Savara Reports Third Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

Financial Analyst

The Q3 results reveal significant strategic and financial developments for Savara. The $24.2M quarterly loss, while higher than last year's $16.6M, reflects planned increased investments in MOLBREEVI's development and commercialization. The 46.5% jump in R&D expenses to $20.3M demonstrates strong execution on manufacturing capabilities and regulatory preparations.

The robust cash position of $219.4M provides substantial runway through Q2 2027, significantly de-risking the company's path to potential commercialization. With BLA submission timeline acceleration and possible priority review, market entry could occur by end of 2025, positioning Savara to capture value in the untapped aPAP market with approximately 3,600 diagnosed patients in the U.S.

Medical Research Analyst

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 ~$219M in Cash and Short-Term Investments, the Company Believes it is Sufficiently Capitalized through 2Q 2027

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 third quarter ending September 30, 2024 and provided a business update.

“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 U.S. by the end of 2025, if priority review is granted,” said Matt Pauls, Chair and CEO, Savara. “BLA submission, coupled with the submission of the MAA to the EMA by the end of 2025, are major regulatory milestones that could bring us one step closer to providing aPAP patients in the U.S. and Europe with the first and only approved therapeutic option for this rare and debilitating lung disease. In parallel, we are accelerating the build-out of our commercial capabilities, complimented by ongoing market development initiatives, to ensure the approximately 3,600 diagnosed aPAP patients in the U.S. get access to MOLBREEVI post-approval. Lastly, after strengthening our balance sheet, we believe our cash runway now extends from the end of 2026 through the second quarter of 2027.”

Third Quarter Financial Results (Unaudited)

Savara's net loss for the third quarter of 2024 was $24.2 million, or $(0.11) per share, compared with a net loss of $16.6 million, or $(0.10) per share, for the third quarter of 2023.

Research and development expenses increased by $6.4 million, or 46.5%, to $20.3 million for the three months ended September 30, 2024 from $13.9 million for the three months ended September 30, 2023. This increase was primarily due to the performance of tasks related to our MOLBREEVI program, which includes ~$3.7 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our second drug substance manufacturer, ~$0.2 million of clinical costs driven by the pediatric study, ~$1.0 million of costs related to regulatory affairs and quality assurance, and ~$1.5 million due to an increase in personnel and related costs as well as other departmental overhead.

General and administrative expenses increased by $1.9 million, or 45.0%, to $6.0 million for the three months ended September 30, 2024 from $4.1 million for the three months ended September 30, 2023. The increase was due to personnel and related costs of ~$0.8 million, certain commercial activities of ~$0.9 million, and other departmental overhead of ~$0.2 million.

As of September 30, 2024, the Company had cash, cash equivalents and short-term investments of ~$219.4 million and debt of ~$26.6 million.

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
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except for share and per share amounts)
Unaudited
		Three months ended								Nine months ended
		September 30,								September 30,
			2024				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	)
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	)

Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
		September 30,			December 31,
		2024			2023
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

 

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?

Savara reported a net loss of $24.2 million, or $0.11 per share, in Q3 2024.

When does Savara (SVRA) plan to complete the MOLBREEVI BLA submission?

Savara plans to complete the MOLBREEVI BLA submission by the end of Q1 2025.

How much cash and short-term investments does Savara (SVRA) have as of Q3 2024?

Savara had approximately $219.4 million in cash and short-term investments as of September 30, 2024.

When does Savara (SVRA) expect to submit the MOLBREEVI MAA to EMA?

Savara expects to submit the MOLBREEVI Marketing Authorization Application to the European Medicines Agency by the end of 2025.