Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Adverum Biotechnologies, Inc. following the company's announcement of the need to restate its financial statements due to accounting errors [1][2]. Group 1: Company Financials - On March 31, 2025, Adverum disclosed that certain previously issued financial statements should no longer be relied upon due to non-cash errors related to tenant improvement allowances for an operating lease in North Carolina [2]. - Adverum will restate its financial statements for the years ended December 31, 2022 and 2023, as well as the unaudited quarterly financial information for the periods in 2023 and 2024 [2]. - Following this announcement, Adverum's stock price fell by $0.54 per share, or 12.36%, closing at $3.83 per share on April 1, 2025 [2]. Group 2: Legal Context - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of fighting for victims of securities fraud and corporate misconduct [3]. - The firm has a track record of recovering multimillion-dollar damages for class members [3].

Core Insights - Adverum Biotechnologies is participating in the 2025 RBC Capital Markets Ophthalmology Virtual Conference on April 3, 2025, at 10:45 a.m. ET [1] - The company focuses on gene therapy as a new standard of care for prevalent ocular diseases, aiming to develop functional cures to restore vision and prevent blindness [3] Company Overview - Adverum Biotechnologies is a clinical-stage company that leverages its proprietary intravitreal (IVT) platform to create durable, single-administration therapies [3] - The company is evaluating its gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), as a one-time IVT injection for patients with neovascular or wet age-related macular degeneration [3] - Adverum aims to transform the standard of care for debilitating ocular diseases, preserving vision and creating a significant societal impact globally [3]

Core Insights - Adverum Biotechnologies has initiated the ARTEMIS Phase 3 study to evaluate the efficacy and safety of Ixo-vec for treating wet age-related macular degeneration (AMD) [1][4] - The trial aims to demonstrate that a single injection of Ixo-vec is non-inferior to the standard treatment with aflibercept, potentially transforming the treatment landscape for wet AMD patients [5][10] Company Overview - Adverum Biotechnologies is a clinical-stage company focused on gene therapy to treat prevalent ocular diseases, aiming to establish a new standard of care [11][12] - The company is developing Ixo-vec, a one-time gene therapy designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections for wet AMD patients [10][11] Study Design - The ARTEMIS trial is a randomized, double-masked, sham-controlled study involving approximately 284 patients, including both treatment-naïve and previously treated individuals [7][8] - The primary endpoint is the mean change in best corrected visual acuity (BCVA) from baseline at one year, with a non-inferiority margin of -4.5 letters [2][8] Treatment Context - Wet AMD affects around 20 million individuals globally and is a leading cause of blindness in those over 65 years of age [9] - Current treatment requires frequent injections, with up to 42% of patients discontinuing treatment after two years, leading to poor long-term vision outcomes [4][9] Ixo-vec Characteristics - Ixo-vec utilizes a proprietary vector for a one-time intravitreal injection, aiming to provide stable therapeutic levels of anti-VEGF and improve patient compliance [10][11] - The therapy has received Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA, indicating its potential as a transformative treatment option [10]

Core Insights - Adverum Biotechnologies is a clinical-stage company focused on gene therapy for ocular diseases, aiming to establish a new standard of care [3] - The company will present at the Cowen 45th Annual Healthcare Life Sciences Conference on March 4, 2025 [1] - Adverum is developing a one-time intravitreal injection therapy, ixoberogene soroparvovec (Ixo-vec), for neovascular or wet age-related macular degeneration [3] Company Overview - Adverum Biotechnologies aims to develop functional cures to restore vision and prevent blindness through gene therapy [3] - The company utilizes a proprietary intravitreal (IVT) platform to create durable, single-administration therapies, reducing the need for frequent ocular injections [3] - Adverum's mission includes transforming the standard of care for debilitating ocular diseases and making a significant societal impact globally [3]

Company Overview - Adverum Biotechnologies, Inc. is a clinical-stage company focused on pioneering gene therapy as a new standard of care for prevalent ocular diseases [3] - The company aims to develop functional cures to restore vision and prevent blindness, utilizing its proprietary intravitreal (IVT) platform [3] - Adverum is working on a novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), intended as a one-time IVT injection for patients with neovascular or wet age-related macular degeneration [3] Upcoming Events - Adverum will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 4:40 p.m. ET [1] - The presentation will be accessible via a webcast, which will be available for replay on the company's website for at least 30 days following the event [2]

