==Verve Therapeutics (VERV) to be acquired by Eli Lilly (LLY) for $10.50 per share or $1 billion

The two companies were already partnered on a handful of one-time treatments for cardiovascular diseases. Verve's leading program would use gene editing to permanently turn off the PCSK9 gene. The gene makes a protein that, when elevated, leads to high cholesterol.

• Under the terms of the agreement, Lilly will commence a tender offer to acquire all of the outstanding shares of Verve for a purchase price of $10.50 per share in cash (an aggregate of approximately $1.0 billion) payable at closing, plus one non-tradeable contingent value right (CVR) per share that entitles the holder to receive up to an additional $3.00 per share, for a total potential consideration of up to $13.50 per share in cash without interest (an aggregate of up to approximately $1.3 billion). CVR holders would become entitled to receive the contingent payment upon the first patient being dosed with VERVE-102 for ASCVD in a U.S. Phase 3 clinical trial on or prior to the tenth anniversary of closing or termination of the CVR. There can be no assurance that any payments will be made with respect to the CVR.
• The transaction is not subject to any financing condition and is expected to close in the third quarter of 2025, subject to customary closing conditions, including the tender of a majority of the outstanding shares of Verve's common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Verve that are not tendered in the tender offer through a second step merger at the same consideration as paid in the tender offer. The purchase price payable at closing represents a premium of approximately 113% to the 30-day volume-weighted average trading price of Verve's common stock ended on June 16, 2025, the last trading day before the announcement of the transaction.
• Verve's board of directors unanimously recommends that Verve's stockholders tender their shares in the tender offer.
• To demonstrate their commitment to the transaction, Sekar Kathiresan, Andrew Ashe and entities affiliated with GV have signed tender and support agreements whereby they agreed, subject to certain terms and conditions, to tender their shares in the tender offer. The shares subject to the agreements that are beneficially owned by such stockholders represent a total of approximately 17.8% of Verve's outstanding common stock.
• Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly's financial results and financial guidance.

===Verve Therapeutics (VERV) reported earnings on Mon 7 Nov 22 (b/o)

• reports VERVE-101 Investigational New Drug Application placed on hold by FDA 

Verve Therapeutics reports VERVE-101 Investigational New Drug Application placed on hold by U.S. Food and Drug Administration 

• Verve announced today that the U.S. Food and Drug Administration (FDA) has placed a hold on its IND application to conduct a clinical trial evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia (HeFH), a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease (ASCVD), in the United States. VERVE-101 is a novel, investigational gene editing medicine designed to be a single-course treatment to permanently turn off the PCSK9 gene in the liver to reduce disease-driving low-density lipoprotein cholesterol (LDL-C). VERVE-101 is currently being evaluated in the heart-1 Phase 1 clinical trial in New Zealand and the United Kingdom (U.K.). Verve submitted its IND application for VERVE-101 to the FDA in October and received notification of a hold from the FDA on Friday, November 4, 2022. The company expects to receive an official letter with the FDA's questions within 30 days. Verve plans to provide updates pending engagement with the FDA and intends to work closely with the FDA to resolve the hold as promptly as possible in order to initiate dosing in the U.S.
• heart-1 Trial Update: Clinical data from the ongoing heart-1 study in New Zealand and the U.K. were not included in the IND package submitted to the FDA. Verve has completed dosing of VERVE-101 in the first dose cohort of the dose-escalation portion of the heart-1 trial, which was well tolerated in all three patients. There have been no treatment-related adverse events reported to date, and all adverse events observed have been Grade 1 in nature. The independent Data Safety Monitoring Board (DSMB) has reviewed safety data from the first cohort and recommended dose escalation to the planned second dose level, which is expected to begin soon. Enrollment efforts are ongoing in New Zealand and the U.K. The company plans to report initial safety and pharmacodynamic data for all dose cohorts of the dose-escalation portion of the heart-1 study at a medical meeting in the second half of 2023.