4.36%
Expected term (years)	5.50 - 6.08
Expected dividend yield		—

Summary of Restricted Stock Units activities

The following table summarizes the activities related to the Company’s unvested RSUs and PSUs:


				Weighted
				Average
				Grant Date
				Fair Value
	Shares			(per share)
Outstanding PSU and RSU Grants at December 31, 2025		-		$	-
PSUs Granted		13,000		$	119.86
RSUs Granted		2,291		$	112.59
PSUs Released (1)		(3,250	)	$	119.86
PSUs Cancelled		-		$	-
RSUs Cancelled		-		$	-
Outstanding PSU and RSU Grants at June 30, 2026		12,041		$	118.48

Segment Information - Schedule of Reconciles Segment Direct Profit or Loss (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025
Segment Reporting Information [Line Items]
Total research and development	$ 12,473	$ 5,118	$ 21,807	$ 9,192
Total general and administrative	8,932	4,132	14,453	7,929
Loss from operations	(21,405)	(9,250)	(36,260)	(17,121)
QTORIN CMC [Member]
Segment Reporting Information [Line Items]
Total research and development	3,308	1,517	5,135	2,289
QTORIN Rapamycin for Microcystic LM [Member]
Segment Reporting Information [Line Items]
Total research and development	865	1,235	2,400	2,389
Qtorin Rapamycin For Angiokeratomas [Member]
Segment Reporting Information [Line Items]
Total research and development	749	0	1,201	0
QTORIN Rapamycin For Cutaneous VM [Member]
Segment Reporting Information [Line Items]
Total research and development	712	354	1,157	700
QTORIN Rapamycin for Microcystic LM - Government Grant Income [Member]
Segment Reporting Information [Line Items]
Total research and development	0	(212)	0	(339)
Salaries and Stock-based Compensation [Member]
Segment Reporting Information [Line Items]
Total research and development	3,697	1,501	6,887	2,823
Total general and administrative	5,147	1,744	8,429	3,197
Consultants [Member]
Segment Reporting Information [Line Items]
Total research and development	2,081	385	3,434	632
Total general and administrative	1,977	914	2,693	1,910
Other [Member]
Segment Reporting Information [Line Items]
Total research and development	1,061	338	1,593	698
Total general and administrative	$ 1,808	$ 1,474	$ 3,331	$ 2,822

Summary of Significant Accounting Policies (Policies)	6 Months Ended
Summary of Significant Accounting Policies (Policies)	Jun. 30, 2026
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial reporting. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States (“U.S. GAAP”) for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary to fairly present the results of the interim periods. The results of operations and cash flows for the six months ended June 30, 2026 are not necessarily indicative of the results that may be expected for the fiscal year ended December 31, 2026 or any other future period.
Use of Estimates	Use of Estimates The preparation of consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process and actual results could differ materially from those estimates.
Concentration of Credit Risk and Other Risks and Uncertainties	Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company holds cash at two accredited financial institutions in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. In addition, the Company also maintains cash in a German bank account in denominations of Euros and U.S. dollars. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company is dependent on contract manufacturing organizations (“CMOs”) to supply products for research and development of its product candidates, including pre-clinical and clinical studies, and for commercialization of its product candidates, if approved. The Company’s development programs could be adversely affected by any significant interruption in its CMOs’ operations or by a significant interruption in the supply of active pharmaceutical ingredients and other components. Products developed by the Company require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary approvals. If the Company is denied approvals, approvals are delayed, or it is unable to maintain approvals received, such events could have a materially adverse impact on the Company.
Comprehensive Loss and Accumulated Other Comprehensive (Loss) Income	Comprehensive Loss and Accumulated Other Comprehensive (Loss) Income Other comprehensive (loss) income is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.
Cash and Cash Equivalents	Cash and Cash Equivalents Cash and cash equivalents are held in accounts at multiple independent financial institutions. Cash equivalents are defined as money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.
Investments	Investments The Company invests in fixed maturity securities including U.S. Treasury bills and bonds. The investments are classified as available-for-sale and reported at fair value. Unrealized gains or losses are determined by comparing the fair market value of the securities with their cost or amortized cost. Realized gains and losses on investments are recorded on the trade date and are included in the statement of operations. Unrealized gains and losses on investments are recorded in other comprehensive income (loss) on the consolidated statements of operations and comprehensive income (loss) and the consolidated statements of changes in preferred stock and stockholders’ equity (deficit). The cost of securities sold is based on the specified identification method. Investment income is recognized as earned and discounts or premiums arising from the purchase of debt securities are recognized in investment income using the interest method over the remaining term of the security. Securities with an original maturity date greater than three months that mature within one year of the balance sheet date are classified as short-term, while investments with a maturity date greater than one year are classified as long-term.
Fair Value Measurements	Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 – Quoted prices in active markets for identical assets or liabilities. • Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques. At June 30, 2026 and December 31, 2025, the carrying amounts of financial instruments, which include cash and cash equivalents, accounts payable, and accrued expenses and other liabilities, approximate their fair value due to their short maturities. At June 30, 2026 and December 31, 2025, the fair value of the royalty agreement liability, which is based on Level 3 inputs (including probability-weighted cash flow estimates of the Company’s potential future royalty payments and a weighted-average cost of capital of 16.0% and 18.0%, respectively) is approximately $97.3 million and $61.5 million, respectively. The Company records its investments and derivative liabilities at fair value.
Derivative Instruments	Derivative Instruments The Company evaluates its contracts to determine if those contracts qualify as derivatives under ASC 815, Derivatives and Hedging. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date. Any changes in fair value are recorded as other income or expense for each reporting period. Derivative instrument assets or liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is probable within the next 12 months from the balance sheet date. The Company has milestone payments which may be required in connection with the royalty agreement (see Note 3) that were determined to be derivative liabilities. The valuation of the derivative liabilities is based on unobservable inputs and, therefore, represent Level 3 financial liabilities. The fair value of the derivative liabilities – royalty agreement was calculated using the present value of the potential payments using a weighted-average cost of capital and an assessment of the probability of the achievement of the milestones as well as an assessment of the timing of the potential milestone payments. The derivative liabilities – royalty agreement was initially recorded at fair value, with gains and losses arising for changes in fair value of the derivative liabilities – royalty agreement recognized within the condensed consolidated statements of operations as fair value adjustments on the derivative liabilities at each financial reporting period. The Company determined that certain contingent payments that may become payable under the Contingent Value Rights Agreement entered into on December 13, 2024 with a rights agent, immediately prior to the closing of the Reverse Merger (the “CVR Agreement”) related to the asset sales prior to the Reverse Merger qualify as derivatives under ASC 815. Upon such time that these payments were assessed a fair value, they were recorded as a liability on the balance sheet. These values are then remeasured for future expected payout or receipt, as well as the increase in fair value due to the time value of money. These gains or losses, if any, are recognized in the condensed consolidated statements of operations within other income, net. The derivative liabilities – CVR agreement was initially recorded at fair value, with gains and losses arising from changes in fair value of the derivative liabilities – CVR recognized within the condensed consolidated statements of operations as fair value adjustments on the derivative liabilities at each financial reporting period.
Research and Development Expenses	Research and Development Expenses Research and development costs are charged to expense as incurred. Research and development expenses include, among other costs, salaries and benefits of scientific personnel and the external cost of producing and testing the clinical material for clinical trials. The Company has entered into various research and development and clinical trial-related contracts. The Company defers and capitalizes prepaid nonrefundable advance research and development payments to third parties for goods and services to be used in future research and development activities and recognizes to research and development expense over the period that the research and development activities are performed, or the services are provided. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and clinical trial costs. When determining the accruals, at the end of a reporting period, the Company analyzes progress of its studies and clinical trials, including the phase or completion of events, invoices received and contracted costs. Actual results could differ from the Company’s estimates.
Stock-Based Compensation	Stock-Based Compensation The Company accounts for stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments, including grants of stock options and restricted stock, to be recognized in the condensed consolidated statements of operations based on their fair values. Stock-based awards are subject to service-based or performance-based vesting conditions. Management estimates the fair value of the stock option awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the fair value of the Company’s common stock, (b) the expected stock price volatility, (c) the calculation of expected term of the award, (d) the risk-free interest rate and (e) expected dividends. Management estimates the fair value of the restricted stock awards using the fair value of the Company’s common stock. Forfeitures are recognized as they are incurred. The fair value of the Company’s common stock is based on the closing stock price on the date of grant as reported on the Nasdaq Global Market. The expected life of the stock options in years is estimated using the “simplified method,” as prescribed in SEC’s Staff Accounting Bulletin (SAB) No. 107, as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected life of the option. The expected dividend yield is zero as the Company has no history of paying dividends and no plans to do so in the near term. Compensation cost related to restricted stock units (“RSUs”) and performance stock units (“PSUs”) is based on the fair market value at the time of the grant. The Company recognizes the compensation cost related to RSUs over the requisite service period as determined by the grant, amortized ratably or on a straight-line basis over the life of the grant. The Company recognizes compensation cost for PSUs over the performance period, adjusting this cost based on the Company's estimate of the probability that performance metrics will be achieved. The Company classifies stock-based compensation expense in its condensed consolidated statements of operations and comprehensive loss in the same manner of the award recipient’s payroll costs.
Government Grants	Government Grants The Company recognizes grants from governmental agencies when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and the grant will be received. The Company evaluates the conditions of each grant as of each reporting period to evaluate whether the Company has reached reasonable assurance of meeting the conditions of each grant arrangement and that it is expected that the grant will be received as a result of meeting the necessary conditions. Grants are recognized in the condensed consolidated statements of operations on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate. Specifically, grant income related to research and development costs is recognized as such expenses are incurred. Grant income is recorded as a reduction of research and development costs in the condensed consolidated statements of operations. In September 2024, the Company received a grant award notice from the Department of Health and Human Services in connection with its ongoing Phase 3 clinical trial, SELVA. During the three and six months ended June 30, 2025, the Company recognized $0.2 million and $0.3 million, respectively, of grant income as a reduction to research and development costs in the accompanying condensed consolidated statements of operations. The Company did not recognize any grant income during the three and six months ended June 30, 2026.
Income Taxes	Income Taxes In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes, the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and six months ended June 30, 2026 and 2025, the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company has not recorded its net deferred tax asset as of either June 30, 2026 or December 31, 2025 because it maintained a full valuation allowance against all deferred tax assets as of these dates as management has determined that it is not more likely than not that the Company will realize these future tax benefits. As of June 30, 2026 and December 31, 2025, the Company had no uncertain tax positions. On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company evaluated the OBBBA and estimated its impact on the condensed consolidated financial statements to be immaterial.
Related Party Transactions	Related Party Transactions The Company’s board of directors reviews and approves transactions with directors, officers, and holders of 5% or more of its voting securities and their affiliates, each a related party. The material facts as to the related party’s relationship or interest in the transaction are disclosed to its board of directors prior to their consideration of such transaction, and the transaction is not considered approved by its board of directors unless a majority of the directors who are not interested in the transaction approve the transaction.
Segments	Segments Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision maker (“CODM”), in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its chief executive officer. The Company has determined it operates in one segment. The Company follows ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) which applies to public entities with a single reportable segment and requires disclosures about each reportable segments’ significant expenses and other segment items on an interim and annual basis. See Note 9 for related disclosures.
Net Loss Per Share	Net Loss Per Share Basic net loss per share is calculated by dividing net income loss by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, stock options and warrants are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. For the three and six months ended June 30, 2026 and 2025, basic and diluted net loss per share are the same.
Recently Issued (Not Yet Adopted) Accounting Standards	Recently Issued (Not Yet Adopted) Accounting Standards In November 2024, the Financial Account Standards Board (“FASB”) issued ASU 2024-03, Income Statement – Disaggregation of Income Statement Expenses (DISE), which requires disaggregated disclosure of income statement expenses for public business entities (“PBEs”). The ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the consolidated financial statements. ASU 2024-03 is effective for all PBEs for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impacts the ASU has on its consolidated financial statements. In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topics 832) - Accounting for Government Grants Received by Business Entities, which provides authoritative guidance for the recognition, measurement and presentation of government grants received by a business entity. The standard is effective for fiscal years beginning after December 15, 2028 and early adoption is permitted. The Company is currently evaluating the potential impact of this standard on its consolidated financial statements.

