Savara Enters Into Non-Dilutive Debt Financing for up to $200M With Hercules Capital
Savara Inc. (SVRA) has secured a non-dilutive debt financing agreement with Hercules Capital for up to $200 million. The initial $30 million will refinance existing debt, with an additional $100 million available upon FDA approval of MOLBREEVI and certain milestones. The remaining $70 million can be accessed at Hercules' discretion.
The five-year loan agreement features a 36-month interest-only period, extendable to 60 months upon FDA approval of MOLBREEVI. This financing follows Savara's Biologics License Application submission to the FDA for MOLBREEVI, a potential first-in-class therapy for autoimmune pulmonary alveolar proteinosis (aPAP). With Priority Review, approval could come by year-end, coinciding with planned European Marketing Authorization Application submission.
Savara Inc. (SVRA) ha ottenuto un accordo di finanziamento debitorio non diluitivo con Hercules Capital per un massimo di 200 milioni di dollari. I primi 30 milioni serviranno a rifinanziare il debito esistente, con ulteriori 100 milioni disponibili all'approvazione da parte della FDA di MOLBREEVI e al raggiungimento di determinati obiettivi. I restanti 70 milioni possono essere accessibili a discrezione di Hercules.
L'accordo di prestito di cinque anni prevede un periodo di soli interessi di 36 mesi, estendibile a 60 mesi all'approvazione della FDA di MOLBREEVI. Questo finanziamento segue la presentazione da parte di Savara della domanda di licenza biologica alla FDA per MOLBREEVI, una potenziale terapia di prima classe per la proteinosi alveolare autoimmune (aPAP). Con la Revisione Prioritaria, l'approvazione potrebbe arrivare entro la fine dell'anno, in coincidenza con la prevista presentazione della domanda di autorizzazione al commercio in Europa.
Savara Inc. (SVRA) ha asegurado un acuerdo de financiamiento de deuda no dilutivo con Hercules Capital por hasta 200 millones de dólares. Los primeros 30 millones se destinarán a refinanciar la deuda existente, con otros 100 millones disponibles tras la aprobación de la FDA de MOLBREEVI y ciertos hitos. Los restantes 70 millones pueden ser accesibles a discreción de Hercules.
El acuerdo de préstamo a cinco años incluye un período de solo intereses de 36 meses, ampliable a 60 meses con la aprobación de la FDA de MOLBREEVI. Este financiamiento sigue a la presentación de Savara de la Solicitud de Licencia Biológica a la FDA para MOLBREEVI, una potencial terapia de primera clase para la proteinosis alveolar autoinmune (aPAP). Con la Revisión Prioritaria, la aprobación podría llegar a finales de año, coincidiendo con la presentación prevista de la Solicitud de Autorización de Comercialización en Europa.
Savara Inc. (SVRA)는 Hercules Capital와 최대 2억 달러의 비희석 채무 금융 계약을 체결했습니다. 초기 3천만 달러는 기존 채무를 재융자하는 데 사용되며, 추가 1억 달러는 MOLBREEVI의 FDA 승인 및 특정 이정표 달성 시 이용 가능합니다. 나머지 7천만 달러는 Hercules의 재량에 따라 접근할 수 있습니다.
5년 대출 계약은 36개월의 이자만 지불하는 기간을 포함하며, MOLBREEVI의 FDA 승인 시 60개월로 연장될 수 있습니다. 이 금융은 Savara가 MOLBREEVI에 대한 생물학적 라이센스 신청서를 FDA에 제출한 이후에 이루어졌으며, 이는 자가면역 폐포 단백증(aPAP)을 위한 잠재적 1세대 치료제입니다. 우선 심사를 통해 연말까지 승인이 이루어질 수 있으며, 이는 유럽 마케팅 승인 신청서 제출 계획과 일치합니다.
Savara Inc. (SVRA) a obtenu un accord de financement par emprunt non dilutif avec Hercules Capital pouvant atteindre 200 millions de dollars. Les premiers 30 millions serviront à refinancer la dette existante, avec 100 millions supplémentaires disponibles après l'approbation de la FDA de MOLBREEVI et l'atteinte de certains jalons. Les 70 millions restants peuvent être accessibles à la discrétion d'Hercules.
Le contrat de prêt de cinq ans comprend une période de paiement d'intérêts uniquement de 36 mois, pouvant être prolongée à 60 mois après l'approbation de la FDA de MOLBREEVI. Ce financement fait suite à la soumission par Savara de la demande de licence biologique à la FDA pour MOLBREEVI, une thérapie potentielle de première classe pour la protéinosis alvéolaire auto-immune (aPAP). Avec la Révision Prioritaire, l'approbation pourrait intervenir d'ici la fin de l'année, coïncidant avec la soumission prévue de la demande d'autorisation de mise sur le marché en Europe.
