vTv Therapeutics Inc. (Nasdaq: VTVT) today announced entry
into agreements that include a $10 million investment by CinPax,
LLC (“CinPax”), a subsidiary of CinRx Pharma, LLC (“CinRx”). Under
the terms of the agreements, CinPax acquired 4,154,549 shares of
Class A Common Stock of vTv at an issue price of approximately
$2.41 per share, with $6 million paid in cash at closing, and the
remaining amount of $4 million payable on November 22, 2022. The
agreements also provide for the issuance of 1.2 million warrants to
CinRx to acquire additional shares of Class A Common Stock that
become exercisable upon agreed vesting triggers (including FDA
approval of TTP399 (“FDA Approval”)). In addition to the
investment, the agreements set forth the terms under which vTv will
leverage the CinRx team’s industry experience to collaborate on the
oversight of the clinical trials for pharmaceutical products that
contain TTP399.
“We have been hard at work on TTP399 since obtaining
Breakthrough Therapy Designation from the FDA in April 2021 and are
thrilled to welcome another partner to work with us to accelerate
the development and potential approval and commercialization of
this treatment. In addition to the $10 million investment, the
CinRx team brings exceptional industry experience in developing
therapeutics. On top of last month’s announcement of G42
Healthcare’s $25 million investment into vTv, this investment
provides additional funding towards our Phase 3 clinical trials for
TTP399,” said Rich Nelson, Interim Chief Executive Officer of
vTv.
Dr. Jon Isaacsohn, Chief Executive Officer of CinRx, who has
been involved in the clinical development of countless
therapeutics, is expected to join the vTv Board of Directors. Dr.
Isaacsohn noted “CinRx values the new partnership with the team at
vTv. We believe that TTP399 has the potential to reduce the
frequency of hypoglycemic events in type 1 diabetics, thus easing
the burden of managing their disease and allowing for tighter
long-term diabetic control.”
A more detailed description of the agreements is set forth in
vTv's Current Report on Form 8-K filed with the SEC. The Common
Stock and Warrant Purchase Agreement is attached to the Current
Report on Form 8-K.
This press release does not constitute an offer to sell or a
solicitation of an offer to buy the securities in this offering,
nor will there be any sale of these securities in any jurisdiction
in which such offer solicitation or sale are unlawful prior to
registration or qualification under securities laws of any such
jurisdiction.
About TTP399TTP399 is a novel,
oral, small molecule, liver selective glucokinase activator being
developed as a potential adjunct therapy to insulin in patients
with type 1 diabetes. In a recent Phase 2 clinical trial, TTP399
showed a 40% reduction in hypoglycemic episodes compared to
placebo. In April 2021, the FDA granted Breakthrough Therapy
designation to TTP399 for the treatment of type 1 diabetes. This
past October, vTv announced results of a mechanistic study of
TTP399 in patients with type 1 diabetes demonstrating no increased
risk of ketoacidosis. TTP399 has now been tested in almost 600
subjects. TTP399 is still in the development phase; the FDA
has not reviewed or approved TTP399 for use in the United States,
and a Breakthrough Therapy designation does not mean a product has
been, or will be, approved for use in the United States.
About vTv TherapeuticsvTv Therapeutics Inc. is
a clinical stage biopharmaceutical company focused on developing
oral, small molecule drug candidates. vTv has a pipeline of
clinical drug candidates led by programs for the treatment of type
1 diabetes and cystic fibrosis related diabetes. vTv’s development
partners are pursuing additional indications in type 2 diabetes,
chronic obstructive pulmonary disease, renal disease, primary
mitochondrial myopathy, and pancreatic cancer.
About CinRx PharmaCinRx Pharma is a
biotechnology company that leverages its team’s exceptional
industry experience to develop therapeutics in a novel way that
meets the modern paradigm of drug development. CinRx acquires
compounds from multiple sources, as well as partners with other
biotechnology companies, to invest in and develop innovative
products that will transform the lives of patients. With its broad
preclinical, clinical pharmacology, medical, biostatistical and
regulatory expertise, CinRx accelerates drug development programs
to help achieve marketing approval or bring about a successful
commercial exit. For more information, please
visit www.CinRx.com.
About Dr. IsaacsohnDr. Jon Isaacsohn has served
as Chief Executive Officer of CinRx Pharma since founding the
company in 2015 and serves as a member of the company’s board of
directors. During his career, Jon has been involved in developing
multiple drugs from protocol design to global submission in various
therapeutic areas. Prior to founding CinRx Pharma in 2015, Jon
served as Chief Medical Officer for Teva Pharmaceuticals where he
was responsible for developing Teva’s specialty drugs. Jon
also served as Executive Vice President, Head of Medical &
Regulatory Affairs at Medpace, a global leader in research-based
drug and device development, for nearly 15 years.
He trained in Internal Medicine and Cardiology at Harvard
Medical School and was a member of the cardiology faculty at Yale
Medical School. Jon is also a co-founder of the Metabolic &
Atherosclerosis Research Center in Cincinnati, Ohio, U.S.A.
Forward-Looking StatementsThis release contains
forward-looking statements, which involve risks and uncertainties,
including statements regarding the potential grant of the FDA
Approval. These forward-looking statements can be identified by the
use of forward-looking terminology, including the terms
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and, in each case, their negative or
other various or comparable terminology. All statements other than
statements of historical facts contained in this release, including
statements regarding the agreements and transactions described in
this release are forward-looking statements. These statements
involve known and unknown risks, uncertainties and other important
factors, including the risk that the FDA Approval is not received
on a timely basis or at all, that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause
our results to vary from expectations include those described under
the heading “Risk Factors” in our Annual Report on Form 10-K and
our other filings with the SEC. These forward-looking statements
reflect our views with respect to future events as of the date of
this release and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place
undue reliance on these forward-looking statements. These
forward-looking statements represent our estimates and assumptions
only as of the date of this release and, except as required by law,
we undertake no obligation to update or review publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise after the date of this release. We
anticipate that subsequent events and developments will cause our
views to change. Our forward-looking statements do not reflect the
potential impact of any future acquisitions, merger, dispositions,
joint ventures or investments we may undertake. We qualify all of
our forward-looking statements by these cautionary statements.
Contacts: |
vTv: |
Katie Larch / Robert Flamm, Ph.D. |
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Burns McClellan, Inc. |
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klarch@burnsmc.com / rflamm@burnsmc.com |
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CinRx: |
jwesterheide@cinrx.com |
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