0001558370-25-006848 | 10-Q | XBRL Viewer

Property, Plant, and Equipment - Schedule of Property, plant and equipment (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Total property, plant and equipment	$ 24,588	$ 24,107
Accumulated depreciation and amortization	(16,104)	(15,809)
Property, plant and equipment, net	8,484	8,298
Lab and build-to-suit equipment
Total property, plant and equipment	7,357	6,918
Office equipment
Total property, plant and equipment	7	7
Furniture and fixtures
Total property, plant and equipment	481	481
Computer and other equipment
Total property, plant and equipment	833	741
Leasehold improvements
Total property, plant and equipment	13,010	12,959
Construction-in-progress
Total property, plant and equipment	$ 2,900	$ 3,001

Commitments and Contingencies	3 Months Ended
Mar. 31, 2025
Commitments and Contingencies.
Commitments and Contingencies	13. Commitments and Contingencies Pharmosa License Agreement and Device License Agreement In June 2023, we entered into a License Agreement with Pharmosa pursuant to which we were granted an exclusive license in North America to develop and commercialize L606, an inhaled, sustained-release formulation of treprostinil currently being evaluated in a clinical trial for the treatment of PAH and PH-ILD, and a non-exclusive license for the manufacture, development and use (but not commercialization) of such licensed product in most countries outside North America (the “Pharmosa License Agreement”). On October 2, 2024, we and Pharmosa entered into a First Amendment to the Pharmosa License Agreement (the “First Amendment”) which, among other things, expands our licensed territory beyond North America to include key markets in Europe, Japan and elsewhere. Concurrently with the execution of the First Amendment, we and Pharmosa also entered into a Device License Agreement (the “Device License Agreement”). Pursuant to the terms of the Device License Agreement, Pharmosa will provide (i) an exclusive license to Liquidia Technologies for the right to develop, manufacture, use and commercialize Pharmosa’s next-generation smart-technology nebulizers (the “Device”) for use with L606 in most countries (subject to certain exceptions) (the “Territory”) and (ii) a non-exclusive license to Liquidia Technologies for the right to develop, manufacture and use (but not commercialize) the Device outside of the Territory. Under the terms of the Pharmosa License Agreement, as amended, we will be responsible for development, regulatory and commercial activities of L606 in the Territory. Pharmosa will manufacture clinical and commercial supplies of the liposomal formulation through its global supply chain and support us in establishing a redundant global supply chain. In consideration for these exclusive rights, we paid Pharmosa an upfront license fee of $10 million and paid an additional $3.5 million upfront license fee in October 2024 in connection with the rights granted in the First Amendment and the Device License Agreement. In addition to the upfront fees, we will pay Pharmosa potential development milestone payments tied to clinical development and approvals in PAH and/or PH-ILD of up to $37.75 million, potential sales milestones of up to $185 million in North America and $150 million outside North American and two tiers of low, double-digit royalties on all net sales of L606. Pharmosa will also receive a $10 million milestone payment for each additional indication approved by the FDA after PAH and PH-ILD and each additional product approved by the FDA under the license, a $2 million milestone payment for each additional indication approved by the EMA after PAH and PH-ILD, and a $0.5 million milestone payment for each additional indication approved by the PMDA after PAH and PH-ILD. We also retain the first right to negotiate for development and commercialization of L606 in Europe and other territories should Pharmosa seek a partner, subject to satisfaction of certain conditions as set forth in the Pharmosa License Agreement. Mainbridge Health Care Device Development and Supply Agreement In December 2022, we entered into a Device Development and Supply Agreement (the “Pump Development Agreement”) with Mainbridge Health Partners, LLC (“Mainbridge”) and Sandoz Inc. (“Sandoz”). The Pump Development Agreement provides for the cooperation between us, Sandoz and Mainbridge to develop a new pump that is suitable for the subcutaneous administration of Treprostinil Injection. Mainbridge will perform development, validation and testing activities required for the pump and related consumables in anticipation of submitting a 510(k) clearance application for the pump to the FDA. In connection with the Pump Development Agreement, we and Sandoz have agreed to pay Mainbridge certain future contingent milestone payments in accordance with the terms and conditions set forth therein. UNC License Agreement In December 2008, we entered into the Amended and Restated License Agreement with The University of North Carolina at Chapel Hill (“UNC”) for the use of certain patent rights and technology relating to initial innovations of our PRINT technology (the “UNC License Agreement”). As part of the UNC License Agreement, we hold an exclusive license to certain research and development technologies and processes in various stages of patent pursuit, for use in our research and development and commercial activities, with a term until the expiration date of the last to expire patent subject to the UNC License Agreement, subject to industry standard contractual compliance. Under the UNC License Agreement, we are obligated to pay UNC royalties equal to a low single digit percentage of all net sales of drug products whose manufacture, use or sale includes any use of the technology or patent rights covered by the UNC License Agreement, including YUTREPIA. We may grant sublicenses of UNC licensed intellectual property in return for specified payments based on a percentage of any fee, royalty or other consideration received. Chasm Technologies In March 2012, we entered into an agreement, as amended, with Chasm Technologies, Inc. for manufacturing consulting services related to our manufacturing capabilities during the term of the agreement. We agreed to pay future contingent milestones and royalties on net sales totaling no more than $1.5 million, $0.2 million of which has been accrued as of March 31, 2025. Employment Agreements and Executive Severance and Change in Control Plan We have agreements with certain employees and an Executive Severance and Change in Control Plan which covers certain other employees which require payments if certain events, such as a change in control or termination without cause, occur. Purchase Obligations We enter into contracts in the normal course of business with contract service providers to assist in the performance of research and development and manufacturing activities. Subject to required notice periods and obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time. On July 14, 2023, we entered into an Amended and Restated Commercial Manufacturing Services and Supply Agreement with Lonza Tampa LLC (“Lonza”) (as amended, the “CSA”). Lonza is our sole supplier for encapsulation and packaging services for YUTREPIA. Pursuant to the terms of the CSA, we deliver bulk treprostinil powder, manufactured using our proprietary PRINT® technology, and Lonza encapsulates and packages it. The CSA was effective upon signing, will be in effect until December 31, 2028 and may thereafter be extended upon the mutual written agreement of the parties in accordance with the terms of the CSA. We may terminate the CSA upon 60 days’ written notice to Lonza in the event that the application for regulatory approval of YUTREPIA is rejected by the FDA and such FDA decision is not caused by the fault of the Company (the “Termination for FDA Rejection”). Lonza may terminate the CSA upon 120 days written notice if we do not receive regulatory approval of YUTREPIA from the FDA by December 31, 2025 (the “Termination for FDA Delay”). Upon any Termination for FDA Rejection or Termination for FDA Delay, we would reimburse Lonza for 50% of its documented out-of-pocket expenditures for any capital equipment that is purchased by Lonza after the effective date of the Agreement to perform the services for us, not to exceed $2.5 million in the aggregate. We are required to provide Lonza with quarterly forecasts of our expected production requirements for the following 24-month period, the first twelve months of which is considered a binding, firm order. We are required to purchase certain minimum annual order quantities, which may be adjusted by us after the thirteenth month after receipt of regulatory approval of YUTREPIA. The CSA provides for tiered pricing depending upon the batch size ordered. In addition, we entered into a multi-year supply agreement with LGM Pharma, LLC (“LGM”) to supply active pharmaceutical ingredients for YUTREPIA. Under the supply agreement with LGM, we are required to provide rolling forecasts, a portion of which will be considered a binding, firm order, subject to an annual minimum purchase commitment of $2.7 million for the term of the agreement. The agreement expires five years from the first marketing authorization approval of YUTREPIA. As of March 31, 2025, we have non-cancelable commitments for product manufacturing and supply costs of approximately $20.4 million. Other Contingencies and Commitments From time-to-time we are subject to claims and litigation in the normal course of business, none of which do we believe represent a risk of material loss or exposure. See Note 14 “Legal Proceedings” for further discussion of pending legal proceedings. In addition to the commitments described above, we are party to other commitments, including non-cancelable leases and long-term debt, which are described elsewhere in these notes to the condensed consolidated financial statements.

Commitments and Contingencies

3 Months Ended

Mar. 31, 2025

Commitments and Contingencies.

Commitments and Contingencies

13. Commitments and Contingencies

Pharmosa License Agreement and Device License Agreement

In June 2023, we entered into a License Agreement with Pharmosa pursuant to which we were granted an exclusive license in North America to develop and commercialize L606, an inhaled, sustained-release formulation of treprostinil currently being evaluated in a clinical trial for the treatment of PAH and PH-ILD, and a non-exclusive license for the manufacture, development and use (but not commercialization) of such licensed product in most countries outside North America (the “Pharmosa License Agreement”). On October 2, 2024, we and Pharmosa entered into a First Amendment to the Pharmosa License Agreement (the “First Amendment”) which, among other things, expands our licensed territory beyond North America to include key markets in Europe, Japan and elsewhere.

Concurrently with the execution of the First Amendment, we and Pharmosa also entered into a Device License Agreement (the “Device License Agreement”). Pursuant to the terms of the Device License Agreement, Pharmosa will provide (i) an exclusive license to Liquidia Technologies for the right to develop, manufacture, use and commercialize Pharmosa’s next-generation smart-technology nebulizers (the “Device”) for use with L606 in most countries (subject to certain exceptions) (the “Territory”) and (ii) a non-exclusive license to Liquidia Technologies for the right to develop, manufacture and use (but not commercialize) the Device outside of the Territory.

Under the terms of the Pharmosa License Agreement, as amended, we will be responsible for development, regulatory and commercial activities of L606 in the Territory. Pharmosa will manufacture clinical and commercial supplies of the liposomal formulation through its global supply chain and support us in establishing a redundant global supply chain. In consideration for these exclusive rights, we paid Pharmosa an upfront license fee of $10 million and paid an additional $3.5 million upfront license fee in October 2024 in connection with the rights granted in the First Amendment and the Device License Agreement. In addition to the upfront fees, we will pay Pharmosa potential development milestone payments tied to clinical development and approvals in PAH and/or PH-ILD of up to $37.75 million, potential sales milestones of up to $185 million in North America and $150 million outside North American and two tiers of low, double-digit royalties on all net sales of L606. Pharmosa will also receive a $10 million milestone payment for each additional indication approved by the FDA after PAH and PH-ILD and each additional product approved by the FDA under the license, a $2 million milestone payment for each additional indication approved by the EMA after PAH and PH-ILD, and a $0.5 million milestone payment for each additional indication approved by the PMDA after PAH and PH-ILD. We also retain the first right to negotiate for development and commercialization of L606 in Europe and other territories should Pharmosa seek a partner, subject to satisfaction of certain conditions as set forth in the Pharmosa License Agreement.

Mainbridge Health Care Device Development and Supply Agreement

In December 2022, we entered into a Device Development and Supply Agreement (the “Pump Development Agreement”) with Mainbridge Health Partners, LLC (“Mainbridge”) and Sandoz Inc. (“Sandoz”). The Pump Development Agreement provides for the cooperation between us, Sandoz and Mainbridge to develop a new pump that is suitable for the subcutaneous administration of Treprostinil Injection. Mainbridge will perform development, validation and testing activities required for the pump and related consumables in anticipation of submitting a 510(k) clearance application for the pump to the FDA. In connection with the Pump Development Agreement, we and Sandoz have agreed to pay Mainbridge certain future contingent milestone payments in accordance with the terms and conditions set forth therein.

UNC License Agreement

In December 2008, we entered into the Amended and Restated License Agreement with The University of North Carolina at Chapel Hill (“UNC”) for the use of certain patent rights and technology relating to initial innovations of our PRINT technology (the “UNC License Agreement”). As part of the UNC License Agreement, we hold an exclusive license to certain research and development technologies and processes in various stages of patent pursuit, for use in our research and development and commercial activities, with a term until the expiration date of the last to expire patent subject to the UNC License Agreement, subject to industry standard contractual compliance. Under the UNC License Agreement, we are obligated to pay UNC royalties equal to a low single digit percentage of all net sales of drug products whose manufacture, use or sale includes any use of the technology or patent rights covered by the UNC License Agreement, including YUTREPIA. We may grant sublicenses of UNC licensed intellectual property in return for specified payments based on a percentage of any fee, royalty or other consideration received.

Chasm Technologies

In March 2012, we entered into an agreement, as amended, with Chasm Technologies, Inc. for manufacturing consulting services related to our manufacturing capabilities during the term of the agreement. We agreed to pay future contingent milestones and royalties on net sales totaling no more than $1.5 million, $0.2 million of which has been accrued as of March 31, 2025.

Employment Agreements and Executive Severance and Change in Control Plan

We have agreements with certain employees and an Executive Severance and Change in Control Plan which covers certain other employees which require payments if certain events, such as a change in control or termination without cause, occur.

Purchase Obligations

We enter into contracts in the normal course of business with contract service providers to assist in the performance of research and development and manufacturing activities. Subject to required notice periods and obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time.

On July 14, 2023, we entered into an Amended and Restated Commercial Manufacturing Services and Supply Agreement with Lonza Tampa LLC (“Lonza”) (as amended, the “CSA”). Lonza is our sole supplier for encapsulation and packaging services for YUTREPIA. Pursuant to the terms of the CSA, we deliver bulk treprostinil powder, manufactured using our proprietary PRINT® technology, and Lonza encapsulates and packages it. The CSA was effective upon signing, will be in effect until December 31, 2028 and may thereafter be extended upon the mutual written agreement of the parties in accordance with the terms of the CSA. We may terminate the CSA upon 60 days’ written notice to Lonza in the event that the application for regulatory approval of YUTREPIA is rejected by the FDA and such FDA decision is not caused by the fault of the Company (the “Termination for FDA Rejection”). Lonza may terminate the CSA upon 120 days written notice if we do not receive regulatory approval of YUTREPIA from the FDA by December 31, 2025 (the “Termination for FDA Delay”). Upon any Termination for FDA Rejection or Termination for FDA Delay, we would reimburse Lonza for 50% of its documented out-of-pocket expenditures for any capital equipment that is purchased by Lonza after the effective date of the Agreement to perform the services for us, not to exceed $2.5 million in the aggregate.

We are required to provide Lonza with quarterly forecasts of our expected production requirements for the following 24-month period, the first twelve months of which is considered a binding, firm order. We are required to purchase certain minimum annual order quantities, which may be adjusted by us after the thirteenth month after receipt of regulatory approval of YUTREPIA. The CSA provides for tiered pricing depending upon the batch size ordered.

In addition, we entered into a multi-year supply agreement with LGM Pharma, LLC (“LGM”) to supply active pharmaceutical ingredients for YUTREPIA. Under the supply agreement with LGM, we are required to provide rolling forecasts, a portion of which will be considered a binding, firm order, subject to an annual minimum purchase commitment of $2.7 million for the term of the agreement. The agreement expires five years from the first marketing authorization approval of YUTREPIA.

As of March 31, 2025, we have non-cancelable commitments for product manufacturing and supply costs of approximately $20.4 million.

Other Contingencies and Commitments

From time-to-time we are subject to claims and litigation in the normal course of business, none of which do we believe represent a risk of material loss or exposure. See Note 14 “Legal Proceedings” for further discussion of pending legal proceedings.

