Savara Reports Second Quarter 2024 Financial Results and Provides Business Update
Savara Inc. (Nasdaq: SVRA) reported positive top-line results from the IMPALA-2 Phase 3 trial of molgramostim for treating autoimmune pulmonary alveolar proteinosis (aPAP). The trial met its primary endpoint, showing statistically significant improvement in lung diffusing capacity at 24 weeks. Key secondary endpoints were also met, including improvements in respiratory quality of life.
The FDA conditionally accepted the trade name MOLBREEVI™ for molgramostim. Savara plans to complete the BLA submission in H1 2025. The company raised ~$100M in equity financing in July 2024, bringing its total cash position to over $200M, expected to fund operations through 2026.
For Q2 2024, Savara reported a net loss of $22.2M, or $(0.12) per share. R&D expenses increased 97.7% YoY to $17.6M, while G&A expenses rose 67.8% to $5.5M.
Savara Inc. (Nasdaq: SVRA) ha riportato risultati positivi dalla fase 3 dello studio IMPALA-2 riguardante molgramostim per il trattamento della proteinosi alveolare autoimmune (aPAP). Lo studio ha raggiunto il suo obiettivo primario, mostrando un miglioramento statisticamente significativo nella capacità di diffusione polmonare a 24 settimane. Anche gli obiettivi secondari chiave sono stati raggiunti, inclusi miglioramenti nella qualità della vita respiratoria.
La FDA ha accettato condizionatamente il nome commerciale MOLBREEVI™ per il molgramostim. Savara prevede di completare la sottomissione BLA nel primo semestre del 2025. L'azienda ha raccolto circa 100 milioni di dollari in finanziamenti azionari a luglio 2024, portando la sua posizione di liquidità a oltre 200 milioni di dollari, che si prevede finanzieranno le operazioni fino al 2026.
Per il secondo trimestre del 2024, Savara ha riportato una perdita netta di 22,2 milioni di dollari, pari a $(0,12) per azione. Le spese per ricerca e sviluppo sono aumentate del 97,7% rispetto all'anno precedente, raggiungendo 17,6 milioni di dollari, mentre le spese generali e amministrative sono aumentate del 67,8% fino a 5,5 milioni di dollari.
Savara Inc. (Nasdaq: SVRA) reportó resultados positivos de la fase 3 del ensayo IMPALA-2 de molgramostim para el tratamiento de la proteinosis alveolar autoinmune (aPAP). El ensayo cumplió su objetivo principal, mostrando una mejora estadísticamente significativa en la capacidad de difusión pulmonar a las 24 semanas. También se cumplieron los principales objetivos secundarios, incluidos los avances en la calidad de vida respiratoria.
La FDA aceptó condicionalmente el nombre comercial MOLBREEVI™ para molgramostim. Savara planea completar la presentación del BLA en el primer semestre de 2025. La compañía recaudó aproximadamente 100 millones de dólares en financiamiento de capital en julio de 2024, llevando su posición de efectivo a más de 200 millones de dólares, lo que se espera financie las operaciones hasta 2026.
Para el segundo trimestre de 2024, Savara reportó una pérdida neta de 22,2 millones de dólares, o $(0,12) por acción. Los gastos de I+D aumentaron un 97,7% interanual a 17,6 millones de dólares, mientras que los gastos generales y administrativos aumentaron un 67,8% a 5,5 millones de dólares.
Savara Inc. (Nasdaq: SVRA)는 자가 면역 폐 알베올 단백질증(aPAP) 치료를 위한 몰그램오스팀의 IMPALA-2 3상 임상시험에서 긍정적인 주요 결과를 보고했습니다. 이 시험은 주요 목표를 달성하였으며, 24주에서 폐의 확산 능력이 통계적으로 유의미하게 개선되었음을 보여주었습니다. 호흡기 삶의 질 향상 등 주요 2차 목표도 달성되었습니다.