Fair Value Measurements - Fair Value Measurement Derivative Liabilities (Details) - USD ($) $ in Thousands	6 Months Ended	12 Months Ended
	Jun. 30, 2026	Dec. 31, 2025
Royalty Agreement [Member]
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance, beginning of period	$ 2,041	$ 1,647
Fair value adjustments on derivative liabilities	$ 230	$ 394
Fair Value, Net Derivative Asset (Liability), Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Unrealized Gain (Loss) on Derivatives	Unrealized Gain (Loss) on Derivatives
Balance, end of the period	$ 2,271	$ 2,041
Contingent Value Right Liability [Member]
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Balance, beginning of period	2,196	1,978
Settlement of contingent value right	(1,994)
Fair value adjustments on derivative liabilities	$ (202)	$ 218
Fair Value, Net Derivative Asset (Liability), Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Unrealized Gain (Loss) on Derivatives	Unrealized Gain (Loss) on Derivatives
Balance, end of the period	$ 0	$ 2,196

Fair Value Measurements

6 Months Ended

Jun. 30, 2026

Fair Value Disclosures [Abstract]

Fair Value Measurements

Note 3. Fair Value Measurements

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):


	June 30, 2026
	Level 1		Level 2		Level 3		Total
Current assets:
Cash and cash equivalents	$	187,803	$	—	$	—	$	187,803
U.S. Treasury		—		62,781		—		62,781
Total assets measured at fair value	$	187,803	$	62,781	$	—	$	250,584

Liabilities:
Derivative liabilities – royalty agreement	$	—	$	—	$	2,271	$	2,271
Total liabilities measured at fair value	$	—	$	—	$	2,271	$	2,271


	December 31, 2025
	Level 1		Level 2		Level 3		Total
Current assets:
Cash and cash equivalents	$	57,982	$	—	$	—	$	57,982
Total assets measured at fair value	$	57,982	$	—	$	—	$	57,982

Liabilities:
Derivative liabilities – royalty agreement	$	—	$	—	$	2,041	$	2,041
Derivative liabilities – contingent value right liability		—		—		2,196		2,196
Total liabilities measured at fair value	$	—	$	—	$	4,237	$	4,237

Cash and cash equivalents as of June 30, 2026 and December 31, 2025 includes cash and investments in money market funds. Money market funds, which are cash equivalents, are highly liquid investments and are actively traded. The pricing information on the Company’s money market funds is based on quoted prices in active markets for identical securities. This approach results in a classification of these securities as Level 1 of the fair value hierarchy.