In addition to the commitments described above, we are party to other commitments, including non-cancelable leases and long-term debt, which are described elsewhere in these notes to the condensed consolidated financial statements.

Stock-Based Compensation

3 Months Ended

Mar. 31, 2025

Stock-Based Compensation

Stock-Based Compensation

9. Stock-Based Compensation

2020 Long-Term Incentive Plan

Our 2020 Long-Term Incentive Plan (the “2020 Plan”) provides for the granting of stock appreciation rights, stock awards, stock units, and other stock-based awards and for accelerated vesting under certain change of control transactions. The number of shares of our common stock available for issuance under the 2020 plan will automatically increase on January 1 of each year through 2030, by an amount equal to the smaller of (a) 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or (b) an amount determined by the Board of Directors (the “Evergreen Provision”). On January 1, 2025, the number of shares of common stock available for issuance under the 2020 Plan automatically increased by 3,387,323 shares pursuant to the Evergreen Provision. As of March 31, 2025, there were 1,762,333 shares available for future grants under the 2020 Plan.

The 2020 Plan replaced all prior equity award plans and such plans have been discontinued. However, the awards outstanding under the prior equity award plans will continue to remain in effect in accordance with their terms. Awards that are forfeited under these prior plans upon cancellation, termination or expiration will not be available for grant under the 2020 Plan. As of March 31, 2025, a total of 429,694 shares of common stock were reserved for issuance related to the remaining outstanding equity awards granted under the prior plans.

2022 Inducement Plan

On January 25, 2022, the Board of Directors approved the adoption of our 2022 Inducement Plan (the “2022 Inducement Plan”). The 2022 Inducement Plan was recommended for approval by the Compensation Committee of the Board (the “Compensation Committee”), and subsequently approved and adopted by the Board of Directors without stockholder approval pursuant to Rule 5635(c)(4) of the rules and regulations of The Nasdaq Stock Market, LLC (the “Nasdaq Listing Rules”).

310,000 shares of our common stock were reserved for issuance pursuant to equity awards that may be granted under the 2022 Inducement Plan, and the 2022 Inducement Plan will be administered by the Compensation Committee. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2022 Inducement Plan may only

be made to an employee who has not previously been an employee or member of the Board of Directors, or following a bona fide period of non-employment by us, if he or she is granted such equity awards in connection with his or her commencement of employment with us and such grant is an inducement material to his or her entering into employment with us. As of March 31, 2025, a total of 27,608 shares were available for issuance under the 2022 Inducement Plan.

Employee Stock Purchase Plan

In November 2020, stockholders approved the Liquidia Corporation 2020 Employee Stock Purchase Plan (the “ESPP”). The number of shares of our common stock available for issuance under the ESPP will automatically increase on January 1 of each year through 2030, by the lesser of (a) 1.0% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, (b) 150,000 shares, or (c) an amount determined by the Board of Directors. On January 1, 2025, the number of shares of common stock available for issuance under the ESPP increased by 150,000 shares. As of March 31, 2025, a total of 567,422 shares of common stock are reserved for issuance under the ESPP. The ESPP allows eligible employees to purchase shares of our common stock at a discount through payroll deductions, subject to plan limitations. Unless otherwise determined by the administrator, the common stock will be purchased for the accounts of employees participating in the ESPP at a price per share that is 85% of the lesser of the fair market value of our common stock on the first and last trading day of the offering period. During the three months ended March 31, 2025 and 2024, 117,320 and 67,982 shares were issued under the ESPP, respectively.

Stock-Based Compensation Valuation and Expense

We account for employee stock-based compensation plans using the fair value method. The fair value method requires us to estimate the grant-date fair value of stock-based awards and amortize this fair value to compensation expense over the requisite service period or vesting term. The fair value of each option grant is estimated using a Black-Scholes option-pricing model. For restricted stock units (“RSUs”) and performance stock units (“PSUs”), the grant-date fair value is based upon the market price of our common stock on the date of the grant. This fair value is then amortized to compensation expense over the requisite service period or vesting term.

Total stock-based compensation expense recognized for employees and non-employees was as follows:


	Three Months Ended
	March 31,
By Expense Category:	2025		2024
Cost of revenue	$	149	$	64
Research and development		340		1,011
General and administrative		6,949		3,449
Total stock-based compensation expense	$	7,438	$	4,524

The following table summarizes the unamortized compensation expense and the remaining years over which such expense would be expected to be recognized, on a weighted average basis, by type of award:


	As of March 31, 2025
			Weighted
			Average
			Remaining
			Recognition
	Unamortized		Period
	Expense		(Years)
Stock options	$	6,603	1.2
Restricted and performance stock units	$	49,140	2.6

Fair Value of Stock Options Granted and Purchase Rights Issued under the ESPP

We use the Black-Scholes option-pricing model to determine the fair value of stock options granted and purchase rights issued under the ESPP.

There were no stock options granted during the three months ended March 31, 2025. The following table summarizes the assumptions used for estimating the fair value of stock options granted under the Black-Scholes option-pricing model during the three months ended March 31, 2024:


		Three Months Ended
		March 31,
		2024
Expected dividend yield		—
Risk-free interest rate		3.98%
Expected volatility		90%
Expected life (years)		6.1

The following table summarizes the assumptions used for estimating the fair value of purchase rights granted to employees under the ESPP under the Black-Scholes option-pricing model:


	Three Months Ended
	March 31,
	2025	2024
Expected dividend yield	—	—
Risk-free interest rate	4.31%	5.27%
Expected volatility	44%	90%
Expected life (years)	0.50	0.50

Stock Options

Options generally vest over a four-year period in multiple tranches.

The following table summarizes stock option activity during the three months ended March 31, 2025:


				Weighted
		Weighted		Average
		Average		Contractual	Aggregate
	Number of	Exercise		Term	Intrinsic
	Shares	Price		(in years)	Value
Outstanding as of December 31, 2024	9,009,005	$	4.76
Granted	—		—
Exercised	(84,505)		4.23
Cancelled	—		—
Outstanding as of March 31, 2025	8,924,500	$	4.77	6.6	$	89,140
Exercisable as of March 31, 2025	7,342,039	$	4.57	6.4	$	74,824
Vested and expected to vest as of March 31, 2025	8,850,445	$	4.76	6.6	$	88,511

No options were granted during the three months ended March 31, 2025. The weighted average fair value for options granted during the three months ended March 31, 2024 ended was $9.84 per share. The aggregate intrinsic value of stock options in the table above represents the difference between the $14.75 closing price of our common stock as of March 31, 2025 and the exercise price of outstanding, exercisable, and vested and expected to vest in-the-money stock options.

Restricted and Performance Stock Units

RSUs represent the right to receive shares of our common stock at the end of a specified time period and/or upon the achievement of a specific milestone. RSUs can only be settled in shares of our common stock. RSUs generally vest over a four-year period similar to stock options granted to employees. RSUs granted to directors generally vest over a one-year period.

PSUs granted during 2025 and 2024 included 749,793 and 520,526 performance-based RSUs, respectively, granted to our executive officers. These PSUs vest upon the later of (a) time-based vesting conditions and (b) the first commercial sale of YUTREPIA in the United States and are considered probable of vesting. The time-based vesting condition means 25% of the performance-based RSUs vest one year after grant date and quarterly thereafter for three years, subject to the executive’s continued service.

The tax withholding method used for most RSUs and PSUs is the sell-to-cover method, in which shares with a market value equivalent to the tax withholding obligation are sold on behalf of the holder of the RSUs and PSUs upon vesting and settlement to cover the tax withholding liability and the cash proceeds from such sales are remitted to taxing authorities by us. In circumstances where the sell-to-cover method is not used, the holder of the RSUs or PSUs is required to remit cash to us to cover the tax withholding liability and the cash is then remitted to taxing authorities by us.

The following table summarizes our RSU and PSU activity during the three months ended March 31, 2025:


		Weighted
		Average
		Grant-Date
	Number of	Fair Value
	RSUs	(per RSU)
Unvested as of December 31, 2024	2,948,049	$	10.82
Granted	2,585,400		12.31
Vested	(414,053)		10.95
Forfeited	(13,503)		12.87
Unvested as of March 31, 2025	5,105,893	$	11.56

Legal Proceedings	3 Months Ended
Mar. 31, 2025
Legal Proceedings
Legal Proceedings	14. Legal Proceedings YUTREPIA-Related Litigation In connection with an amendment to the Company’s NDA filed in July 2023 to add PH-ILD as an indication for YUTREPIA, the Company provided a notice of the paragraph IV certification to United Therapeutics as the owner of the patents that are the subject of the certification to which the NDA for YUTREPIA refers. As a result, in September 2023, United Therapeutics filed a complaint for patent infringement against the Company in the U.S. District Court for the District of Delaware (Case No. 1:23-cv-00975-RGA) (the “New Hatch-Waxman Litigation”), asserting infringement by the Company of U.S. Patent No. 10,716,793, entitled “Treprostinil Administration by Inhalation” (the “‘793 Patent”). In November 2023, the U.S. Patent and Trademark Office (the “USPTO”) issued U.S. Patent No. 11,826,327, entitled “Treatment for Interstitial Lung Disease” (the “‘327 Patent”), to United Therapeutics. On November 30, 2023, United Therapeutics filed an amended complaint in the New Hatch-Waxman Litigation asserting infringement of the ‘327 Patent by the practice of YUTREPIA based on the amended NDA. In January 2024, the Company filed an answer, counterclaims and a partial motion to dismiss the claims related to the ‘793 Patent as a result of the decision by the United States Court of Appeals for the Federal Circuit to affirm a finding by the Patent Trial and Appeal Board (the “PTAB”) that the ’793 Patent is unpatentable. In February 2024, United Therapeutics stipulated to the dismissal of the claims in the New Hatch-Waxman Litigation related to the ‘793 Patent. In February 2024, United Therapeutics also filed a motion seeking a preliminary injunction to prevent the Company from manufacturing, marketing, storing, importing, distributing, offering for sale, and/or selling YUTREPIA for the treatment of PH-ILD. Judge Andrews denied the motion for a preliminary injunction in May 2024. Trial is scheduled for June 2025. FDA Litigation In August 2024, the Company filed a lawsuit in the D.C. District Court to challenge the decision by the FDA to grant three-year regulatory exclusivity to Tyvaso DPI (the “New FDA Litigation”). In February 2025, the D.C. District Court issued a decision granting the motions for summary judgment filed by the FDA and United Therapeutics. In so doing, the D.C. District Court affirmed the FDA’s award of regulatory exclusivity to Tyvaso DPI. This decision does not affect the expiration of the regulatory exclusivity, which will still occur on May 23, 2025. In September 2024, United Therapeutics filed a cross claim in the New FDA Litigation, challenging FDA’s acceptance for review of the Company’s amendment to the NDA for YUTREPIA to add PH-ILD to the label. The Company intervened and became a party with respect to the cross claim in November 2024. In November 2024, both the Company and the FDA filed motions to dismiss United Therapeutics’ cross claim. On May 2, 2025, the D.C. District Court granted the motions filed by the FDA and the Company and dismissed United Therapeutics’ cross claim without prejudice. United Therapeutics has the right to appeal the D.C. District Court’s ruling. Trade Secret Litigation In December 2021, United Therapeutics filed a complaint in the Superior Court in Durham County, North Carolina, alleging that the Company and a former United Therapeutics employee who later joined the Company as an employee many years after terminating his employment with United Therapeutics (the “Former Employee”) conspired to misappropriate certain trade secrets of United Therapeutics and engaged in unfair or deceptive trade practices. In January 2024, the Former Employee filed a motion for summary judgment with respect to all claims, but the motion was denied in July 2024. In addition, in July 2024, the Company filed a motion for summary judgment with respect to all claims. A hearing on the Company’s motion for summary judgment was held in December 2024. The motion remains pending. In May 2024, United Therapeutics filed a second complaint in the Superior Court in Durham County, North Carolina, against the Former Employee, alleging that he breached prior employment agreements with United Therapeutics by failing to assign to United Therapeutics his interest in patents obtained by the Company that relied upon or benefitted from certain inventions, discoveries, materials, authorship, derivatives and results developed by the Former Employee while he was employed by United Therapeutics. The Company was also named as a defendant in this new lawsuit. As part of the lawsuit, United Therapeutics alleges that the Former Employee misappropriated certain intellectual property of United Therapeutics which led to the development of YUTREPIA. The complaint also seeks declaratory judgement such that all right, title and interest in and to any patentable or unpatentable inventions, discoveries, and ideas made or conceived by the Former Employee while employed by the Company should be assigned and transferred to United Therapeutics because they involved the use of United Therapeutics’ confidential information. In July 2024, the Company filed a motion to dismiss all claims. A hearing on the Company’s motion to dismiss was held in December 2024. The motion remains pending. ‘494 Patent Litigation On April 21, 2025, the Company filed a complaint for patent infringement against United Therapeutics in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00299) (the “’494 Patent Litigation”), asserting infringement by United Therapeutics of U.S. Patent No. 10,898,494, entitled “Dry Powder Treprostinil for the Treatment of Pulmonary Hypertension” (the “‘494 Patent”) with respect to its Tyvaso DPI product. United Therapeutics has not yet filed its responsive pleading. RareGen Litigation In April 2019, Sandoz and Liquidia PAH (then known as RareGen) filed a complaint against United Therapeutics and Smiths Medical (now ICU Medical) in the District Court of New Jersey (Case No. No. 3:19 cv 10170), (the “RareGen Litigation”), alleging that United Therapeutics and Smiths Medical violated the Sherman Antitrust Act of 1890, state law antitrust statutes and unfair competition statutes by engaging in anticompetitive acts regarding the drug treprostinil for the treatment of PAH. In March 2020, Sandoz and Liquidia PAH filed a first amended complaint adding a claim that United Therapeutics breached a settlement agreement that was entered into in 2015, in which United Therapeutics agreed to not interfere with Sandoz’s efforts to launch its generic treprostinil, by taking calculated steps to restrict and interfere with the launch of Sandoz’s competing generic product. United Therapeutics developed treprostinil under the brand name Remodulin® and Smiths Medical manufactured a pump and cartridges that are used to inject treprostinil into patients continuously throughout the day. Sandoz and Liquidia PAH allege that United Therapeutics and Smiths Medical entered into anticompetitive agreements (i) whereby Smiths Medical placed restrictions on the cartridges such that they can only be used with United Therapeutics’ branded Remodulin® product and (ii) requiring Smiths Medical to enter into agreements with specialty pharmacies to sell the cartridges only for use with Remodulin®. In November 2020, Sandoz and Liquidia PAH entered into a binding term sheet (the “Term Sheet”) with Smiths Medical in order to resolve the outstanding RareGen Litigation solely with respect to disputes between Smiths Medical, Liquidia PAH and Sandoz. In April 2021, Liquidia PAH and Sandoz entered into a Long Form Settlement Agreement (the “Settlement Agreement”) with Smiths Medical to further detail the terms of the settlement among such parties as reflected in the Term Sheet. Pursuant to the Term Sheet and the Settlement Agreement, the former RareGen members and Sandoz received a payment of $4.25 million that was evenly split between the parties. In addition, pursuant to the Settlement Agreement, Smiths Medical granted Liquidia PAH and Sandoz a non-exclusive, royalty-free license in the United States to Smiths Medical’s patents and copyrights associated with the cartridge that Smiths Medical developed and manufactures for use with the CADD-MS 3 infusion pump (the “CADD-MS 3 Cartridge”) and certain other information for use of the CADD-MS 3 infusion pump and the CADD-MS 3 Cartridges. In connection with the license, Liquidia PAH and Sandoz agreed, among other things, to indemnify Smiths from certain liabilities related to any cartridge they developed for use with the CADD-MS 3 infusion pumps. In September 2021, United Therapeutics filed a motion for summary judgment with respect to all of the claims brought by Sandoz and Liquidia PAH against United Therapeutics. At the same time, Sandoz filed a motion for summary judgment with respect to the breach of contract claim. In March 2022, the Court issued an order granting partial summary judgment to United Therapeutics with respect to the antitrust and unfair competition claims, denying summary judgment to United Therapeutics with respect to the breach of contract claim, and granting partial summary judgment to Sandoz with respect to the breach of contract claim. A trial to determine the amount of damages due from United Therapeutics to Sandoz with respect to the breach of contract claim was held from late April to early May 2024. In November 2024, the Court entered a judgment in the amount of $70.6 million. United Therapeutics, Sandoz and Liquidia PAH have all appealed the Court’s decision to the United States Court of Appeals for the Third Circuit, and briefing is ongoing. Under the Promotion Agreement, all proceeds from the litigation will be divided evenly between Sandoz and Liquidia PAH. Under the litigation finance agreements that Liquidia PAH has entered into with Henderson and PBM, any net proceeds received by Liquidia PAH with respect to the RareGen Litigation will be divided between Henderson and PBM.