Core Viewpoint - Adverum Biotechnologies reported a quarterly loss of $1.30 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.20, but an improvement from a loss of $3.30 per share a year ago [1][2] Financial Performance - The company posted revenues of $1 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 100%, compared to zero revenues a year ago [2] - Over the last four quarters, Adverum has surpassed consensus EPS estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$1.20 on revenues of $0.53 million, and for the current fiscal year, it is -$4.64 on revenues of $1.03 million [7] Stock Performance - Adverum shares have declined approximately 1.6% since the beginning of the year, while the S&P 500 has gained 20.1% [3] - The stock currently holds a Zacks Rank of 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Adverum belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - As of September 30, 2024, the company had an accumulated deficit of $990.2 million and has not generated positive cash flow or net income since inception[52]. - The company reported a net loss of $70.4 million for the nine months ended September 30, 2024, primarily due to ongoing research and development activities[73]. - Net loss before income taxes improved by $5.7 million to $(27.1) million for the three months ended September 30, 2024, compared to $(32.9) million for the same period in 2023[61]. - License revenue for the three months ended September 30, 2024, was $1.0 million, a decrease of $2.6 million compared to $3.6 million for the same period in 2023[62]. - The company has not generated any revenue from product sales to date, relying instead on research, collaboration, and license arrangements[54]. Cash Flow and Financing - As of September 30, 2024, the company had $153.2 million in cash, cash equivalents, and short-term investments, sufficient to fund operations into late 2025[53]. - During the nine months ended September 30, 2024, net cash used in operating activities was $64.2 million, compared to $69.6 million for the same period in 2023[73]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $119.8 million, mainly from the issuance of common stock and pre-funded warrants[75]. - The company expects that its existing cash and cash equivalents will be sufficient to fund operations into late 2025, but may need to raise additional funds sooner due to various risks and uncertainties[70]. - The company has a sales agreement with Cowen & Company to sell up to $100.0 million of common stock in an "at-the-market" offering, but no sales have been made as of November 4, 2024[70]. Research and Development - The LUNA Phase 2 trial of Ixo-vec was fully enrolled with 60 subjects, and interim analysis indicated maintenance of visual and anatomic outcomes[49]. - The company plans to initiate a Phase 3 clinical trial of Ixo-vec in wet AMD in the first half of 2025[49]. - Ixo-vec has received multiple regulatory designations, including Fast Track designation from the FDA and PRIME designation from the EMA[50]. - Research and development expenses include personnel-related costs, stock-based compensation, and external contract research expenses, with significant spending expected as the company advances into Phase 3 trials[55]. - Research and development expenses decreased by $0.3 million to $20.4 million for the three months ended September 30, 2024, from $20.7 million for the same period in 2023[65]. - Research and development expenses for the nine months ended September 30, 2024, were $52.9 million, a decrease of $9.5 million from $62.4 million for the same period in 2023[65]. General and Administrative Expenses - General and administrative expenses decreased by $4.0 million to $9.8 million for the three months ended September 30, 2024, from $13.8 million for the same period in 2023[66]. - General and administrative expenses for the nine months ended September 30, 2024, were $25.0 million, a decrease of $14.0 million from $39.0 million for the same period in 2023[66]. Other Income and Expenses - Other income, net increased by $0.4 million to $2.1 million for the three months ended September 30, 2024, from $1.7 million for the same period in 2023[67]. - Other income, net increased by $2.1 million to $6.5 million for the nine months ended September 30, 2024, from $4.4 million for the same period in 2023[67]. - Total operating expenses decreased by $4.3 million to $30.2 million for the three months ended September 30, 2024, from $34.5 million for the same period in 2023[61]. - Sublease income was $1.5 million for the three months ended September 30, 2024, compared to $1.3 million for the same period in 2023[61]. - The company reported $14.2 million in non-cash charges during the nine months ended September 30, 2024, primarily related to stock-based compensation[73]. Market and Manufacturing - The company utilizes third-party contract research organizations for clinical development and does not have its own operational clinical or commercial manufacturing facilities[52]. - The company aims to improve manufacturing processes for large-scale production to address the needs of prevalent diseases like wet AMD[51]. - The company incurred $37.4 million in net purchases from marketable securities during the nine months ended September 30, 2024, compared to $107.4 million in net maturities in the same period of 2023[74].

