- Pivotal Phase 3 IMPALA-2 Trial Remains On-track, Top Line
Results Expected 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
- Pending Results from the IMPALA-2 Trial, a Biologics License
Application (BLA) Filing is Anticipated in 1H 2025
- With ~$143M in Cash and Short-term Investments, the Company
Continues to Believe 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 first quarter ending March 31,
2024 and provided a business update.
“The IMPALA-2 trial remains on-track and we look forward to
reporting top line results by the end of the second quarter,” said
Matt Pauls, Chair and CEO, Savara. “Following that, and assuming
positive data, we expect to file a BLA in the first half of 2025.
Importantly, with $143 million in cash and investments, we believe
we are capitalized into 2026 which is well beyond the data read-out
and includes investments in programs such as the extension of the
IMPALA-2 open-label period from 48 weeks to 96 weeks, anticipated
launch of a global Expanded Access program for molgramostim, build
out of the U.S. Commercial infrastructure, and pre-Commercial
preparations in Europe.”
First Quarter Financial Results (Unaudited)
Savara's net loss for the first quarter of 2024 was $20.3
million, or $(0.11) per share, compared with a net loss of $10.6
million, or $(0.07) per share, for the first quarter of 2023.
Research and development expenses increased by $8.1 million, or
92.3%, to $16.8 million for the three months ended March 31, 2024
from $8.7 million for the three months ended March 31, 2023. The
increase was largely due to the performance of tasks related to the
molgramostim program, which included approximately $4.3 million
associated with chemistry, manufacturing, and controls activities
and primarily driven by initiatives at second source drug substance
manufacturers, $1.0 million related to the IMPALA-2 clinical trial,
including clinical research organization (CRO) related activities,
$0.6 million associated with regulatory affairs and quality
assurance work, and $2.2 million due to an increase in personnel
and related costs.
General and administrative expenses increased by $2.3 million,
or 67.4%, to $5.6 million for the three months ended March 31, 2024
from $3.4 million for the three months ended March 31, 2023. The
increase was due to personnel and related costs of $0.6 million,
certain commercial activities of $1.1 million, and other overhead
of $0.6 million primarily driven by patient advocacy
activities.
As of March 31, 2024, the Company had cash, cash equivalents and
short-term investments of approximately $143.0 million and debt of
approximately $26.4 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, the anticipated timing of the BLA
filing, our belief the Company is capitalized into 2026, and the
planned investments in the extension of the IMPALA-2 open label
period, the anticipated launch of a global Expanded Access program,
the build out of the U.S. Commercial infrastructure, and
pre-Commercial preparations in Europe. 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
March 31,
2024
2023
Operating expenses: Research and development
$
16,807
$
8,738
General and administrative
5,636
3,366
Depreciation and amortization
32
8
Total operating expenses
22,475
12,112
Loss from operations
(22,475
)
(12,112
)
Other income (expense), net:
2,129
1,555
Net loss attributable to common stockholders
$
(20,346
)
$
(10,557
)
Net loss per share - basic and diluted
$
(0.11
)
$
(0.07
)
Weighted average shares - basic and diluted
182,550,109
152,781,580
Other comprehensive (loss) gain
(471
)
144
Total comprehensive loss
$
(20,817
)
$
(10,413
)
Savara Inc. and
Subsidiaries
Condensed Consolidated Balance
Sheet Data
(in thousands)
(Unaudited)
March 31,
December 31,
2024
2023
Cash, cash equivalents, and short-term investments
$
143,043
$
162,319
Working capital
136,377
155,350
Total assets
158,295
177,564
Total liabilities
36,434
37,192
Stockholders’ equity:
121,861
140,372
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240509719255/en/
Savara Inc. IR & PR Anne Erickson
(anne.erickson@savarapharma.com) (512) 851-1366
Savara (NASDAQ:SVRA)
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