Legal Proceedings

3 Months Ended

Mar. 31, 2025

Legal Proceedings

Legal Proceedings

14. Legal Proceedings

YUTREPIA-Related Litigation

In connection with an amendment to the Company’s NDA filed in July 2023 to add PH-ILD as an indication for YUTREPIA, the Company provided a notice of the paragraph IV certification to United Therapeutics as the owner of the patents that are the subject of the certification to which the NDA for YUTREPIA refers. As a result, in September 2023, United Therapeutics filed a complaint for patent infringement against the Company in the U.S. District Court for the District of Delaware (Case No. 1:23-cv-00975-RGA) (the “New Hatch-Waxman Litigation”), asserting infringement by the Company of U.S. Patent No. 10,716,793, entitled “Treprostinil Administration by Inhalation” (the “‘793 Patent”). In November 2023, the U.S. Patent and Trademark Office (the “USPTO”) issued U.S. Patent No. 11,826,327, entitled

“Treatment for Interstitial Lung Disease” (the “‘327 Patent”), to United Therapeutics. On November 30, 2023, United Therapeutics filed an amended complaint in the New Hatch-Waxman Litigation asserting infringement of the ‘327 Patent by the practice of YUTREPIA based on the amended NDA. In January 2024, the Company filed an answer, counterclaims and a partial motion to dismiss the claims related to the ‘793 Patent as a result of the decision by the United States Court of Appeals for the Federal Circuit to affirm a finding by the Patent Trial and Appeal Board (the “PTAB”) that the ’793 Patent is unpatentable. In February 2024, United Therapeutics stipulated to the dismissal of the claims in the New Hatch-Waxman Litigation related to the ‘793 Patent. In February 2024, United Therapeutics also filed a motion seeking a preliminary injunction to prevent the Company from manufacturing, marketing, storing, importing, distributing, offering for sale, and/or selling YUTREPIA for the treatment of PH-ILD. Judge Andrews denied the motion for a preliminary injunction in May 2024. Trial is scheduled for June 2025.

FDA Litigation

In August 2024, the Company filed a lawsuit in the D.C. District Court to challenge the decision by the FDA to grant three-year regulatory exclusivity to Tyvaso DPI (the “New FDA Litigation”). In February 2025, the D.C. District Court issued a decision granting the motions for summary judgment filed by the FDA and United Therapeutics. In so doing, the D.C. District Court affirmed the FDA’s award of regulatory exclusivity to Tyvaso DPI. This decision does not affect the expiration of the regulatory exclusivity, which will still occur on May 23, 2025.

In September 2024, United Therapeutics filed a cross claim in the New FDA Litigation, challenging FDA’s acceptance for review of the Company’s amendment to the NDA for YUTREPIA to add PH-ILD to the label. The Company intervened and became a party with respect to the cross claim in November 2024. In November 2024, both the Company and the FDA filed motions to dismiss United Therapeutics’ cross claim. On May 2, 2025, the D.C. District Court granted the motions filed by the FDA and the Company and dismissed United Therapeutics’ cross claim without prejudice. United Therapeutics has the right to appeal the D.C. District Court’s ruling.

Trade Secret Litigation

In December 2021, United Therapeutics filed a complaint in the Superior Court in Durham County, North Carolina, alleging that the Company and a former United Therapeutics employee who later joined the Company as an employee many years after terminating his employment with United Therapeutics (the “Former Employee”) conspired to misappropriate certain trade secrets of United Therapeutics and engaged in unfair or deceptive trade practices. In January 2024, the Former Employee filed a motion for summary judgment with respect to all claims, but the motion was denied in July 2024. In addition, in July 2024, the Company filed a motion for summary judgment with respect to all claims. A hearing on the Company’s motion for summary judgment was held in December 2024. The motion remains pending.

In May 2024, United Therapeutics filed a second complaint in the Superior Court in Durham County, North Carolina, against the Former Employee, alleging that he breached prior employment agreements with United Therapeutics by failing to assign to United Therapeutics his interest in patents obtained by the Company that relied upon or benefitted from certain inventions, discoveries, materials, authorship, derivatives and results developed by the Former Employee while he was employed by United Therapeutics. The Company was also named as a defendant in this new lawsuit. As part of the lawsuit, United Therapeutics alleges that the Former Employee misappropriated certain intellectual property of United Therapeutics which led to the development of YUTREPIA. The complaint also seeks declaratory judgement such that all right, title and interest in and to any patentable or unpatentable inventions, discoveries, and ideas made or conceived by the Former Employee while employed by the Company should be assigned and transferred to United Therapeutics because they involved the use of United Therapeutics’ confidential information. In July 2024, the Company filed a motion to dismiss all claims. A hearing on the Company’s motion to dismiss was held in December 2024. The motion remains pending.

‘494 Patent Litigation

On April 21, 2025, the Company filed a complaint for patent infringement against United Therapeutics in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00299) (the “’494 Patent Litigation”), asserting infringement by United Therapeutics of U.S. Patent No. 10,898,494, entitled “Dry Powder Treprostinil for the

Treatment of Pulmonary Hypertension” (the “‘494 Patent”) with respect to its Tyvaso DPI product. United Therapeutics has not yet filed its responsive pleading.

RareGen Litigation

In April 2019, Sandoz and Liquidia PAH (then known as RareGen) filed a complaint against United Therapeutics and Smiths Medical (now ICU Medical) in the District Court of New Jersey (Case No. No. 3:19 cv 10170), (the “RareGen Litigation”), alleging that United Therapeutics and Smiths Medical violated the Sherman Antitrust Act of 1890, state law antitrust statutes and unfair competition statutes by engaging in anticompetitive acts regarding the drug treprostinil for the treatment of PAH. In March 2020, Sandoz and Liquidia PAH filed a first amended complaint adding a claim that United Therapeutics breached a settlement agreement that was entered into in 2015, in which United Therapeutics agreed to not interfere with Sandoz’s efforts to launch its generic treprostinil, by taking calculated steps to restrict and interfere with the launch of Sandoz’s competing generic product. United Therapeutics developed treprostinil under the brand name Remodulin® and Smiths Medical manufactured a pump and cartridges that are used to inject treprostinil into patients continuously throughout the day. Sandoz and Liquidia PAH allege that United Therapeutics and Smiths Medical entered into anticompetitive agreements (i) whereby Smiths Medical placed restrictions on the cartridges such that they can only be used with United Therapeutics’ branded Remodulin® product and (ii) requiring Smiths Medical to enter into agreements with specialty pharmacies to sell the cartridges only for use with Remodulin®.

In November 2020, Sandoz and Liquidia PAH entered into a binding term sheet (the “Term Sheet”) with Smiths Medical in order to resolve the outstanding RareGen Litigation solely with respect to disputes between Smiths Medical, Liquidia PAH and Sandoz. In April 2021, Liquidia PAH and Sandoz entered into a Long Form Settlement Agreement (the “Settlement Agreement”) with Smiths Medical to further detail the terms of the settlement among such parties as reflected in the Term Sheet. Pursuant to the Term Sheet and the Settlement Agreement, the former RareGen members and Sandoz received a payment of $4.25 million that was evenly split between the parties. In addition, pursuant to the Settlement Agreement, Smiths Medical granted Liquidia PAH and Sandoz a non-exclusive, royalty-free license in the United States to Smiths Medical’s patents and copyrights associated with the cartridge that Smiths Medical developed and manufactures for use with the CADD-MS 3 infusion pump (the “CADD-MS 3 Cartridge”) and certain other information for use of the CADD-MS 3 infusion pump and the CADD-MS 3 Cartridges. In connection with the license, Liquidia PAH and Sandoz agreed, among other things, to indemnify Smiths from certain liabilities related to any cartridge they developed for use with the CADD-MS 3 infusion pumps.

In September 2021, United Therapeutics filed a motion for summary judgment with respect to all of the claims brought by Sandoz and Liquidia PAH against United Therapeutics. At the same time, Sandoz filed a motion for summary judgment with respect to the breach of contract claim. In March 2022, the Court issued an order granting partial summary judgment to United Therapeutics with respect to the antitrust and unfair competition claims, denying summary judgment to United Therapeutics with respect to the breach of contract claim, and granting partial summary judgment to Sandoz with respect to the breach of contract claim. A trial to determine the amount of damages due from United Therapeutics to Sandoz with respect to the breach of contract claim was held from late April to early May 2024. In November 2024, the Court entered a judgment in the amount of $70.6 million. United Therapeutics, Sandoz and Liquidia PAH have all appealed the Court’s decision to the United States Court of Appeals for the Third Circuit, and briefing is ongoing.

Under the Promotion Agreement, all proceeds from the litigation will be divided evenly between Sandoz and Liquidia PAH. Under the litigation finance agreements that Liquidia PAH has entered into with Henderson and PBM, any net proceeds received by Liquidia PAH with respect to the RareGen Litigation will be divided between Henderson and PBM.

Stock-Based Compensation - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Stock-Based Compensation
Outstanding, number of shares (in shares)	9,009,005
Outstanding, weighted average exercise price (in dollars per share)	$ 4.76
Granted, number of shares (in shares)	0
Exercised, number of shares (in shares)	(84,505)
Exercised, weighted average exercise price (in dollars per share)	$ 4.23
Outstanding, number of shares (in shares)	8,924,500
Outstanding, weighted average exercise price (in dollars per share)	$ 4.77
Outstanding, weighted average contractual term (Year)	6 years 7 months 6 days
Outstanding, aggregate intrinsic value	$ 89,140
Exercisable, number of shares (in shares)	7,342,039
Exercisable, weighted average exercise price (in dollars per share)	$ 4.57
Exercisable, weighted average contractual term (Year)	6 years 4 months 24 days
Exercisable, aggregate intrinsic value	$ 74,824
Vested and expected to vest, number of shares (in shares)	8,850,445
Vested and expected to vest, weighted average exercise price (in dollars per share)	$ 4.76
Vested and expected to vest, weighted average contractual term (Year)	6 years 7 months 6 days
Vested and expected to vest, aggregate intrinsic value	$ 88,511
Other
Weighted average fair value for options granted (in dollars per share)		$ 9.84
Share Price (in dollars per share)	$ 14.75

Long-term Debt (Tables)

3 Months Ended

Mar. 31, 2025

Long-term Debt

Schedule of changes in the liability related to HCR agreement


Balance as of December 31, 2024	$	113,284
Accretion		3,823
Payments		(2,122)
Funding, net of fees		24,975
Balance as of March 17, 2025	$	139,960
Accretion		847
Balance as of March 31, 2025	$	140,807
Less: current portion of long-term debt		(37,625)
Long-term portion of long-term debt	$	103,182

Schedule of expected annual payments on long-term debt

The expected annual payments on long-term debt as of March 31, 2025 are as follows:


Year ending December 31:
2025 (nine months remaining)	$	18,093
2026		56,656
2027		39,894
2028		39,894
2029		22,235
Thereafter		33,350
Total	$	210,122

Legal Proceedings (Details) - Liquidia PAH and Sandoz - USD ($) $ in Thousands	1 Months Ended
	Nov. 30, 2024	Apr. 30, 2021
UTC and Smiths Medical Litigation \| Pending Litigation
Legal Proceedings
Proceeds from Legal Settlements		$ 4,250
Breach of contract claim
Legal Proceedings
Judgement amount awarded from other party	$ 70,600

- 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

Property, Plant, and Equipment - Expense (Details) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Property, Plant, and Equipment
Depreciation and amortization expense	$ 0.2	$ 0.2

Inventory (Tables)

3 Months Ended

Mar. 31, 2025

Inventory

Schedule of inventory


	March 31,		December 31,
	2025		2024
Raw materials	$	5,387	$	3,737
Work in process		11,166		7,069
Inventory	$	16,553	$	10,806

Recognized as:
Inventory	$	1,349	$	241
Other assets		15,205		10,565

Contract Acquisition Costs and Intangible Asset

3 Months Ended

Mar. 31, 2025

Contract Acquisition Costs and Intangible Asset

Contract Acquisition Costs and Intangible Asset

5. Contract Acquisition Costs and Intangible Asset

Contract acquisition costs and intangible asset are summarized as follows:


	March 31, 2025						December 31, 2024
	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
Contract acquisition costs	$	12,980	$	(5,802)	$	7,178	$	12,980	$	(5,694)	$	7,286
Intangible asset	$	5,620	$	(2,512)	$	3,108	$	5,620	$	(2,464)	$	3,156

We are amortizing the value of the contract acquisition costs and intangible asset on a pro-rata basis based on the estimated total revenue or net profits to be recognized over the period from November 18, 2020 through December 2032, the termination date of the Promotion Agreement (see Note 2 “Basis of Presentation, Significant Accounting Policies and Fair Value Measurements”). Amortization of contract acquisition costs is recorded as a reduction of revenue, and amortization of the intangible asset is recorded as cost of revenue.

We recorded amortization related to the contract acquisition costs of $0.1 million for each of the three months ended March 31, 2025 and 2024, respectively. We recorded amortization related to the intangible asset of less than $0.1 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively. Annual amortization over the next five years is expected to immaterially fluctuate from the 2025 amounts, consistent with changes to net profits to be recognized pursuant to the Promotion Agreement over the period.

