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Eli Lilly has agreed to acquire Verve Therapeutics for up to $1.3 billion, the companies said today, in a deal designed to bolster the buyer’s cardiovascular treatment pipeline with Verve’s gene edited therapies, led by PCSK9-targeting VERVE-102.
The deal comes two months after publicly-traded Verve announced positive initial data from the Phase Ib Heart-2 trial (NCT06164730) assessing VERVE-102 in patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease. Among 14 participants across three dose levels, a single VERVE-102 infusion yielded dose-dependent decreases in blood PCSK9 protein levels and low-density lipoprotein cholesterol (LDL-C), with a mean reduction in blood LDL-C of 53% and a maximum of 69% seen among four participants in the 0.6 mg/kg dose cohort.
Yet last year, investors punished Verve by sending its shares nosediving 35% after the company reported a serious adverse event in one patient during its Phase Ib Heart-1 trial (NCT05398029), a grade 3 drug-induced transient elevation of serum alanine aminotransferase (ALT) and grade 3 drug-induced thrombocytopenia. After pausing Heart-1 which assessed VERVE-101 in heterozygous familial hypercholesterolemia (HeFH), Verve pivoted its development effort toward VERVE-102.
“VERVE-102 has the potential to be the first in vivo gene editing therapy for broad patient populations and could shift the treatment paradigm for cardiovascular disease from chronic care to one-and-done treatment,” Ruth Gimeno, Lilly group vice president, Diabetes and Metabolic Research and Development, said in a statement.
Verve has said it expected to dose the first patient in its Phase II trial of VERVE-102 in the second half of this year. Also during the second half, Verve expects to offer a program update on its second LDL-C fighting clinical program, VERVE-201.
Verve ranked fifth in GEN’s recent-updated annual A-List of Top 10 Publicly-Owned Editing Therapy Companies, published Friday. During the first quarter, Verve reported collaboration revenue of $32.976 million, while placing fourth among the 10 ranked companies in cash position ($497.077 million), fifth in market cap ($384.207 million), and sixth in pipeline activity with VERVE-102 and -201.
‘Chronic care to a one-dose future’
“Verve was founded with one mission in mind: transform the treatment of cardiovascular disease from chronic care to a one-dose future. In just seven years, our team has progressed three in vivo gene editing products, with two currently in the clinic,” stated Sekar Kathiresan, MD, Verve’s co-founder and CEO. “Now, we will take the next steps in the drug development journey together with an ideal strategic partner in Lilly. Lilly shares our vision, and we believe their global research, clinical, regulatory and commercial capabilities will help to accelerate the development of our medicines.”
Lilly has agreed to pay Verve $1 billion upfront or $10.50 per share, plus a potential additional $300 million non-tradeable contingent value right (CVR) per share entitling shareholders to up to an additional $3 per share.
CVR holders would receive the payment when the first patient is dosed with VERVE-102 for ASCVD in a U.S. Phase III trial—or before the 10th anniversary of closing or termination of the CVR.
The deal price marks an approximately 113% premium to the 30-day volume weighted average trading price of Verve’s common stock as of Monday.
The deal is expected to close in the third quarter subject to the tender of a majority of outstanding shares of Verve’s common stock, and other customary closing conditions. Verve’s board has unanimously recommended that its shareholders tender their shares in the offer. Among shareholders agreeing to do so are Kathiresan, Andrew Ashe, and entities affiliated with GV (formerly Google Ventures), which together represent about 17.8% of Verve’s outstanding common stock.
Upon a successful closing of the tender offer, Lilly would acquire any shares of Verve that had not been tendered through a second step merger, at the same $10.50 per share price.
“My deepest thanks to the entire Verve team for their expertise, creativity, and grit. We are grateful to the investigators and patients who have contributed to the success of our clinical trials so far,” Kathiresan added. “Under Lilly’s stewardship, we are excited to realize the next chapter in cardiovascular care where a single treatment can lead to lifelong reduction of cardiovascular risk factors and make life better for millions of patients living with cardiovascular disease.”
