Savara Reports Second Quarter Financial Results and Provides Business Update
10 Agosto 2023 - 3:05PM
Business Wire
- Fully Enrolled Pivotal Phase 3 IMPALA-2 Trial Remains On-Track
to Report Top Line Data 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
- ~$105M in Cash and Cash Equivalents at the End of 2Q 2023
- Further Strengthened Balance Sheet in July with an ~$80M Equity
Financing, Resulting in ~$180M in Pro Forma Cash After Giving
Effect to the Offering
- Anne Erickson, SVP, Global Business Operations, Promoted to
Chief Business Officer, Effective Immediately
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage
biopharmaceutical company focused on rare respiratory diseases,
reported financial results for the second quarter ending June 30,
2023 and provided a business update.
“The Company continues to make strong progress with the
molgramostim development program,” said Matt Pauls, Chair and CEO,
Savara. “In June, we announced the Phase 3 IMPALA-2 trial completed
enrollment on-time with 164 patients randomized, four more than the
target of 160, and our timeline remains on track for top line
results by the end of 2Q 2024. Additionally, last month we further
strengthened our balance sheet through an $80 million equity raise
and now have approximately $180 million in pro forma cash.”
Second Quarter Financial Results (Unaudited)
Savara's net loss for the second quarter of 2023 was $11.4
million, or $(0.07) per share, compared with a net loss of $9.2
million, or $(0.06) per share, for the second quarter of 2022.
Research and development expenses increased by $2.5 million, or
38.8%, to $8.9 million for the three months ended June 30, 2023
from $6.4 million for the three months ended June 30, 2022. This
increase is primarily due to the performance of tasks related to
our molgramostim program which includes increases of ~$0.6 million
of costs related to our chemistry, manufacturing, and controls
activities, ~$1.4 million of costs related to our IMPALA-2 trial,
including contract research organization related activities, and
~$0.5 million in personnel and related costs.
General and administrative expenses increased by $0.3 million,
or 11.7%, to $3.3 million for the three months ended June 30, 2023
from $3.0 million for the three months ended June 30, 2022. The
increase is due to the hiring of additional personnel for key
positions in the first quarter and related costs to facilitate the
management of our business and operations.
As of June 30, 2023, the Company had cash, cash equivalents and
short-term investments of ~$105.2 million and debt of ~$26.2
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. (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 timing of reporting of top line data.
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 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
Six months ended
June 30,
June 30,
2023
2022
2023
2022
Operating expenses: Research and development
$
8,911
$
6,418
$
17,649
$
12,102
General and administrative
3,302
2,957
6,668
5,311
Depreciation and amortization
8
8
16
16
Total operating expenses
12,221
9,383
24,333
17,429
Loss from operations
(12,221
)
(9,383
)
(24,333
)
(17,429
)
Other income (expense), net:
778
219
2,333
(35
)
Net loss attributable to common stockholders
$
(11,443
)
$
(9,164
)
$
(22,000
)
$
(17,464
)
Net loss per share - basic and diluted
$
(0.07
)
$
(0.06
)
$
(0.14
)
$
(0.11
)
Weighted average shares - basic and diluted
152,796,617
152,771,103
152,778,031
152,770,434
Other comprehensive loss
(158
)
(725
)
(14
)
(1,021
)
Total comprehensive loss
$
(11,601
)
$
(9,889
)
$
(22,014
)
$
(18,485
)
Savara Inc. and Subsidiaries Condensed Consolidated
Balance Sheet Data (in thousands)
(Unaudited)
June 30,
December 31,
2023
2022
Cash, cash equivalents, and short-term investments
$
105,179
$
125,876
Working capital
102,015
123,087
Total assets
119,833
139,777
Total liabilities
32,118
31,999
Stockholders’ equity:
87,715
107,778
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230810730094/en/
Savara Inc. IR & PR Anne Erickson
(anne.erickson@savarapharma.com) (512) 851-1366
Savara (NASDAQ:SVRA)
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