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Cash Balance of ~$193M; Company Estimates it is Sufficiently Capitalized through 2025
Clinical Trial Site Activation Process Underway for Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Patient Randomizations Expected to Begin by End of 2Q or Early 3Q 2021
Dhaval Desai, M.D. Appointed Head of Clinical Development, Brian Maurer Appointed Head of Clinical Operations
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today reported financial results for the first quarter ending March 31, 2021 and provided a business update.
"We made considerable progress in the first quarter of the year," said Matt Pauls, Chair and Chief Executive Officer, Savara. "This includes the strategic decision to wind down two pipeline programs, enabling us to focus solely on advancing our lead asset, molgramostim in aPAP. Additionally, we started the onboarding process of a global, full-service contract research organization that is partnering with us to execute the IMPALA-2 trial. Lastly, we strengthened our cash position through a $130M equity raise. With a balance sheet of approximately $193M, we believe our runway extends through 2025 – well beyond the expected top line results of IMPALA-2 in 2Q 2024."
"We are pleased to announce that the IMPALA-2 site activation process has begun," said Badrul Chowdhury, Chief Medical Officer, Savara. "Sites will be activated on a rolling basis, with approximately 10-15 expected to be active by the end of June. As sites launch, patients are evaluated, and those who are eligible will begin a six-week screening period. This means patients could be randomized and dosed by the end of 2Q or early 3Q 2021. We also recently strengthened our management team with the hire of Dr. Dhaval Desai as Head of Clinical Development and Brian Maurer as Head of Clinical Operations. Both are seasoned professionals with deep expertise in running global clinical trials."
First Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended March 31, 2021 was $10.2 million, or $(0.13) per share, compared with a net loss attributable to common stockholders of $15.4 million, or $(0.27) per share, for the three months ended March 31, 2020.
Research and development expenses decreased by $5.6 million, or 42.5%, to $7.6 million for the three months ended March 31, 2021 from $13.2 million for the three months ended March 31, 2020. The decrease is largely attributable to $5.4 million of costs for the acquisition of inhaled liposomal ciprofloxacin (Apulmiq) in March 2020. There were no research and development costs incurred related to Apulmiq during the three months ended March 31, 2021.
General and administrative expenses decreased by approximately $0.2 million, or 6.8%, to $2.8 million for the three months ended March 31, 2021 from $3.0 million for the three months ended March 31, 2020. This was primarily due to a decrease in noncash stock-based compensation and personnel costs for the three months ended March 31, 2021.
As of March 31, 2021, Savara had cash, cash equivalents, and short-term investments of approximately $192.7 million and debt of approximately $25 million.
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). 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. (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 belief our cash runway extends through 2025; the expected timing of top line results of IMPALA-2 in Q2 2024; that trial sites will be activated on a rolling basis; that approximately 10-15 trial sites are expected to be active by the end of June; and that patients could be randomized and dosed by the end of 2Q or early 3Q 2021. 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 the COVID-19 pandemic on our business and operations, the outcome of our ongoing and planned clinical trials for our product candidates, 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 obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully develop our product candidates, 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.
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Savara Inc. IR & PR
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