Commitments and Contingencies (Details) - USD ($) $ in Thousands			1 Months Ended	3 Months Ended
	Oct. 02, 2024	Jul. 14, 2023	Jun. 30, 2023	Mar. 31, 2025	Oct. 31, 2024
Non-cancelable commitments for product manufacturing and supply costs				$ 20,400
Pharmosa License Agreement
Upfront license fee to be paid			$ 10,000
Accrued additional upfront license fee					$ 3,500
Maximum potential development milestone payments	$ 37,750
Milestone payment for each additional indication approved by the FDA after PAH and PH-ILD and each additional product approved by the FDA under the license	10,000
Milestone payment for each additional indication approved by the EMA after PAH and PH-ILD	2,000
Milestone payment for each additional indication approved by the PMDA after PAH and PH-ILD	500
Pharmosa License Agreement \| North America
Maximum potential sales milestones	185,000
Pharmosa License Agreement \| Other then North America
Maximum potential sales milestones	$ 150,000
Chasm Technologies
Maximum future contingent milestones and royalties				1,500
Accrued contingent milestones and royalties				200
Agreement With LGM Pharma, LLC
Purchase Commitment, Remaining Minimum Amount Committed				$ 2,700
Expiration term of agreement				5 years
Amended and Restated Commercial Manufacturing Services and Supply Agreement with Lonza Tampa LLC
Termination term for FDA rejection		60 days
Termination term for FDA delay		120 days
Percentage of reimburse		50.00%
Aggregate exceed		$ 2,500
Term of submission		24 months
Initial term		12 months

Contract Acquisition Costs and Intangible Asset - Summary (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Contract Acquisition Costs and Intangible Asset
Contract acquisition costs, Gross Carrying Amount	$ 12,980	$ 12,980
Contract acquisition costs, Accumulated Amortization	(5,802)	(5,694)
Contract acquisition costs, Net Carrying Amount	7,178	7,286
Intangible asset, Gross Carrying Amount	5,620	5,620
Intangible asset, Accumulated Amortization	(2,512)	(2,464)
Intangible asset, Net Carrying Amount	$ 3,108	$ 3,156

Segment Information (Tables)

3 Months Ended

Mar. 31, 2025

Segment Information

Schedule of segment revenue, segment loss, and significant segment expenses


	Three Months Ended March 31,
	2025		2024
Revenue		3,120		2,972
Cost of revenue		1,517		1,467
Program expenses ⁽¹⁾
YUTREPIA		9,758		6,630
L606		3,268		1,578
Generic Treprostinil		151		203
Total program expenses		13,177		8,411
Non-program expenses ⁽²⁾		3,770		6,350
Personnel, including stock-based compensation		20,081		15,545
Loss from operations		(35,425)		(28,801)
Other income (expense), net		(2,942)		(1,282)
Net loss		(38,367)		(30,083)

(1)

Includes external research and development and general and administrative expenses

(2)

Includes professional service fees, facilities & infrastructure expenses, insurance, depreciation & amortization, and other corporate expenses

Long-term Debt - Expected Annual Payments (Details) $ in Thousands	Mar. 31, 2025 USD ($)
Long-term Debt
2025 (nine months remaining)	$ 18,093
2026	56,656
2027	39,894
2028	39,894
2029	22,235
Thereafter	33,350
Total	$ 210,122

Stock-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2025

Schedule of stock-based compensation expense recognized for employees and non-employees


	Three Months Ended
	March 31,
By Expense Category:	2025		2024
Cost of revenue	$	149	$	64
Research and development		340		1,011
General and administrative		6,949		3,449
Total stock-based compensation expense	$	7,438	$	4,524

Schedule of unamortized compensation expense and weighted average remaining recognition period


	As of March 31, 2025
			Weighted
			Average
			Remaining
			Recognition
	Unamortized		Period
	Expense		(Years)
Stock options	$	6,603	1.2
Restricted and performance stock units	$	49,140	2.6

Schedule of assumptions used for estimating the fair value of stock options


		Three Months Ended
		March 31,
		2024
Expected dividend yield		—
Risk-free interest rate		3.98%
Expected volatility		90%
Expected life (years)		6.1

Schedule of stock option activity


				Weighted
		Weighted		Average
		Average		Contractual	Aggregate
	Number of	Exercise		Term	Intrinsic
	Shares	Price		(in years)	Value
Outstanding as of December 31, 2024	9,009,005	$	4.76
Granted	—		—
Exercised	(84,505)		4.23
Cancelled	—		—
Outstanding as of March 31, 2025	8,924,500	$	4.77	6.6	$	89,140
Exercisable as of March 31, 2025	7,342,039	$	4.57	6.4	$	74,824
Vested and expected to vest as of March 31, 2025	8,850,445	$	4.76	6.6	$	88,511

Schedule of unvested RSU and PSU activity


		Weighted
		Average
		Grant-Date
	Number of	Fair Value
	RSUs	(per RSU)
Unvested as of December 31, 2024	2,948,049	$	10.82
Granted	2,585,400		12.31
Vested	(414,053)		10.95
Forfeited	(13,503)		12.87
Unvested as of March 31, 2025	5,105,893	$	11.56

Employee Stock Purchase Plan

Schedule of assumptions used for estimating the fair value of stock options


	Three Months Ended
	March 31,
	2025	2024
Expected dividend yield	—	—
Risk-free interest rate	4.31%	5.27%
Expected volatility	44%	90%
Expected life (years)	0.50	0.50

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2025	May 01, 2025
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2025
Document Transition Report	false
Entity File Number	001-39724
Entity Registrant Name	LIQUIDIA CORPORATION
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-1710962
Entity Address, Address Line One	419 Davis Drive, Suite 100
Entity Address, City or Town	Morrisville
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27560
City Area Code	919
Local Phone Number	328-4400
Title of 12(b) Security	Common stock, $0.001 par value per share
Trading Symbol	LQDA
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		85,484,525
Entity Central Index Key	0001819576
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q1
Amendment Flag	false

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements - Revision of Previously Issued Financial Statements (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024	Dec. 31, 2023
Consolidated Balance Sheet
Long-term debt, noncurrent	$ 103,182	$ 69,360	$ 95,268
Total liabilities	177,716	100,011	150,935
Accumulated deficit	(595,756)	(459,181)	(557,389)
Total stockholders' equity	49,713	97,105	$ 79,378	$ 47,293
Consolidated Statement of Operations and Comprehensive Loss
Interest expense	(4,670)	(3,162)
Total other expense, net	(2,942)	(1,282)
Net Income (Loss)	$ (38,367)	$ (30,083)
Net loss per common share, basic (in dollars per share)	$ (0.45)	$ (0.4)
Net loss per common share, diluted (in dollars per share)	$ (0.45)	$ (0.4)
As Previously Reported
Consolidated Balance Sheet
Long-term debt, noncurrent		$ 80,205
Total liabilities		110,856
Accumulated deficit		(470,026)
Total stockholders' equity		86,260
Consolidated Statement of Operations and Comprehensive Loss
Interest expense		(2,524)
Loss on extinguishment of debt		(11,483)
Total other expense, net		(12,127)
Net Income (Loss)		$ (40,928)
Net loss per common share, basic (in dollars per share)		$ (0.54)
Net loss per common share, diluted (in dollars per share)		$ (0.54)
Adjustment
Consolidated Balance Sheet
Long-term debt, noncurrent		$ (10,845)
Total liabilities		(10,845)
Accumulated deficit		10,845
Total stockholders' equity		10,845
Consolidated Statement of Operations and Comprehensive Loss
Interest expense		(638)
Loss on extinguishment of debt		11,483
Total other expense, net		10,845
Net Income (Loss)		$ 10,845
Net loss per common share, basic (in dollars per share)		$ 0.14
Net loss per common share, diluted (in dollars per share)		$ 0.14

Inventory

3 Months Ended

Mar. 31, 2025

Inventory

Inventory

3. Inventory

Inventories are stated at the lower of average cost or net realizable value and consist of the following:


	March 31,		December 31,
	2025		2024
Raw materials	$	5,387	$	3,737
Work in process		11,166		7,069
Inventory	$	16,553	$	10,806

Recognized as:
Inventory	$	1,349	$	241
Other assets		15,205		10,565

Prelaunch Inventory

As of March 31, 2025, we capitalized costs of $16.6 million associated with the production of YUTREPIA as a result of our determination that regulatory approval and subsequent commercialization is probable, and we also expect future economic benefit from the sales of YUTREPIA to be realized.

Amounts recognized as Other Assets are comprised entirely of raw materials and work in process inventories not expected to be sold within one year of the balance sheet date.

Contract Acquisition Costs and Intangible Asset - Other (Details) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Contract Acquisition Costs and Intangible Asset
Contract acquisition costs, amortization expense	$ 0.1	$ 0.1
Intangible asset, amortization expense		$ 0.1
Maximum
Contract Acquisition Costs and Intangible Asset
Intangible asset, amortization expense	$ 0.1

Leases - Remaining Lease Term and Discount Rates (Details)	Mar. 31, 2025
Leases
Weighted average remaining lease term, Operating leases	6 years 9 months 18 days
Weighted average discount rate, Operating leases	15.20%

Long-term Debt - Summary (Details) - USD ($) $ in Thousands		3 Months Ended
Long-term Debt - Summary (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 17, 2025	Dec. 31, 2024	Mar. 31, 2024
Long-term Debt
Beginning balance	$ 139,960	$ 113,284
Accretion	847	3,823
Payments		(2,122)
Funding, net of fees		24,975
Ending balance	140,807	$ 139,960
Less: current portion of long-term debt	(37,625)		$ (18,016)
Long-term portion of long-term debt	$ 103,182		$ 95,268	$ 69,360

Accrued Expenses and Other Current Liabilities (Tables)

3 Months Ended

Mar. 31, 2025

Accrued Expenses and Other Current Liabilities

Schedule of accrued expenses and other current liabilities


	March 31,		December 31,
	2025		2024
Accrued compensation	$	6,276	$	10,251
Accrued research and development expenses		902		2,495
Accrued inventory costs		1,508		1,641
Accrued other expenses		5,155		4,272
Total accrued expenses and other current liabilities	$	13,841	$	18,659

Business - Liquidity and Going Concern (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024	Jan. 09, 2023
Business
Net loss	$ 38,367	$ 30,083
Accumulated deficit	$ 595,756	$ 459,181	$ 557,389
Revenue Interest Financing Agreement \| HCR
Business
Cash covenants, minimum cash and cash equivalents to be maintained				$ 15,000

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

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+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements - Common Stock Equivalent Shares Excluded From Calculation of Diluted Net Loss Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Anti-dilutive shares excluded from calculation of diluted net loss per share (in shares)	14,235,854	13,004,006
Employee Stock Option
Anti-dilutive shares excluded from calculation of diluted net loss per share (in shares)	8,949,015	9,571,521
Restricted Stock Units
Anti-dilutive shares excluded from calculation of diluted net loss per share (in shares)	4,836,839	2,982,485
Warrants
Anti-dilutive shares excluded from calculation of diluted net loss per share (in shares)	450,000	450,000

Stockholders' Equity (Tables)

3 Months Ended

Mar. 31, 2025

Stockholders' Equity

Schedule of outstanding warrants


Number of
warrants	Exercise Price		Expiration Date
250,000	$	5.14	January 6, 2032
100,000	$	3.05	February 26, 2031
100,000	$	n/a¹	February 26, 2031
56,397	$	0.02	December 31, 2026

These warrants were issued on February 26, 2021, in connection with our previously outstanding debt with Silicon Valley Bank. These warrants only became exercisable if there was additional funding under the loan agreement, and the exercise price of these warrants was to be set upon such potential additional funding. The additional funding never occurred, and the loan agreement has since been repaid and terminated. While these warrants technically remain outstanding, they are not, and will never be, exercisable.

Condensed Consolidated Balance Sheets (unaudited) (Parentheticals) - $ / shares	Mar. 31, 2025	Dec. 31, 2024
Condensed Consolidated Balance Sheets (unaudited)
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	115,000,000	115,000,000
Common stock, shares issued (in shares)	85,298,941	84,683,063
Common stock, shares outstanding (in shares)	85,298,941	84,683,063

Stock-Based Compensation - Restricted and Performance Stock Units (Details)	3 Months Ended
	Mar. 31, 2025 $ / shares shares
Stock-Based Compensation
Unvested, number (in shares) \| shares	2,948,049
Unvested , weighted average grant date fair value (in dollars per share) \| $ / shares	$ 10.82
Granted, number (in shares) \| shares	2,585,400
Granted , weighted average grant date fair value (in dollars per share) \| $ / shares	$ 12.31
Vested , number (in shares) \| shares	(414,053)
Vested , weighted average grant date fair value (in dollars per share) \| $ / shares	$ 10.95
Forfeited, number (in shares) \| shares	(13,503)
Forfeited , weighted average grant date fair value (in dollars per share) \| $ / shares	$ 12.87
Unvested , number (in shares) \| shares	5,105,893
Unvested , weighted average grant date fair value (in dollars per share) \| $ / shares	$ 11.56

Indemnification Asset with Related Party and Litigation Finance Payable

3 Months Ended

Mar. 31, 2025

Indemnification Asset with Related Party and Litigation Finance Payable

Indemnification Asset with Related Party and Litigation Finance Payable

6. Indemnification Asset with Related Party and Litigation Finance Payable

On June 3, 2020, Liquidia PAH entered into a litigation financing arrangement (the “Financing Agreement”) with Henderson SPV, LLC (“Henderson”). Liquidia PAH, along with Sandoz (collectively the “Plaintiffs”), are pursuing litigation against United Therapeutics Corporation (“United Therapeutics”) (the “RareGen Litigation”). Under the Financing Agreement, Henderson will fund Liquidia PAH’s legal and litigation expenses (referred to as “Deployments”) in exchange for a share of certain litigation or settlement proceeds. Deployments received from Henderson are recorded as a litigation finance payable.

Litigation proceeds will be split equally between Liquidia PAH and Sandoz. Unless there is an event of default by Henderson, litigation proceeds received by Liquidia PAH must be applied first to repayment of total Deployments received. Litigation proceeds in excess of Deployments received are split between Liquidia PAH and Henderson

according to a formula. Unless there is an event of default by PBM (as defined below), all proceeds received by Liquidia PAH are due to PBM as described further below.

On November 17, 2020, Liquidia PAH entered into a Litigation Funding and Indemnification Agreement (“Indemnification Agreement”) with PBM RG Holdings, LLC (“PBM”). PBM is considered to be a related party as it is controlled by a major stockholder (which beneficially owns approximately 7.8% of Liquidia Corporation common stock as of May 1, 2025), who is also a member of our Board of Directors.

Under the terms of the Indemnification Agreement, PBM now controls the litigation, with Liquidia PAH’s primary responsibility being to cooperate to support the litigation proceedings as needed. The Indemnification Agreement provides that Liquidia PAH and its affiliates will not be entitled to any proceeds resulting from, or bear any financial or other liability for, the RareGen Litigation unless there is an event of default by PBM. Any Liquidia PAH litigation expenses not reimbursed by Henderson under the Financing Agreement will be reimbursed by PBM. Any proceeds received which Henderson is not entitled to under the Financing Agreement will be due to PBM.