FDA는 몰그램오스팀에 대한 상표명 MOLBREEVI™를 조건부로 승인했습니다. Savara는 2025년 상반기 내에 BLA 제출을 완료할 계획입니다. 이 회사는 2024년 7월에 약 1억 달러의 자본 조달을 완료하여 현금 보유액을 2억 달러 이상으로 늘렸으며, 이는 2026년까지 운영 자금을 지원할 것으로 예상됩니다.
2024년 2분기에는 Savara가 2천220만 달러의 순손실을 보고했으며, 주당 $(0.12)입니다. R&D 비용은 전년 대비 97.7% 증가하여 1천760만 달러에 달했고, 일반 관리 비용은 67.8% 증가하여 550만 달러에 이릅니다.
Savara Inc. (Nasdaq: SVRA) a annoncé des résultats positifs de la phase 3 de l'étude IMPALA-2 concernant molgramostim pour le traitement de la protéinosis alvéolaire auto-immune (aPAP). L'essai a atteint son objectif principal, montrant une amélioration statistiquement significative de la capacité de diffusion pulmonaire à 24 semaines. Les objectifs secondaires clés ont également été atteints, y compris des améliorations de la qualité de vie respiratoire.
La FDA a accepté de manière conditionnelle le nom commercial MOLBREEVI™ pour le molgramostim. Savara prévoit de finaliser la soumission du BLA au premier semestre 2025. La société a levé environ 100 millions de dollars en financement d'équité en juillet 2024, portant sa position de liquidités à plus de 200 millions de dollars, ce qui devrait financer les opérations jusqu'en 2026.
Pour le deuxième trimestre de 2024, Savara a enregistré une perte nette de 22,2 millions de dollars, soit $(0,12) par action. Les dépenses de R&D ont augmenté de 97,7 % d'une année sur l'autre pour atteindre 17,6 millions de dollars, tandis que les dépenses générales et administratives ont grimpé de 67,8 % pour atteindre 5,5 millions de dollars.
Savara Inc. (Nasdaq: SVRA) berichtete über positive Ergebnisse aus der IMPALA-2 Phase-3-Studie zu Molgramostim zur Behandlung der autoimmunen alveolären Proteinosis (aPAP). Die Studie erreichte ihr primäres Ziel, indem sie eine statistisch signifikante Verbesserung der Lungendiffusionskapazität nach 24 Wochen zeigte. Auch die wichtigsten sekundären Endpunkte wurden erreicht, darunter Verbesserungen der Lebensqualität in Bezug auf die Atmung.
Die FDA hat den Handelsnamen MOLBREEVI™ für Molgramostim bedingt akzeptiert. Savara plant, die BLA-Einreichung im ersten Halbjahr 2025 abzuschließen. Das Unternehmen hat im Juli 2024 rund 100 Millionen US-Dollar durch Eigenkapitalfinanzierung aufgebracht, wodurch sich die liquiden Mittel auf über 200 Millionen US-Dollar erhöhten, die voraussichtlich die Betriebstätigkeiten bis 2026 finanzieren werden.
Für das zweite Quartal 2024 berichtete Savara einen Nettogewinn von 22,2 Millionen US-Dollar oder $(0,12) pro Aktie. Die F&E-Ausgaben stiegen im Jahresvergleich um 97,7 % auf 17,6 Millionen US-Dollar, während die allgemeinen und Verwaltungskosten um 67,8 % auf 5,5 Millionen US-Dollar anstiegen.
