vTv Therapeutics Announces Investment by and Entry into Collaboration and License Agreement with affiliates of G42 Healthcare
June 01 2022 - 6:54AM
vTv Therapeutics Inc. (Nasdaq: VTVT) today announced entry into
agreements that include a $25 million investment by G42 Investments
AI Holding RSC Ltd (“G42 Investments”). Under the terms of the
agreements, G42 Investments acquired 10,386,274 shares of Class A
Common Stock of vTv at an issue price of $2.407 per share, with
$12.5 million paid in cash at closing, and the remaining amount of
$12.5 million payable on May 31, 2023. The agreements also provide
for the potential issuance of $30 million in additional shares of
Class A Common Stock to G42 Investments (or cash in lieu of such
issuance at the option of G42 Investments) if the United States
Food and Drug Administration (the “FDA”) approves the marketing and
sale of a pharmaceutical product containing TTP399, a liver
selective glucokinase activator, as the active ingredient for
treatment of type 1 diabetes in the United States. The agreements
set forth the terms under which vTv and an affiliate of G42 plan to
collaborate on clinical trials for pharmaceutical products that
contain TTP399, including G42’s affiliate funding a portion of the
Phase 3 clinical trials for TTP399, and vTv granting G42’s
affiliate an exclusive license to develop and commercialize
pharmaceutical products containing TTP399 in certain territories
outside of the United States and the European Union.
“We have focused substantial energy and resources on TTP399
since obtaining Breakthrough Therapy designation from the FDA in
April 2021 and are thrilled to welcome a partner to work with us to
accelerate the development and potential approval and
commercialization of this treatment. G42 Healthcare brings a unique
combination of strong commitment to the development of new
impactful drugs and treatments, as demonstrated by their success
and their leadership on COVID-19 testing and other product and
service offerings in the healthcare spectrum, and substantial
resources, making them an ideal partner for this program. This
investment into vTv will fund a substantial portion of our Phase 3
clinical trials for TTP399 in the United States and the
collaboration with G42 will fund certain of the Phase 3 clinical
trials that will be conducted in other territories. We are excited
to partner with the G42 Healthcare team as we launch our Phase 3
clinical trials and work together towards approval and
commercialization of this treatment for type 1 diabetes,” said Rich
Nelson, Interim Chief Executive Officer of vTv.
Dr. Fahed Al Marzooqi, the Chief Operating Officer of G42
Healthcare, noted that “We have a deep commitment to collaborating
with international organizations to share our knowledge and
expertise in the consumer and clinical health spectrum and we look
forward to working together with vTv to further develop and
commercialize this important treatment. As we move ahead, we will
continue to join forces with the world’s best to innovate and
invest in science and create the next wave of medicines to
future-proof the health of nations.”
A more detailed description of the agreements is set forth in
vTv's Current Report on Form 8-K filed with the SEC. The Stock
Purchase Agreement is attached to the Current Report on Form 8-K
and the Collaboration and License Agreement will be filed with
vTv's Quarterly Report on Form 10-Q for the second quarter.
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
an 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.
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 G42 HealthcareG42 Healthcare,
headquartered in the UAE, is a health-tech company on a mission to
develop a world-class healthcare sector in the UAE and beyond. The
company is committed to harnessing data and advanced medical
technologies to unlock the potential of personalised and preventive
care, while transforming the traditional healthcare ecosystem.
At the forefront in the battle against COVID-19,
G42 Healthcare established Biogenix Labs, the UAE’s first COVID-19
accredited large-scale throughput laboratory. It facilitated the
#4Humanity clinical trials, the world’s first Phase III trials for
an inactivated vaccine against COVID-19.
Beyond COVID-19, G42 Healthcare plans to conduct
research and development on genomics, imaging and diagnostics, and
digitisation programmes to support the health of future
generations. This includes a collaboration to set up a wastewater
monitoring lab in Abu Dhabi, as well as automating and optimising
central testing laboratories in the UAE.
For further information visit
www.g42healthcare.ai
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.
ContactvTv:
IR@vtvtherapeutics.com G42:
Faheem.Ahamed@g42.ai
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