Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update

Key Terms

biologics license application (bla) regulatory

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

priority review regulatory

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

prescription drug user fee act (pdufa) regulatory

The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.

marketing authorization applications (maas) regulatory

Marketing authorization applications (MAAs) are formal requests submitted to health regulators asking for permission to sell a medicine or medical product in a particular market. Investors track MAAs like a company’s “license application” because approval opens the door to legal sales and revenue, while delays or rejections can sharply reduce expected future earnings—similar to a business waiting for a permit before it can start operating.

european medicines agency (ema) regulatory

The European Medicines Agency (EMA) is a public organization responsible for evaluating and supervising medicines used in Europe to ensure they are safe and effective. For investors, the EMA's decisions can influence pharmaceutical companies' success, regulatory approvals, and the availability of new treatments, all of which can impact the value of related stocks and industry trends.

medicines and healthcare products regulatory agency (mhra) regulatory

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency that assesses, approves and monitors medicines, medical devices and vaccines to make sure they are safe and work as claimed. For investors, MHRA rulings are like a building inspector’s stamp: approvals can open markets and boost a company’s prospects, while safety warnings, recalls or delayed clearances can cut revenue and raise risk.

orphan drug designation regulatory

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

breakthrough therapy designations regulatory

A breakthrough therapy designation is a special status granted by a regulatory agency to a drug or treatment that shows strong early signs of being substantially better than current options for a serious illness; it gives the developer faster and more intensive guidance during testing and review. For investors, the designation can shorten time to market, lower development risk and costs, and increase the odds of a valuable approval — like giving a promising product a fast-pass through the approval process.

• Achieved Regulatory Milestones for the MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Development Program:
  • U.S. Food and Drug Administration (FDA) filed the Biologics License Application (BLA)
  • Priority Review granted, Prescription Drug User Fee Act (PDUFA) date set for August 22, 2026
  • FDA indicated an Advisory Committee is not planned for the BLA
  • Submitted Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
    
    

• With ~$236M in Cash and Short-Term Investments as of December 31, 2025, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company is Well Capitalized for Launch

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update.

“Over the last year, we significantly advanced the MOLBREEVI development program,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “With the filing of the BLA, an assigned PDUFA date of August 22^nd, and submission of the MAAs we have strong momentum. U.S. commercial planning is underway, most notably with the onboarding of a market development team that will be complete in the second quarter. With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval, we can fund global commercial launch activities. Strong financial flexibility combined with meaningful near-term catalysts means we enter 2026 in a position of strength and confidence.”

In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA.

Fourth Quarter Financial Results (Unaudited)

Savara's net loss for the fourth quarter of 2025 was $32.2 million, or $(0.13) per share, compared with a net loss of $29.0 million, or $(0.13) per share, for the fourth quarter of 2024.

Research and development expenses for the fourth quarter of 2025 and 2024 were $20.9 million and $23.3 million, respectively.

General and administrative expenses for the fourth quarter of 2025 and 2024 were $12.5 million and $7.8 million, respectively.

As of December 31, 2025, the Company had cash, cash equivalents and short-term investments of $235.7 million.

Fiscal Year 2025 Financial Results

The Company’s net loss for the year ended December 31, 2025 was $118.8 million, or $(0.53) per share, compared with a net loss of was $95.9 million, or $(0.48) per share for the year ended December 31, 2024.

Research and development expenses increased $3.4 million, or 4.3%, to $81.4 million for the year ended December 31, 2025 from $78.0 million for the year ended December 31, 2024. This increase was primarily due to the performance of tasks related to our MOLBREEVI program, which includes $5.7 million of costs related to regulatory affairs and quality assurance, primarily driven by the BLA submission; $0.5 million of costs related to our chemistry, manufacturing, and controls activities; and $1.0 million other departmental overhead, partially offset by a decrease of $3.8 million in clinical costs.

General and administrative expenses increased $17.0 million, or 68.0%, to $42.1 million for the year ended December 31, 2025 from $25.0 million for the year ended December 31, 2024. The increase was due to higher personnel and related costs, in terms of compensation and an increase in valuation and stock awards, driven by strategic workforce expansion to support and scale operations of $11.2 million; certain additional commercial activities of $3.1 million; and other overhead of $2.7 million primarily driven by expanded patient advocacy and medical affairs activities.

About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

About Savara

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow^® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.

*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.

Forward-Looking Statements

Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the timing of the PDUFA date and potential FDA approval for MOLBREEVI, that Savara has access to up to ~$150M of non-dilutive capital upon FDA approval of MOLBREEVI, that the Company is well capitalized for launch and can fund global launch activities, and that onboarding of a market development team that will be complete in the second quarter. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

Financial Information to Follow

Savara Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except for share and per share amounts)
	(Unaudited)
	Three months ended								Twelve months ended
	December 31,								December 31,
		2025				2024				2025				2024
Operating expenses:
Research and development	$	20,902			$	23,294			$	81,404			$	78,029
General and administrative		12,491				7,848				42,056				25,037
Depreciation and amortization		26				32				87				130
Total operating expenses		33,419				31,174				123,547				103,196
Loss from operations		(33,419	)			(31,174	)			(123,547	)			(103,196	)
Other income, net:		1,183				2,130				4,710				7,315
Net loss attributable to common stockholders	$	(32,236	)		$	(29,044	)		$	(118,837	)		$	(95,881	)
Net loss per share - basic and diluted	$	(0.13	)		$	(0.13	)		$	(0.53	)		$	(0.48	)
Weighted average shares - basic and diluted		240,309,306				215,446,265				222,387,531				198,191,936
Other comprehensive income (loss)		68				(1,049	)			663				(479	)
Total comprehensive loss	$	(32,168	)		$	(30,093	)		$	(118,174	)		$	(96,360	)

Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data
(in thousands)
	December 31,			December 31,
	2025			2024
Cash, cash equivalents, and short-term investments	$	235,702		$	196,327
Working capital		221,220			187,411
Total assets		253,436			212,879
Total liabilities		50,303			41,430
Stockholders’ equity		203,133			171,449

 

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Media and Investor Relations Contact

Savara Inc.

Temre Johnson, Executive Director, Corporate Affairs

ir@savarapharma.com

Source: Savara Inc.