Savara Reports Third Quarter 2024 Financial Results and Provides Business Update
Savara Inc. (SVRA) reported Q3 2024 financial results and business updates. The company plans to initiate a rolling BLA submission for MOLBREEVI by year-end, with completion expected by end of Q1 2025. The company reported a net loss of $24.2 million ($0.11 per share) compared to $16.6 million in Q3 2023. R&D expenses increased 46.5% to $20.3 million, while G&A expenses rose 45% to $6.0 million. With approximately $219.4 million in cash and short-term investments, Savara believes it is capitalized through Q2 2027.
Savara Inc. (SVRA) ha riportato i risultati finanziari per il terzo trimestre del 2024 e aggiornamenti aziendali. L'azienda prevede di avviare una presentazione BLA progressiva per MOLBREEVI entro la fine dell'anno, con completamento previsto entro la fine del primo trimestre del 2025. L'azienda ha registrato una perdita netta di 24,2 milioni di dollari (0,11 dollari per azione) rispetto a 16,6 milioni di dollari nel terzo trimestre del 2023. Le spese per R&S sono aumentate del 46,5% a 20,3 milioni di dollari, mentre le spese generali e amministrative sono aumentate del 45% a 6,0 milioni di dollari. Con circa 219,4 milioni di dollari in contante e investimenti a breve termine, Savara ritiene di avere capitale sufficiente fino al secondo trimestre del 2027.
Savara Inc. (SVRA) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones comerciales. La empresa planea iniciar una presentación gradual de BLA para MOLBREEVI antes de fin de año, con un completado esperado para finales del primer trimestre de 2025. La compañía reportó una pérdida neta de 24.2 millones de dólares (0.11 dólares por acción) en comparación con 16.6 millones de dólares en el tercer trimestre de 2023. Los gastos en I+D aumentaron un 46.5% a 20.3 millones de dólares, mientras que los gastos generales y administrativos crecieron un 45% a 6.0 millones de dólares. Con aproximadamente 219.4 millones de dólares en efectivo e inversiones a corto plazo, Savara cree que tiene capital suficiente hasta el segundo trimestre de 2027.
사바라 Inc. (SVRA)가 2024년 3분기 재무 보고서 및 비즈니스 업데이트를 발표했습니다. 이 회사는 연말까지 MOLBREEVI에 대한 점진적인 BLA 제출을 시작할 계획이며, 2025년 1분기 말까지 완료될 것으로 예상하고 있습니다. 이 회사는 2023년 3분기 1,660만 달러와 비교하여 2,420만 달러의 순손실(주당 0.11달러)을 기록했습니다. 연구 개발비는 46.5% 증가하여 2,030만 달러에 달했고, 일반 및 관리비는 45% 증가하여 600만 달러에 이르렀습니다. 사바라는 약 2억 1,940만 달러의 현금 및 단기 투자 자산을 보유하고 있으며, 2027년 2분기까지 자본이 충분할 것이라고 믿고 있습니다.
Savara Inc. (SVRA) a annoncé les résultats financiers du troisième trimestre 2024 ainsi que des mises à jour sur ses activités. La société prévoit de commencer une soumission BLA progressive pour MOLBREEVI d'ici la fin de l'année, avec une achèvement prévu d'ici la fin du premier trimestre 2025. La société a enregistré une perte nette de 24,2 millions de dollars (0,11 dollar par action) par rapport à 16,6 millions de dollars au troisième trimestre 2023. Les dépenses de R&D ont augmenté de 46,5% pour atteindre 20,3 millions de dollars, tandis que les frais généraux et administratifs ont augmenté de 45% pour atteindre 6,0 millions de dollars. Avec environ 219,4 millions de dollars en espèces et investissements à court terme, Savara estime être capitalisée jusqu'au deuxième trimestre 2027.
Savara Inc. (SVRA) hat die finanziellen Ergebnisse und Unternehmensupdates für das dritte Quartal 2024 veröffentlicht. Das Unternehmen plant, bis zum Ende des Jahres eine schrittweise BLA-Einreichung für MOLBREEVI zu beginnen, mit einem Abschluss, der bis Ende des ersten Quartals 2025 erwartet wird. Das Unternehmen berichtete von einem Nettoverlust von 24,2 Millionen Dollar (0,11 Dollar pro Aktie) im Vergleich zu 16,6 Millionen Dollar im dritten Quartal 2023. Die F&E-Ausgaben stiegen um 46,5% auf 20,3 Millionen Dollar, während die allgemeinen und Verwaltungskosten um 45% auf 6,0 Millionen Dollar zulegten. Mit etwa 219,4 Millionen Dollar in Bar und kurzfristigen Anlagen glaubt Savara, dass es bis zum zweiten Quartal 2027 kapitalisierten ist.
