Savara Reports Fourth Quarter / Year-End 2021 Financial Results and Provides Business Update

Rhea-AI Summary

Savara Inc. (Nasdaq: SVRA) provided a business update and reported its financial results for Q4 and FY 2021. The company is advancing its Phase 3 IMPALA-2 trial for molgramostim, activating most of the ~50 clinical sites, and anticipates top-line data by the end of Q2 2024. Financially, Savara ended 2021 with approximately $161M in cash and reduced its net loss to $11.3M in Q4 2021, compared to $13.7M in Q4 2020. For the entire year, the net loss decreased to $43M from $49.6M, attributed mainly to reduced R&D costs and improved financial discipline.

Positive

• Q4 net loss narrowed to $11.3M from $13.7M year-over-year.
• Full-year net loss decreased to $43M from $49.6M year-over-year.
• Research and development expenses declined by 17.3% to $29M for the year.
• Company has $161M in cash, providing a runway through 2025.

Negative

• None.

• Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Progressing, with Most of the ~50 Clinical Trial Sites Activated
• Trial Remains On-Track for a 20-Month Enrollment, with Top Line Data Expected at the End of 2Q 2024
• Company Ends Quarter with ~161M – Reiterates Belief it is Sufficiently Capitalized Through 2025, ~18 Months Beyond Anticipated IMPALA-2 Top Line Data Readout

AUSTIN, Texas--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the fourth quarter and full year ending December 31, 2021 and provided a business update.

“The company underwent a significant amount of positive change in 2021. We streamlined the pipeline to focus solely on the molgramostim development program, strengthened our management team with key hires in clinical, regulatory, and CMC and improved our financial position with a $130M equity raise,” said Matt Pauls, Chair and CEO, Savara. “With a cash position of ~$161M at the end of 2021, and a track record of fiscal discipline, we believe we are funded through 2025 – which is well beyond the anticipated top line read-out of IMPALA-2, our pivotal Phase 3 clinical trial in aPAP. We continue to advance the IMPALA-2 trial with most of the approximately 50 clinical trial sites now activated, and despite the ongoing COVID-19 pandemic and current geopolitical issues impacting parts of Europe, we reaffirm our guidance of top line data by the end of 2Q 2024.”

Fourth Quarter Financial Results (Unaudited)

Savara's net loss for the fourth quarter of 2021 was $11.3 million, or $(0.07) per share, compared with a net loss of $13.7 million, or $(0.23) per share, for the fourth quarter of 2020.

Research and development expenses were $7.6 million for the fourth quarter of 2021, compared with $10.2 million for the fourth quarter of 2020.

General and administrative expenses for the fourth quarter of 2021 and 2020 were $3.0 million and $2.8 million, respectively.

As of December 31, 2021, the Company had cash, cash equivalents and short-term investments of $161.2 million.

Fiscal Year 2021 Financial Results

The Company’s net loss for the year ended December 31, 2021 was $43.0 million, or $(0.32) per share, compared with a net loss of $49.6 million, or $(0.84) per share for the year ended December 31, 2020.

Research and development expenses decreased $6.0 million, or 17.3%, to $29.0 million for the year ended December 31, 2021 from $35.0 million for the year ended December 31, 2020. The decrease was largely attributable to $5.4 million of acquisition costs for the inhaled ciprofloxacin product candidate (in 2020) and a $6.9 million decrease in Chemistry, Manufacturing, and Controls (CMC) and clinical operations activities associated with the wind down of the inhaled vancomycin study. This was partially offset by a $6.4 million increase in costs associated with the startup and progression of the IMPALA-2 trial.

General and administrative expenses decreased $1.9 million, or 13.4%, to $12.4 million for the year ended December 31, 2021 from $14.3 million for the year ended December 31, 2020. The decrease was primarily due to the recognition of a one-time non-recurring charge of $0.8 million for non-cash stock-based compensation and approximately $1.5 million of paid and accrued severance payments to former members of the Company’s executive management during the year ended December 31, 2020.

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. (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 regarding the anticipated timing of enrollment for the IMPALA-2 trial; the anticipated timing of the top line IMPALA-2 data; 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 and current 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 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								Twelve months ended
		December 31,								December 31,
		2021				2020				2021				2020
Milestone revenue		$	-			$	1			$	-			$	257
Operating expenses:
Research and development			7,618				10,157				28,991				35,038
General and administrative			3,019				2,790				12,350				14,264
Depreciation and amortization			2				66				136				255
Total operating expenses			10,639				13,013				41,477				49,557
Loss from operations			(10,639	)			(13,012	)			(41,477	)			(49,300	)
Other expense, net:			(671	)			(729	)			(1,537	)			(315	)
Net loss attributable to common stockholders		$	(11,310	)		$	(13,741	)		$	(43,014	)		$	(49,615	)
Net loss per share - basic and diluted		$	(0.07	)		$	(0.23	)		$	(0.32	)		$	(0.84	)
Weighted average shares - basic and diluted			152,617,779				60,698,962				133,919,145				59,309,090
Other comprehensive loss			(280	)			689				(937	)			959
Total comprehensive loss		$	(11,590	)		$	(13,052	)		$	(43,951	)		$	(48,656	)

Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
		December 31,			December 31,
		2021			2020
Cash, cash equivalents, and short-term investments		$	161,171		$	82,188
Working capital			150,340			76,947
Total assets			176,598			97,745
Total liabilities			32,100			33,362
Stockholders’ equity:			144,498			64,383

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220330005481/en/

Savara Inc. IR & PR

Anne Erickson (anne.erickson@savarapharma.com)

(512) 851-1366

Source: Savara Inc.

FAQ

What is the status of Savara's Phase 3 IMPALA-2 trial for molgramostim?

Savara has activated most of the approximately 50 clinical trial sites for the Phase 3 IMPALA-2 trial and expects top-line data by the end of Q2 2024.

How much cash does Savara have as of the end of 2021?

Savara reported approximately $161 million in cash, cash equivalents, and short-term investments at the end of 2021.

What were Savara's financial results for Q4 2021?

Savara reported a net loss of $11.3 million, or $(0.07) per share, compared to a net loss of $13.7 million, or $(0.23) per share, in Q4 2020.

How did Savara's research and development expenses change in 2021?

Research and development expenses decreased by 17.3%, from $35 million in 2020 to $29 million in 2021.

What is Savara's outlook following the equity raise?

Savara believes it is sufficiently capitalized through 2025, beyond the anticipated top-line data readout from the IMPALA-2 trial.