Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq:
TVGN), a clinical-stage specialty immunotherapy biotech pioneer
developing off-the-shelf, genetically unmodified T cell
therapeutics in oncology, neurology, and virology, announced
financial results for full year 2023, business highlights, and
upcoming operational objectives.
“Saving lives remains our duty, and to that end, we remain
committed to furthering our ExacTcell™ technology platform by
moving Tevogen’s allogeneic cytotoxic CD8+ T lymphocytes (CTLs)
into the next phase of clinical trials” said Dr. Ryan Saadi,
Founder and Chief Executive Officer of Tevogen Bio. “Moving the
first clinical product of Tevogen’s ExacTcell platform, an
allogeneic target specific CTL, from inception to clinical trial in
just 18 months validates Tevogen’s unique business model. I would
also like to assure numerous Long COVID patients and their families
who have contacted us that exploring the therapeutic potential of
TVGN 489 for Long COVID remains my personal priority.”
Tevogen Bio is in discussions to acquire cell therapy
manufacturing facilities that are expected to provide Tevogen Bio
with the capability for both clinical and commercial manufacturing
of drug candidates from its ExacTcell technology platform. These
facilities would support manufacturing for TVGN 489’s continued
development, as well as provide the potential for future clinical
trials for virally induced cancers and multiple sclerosis. In
addition to manufacturing capability, these facilities are also
expected to enhance Tevogen Bio’s research and development
capabilities and serve as new product innovation hubs.
In January, Tevogen Bio announced positive POC clinical trial
results for TVGN 489 for treatment of high-risk patients. The
primary study endpoints were related to safety and there were no
dose-limiting toxicities or significant adverse events related to
TVGN 489 observed in any patient at any of the four dose levels.
Unlike CAR T platforms, Tevogen Bio’s ExacTcell platform targets
antigens present only on diseased cells and is designed for an
ambulatory setting. The expected yield per lot is in hundreds
of doses, providing pricing flexibility for greater access.
“Patients who are immune compromised continue to need novel
treatments for COVID-19. We have completed the design of a new
clinical trial of TVGN 489 to address the unmet need of this
population. The manufacturing facilities are expected to support
our application for FDA approval and expedite the commencement of
that trial” said Lori Grosso, Clinical Development Lead of Tevogen
Bio.
Tevogen Bio is evaluating several funding options to support its
ambitious growth plans over the next 12 months to initiate in-house
manufacturing, clinical trials, and other operational
expenses. “Tevogen finds itself in a unique position by
achieving clinical success while retaining equity control by
executive management. In addition, it’s atypical for a start up to
have received such company-favorable financing terms as Tevogen
has. We will explore funding options that are similarly favorable”
said Tapan Shah, Head of Investor Relations and Corporate
Development of Tevogen Bio.
For full year 2023, the operating expenses for Tevogen Bio Inc
were $8.8 million. As previously announced, as of December 31,
2023, the conversion of promissory notes into common stock removed
$94.9 million in pro forma balance sheet liabilities; the remaining
pro forma total liabilities were $5.4 million.
Tevogen Bio SEC Filings
Form 8-K/A (Current Report filed April 29, 2024)
Form 10-K (Annual Report filed April 29, 2024)
About Tevogen Bio
Tevogen Bio is a clinical-stage specialty immunotherapy company
harnessing one of nature’s most powerful immunological weapons,
CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically
unmodified precision T cell therapies for the treatment of
infectious diseases, cancers, and neurological disorders, aiming to
address the significant unmet needs of large patient populations.
Tevogen Leadership believes that sustainability and commercial
success in the current era of healthcare rely on ensuring patient
accessibility through advanced science and innovative business
models. Tevogen has reported positive safety data from its
proof-of-concept clinical trial, and its key intellectual property
assets are wholly owned by the company, not subject to any
third-party licensing agreements. These assets include three
granted patents and twelve pending patents, two of which are
related to artificial intelligence.