- Strong cash position of $219.4M providing runway through Q2 2027
- Accelerated BLA submission timeline from 1H 2025 to end of Q1 2025
- Potential to be first approved therapeutic for aPAP in US and Europe
- Net loss increased to $24.2M from $16.6M YoY
- R&D expenses increased 46.5% to $20.3M
- G&A expenses rose 45% to $6.0M
Insights
The Q3 results reveal significant strategic and financial developments for Savara. The
The robust cash position of
The accelerated regulatory timeline for MOLBREEVI represents a significant milestone in addressing an unmet medical need in aPAP treatment. The planned rolling BLA submission strategy, coupled with potential priority review, could expedite market access for the first approved therapeutic option in this rare disease space. The parallel pursuit of U.S. and European approvals demonstrates strong clinical development execution and global market potential.
The investment in establishing a second drug substance manufacturer strengthens the supply chain infrastructure, important for serving the rare disease population reliably. The ongoing pediatric study further expands the potential patient population and therapeutic reach.
Recently Completed Pre-BLA Meeting with FDA for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Company Plans to Initiate Biologics License Application (BLA) Rolling Submission by End of Year
Updates Guidance on MOLBREEVI BLA Submission Completion Date to End of 1Q 2025 from 1H 2025 – Intends to Request Priority Review
Expects to Submit MOLBREEVI Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) by End of 2025
With
“After a productive pre-BLA meeting with the FDA, we are working diligently to initiate a rolling submission for MOLBREEVI by the end of this year, with plans to complete the BLA submission by the end of 1Q 2025—thus enabling a potential approval in the
Third Quarter Financial Results (Unaudited)
Savara's net loss for the third quarter of 2024 was
Research and development expenses increased by
General and administrative expenses increased by
As of September 30, 2024, the Company had cash, cash equivalents and short-term investments of
About aPAP
Autoimmune PAP (aPAP) is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli (or air sacs) 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 autoimmune PAP, 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. (X, formerly known as Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals).
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 anticipated timing of our BLA submission and the potential timing for approval if priority review is granted, statements related to the anticipated timing of our MAA submission, statements related to the build-out of our commercial capabilities and our ongoing market development initiatives, and our expectation the Company is sufficiently capitalized through the second quarter of 2027. 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.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution.
Financial Information to Follow
Savara Inc. and Subsidiaries |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(in thousands, except for share and per share amounts) |
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Unaudited |
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2024 |
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|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| Operating expenses: | ||||||||||||||||
| Research and development | $ |
20,311 |
|
$ |
13,867 |
|
$ |
54,735 |
|
$ |
31,516 |
|
||||
| General and administrative |
|
6,013 |
|
|
4,147 |
|
|
17,189 |
|
|
10,816 |
|
||||
| Depreciation and amortization |
|
33 |
|
|
30 |
|
|
98 |
|
|
45 |
|
||||
| Total operating expenses |
|
26,357 |
|
|
18,044 |
|
|
72,022 |
|
|
42,377 |
|
||||
| Loss from operations |
|
(26,357 |
) |
|
(18,044 |
) |
|
(72,022 |
) |
|
(42,377 |
) |
||||
| Other income (expense), net: |
|
2,109 |
|
|
1,445 |
|
|
5,185 |
|
|
3,778 |
|
||||
| Net loss attributable to common stockholders | $ |
(24,248 |
) |
$ |
(16,599 |
) |
$ |
(66,837 |
) |
$ |
(38,599 |
) |
||||
| Net loss per share - basic and diluted | $ |
(0.11 |
) |
$ |
(0.10 |
) |
$ |
(0.35 |
) |
$ |
(0.25 |
) |
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| Weighted average shares - basic and diluted |
|
211,847,651 |
|
|
174,696,191 |
|
|
192,398,514 |
|
|
152,778,072 |
|
||||
| Other comprehensive loss |
|
1,179 |
|
|
(323 |
) |
|
570 |
|
|
(337 |
) |
||||
| Total comprehensive loss | $ |
(23,069 |
) |
$ |
(16,922 |
) |
$ |
(66,267 |
) |
$ |
(38,936 |
) |
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Savara Inc. and Subsidiaries |
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Condensed Consolidated Balance Sheet Data |
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(in thousands) |
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(Unaudited) |
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September 30, |
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December 31, |
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|
|
2024 |
|
2023 |
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| Cash, cash equivalents, and short-term investments | $ |
219,440 |
$ |
162,319 |
||
| Working capital |
|
213,607 |
|
155,350 |
||
| Total assets |
|
238,817 |
|
177,564 |
||
| Total liabilities |
|
39,468 |
|
37,192 |
||
| Stockholders’ equity: |
|
199,349 |
|
140,372 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20241112390854/en/
Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Source: Savara Inc.
FAQ
What was Savara's (SVRA) net loss in Q3 2024?
When does Savara (SVRA) plan to complete the MOLBREEVI BLA submission?
How much cash and short-term investments does Savara (SVRA) have as of Q3 2024?
When does Savara (SVRA) expect to submit the MOLBREEVI MAA to EMA?