There were no transfers between Levels during the period ended June 30, 2026. The Company uses the services of its investment manager, which uses widely accepted models for assumptions in valuing securities with inputs from major third-party data providers.

The Company classifies all of its investments in fixed maturity debt securities as available-for-sale and, accordingly, are carried at estimated fair value.

The amortized cost, gross unrealized gains and losses, and fair value of investments in fixed maturity securities as of June 30, 2026 are as follows:


	June 30, 2026
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
U.S. Treasury	$	62,807	$	195	$	(221	)	$	62,781
Total assets measured at fair value	$	62,807	$	195	$	(221	)	$	62,781

All of the Company’s fixed maturity available-for-sale securities have maturities of less than one year.

The Company has evaluated the unrealized losses on the fixed maturity securities and determined that they are not attributable to credit risk factors. For fixed maturity securities, losses in fair value are viewed as temporary if the fixed maturity security can be held to maturity and it is reasonable to assume that the issuer will be able to service the debt, both as to principal and interest.

As of June 30, 2026, the Company had seven available-for-sale investment debt securities in an unrealized loss position without an allowance for credit losses. Unrealized losses on governmental debt securities have not been recognized into income because the issuers’ securities are of high credit quality (rated AA+ or higher) and the decline in fair value is largely due to market conditions and or changes in interest rates. Management does not intend to sell and it is likely that management will not be required to sell the securities prior to the anticipated recovery of their amortized cost basis. The issuers continue to make timely payments on the securities. The fair value is expected to recover as the securities approach maturity.

As of June 30, 2026, accrued interest receivable on available-for-sale investment debt securities totaling $0.4 million is excluded from the estimate of credit losses and is included in prepaid expenses and other current assets.

Assumptions Used in Determining Fair Value of Derivative Liabilities

The key assumptions used to determine the fair value of the derivative liabilities – royalty agreement at June 30, 2026 and December 31, 2025 are as follows:


	June 30, 2026			December 31, 2025
Discount rate		16.0	%		18.0	%
Probability rate of achieving FDA approval of a product (1)		56.6	%		56.6	%
Expected term to FDA regulatory approval of a product	1.0 years			1.5 years

(1) Source: Clinical Development Success Rates and Contributing Factors 2011-2020 study of drug approval success from February 2021. The probability assumption used reflects the study’s estimate of the likelihood of approval of a Phase 3 drug that has not yet submitted its full NDA.

Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis

The following table provides a reconciliation of the liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands):

Derivative Liabilities – Royalty Agreement


	2026
Derivative liabilities - royalty agreement
Balance at January 1	$	2,041
Fair value adjustments on derivative liabilities		230
Balance at June 30	$	2,271


	2025
Derivative liabilities - royalty agreement
Balance at January 1	$	1,647
Fair value adjustments on derivative liabilities		394
Balance at December 31	$	2,041

The derivative liabilities – royalty agreement is classified as long term on the Company’s condensed consolidated balance sheets according to the estimated timing of the occurrence of the potential payments.

Derivative Liabilities – Contingent Value Right Liability


	2026
Derivative liabilities - contingent value right liability
Balance at January 1	$	2,196
Settlement of contingent value right		(1,994	)
Fair value adjustments on derivative liabilities		(202	)
Balance at June 30	$	—


	2025
Derivative liabilities - contingent value right liability
Balance at January 1	$	1,978
Fair value adjustments on derivative liabilities		218
Balance at December 31	$	2,196

The derivative liabilities – contingent value rights is classified as short term on the Company’s condensed consolidated balance sheets according to the estimated timing of the occurrence of the potential payments.

The Company applies a scenario-based method and weighs them based on the possible likelihood of certain contingencies triggering payments due under the contingent value right (“CVR”) for the liability recognized. The fair value measurements are based on significant inputs not observable in the market and thus represent a Level 3 measurement as defined in ASC 820, Fair Value Measurement. The estimated value of the CVR is based upon available information and certain assumptions, which the Company’s management believes are reasonable under the circumstances. In January 2026, the Company paid out approximately $2.0 million to holders of CVRs in accordance with the CVR Agreement entered into immediately prior to closing of the Merger on December 13, 2024. As of June 30, 2026, the fair value adjustment for the CVR is driven from foreign currency translation. The change in fair value has been recorded in fair value adjustments on derivative liabilities - contingent value right liability on the condensed consolidated statement of operations.

- 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/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/exampleRef
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Reference 3: http://www.xbrl.org/2003/role/exampleRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2E

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 6A
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
-Subparagraph (a)
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-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Current assets:
Cash and cash equivalents	$ 187,803	$ 57,982
Short-term investments	62,781	0
Prepaid expenses and other current assets	2,444	1,005
Total current assets	253,028	58,987
Operating lease right-of-use assets, net	482	572
Total assets	253,510	59,559
Current liabilities:
Accounts payable	6,785	4,595
Derivative liabilities - contingent value right liability	0	2,196
Current portion of operating lease liability	217	202
Accrued expenses and other current liabilities	4,945	4,351
Total current liabilities	11,947	11,344
Long-term portion of operating lease liability	318	431
Royalty agreement liability	22,107	17,760
Derivative liabilities - royalty agreement	2,271	2,041
Total liabilities	36,643	31,576
Commitments and contingencies (Note 8)
Stockholders' deficit:
Common stock, $0.001 par value; 200,000,000 shares authorized; 14,395,705 and 12,380,933 shares issued and outstanding at June 30, 2026 and December 31, 2025	14	12
Additional paid-in capital	389,851	163,338
Accumulated other comprehensive (loss) income	89	83
Accumulated deficit	(173,087)	(135,450)
Total stockholders' equity	216,867	27,983
Total liabilities and stockholders' equity	$ 253,510	$ 59,559

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025	Jun. 30, 2026	Jun. 30, 2025
Operating expenses
Research and development	$ 12,473	$ 5,118	$ 21,807	$ 9,192
General and administrative	8,932	4,132	14,453	7,929
Total operating expenses	21,405	9,250	36,260	17,121
Operating loss	(21,405)	(9,250)	(36,260)	(17,121)
Other (expense) income:
Interest expense - royalty agreement	(2,308)	(1,354)	(4,347)	(2,569)
Fair value adjustments on derivative liabilities - royalty agreement	(114)	(118)	(230)	(193)
Fair value adjustments on derivative liabilities - contingent value right liability	0	0	202	0
Interest income, net	1,965	690	3,038	1,442
Other (expense) income, net	(8)	561	(40)	785
Loss before income taxes	(21,870)	(9,471)	(37,637)	(17,656)
Income tax benefit (expense)	0	0	0	0
Net loss	(21,870)	(9,471)	(37,637)	(17,656)
Other comprehensive loss:
Unrealized loss on investments	(30)	0	(26)	0
Foreign currency translation gain (loss)	24	(108)	32	(114)
Comprehensive loss	$ (21,876)	$ (9,579)	$ (37,631)	$ (17,770)
Net loss per share of Common Stock - basic (in dollars per share)	$ (1.52)	$ (0.86)	$ (2.74)	$ (1.6)
Net loss per share of Common Stock - diluted (in dollars per share)	$ (1.52)	$ (0.86)	$ (2.74)	$ (1.6)
Weighted-average shares used in computing net loss per share of Common Stock - basic (in shares)	14,356,219	11,052,741	13,724,256	11,033,327
Weighted-average shares used in computing net loss per share of Common Stock - diluted (in shares)	14,356,219	11,052,741	13,724,256	11,033,327

Stockholders' Equity

6 Months Ended

Jun. 30, 2026

Stockholders' Equity Note [Abstract]

Stockholders' Equity

Note 6. Stockholders’ Equity

Authorized Capital

Upon closing of the Reverse Merger, pursuant to the terms of the Amendment to the Company’s Amended and Restated Articles of Incorporation with the Nevada Secretary of State, the Company was authorized to issue up to 200,000,000 shares of common stock, par value $0.001 per share (“Common Stock”). As of June 30, 2026 and December 31, 2025, 14,395,705 and 12,380,933 shares of Common Stock were issued and outstanding, respectively.

