Adverum is developing a pipeline of intravitreal single-administration gene therapies with the aspiration of developing functional cures to restore vision and prevent blindness. Its lead product candidate, Ixo-vec, is an intravitreal gene therapy being developed for the treatment of wet age-related macular degeneration (wAMD). This serious, chronic and progressive retinal disease affects millions of people worldwide. Ixo-vec is designed as a single one-time treatment to deliver continuous and stable intraocular aflibercept levels, thereby reducing the significant patient burden associated with current chronic anti-VEGF therapies, while also potentially leading to improved vision outcomes.
Ixo-vec is being evaluated in the ARTEMIS Phase 3 clinical trial, which has completed screening. The program has been granted Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations by the U.S. Food and Drug Administration, as well as PRIME designation by the European Medicines Agency and the Innovation Passport from the United Kingdom's Medicines and Healthcare Products Regulatory Agency for the treatment of wAMD.
"Ixo-vec has the potential to transform wAMD treatment from a paradigm of chronic care with repeated intravitreal injections to a convenient one-time therapy," said Andrew Adams, Lilly group vice president, Molecule Discovery. "We are eager to welcome Adverum colleagues to Lilly and to help accelerate this innovative medicine to patients."
"We are excited about the potential to join Lilly, with a proven track record in the discovery, development, and commercialization of innovative medicines for chronic and age-related conditions," said Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. "We share Lilly's commitment to healthy aging and genetic medicines innovation. Their scientific depth and global reach offer the opportunity to accelerate our vision to deliver a transformative One and Done therapy that can potentially restore and preserve vision for millions of patients living with wAMD. My deepest appreciation goes out to the entire Adverum team for their expertise, creativity and commitment. We are also grateful to the investigators, patients and caregivers who have contributed to the success of Ixo-vec thus far."
Under the terms of the merger agreement, Lilly will commence a tender offer to acquire all of the outstanding shares of Adverum common stock for a per share price of (1) $3.56 per share in cash payable at closing plus (2) one non-transferrable contingent value right (CVR) that entitles the holder to receive up to an additional $8.91 per CVR in cash upon the achievement of two milestones described below, for total potential per share consideration of up to $12.47.
The CVR provides payments if and when the following milestones are achieved:
The transaction is subject to closing conditions that appear in the merger agreement and tender offer documents that will be filed with the SEC, including the tender of a majority of the outstanding shares of Adverum's common stock. These conditions do not include a financing condition. The transaction is expected to close in the fourth quarter of 2025, subject to satisfaction of the closing conditions. If the tender offer successfully closes, then Lilly would acquire any shares of Adverum that are not tendered in the tender offer through a second-step merger for the same consideration as is paid in the tender offer.
In conjunction with the transaction, Adverum has entered into a Promissory Note (the "Promissory Note") with Lilly. The Promissory Note is secured by all of Adverum's assets, including all of its intellectual property rights, and enables Adverum to receive a loan of up to $65 million from Lilly, drawable by Adverum in four installments, subject to specified conditions, to support ongoing Ixo-vec clinical trials and registrational development activities prior to the anticipated closing of the transaction. Funding obligations cease and the Promissory Note immediately becomes due if the transaction is terminated, including as a result of the minimum tender condition not being satisfied. Absent funds provided by Lilly under the Promissory Note, Adverum's remaining cash and cash equivalents were expected to finance only its October 2025 operations and wind down activities.
The transaction was unanimously approved by Adverum's board of directors following a comprehensive evaluation of strategic alternatives. This evaluation process included numerous discussions with potential partners and buyers. In addition, the board of directors evaluated a range of potential sources of additional capital and financing options. It was determined that the merger agreement with Lilly, inclusive of the potential upside for Adverum's stockholders of the CVR as Lilly advances development of Ixo-vec, is in the best interests of Adverum and its stockholders.
For Lilly, Ropes & Gray LLP is acting as legal counsel. For Adverum, Aquilo Partners, L.P. is acting as exclusive financial advisor and Cooley LLP is acting as legal counsel.
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