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Savara Reports Second Quarter 2021 Financial Results and Provides Business Update

  • Advancing Pivotal Phase 3 IMPALA 2 Trial of Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP); Numerous Clinical Trial Sites Activated, Patients Dosed, Timelines Remain on Track
  • Cash Balance of ~$181M; Company Believes it is Sufficiently Capitalized through 2025

AUSTIN, Texas--(BUSINESS WIRE)--Aug. 12, 2021-- Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today reported financial results for the second quarter ending June 30, 2021 and provided a business update.

“Over the last 9 months we streamlined our portfolio, reduced and restructured the organization, and significantly strengthened the balance sheet so that we could focus solely on advancing the pivotal Phase 3 IMPALA 2 clinical trial,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “With the first patient dosed just over one month ago, numerous sites now activated, and patients dosed the trial is progressing as planned and our timelines remain on track. Importantly, we continue to leverage key learnings from the first IMPALA trial so that we can execute IMPALA 2 with the highest efficiency and quality.”

Second Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended June 30, 2021, was $10.9 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $9.4 million, or $(0.16) per share, for the three months ended June 30, 2020.

Research and development expenses increased by $1.2 million, or 19.3%, to $7.3 million for the three months ended June 30, 2021, from $6.1 million for the three months ended June 30, 2020. The increase was largely attributable to a $3.6 million increase in costs associated with advancement of the molgramostim in aPAP development program and was partially offset by a decrease in Chemistry Manufacturing and Controls (CMC) and clinical operations activities associated with the wind down of the vancomycin hydrochloride inhalation powder development program.

General and administrative expenses were consistent with a slight increase of approximately 1.2%, to $3.2 million for the three months ended June 30, 2021, from $3.1 million for the three months ended June 30, 2020.

As of June 30, 2021, Savara had cash, cash equivalents, and short-term investments of approximately $181 million and debt of approximately $25 million.

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 https://savarapharma.com/. (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, our belief the Company is sufficiently capitalized through 2025; that our timelines remain on track; and that we continue to leverage key learnings from the first IMPALA trial so that we can execute IMPALA 2 with the highest efficiency and quality. 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 on our business and operations, the outcome of our ongoing and planned clinical trials for our product candidates, 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 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

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except for share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Three months ended

 

Six months ended

 

 

June 30,

 

June 30,

 

 

2021

 

2020

 

2021

 

2020

Operating expenses:
Research and development

$

7,252

 

$

6,079

 

$

14,841

 

$

19,279

 

General and administrative

 

3,153

 

 

3,117

 

 

5,931

 

 

6,099

 

Depreciation and amortization

 

47

 

 

68

 

 

94

 

 

126

 

Total operating expenses

 

10,452

 

 

9,264

 

 

20,866

 

 

25,504

 

 
Loss from operations

 

(10,452

)

 

(9,264

)

 

(20,866

)

 

(25,504

)

 
Other income, net:

 

(489

)

 

(125

)

 

(292

)

 

693

 

 
Net loss attributable to common stockholders

$

(10,941

)

$

(9,389

)

$

(21,158

)

$

(24,811

)

 
Net loss per share - basic and diluted

$

(0.07

)

$

(0.16

)

$

(0.18

)

$

(0.43

)

 
Weighted average shares - basic and diluted

 

152,460,531

 

 

58,858,216

 

 

114,934,938

 

 

58,111,225

 

 
Other comprehensive loss

 

107

 

 

247

 

 

(350

)

 

136

 

 
Total comprehensive loss

$

(10,834

)

$

(9,142

)

$

(21,508

)

$

(24,675

)

 

Savara Inc. and Subsidiaries

Condensed Consolidated Balance Sheet Data

(in thousands)

(Unaudited)

 

 

 

 

 

 

 

June 30,

 

December 31,

 

 

2021

 

2020

Cash, cash equivalents, and short-term investments

$

180,671

$

82,188

 
Working capital

 

177,853

 

76,947

 
Total assets

 

196,433

 

97,745

 
Total liabilities

 

31,051

 

33,362

 
Stockholders’ equity:

 

165,382

 

64,383

 

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

Source: Savara Inc.

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Savara Nasdaq Opening Bell Ceremony - July 23, 2018
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