- 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
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
Savara (NASDAQ:SVRA)
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