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,
2024 and provided a business update.
Recent Business Highlights
- Reported positive top line results from IMPALA-2, a pivotal,
Phase 3 clinical trial of molgramostim nebulizer solution
(molgramostim) for the treatment of autoimmune pulmonary alveolar
proteinosis (aPAP)
— Statistically significant improvement in
Percent Predicted Diffusing Capacity of the Lungs for Carbon
Monoxide (DLCO) versus placebo at week 24 (primary endpoint) and
week 48 (secondary endpoint) — Statistically significant
improvement in St. George’s Respiratory Questionnaire (SGRQ) Total
Score at week 24 (secondary endpoint) — Nominally significant
improvements in SGRQ Activity Score at week 24 and exercise
capacity using a treadmill test at week 48 (secondary endpoints) —
97% of patients completed double-blind treatment through week 48
with no trial drug-related adverse events leading to
discontinuation — 100% of patients completing the 48-week
double-blind period elected to participate in the 96-week
open-label period
- Abstracts accepted for presentation at 2024’s European
Respiratory Society (ERS) Congress, the CHEST Annual Meeting, and
the British Thoracic Society (BTS) Winter Meeting
— Abstracts highlight new IMPALA-2 data and
the aPAP patient journey — Company-sponsored industry symposia to
be held at the ERS Congress and the CHEST Annual Meeting
- FDA conditionally accepted the trade name MOLBREEVI™ for
molgramostim
- Company to host investor webinar on September 30, 2024
— Data from the IMPALA-2 trial will be
presented and updates on the global commercial landscape and aPAP
market development work will be provided — Details for accessing
the webinar forthcoming
- In July 2024, further strengthened balance sheet with an ~$100M
equity financing, which added ~$94M to the ~$122M in cash, cash
equivalents, and short-term investments reported as of June 30,
2024; Company expects to be sufficiently capitalized through
2026
“Following strong top line results in the IMPALA-2 trial, we
plan to complete the BLA submission for MOLBREEVI, the trade name
that the FDA has conditionally accepted for molgramostim, in the
first half of 2025,” said Matt Pauls, Chair and CEO, Savara. “In
parallel, we are now significantly ramping up global market
development activities and look forward to presenting this work, as
well as data from the IMPALA-2 trial, during our investor webinar
in September.”
Pauls continued, “The IMPALA-2 data support our view that
MOLBREEVI could fundamentally change the way aPAP is treated. With
approximately 3,600 currently diagnosed U.S. patients and
literature suggesting prevalence may be underestimated, plus our
increased focus on developing the aPAP market and the potential for
MOLBREEVI to be the first and only approved therapy for aPAP in the
U.S. and Europe, we believe the global commercial opportunity is
significant.”
Abstract Acceptances and Symposia ERS 2024 (September 7-11) Abstract: “Inhaled
Molgramostim Improves Pulmonary Gas Exchange and Respiratory
Health-Related Quality of Life (HRQoL) in Patients with Autoimmune
Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2”
Session: Details are forthcoming Date and Time: Details are
forthcoming
The Company is also sponsoring a symposium entitled “Pulmonary
Alveolar Proteinosis: Pathophysiology, Diagnosis, and
Management.”
- Date and Time: ERS Congress Industry Theater, September 8,
2024, 5:30PM – 7:00PM (CET)
CHEST 2024 (October 6-9) Abstract:
“A Patient Journey Map for People Living with Autoimmune Pulmonary
Alveolar Proteinosis (aPAP)” Poster Session: Diffuse Lung Disease
Abstracts Posters (D) Date and Time: October 8, 2024; 1:45PM –
2:30PM (EDT)
The Company is also sponsoring a symposium entitled “Pulmonary
Alveolar Proteinosis: Pathophysiology, Diagnosis, and
Management.”