The Company is authorized to issue up to 10,000,000 shares of preferred stock, par value $0.001 per share (“Preferred Stock”). As of December 31, 2025, BVF has fully converted its shares of Preferred Stock to shares of Common Stock and no shares of Preferred Stock were outstanding as of June 30, 2026.

Common Stock, Preferred Stock, and Pre-Funded Warrants

Each share of Common Stock is entitled to one vote and all shares rank equally as to voting and other matters. Dividends may be declared and paid on the Common Stock from funds legally available therefore, if, as and when determined by the Board of Directors.

The Company has pre-funded warrants outstanding to purchase an aggregate of 1,394,761 shares of Common Stock as of June 30, 2026 and December 31, 2025. The pre-funded warrants are exercisable at any time for an exercise price of $0.001, except that the pre-funded warrants cannot be exercised by the holders if, after giving effect thereto, the holders would beneficially own more than 9.99% or 4.99% of the outstanding Common Stock, depending on the investor and subject to certain exceptions. However, any holder may increase or decrease such percentage to any other percentage (not in excess of 19.99%) upon at least 61 days’ prior notice from the holder to the Company. The holders of the pre-funded warrants will not have the right to vote the shares underlying the pre-funded warrants on any matter except to the extent required by Delaware law. These warrants were classified as equity.

Prior to the Reverse Merger, Legacy Pieris had issued multiple series (Series A through E) of Preferred Stock to certain entities affiliated with Biotechnology Value Fund, L.P. (“BVF”). In each case, each share Preferred Stock is convertible into 13.34 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation for each series) at any time at the option of the holder, provided that the holder is prohibited from converting the Preferred Stock into shares of Common Stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99% of the total number of shares of Common Stock then issued and outstanding, or the Beneficial Ownership Limitation. The holder may reset the Beneficial Ownership Limitation to a higher or lower number, not to exceed 19.99% of the total number of common shares issued and outstanding immediately after giving

effect to a conversion, upon providing written notice to the Company. Any such notice providing for an increase to the Beneficial Ownership Limitation will be effective 61 days after delivery to the Company.

Series A, Series B, Series C, Series D and Series E Preferred Stock rank senior to Common Stock; senior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as junior to the five series of Preferred Stock; in parity with each other and with any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as in parity with the existing five series of Preferred Stock; and junior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as senior to the existing five series of Preferred Stock. In the event of the Company’s liquidation, dissolution or winding up, subject to the rights of holders of Preferred Stock, holders are entitled to receive a payment equal to $0.001 per share of Preferred Stock pursuant to the rights and preferences discussed above, plus an additional amount equal to any dividends declared but unpaid on such shares. However, if the assets of the Company are insufficient to comply with the preceding sentence, then all remaining assets of the Company shall be distributed ratably to holders of the shares of the existing five series of Preferred Stock.

For each series of Preferred Stock, the Company designated the requisite number of shares of its authorized and unissued preferred stock as a specific series of Preferred Stock and filed a Certificate of Designation with the Nevada Secretary of State.

Shares of Preferred Stock generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Preferred Stock is required to amend the terms of the Certificate of Designation for each respective series of Preferred Stock. Holders of Preferred Stock are entitled to receive any dividends payable to holders of the Company’s common stock subject to the rights and preferences discussed above, in each case, as to distributions of assets upon the Company’s liquidation, dissolution or winding up whether voluntarily or involuntarily and/or the right to receive dividends.

Equity Financing

On February 25, 2026, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC, Cantor Fitzgerald & Co. and Stifel, Nicolaus & Company, Incorporated, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to an underwritten public offering of 1,600,000 shares of its Common Stock, at a price to the public of $125.00 per share. Under the terms of the Underwriting Agreement, the Company granted the underwriters an option to purchase up to an additional 240,000 shares of Common Stock at the same price. The option was exercised in full and the offering closed on February 27, 2026.

The offering resulted in net proceeds of $215.8 million, after deducting underwriting discounts and commissions and other offering expenses.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
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-Section 50
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
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+ Details

Strategic Agreements

6 Months Ended

Jun. 30, 2026

us-gaap_DisclosureTextBlockAbstract

Strategic Agreements

Note 4. Strategic Agreements

Ligand Development Funding Agreement

The Company is party to a Development Funding and Royalties Agreement with Ligand Pharmaceuticals, Inc. (“Ligand”), dated December 13, 2018, as amended May 22, 2020 and November 28, 2023 (the “Ligand Agreement”). Under the Ligand Agreement, Ligand has made payments totaling $15.0 million to fund the development of QTORIN rapamycin. As partial consideration for the funding received, the Company granted Ligand the right to receive up to $8.0 million in milestone payments upon the achievement of certain corporate, financing and regulatory milestones by the Company related to QTORIN rapamycin for the treatment of any and all indications. In addition, the Company is currently obligated to pay to Ligand tiered royalties ranging from 8.0% to 9.8% of any aggregate annual worldwide net product sales of any products based on QTORIN rapamycin. On a licensed product-by-licensed product and country-by-country basis, the royalty period is from the date of first commercial sale of such licensed product in a country until the latest of (i) the expiration of the last valid claim within the licensed patent rights covering such licensed product in the country in which such licensed product is made, used or sold, (ii) the expiration of the regulatory exclusivity term conferred by the applicable regulatory authority in such country with respect to such licensed product, and (iii) the fifteenth anniversary of the first commercial sale of such licensed product in such country.

The Ligand Agreement may be terminated by the earlier of a mutual written agreement of the parties or when the royalties contemplated by the agreement are paid to Ligand. Additionally, Ligand may terminate the agreement for (i) any or no reason upon a 90-day notice to the Company, or (ii) cause in connection with a material breach that the Company does not cure within a certain period of time.

The total amount of potential future milestone payments remaining under the arrangement was $5.0 million as of June 30, 2026. The potential future milestone payments represent derivative liabilities with a fair value of $2.3 million and $2.0 million as of June 30, 2026 and December 31, 2025, respectively, which are classified as “derivative liabilities – royalty agreement” on the accompanying condensed consolidated balance sheets. See Note 3 for fair value measurements.

