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Release
Savara Reports First Quarter 2024 Financial Results and Provides Business Update
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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
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With
~$143M in Cash and Short-term Investments, the Company Continues to Believe it is Sufficiently Capitalized into 2026
“The IMPALA-2 trial remains on-track and we look forward to reporting top line results by the end of the second quarter,” said
First Quarter Financial Results (Unaudited)
Savara's net loss for the first quarter of 2024 was
Research and development expenses increased by
General and administrative expenses increased by
As 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 (
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
Financial Information to Follow
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(in thousands, except for share and per share amounts) |
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Unaudited |
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Three months ended |
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2024 |
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2023 |
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Operating expenses: | ||||||||
Research and development |
$ |
16,807 |
|
$ |
8,738 |
|
||
General and administrative |
|
5,636 |
|
|
3,366 |
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||
Depreciation and amortization |
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32 |
|
|
8 |
|
||
Total operating expenses |
|
22,475 |
|
|
12,112 |
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Loss from operations |
|
(22,475 |
) |
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(12,112 |
) |
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Other income (expense), net: |
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2,129 |
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|
1,555 |
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Net loss attributable to common stockholders |
$ |
(20,346 |
) |
$ |
(10,557 |
) |
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Net loss per share - basic and diluted |
$ |
(0.11 |
) |
$ |
(0.07 |
) |
||
Weighted average shares - basic and diluted |
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182,550,109 |
|
|
152,781,580 |
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Other comprehensive (loss) gain |
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(471 |
) |
|
144 |
|
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Total comprehensive loss |
$ |
(20,817 |
) |
$ |
(10,413 |
) |
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Condensed Consolidated Balance Sheet Data |
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(in thousands) |
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(Unaudited) |
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2024 |
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2023 |
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Cash, cash equivalents, and short-term investments |
$ |
143,043 |
$ |
162,319 |
||
Working capital |
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136,377 |
|
155,350 |
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Total assets |
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158,295 |
|
177,564 |
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Total liabilities |
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36,434 |
|
37,192 |
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Stockholders’ equity: |
|
121,861 |
|
140,372 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240509719255/en/
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Source: