Savara Reports Second Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

Financial Analyst

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 $22.2 million from $11.4 million year-over-year, primarily due to increased R&D expenses (97.7% rise) and G&A costs (67.8% rise).

The cash position of $121.5 million, bolstered by a recent $100 million equity financing, provides a runway through 2026. This financial cushion is important as Savara approaches potential commercialization. The debt of $26.5 million seems manageable given the cash reserves. Investors should monitor burn rate and potential revenue timelines as Savara progresses towards BLA submission in H1 2025.

Medical Research Analyst

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.

Market Research Analyst

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.

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 second quarter ending June 30, 2024 and provided a business update.

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)
— 97% of patients completed double-blind treatment through week 48 with no trial drug-related adverse events leading to discontinuation
— 100% of patients completing the 48-week double-blind period elected to participate in the 96-week open-label period

• 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 ~$100M equity financing, which added ~$94M to the ~$122M in cash, cash equivalents, and short-term investments reported as of June 30, 2024; Company expects to be sufficiently capitalized through 2026

“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 U.S. patients and literature suggesting prevalence may be underestimated, plus our increased focus on developing the aPAP market and the potential for MOLBREEVI to be the first and only approved therapy for aPAP in the U.S. and Europe, we believe the global commercial opportunity is significant.”

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 $22.2 million, or $(0.12) per share, compared with a net loss of $11.4 million, or $(0.07) per share, for the second quarter of 2023.

Research and development expenses increased by $8.7 million, or 97.7%, to $17.6 million for the three months ended June 30, 2024 from $8.9 million for the three months ended June 30, 2023. This increase was primarily due to the performance of tasks related to the molgramostim program, which include ~$4.8 million of costs related to chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish a second drug substance manufacturer, ~$1.2 million of costs related to the IMPALA-2 trial and pediatric study, including CRO-related activities, ~$1.3 million of costs related to regulatory affairs and quality assurance, and ~$1.4 million due to an increase in personnel and other departmental overhead.

General and administrative expenses increased by $2.2 million, or 67.8%, to $5.5 million for the three months ended June 30, 2024 from $3.3 million for the three months ended June 30, 2023. The increase was due to personnel and related costs of ~$1.1 million, certain commercial activities of ~$0.8 million, and other overhead of ~$0.3 million primarily driven by consultant costs.

As of June 30, 2024, the Company had cash, cash equivalents and short-term investments of ~$121.5 million and debt of ~$26.5 million.

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

 

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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?

The IMPALA-2 trial met its primary endpoint, showing statistically significant improvement in lung diffusing capacity (DLCO) at 24 weeks compared to placebo. It also met key secondary endpoints, including improvements in respiratory quality of life measured by the St. George's Respiratory Questionnaire.

When does Savara (SVRA) plan to submit the BLA for molgramostim?

Savara plans to complete the Biologics License Application (BLA) submission for molgramostim, under the trade name MOLBREEVI™, in the first half of 2025.

How much cash does Savara (SVRA) have following its recent equity financing?

After raising approximately $100 million in equity financing in July 2024, Savara's total cash position exceeds $200 million, which is expected to fund operations through 2026.

What was Savara's (SVRA) net loss for Q2 2024?

Savara reported a net loss of $22.2 million, or $(0.12) per share, for the second quarter of 2024.