The Company’s obligation to pay tiered royalties under the Ligand Agreement was determined to be a debt instrument based on the likelihood of repaying the amounts provided to fund the development of QTORIN rapamycin and that the Company has significant continuing involvement in the generation of the cash flows potentially due to Ligand. This obligation is reflected as royalty agreement liability which is classified as a long-term liability on the accompanying condensed consolidated balance sheets and was $22.1 million and $17.8 million as of June 30, 2026 and December 31, 2025, respectively. Interest expense with respect to the royalty agreement liability is determined using the effective interest method based upon probability-adjusted cash flow estimates of the Company’s potential future royalty payments under the Ligand Agreement, yielding an effective interest rate of 45.1% and 44.9% as of June 30, 2026 and December 31, 2025, respectively. Changes in these estimates impact the amount of interest expense recognized through the accompanying condensed consolidated statements of operations. The Company incurred non-cash interest expense of $2.3 million and $1.4 million for the three months ended June 30, 2026 and 2025, respectively, and $4.3 million and $2.6 million for the six months ended June 30, 2026 and 2025, respectively, all of which is a component of the royalty agreement liability on the accompanying condensed consolidated balance sheets.

The Ligand Agreement requires the Company to make certain estimates and assumptions about future development, FDA approval, commercialization, and net sales of any product containing QTORIN rapamycin. These estimates and assumptions are subject to significant variability and are thus subject to significant uncertainty. Therefore, these estimates and assumptions are likely to change as the Company develops and commercializes products containing QTORIN rapamycin. This may result in significant future adjustments to the royalty agreement liability, the derivative liabilities, and the accretion of interest expense.

Accrued Expenses and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2026

Payables and Accruals [Abstract]

Schedule of Accrued Expenses and Other Current Liabilities

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


	June 30, 2026		December 31, 2025
Research and development expenses	$	1,635	$	1,200
Compensation expense		1,469		1,915
Professional fees		597		531
Other		1,244		705
Total accrued expenses and other current liabilities	$	4,945	$	4,351

Equity Incentive Plans - Schedule of Weighted Average Fair Value Of Stock Options Granted (Details) - Employee Stock Option	6 Months Ended
	Jun. 30, 2026
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected volatility, Minimum	72.43%
Expected volatility, Maximum	76.17%
Risk-free interest rate, Minimum	3.05%
Risk-free interest rate, Maximum	4.36%
Expected dividend yield	0.00%
Minimum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (years)	5 years 6 months
Maximum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (years)	6 years 29 days

Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Thousands			6 Months Ended
	Feb. 25, 2026 USD ($) $ / shares shares	May 20, 2021 $ / shares shares	Jun. 30, 2026 USD ($) Vote $ / shares shares	Jun. 30, 2025 USD ($)	Dec. 31, 2025 $ / shares shares
Stockholder's Equity [Line Items]
Common stock, shares authorized (in shares)			200,000,000		200,000,000
Common stock, par value (in dollars per share) \| $ / shares			$ 0.001		$ 0.001
Common stock, shares, issued (in shares)			14,395,705		12,380,933
Common stock, shares outstanding (in shares)			14,395,705		12,380,933
Preferred stock, shares authorized (in shares)			10,000,000		10,000,000
Preferred stock, par value (in dollars per share) \| $ / shares			$ 0.001		$ 0.001
Preferred stock, shares outstanding (in shares)			0
Net proceeds from offering, after deducting underwriting discounts and commissions and other estimated offering expenses \| $			$ 230,000	$ 0
Underwritten Public Offering [Member]
Stockholder's Equity [Line Items]
Net proceeds from offering, after deducting underwriting discounts and commissions and other estimated offering expenses \| $	$ 215,800
Prefunded Warrants [Member]
Stockholder's Equity [Line Items]
Number of pre-funded warrants outstanding to purchase common stock			1,394,761		1,394,761
Class of warrant or right, exercise price of warrants or rights (in dollars per share) \| $ / shares			$ 0.001
Convertible preferred stock, common stock ownership limit, percent			9.99%
Convertible preferred stock, common stock ownership limit, percent			19.99%
Convertible preferred stock, beneficial ownership limitation, notice period before increase (Year)			61 days
Common Stock [Member]
Stockholder's Equity [Line Items]
Number of votes per share \| Vote			1
Convertible preferred stock, common stock ownership limit, percent			4.99%
Common Stock [Member] \| Underwritten Public Offering [Member]
Stockholder's Equity [Line Items]
Sale of stock, number of shares issued in transaction	1,600,000
Sale of stock, price per share \| $ / shares	$ 125
Sale of stock, number of additional shares issued in transaction	240,000
Series A Through E [Member] \| Preferred Stock [Member]
Stockholder's Equity [Line Items]
Preferred stock, par value (in dollars per share) \| $ / shares		$ 0.001
Convertible preferred stock, shares issued upon conversion (in shares)		13.34
Convertible preferred stock, common stock ownership limit, percent		9.99%
Convertible preferred stock, common stock ownership limit, percent		19.99%
Convertible preferred stock, beneficial ownership limitation, notice period before increase (Year)		61 days

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2026

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Note 2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial reporting. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States (“U.S. GAAP”) for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary to fairly present the results of the interim periods. The results of operations and cash flows for the six months ended June 30, 2026 are not necessarily indicative of the results that may be expected for the fiscal year ended December 31, 2026 or any other future period.

Use of Estimates

The preparation of consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Management considers many factors in selecting appropriate financial accounting policies and controls and in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process and actual results could differ materially from those estimates.

Concentration of Credit Risk and Other Risks and Uncertainties

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company holds cash at two accredited financial institutions in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. In addition, the Company also maintains cash in a German bank account in denominations of Euros and U.S. dollars. The Company has not experienced any losses on its deposits of cash and cash equivalents.

The Company is dependent on contract manufacturing organizations (“CMOs”) to supply products for research and development of its product candidates, including pre-clinical and clinical studies, and for commercialization of its product candidates, if approved. The Company’s development programs could be adversely affected by any significant interruption in its CMOs’ operations or by a significant interruption in the supply of active pharmaceutical ingredients and other components.

Products developed by the Company require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary approvals. If the Company is denied approvals, approvals are delayed, or it is unable to maintain approvals received, such events could have a materially adverse impact on the Company.

Comprehensive Loss and Accumulated Other Comprehensive (Loss) Income

Other comprehensive (loss) income is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.

Cash and Cash Equivalents

Cash and cash equivalents are held in accounts at multiple independent financial institutions. Cash equivalents are defined as money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

Investments

The Company invests in fixed maturity securities including U.S. Treasury bills and bonds. The investments are classified as available-for-sale and reported at fair value. Unrealized gains or losses are determined by comparing the fair market value of the securities with their cost or amortized cost. Realized gains and losses on investments are recorded on the trade date and are included in the statement of operations. Unrealized gains and losses on investments are recorded in other comprehensive income (loss) on the consolidated statements of operations and comprehensive income (loss) and the consolidated statements of changes in preferred stock and stockholders’ equity (deficit). The cost of securities sold is based on the specified identification method. Investment income is recognized as earned and discounts or premiums arising from the purchase of debt securities are recognized in investment income using the interest method over the remaining term of the security. Securities with an original maturity date greater than three months that mature within one year of the balance sheet date are classified as short-term, while investments with a maturity date greater than one year are classified as long-term.

Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

•

Level 1 – Quoted prices in active markets for identical assets or liabilities.

•

Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

•

Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques.

At June 30, 2026 and December 31, 2025, the carrying amounts of financial instruments, which include cash and cash equivalents, accounts payable, and accrued expenses and other liabilities, approximate their fair value due to their short maturities. At June 30, 2026 and December 31, 2025, the fair value of the royalty agreement liability, which is based on Level 3 inputs (including probability-weighted cash flow estimates of the Company’s potential future royalty payments and a weighted-average cost of capital of 16.0% and 18.0%, respectively) is approximately $97.3 million and $61.5 million, respectively. The Company records its investments and derivative liabilities at fair value.