The Indemnification Asset is increased as we record third party legal and litigation expenses related to the RareGen litigation.

As of March 31, 2025 and December 31, 2024, the Indemnification Asset and Litigation Finance Payable were classified as long-term assets and liabilities, respectively, as it is considered unlikely that the RareGen Litigation would conclude prior to March 31, 2026.

Indemnification Asset with Related Party and Litigation Finance Payable (Details)	May 01, 2025
PBM \| Subsequent Events
Indemnification Asset with Related Party and Litigation Finance Payable
Major stockholder ownership percentage of Liquidia Corporation Common Stock	7.80%

Stock-Based Compensation - Fair Value of Stock Options Granted and Purchase Rights Issued under the ESPP (Details) - Employee Stock Purchase Plan	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Employee Stock Option
Expected dividend yield		0.00%
Risk-free interest rate		3.98%
Expected volatility		90.00%
Expected life (years)		6 years 1 month 6 days
Employee Purchase Rights
Expected dividend yield	0.00%	0.00%
Risk-free interest rate	4.31%	5.27%
Expected volatility	44.00%	90.00%
Expected life (years)	6 months	6 months

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 31, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ (38,367)	$ (30,083)

- Definition

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

+ References

+ Details

Segment Information (Details) - USD ($) $ in Thousands	3 Months Ended
Segment Information (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 31, 2024
Segment Information
Revenue	$ 3,120	$ 2,972
Cost of revenue	1,517	1,467
Loss from operations	(35,425)	(28,801)
Other income (expense), net	(2,942)	(1,282)
Net loss	(38,367)	(30,083)
Single reportable segment
Segment Information
Revenue	3,120	2,972
Cost of revenue	1,517	1,467
Program expenses	13,177	8,411
Non-program expenses	3,770	6,350
Personnel, including stock-based compensation	20,081	15,545
Loss from operations	(35,425)	(28,801)
Other income (expense), net	(2,942)	(1,282)
Net loss	(38,367)	(30,083)
Single reportable segment \| YUTREPIA
Segment Information
Program expenses	9,758	6,630
Single reportable segment \| L606
Segment Information
Program expenses	3,268	1,578
Single reportable segment \| Generic Treprostinil
Segment Information
Program expenses	$ 151	$ 203

Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Dec. 31, 2023	$ 69	$ 476,322	$ (429,098)	$ 47,293
Balance (in shares) at Dec. 31, 2023	68,629,575
Issuance of common stock upon exercise of stock options		99	0	99
Issuance of common stock upon exercise of stock options (in shares)	23,247
Issuance of common stock upon vesting of restricted stock units			0
Issuance of common stock upon vesting of restricted stock units (in shares)	383,133
Issuance of common stock under employee stock purchase plan		404	0	404
Issuance of common stock under employee stock purchase plan (in shares)	67,982
Issuance of common stock upon exercise of warrants			0
Issuance of common stock upon exercise of warrants (in shares)	946
Sale of common stock, net	$ 7	74,861	0	74,868
Sale of common stock, net (in shares)	7,182,532
Stock-based compensation		4,524	0	4,524
Net loss			(30,083)	(30,083)
Balance at Mar. 31, 2024	$ 76	556,210	(459,181)	97,105
Balance (in shares) at Mar. 31, 2024	76,287,415
Balance at Dec. 31, 2024	$ 85	636,682	(557,389)	79,378
Balance (in shares) at Dec. 31, 2024	84,683,063
Issuance of common stock upon exercise of stock options		358	0	$ 358
Issuance of common stock upon exercise of stock options (in shares)	84,505			84,505
Issuance of common stock upon vesting of restricted stock units			0
Issuance of common stock upon vesting of restricted stock units (in shares)	414,053
Issuance of common stock under employee stock purchase plan		906	0	$ 906
Issuance of common stock under employee stock purchase plan (in shares)	117,320
Stock-based compensation		7,438	0	7,438
Net loss			(38,367)	(38,367)
Balance at Mar. 31, 2025	$ 85	$ 645,384	$ (595,756)	$ 49,713
Balance (in shares) at Mar. 31, 2025	85,298,941

Inventory (Details) - USD ($) $ in Thousands	3 Months Ended
Inventory (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Inventory
Raw materials	$ 5,387	$ 3,737
Work in process	11,166	7,069
Inventory	16,553	10,806
Recognized as: Inventory	1,349	241
Capitalized costs	16,600
Other assets
Inventory
Recognized as: Other assets	$ 15,205	$ 10,565

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements (Policies)

3 Months Ended

Mar. 31, 2025

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements

Basis of Presentation

The unaudited interim condensed consolidated financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial reporting. These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments (consisting only of normal recurring adjustments and accruals) necessary for a fair statement of the results for the periods presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The year-end condensed consolidated balance sheet data was derived from our audited consolidated financial statements but does not include all disclosures required by GAAP. Operating results for the three months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025. Certain information and footnote disclosures normally included in the annual consolidated financial statements prepared in accordance with GAAP have been omitted in accordance with the SEC’s rules and regulations for interim reporting. Certain amounts have been reclassified from the prior year presentation to conform to current presentation, specifically in relation to the balance sheet presentation of finance and operating leases. Our financial position, results of operations and cash flows are presented in U.S. Dollars.

The accompanying unaudited condensed consolidated financial statements and related notes should be read in conjunction with our audited consolidated financial statements for the year ended December 31, 2024, which are included in Exhibit 99.1 to our Current Report on Form 8-K filed on May 8, 2025.

Consolidation

The accompanying condensed consolidated financial statements include our wholly owned subsidiaries, Liquidia Technologies and Liquidia PAH. All intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the period. These estimates are based on historical experience and various other assumptions believed to be reasonable under the circumstances. We evaluate our estimates on an ongoing basis, including those related to the valuation of stock-based awards, certain accruals, and intangible and contract acquisition cost amortization, and make changes to the estimates and related disclosures as our experience develops or new information becomes known. Actual results will most likely differ from those estimates.

Revision of Previously Issued Financial Statements

During the three months ended March 31, 2025, we identified immaterial errors in our accounting treatment of the fourth and fifth amendments to the HCR Agreement. While we initially concluded that the amendments constituted extinguishments under ASC 470 Debt, we reevaluated the accounting treatment, revised our conclusions and determined the amendments to be modifications. The identified errors impacted our previously issued 2024 annual consolidated financial statements. We have evaluated these errors and determined that the errors were not material to our consolidated financial statements taken as a whole. However, we voluntarily revised our previously issued 2024 annual consolidated financial statements to correct the immaterial errors and disclosed the impacts to our quarterly financial statements for

the respective 2024 interim periods in our Current Report on Form 8-K filed on May 8, 2025. As a result of the revision, the loss on extinguishment has been eliminated and an adjustment to interest expense resulting from the modifications has been recorded, with corresponding adjustments to the long-term debt and accumulated deficit accounts.

A summary of the revisions to certain financial statement line items as of and for the three months ended March 31, 2024 in the condensed consolidated financial statements is presented below:

Condensed Consolidated Balance Sheet


	March 31, 2024
	As Previously Reported		Adjustment		As Revised
Long-term debt, noncurrent	$	80,205	$	(10,845)	$	69,360
Total liabilities	$	110,856	$	(10,845)	$	100,011
Accumulated deficit	$	(470,026)	$	10,845	$	(459,181)
Total stockholders’ equity	$	86,260	$	10,845	$	97,105

Condensed Consolidated Statement of Operations and Comprehensive Loss



	Three Months Ended March 31, 2024
	As Previously Reported		Adjustment		As Revised
Interest expense	$	(2,524)	$	(638)	$	(3,162)
Loss on extinguishment of debt	$	(11,483)	$	11,483	$	—
Total other expense, net	$	(12,127)	$	10,845	$	(1,282)
Net loss and comprehensive loss	$	(40,928)	$	10,845	$	(30,083)
Net loss per common share, basic and diluted	$	(0.54)	$	0.14	$	(0.40)

The adjustments noted above had a corresponding impact on the related line items in the condensed consolidated statement of stockholders' equity lines for the three months ended March 31, 2024. There was no impact to our condensed consolidated statement of cash flows except for the presentation of net loss offset by the corresponding adjustment to reconcile net loss to net cash used in operating activities. In addition, Note 12 “Long-term Debt” has been updated to reflect the revised amounts.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board under its accounting standards codifications (ASC) or other standard setting bodies and are adopted by us as of the specified effective date. For the three months ended March 31, 2025, there were no newly adopted accounting pronouncements that had a material impact on our condensed consolidated financial statements. As of March 31, 2025, there are no recently issued but not yet adopted accounting pronouncements that are expected to materially impact our condensed consolidated financial statements.

Cash, Cash Equivalents, and Concentration of Credit Risk

We consider all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents.

Financial instruments that potentially subject us to concentrations of credit risk consist of cash and cash equivalents. We are exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding our cash and cash equivalents to the extent of amounts recorded on the condensed consolidated balance sheet. Our cash and cash equivalents are held at multiple accredited financial institutions. We have not experienced any losses on such accounts and do not believe that we are subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Such deposits have exceeded and will continue to exceed federally insured limits.

Accounts Receivable

Accounts receivable are stated at net realizable value and net of an allowance for credit losses as of each balance sheet date, if applicable. One customer accounted for 93% and 95% of our accounts receivable, net at March 31, 2025 and December 31, 2024, respectively. As of March 31, 2025 and December 31, 2024, we have not recorded an allowance for credit losses.

Prelaunch Inventory

We capitalize prelaunch inventory prior to receiving regulatory approval if regulatory approval and subsequent commercialization of a product is probable and we also expect future economic benefit from the sales of the product to be realized. Prior to this conclusion, we expense prelaunch inventory as research and development expense in the period incurred. For prelaunch inventory that is capitalized, we consider a number of specific facts and circumstances, including the product’s shelf life, the product's current status in the development and regulatory approval process, results from related clinical trials, results from meetings with relevant regulatory agencies prior to the filing of regulatory applications, potential obstacles to the approval process, viability of commercialization and market trends. In late 2023, based on our assessment of the legal and regulatory process related to YUTREPIA, we concluded that we met the criteria to capitalize expenditures for prelaunch inventory. We capitalized $16.6 million of prelaunch inventory as of March 31, 2025 and $10.8 million as of December 31, 2024. If either regulatory approval or market acceptance post-approval of YUTREPIA do not occur at all or on a timely basis prior to the inventory shelf-life expiration, we may be required to write-off some or all prelaunch inventory, which could affect our financial condition and financial results.

Long-Lived Assets

We review long-lived assets, including definite-life intangible assets, for realizability on an ongoing basis. Changes in depreciation and amortization, generally accelerated depreciation and variable amortization, are determined and recorded when estimates of the remaining useful lives or residual values of long-term assets change. We also review for impairment when conditions exist that indicate the carrying amount of the assets may not be fully recoverable. In those circumstances, we perform undiscounted operating cash flow analyses to determine if an impairment exists. When testing for asset impairment, we group assets and liabilities at the lowest level for which cash flows are separately identifiable. Any impairment loss is calculated as the excess of the asset’s carrying value over its estimated fair value. Fair value is estimated based on the discounted cash flows for the asset group over the remaining useful life or based on the expected cash proceeds for the asset less costs of disposal. Any impairment losses would be recorded in the consolidated statements of operations. To date, no such impairments have occurred.

Goodwill

We assess goodwill for impairment at least annually as of July 1 or whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. For example, significant and unanticipated changes or our inability to obtain or maintain regulatory approvals for our product candidates, including the NDA for YUTREPIA, could trigger testing of our goodwill for impairment at an interim date. We have one reporting unit. We have the option to first assess qualitative factors to determine whether events or circumstances indicate it is more likely

than not that the fair value of a reporting unit is greater than its carrying amount, in which case a quantitative impairment test is not required.

Per ASC 350, Intangibles Goodwill and Other, the quantitative goodwill impairment test is performed by comparing the fair value of the reporting unit with its carrying amount, including goodwill. If the fair value of the reporting unit exceeds its carrying amount, goodwill is not impaired. An impairment loss is recognized for any excess of the carrying amount of the reporting unit’s goodwill over the fair value up to the amount of goodwill allocated to the reporting unit. Income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit are considered when measuring the goodwill impairment loss, if applicable.

As of March 31, 2025, we concluded there were no significant events or changes in circumstances which indicated that the carrying amount of goodwill was not recoverable. We completed our annual impairment test as of July 1, 2024 and concluded that no impairments had occurred.

Long-term Debt

We recognized a liability related to amounts received pursuant to the HCR Agreement under ASC 470-10, Debt and ASC 835-30, Interest – Imputation of Interest. The liability will be accreted under the effective interest method based upon the amount of contractual future payments to be made pursuant to the HCR Agreement. Amendments are assessed under ASC 470 to determine the appropriate treatment as troubled debt restructurings, extinguishments or modifications. If the timing or amounts of any future payments change, we will prospectively adjust the effective interest and the related amortization of the liability.

Revenue Recognition

We recognize revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:

●

Step 1: Identify the contract with the customer

●

Step 2: Identify the performance obligations in the contract

●

Step 3: Determine the transaction price

●

Step 4: Allocate the transaction price to the performance obligations in the contract

●

Step 5: Recognize revenue when the company satisfies a performance obligation

In order to identify the performance obligations in a contract with a customer, we assess the promised goods or services in the contract and identify each promised good or service that is distinct.

If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct.

The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both.

Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. We evaluate any non-cash consideration, consideration payable to the customer,

potential returns and refunds, and whether consideration contains a significant financing element in determining the transaction price.

Revenue is measured based on consideration specified in a contract with a customer. We recognize revenue when it satisfies a performance obligation by transferring control over a service to a customer. The amount of revenue recognized reflects estimates for refunds and returns, which are presented as a reduction of accounts receivable where the right of setoff exists.

Research and Development Expense

Research and development costs are expensed as incurred in accordance with ASC 730, Research and Development and include facility-related costs related to research and development activities, direct costs from third parties, such as contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and consultants, as well as employee-related expenses, including salaries, benefits, and stock-based compensation. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use.

Accrued Research and Development Expenses

As part of the process of preparing the condensed consolidated financial statements, we are required to estimate accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our condensed consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of these estimates with the service providers and make adjustments if necessary.

The significant estimates in our accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities. The financial terms of our agreements with CROs and CMOs are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from such estimate, we adjust the accrual or prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented.

Stock-Based Compensation

We estimate the grant date fair value of stock-based awards and amortize this fair value to compensation expense over the requisite service period or the vesting period of the respective award. In arriving at stock-based compensation expense, we estimate the number of stock-based awards that will be forfeited due to employee turnover. The forfeiture assumption is based primarily on turn-over historical experience. If the actual forfeiture rate is higher than the estimated forfeiture rate, then an adjustment will be made to increase the estimated forfeiture rate, which will result in a decrease to the expense recognized in our financial statements. If the actual forfeiture rate is lower than the estimated forfeiture rate, then an adjustment will be made to lower the estimated forfeiture rate, which will result in an increase to expense recognized in our financial statements. The expense we recognize in future periods will be affected by changes in the estimated forfeiture rate and may differ from amounts recognized in the current period. See Note 9 “Stock-Based Compensation.”