- Positive top-line results from IMPALA-2 Phase 3 trial, meeting primary and key secondary endpoints
- FDA conditionally accepted trade name MOLBREEVI™ for molgramostim
- Raised ~$100M in equity financing, strengthening balance sheet
- Cash position of over $200M expected to fund operations through 2026
- 97% patient completion rate in IMPALA-2 trial with no drug-related discontinuations
- Potential to be first approved therapy for aPAP in U.S. and Europe
- Net loss increased to $22.2M in Q2 2024 from $11.4M in Q2 2023
- R&D expenses nearly doubled YoY to $17.6M in Q2 2024
- G&A expenses increased by 67.8% YoY to $5.5M in Q2 2024
Insights
Savara's Q2 2024 results show significant progress in their aPAP treatment development, but with increased expenses. Revenue figures are absent, indicating the company is still pre-commercial. The net loss widened to
The cash position of
The IMPALA-2 trial results for molgramostim (MOLBREEVI) are highly promising for aPAP treatment. Key highlights include:
- Statistically significant improvement in lung diffusing capacity (DLCO) at 24 and 48 weeks
- Improved quality of life scores (SGRQ)
- High patient retention (
97% ) and safety profile - All patients opting for the open-label extension
These outcomes suggest strong efficacy and patient acceptability. The potential to be the first approved therapy for aPAP in the U.S. and Europe is a significant milestone. The estimated 3,600 diagnosed U.S. patients, with potential underestimation, indicates a substantial market opportunity. Upcoming presentations at major respiratory conferences will be important for building clinical credibility and awareness.
Savara's focus on rare respiratory diseases, specifically aPAP, positions it in a niche market with potential for high returns. The positive IMPALA-2 results and FDA's conditional acceptance of the MOLBREEVI trade name are significant steps towards commercialization. The company's estimate of 3,600 diagnosed U.S. patients, with potential for higher prevalence, suggests an untapped market.
The planned investor webinar and presentations at major respiratory conferences (ERS, CHEST, BTS) indicate a strong push for market awareness and education. This is important for rare disease treatments. The company's focus on market development activities alongside clinical progress shows a comprehensive approach to market entry. Investors should watch for updates on market size estimates, pricing strategies and potential partnerships for global distribution.
Recent Business Highlights
- Reported positive top line results from IMPALA-2, a pivotal, Phase 3 clinical trial of molgramostim nebulizer solution (molgramostim) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP)
— Statistically significant improvement in Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) versus placebo at week 24 (primary endpoint) and week 48 (secondary endpoint)
— Statistically significant improvement in St. George’s Respiratory Questionnaire (SGRQ) Total Score at week 24 (secondary endpoint)
— Nominally significant improvements in SGRQ Activity Score at week 24 and exercise capacity using a treadmill test at week 48 (secondary endpoints)
—
—
- Abstracts accepted for presentation at 2024’s European Respiratory Society (ERS) Congress, the CHEST Annual Meeting, and the British Thoracic Society (BTS) Winter Meeting
— Abstracts highlight new IMPALA-2 data and the aPAP patient journey
— Company-sponsored industry symposia to be held at the ERS Congress and the CHEST Annual Meeting
-
FDA conditionally accepted the trade name MOLBREEVI™ for molgramostim
- Company to host investor webinar on September 30, 2024
— Data from the IMPALA-2 trial will be presented and updates on the global commercial landscape and aPAP market development work will be provided
— Details for accessing the webinar forthcoming
-
In July 2024, further strengthened balance sheet with an
~ equity financing, which added$100M ~ to the$94M ~ in cash, cash equivalents, and short-term investments reported as of June 30, 2024; Company expects to be sufficiently capitalized through 2026$122M
“Following strong top line results in the IMPALA-2 trial, we plan to complete the BLA submission for MOLBREEVI, the trade name that the FDA has conditionally accepted for molgramostim, in the first half of 2025,” said Matt Pauls, Chair and CEO, Savara. “In parallel, we are now significantly ramping up global market development activities and look forward to presenting this work, as well as data from the IMPALA-2 trial, during our investor webinar in September.”
Pauls continued, “The IMPALA-2 data support our view that MOLBREEVI could fundamentally change the way aPAP is treated. With approximately 3,600 currently diagnosed
Abstract Acceptances and Symposia
ERS 2024 (September 7-11)
Abstract: “Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life (HRQoL) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2”
Session: Details are forthcoming
Date and Time: Details are forthcoming
The Company is also sponsoring a symposium entitled “Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management.”