Derivative Instruments

The Company evaluates its contracts to determine if those contracts qualify as derivatives under ASC 815, Derivatives and Hedging. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date. Any changes in fair value are recorded as other income or expense for each reporting period. Derivative instrument assets or liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument is probable within the next 12 months from the balance sheet date.

The Company has milestone payments which may be required in connection with the royalty agreement (see Note 3) that were determined to be derivative liabilities. The valuation of the derivative liabilities is based on unobservable inputs and, therefore, represent Level 3 financial liabilities. The fair value of the derivative liabilities – royalty agreement was calculated using the present value of the potential payments using a weighted-average cost of capital and an assessment of the probability of the achievement of the milestones as well as an assessment of the timing of the potential milestone payments.

The derivative liabilities – royalty agreement was initially recorded at fair value, with gains and losses arising for changes in fair value of the derivative liabilities – royalty agreement recognized within the condensed consolidated statements of operations as fair value adjustments on the derivative liabilities at each financial reporting period.

The Company determined that certain contingent payments that may become payable under the Contingent Value Rights Agreement entered into on December 13, 2024 with a rights agent, immediately prior to the closing of the Reverse Merger (the “CVR Agreement”) related to the asset sales prior to the Reverse Merger qualify as derivatives under ASC 815. Upon such time that these payments were assessed a fair value, they were recorded as a liability on the balance sheet. These values are then remeasured for future expected payout or receipt, as well as the increase in fair value due to the time value of money. These gains or losses, if any, are recognized in the condensed consolidated statements of operations within other income, net.

The derivative liabilities – CVR agreement was initially recorded at fair value, with gains and losses arising from changes in fair value of the derivative liabilities – CVR recognized within the condensed consolidated statements of operations as fair value adjustments on the derivative liabilities at each financial reporting period.

Research and Development Expenses

Research and development costs are charged to expense as incurred. Research and development expenses include, among other costs, salaries and benefits of scientific personnel and the external cost of producing and testing the clinical material for clinical trials.

The Company has entered into various research and development and clinical trial-related contracts. The Company defers and capitalizes prepaid nonrefundable advance research and development payments to third parties for goods and services to be used in future research and development activities and recognizes to research and development expense over the period that the research and development activities are performed, or the services are provided. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and clinical trial costs. When determining the accruals, at the end of a reporting period, the Company analyzes progress of its studies and clinical trials, including the phase or completion of events, invoices received and contracted costs. Actual results could differ from the Company’s estimates.

Stock-Based Compensation

The Company accounts for stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments, including grants of stock options and restricted stock, to be recognized in the condensed consolidated statements of operations based on their fair values. Stock-based awards are subject to service-based or performance-based vesting conditions. Management estimates the fair value of the stock option awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the fair value of the Company’s common stock, (b) the expected stock price volatility, (c) the calculation of expected term of the award, (d) the risk-free interest rate and (e) expected dividends. Management estimates the fair value of the restricted stock awards using the fair value of the Company’s common stock. Forfeitures are recognized as they are incurred.

The fair value of the Company’s common stock is based on the closing stock price on the date of grant as reported on the Nasdaq Global Market. The expected life of the stock options in years is estimated using the “simplified method,” as prescribed in SEC’s Staff Accounting Bulletin (SAB) No. 107, as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants. The simplified method is the midpoint between the vesting period and the contractual term of the option. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The risk-free rate is based on the U.S. Treasury yield curve commensurate with the expected life of the option. The expected dividend yield is zero as the Company has no history of paying dividends and no plans to do so in the near term.

Compensation cost related to restricted stock units (“RSUs”) and performance stock units (“PSUs”) is based on the fair market value at the time of the grant. The Company recognizes the compensation cost related to RSUs over the requisite service period as determined by the grant, amortized ratably or on a straight-line basis over the life of the

grant. The Company recognizes compensation cost for PSUs over the performance period, adjusting this cost based on the Company's estimate of the probability that performance metrics will be achieved.

The Company classifies stock-based compensation expense in its condensed consolidated statements of operations and comprehensive loss in the same manner of the award recipient’s payroll costs.

Government Grants

The Company recognizes grants from governmental agencies when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and the grant will be received. The Company evaluates the conditions of each grant as of each reporting period to evaluate whether the Company has reached reasonable assurance of meeting the conditions of each grant arrangement and that it is expected that the grant will be received as a result of meeting the necessary conditions. Grants are recognized in the condensed consolidated statements of operations on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate. Specifically, grant income related to research and development costs is recognized as such expenses are incurred. Grant income is recorded as a reduction of research and development costs in the condensed consolidated statements of operations. In September 2024, the Company received a grant award notice from the Department of Health and Human Services in connection with its ongoing Phase 3 clinical trial, SELVA. During the three and six months ended June 30, 2025, the Company recognized $0.2 million and $0.3 million, respectively, of grant income as a reduction to research and development costs in the accompanying condensed consolidated statements of operations. The Company did not recognize any grant income during the three and six months ended June 30, 2026.

Income Taxes

In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes, the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and six months ended June 30, 2026 and 2025, the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company has not recorded its net deferred tax asset as of either June 30, 2026 or December 31, 2025 because it maintained a full valuation allowance against all deferred tax assets as of these dates as management has determined that it is not more likely than not that the Company will realize these future tax benefits. As of June 30, 2026 and December 31, 2025, the Company had no uncertain tax positions.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company evaluated the OBBBA and estimated its impact on the condensed consolidated financial statements to be immaterial.

Related Party Transactions

The Company’s board of directors reviews and approves transactions with directors, officers, and holders of 5% or more of its voting securities and their affiliates, each a related party. The material facts as to the related party’s relationship or interest in the transaction are disclosed to its board of directors prior to their consideration of such transaction, and the transaction is not considered approved by its board of directors unless a majority of the directors who are not interested in the transaction approve the transaction.

Segments

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision maker (“CODM”), in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its chief executive officer. The Company has determined it operates in one segment.

The Company follows ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) which applies to public entities with a single reportable segment and requires disclosures about each reportable segments’ significant expenses and other segment items on an interim and annual basis. See Note 9 for related disclosures.

Net Loss Per Share

Basic net loss per share is calculated by dividing net income loss by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, stock options and warrants are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. For the three and six months ended June 30, 2026 and 2025, basic and diluted net loss per share are the same.

Recently Issued (Not Yet Adopted) Accounting Standards

In November 2024, the Financial Account Standards Board (“FASB”) issued ASU 2024-03, Income Statement – Disaggregation of Income Statement Expenses (DISE), which requires disaggregated disclosure of income statement expenses for public business entities (“PBEs”). The ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the consolidated financial statements. ASU 2024-03 is effective for all PBEs for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impacts the ASU has on its consolidated financial statements.

In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topics 832) - Accounting for Government Grants Received by Business Entities, which provides authoritative guidance for the recognition, measurement and presentation of government grants received by a business entity. The standard is effective for fiscal years beginning after December 15, 2028 and early adoption is permitted. The Company is currently evaluating the potential impact of this standard on its consolidated financial statements.

