Verve Establishes Global Collaboration with Lilly to Advance Verve’s In Vivo Gene Editing Program Targeting Lp(a) for the Treatment of Atherosclerotic Cardiovascular Disease
15 Juni 2023 - 12:30PM
Verve Therapeutics, Inc. (Nasdaq: VERV) today announced an
exclusive research collaboration with Eli Lilly and Company focused
on advancing Verve’s preclinical stage in vivo gene editing program
targeting lipoprotein(a) (Lp(a)). Elevated Lp(a) is an established
and genetically validated, independent risk factor for
atherosclerotic cardiovascular disease (ASCVD), ischemic stroke,
thrombosis, and aortic stenosis.
Under the terms of the collaboration, Verve will advance the
research and development of the Lp(a) program through the
completion of Phase 1 clinical development. Lilly will be
responsible for subsequent development, manufacturing, and
commercialization of the Lp(a) program.
“Verve was created with a singular focus to protect the world
from ASCVD by developing single-course gene editing medicines that
address the underlying causal drivers of the disease. Lp(a) is
validated as one of these key drivers, and as such, this program
represents another important step in our efforts to transform the
care of ASCVD,” said Sekar Kathiresan, M.D., co-founder and chief
executive officer of Verve. “Blood concentrations of Lp(a) are
determined almost entirely by inheritance, and unfortunately,
lifestyle and currently approved lipid-lowering therapies have
minimal to no impact. In patients with established ASCVD and
elevated blood Lp(a), we believe there is a substantial opportunity
for a single-course gene editing medicine to permanently lower
Lp(a) levels, and we are thrilled to have joined forces with Lilly,
an industry leader in cardiometabolic disease, to accelerate this
program toward patients. Additionally, with the $60 million in
capital expected from Lilly, we anticipate having a cash runway
that extends into 2026.”
Ruth Gimeno, Ph.D., group vice president, diabetes, obesity and
cardiometabolic research at Lilly, added: “We are pleased to
establish this collaboration with Verve, a company uniquely
positioned to develop gene editing medicines for common
cardiovascular conditions such as elevated Lp(a), a lipoprotein
particle that has been established as an important causal and
modifiable driver of ASCVD. We look forward to working with Verve
to develop a much-needed treatment option for patients with
elevated levels of Lp(a).”
Transaction TermsUnder the terms of the
agreement, Verve will receive $60 million consisting of an upfront
payment and equity investment. Research program costs through
Phase 1 clinical trials will be funded by Lilly. Verve is also
eligible to receive up to $465 million in research, development,
and commercial milestones, as well as tiered royalties on global
net sales. In addition, following the completion of Phase 1
clinical trials, Verve has the right to opt-in to co-fund and share
margins globally on the Lp(a) program (in lieu of receipt of
milestones and royalties).
The closing of the transaction is subject to customary closing
conditions, including clearance under the Hart-Scott-Rodino
Antitrust Improvements Act (HSR Act).
About Lipoprotein(a) Lipoprotein (a), also
known as Lp(a), is an LDL-like particle with apolipoprotein B
covalently linked to apolipoprotein(a), produced in the liver and
circulates in the blood. Lp(a) is a genetically validated,
independent risk factor for atherosclerotic cardiovascular disease
(ASCVD), ischemic stroke, thrombosis, and aortic stenosis. This
increased risk is most pronounced in individuals with very high
Lp(a) concentrations (e.g., ≥ 150 nmol/L). An estimated 20% of
ASCVD patients have a Lp(a) concentration above this threshold.
Lp(a) concentrations are determined at birth. Lifestyle changes,
such as diet and exercise, as well as currently approved
lipid-lowering therapies have minimal to no impact on Lp(a) levels.
Human genetics studies have validated Lp(a) as a causal driver of
ASCVD and pharmacologic studies of Lp(a)-lowering medicines are
ongoing to test the hypothesis that specific lowering of Lp(a) will
reduce ASCVD events.
About Verve Therapeutics Verve Therapeutics,
Inc. (Nasdaq: VERV) is a clinical-stage genetic medicines company
pioneering a new approach to the care of cardiovascular disease,
potentially transforming treatment from chronic management to
single-course gene editing medicines. The company’s initial three
programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that
have been extensively validated as targets for lowering low-density
lipoprotein cholesterol (LDL-C), a root cause of cardiovascular
disease, in order to durably reduce blood LDL-C levels. VERVE-101
and VERVE-102 are designed to permanently turn off the PCSK9 gene
in the liver and are being developed initially for heterozygous
familial hypercholesterolemia (HeFH) and ultimately to treat
atherosclerotic cardiovascular disease (ASCVD) patients not at goal
on oral therapy. VERVE-201 is designed to permanently turn off the
ANGPTL3 gene in the liver and is initially being developed for
homozygous familial hypercholesterolemia (HoFH) and ultimately to
treat patients with refractory hypercholesterolemia. For more
information, please visit www.VerveTx.com.
Verve Forward Looking StatementsThis press
release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties, including statements regarding
the potential benefits and results that may be achieved through the
collaboration with Lilly; the potential upfront and milestone
payments and potential royalties on future sales; the potential
co-fund and margin share arrangement; clearance of the transaction
under the HSR Act; and the company’s expectations regarding its
cash runway. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements are based on management’s current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in, or implied by, such forward-looking statements.
These risks and uncertainties include, but are not limited to,
risks associated with the company’s limited operating history; the
regulatory approval processes including clearance under the HSR
Act; whether the company’s cash resources will be sufficient to
fund the company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements on the company’s expected
timeline; the timing of and the company’s ability to submit
applications for, its product candidates; advance its product
candidates in clinical trials; initiate, enroll and complete its
ongoing and future clinical trials on the timeline expected or at
all; correctly estimate the potential patient population and/or
market for the company’s product candidates; replicate in clinical
trials positive results found in preclinical studies and/or
earlier-stage clinical trials of VERVE-101, VERVE-102 and
VERVE-201; advance the development of its product candidates under
the timelines it anticipates in current and future clinical trials;
obtain, maintain or protect intellectual property rights related to
its product candidates; manage expenses; and raise the substantial
additional capital needed to achieve its business objectives. For a
discussion of other risks and uncertainties, and other important
factors, any of which could cause the company’s actual results to
differ from those contained in the forward-looking statements, see
the “Risk Factors” section, as well as discussions of potential
risks, uncertainties and other important factors, in the company’s
most recent filings with the Securities and Exchange Commission and
in other filings that the company makes with the Securities and
Exchange Commission in the future. In addition, the forward-looking
statements included in this press release represent the company’s
views as of the date hereof and should not be relied upon as
representing the company’s views as of any date subsequent to the
date hereof. The company anticipates that subsequent events and
developments will cause the company’s views to change. However,
while the company may elect to update these forward-looking
statements at some point in the future, the company specifically
disclaims any obligation to do so.
Verve Investor Contact:Jen RobinsonVerve
Therapeutics, Inc.jrobinson@vervetx.com
Verve Media Contact:Ashlea
Kosikowski1ABashlea@1abmedia.com
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