NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Adverum Biotechnologies, Inc. (“Adverum” or the “Company”) (NASDAQ: ADVM).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Adverum and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] ...

NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Adverum Biotechnologies, Inc. (“Adverum” or the “Company”) (NASDAQ: ADVM).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Adverum and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] ...

LOS ANGELES, April 15, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Adverum Biotechnologies, Inc. ("Adverum" or "the Company") (NASDAQ: ADVM) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Adverum disclosed in an SEC filing on March 31, 2025, that "certain ...

Financial Performance - Cash, cash equivalents, and short-term investments were $125.7 million as of December 31, 2024, down from $153.2 million as of September 30, 2024, and up from $96.5 million as of December 31, 2023[4] - Net loss for the three months ended December 31, 2024, was $40.9 million, or $1.96 per share, compared to a net loss of $24.5 million, or $2.42 per share, for the same period in 2023[8] - Total stockholders' equity increased to $70.7 million as of December 31, 2024, compared to $67.2 million as of December 31, 2023[12] Expenses - Research and development expenses increased to $24.1 million for the three months ended December 31, 2024, compared to $15.3 million for the same period in 2023[8] - General and administrative expenses rose to $18.5 million for the three months ended December 31, 2024, compared to $11.7 million for the same period in 2023[8] Clinical Trials - The ARTEMIS trial, the first registrational intravitreal gene therapy trial for wet AMD, will evaluate Ixo-vec in approximately 284 patients[3] - The primary endpoint of the ARTEMIS trial is the mean change from baseline of best corrected visual acuity (BCVA) at one year with a non-inferiority margin of -4.5 letters[3] - The company plans to initiate the global AQUARIUS Phase 3 trial in the second half of 2025[5] - Results from the Phase 2 LUNA trial support the selection of the 6E10 dose, demonstrating potential best-in-class efficacy and favorable long-term safety[5] Regulatory Designations - Ixo-vec has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA for the treatment of wet AMD[6]

Core Viewpoint - Adverum Biotechnologies is advancing its gene therapy candidate Ixo-vec for the treatment of wet age-related macular degeneration (AMD), with promising clinical trial results and a strong pipeline of upcoming studies aimed at redefining treatment standards for patients [2][3][6]. Financial Results - As of December 31, 2024, Adverum reported cash, cash equivalents, and short-term investments of $125.7 million, a decrease from $153.2 million as of September 30, 2024, but an increase from $96.5 million as of December 31, 2023 [8]. - Research and development expenses for Q4 2024 were $24.1 million, up from $15.3 million in Q4 2023, attributed to higher material production and preparation for Phase 3 trials [8]. - General and administrative expenses rose to $18.5 million in Q4 2024 from $11.7 million in Q4 2023, driven by increased consultant fees and a non-cash tenant improvement allowance [8]. - The net loss for Q4 2024 was $40.9 million, or $1.96 per share, compared to a net loss of $24.5 million, or $2.42 per share, for the same period in 2023 [8][11]. Pipeline Highlights - The ARTEMIS trial, the first registrational intravitreal gene therapy trial for wet AMD, has been initiated, evaluating Ixo-vec against aflibercept in approximately 284 patients [3]. - The primary endpoint of ARTEMIS is the mean change from baseline in best corrected visual acuity (BCVA) at one year, with a non-inferiority margin of -4.5 letters [3]. - Long-term data from the LUNA trial support the selected 6E10 dose for the pivotal program, showing potential best-in-class efficacy and favorable long-term safety [3][4]. Upcoming Milestones - The global AQUARIUS Phase 3 trial is expected to be initiated in the second half of 2025, with the presentation of two-year long-term follow-up data from the LUNA trial planned for Q4 2025 [8][9]. Product Overview - Ixo-vec, a gene therapy product candidate, is designed for a one-time intravitreal injection to treat wet AMD, aiming to provide long-term efficacy and reduce the burden of frequent anti-VEGF injections [6][7]. - The therapy has received Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA, as well as PRIME designation from the EMA [6]. Company Overview - Adverum Biotechnologies is focused on establishing gene therapy as a new standard of care for prevalent ocular diseases, with aspirations to develop functional cures to restore vision and prevent blindness [7].