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2026	Jun. 30, 2025
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (37,637)	$ (17,656)
Adjustments to reconcile net loss income to net cash used in operating activities:
Non-cash interest expense - royalty agreement	4,347	2,569
Change in fair value of derivative liabilities - royalty agreement	230	193
Change in fair value of derivative liabilities - contingent value right liability	(202)	0
Stock-based compensation	8,531	2,527
Accretion on marketable securities	(335)	0
Non-cash lease operating expense	89	0
Change in operating assets and liabilities:
Prepaid expenses and other current assets	(1,422)	1,318
Accounts payable	2,202	1,240
Accrued expenses and other current liabilities	586	(2,393)
Payments on operating lease liabilities	(98)	0
Net cash used in operating activities	(23,709)	(12,202)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of marketable securities	(70,472)	0
Maturities of marketable securities	8,000	0
Net cash used in investing activities	(62,472)	0
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of transaction costs in connection with Reverse Merger	0	(1,269)
Proceeds from issuance of common stock in connection with equity financing	230,000	0
Payment of financing cost in connection with equity financing	(14,247)	0
Payment of contingent value right liability	(1,978)	0
Proceeds from exercise of stock options	2,236	416
Net cash provided by (used in) financing activities	216,011	(853)
Effect of exchange rate change on cash and cash equivalents	(9)	(114)
Net increase (decrease) in cash and cash equivalents	129,821	(13,169)
Cash and cash equivalents at beginning of period	57,982	83,602
Cash and cash equivalents at end of period	$ 187,803	$ 70,433

Condensed Consolidated Statements of Changes in Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical)	3 Months Ended
	Jun. 30, 2026 shares
Statement of Stockholders' Equity [Abstract]
Issuance of Common Stock upon settlement of employee performance stock units and restricted stock units, net of shares withheld for taxes	3,250

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Jun. 30, 2026	Dec. 31, 2025
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares, issued (in shares)	14,395,705	12,380,933
Common stock, shares outstanding (in shares)	14,395,705	12,380,933

Fair Value Measurements - Additional Information (Details) $ in Millions	1 Months Ended	6 Months Ended
	Jan. 31, 2026 USD ($)	Jun. 30, 2026 USD ($) Position
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Number of unrealized loss position \| Position		7
Accrued interest receivable on available-for-sale investment debt securities		$ 0.4
Contingent value rights agreement amount paid	$ 2.0
Maximum [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale securities maturity period		1 year

Summary of Significant Accounting Policies - Additional Information (Details)	3 Months Ended	6 Months Ended
	Jun. 30, 2025 USD ($)	Jun. 30, 2026 USD ($) Segment	Jun. 30, 2025 USD ($)	Dec. 31, 2025 USD ($)
Accounting Policies [Abstract]
Grant income	$ 200,000		$ 300,000
Government Assistance, Income, Increase (Decrease), Statement of Income or Comprehensive Income [Extensible Enumeration]	us-gaap_OperatingIncomeLoss		us-gaap_OperatingIncomeLoss
Uncertain tax positions		$ 0		$ 0
Number of operating segments \| Segment		1
Weighted average cost of capital		16.00%		18.00%
Potential future royalty payment		$ 97,300,000		$ 61,500,000

Segment Information

6 Months Ended

Jun. 30, 2026

Segment Reporting [Abstract]

Segment Information

Note 9. Segment Information

The Company is comprised of one reportable segment, the Company operations. As of June 30, 2026, the Company operations segment has not generated any product revenue since inception, as it does not yet have approved products for sale. However, the Company operations segment anticipates future revenue generation upon the successful development and commercialization of product candidates either independently or through partnerships.

The Company expects to primarily generate revenue in North America, with its long-lived assets also concentrated in this region, and manages its business activities on a consolidated basis. Decisions concerning the allocation of the Company’s resources are made by the Company’s CODM, which is the Company’s CEO. The CODM views the Company’s operations as a single operating segment which is the business of discovering and developing products for individuals with serious and rare skin diseases.

The Company’s significant segment expenses that are regularly provided to the CODM are related to:

•

Research and Development Expenses: These expenses include costs incurred in conducting research and development activities for the specific clinical trials including facilities costs, license fee and other costs incurred in connection with preclinical research and development activities. Research and development also encompass non-program specific costs such as salaries and stock-based compensation costs, third party consulting fees, and other related costs.

•

General and Administrative Expenses: These expenses include costs associated with the overall administration and management of the Company, including salaries and benefits for administrative personnel, professional service fees (e.g., accounting and legal services) and other office expenses.

The CODM assesses performance for the Company operations segment and decides how to allocate resources based on net income or loss that is also reported on the income statement as consolidated net income or loss and the measure

of segment assets as reported on the balance sheet as total consolidated assets. Net income or loss is used to monitor budget versus actual results as well as to assess the general performance of the segment in a given period.

The following table reconciles segment direct profit or loss to the Company’s consolidated results:


	Three Months Ended June 30,						Six Months Ended June 30,
(in thousands)	2026			2025			2026			2025
Research and development:
QTORIN CMC	$	3,308		$	1,517		$	5,135		$	2,289
QTORIN rapamycin for microcystic LM		865			1,235			2,400			2,389
QTORIN rapamycin for angiokeratomas		749			—			1,201			—
QTORIN rapamycin for cutaneous VM		712			354			1,157			700
QTORIN rapamycin for microcystic LM - Government grant income		—			(212	)		—			(339	)
Non-program specific and unallocated research and development expenses:
Salaries and stock-based compensation		3,697			1,501			6,887			2,823
Consultants		2,081			385			3,434			632
Other		1,061			338			1,593			698
Total research and development	$	12,473		$	5,118		$	21,807		$	9,192
General and administrative:
Salaries and stock-based compensation	$	5,147		$	1,744		$	8,429		$	3,197
Consultants		1,977			914			2,693			1,910
Other		1,808			1,474			3,331			2,822
Total general and administrative	$	8,932		$	4,132		$	14,453		$	7,929
Loss from operations	$	(21,405	)	$	(9,250	)	$	(36,260	)	$	(17,121	)

- 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-21

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-21

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 31
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-31

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-15

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 42
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-42

Reference 7: http://www.xbrl.org/2003/role/exampleRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 48
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482785/280-10-55-48

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

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

Reference 11: http://fasb.org/us-gaap/role/ref/otherTransitionRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (d)
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+ Details

Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Liabilities:
Derivative liabilities - royalty agreement	$ 2,271	$ 2,041
Derivative liabilities - contingent value right liability	0	2,196
Recurring Basis [Member]
Current assets:
Cash and cash equivalents	187,803	57,982
U.S. Treasury	62,781
Total assets measured at fair value	250,584	57,982
Liabilities:
Derivative liabilities - royalty agreement	2,271	2,041
Derivative liabilities - contingent value right liability		2,196
Total liabilities measured at fair value	2,271	4,237
Recurring Basis [Member] \| Level 1 [Member]
Current assets:
Cash and cash equivalents	187,803	57,982
U.S. Treasury	0
Total assets measured at fair value	187,803	57,982
Liabilities:
Derivative liabilities - royalty agreement	0	0
Derivative liabilities - contingent value right liability		0
Total liabilities measured at fair value	0	0
Recurring Basis [Member] \| Level 2 [Member]
Current assets:
Cash and cash equivalents	0	0
U.S. Treasury	62,781
Total assets measured at fair value	62,781	0
Liabilities:
Derivative liabilities - royalty agreement	0	0
Derivative liabilities - contingent value right liability		0
Total liabilities measured at fair value	0	0
Recurring Basis [Member] \| Level 3 [Member]
Current assets:
Cash and cash equivalents	0	0
U.S. Treasury	0
Total assets measured at fair value	0	0
Liabilities:
Derivative liabilities - royalty agreement	2,271	2,041
Derivative liabilities - contingent value right liability		2,196
Total liabilities measured at fair value	$ 2,271	$ 4,237

