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Savara Inc. (Nasdaq: SVRA) reported their first-quarter financial results for 2024, showcasing a net loss of $20.3 million compared to $10.6 million in 2023. The company remains focused on the Phase 3 IMPALA-2 trial evaluating molgramostim for autoimmune Pulmonary Alveolar Proteinosis, with top-line results expected by 2Q 2024. Savara anticipates submitting a Biologics License Application in 1H 2025 and is well-capitalized with $143 million in cash into 2026.
Positive
Savara Inc. is progressing with the Phase 3 IMPALA-2 trial, and top-line results are anticipated by the end of the second quarter of 2024.
The company expects to file a Biologics License Application in the first half of 2025, assuming positive data from the trial.
Savara is well-capitalized with approximately $143 million in cash and short-term investments, ensuring financial stability into 2026.
Negative
Savara reported a net loss of $20.3 million for the first quarter of 2024, compared to $10.6 million in the same period in 2023.
Research and development expenses increased by $8.1 million, mainly driven by activities related to the molgramostim program.
General and administrative expenses also rose by $2.3 million, impacting the overall financial performance of the company.
Insights
Savara Inc.'s report of a net loss of $20.3 million for Q1 2024, which is almost double the loss of Q1 2023, signifies a substantial increase in their financial burn rate. The almost 100% increase in research and development expenses, largely attributed to the molgramostim program, reflects an aggressive investment in their drug development pipeline. While such investments are necessary for long-term success in the biopharmaceutical industry, they can be a source of concern if not managed prudently. An increase in general and administrative expenses by 67.4% also indicates ramping up commercial and operational efforts. The liquidity position, with $143 million in cash and short-term investments, suggests that, despite the increased spend, Savara seems adequately capitalized to support its ongoing trials and potential commercialization activities. However, investors should note the $26.4 million in debt, which adds a layer of financial obligation. The expectation to remain sufficiently capitalized into 2026 appears optimistic and could be favorable if the upcoming IMPALA-2 trial results are positive and lead to successful BLA filing and product commercialization.
The ongoing IMPALA-2 trial is a significant catalyst for Savara, with investors keenly watching for the top line results expected by the end of Q2 2024. Molgramostim is a novel inhaled biologic aimed at treating autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease. If successful, this could fill an unmet medical need and represent a lucrative market opportunity due to the lack of effective treatments for aPAP. The planned Biologics License Application (BLA) in the first half of 2025 suggests confidence in the trial's outcome, although it's vital for investors to remain cautious until the data is released, as clinical trials are inherently risky and outcomes are unpredictable. The extension of the IMPALA-2 open-label period and preparations for commercial launch are indicators of Savara's strategic planning; however, these activities also involve substantial investment and risk. The potential for a global Expanded Access program indicates a commitment to patient access, which may enhance the drug's profile and adoption if approved.
Pivotal Phase 3 IMPALA-2 Trial Remains On-track, Top Line Results Expected by End of 2Q 2024
48-week placebo-controlled trial is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease
Pending Results from the IMPALA-2 Trial, a Biologics License Application (BLA) Filing is Anticipated in 1H 2025
With ~$143M in Cash and Short-term Investments, the Company Continues to Believe it is Sufficiently Capitalized into 2026
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 first quarter ending March 31, 2024 and provided a business update.
“The IMPALA-2 trial remains on-track and we look forward to reporting top line results by the end of the second quarter,” said Matt Pauls, Chair and CEO, Savara. “Following that, and assuming positive data, we expect to file a BLA in the first half of 2025. Importantly, with $143 million in cash and investments, we believe we are capitalized into 2026 which is well beyond the data read-out and includes investments in programs such as the extension of the IMPALA-2 open-label period from 48 weeks to 96 weeks, anticipated launch of a global Expanded Access program for molgramostim, build out of the U.S. Commercial infrastructure, and pre-Commercial preparations in Europe.”
First Quarter Financial Results (Unaudited)
Savara's net loss for the first quarter of 2024 was $20.3 million, or $(0.11) per share, compared with a net loss of $10.6 million, or $(0.07) per share, for the first quarter of 2023.
Research and development expenses increased by $8.1 million, or 92.3%, to $16.8 million for the three months ended March 31, 2024 from $8.7 million for the three months ended March 31, 2023. The increase was largely due to the performance of tasks related to the molgramostim program, which included approximately $4.3 million associated with chemistry, manufacturing, and controls activities and primarily driven by initiatives at second source drug substance manufacturers, $1.0 million related to the IMPALA-2 clinical trial, including clinical research organization (CRO) related activities, $0.6 million associated with regulatory affairs and quality assurance work, and $2.2 million due to an increase in personnel and related costs.
General and administrative expenses increased by $2.3 million, or 67.4%, to $5.6 million for the three months ended March 31, 2024 from $3.4 million for the three months ended March 31, 2023. The increase was due to personnel and related costs of $0.6 million, certain commercial activities of $1.1 million, and other overhead of $0.6 million primarily driven by patient advocacy activities.
As of March 31, 2024, the Company had cash, cash equivalents and short-term investments of approximately $143.0 million and debt of approximately $26.4 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, statements related to the expected timing of reporting top line data from the IMPALA-2 trial, the anticipated timing of the BLA filing, our belief the Company is capitalized into 2026, and the planned investments in the extension of the IMPALA-2 open label period, the anticipated launch of a global Expanded Access program, the build out of the U.S. Commercial infrastructure, and pre-Commercial preparations in Europe. 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 and uncertainties relating to the impact of widespread health concerns impacting healthcare providers or patients, disruptions or inefficiencies in the supply chain and geopolitical conditions, the outcome of our ongoing and planned clinical trials for our product candidate, 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, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, 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
March 31,
2024
2023
Operating expenses:
Research and development
$
16,807
$
8,738
General and administrative
5,636
3,366
Depreciation and amortization
32
8
Total operating expenses
22,475
12,112
Loss from operations
(22,475
)
(12,112
)
Other income (expense), net:
2,129
1,555
Net loss attributable to common stockholders
$
(20,346
)
$
(10,557
)
Net loss per share - basic and diluted
$
(0.11
)
$
(0.07
)
Weighted average shares - basic and diluted
182,550,109
152,781,580
Other comprehensive (loss) gain
(471
)
144
Total comprehensive loss
$
(20,817
)
$
(10,413
)
Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
March 31,
December 31,
2024
2023
Cash, cash equivalents, and short-term investments
