Savara Reports Third Quarter Financial Results and Provides Business Update
09 Novembro 2023 - 6:05PM
Business Wire
- Top Line Data from the Pivotal Phase 3 IMPALA-2 Trial
Remains On-Track to Read Out 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
- Company Expects to Launch an aPAP Antibody Blood Test and
Disease Awareness Campaign in the U.S. by End of Year
- Following the Close of an ~$80M Equity Financing, the Company
Ended the Quarter with ~$168.3M in Cash, Cash Equivalents, and
Short-term Investments
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage
biopharmaceutical company focused on rare respiratory diseases,
reported financial results for the third quarter ending September
30, 2023 and provided a business update.
“We remain on track to report top line data from the pivotal,
Phase 3 IMPALA-2 trial by the end of the second quarter 2024,” said
Matt Pauls, Chair and CEO, Savara. “In parallel, we are working to
provide pulmonologists in the U.S. and Europe with a simple,
accurate, no-cost, laboratory-based antibody blood test for aPAP.
This antibody test is expected to be available in the U.S. by the
end of this year and in Europe by the end of 2024. We will also be
launching a supporting disease awareness campaign that will educate
pulmonologists on the hallmark signs and symptoms of aPAP. Lastly,
with approximately $168M in cash, we have a strong balance sheet
and believe we are capitalized into 2026.”
Third Quarter Financial Results (Unaudited)
Savara's net loss for the third quarter of 2023 was $16.6
million, or $(0.10) per share, compared with a net loss of $10.4
million, or $(0.07) per share, for the third quarter of 2022.
Research and development expenses increased by $5.7 million, or
70.1%, to $13.9 million for the three months ended September 30,
2023 from $8.2 million for the three months ended September 30,
2022. This increase was primarily due to the performance of tasks
related to our molgramostim program, which included approximately
$2.5 million of costs related to our chemistry, manufacturing, and
controls activities, $1.8 million of costs related to our IMPALA-2
trial, including CRO-related activities, $0.5 million of costs
related to quality assurance, and $0.9 million due to an increase
in personnel and related costs.
General and administrative expenses increased by $1.8 million,
or 74.5%, to $4.1 million for the three months ended September 30,
2023 from $2.4 million for the three months ended September 30,
2022. The increase was due to the addition of key personnel and
related costs to facilitate the management of our business and
operations of ~$1.2 million and certain commercial activities of
~$0.6 million.
As of September 30, 2023, the Company had cash, cash equivalents
and short-term investments of ~$168.3 million and debt of ~$26.3
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
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, statements regarding the aPAP
antibody blood test and disease awareness campaign, including the
expected timing of the launches in the U.S. and Europe, 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 Condensed Consolidated
Statements of Operations and Comprehensive Loss (in thousands,
except for share and per share amounts)
Unaudited
Three months ended
Nine months ended
September 30,
September 30,
2023
2022
2023
2022
Operating expenses: Research and development
$
13,867
$
8,151
$
31,516
$
20,253
General and administrative
4,147
2,376
10,816
7,687
Depreciation and amortization
30
8
45
24
Total operating expenses
18,044
10,535
42,377
27,964
Loss from operations
(18,044
)
(10,535
)
(42,377
)
(27,964
)
Other income, net:
1,445
149
3,778
114
Net loss attributable to common stockholders
$
(16,599
)
$
(10,386
)
$
(38,599
)
$
(27,850
)
Net loss per share - basic and diluted
$
(0.10
)
$
(0.07
)
$
(0.24
)
$
(0.18
)
Weighted average shares - basic and diluted
164,342,634
152,773,015
158,444,739
152,771,302
Other comprehensive loss
(323
)
(591
)
(337
)
(1,612
)
Total comprehensive loss
$
(16,922
)
$
(10,977
)
$
(38,936
)
$
(29,462
)
Savara Inc. and Subsidiaries Condensed Consolidated
Balance Sheet Data (in thousands)
(Unaudited)
September 30,
December 31,
2023
2022
Cash, cash equivalents, and short-term investments
$
168,251
$
125,876
Working capital
161,133
123,087
Total assets
182,072
139,777
Total liabilities
35,528
31,999
Stockholders’ equity
146,544
107,778
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231109539209/en/
Savara Inc. IR & PR Anne Erickson
(anne.erickson@savarapharma.com) (512) 851-1366
Savara (NASDAQ:SVRA)
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