- Date and Time: CHEST Learning Theater, October 8, 2024, 2:00PM
– 2:45PM (EDT)
BTS Winter Meeting 2024 (November
27-29) Abstract: “Molgramostim Improves Pulmonary Gas
Exchange in Patients with Autoimmune Pulmonary Alveolar Proteinosis
(aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial” Session:
Details are forthcoming Date and Time: Details are forthcoming
Second Quarter Financial Results (Unaudited)
Savara's net loss for the second quarter of 2024 was $22.2
million, or $(0.12) per share, compared with a net loss of $11.4
million, or $(0.07) per share, for the second quarter of 2023.
Research and development expenses increased by $8.7 million, or
97.7%, to $17.6 million for the three months ended June 30, 2024
from $8.9 million for the three months ended June 30, 2023. This
increase was primarily due to the performance of tasks related to
the molgramostim program, which include ~$4.8 million of costs
related to chemistry, manufacturing, and controls activities,
primarily driven by initiatives to establish a second drug
substance manufacturer, ~$1.2 million of costs related to the
IMPALA-2 trial and pediatric study, including CRO-related
activities, ~$1.3 million of costs related to regulatory affairs
and quality assurance, and ~$1.4 million due to an increase in
personnel and other departmental overhead.
General and administrative expenses increased by $2.2 million,
or 67.8%, to $5.5 million for the three months ended June 30, 2024
from $3.3 million for the three months ended June 30, 2023. The
increase was due to personnel and related costs of ~$1.1 million,
certain commercial activities of ~$0.8 million, and other overhead
of ~$0.3 million primarily driven by consultant costs.
As of June 30, 2024, the Company had cash, cash equivalents and
short-term investments of ~$121.5 million and debt of ~$26.5
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, our
expectation the Company is sufficiently capitalized through 2026,
statements related to the timing and contents of our planned
investor webinar in September 2024 and upcoming meetings and
symposia, the anticipated timing of our BLA submission, that we are
significantly ramping up global market development activities, that
the IMPALA-2 data support our view that MOLBREEVI could
fundamentally change the way aPAP is treated, our belief that the
global commercial opportunity for MOLBREEVI is significant and the
basis for that belief. 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 risk that
further analysis of the full data set from the IMPALA-2 clinical
trial could result in unexpected observations; the risks associated
with our ability to successfully develop, obtain regulatory
approval for, and commercialize molgramostim for aPAP; the risks
and uncertainties related to the impact of widespread health
concerns or changing economic or geopolitical conditions; 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; 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,
2024
2023
2024
2023
Operating expenses: Research and development
$
17,617
$
8,911
$
34,424
$
17,649
General and administrative
5,540
3,302
11,176
6,668
Depreciation and amortization
33
8
65
16
Total operating expenses
23,190
12,221
45,665
24,333
Loss from operations
(23,190
)
(12,221
)
(45,665
)
(24,333
)
Other income (expense), net:
947
778
3,076
2,333
Net loss attributable to common stockholders
$
(22,243
)
$
(11,443
)
$
(42,589
)
$
(22,000
)
Net loss per share - basic and diluted
$
(0.12
)
$
(0.07
)
$
(0.23
)
$
(0.14
)
Weighted average shares - basic and diluted
182,584,078
152,796,617
182,567,091
152,778,031
Other comprehensive loss
(138
)
(158
)
(609
)
(14
)
Total comprehensive loss
$
(22,381
)
$
(11,601
)
$
(43,198
)
$
(22,014
)
Savara Inc. and Subsidiaries Condensed Consolidated
Balance Sheet Data (in thousands)
(Unaudited)
June 30, December 31,
2024
2023
Cash, cash equivalents, and short-term investments
$
121,516
$
162,319
Working capital
116,408
155,350
Total assets
139,670
177,564
Total liabilities
37,939
37,192
Stockholders’ equity:
101,731
140,372
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version on businesswire.com: https://www.businesswire.com/news/home/20240812280186/en/
Savara Inc. IR & PR Anne Erickson
(anne.erickson@savarapharma.com) (512) 851-1366
Savara (NASDAQ:SVRA)
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