Savara Inc. (SVRA) hat eine nicht verwässernde Schuldenfinanzierungsvereinbarung mit Hercules Capital über bis zu 200 Millionen Dollar gesichert. Die ersten 30 Millionen werden zur Refinanzierung bestehender Schulden verwendet, während zusätzliche 100 Millionen nach der FDA-Zulassung von MOLBREEVI und bestimmten Meilensteinen verfügbar sind. Die verbleibenden 70 Millionen können nach Ermessen von Hercules abgerufen werden.
Die fünfjährige Darlehensvereinbarung sieht eine 36-monatige Zinszahlungsphase vor, die nach der FDA-Zulassung von MOLBREEVI auf 60 Monate verlängert werden kann. Diese Finanzierung folgt der Einreichung des Biologics License Application von Savara bei der FDA für MOLBREEVI, einer potenziellen Therapie der ersten Klasse für die autoimmune alveoläre Proteinosis (aPAP). Mit der Prioritätsprüfung könnte die Genehmigung bis zum Jahresende erfolgen, was mit der geplanten Einreichung des Antrags auf Marktzulassung in Europa zusammenfällt.
- Secured non-dilutive financing up to $200M, strengthening balance sheet without shareholder dilution
- Initial $30M received to refinance existing debt at favorable terms
- Additional $100M available upon FDA approval, supporting potential commercial launch
- Favorable loan terms with 36-60 month interest-only period and no warrants
- BLA submission completed with potential approval by year-end if granted Priority Review
- Additional $70M portion is subject to Hercules Capital's discretion
- Access to $100M tranche dependent on FDA approval and milestone achievements
Insights
Savara's
The deal structure offers several compelling advantages: immediate access to
The 36-month interest-only period (extendable to 60 months upon approval) provides substantial operational runway during the capital-intensive commercialization phase. Notably, the absence of warrants is uncommon in biotech financing deals and further protects shareholders from future dilution.
This financing significantly de-risks Savara's commercialization pathway for MOLBREEVI, particularly as the company transitions from development to potential commercialization. With BLA submission complete and possible FDA approval by year-end (if granted Priority Review), this capital infusion comes at a pivotal moment in the company's evolution.
Savara's debt financing arrives at a critical regulatory inflection point for MOLBREEVI, their potential first-in-class therapy for autoimmune pulmonary alveolar proteinosis (aPAP). The company has crossed the significant milestone of BLA submission to the FDA, with a Marketing Authorization Application for Europe planned by year-end.
The potential for Priority Review designation is particularly significant, as it could accelerate FDA approval to late 2025. Priority Review is typically granted to therapies addressing serious conditions with potential to provide significant improvements over available treatments - suggesting regulatory confidence in MOLBREEVI's clinical profile.
For rare respiratory diseases like aPAP, first-mover advantage is critical. As a potential first-in-class therapy, MOLBREEVI would likely face initial competition if approved, potentially commanding premium pricing and establishing treatment protocols that benefit the first approved therapy.
The structure of this financing cleverly aligns capital availability with regulatory milestones, with
This financing substantially de-risks the critical transition from clinical-stage to commercial operations, typically the most vulnerable period for emerging biotech companies.
Includes
“We’re pleased to partner with Hercules Capital as we work to get MOLBREEVI, a potential first-in-class therapy for aPAP, approved in the
“We are proud to support Savara during this transformative time for the company,” said Tom Hertzberg, Managing Director, Hercules Capital. “As Savara approaches their first potential approval with MOLBREEVI, providing this capital underscores our dedication and commitment to helping bring novel and life-changing therapies to market.”
Under the terms of this loan agreement,
About Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
aPAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. 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 exchange, 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 (aPAP). 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 impact of Priority Review and the timing of FDA approval for MOLBREEVI, the anticipated timing of our MAA submission, that MOLBREEVI is a potential first-in-class therapy for aPAP, and statements related to the potential impact of the debt financing. 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 aPAP; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250326230627/en/
Media and Investor Contact:
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Source: Savara Inc.
FAQ
What is the total value of Savara's (SVRA) debt financing agreement with Hercules Capital?
How much initial funding did SVRA receive and what will it be used for?
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What are the terms of SVRA's loan agreement with Hercules Capital?
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