Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon U.S. Food and Drug Administration (FDA) Approval of MOLBREEVI*
Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon U.S. Food and Drug Administration (FDA) Approval of MOLBREEVI*
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.
A marketing authorization application (MAA) is a formal package submitted to a health regulator asking for permission to sell a medicine or medical product; it includes evidence about safety, effectiveness and how the product is made. Investors care because approval is the gate that allows a product to reach the market and generate revenue, so the status and timing of an MAA are key drivers of a company’s future sales prospects and valuation — like applying for a business license before opening a store.
priority reviewregulatory
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.
royalty financingfinancial
Royalty financing is a way for a business to raise money by selling a share of future revenue or product sales in exchange for upfront cash; the investor is paid back as the company earns money, like buying a claim on a slice of each future sale. It matters to investors because returns depend on the company’s actual sales rather than its profits or stock price, offering potential steady income if products perform well but carrying risk if revenue falls short.
autoimmune pulmonary alveolar proteinosismedical
A rare lung disease in which the tiny air sacs that exchange oxygen become filled with excess protein and fat, like a sponge clogged with foam so it can’t hold air properly. It matters to investors because it creates specific needs for diagnostics, treatments and long-term care; the rarity and complexity drive regulatory scrutiny, clinical trial risk and potential niche market opportunities for companies developing drugs or medical devices.
autoimmune papmedical
Autoimmune PAP is a rare lung disease in which the immune system produces antibodies that block a protein needed to clear surfactant, the material that lines air sacs; as a result, the sacs fill with excess fluid and debris and breathing becomes difficult. Investors should care because treatments, tests, and drugs that restore the clearing mechanism or remove the buildup can change patient outcomes and create commercial opportunities—think of it as repairing a clogged air filter in the lungs.
-- When Combined with Recently Announced $75M Royalty Financing, the Company Will Have Access to ~$150M of Non-Dilutive Capital for Launch of MOLBREEVI --
LANGHORNE, Pa.--(BUSINESS WIRE)--
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the amendment of its loan and security agreement with Hercules Capital, Inc. (NYSE:HTGC), strengthening its balance sheet and liquidity.
Under the terms of the amended loan agreement, up to an additional $75 million will become available upon FDA’s approval of MOLBREEVI, the Company’s investigational therapy in autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The loan agreement maturity date and interest-only period remain unchanged. There are no warrants in connection with the agreement.
“In anticipation of the potential approval of MOLBREEVI later this year, Savara will be well capitalized with ~$150 million of non-dilutive capital to support launch activities,” said Dave Lowrance, Chief Financial and Administrative Officer, Savara. “This includes the amended debt facility announced today combined with the strategic royalty financing from RTW announced in October last year.”
“Hercules Capital is thrilled to continue our partnership with Savara as they prepare for the potential launch of MOLBREEVI,” said Tom Hertzberg, Managing Director, Hercules Capital.
The Company resubmitted the MOLBREEVI Biologics License Application (BLA) to the FDA in December 2025. If Priority Review is granted, MOLBREEVI could potentially be approved in 3Q 2026. The Company remains on track to file the Marketing Authorization Applications (MAA) for MOLBREEVI in Europe and the U.K. by the end of 1Q 2026.
In October 2025, Savara announced its entry into a $75 million royalty funding agreement, subject to FDA approval of MOLBREEVI, with RTW to support the potential launch of MOLBREEVI.
“We have shown strong operational excellence over the last few quarters and believe that positive momentum will continue,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “The Company resubmitted the MOLBREEVI BLA to the FDA, completed a U.S. claims analysis that found the autoimmune PAP market to be ~50% larger than previously estimated, and closed strategic equity and royalty financings. We enter this potential launch year on strong financial footing, enabling us to accelerate commercial investment in MOLBREEVI, a potentially first-in-class therapy in 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 aPAP, GM-CSF is neutralized by antibodies 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 infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
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 a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. 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 potential impact of the amendment, including the funds available for the launch of MOLBREEVI when combined with the royalty financing with RTW, the impact of Priority Review and the timing of FDA approval for MOLBREEVI, that Savara will be well capitalized to support launch activities, the anticipated timing of the MAA submissions in Europe and the UK, our belief that positive momentum will continue, that Savara’s financial footing will enable us to accelerate commercial investment in MOLBREEVI, and that MOLBREEVI is a potential first-in-class therapy for aPAP. 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; 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.