Condensed Consolidated Statements of Changes in Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Total	Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Other Comprehensive Income (Loss) [Member]	Accumulated Deficit [Member]
Balance (in shares) at Dec. 31, 2024		15,617	11,012,105
Balance at Dec. 31, 2024	$ 62,607		$ 11	$ 156,328	$ 3	$ (93,735)
Exercise of common stock options for cash, net of expense (in shares)			9,284
Exercise of common stock options for cash, net of expense	67			67
Stock-based compensation	1,094			1,094
Foreign currency translation gain	(6)				(6)
Net Income (Loss)	(8,185)					(8,185)
Balance (in shares) at Mar. 31, 2025		15,617	11,021,389
Balance at Mar. 31, 2025	55,577		$ 11	157,489	(3)	(101,920)
Balance (in shares) at Dec. 31, 2024		15,617	11,012,105
Balance at Dec. 31, 2024	62,607		$ 11	156,328	3	(93,735)
Unrealized gain (loss) on investments	0
Net Income (Loss)	(17,656)
Balance (in shares) at Jun. 30, 2025		15,617	11,059,665
Balance at Jun. 30, 2025	47,780		$ 11	159,271	(111)	(111,391)
Balance (in shares) at Mar. 31, 2025		15,617	11,021,389
Balance at Mar. 31, 2025	55,577		$ 11	157,489	(3)	(101,920)
Exercise of common stock options for cash, net of expense	349		$ 38,276	349
Stock-based compensation	1,433			1,433
Foreign currency translation gain	(108)				(108)
Unrealized gain (loss) on investments	0
Net Income (Loss)	(9,471)					(9,471)
Balance (in shares) at Jun. 30, 2025		15,617	11,059,665
Balance at Jun. 30, 2025	47,780		$ 11	159,271	(111)	(111,391)
Balance (in shares) at Dec. 31, 2025			12,380,933
Balance at Dec. 31, 2025	27,983		$ 12	163,338	83	(135,450)
Issuance of common stock (in shares)			1,840,000
Issuance of common stock	215,753		$ 2	215,751
Exercise of common stock options for cash, net of expense (in shares)			92,726
Exercise of common stock options for cash, net of expense	956			956
Stock-based compensation	3,376			3,376
Foreign currency translation gain	8				8
Unrealized gain (loss) on investments	4				4
Net Income (Loss)	(15,767)					(15,767)
Balance (in shares) at Mar. 31, 2026			14,313,659
Balance at Mar. 31, 2026	232,313		$ 14	383,421	95	(151,217)
Balance (in shares) at Dec. 31, 2025			12,380,933
Balance at Dec. 31, 2025	27,983		$ 12	163,338	83	(135,450)
Unrealized gain (loss) on investments	(26)
Net Income (Loss)	(37,637)
Balance (in shares) at Jun. 30, 2026			14,395,705
Balance at Jun. 30, 2026	216,867		$ 14	389,851	89	(173,087)
Balance (in shares) at Mar. 31, 2026			14,313,659
Balance at Mar. 31, 2026	$ 232,313		$ 14	383,421	95	(151,217)
Issuance of 3,250 shares of common stock upon settlement of employee performance stock units and restricted stock units, net of shares withheld for taxes	3,250		2,293
Exercise of common stock options for cash, net of expense (in shares)			79,753
Exercise of common stock options for cash, net of expense	$ 1,280			1,280
Stock-based compensation	5,155			5,155
Equity issuance costs	(5)			(5)
Foreign currency translation gain	24				24
Unrealized gain (loss) on investments	(30)				(30)
Net Income (Loss)	(21,870)					(21,870)
Balance (in shares) at Jun. 30, 2026			14,395,705
Balance at Jun. 30, 2026	$ 216,867		$ 14	$ 389,851	$ 89	$ (173,087)

Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2026	Dec. 31, 2025
Payables and Accruals [Abstract]
Research and development expenses	$ 1,635	$ 1,200
Compensation expense	1,469	1,915
Professional fees	597	531
Other	1,244	705
Total accrued expenses and other current liabilities	$ 4,945	$ 4,351

Fair Value Measurements (Tables)

6 Months Ended

Jun. 30, 2026

Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]

Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis


	June 30, 2026
	Level 1		Level 2		Level 3		Total
Current assets:
Cash and cash equivalents	$	187,803	$	—	$	—	$	187,803
U.S. Treasury		—		62,781		—		62,781
Total assets measured at fair value	$	187,803	$	62,781	$	—	$	250,584

Liabilities:
Derivative liabilities – royalty agreement	$	—	$	—	$	2,271	$	2,271
Total liabilities measured at fair value	$	—	$	—	$	2,271	$	2,271


	December 31, 2025
	Level 1		Level 2		Level 3		Total
Current assets:
Cash and cash equivalents	$	57,982	$	—	$	—	$	57,982
Total assets measured at fair value	$	57,982	$	—	$	—	$	57,982

Liabilities:
Derivative liabilities – royalty agreement	$	—	$	—	$	2,041	$	2,041
Derivative liabilities – contingent value right liability		—		—		2,196		2,196
Total liabilities measured at fair value	$	—	$	—	$	4,237	$	4,237

Schedule of Amortized Cost, Gross Unrealized Gains and Losses, and Fair Value of Investments in Fixed Maturity Securities

The amortized cost, gross unrealized gains and losses, and fair value of investments in fixed maturity securities as of June 30, 2026 are as follows:


	June 30, 2026
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
U.S. Treasury	$	62,807	$	195	$	(221	)	$	62,781
Total assets measured at fair value	$	62,807	$	195	$	(221	)	$	62,781

Schedule of Fair Value Measurement Key Assumptions

The key assumptions used to determine the fair value of the derivative liabilities – royalty agreement at June 30, 2026 and December 31, 2025 are as follows:


	June 30, 2026			December 31, 2025
Discount rate		16.0	%		18.0	%
Probability rate of achieving FDA approval of a product (1)		56.6	%		56.6	%
Expected term to FDA regulatory approval of a product	1.0 years			1.5 years

Royalty Agreement [Member]

Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]

Fair Value Measurement Derivative Liabilities

The following table provides a reconciliation of the liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands):

Derivative Liabilities – Royalty Agreement


	2026
Derivative liabilities - royalty agreement
Balance at January 1	$	2,041
Fair value adjustments on derivative liabilities		230
Balance at June 30	$	2,271


	2025
Derivative liabilities - royalty agreement
Balance at January 1	$	1,647
Fair value adjustments on derivative liabilities		394
Balance at December 31	$	2,041

Contingent Value Right Liability [Member]

Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]

Fair Value Measurement Derivative Liabilities

Derivative Liabilities – Contingent Value Right Liability


	2026
Derivative liabilities - contingent value right liability
Balance at January 1	$	2,196
Settlement of contingent value right		(1,994	)
Fair value adjustments on derivative liabilities		(202	)
Balance at June 30	$	—


	2025
Derivative liabilities - contingent value right liability
Balance at January 1	$	1,978
Fair value adjustments on derivative liabilities		218
Balance at December 31	$	2,196