Release
Savara Reports Second Quarter 2022 Financial Results and Provides Business Update
- Pivotal Phase 3 IMPALA-2 Trial of Novel Inhaled Biologic, Molgramostim Nebulizer Solution (Molgramostim), in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Remains On-Track
- IMPALA-2 Top Line Data Expected at the End of 2Q 2024
-
Company Ends Quarter with~$142M – Believes it is Sufficiently Capitalized Through 2025
“Despite ongoing factors such as geographical COVID surges, geopolitical issues and supply chain constraints, IMPALA-2, the pivotal Phase 3 trial of our novel inhaled biologic, is currently on-track for a top line read-out by the end of 2Q 2024,” said
Second Quarter Financial Results (Unaudited)
Savara’s net loss for the three months ended
Research and development expenses decreased by
General and administrative expenses decreased 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 timing of the IMPALA-2 top line data read-out and that it is currently on-track to occur by the end of the second quarter of 2024 and our belief the Company is funded through 2025. 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 or other widespread health concerns impacting healthcare providers or patients, disruptions or inefficiencies in the supply chain, and geopolitical conditions on our business and operations, 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 obtain the necessary patient enrollment for our product candidate in a timely manner, 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
Financial Information to Follow
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except for share and per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
|
Three months ended |
|
Six months ended |
||||||||||||||
|
|
|
|
||||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
||
| Operating expenses: | ||||||||||||||||
| Research and development |
$ |
6,418 |
|
$ |
7,252 |
|
$ |
12,102 |
|
$ |
14,841 |
|
||||
| General and administrative |
|
2,957 |
|
|
3,153 |
|
|
5,311 |
|
|
5,931 |
|
||||
| Depreciation and amortization |
|
8 |
|
|
47 |
|
|
16 |
|
|
94 |
|
||||
| Total operating expenses |
|
9,383 |
|
|
10,452 |
|
|
17,429 |
|
|
20,866 |
|
||||
| Loss from operations |
|
(9,383 |
) |
|
(10,452 |
) |
|
(17,429 |
) |
|
(20,866 |
) |
||||
| Other income (expense), net: |
|
219 |
|
|
(489 |
) |
|
(35 |
) |
|
(292 |
) |
||||
| Net loss attributable to common stockholders |
$ |
(9,164 |
) |
$ |
(10,941 |
) |
$ |
(17,464 |
) |
$ |
(21,158 |
) |
||||
| Net loss per share - basic and diluted |
$ |
(0.06 |
) |
$ |
(0.07 |
) |
$ |
(0.11 |
) |
$ |
(0.18 |
) |
||||
| Weighted average shares - basic and diluted |
|
152,771,103 |
|
|
152,460,531 |
|
|
152,770,434 |
|
|
114,934,938 |
|
||||
| Other comprehensive (loss) gain |
|
(725 |
) |
|
107 |
|
|
(1,021 |
) |
|
(350 |
) |
||||
| Total comprehensive loss |
$ |
(9,889 |
) |
$ |
(10,834 |
) |
$ |
(18,485 |
) |
$ |
(21,508 |
) |
||||
| Condensed Consolidated Balance Sheet Data | ||||||
| (in thousands) | ||||||
| (Unaudited) | ||||||
|
|
|
|
||||
|
2022 |
|
2021 |
||||
| Cash, cash equivalents, and short-term investments |
$ |
142,439 |
$ |
161,171 |
||
| Working capital |
|
141,679 |
|
150,340 |
||
| Total assets |
|
156,777 |
|
176,598 |
||
| Total liabilities |
|
29,735 |
|
32,100 |
||
| Stockholders’ equity: |
|
127,042 |
|
144,498 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005414/en/
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