Savara Reports Fourth Quarter/Year-End 2023 Financial Results and Provides Business Update
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Insights
From a medical research perspective, the progression of the Phase 3 IMPALA-2 trial is a critical milestone for Savara Inc. The trial's focus on molgramostim, an inhaled biologic for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), addresses a significant unmet medical need given the rarity and severity of the disease. The anticipation of filing a Biologics License Application (BLA) indicates confidence in the potential efficacy and safety of the treatment. The patient population identified through the health claims database underscores the market potential for molgramostim, should it receive approval.
Furthermore, the development of aPAP ClearPath™, a GM-CSF autoantibody blood test, represents an advancement in diagnostic capabilities for aPAP. This could lead to earlier diagnosis and treatment, improving patient outcomes and potentially increasing the treatment-eligible population. The disease awareness campaign is likely to increase recognition of aPAP symptoms among pulmonologists, potentially leading to more diagnoses and a larger target market for Savara's product.
Financially, Savara Inc.'s statement of having approximately $162 million in cash and short-term investments is a strong indicator of its fiscal health and its ability to fund operations into 2026. This financial runway is crucial as it allows the company to continue its research and development activities without the immediate need for additional capital. The upcoming top line data from the IMPALA-2 trial will be a significant catalyst for the company's stock as positive results could lead to an increase in investor confidence and potential partnerships or funding opportunities.
However, investors should note the inherent risks associated with biopharmaceutical companies in the clinical stage. The success of Savara's stock will heavily depend on the outcomes of the IMPALA-2 trial and the subsequent regulatory path. Positive trial data and a successful BLA filing could result in stock appreciation, while any setbacks could negatively impact the company's valuation.
The rare disease market, particularly for conditions like aPAP, is often characterized by high drug prices due to the specialized nature of treatments and the lack of competition. If molgramostim is approved, Savara Inc. could potentially capitalize on orphan drug status, which may provide market exclusivity and other incentives. The identification of approximately 3,600 diagnosed and 1,400 potential undiagnosed aPAP patients in the U.S. alone provides a clearer picture of the addressable market for investors.
Moreover, the strategic initiatives, including the launch of aPAP ClearPath™ and the disease awareness campaign, can be seen as efforts to build a foundation for market penetration. These initiatives not only aid in diagnosis but also help in creating a potential customer base for Savara's product. The successful commercialization of molgramostim will hinge on effective marketing strategies and the ability to navigate the complexities of the healthcare reimbursement landscape.
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Remains On-Track to Report Top Line Data from the Pivotal Phase 3 IMPALA-2 Trial 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
- Anticipate Filing Biologics License Application (BLA) in 1H 2025, Pending Outcome of IMPALA-2 Trial
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With
~ in Cash and Short-term Investments, Company Believes it is Sufficiently Capitalized into 2026$162M
“We look forward to reporting IMPALA-2 top line results at the end of the second quarter and, assuming positive data, anticipate filing the BLA in the first half of 2025,” said Matt Pauls, Chair and CEO, Savara. “2023 was a year of strong execution that included the on-time, over-enrollment of the Phase 3 IMPALA-2 trial and an analysis of a health claims database that identified ~3,600 currently diagnosed aPAP patients and another ~1,400 potential, currently undiagnosed, aPAP patients in the
Fourth Quarter Financial Results (Unaudited)
Savara’s net loss for the fourth quarter of 2023 was
Research and development expenses for the fourth quarter of 2023 and 2022 were
General and administrative expenses for the fourth quarter of 2023 and 2022 were
As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of
Fiscal Year 2023 Financial Results
The Company’s net loss for the year ended December 31, 2023 was
Research and development expenses increased
General and administrative expenses increased
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, the number of potential aPAP patients, and our belief the Company is capitalized into 2026. 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 | ||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except for share and per share amounts) | ||||||||||||||||
(Unaudited) |
|
|
|
|
||||||||||||
Three months ended |
|
Twelve months ended |
||||||||||||||
December 31, |
|
December 31, |
||||||||||||||
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ |
12,746 |
|
$ |
7,626 |
|
$ |
44,262 |
|
$ |
27,879 |
|
||||
| General and administrative |
|
4,852 |
|
|
3,242 |
|
|
15,668 |
|
|
10,929 |
|
||||
| Depreciation and amortization |
|
32 |
|
|
7 |
|
|
77 |
|
|
31 |
|
||||
| Total operating expenses |
|
17,630 |
|
|
10,875 |
|
|
60,007 |
|
|
38,839 |
|
||||
| Loss from operations |
|
(17,630 |
) |
|
(10,875 |
) |
|
(60,007 |
) |
|
(38,839 |
) |
||||
| Other income (expense), net: |
|
1,531 |
|
|
575 |
|
|
5,309 |
|
|
689 |
|
||||
| Net loss attributable to common stockholders | $ |
(16,099 |
) |
$ |
(10,300 |
) |
$ |
(54,698 |
) |
$ |
(38,150 |
) |
||||
| Net loss per share - basic and diluted | $ |
(0.09 |
) |
$ |
(0.07 |
) |
$ |
(0.33 |
) |
$ |
(0.25 |
) |
||||
| Weighted average shares - basic and diluted |
|
179,843,515 |
|
|
152,773,739 |
|
|
165,204,652 |
|
|
152,771,817 |
|
||||
| Other comprehensive (loss) gain |
|
671 |
|
|
1,002 |
|
|
334 |
|
|
(610 |
) |
||||
| Total comprehensive loss | $ |
(15,428 |
) |
$ |
(9,298 |
) |
$ |
(54,364 |
) |
$ |
(38,760 |
) |
||||
| Savara Inc. and Subsidiaries | ||||||
| Consolidated Balance Sheet Data | ||||||
| (in thousands) | ||||||
December 31, |
|
December 31, |
||||
2023 |
|
2022 |
||||
| Cash, cash equivalents, and short-term investments | $ |
162,319 |
$ |
125,876 |
||
| Working capital |
|
155,350 |
|
123,087 |
||
| Total assets |
|
177,564 |
|
139,777 |
||
| Total liabilities |
|
37,192 |
|
31,999 |
||
| Stockholders’ equity: |
|
140,372 |
|
107,778 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240307470314/en/
Savara Inc. IR & PR
Anne Erickson (anne.erickson@savarapharma.com)
(512) 851-1366
Source: Savara Inc.
FAQ
When is Savara Inc. expected to report top-line data from the Phase 3 IMPALA-2 trial?
What is the purpose of the IMPALA-2 trial?
When does Savara Inc. anticipate filing a Biologics License Application (BLA)?
How much cash and short-term investments does Savara Inc. have?
What is the significance of the aPAP ClearPathTM?
