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
Verve to Receive $60 Million in Combined Upfront Payment and Equity Investment; Additional Capital Positioned to Extend Verve’s Expected Cash Runway into 2026
Verve has Opt-in Rights to Co-fund and Share in Potential Margins of Products Resulting from the Collaboration
BOSTON, June 15, 2023 (GLOBE NEWSWIRE) -- 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).”
Under 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).
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 Statements
This 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.
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