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted average shares outstanding during the period, without consideration of 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 method. Due to their anti-dilutive effect, the calculation of diluted net loss per share excludes the following common stock equivalent shares:


	Three Months Ended
	March 31,
	2025	2024
Stock Options	8,949,015	9,571,521
Restricted Stock Units	4,836,839	2,982,485
Warrants	450,000	450,000
Total	14,235,854	13,004,006

Certain common stock warrants are included in the calculation of basic and diluted net loss per share since their exercise price is de minimis.

Fair Value Measurements

ASC 825, Financial Instruments defines fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants (an exit price). As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. ASC 825 establishes a three-tiered approach for valuation of financial instruments, which requires that fair value measurements be classified and disclosed in one of three tiers, whether or not recognized on our condensed consolidated balance sheets at fair value. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows:

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

Level 2 — Inputs other than quoted prices included in active markets that are observable for the asset or liability, either directly or indirectly; and

Level 3 — Unobservable inputs for the asset and liability used to measure fair value, to the extent that observable inputs are not available.

The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The following table presents the placement in the fair value hierarchy of financial assets and liabilities measured at fair value as of March 31, 2025 and December 31, 2024:

Quoted

Significant

Prices in

Other

Significant

Active

Observable

Unobservable

Markets

Inputs

Carrying

March 31, 2025

(Level 1)

(Level 2)

(Level 3)

Value

Money market funds (cash equivalents)

163,945

—

163,945

Quoted

Significant

Prices in

Other

Significant

Active

Observable

Unobservable

Markets

Inputs

Carrying

December 31, 2024

(Level 1)

(Level 2)

(Level 3)

Value

Money market funds (cash equivalents)

170,672

—

170,672

Money market funds are included in cash and cash equivalents on our condensed consolidated balance sheet and are classified within Level 1 of the fair value hierarchy since they are valued using quoted market prices.

Other Fair Value Disclosures

The carrying amounts reflected in our condensed consolidated balance sheets for cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities approximate their fair values due to their short-term nature.

The carrying value and fair value of long-term debt as of March 31, 2025 and December 31, 2024 is as follows. The fair value is estimated using Level 3 inputs based on a discounted cash flow model incorporating company-specific projections and a market-based discount rates of 12.1% to 12.5% as of March 31, 2025 and 15.6% to 17.5% as of December 31, 2024, based on the tenor of the expected payment, and reflective of debt with similar risk characteristics.


	March 31, 2025				December 31, 2024
	Carrying Value		Fair Value		Carrying Value		Fair Value
Long-term debt, including amounts due within one year	$	140,807	$	155,000	$	113,284	$	110,174

Leases - Future Minimum Operating Lease Payments (Details) $ in Thousands	Mar. 31, 2025 USD ($)
Operating Leases
2025 (nine months remaining)	$ 1,029
2026	1,442
2027	1,643
2028	1,692
2029	1,743
Thereafter	3,644
Total minimum lease payments	11,193
Less: interest	(4,335)
Present value of lease liabilities	$ 6,858

Revenue From Contracts With Customers (Details) - Sandoz - USD ($) $ in Millions	1 Months Ended	3 Months Ended
	Aug. 31, 2018	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024
Promotion Agreement, Payment	$ 20.0
Contract with Customer, Refund Liability		$ 0.9		$ 2.0
Percentage of Revenue from Promotion Agreement		100.00%	99.00%

Property, Plant, and Equipment

3 Months Ended

Mar. 31, 2025

Property, Plant, and Equipment

Property, Plant, and Equipment

4. Property, Plant, and Equipment

Property, plant and equipment consisted of the following:


	March 31,		December 31,
	2025		2024
Lab and build-to-suit equipment	$	7,357	$	6,918
Office equipment		7		7
Furniture and fixtures		481		481
Computer and other equipment		833		741
Leasehold improvements		13,010		12,959
Construction-in-progress		2,900		3,001
Total property, plant and equipment		24,588		24,107
Accumulated depreciation and amortization		(16,104)		(15,809)
Property, plant and equipment, net	$	8,484	$	8,298

We recorded depreciation and amortization expense related to property, plant and equipment of $0.2 million and $0.2 million for the three months ended March 31, 2025 and 2024, respectively.

Property, Plant, and Equipment (Tables)

3 Months Ended

Mar. 31, 2025

Property, Plant, and Equipment

Schedule of Property, plant and equipment


	March 31,		December 31,
	2025		2024
Lab and build-to-suit equipment	$	7,357	$	6,918
Office equipment		7		7
Furniture and fixtures		481		481
Computer and other equipment		833		741
Leasehold improvements		13,010		12,959
Construction-in-progress		2,900		3,001
Total property, plant and equipment		24,588		24,107
Accumulated depreciation and amortization		(16,104)		(15,809)
Property, plant and equipment, net	$	8,484	$	8,298

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2025

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements

Schedule of corrections of previously issued consolidated financial statements

Condensed Consolidated Balance Sheet


	March 31, 2024
	As Previously Reported		Adjustment		As Revised
Long-term debt, noncurrent	$	80,205	$	(10,845)	$	69,360
Total liabilities	$	110,856	$	(10,845)	$	100,011
Accumulated deficit	$	(470,026)	$	10,845	$	(459,181)
Total stockholders’ equity	$	86,260	$	10,845	$	97,105

Condensed Consolidated Statement of Operations and Comprehensive Loss



	Three Months Ended March 31, 2024
	As Previously Reported		Adjustment		As Revised
Interest expense	$	(2,524)	$	(638)	$	(3,162)
Loss on extinguishment of debt	$	(11,483)	$	11,483	$	—
Total other expense, net	$	(12,127)	$	10,845	$	(1,282)
Net loss and comprehensive loss	$	(40,928)	$	10,845	$	(30,083)
Net loss per common share, basic and diluted	$	(0.54)	$	0.14	$	(0.40)

Schedule of anti-dilutive securities


	Three Months Ended
	March 31,
	2025	2024
Stock Options	8,949,015	9,571,521
Restricted Stock Units	4,836,839	2,982,485
Warrants	450,000	450,000
Total	14,235,854	13,004,006

Schedule of financial assets and liabilities measured at fair value

Quoted

Significant

Prices in

Other

Significant

Active

Observable

Unobservable

Markets

Inputs

Carrying

March 31, 2025

(Level 1)

(Level 2)

(Level 3)

Value

Money market funds (cash equivalents)

163,945

—

163,945

Quoted

Significant

Prices in

Other

Significant

Active

Observable

Unobservable

Markets

Inputs

Carrying

December 31, 2024

(Level 1)

(Level 2)

(Level 3)

Value

Money market funds (cash equivalents)

170,672

—

170,672

Schedule of carrying value and fair value of long-term debt


	March 31, 2025				December 31, 2024
	Carrying Value		Fair Value		Carrying Value		Fair Value
Long-term debt, including amounts due within one year	$	140,807	$	155,000	$	113,284	$	110,174

Accrued Expenses and Other Current Liabilities

3 Months Ended

Mar. 31, 2025

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

7. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:


	March 31,		December 31,
	2025		2024
Accrued compensation	$	6,276	$	10,251
Accrued research and development expenses		902		2,495
Accrued inventory costs		1,508		1,641
Accrued other expenses		5,155		4,272
Total accrued expenses and other current liabilities	$	13,841	$	18,659

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements - Fair Value of Financial Assets and Financial Liabilities (Details) - USD ($)	Mar. 31, 2025	Dec. 31, 2024
Other Fair Value Disclosures
Debt Instrument, Measurement Input [Extensible Enumeration]	us-gaap:MeasurementInputDiscountRateMember	us-gaap:MeasurementInputDiscountRateMember
Minimum
Other Fair Value Disclosures
Debt instrument, measurement input	0.121	0.156
Maximum
Other Fair Value Disclosures
Debt instrument, measurement input	0.125	0.175
Estimate of Fair Value Measurement
Other Fair Value Disclosures
Long-term debt, including amounts due within one year	$ 155,000,000	$ 110,174,000
Reported Value Measurement
Other Fair Value Disclosures
Long-term debt, including amounts due within one year	140,807,000	113,284,000
Money market funds (cash equivalents) \| Reported Value Measurement
Fair Value of Financial Instruments
Money market funds	163,945,000	170,672,000
Money market funds (cash equivalents) \| Fair Value, Inputs, Level 1 \| Estimate of Fair Value Measurement
Fair Value of Financial Instruments
Money market funds	$ 163,945,000	$ 170,672,000

Stock-Based Compensation - Unamortized Compensation Expense (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2025 USD ($)
Employee Stock Option
Unamortized Expense	$ 6,603
Weighted Average Remaining Recognition Period (Years)	1 year 2 months 12 days
Restricted and performance stock units
Unamortized Expense	$ 49,140
Weighted Average Remaining Recognition Period (Years)	2 years 7 months 6 days

Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Operating activities
Net loss	$ (38,367)	$ (30,083)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	7,438	4,524
Depreciation and amortization	451	489
Non-cash lease expense	55	113
Loss (gain) on disposal of property and equipment		3
Accretion and non-cash interest expense	4,670	3,159
Changes in operating assets and liabilities:
Accounts receivable, net	1,472	1,491
Inventory	(1,108)	(3,517)
Prepaid expenses and other current assets	815	(1,832)
Other noncurrent assets	(4,624)	63
Accounts payable	3,418	303
Accrued expenses and other current liabilities	(4,818)	668
Operating lease liabilities	(81)	(247)
Net cash used in operating activities	(30,679)	(24,866)
Investing activities
Purchases of property, plant and equipment	(330)	(624)
Net cash used in investing activities	(330)	(624)
Financing activities
Proceeds from long-term debt, net of fees	24,975	24,975
Payments on long-term debt	(2,122)	(654)
Principal payments on finance leases	(64)	(26)
Receipts from litigation financing	235	3
Proceeds from sale of common stock, net of issuance costs		74,868
Proceeds from issuance of common stock under stock incentive plans	1,264	503
Net cash provided by financing activities	24,288	99,669
Net increase (decrease) in cash and cash equivalents	(6,721)	74,179
Cash and cash equivalents, beginning of period	176,479	83,679
Cash and cash equivalents, end of period	169,758	157,858
Supplemental disclosure of cash flow information
Cash paid for operating lease liabilities	341	328
Non-cash increase in property, plant and equipment through accounts payable	151	786
Non-cash increase in indemnification asset through accounts payable	$ 417	$ 5

Long-term Debt

3 Months Ended

Mar. 31, 2025

Long-term Debt

Long-term Debt

12. Long-term Debt

On January 9, 2023, we entered into the HCR Agreement pursuant to which and subject to the terms and conditions contained therein, HCR has paid us an aggregate investment amount of $100.0 million (the “Investment Amount”).

On January 27, 2023, $32.5 million of the Investment Amount was funded from the first tranche, $22.2 million of which was used to satisfy existing obligations due to Silicon Valley Bank. This repayment resulted in a loss on extinguishment during the year ended December 31, 2023 of $2.3 million.

On June 28, 2023 and July 27, 2023, we entered into the Second Amendment to the HCR Agreement and Third Amendment to the HCR Agreement, respectively, pursuant to which HCR funded $10.0 million from the second tranche on July 27, 2023.

On January 3, 2024, we entered into the Fourth Amendment to the HCR Agreement pursuant to which HCR funded an additional $25.0 million from the second tranche on January 5, 2024.

On September 11, 2024 we entered into the Fifth Amendment to the HCR Agreement pursuant to which HCR funded an additional $32.5 million from the second tranche on September 12, 2024 and eliminated the third and fourth tranches.

On March 17, 2025, we entered into the Sixth Amendment to the HCR Agreement pursuant to which HCR made an additional $100.0 million available for funding in three tranches. On March 17, 2025, $25.0 million of the additional $100.0 million was funded.

As consideration for the Investment Amount and pursuant to the HCR Agreement, we have agreed to pay HCR according to a fixed quarterly payment schedule. As of March 31, 2025, we were required to pay $37.6 million within one year of the balance sheet date, which is classified as current in our condensed consolidated balance sheet.

Aggregate payments to HCR are capped at 175% of funded portion of the Investment Amount (the “Hard Cap”), plus an amount, if any, that HCR would need to receive to yield an internal rate of return of (i) 18% on the first $67.5 million funded, (ii) 16% on the next $57.5 million funded, (iii) 13% on the next $50.0 million funded, and (iv) 12% on the next $25.0 million funded (the “IRR True-Up Payment”), unless the HCR Agreement is earlier terminated. If a change of control occurs or upon the occurrence of an event of default, HCR may accelerate payments due under the HCR Agreement up to the Hard Cap, plus the IRR True-Up Payment, plus any other obligations payable under the HCR Agreement.

The HCR Agreement contains customary affirmative and negative covenants and customary events of default and other events that would cause acceleration, including, among other things, the occurrence of certain material adverse events or the material breach of certain representations and warranties and specified covenants, in which event HCR may elect to terminate the HCR Agreement and require us to make payments to HCR equal to the lesser of (a) the Hard Cap, plus any other obligations payable under the HCR Agreement, or (b) the funded portion of the Investment Amount, minus payments received by HCR, plus the IRR True-Up Payment. If the FDA grants final approval to an inhaled treprostinil product therapeutically equivalent to YUTREPIA and HCR has not received 100% of the amount funded by HCR to date, then we will be required to make payments to HCR equal to 100% of the amount funded by HCR to date, minus payments received by HCR.

The HCR Agreement contains certain restrictions on our ability, among other things, to incur additional debt, grant or permit additional liens, make investments and acquisitions, dispose of assets, pay dividends and distributions, subject to certain exceptions. In addition, the HCR Agreement contains a financial covenant that requires us to maintain cash and cash equivalents in an amount at least equal to $15.0 million for the remainder of the payment term, which based on amounts funded as of March 31, 2025, concludes in 2032.

As of the filing date of these condensed consolidated financial statements, we are not aware of any breach of covenants, or the occurrence of any material adverse event, nor have we received any notice of event of default from HCR.

We recorded the total funds received from HCR under the terms of the HCR Agreement as a liability. Cumulative fees to the lender and third parties of approximately $0.9 million are reflected as a discount on the long-term debt and is being accreted over the term using the effective interest method. All amendments to date were treated as debt modifications in accordance with ASC 470 Debt. The HCR Agreement’s initial effective interest rate was 17.3%, which decreased to 17.2% following the Third Amendment. Following the Fourth Amendment the effective interest rate was 18.0% and was 16.0% following the Fifth Amendment. Following the Sixth Amendment the effective interest rate is 15.8%. We use the contractual payment schedule to determine the interest expense to record to accrete the liability to the amount ultimately due. Over the course of the HCR Agreement, the effective interest rate may be affected by potential changes in contractual payments.

We recorded the total funds received from HCR under the terms of the HCR Agreement as a liability. We use the contractual payment schedule to determine the interest expense to record to accrete the liability to the amount ultimately due. For the three months ended March 31, 2025, we estimated an effective annual interest rate of approximately 15.8%. Over the course of the HCR Agreement, the effective annual interest rate may be affected by potential changes in contractual payments.

