Adverum Biotechnologies Appoints Jason L. Mitchell as Chief Commercial Officer as it Prepares to Initiate Pivotal Program

Rhea-AI Summary

Adverum Biotechnologies (Nasdaq: ADVM) has appointed Jason L. Mitchell as chief commercial officer. Mitchell brings over 20 years of commercial experience, including in retinal disease and the successful launch of SYFOVRE® for geographic atrophy. He will be responsible for the launch strategy and commercial infrastructure for ixoberogene soroparvovec (Ixo-vec), Adverum's potential one-time intravitreal injection for wet age-related macular degeneration (wet AMD).

Adverum plans to announce LUNA 52-week data and pivotal program details in Q4 2024, with the Ixo-vec pivotal program set to initiate in H1 2025. The company believes Ixo-vec has demonstrated a potential best-in-class product profile, with 88% of LUNA patients preferring it over prior anti-VEGF injections. Mitchell's appointment aligns with Adverum's focus on progressing Ixo-vec toward approval and commercialization.

Positive

• Appointment of experienced commercial leader Jason L. Mitchell as chief commercial officer
• Plans to initiate Ixo-vec pivotal program in H1 2025
• 88% of patients in LUNA trial preferred Ixo-vec over prior anti-VEGF injections
• Potential for Ixo-vec to extend therapeutic benefit from weeks to years or life after a single injection

Negative

• None.

REDWOOD CITY, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced the appointment of Jason L. Mitchell as chief commercial officer. Mr Mitchell brings to Adverum over 20 years of commercial experience, including in retinal disease, and most recently oversaw the successful launch of SYFOVRE® in geographic atrophy (GA). In his new role, Mr. Mitchell will be responsible for setting the launch strategy and building the commercial infrastructure for ixoberogene soroparvovec (Ixo-vec), Adverum’s potential one-time intravitreal (IVT) injection for the treatment of neovascular or wet age-related macular degeneration (wet AMD). Ixo-vec is currently being evaluated in the Phase 2 LUNA clinical trial. The company plans to announce LUNA 52-week data and pivotal program details in the 4^th quarter of 2024. In addition, the company is on track to initiate the Ixo-vec pivotal program in the 1^st half of 2025.

“It is an exciting time at Adverum as we progress toward the initiation of Ixo-vec’s pivotal program in the first half of 2025,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “Given the long-term OPTIC efficacy and safety data, combined with the confirmatory LUNA data we’ve recently presented, we believe Ixo-vec has demonstrated a potential best-in-class product profile with 88% of patients in LUNA preferring Ixo-vec over their prior anti-VEGF injections. We are laser focused on initiating our Phase 3 program and progressing Ixo-vec toward approval and commercialization. Jason will be a great asset to us as we enter this next phase for the company. I look forward to the value he will bring as we continue to advance this exciting treatment for patients.”

“It isn’t often in one’s career you can be a part of shaping the strategy to deliver a truly transformational therapy to patients. I am thrilled to join Adverum as we look to establish IVT gene therapy as the new standard of care for patients with wet AMD,” said Jason L. Mitchell, chief commercial officer of Adverum Biotechnologies. “I had the privilege of helping to build and lead the team for one of the most successful launches in advanced retinal diseases. I look forward to applying my retinal expertise in support of introducing Ixo-vec as an industry leading mass-market gene therapy for wet AMD. After a single intravitreal injection, Ixo-vec has the potential to extend therapeutic benefit from weeks to years and maybe even for life, offering the opportunity to address the current treatment burden of wet AMD for patients and their families, and the retina specialists and health systems that care for them.”

Jason L. Mitchell is an accomplished commercial pharmaceutical executive with over 20 years of experience in strategic leadership and building high-performing, diverse teams in multiple commercial areas, including sales, marketing and operations, for several specialty pharmaceutical companies. Most recently, Mr. Mitchell was the head of sales & training for Apellis Pharmaceuticals, where he was integral to the design and implementation of pre-market strategy for SYFOVRE® in GA, the advanced form of dry AMD, and responsible for the commercial buildout of sales, training, KOL engagement and multiple operational functions and processes. Prior to Apellis, Mr. Mitchell was the senior director of commercial learning & development at Gilead Sciences, where he was responsible for developing six core business units and all US marketing and market access functions. Earlier in his career Mr. Mitchell held sales, marketing and training leadership roles with companies such as Neos Therapeutics and Salix Pharmaceuticals. He received his B.A. in Sociology and Criminal Justice from Missouri State University and attended the Leadership Development Bell Leadership Institute at the University of North Carolina.

Inducement Grant
In connection with Mr. Mitchell’s employment with the Company, he will be granted a stock option to purchase 65,000 shares of common stock under Adverum’s 2017 Inducement Plan on October 16, 2024. The Compensation Committee of Adverum’s Board of Directors approved the award as inducement material to Mr. Mitchell’s employment in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have a per-share exercise price equal to Adverum’s closing trading price on October 16, 2024, and will vest over four years, with 25% of the underlying shares vesting on October 16, 2025, and 1/48^th of the balance of the underlying shares vesting monthly thereafter over 36 months, subject to his continued service with Adverum through the applicable vesting dates. The award is subject to the terms and conditions of Adverum’s 2017 Inducement Plan and the terms and conditions of the award agreement covering the grant.

About Adverum Biotechnologies

Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding the favorable safety profile and potential best-in-class efficacy of Ixo-vec, anticipated timing of interim data and trial design update for the Phase 2 LUNA trial and initiation of a Phase 3 trial, and the potential of Ixo-vec to shift the treatment paradigm for patients with wet AMD. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverum’s novel technology, which makes it difficult to predict the timing of commencement and completion of clinical trials; regulatory uncertainties; enrollment uncertainties; the results of early clinical trials not always being predictive of future clinical trials and results; and the potential for future complications or side effects in connection with use of Ixo-vec. Additional risks and uncertainties facing Adverum are set forth under the caption “Risk Factors” and elsewhere in Adverum’s Securities and Exchange Commission (SEC) filings and reports, including Adverum’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with the SEC on May 9, 2024 and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Inquiries:
Adverum Investor Relations
Email: ir@adverum.com

FAQ

What is Adverum Biotechnologies' stock symbol?

Adverum Biotechnologies' stock symbol is ADVM, traded on the Nasdaq.

When will Adverum announce LUNA 52-week data and pivotal program details for Ixo-vec?

Adverum plans to announce LUNA 52-week data and pivotal program details in the 4th quarter of 2024.

What is the potential benefit of Ixo-vec for wet AMD patients?

Ixo-vec has the potential to extend therapeutic benefit from weeks to years or possibly life after a single intravitreal injection, potentially reducing the treatment burden for wet AMD patients.

When is Adverum planning to initiate the Ixo-vec pivotal program?

Adverum is on track to initiate the Ixo-vec pivotal program in the 1st half of 2025.