Savara Reports Fourth Quarter / Year-End 2022 Financial Results and Provides Business Update
Savara Inc. (Nasdaq: SVRA) announced that its pivotal Phase 3 IMPALA-2 trial evaluating molgramostim for autoimmune Pulmonary Alveolar Proteinosis is on track, with top-line data expected by the end of Q2 2024. Following a positive review from the Independent Data Monitoring Committee, the trial proceeds unmodified. The company also reported a net loss of $10.3 million for Q4 2022, maintaining a stable loss per share of $(0.07), and ended 2022 with $125.9 million in cash. Savara aims to launch a global aPAP market development campaign in 2H23 and believes it is sufficiently capitalized through 2025.
- Top-line data from the IMPALA-2 trial expected by end of Q2 2024.
- Financial discipline maintained with reduced net losses in 2022 compared to 2021.
- Sufficient capitalization through 2025 with $125.9 million in cash.
- Q4 2022 net loss of $10.3 million remains significant.
- No revenue reported, which could impact future growth.
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Pivotal Phase 3 IMPALA-2 Trial Remains On-Track with Top Line Data Expected End of 2Q 2024
- IMPALA-2 is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease
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IMPALA-2 Trial Continues, Unmodified, Following Positive Review from Independent Data Monitoring Committee (DMC)
- DMC assessed the safety and benefit/risk of molgramostim in aPAP patients
- Company To Launch Global aPAP Market Development Campaign in 2H23
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Company Ends Quarter with~ , Believes it is Sufficiently Capitalized Through 2025$126M
“Enrollment in the pivotal Phase 3 IMPALA-2 trial remains on-track, and we continue to anticipate reporting top line safety and efficacy data by the end of 2Q 2024,” said
Fourth Quarter Financial Results (Unaudited)
Savara's net loss for the fourth quarter of 2022 was
Research and development expenses were
General and administrative expenses for the fourth quarter of 2022 and 2021 were
As of
Fiscal Year 2022 Financial Results
The Company’s net loss for the year ended
Research and development expenses decreased
General and administrative expenses decreased
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 IMPALA-2 enrollment and top line data read-out and top line data is expected by the end of the second quarter of 2024, the launch of a global aPAP market development campaign in the second half of 2023, and our belief the Company is sufficiently capitalized 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
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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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Twelve months ended |
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2022 |
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2021 |
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2022 |
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2021 |
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| Operating expenses: | ||||||||||||||||
| Research and development | $ |
7,626 |
|
$ |
7,618 |
|
$ |
27,879 |
|
$ |
28,991 |
|
||||
| General and administrative |
|
3,242 |
|
|
3,019 |
|
|
10,929 |
|
|
12,350 |
|
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| Depreciation and amortization |
|
7 |
|
|
2 |
|
|
31 |
|
|
136 |
|
||||
| Total operating expenses |
|
10,875 |
|
|
10,639 |
|
|
38,839 |
|
|
41,477 |
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| Loss from operations |
|
(10,875 |
) |
|
(10,639 |
) |
|
(38,839 |
) |
|
(41,477 |
) |
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| Other income (expense), net: |
|
575 |
|
|
(671 |
) |
|
689 |
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|
(1,537 |
) |
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| Net loss attributable to common stockholders | $ |
(10,300 |
) |
$ |
(11,310 |
) |
$ |
(38,150 |
) |
$ |
(43,014 |
) |
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| Net loss per share - basic and diluted | $ |
(0.07 |
) |
$ |
(0.07 |
) |
$ |
(0.25 |
) |
$ |
(0.32 |
) |
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| Weighted average shares - basic and diluted |
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152,773,739 |
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152,617,779 |
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152,771,817 |
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133,919,145 |
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| Other comprehensive (loss) gain |
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1,002 |
|
|
(280 |
) |
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(610 |
) |
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(937 |
) |
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| Total comprehensive loss | $ |
(9,298 |
) |
$ |
(11,590 |
) |
$ |
(38,760 |
) |
$ |
(43,951 |
) |
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| Consolidated Balance Sheet Data | ||||||
| (in thousands) | ||||||
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2022 |
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2021 |
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| Cash, cash equivalents, and short-term investments | $ |
125,876 |
$ |
161,171 |
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| Working capital |
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123,087 |
|
150,340 |
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| Total assets |
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139,777 |
|
176,598 |
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| Total liabilities |
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31,999 |
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32,100 |
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| Stockholders’ equity: |
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107,778 |
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144,498 |
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FAQ
What is the status of Savara's Phase 3 IMPALA-2 Trial for SVRA?
What were Savara's financial results for Q4 2022?
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