Tevogen Bio is driven by a team of highly experienced industry
leaders and distinguished scientists with drug development and
global product launch experience. Tevogen Bio’s leadership believes
that accessible personalized therapeutics are the next frontier of
medicine, and that disruptive business models are required to
sustain medical innovation.
Forward Looking Statements
This press release contains certain forward-looking statements,
including without limitation statements relating to: Tevogen’s
development of, the potential benefits of, and patient access to
its product candidates for the treatment of infectious diseases,
cancer and neurological disorders, including TVGN 489 for the
treatment of COVID-19 and Long COVID; Tevogen’s ability to develop
additional product candidates, including through use of Tevogen’s
ExacTcell platform; the anticipated benefits of ExacTcell;
expectations regarding Tevogen’s future clinical trials, Tevogen’s
manufacturing plans, Tevogen’s future financing and the terms
thereof, and Tevogen’s ability to commercialize products in the
future. Forward-looking statements can sometimes be identified by
words such as “may,” “could,” “would,” “expect,” “possible,”
“potential,” “goal,” “opportunity,” “project,” “believe,” “future,”
and similar words and expressions or their opposites. These
statements are based on management’s expectations, assumptions,
estimates, projections and beliefs as of the date of this press
release and are subject to a number of factors that involve known
and unknown risks, delays, uncertainties and other factors not
under the company’s control that may cause actual results,
performance or achievements of the company to be materially
different from the results, performance or other expectations
expressed or implied by these forward-looking statements.
These factors include, but are not limited to: (i) the effect of
the recent business combination with Semper Paratus Acquisition
Corporation (the “Business Combination”) on Tevogen’s business
relationships, operating results, and business generally; (ii) the
challenges in negotiating and completing the acquisition of
manufacturing facilities, and the risk that the Company may not be
able to complete the acquisition of manufacturing facilities; (iii)
that Tevogen will need to raise additional capital to execute its
business plan, which may not be available on acceptable terms or at
all; (iv) the outcome of any legal proceedings that may be
instituted against Tevogen related to the Business Combination; (v)
changes in the markets in which Tevogen competes, including with
respect to its competitive landscape, technology evolution, or
regulatory changes; (vi) the risk that Tevogen may not be able to
execute its growth strategies or may experience difficulties in
managing its growth and expanding operations; (vii) the risk that
Tevogen may not be able to develop and maintain effective internal
controls; (viii) costs related to the Business Combination and the
failure to realize anticipated benefits of the Business
Combination; (ix) the failure to achieve Tevogen’s
commercialization and development plans, and identify and realize
additional opportunities, which may be affected by, among other
things, competition, (ix) the ability of Tevogen to grow and manage
growth economically and hire and retain key employees; (x) the risk
that Tevogen may fail to keep pace with rapid technological
developments to provide new and innovative products and services or
make substantial investments in unsuccessful new products and
services; (xi) the ability to develop, license or acquire new
therapeutics; (xii) the risk of regulatory lawsuits or proceedings
relating to Tevogen’s business; (xiii) uncertainties inherent in
the execution, cost, and completion of preclinical studies and
clinical trials; (xiv) risks related to regulatory review, and
approval and commercial development; (xv) risks associated with
intellectual property protection; (xvi) Tevogen’s limited operating
history; and (xvii) those factors discussed in Tevogen’s filings
with the SEC, including in Tevogen’s Annual Report on Form
10-K.
You should not place undue reliance on forward-looking
statements, which speak only as of the date they are made. Tevogen
undertakes no obligation to update any forward-looking statements,
except as required by applicable law.
Contacts
Tevogen Bio CommunicationsT: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com
Tevogen Bio (NASDAQ:TVGN)
過去 株価チャート
から 8 2024 まで 9 2024
Tevogen Bio (NASDAQ:TVGN)
過去 株価チャート
から 9 2023 まで 9 2024