Invivyd Announces $20 Million to $25 Million Improvement in Projected 2024 Year-End Cash Position
2024年4月30日 - 8:30PM
Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted
to protection from serious viral infectious diseases, today
announced that following a comprehensive strategic review, the
company is improving its projected 2024 year-end cash position by
approximately $20 million to $25 million. Invivyd now expects to
end 2024 with at least $75 million in cash and cash equivalents.
“The Executive Committee of the Board of Directors has been
working very closely with the management team to ensure that we are
investing the company’s resources in the areas that have the
greatest potential to deliver appreciable benefits for patients and
shareholders,” said Marc Elia, Chairman of the Invivyd Board of
Directors. “Following a comprehensive strategic review which was
conducted over the past several weeks, we were able to reallocate
resources to support the launch of PEMGARDA™, bolster our ability
to deliver novel pipeline monoclonal antibody candidates, and
further strengthen our balance sheet going forward. We look forward
to sharing more details on our financials and our commercial
progress when we report Q1 results in May.”
The improvements were primarily achieved through cash
optimization in clinical operations and chemistry, manufacturing
and controls (CMC). Fourteen full-time positions were eliminated in
connection with the changes. Invivyd continues to anticipate 2024
PEMGARDA net product revenue in the range of $150 million to $200
million.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational
monoclonal antibody (mAb). PEMGARDA was engineered from
adintrevimab, Invivyd’s investigational mAb that has a robust
safety data package and provided evidence of clinical efficacy in a
global Phase 2/3 clinical trial for the prevention of COVID-19.
PEMGARDA has demonstrated in vitro neutralizing activity in
pseudotyped virus-like particle and authentic virus neutralization
assays against major SARS-CoV-2 variants, including JN.1. PEMGARDA
targets the SARS-CoV-2 spike protein receptor binding domain (RBD),
thereby inhibiting virus attachment to the human ACE2 receptor on
host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use
is an investigational mAb that has not been approved, but has been
authorized for emergency use by the U.S. FDA under an EUA for the
pre-exposure prophylaxis (prevention) of COVID-19 in adults and
adolescents (12 years of age and older weighing at least 40 kg) who
have moderate-to-severe immune compromise due to certain medical
conditions or receipt of certain immunosuppressive medications or
treatments and are unlikely to mount an adequate immune response to
COVID-19 vaccination. Recipients should not be currently infected
with or have had a known recent exposure to an individual infected
with SARS-CoV-2. PEMGARDA is not authorized for use for treatment
of COVID-19 or post-exposure prophylaxis of COVID-19. Anaphylaxis
has been observed with PEMGARDA and the PEMGARDA Fact Sheet for
Healthcare Providers includes a boxed warning for anaphylaxis. The
most common adverse events (all grades, incidence ≥2%) observed in
participants who have moderate-to-severe immune compromise treated
with PEMGARDA included systemic and local infusion-related or
hypersensitivity reactions, upper respiratory tract infection,
viral infection, influenza-like illness, fatigue, headache, and
nausea. For additional information, please see the PEMGARDA full
product Fact Sheet for Healthcare Providers, including important
safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was
used to determine if PEMGARDA may be effective for pre-exposure
prophylaxis of COVID-19. Immunobridging is based on the serum virus
neutralizing titer-efficacy relationships identified with other
neutralizing human mAbs against SARS-CoV-2. This includes
adintrevimab, the parent mAb of pemivibart, and other mAbs that
were previously authorized for EUA. There are limitations of the
data supporting the benefits of PEMGARDA. Evidence of clinical
efficacy for other neutralizing human mAbs against SARS-CoV-2 was
based on different populations and SARS-CoV-2 variants that are no
longer circulating. Additionally, the variability associated with
cell-based EC50 value determinations, along with limitations
related to pharmacokinetic data and efficacy estimates for the mAbs
in prior clinical trials, impact the ability to precisely estimate
protective titer ranges.