The following table presents the changes in the HCR Agreement payable during the three months ended March 31, 2025:


Balance as of December 31, 2024	$	113,284
Accretion		3,823
Payments		(2,122)
Funding, net of fees		24,975
Balance as of March 17, 2025	$	139,960
Accretion		847
Balance as of March 31, 2025	$	140,807
Less: current portion of long-term debt		(37,625)
Long-term portion of long-term debt	$	103,182

The expected annual payments on long-term debt as of March 31, 2025 are as follows:


Year ending December 31:
2025 (nine months remaining)	$	18,093
2026		56,656
2027		39,894
2028		39,894
2029		22,235
Thereafter		33,350
Total	$	210,122

Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Current assets:
Cash and cash equivalents	$ 169,758	$ 176,479
Accounts receivable, net	1,247	2,719
Inventory	1,349	241
Prepaid expenses and other current assets	4,851	5,666
Total current assets	177,205	185,105
Property, plant and equipment, net	8,484	8,298
Operating lease right-of-use assets, net	4,132	4,187
Indemnification asset, related party	7,877	7,460
Contract acquisition costs, net	7,178	7,286
Intangible asset, net	3,108	3,156
Goodwill	3,903	3,903
Other assets	15,542	10,918
Total assets	227,429	230,313
Current liabilities:
Accounts payable	8,675	4,689
Accrued expenses and other current liabilities	13,841	18,659
Long-term debt, current	37,625	18,016
Operating and finance lease liabilities, current	377	417
Total current liabilities	60,518	41,781
Litigation finance payable	7,535	7,300
Long-term debt, noncurrent	103,182	95,268
Operating and finance lease liabilities, noncurrent	6,481	6,586
Total liabilities	177,716	150,935
Commitments and contingencies (Note 13)
Stockholders' equity:
Preferred stock - 10,000,000 shares authorized, none outstanding	0	0
Common stock - $0.001 par value, 115,000,000 shares authorized as of March 31, 2025 and December 31, 2024, respectively, 85,298,941 and 84,683,063 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively	85	85
Additional paid-in capital	645,384	636,682
Accumulated deficit	(595,756)	(557,389)
Total stockholders' equity	49,713	79,378
Total liabilities and stockholders' equity	$ 227,429	$ 230,313

Leases (Tables)

3 Months Ended

Mar. 31, 2025

Leases

Schedule of lease cost, weighted average remaining lease term and discount rates


		Three Months Ended March 31,
	Classification	2025		2024
Operating lease cost:
Fixed lease cost	General and administrative	$	314	$	19
Fixed lease cost	Research and development		—		175
Finance lease cost:
Amortization of lease assets	General and administrative		22		—
Amortization of lease assets	Research and development		—		22
Interest on lease liabilities	Interest expense		1		2
Total Lease Cost		$	337	$	218

The weighted average remaining lease term and discount rates as of March 31, 2025 were as follows:


Weighted average remaining lease term (years):
Operating leases	6.8
Weighted average discount rate:
Operating leases	15.2	%

Schedule of future minimum operating lease payments

The future minimum operating lease payments as of March 31, 2025, were as follows:



Year ending December 31:	Total
2025 (nine months remaining)	$	1,029
2026		1,442
2027		1,643
2028		1,692
2029		1,743
Thereafter		3,644
Total minimum lease payments		11,193
Less: interest		(4,335)
Present value of lease liabilities	$	6,858

Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands			1 Months Ended	3 Months Ended
	Jan. 08, 2024	Jan. 04, 2024	Sep. 30, 2024	Mar. 31, 2025	Mar. 31, 2024
Sale of common stock, net					$ 74,868
Warrants, Expiration, January 6, 2032
Class of warrant or right, outstanding (in shares)				250,000
Class of warrant or right, exercise price of warrants or rights (in dollars per share)				$ 5.14
Warrants, Initial Tranche, Expiration, February 26, 2031
Class of warrant or right, outstanding (in shares)				100,000
Class of warrant or right, exercise price of warrants or rights (in dollars per share)				$ 3.05
Warrants, Other Tranches, Expiration, February 26, 2031
Class of warrant or right, outstanding (in shares)				100,000
Warrants, Expiration, December 31, 2026
Class of warrant or right, outstanding (in shares)				56,397
Class of warrant or right, exercise price of warrants or rights (in dollars per share)				$ 0.02
Warrants to Purchase Common Stock
Class of warrant or right, exercised during period (in shares)				0	948
Private Placement
Stock issued during period, new issues (in shares)		7,182,532		1,123,595
Shares issued, price per share (in dollars per share)		$ 10.442		$ 8.9
Proceeds from issuance of private placement	$ 75,000			$ 10,000
Private Placement \| Maximum
Before deducting offering costs	$ 100
Underwritten Public Offering
Stock issued during period, new issues (in shares)			6,460,674
Shares issued, price per share (in dollars per share)			$ 8.9
Proceeds from issuance of common stock, net			$ 57,500
Payments for offering costs			$ 3,800
Underwritten Public Offering \| Board of Directors
Sale of common stock, net				$ 3,000

Business

3 Months Ended

Mar. 31, 2025

Business

Business

1. Business

Description of the Business

We are a biopharmaceutical company focused on the development, manufacture, and commercialization of products that address unmet patient needs, with current focus directed towards rare cardiopulmonary diseases such as pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). We operate through our wholly owned operating subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC, formerly known as RareGen.

We currently generate revenue pursuant to a promotion agreement between Liquidia PAH and Sandoz Inc. (“Sandoz”), dated as of August 1, 2018, as amended (the “Promotion Agreement”), sharing profit derived from the sale of Sandoz’s substitutable generic treprostinil injection (“Treprostinil Injection”) in the United States. Liquidia PAH has the exclusive rights to conduct commercial activities to encourage the appropriate use of Treprostinil Injection. We employ a targeted sales force calling on physicians and hospital pharmacies involved in the treatment of PAH and PH-ILD in the United States, as well as key stakeholders involved in the distribution and reimbursement of medicines to treat these patients. We established our commercial presence in the field to support Treprostinil Injection and have since expanded our presence to support the potential launch of YUTREPIA (treprostinil) inhalation powder (“YUTREPIA”), further validating our reputation as a company committed to supporting PAH and PH-ILD patients.

We conduct research, development and manufacturing of novel products by applying our subject matter expertise in cardiopulmonary diseases and our proprietary PRINT® technology, a particle engineering platform, to enable precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Through development of our own products and research with third parties, we have experience applying PRINT across multiple routes of administration and drug payloads including inhaled therapies, vaccines, biologics, nucleic acids and ophthalmic implants, among others.

Our lead product candidate is YUTREPIA for the treatment of PAH and PH-ILD. YUTREPIA is an inhaled dry powder formulation of treprostinil designed with PRINT to improve the therapeutic profile of treprostinil by enhancing deep lung delivery while using a convenient, low effort dry-powder inhaler (“DPI”) and by achieving higher dose levels than the labeled doses of current inhaled therapies. On August 16, 2024, the United States Food and Drug Administration (the “FDA”) (i) granted tentative approval for our New Drug Application (“NDA”) for YUTREPIA for the treatment of PAH and PH-ILD and (ii) simultaneously determined that Tyvaso DPI, approved on May 23, 2022, qualifies for a three-year New Clinical Investigation exclusivity for the chronic use of dry powder formulations of treprostinil for the approved indications. As a result, final approval of YUTREPIA for PAH and PH-ILD is delayed until after expiry of the three-year regulatory exclusivity for Tyvaso DPI on May 23, 2025. In March 2025, we resubmitted a request for final approval of YUTREPIA for both PAH and PH-ILD. The FDA has confirmed that the resubmission was a complete, Class 1 response to the previous action letter and has set a Prescription Drug User Fee Act (“PDUFA”) goal date of May 24, 2025.

We are also developing L606, an investigational, liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, which we licensed from Pharmosa Biopharm Inc. (“Pharmosa”). L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD with a planned pivotal study for the treatment of PH-ILD.

Risks and Uncertainties

We are subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on third parties and key personnel, protection of proprietary technology, compliance with government regulations, and the ability to secure additional capital to fund operations.

The current global macro-economic environment is volatile, which may result in supply chain constraints and elevated rates of inflation. In addition, we operate in a dynamic and highly competitive industry and believe that changes in any of the following areas could have a material adverse effect on our future financial position, results of operations, or cash flows: the ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval, market acceptance and third-party payor coverage for our products; development of sales channels; certain strategic relationships; litigation or claims against us, including claims related to intellectual property, product, regulatory, or other matters; and our ability to attract and retain employees necessary to support our growth.

Product candidates we develop require approval from the FDA and/or other international regulatory agencies prior to commercial sales. There can be no assurance that our product candidates will receive the necessary approvals or, if we do, the indications for which our products will be approved. If we are denied approval, approval is delayed, approval is for less than all of the indications we are seeking, or we are unable to maintain approval, it could have a material adverse impact on our business, financial position and results of operations.

We rely on single source manufacturers and suppliers for the supply of our product candidates, adding to the manufacturing risks we face. In the event of any failure by a supplier, we could be left without backup facilities. Any disruption from these manufacturers or suppliers could have a negative impact on our business, financial position and results of operations.

Liquidity and Going Concern

In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are issued. We have financed our growth and operations through a combination of funds generated from revenues, the issuance of convertible preferred stock and common stock, bank borrowings, bank borrowings with warrants, the issuance of convertible notes and warrants, and other long-term debt. Since inception, we have incurred recurring operating losses, including a net loss of $38.4 million for the three months ended March 31, 2025. As of March 31, 2025, we had an accumulated deficit of $595.8 million.

We expect to incur significant expenses, operating losses, and negative cash flows from operations for the foreseeable future as we advance our product candidates through clinical trials, seek regulatory approval of such product candidates and pursue commercialization of any approved product candidates. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if our development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales. Additionally, the revenue interest financing agreement with HealthCare Royalty Partners IV, L.P. (“HCR”) dated January 9, 2023, as amended (the “HCR Agreement”) contains fixed quarterly payments and minimum cash covenants that require us to maintain cash and cash equivalents in an amount at least equal to $15.0 million for the remainder of the payment term, which based on amounts funded as of March 31, 2025, is expected to conclude in 2031.

Our future funding requirements will be heavily determined by the timing of the potential commercialization of YUTREPIA and the resources needed to support development of our product candidates. Based on current operating plans and excluding any external financing and potential YUTREPIA sales, we will not have sufficient cash and cash equivalents to fund operating expenses and capital requirements and meet our minimum cash covenants beyond one year from the issuance of these consolidated financial statements, and therefore, we have concluded that there is substantial

doubt about our ability to continue as a going concern. Without factoring in potential cash generated from the sales of YUTREPIA and the additional contingent tranche that would become available under the HCR Agreement following first commercial sale and approval of YUTREPIA in PAH and PH-ILD, we will require additional funding over the next twelve months to continue our operations and maintain compliance with debt covenants, and could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or commercialization efforts, which could adversely affect our business prospects, or potentially force us to cease operations.

Stock-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Total stock-based compensation expense	$ 7,438	$ 4,524
Cost of Revenue
Total stock-based compensation expense	149	64
Research and development
Total stock-based compensation expense	340	1,011
General and administrative
Total stock-based compensation expense	$ 6,949	$ 3,449

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements - Other (Details)		3 Months Ended	12 Months Ended
	Jul. 01, 2024 USD ($)	Mar. 31, 2025 USD ($) customer	Dec. 31, 2024 USD ($) customer
Inventory, Capitalized Cost		$ 16,600,000	$ 10,800,000
Impairment of long-lived assets		$ 0
Number of reporting units		1
Impairment of goodwill	$ 0
Credit Concentration Risk \| Accounts Receivable \| Customer One
Number of customers \| customer		1	1
Concentration risk, percentage		93.00%	95.00%

Contract Acquisition Costs and Intangible Asset (Tables)

3 Months Ended

Mar. 31, 2025

Contract Acquisition Costs and Intangible Asset

Schedule of contract acquisition costs and intangible asset


	March 31, 2025						December 31, 2024
	Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount		Gross Carrying Amount		Accumulated Amortization		Net Carrying Amount
Contract acquisition costs	$	12,980	$	(5,802)	$	7,178	$	12,980	$	(5,694)	$	7,286
Intangible asset	$	5,620	$	(2,512)	$	3,108	$	5,620	$	(2,464)	$	3,156

Leases

3 Months Ended

Mar. 31, 2025

Leases

Leases

11. Leases

We are party to a non-cancelable operating lease for our laboratory and office space in Morrisville, North Carolina. The lease expires on December 31, 2031, with an option to extend for an additional period of five years with appropriate notice. We have not included the optional extension period in the measurement of lease liabilities because it is not reasonably certain that we will exercise the option to extend. The payments under this lease are subject to escalation clauses. Operating lease cost is allocated between inventory, research and development, and general and administrative expenses based on the usage of the leased facilities. The related right-of-use assets are amortized on a straight-line basis over the lesser of the lease term or the estimated useful life of the asset.

Lease Balances, Costs, and Future Minimum Payments

Leases with an initial term of 12 months or less are not recorded on the balance sheet. As of March 31, 2025, we have not entered into any short-term leases. For lease agreements entered into or reassessed after the adoption of ASC 842 Leases, we combine lease and non-lease components, if any. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants.

Our lease cost is reflected in the accompanying condensed statements of operations and comprehensive loss as follows:


		Three Months Ended March 31,
	Classification	2025		2024
Operating lease cost:
Fixed lease cost	General and administrative	$	314	$	19
Fixed lease cost	Research and development		—		175
Finance lease cost:
Amortization of lease assets	General and administrative		22		—
Amortization of lease assets	Research and development		—		22
Interest on lease liabilities	Interest expense		1		2
Total Lease Cost		$	337	$	218

The weighted average remaining lease term and discount rates as of March 31, 2025 were as follows:


Weighted average remaining lease term (years):
Operating leases	6.8
Weighted average discount rate:
Operating leases	15.2	%

The discount rate for leases was estimated based upon market rates of collateralized loan obligations of comparable companies on comparable terms at the time of lease inception.

