Adverum Biotechnologies, Inc. (ADVM) experiences an incline of 18.35% in the aftermarket. However, the last trading session closed at $2.18 with an increase of 0.46%.
2-Year OPTIC Data Demonstrating Sustained Durability
On 1st October 2021, ADVM announced new long-term results from the OPTIC clinical trial of ADVM-022. It is a single, in-office intravitreal (IVT) injection gene therapy in patients with neovascular or wet age-related macular degeneration. The Retina Society’s 54th Annual Scientific Meeting in Chicago, Illinois, will provide safety and effectiveness data from patients who were tracked for two years after injection. The presentation may be seen on Adverum’s website’s Publications page, which is part of the Pipeline section.
After therapy with a single in-office intravitreal injection of ADVM-022, ADVM has now tracked all wet AMD patients in the OPTIC study. The company is extremely delighted to announce that both the promising safety profile and the durability of the treatment effect continue to be maintained in this patient group. They are ecstatic to learn that ADVM-022 has the potential to prolong the duration of therapeutic effect from weeks to years.
ADVM appoints Global Regulatory Leader
ADVM stated that the company has appointed a new global regulatory company on 23rd August 2021. Jim Wang is the senior vice president and head of regulatory affairs at the company. Dr. Wang will report directly to Laurent Fischer, M.D., Adverum’s president and chief executive officer. He will be in charge of the company’s regulatory strategy and execution. Moreover, he has over 17 years of worldwide regulatory expertise, including a decade in gene therapy, including the submission and approval of LUXTURNA.
Dr. Wang comes to Adverum from PTC Therapeutics, where he was vice president and global head of regulatory strategy. There he was responsible for the planning and implementation of global regulatory operations in all therapeutic areas with a focus on rare diseases. Lastly, he also oversaw a cross-functional team that was responsible for the commercialization of the gene therapy medicine eladocagene exuparvovec.
Second Quarter 2021 Financial Results
ADVM announced second-quarter 2021 financial results on 5th August 2021. Firstly, as of June 30, 2021, cash, and short-term investments were $363.8 million, down from $404.0 million at the end of March. ADVM anticipates its cash position at the conclusion of the quarter to last until 2024. Secondly, research and development costs were $22.6 million, up from $19.2 million in the same period of 2020. Thirdly, the stock-based compensation expenditure was $2.6 million, up from $1.7 million in the same quarter of 2020. Lastly, the general and administrative costs were $21.9 million, up from $10.6 million in the same period of 2020.
Update on ADVM-022 and the INFINITY Trial in Patients with Diabetic Macular Edema
On 22 July 2021, the company announced updates regarding ADVM-022. According to the report, the safety profiles of the two patient groups, as well as the low (2 x 1011 VG/eye) and high (6 x 1011 VG/eye) dosages, reveal significant variations. Moreover, in a future Phase 2 clinical study in wet AMD, the firm plans to compare ADVM-022. It is a single intravitreal (IVT) injection gene therapy, to other preventive regimens at low dosages (2 x 1011 VG/eye and lower).
Lastly, the pathophysiological reasons of wet AMD and DME are distinct, as are the risk factors. While the etiology of the DLT is unknown, diabetic individuals with DME often have various underlying comorbidities.