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Overview of Adverum Biotechnologies, Inc. (NASDAQ: ADVM)
Adverum Biotechnologies, Inc. is a U.S.-based clinical-stage gene therapy company at the forefront of developing innovative treatments for serious and rare ocular diseases. Leveraging a proprietary adeno-associated virus (AAV)-based directed evolution platform, Adverum aims to provide durable efficacy through sustained expression of therapeutic proteins. The company focuses on developing gene therapies for conditions such as alpha-1 antitrypsin (A1AT) deficiency, hereditary angioedema (HAE), and wet age-related macular degeneration (wet AMD).
Core Business and Achievements:
Adverum is advancing a robust pipeline of gene therapy product candidates. Its lead candidate, ADVM-022 (also known as Ixo-vec), is an intravitreal (IVT) injection designed to deliver long-term aflibercept levels, significantly reducing the need for frequent anti-VEGF injections in patients with wet AMD. ADVM-022 is currently being evaluated in multiple clinical trials, including the Phase 2 LUNA trial, showing promising results in maintaining vision and reducing treatment burdens.
Recent Developments:
- Leadership Appointments: In 2023, Adverum appointed Dr. C. David Nicholson and Dr. Rabia Gurses Ozden to its Board of Directors, bringing extensive pharmaceutical and clinical development expertise.
- Clinical Trials: The company reported positive preliminary efficacy and safety data from the LUNA Phase 2 trial, demonstrating significant reductions in anti-VEGF injection rates and strong safety profiles.
- Financial Growth: Adverum completed a $127.5 million private placement financing, expected to fund operations into late 2025.
Key Products and Partnerships:
Adverum’s flagship product, ADVM-022, is a gene therapy candidate for wet AMD. The company collaborates with strategic partners to enhance its research and development efforts, generating revenue through licensing, research agreements, and collaborations.
With its innovative gene therapy platform and strategic initiatives, Adverum aims to transform the standard of care for ocular diseases, preserving vision and potentially offering functional cures.
Latest News:
- November 2023: Appointment of C. David Nicholson, Ph.D., to Board of Directors.
- February 2024: Presentation of preliminary LUNA Phase 2 data at the Macula Society meeting.
- March 2024: Completion of $127.5 million private placement financing.
- April 2024: Upcoming presentation of 26-week LUNA interim analysis at the ASRS Annual Scientific Meeting.
Rhea-AI Summary
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) announced preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial in patients with wet age-related macular degeneration (AMD). Both dose levels (2E11 & 6E10) demonstrate potential best-in-class clinical activity, with preliminary safety data supporting a favorable benefit-risk profile at both dose levels. The vast majority of patients on the “go-forward” regimen had no inflammation and >90% of patients have no or minimal inflammation. Preliminary efficacy and safety data trending similar to or better than the OPTIC study, indicating potential for best-in-class efficacy. The company is pleased with the emerging treatment profile, showing potential for best-in-class efficacy and over 90% of subjects having no or minimal inflammation with their go-forward local prophylactic regimen.
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Adverum Biotechnologies, Inc. has agreed to sell approximately 106.25 million shares of its common stock to institutional and accredited healthcare specialist investors in a private placement, at a price per share of $1.20, representing a premium of approximately 20% to Adverum’s 30-day volume-weighted average price. The financing, led by TCGX, is expected to close on February 8, 2024, with gross proceeds of approximately $127.5 million. The company expects the proceeds, combined with current cash, cash equivalents, and marketable securities, to fund the current operating plan into late 2025.
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Adverum Biotechnologies, Inc. (Nasdaq: ADVM) announced the presentation of preliminary safety and efficacy data from the ongoing LUNA Phase 2 study of Ixo-vec for the treatment of wet AMD at the 47th Annual Meeting of the Macula Society. The webcast will include details of the preliminary results and will be hosted by Adverum on Thursday, February 8th, 2024 at 8:00am ET. The presentation will be available on Adverum's website after the event.
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Adverum Biotechnologies, Inc. announced the addition of Romuald Corbau, Ph.D., as its chief scientific officer. Dr. Corbau brings over 25 years of industry experience and will play a crucial role in advancing Ixo-vec, a gene therapy product for wet AMD, towards pivotal trials and commercialization. The company also granted Dr. Corbau a stock option to purchase 600,000 shares of Adverum's common stock.
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Adverum Biotechnologies, Inc. (Nasdaq: ADVM) announced the initial LUNA preliminary efficacy and safety data will be presented at the upcoming 47th Annual Meeting of the Macula Society, being held February 7 – 10, 2024. The company aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases. The presentation will focus on Ixoberogene soroparvovec (Ixo-vec) Intravitreal Gene Therapy for Neovascular Age-Related Macular Degeneration, with preliminary results from the Phase 2 LUNA Study. The presentation will be delivered by Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at University of Nevada, Reno School of Medicine. Adverum Biotechnologies plans to host a conference call to discuss these data, with details to be provided at a future date. The presentation will also be made available on Adverum’s website under News & Publications.