The future minimum operating lease payments as of March 31, 2025, were as follows:



Year ending December 31:	Total
2025 (nine months remaining)	$	1,029
2026		1,442
2027		1,643
2028		1,692
2029		1,743
Thereafter		3,644
Total minimum lease payments		11,193
Less: interest		(4,335)
Present value of lease liabilities	$	6,858

Revenue From Contracts With Customers

3 Months Ended

Mar. 31, 2025

Revenue From Contracts With Customers

Revenue From Contracts With Customers

10. Revenue From Contracts With Customers

In August 2018, we entered into a Promotion Agreement with Sandoz under which we have the exclusive rights to conduct commercial activities to encourage the appropriate use of Treprostinil Injection for the treatment of patients with PAH in the United States. We paid Sandoz $20 million at the inception of the Promotion Agreement in consideration for these rights. In exchange for conducting these commercial activities, we are entitled to receive a share of Net Profits (as defined within the Promotion Agreement) based on specified profit levels. The share of Net Profits received is subject to adjustments from Sandoz for certain items, such as distributor chargebacks, rebates, inventory returns, inventory write-offs and other adjustments. We expect to refund certain amounts to Sandoz through a reduction of the cash received from future Net Profits generated under the Promotion Agreement. As of March 31, 2025 and December 31, 2024, a $0.9 million and $2.0 million refund liability, respectively, is offset against accounts receivable from Sandoz related to expected refund amounts. Approximately, 100% and 99% of revenue during the three months ended March 31, 2025 and 2024, respectively, was generated from the Promotion Agreement.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-10

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

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+ Details

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
Revenue	$ 3,120	$ 2,972
Costs and expenses:
Cost of revenue	1,517	1,467
Research and development	6,966	10,057
General and administrative	30,062	20,249
Total costs and expenses	38,545	31,773
Loss from operations	(35,425)	(28,801)
Other income (expense):
Interest income	1,728	1,880
Interest expense	(4,670)	(3,162)
Total other expense, net	(2,942)	(1,282)
Net loss and comprehensive loss	$ (38,367)	$ (30,083)
Net loss per common share, basic (in dollars per share)	$ (0.45)	$ (0.4)
Net loss per common share, diluted (in dollars per share)	$ (0.45)	$ (0.4)
Weighted average common shares outstanding, basic (in shares)	85,172,696	75,393,907
Weighted average common shares outstanding, diluted (in shares)	85,172,696	75,393,907

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Dec. 31, 2024
Accrued Expenses and Other Current Liabilities
Accrued compensation	$ 6,276	$ 10,251
Accrued research and development expenses	902	2,495
Accrued inventory costs	1,508	1,641
Accrued other expenses	5,155	4,272
Total accrued expenses and other current liabilities	$ 13,841	$ 18,659

Leases - Other (Details)	3 Months Ended
Leases - Other (Details)	Mar. 31, 2025
Leases
Renewal term	5 years
Lessee, Operating Lease, Existence of Option to Extend [true false]	true

Long-term Debt - Terms (Details)									3 Months Ended	12 Months Ended
Long-term Debt - Terms (Details)	Mar. 17, 2025 USD ($)	Sep. 12, 2024 USD ($)	Sep. 11, 2024	Jan. 05, 2024 USD ($)	Jan. 03, 2024	Jul. 27, 2023 USD ($)	Jan. 27, 2023 USD ($)	Jan. 09, 2023 USD ($)	Mar. 31, 2025 USD ($)	Dec. 31, 2023 USD ($)	Dec. 31, 2024 USD ($)
Long-Term Debt
Revenue interest financing payable, current									$ 37,625,000		$ 18,016,000
Discount on long-term debt									$ 900,000
A&R Silicon Valley Bank Term Loan
Long-Term Debt
Amount of debt repaid with initial investment from RIFA							$ 22,200,000
Loss on extinguishment of debt										$ 2,300,000
Revenue Interest Financing Agreement
Long-Term Debt
RIFA, maximum investment amount								$ 100,000,000
RIFA, initial investment amount							$ 32,500,000
RIFA, Hard Cap percentage								175
Percentage of investment amount to be repaid on final approval								100
Percentage of investment amount to be paid								100
Minimum cash and cash equivalents required to be maintained during next year								$ 15,000,000
Effective interest rate percentage								17.30%	15.80%
Revenue Interest Financing Agreement \| On first funded portion of investment amount
Long-Term Debt
RIFA, internal rate of return								18.00%
RIFA, total amount funded								$ 67,500,000
Revenue Interest Financing Agreement \| On Third Portion Of Funded Investment Amount
Long-Term Debt
RIFA, internal rate of return								13.00%
RIFA, total amount funded								$ 50,000,000
Revenue Interest Financing Agreement \| On Fourth Portion Of Funded Investment Amount
Long-Term Debt
RIFA, internal rate of return								12.00%
RIFA, total amount funded								$ 25,000,000
Revenue Interest Financing Agreement \| On second portion of funded investment amount
Long-Term Debt
RIFA, internal rate of return								16.00%
RIFA, total amount funded								$ 57,500,000
Second and Third Amendments to Revenue Interest Financing Agreement
Long-Term Debt
Amount funded under the second tranche						$ 10,000,000
Effective interest rate percentage						17.20%
Fourth Amendment to Revenue Interest Financing Agreement
Long-Term Debt
Amount funded under the second tranche				$ 25,000,000
Effective interest rate percentage					18.00%
Fifth Amendment to Revenue Interest Financing Agreement
Long-Term Debt
Amount funded under the second tranche		$ 32,500,000
Effective interest rate percentage			16.00%
Sixth Amendment to Revenue Interest Financing Agreement
Long-Term Debt
Revenue interest financing agreement	$ 100,000,000
Number of tranches	3
RIFA, total amount funded	$ 25,000,000
Effective interest rate percentage	15.80%

Leases - Cost (Details) - USD ($) $ in Thousands	3 Months Ended
Leases - Cost (Details) - USD ($) $ in Thousands	Mar. 31, 2025	Mar. 31, 2024
Leases
Total Lease Cost	$ 337	$ 218
Research and development
Leases
Fixed lease cost		175
Amortization of lease assets		22
General and administrative
Leases
Fixed lease cost	314	19
Amortization of lease assets	22
Interest Expense
Leases
Interest on lease liabilities	$ 1	$ 2

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements

3 Months Ended

Mar. 31, 2025

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements

Basis of Presentation, Significant Accounting Policies and Fair Value Measurements

2. Basis of Presentation, Significant Accounting Policies and Fair Value Measurements

Basis of Presentation

Consolidation

Use of Estimates

Revision of Previously Issued Financial Statements

A summary of the revisions to certain financial statement line items as of and for the three months ended March 31, 2024 in the condensed consolidated financial statements is presented below:

Condensed Consolidated Balance Sheet


	March 31, 2024
	As Previously Reported		Adjustment		As Revised
Long-term debt, noncurrent	$	80,205	$	(10,845)	$	69,360
Total liabilities	$	110,856	$	(10,845)	$	100,011
Accumulated deficit	$	(470,026)	$	10,845	$	(459,181)
Total stockholders’ equity	$	86,260	$	10,845	$	97,105

Condensed Consolidated Statement of Operations and Comprehensive Loss



	Three Months Ended March 31, 2024
	As Previously Reported		Adjustment		As Revised
Interest expense	$	(2,524)	$	(638)	$	(3,162)
Loss on extinguishment of debt	$	(11,483)	$	11,483	$	—
Total other expense, net	$	(12,127)	$	10,845	$	(1,282)
Net loss and comprehensive loss	$	(40,928)	$	10,845	$	(30,083)
Net loss per common share, basic and diluted	$	(0.54)	$	0.14	$	(0.40)

Summary of Significant Accounting Policies

Our significant accounting policies are disclosed in Note 2 “Basis of Presentation, Significant Accounting Policies and Fair Value Measurements” of the consolidated financial statements for the years ended December 31, 2024 and 2023, which are included in Exhibit 99.1 to our Current Report on Form 8-K filed on May 8, 2025. There have been no material changes to our significant accounting policies during the three months ended March 31, 2025.

Recent Accounting Pronouncements

Cash, Cash Equivalents, and Concentration of Credit Risk

We consider all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents.

Accounts Receivable

Prelaunch Inventory

Long-Lived Assets

Goodwill

than not that the fair value of a reporting unit is greater than its carrying amount, in which case a quantitative impairment test is not required.

Long-term Debt

Revenue Recognition

●

Step 1: Identify the contract with the customer

●

Step 2: Identify the performance obligations in the contract

●

Step 3: Determine the transaction price

●

Step 4: Allocate the transaction price to the performance obligations in the contract

●

Step 5: Recognize revenue when the company satisfies a performance obligation

In order to identify the performance obligations in a contract with a customer, we assess the promised goods or services in the contract and identify each promised good or service that is distinct.

If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct.

potential returns and refunds, and whether consideration contains a significant financing element in determining the transaction price.

Research and Development Expense

Accrued Research and Development Expenses

Stock-Based Compensation

Net Loss Per Share


	Three Months Ended
	March 31,
	2025	2024
Stock Options	8,949,015	9,571,521
Restricted Stock Units	4,836,839	2,982,485
Warrants	450,000	450,000
Total	14,235,854	13,004,006

Certain common stock warrants are included in the calculation of basic and diluted net loss per share since their exercise price is de minimis.

Fair Value Measurements

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

Level 2 — Inputs other than quoted prices included in active markets that are observable for the asset or liability, either directly or indirectly; and

Level 3 — Unobservable inputs for the asset and liability used to measure fair value, to the extent that observable inputs are not available.

Quoted

Significant

Prices in

Other

Significant

Active

Observable

Unobservable

Markets

Inputs

Carrying

March 31, 2025

(Level 1)

(Level 2)

(Level 3)

Value

Money market funds (cash equivalents)

163,945

—

163,945

Quoted

Significant

Prices in

Other

Significant

Active

Observable

Unobservable

Markets

Inputs

Carrying

December 31, 2024

(Level 1)

(Level 2)

(Level 3)

Value

Money market funds (cash equivalents)

170,672

—

170,672

Other Fair Value Disclosures


	March 31, 2025				December 31, 2024
	Carrying Value		Fair Value		Carrying Value		Fair Value
Long-term debt, including amounts due within one year	$	140,807	$	155,000	$	113,284	$	110,174

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2025
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Stockholders' Equity

3 Months Ended

Mar. 31, 2025

Stockholders' Equity

Stockholders' Equity

8. Stockholders’ Equity

Common Stock

Issuance of Common Stock on September 11, 2024 from an Underwritten Public Offering and Private Placement

In September 2024, we sold 6,460,674 shares of our common stock in an underwritten registered public offering at an offering price of $8.90 per share (the “2024 Offering”) for gross proceeds of approximately $57.5 million, before deducting offering costs of approximately $3.8 million.

A fund affiliated with Paul B. Manning, a member of our Board of Directors, participated in the 2024 Offering and purchased shares of common stock in an aggregate amount of approximately $3.0 million at the public offering price per share and on the same terms as the other purchasers in the 2024 Offering.

Concurrently with the 2024 Offering referenced above, we entered into a common stock purchase agreement with funds managed by Caligan Partners LP (“Caligan”), our largest stockholder, for the sale by us in a private placement of an aggregate of 1,123,595 shares of our common stock at a purchase price of $8.90 per share for gross and net proceeds of approximately $10.0 million.

Issuance of Common Stock on January 4, 2024 from a Private Placement

On January 4, 2024, we entered into a common stock purchase agreement with Legend Aggregator, LP for the sale by us in a private placement (the “2024 Private Placement”) of an aggregate of 7,182,532 shares of our common stock at a purchase price of $10.442 per share. The 2024 Private Placement closed on January 8, 2024, and we received gross proceeds of approximately $75.0 million, before deducting offering costs of less than $0.1 million.

Warrants

During the three months ended March 31, 2025 and 2024, zero and 948 warrants to purchase shares of common stock were exercised, respectively. Outstanding warrants consisted of the following as of March 31, 2025:


Number of
warrants	Exercise Price		Expiration Date
250,000	$	5.14	January 6, 2032
100,000	$	3.05	February 26, 2031
100,000	$	n/a¹	February 26, 2031
56,397	$	0.02	December 31, 2026

- Definition

The entire disclosure for equity.

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+ Details

Segment Information

3 Months Ended

Mar. 31, 2025

Segment Information

Segment Information

15. Segment Information

We operate as a single business segment focused on the development, manufacture, and commercialization of products that address unmet patient needs, with current focus directed towards rare cardiopulmonary diseases such as PAH and PH-ILD. The determination of a single business segment is consistent with the consolidated financial information

regularly reviewed by our Chief Executive Officer, the chief operating decision maker (“CODM”), in assessing segment performance and deciding how to allocate resources on a consolidated basis. The accounting policies of the segment are the same as those described in the summary of significant accounting policies.

The CODM measures segment profit and loss by net loss as reported in the consolidated income statements. The CODM uses net loss to monitor budget and forecast versus actual results to assess segment performance and to allocate resources across the organization. The measure of segment assets is reported on the consolidated balance sheet as total assets.

The following table summarizes segment revenue, segment loss, and significant segment expenses regularly reported to the CODM during the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025		2024
Revenue		3,120		2,972
Cost of revenue		1,517		1,467
Program expenses ⁽¹⁾
YUTREPIA		9,758		6,630
L606		3,268		1,578
Generic Treprostinil		151		203
Total program expenses		13,177		8,411
Non-program expenses ⁽²⁾		3,770		6,350
Personnel, including stock-based compensation		20,081		15,545
Loss from operations		(35,425)		(28,801)
Other income (expense), net		(2,942)		(1,282)
Net loss		(38,367)		(30,083)

(1)

Includes external research and development and general and administrative expenses

(2)

Includes professional service fees, facilities & infrastructure expenses, insurance, depreciation & amortization, and other corporate expenses

- Definition

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

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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Section 50
-Paragraph 32
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

+ Details

Stock-Based Compensation - Other (Details) - shares		1 Months Ended	3 Months Ended		12 Months Ended
Stock-Based Compensation - Other (Details) - shares	Jan. 01, 2025	Nov. 30, 2020	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024	Jan. 25, 2022
Granted, number (in shares)			2,585,400
Employee Stock Option
Share-based compensation arrangement by share-based payment award, award vesting period			4 years
Restricted Stock Units
Share-based compensation arrangement by share-based payment award, award vesting period			4 years
Restricted Stock Units \| Director
Share-based compensation arrangement by share-based payment award, award vesting period			1 year
Performance Based Restricted Stock Units
Granted, number (in shares)			749,793		520,526
Common Stock
Issuance of common stock under employee stock purchase plan (in shares)			117,320	67,982
Share-based Payment Arrangement, Tranche One \| Performance Based Restricted Stock Units
Share-based compensation arrangement by share-based payment award, award vesting period			1 year		1 year
Share-based compensation arrangement by share-based payment award, award vesting rights, percentage			25.00%		25.00%
Share-based Payment Arrangement, Tranche Two \| Performance Based Restricted Stock Units
Share-based compensation arrangement by share-based payment award, award vesting period			3 years		3 years
The 2020 Plan
Share-based compensation arrangement by share-based payment award, percent annual increase in capital shares reserved for future issuance			4.00%
Share-based compensation arrangement by share-based payment award, number of additional shares authorized (in shares)	3,387,323
Share-based compensation arrangement by share-based payment award, number of shares available for grant (in shares)			1,762,333
Common stock, capital shares reserved for future issuance (in shares)			429,694
2022 Inducement Plan
Common stock, capital shares reserved for future issuance (in shares)			27,608			310,000
Employee Stock Purchase Plan
Common stock, capital shares reserved for future issuance (in shares)			567,422
Percentage of the number of shares of common stock issued and outstanding		1.00%
Number of common stock shares outstanding		150,000
Available of issuance under the ESPP	150,000
Share-based compensation arrangement by share-based payment award, purchase price of common stock, percent			85.00%
Issuance of common stock under employee stock purchase plan (in shares)			117,320	67,982