The emergency use of PEMGARDA is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products
during the COVID-19 pandemic under Section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the declaration is terminated or authorization revoked sooner.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company
devoted to protection from serious viral infectious diseases,
beginning with SARS-CoV-2. The company’s proprietary INVYMAB™
platform approach combines state-of-the-art viral surveillance and
predictive modeling with advanced antibody engineering. INVYMAB is
designed to facilitate the rapid, serial generation of new
monoclonal antibodies (mAbs) to keep pace with evolving viral
threats. In March 2024, Invivyd received emergency use
authorization (EUA) from the U.S. FDA for its first mAb in a
planned series of innovative antibody candidates. Visit
https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “anticipates,” “believes,” “could,” “expects,”
“intends,” “potential,” “projects,” and “future” or similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. Forward-looking statements
include statements concerning, among other things, the company’s
plans regarding a comprehensive resource realignment and the
anticipated benefits thereof; the company’s anticipated 2024
PEMGARDA net product revenue and the company’s projected 2024 year
end cash and cash equivalents balance; the potential of PEMGARDA as
a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in
certain adults and adolescents (12 years of age and older weighing
at least 40 kg) with moderate-to-severe immune compromise; the
company’s plans and expectations related to the commercialization
of PEMGARDA; the company’s ongoing research and clinical
development efforts; the design of the company’s INVYMAB platform
approach to facilitate the rapid, serial generation of new mAbs to
keep pace with evolving viral threats; the company’s expectation
that PEMGARDA is the first mAb in a planned series of innovative
antibody candidates; and other statements that are not historical
fact. The company may not actually achieve the plans, intentions or
expectations disclosed in the company’s forward-looking statements
and you should not place undue reliance on the company’s
forward-looking statements. These forward-looking statements
involve risks and uncertainties that could cause the company’s
actual results to differ materially from the results described in
or implied by the forward-looking statements, including, without
limitation: the company’s ability to realize the anticipated
benefits of its comprehensive resource realignment; how long the
EUA granted by the FDA for PEMGARDA will remain in effect and
whether the EUA is revoked or revised by the FDA; the company’s
ability to maintain and expand sales, marketing and distribution
capabilities to successfully commercialize PEMGARDA; changes in
expected or existing competition; the timing and progress of the
company’s discovery, preclinical and clinical development
activities; the uncertainties and timing of the regulatory
authorization or approval process, and available development and
regulatory pathways for authorization or approval of the company’s
product candidates; changes in the regulatory environment;
unexpected safety or efficacy data observed during preclinical
studies or clinical trials; the ability to maintain a continued
acceptable safety, tolerability and efficacy profile of PEMGARDA or
any other product candidate following regulatory authorization or
approval; the predictability of clinical success of the company’s
product candidates based on neutralizing activity in preclinical
studies; the risk that results of preclinical studies or clinical
trials may not be predictive of future results, and interim data
are subject to further analysis; the company’s reliance on third
parties with respect to virus assay creation and product candidate
testing and with respect to its clinical trials; variability of
results in models used to predict activity against SARS-CoV-2
variants; whether PEMGARDA or any other product candidate is able
to demonstrate and sustain neutralizing activity against major
SARS-CoV-2 variants, particularly in the face of viral evolution;
the complexities of manufacturing mAb therapies; the company’s
dependence on third parties to manufacture, label, package, store
and distribute clinical and commercial supplies of its product
candidates; whether the company is able to provide sufficient
commercial supply of PEMGARDA to meet market demand; whether the
company can obtain and maintain third-party coverage and adequate
reimbursement for PEMGARDA or any other product candidate; the
company’s ability to leverage its INVYMAB platform approach to
facilitate the rapid, serial generation of new mAbs to keep pace
with evolving viral threats; any litigation and other proceedings
or government investigations relating to the company; the company’s
ability to continue as a going concern; and whether the company has
adequate funding to meet future operating expenses and capital
expenditure requirements. Other factors that may cause the
company’s actual results to differ materially from those expressed
or implied in the forward-looking statements in this press release
are described under the heading “Risk Factors” in the company’s
Annual Report on Form 10-K for the year ended December 31, 2023
filed with the Securities and Exchange Commission (SEC), and in the
company’s other filings with the SEC, and in its future reports to
be filed with the SEC and available at www.sec.gov. Forward-looking
statements contained in this press release are made as of this
date, and Invivyd undertakes no duty to update such information
whether as a result of new information, future events or otherwise,
except as required under applicable law.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
Contacts:
Media Relations(781) 208-1747media@invivyd.com
Investor Relations(781) 208-1747investors@invivyd.com
Invivyd (NASDAQ:IVVD)
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Invivyd (NASDAQ:IVVD)
過去 株価チャート
から 5 2023 まで 5 2024