- Date and Time: ERS Congress Industry Theater, September 8, 2024, 5:30PM – 7:00PM (CET)
CHEST 2024 (October 6-9)
Abstract: “A Patient Journey Map for People Living with Autoimmune Pulmonary Alveolar Proteinosis (aPAP)”
Poster Session: Diffuse Lung Disease Abstracts Posters (D)
Date and Time: October 8, 2024; 1:45PM – 2:30PM (EDT)
The Company is also sponsoring a symposium entitled “Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management.”
- Date and Time: CHEST Learning Theater, October 8, 2024, 2:00PM – 2:45PM (EDT)
BTS Winter Meeting 2024 (November 27-29)
Abstract: “Molgramostim Improves Pulmonary Gas Exchange in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial”
Session: Details are forthcoming
Date and Time: Details are forthcoming
Second Quarter Financial Results (Unaudited)
Savara's net loss for the second quarter of 2024 was
Research and development expenses increased by
General and administrative expenses increased by
As of June 30, 2024, the Company had cash, cash equivalents and short-term investments of
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH). 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, our expectation the Company is sufficiently capitalized through 2026, statements related to the timing and contents of our planned investor webinar in September 2024 and upcoming meetings and symposia, the anticipated timing of our BLA submission, that we are significantly ramping up global market development activities, that the IMPALA-2 data support our view that MOLBREEVI could fundamentally change the way aPAP is treated, our belief that the global commercial opportunity for MOLBREEVI is significant and the basis for that belief. 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 risk that further analysis of the full data set from the IMPALA-2 clinical trial could result in unexpected observations; the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize molgramostim 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.
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 | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
||
| Operating expenses: | ||||||||||||||||
| Research and development | $ |
17,617 |
|
$ |
8,911 |
|
$ |
34,424 |
|
$ |
17,649 |
|
||||
| General and administrative |
|
5,540 |
|
|
3,302 |
|
|
11,176 |
|
|
6,668 |
|
||||
| Depreciation and amortization |
|
33 |
|
|
8 |
|
|
65 |
|
|
16 |
|
||||
| Total operating expenses |
|
23,190 |
|
|
12,221 |
|
|
45,665 |
|
|
24,333 |
|
||||
| Loss from operations |
|
(23,190 |
) |
|
(12,221 |
) |
|
(45,665 |
) |
|
(24,333 |
) |
||||
| Other income (expense), net: |
|
947 |
|
|
778 |
|
|
3,076 |
|
|
2,333 |
|
||||
| Net loss attributable to common stockholders | $ |
(22,243 |
) |
$ |
(11,443 |
) |
$ |
(42,589 |
) |
$ |
(22,000 |
) |
||||
| Net loss per share - basic and diluted | $ |
(0.12 |
) |
$ |
(0.07 |
) |
$ |
(0.23 |
) |
$ |
(0.14 |
) |
||||
| Weighted average shares - basic and diluted |
|
182,584,078 |
|
|
152,796,617 |
|
|
182,567,091 |
|
|
152,778,031 |
|
||||
| Other comprehensive loss |
|
(138 |
) |
|
(158 |
) |
|
(609 |
) |
|
(14 |
) |
||||
| Total comprehensive loss | $ |
(22,381 |
) |
$ |
(11,601 |
) |
$ |
(43,198 |
) |
$ |
(22,014 |
) |
||||
| Savara Inc. and Subsidiaries | ||||||
| Condensed Consolidated Balance Sheet Data | ||||||
| (in thousands) | ||||||
| (Unaudited) | ||||||
| June 30, | December 31, | |||||
2024 |
2023 |
|||||
| Cash, cash equivalents, and short-term investments | $ |
121,516 |
$ |
162,319 |
||
| Working capital |
|
116,408 |
|
155,350 |
||
| Total assets |
|
139,670 |
|
177,564 |
||
| Total liabilities |
|
37,939 |
|
37,192 |
||
| Stockholders’ equity: |
|
101,731 |
|
140,372 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240812280186/en/
Savara Inc. IR & PR
Anne Erickson (anne.erickson@savarapharma.com)
(512) 851-1366
Source: Savara Inc.
FAQ
What were the key results of Savara's IMPALA-2 Phase 3 trial for molgramostim?
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