Financial Performance - Cash, cash equivalents, and short-term investments were $153.2 million as of September 30, 2024, up from $96.5 million as of December 31, 2023, expected to fund operations into late 2025[3] - Net loss for Q3 2024 was $27.1 million, or $1.30 per share, compared to a net loss of $32.9 million, or $3.26 per share, in Q3 2023[6] - Total assets as of September 30, 2024, were $234.4 million, compared to $173.0 million as of December 31, 2023[12] - Total stockholders' equity increased to $144.1 million as of September 30, 2024, from $83.5 million as of December 31, 2023[12] Expenses - Research and development expenses for Q3 2024 were $20.4 million, slightly down from $20.7 million in Q3 2023, attributed to lower facility-related expenses[4] - General and administrative expenses decreased to $9.8 million in Q3 2024 from $13.8 million in Q3 2023, due to lower facility-related and compensation expenses[5] Clinical Development - The company plans to present LUNA 52-week data and OPTIC 4-year data updates in Q4 2024, alongside a Phase 3 trial design update[3] - The planned initiation of the Phase 3 trial for Ixo-vec is set for the first half of 2025[3] - Ixo-vec is designed as a one-time intravitreal injection for the treatment of wet AMD, aiming to reduce the need for frequent injections[8] Leadership Changes - Jason Mitchell was appointed as Chief Commercial Officer in October 2024, bringing over 20 years of experience in commercial strategy for retinal diseases[2]

Core Viewpoint - Adverum Biotechnologies is advancing its gene therapy candidate Ixo-vec for the treatment of wet age-related macular degeneration (AMD), with significant clinical data updates and a focus on commercialization strategies. Corporate Highlights - Jason Mitchell has been appointed as Chief Commercial Officer, bringing over 20 years of experience in retinal disease, including the launch of SYFOVRE® [3] - The company has $153.2 million in cash and equivalents, expected to fund operations into late 2025 [4][9] - The planned initiation of the pivotal Phase 3 trial is set for the first half of 2025 [4] Upcoming Anticipated Milestones - In Q4 2024, Adverum will present LUNA 52-week data, OPTIC 4-year clinical data, and updates on the Phase 3 trial design [4] - The initiation of the Phase 3 trial is planned for the first half of 2025 [4] Financial Results - For Q3 2024, cash and cash equivalents increased to $153.2 million from $96.5 million at the end of 2023 [4][9] - Research and development expenses were $20.4 million, slightly down from $20.7 million in Q3 2023 [4][10] - General and administrative expenses decreased to $9.8 million from $13.8 million in the same period last year [4][10] - The net loss for Q3 2024 was $27.1 million, or $1.30 per share, compared to a net loss of $32.9 million, or $3.26 per share, in Q3 2023 [4][10] About Wet AMD - Wet AMD is a leading cause of blindness in individuals over 65, with approximately 20 million affected globally [5] - The incidence of new cases is expected to rise significantly as populations age, with AMD projected to impact 288 million people by 2040 [5] About Ixo-vec - Ixo-vec is a gene therapy product candidate designed for a one-time intravitreal injection to treat wet AMD, aiming to reduce the need for frequent anti-VEGF injections [6] - The therapy has received Fast Track and RMAT designations from the FDA, as well as PRIME designation from the European Medicines Agency [6]

Core Insights - Adverum Biotechnologies has appointed Jason L. Mitchell as chief commercial officer, who has over 20 years of experience in the commercial sector, particularly in retinal diseases [1][2] - The company is advancing its gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), which is currently in Phase 2 clinical trials and aims to establish a new standard of care for wet age-related macular degeneration (wet AMD) [1][5] - Adverum plans to announce 52-week data from the LUNA trial and pivotal program details in Q4 2024, with the initiation of the pivotal program expected in the first half of 2025 [1][2] Company Overview - Adverum Biotechnologies is a clinical-stage company focused on developing gene therapies for prevalent ocular diseases, aiming to restore vision and prevent blindness [4][5] - The company utilizes a proprietary intravitreal (IVT) platform to create durable, single-administration therapies that reduce the need for frequent ocular injections [5] Leadership Background - Jason L. Mitchell previously led the successful launch of SYFOVRE® for geographic atrophy and has held significant roles in sales, marketing, and operations at various pharmaceutical companies [2][3] - His expertise is expected to enhance Adverum's strategy for introducing Ixo-vec as a leading gene therapy for wet AMD [2]