• 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
  • With ~$162M in Cash and Short-term Investments, Company Believes it is Sufficiently Capitalized into 2026

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2023 and provided a business update.

“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 U.S. Additionally, we launched aPAP ClearPathTM, a simple, accurate, no-cost, lab-developed GM-CSF autoantibody blood test, along with a disease state awareness campaign, that is educating U.S. pulmonologists about the disease and need for earlier testing. Finally, we completed an $80 million equity financing last July, and with $162 million in cash and investments and a track record of strong fiscal discipline, we believe we are capitalized into 2026.”

Fourth Quarter Financial Results (Unaudited)

Savara’s net loss for the fourth quarter of 2023 was $16.1 million, or $(0.09) per share, compared with a net loss of $10.3 million, or $(0.07) per share, for the fourth quarter of 2022.

Research and development expenses for the fourth quarter of 2023 and 2022 were $12.7 million and $7.6 million, respectively.

General and administrative expenses for the fourth quarter of 2023 and 2022 were $4.9 million and $3.2 million, respectively.

As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of $162.3 million.

Fiscal Year 2023 Financial Results

The Company’s net loss for the year ended December 31, 2023 was $54.7 million, or $(0.33) per share, compared with a net loss of $38.2 million, or $(0.25) per share for the year ended December 31, 2022.

Research and development expenses increased $16.4 million, or 58.8%, to $44.3 million for the year ended December 31, 2023 from $27.9 million for the year ended December 31, 2022. This increase was primarily due to the performance of tasks related to our molgramostim program which includes approximately $6.8 million of costs related to our chemistry, manufacturing, and controls activities, $4.4 million of costs related to our IMPALA-2 trial, including CRO-related activities, $1.6 million of costs related to quality assurance, and $3.6 million due to an increase in personnel and related costs.

General and administrative expenses increased $4.7 million, or 43.4%, to $15.7 million for the year ended December 31, 2023 from $10.9 million for the year ended December 31, 2022. Approximately $3.6 million of this was primarily attributable to the addition of key personnel to facilitate the management of our business and $1.1 million was attributable to certain commercial activities.

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

 

Savara Inc. IR & PR Anne Erickson (anne.erickson@savarapharma.com) (512) 851-1366

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