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Adverum Biotechnologies, Inc. (Nasdaq: ADVM) announced participation in the Evercore ISI 6th Annual HealthCONx Conference by its CFO and CDO. The webcast will be available on the company's website.
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Adverum Biotechnologies, Inc. (Nasdaq: ADVM) reported positive preliminary aflibercept protein levels from the Phase 2 LUNA trial, indicating therapeutic activity. Long-term OPTIC data showed sustained benefits for patients. Initial LUNA safety and efficacy data expected in Q4 2023. Cash runway projected into 2025.
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Adverum Biotechnologies, Inc. appoints Dr. C. David Nicholson as an independent member of its Board of Directors. Dr. Nicholson brings over forty years of pharmaceutical experience and deep experience in ophthalmology. His appointment reflects the company's commitment to excellence in clinical and preclinical development. Adverum's lead product candidate, Ixo-vec, is currently being evaluated in the Phase 2 LUNA trial for wet age-related macular degeneration.
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Adverum Biotechnologies announces updated data from the OPTIC extension study of patients with wet AMD, showing long-term benefit from Ixo-vec gene therapy. Key findings include an 84% reduction in annualized anti-VEGF injections and durable aflibercept protein levels up to 4.5 years post-treatment. The treatment continues to be well-tolerated. A summary of previously announced aflibercept protein levels from the LUNA study was also presented.
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Adverum Biotechnologies announces positive initial data from Phase 2 LUNA trial for wet AMD treatment. Aflibercept protein levels at both 2E11 and 6E10 doses are within therapeutically active range. Gene therapy has potential to reduce treatment burden. Preliminary clinical activity and safety data are encouraging. Q4 2023: OPTIC trial long-term follow-up data to be presented. Q4 2023: Anticipated release of LUNA preliminary efficacy and safety data. Mid-2024: Additional LUNA data.
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FAQ
What is the current stock price of Adverum Biotechnologies (ADVM)?
The current stock price of Adverum Biotechnologies (ADVM) is $6.04 as of November 22, 2024.
What is the market cap of Adverum Biotechnologies (ADVM)?
The market cap of Adverum Biotechnologies (ADVM) is approximately 119.6M.
What is Adverum Biotechnologies' main focus?
Adverum Biotechnologies focuses on developing gene therapies for serious and rare ocular diseases, including wet age-related macular degeneration (wet AMD).
What is ADVM-022?
ADVM-022, also known as Ixo-vec, is Adverum's lead gene therapy candidate designed to deliver long-term aflibercept levels to treat wet AMD, reducing the need for frequent anti-VEGF injections.
What recent leadership changes have occurred at Adverum?
In 2023 and 2024, Adverum appointed Dr. C. David Nicholson and Dr. Rabia Gurses Ozden to its Board of Directors, enhancing its pharmaceutical and clinical expertise.
How is Adverum Biotechnologies funded?
Adverum generates revenue through licensing, research agreements, and collaborations. The company also recently completed a $127.5 million private placement financing.
What are the recent achievements of ADVM-022 in clinical trials?
ADVM-022 has shown promising results in the Phase 2 LUNA trial, with significant reductions in anti-VEGF injection rates and a strong safety profile.
When is Adverum's next major presentation?
Adverum will present the 26-week interim analysis from its LUNA Phase 2 study at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting in July 2024.
What is the significance of Adverum's proprietary AAV-based platform?
Adverum's AAV-based directed evolution platform enables the development of gene therapies that provide durable efficacy through sustained expression of therapeutic proteins, potentially offering long-term solutions for patients.
How does ADVM-022 benefit patients with wet AMD?
ADVM-022 aims to provide long-term aflibercept levels, significantly reducing the treatment burden and fluctuations in macular fluid associated with frequent anti-VEGF injections.
What are the financial projections for Adverum Biotechnologies?
Following its recent financing, Adverum's cash runway is expected to extend into late 2025, supporting ongoing and future clinical trials.
What are the main goals of Adverum Biotechnologies?
Adverum aims to transform the standard of care for ocular diseases, preserve vision, and create a profound societal impact with its innovative gene therapy solutions.
Adverum Biotechnologies, Inc.
Nasdaq:ADVM
ADVM Rankings
ADVM Stock Data
119.61M
15.44M
11.67%
79.15%
7.71%
Biotechnology
Biological Products, (no Disgnostic Substances)
United States of America
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