Financial Restatement and Internal Controls - Adverum Biotechnologies identified non-cash errors in accounting for tenant improvement allowances related to an operating lease, necessitating restatement of financial statements for the years ended December 31, 2022 and 2023[15]. - The restated financial statements include corrections for misstatements affecting non-cash assets, liabilities, and general and administrative expenses[19]. - The Audit Committee concluded that the misstatements indicate a material weakness in internal control over financial reporting as of December 31, 2024[20]. - The company has identified a material weakness in internal control over financial reporting, which could adversely affect investor confidence and the value of its common stock if not remedied[30]. - Adverum's financial statements for the restated periods should be relied upon, as previously issued statements are no longer valid[18]. Financial Performance and Going Concern - Adverum has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[29]. - The company faces substantial doubt regarding its ability to continue as a going concern without raising additional funding[29]. Drug Development Challenges - Drug development is characterized by long timelines and high costs, with potential delays or failures at any stage[29]. - The company relies on third parties for various aspects of research and development, which may impact the success of clinical trials[29]. Intellectual Property and Competitive Landscape - Adverum's success is contingent on its ability to protect its intellectual property and proprietary technologies[29]. - The company anticipates facing intense competition from larger pharmaceutical companies and other entities in the biopharmaceutical industry[112]. - The proprietary AAV.7m8 vector is expected to compete with existing anti-VEGF therapies, which are widely accepted as standard-of-care treatments for wet AMD[113]. Clinical Trials and Product Development - The lead product candidate, Ixo-vec, is designed for a single in-office intravitreal injection to treat wet age-related macular degeneration (wet AMD), with top-line results from the LUNA Phase 2 trial showing a reduction in annualized anti-VEGF injections by 88% and 92% for the 6E10 and 2E11 doses, respectively[36]. - The OPTIC trial demonstrated that nearly 50% of patients were injection-free four years after Ixo-vec treatment, with an 86% reduction in annualized anti-VEGF injections[35]. - Ixo-vec has received several regulatory designations, including Fast Track designation from the FDA and Priority Medicines (PRIME) designation from the EMA, aimed at expediting its development and review[38]. - The company aims to initiate the second Phase 3 trial, AQUARIUS, in the second half of 2025, following the initiation of the ARTEMIS trial in March 2025[37]. - The ARTEMIS Phase 3 trial aims to enroll 284 patients, focusing on non-inferiority in mean BCVA change between Ixo-vec (6E10) and aflibercept (2mg Q8W)[93]. Market Potential and Treatment Demand - Approximately 20 million individuals worldwide are living with wet AMD, and the incidence of age-related macular degeneration is expected to impact 288 million people globally by 2040, with wet AMD accounting for about 10% of those cases[33]. - The global sales of standard-of-care anti-VEGF therapies for wet AMD were approximately $14 billion in 2023, highlighting the demand for effective treatments[40]. - Wet AMD affects approximately 20 million individuals worldwide, with an expected increase in incidence as populations age, potentially impacting 288 million people by 2040[52]. Manufacturing and Production - The company is focused on developing scalable manufacturing processes for Ixo-vec to meet the needs of a large patient population affected by wet AMD[39]. - The AAV manufacturing process utilizes the Baculovirus Expression Vector System (BEVS), designed for high yield and cost-effectiveness, capable of producing AAV vectors at a scale of up to 2000 liters[115]. - The company has produced multiple batches of Ixo-vec at proposed commercial scale for use in Phase 3 clinical trials[111]. - The company maintains control over key aspects of the manufacturing process, including scalable processes and GMP quality controls, while contracting clinical manufacturing to third parties[107]. Regulatory Environment and Compliance - The FDA regulates gene therapy products under the FD&C Act and PHS Act, requiring an investigational new drug application (IND) before human clinical testing[138]. - Clinical trials are conducted in three phases, with Phase 3 trials being pivotal for FDA approval[144]. - The FDA aims to review Biologics License Applications (BLAs) within six months for priority reviews and ten months for standard reviews, starting from the acceptance of the application[154]. - The centralized procedure for Marketing Authorization (MA) in the EU allows a single application to be submitted to the EMA, with a maximum evaluation timeframe of 210 days[164]. - The FDA has established expedited development and review programs for new drugs addressing serious or life-threatening conditions[174]. Pricing and Market Access Challenges - Increased scrutiny on drug pricing practices by U.S. federal prosecutors could negatively impact revenue and future profitability if regulatory proposals limit price increases[204]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of its products for third-party payer coverage[208]. - Legislative changes related to the Affordable Care Act could affect the number of individuals with health coverage, impacting the company's ability to commercialize product candidates[210]. - The Budget Control Act of 2011 triggered automatic reductions of Medicare payments to providers by 2% per fiscal year, effective April 1, 2013, and will remain in effect through 2032 unless further congressional action is taken[212].

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].

REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the company will participate in a fireside chat at the 2025 RBC Capital Markets Ophthalmology Virtual Conference on Thursday, April 3 at 10:45 a.m. ET. The webcast of the fireside chat may be accessed under Events and Presentations in the Investors section of Adver ...

Ixo-vec is a potential best-in-class one-time gene therapy designed to deliver long-term efficacy, reduce the burden of frequent anti-VEGF and improve vision outcomes for patients with wet AMDARTEMIS is the first-ever initiation of a registrational intravitreal gene therapy trial in patients with wet AMDNon-inferiority study to evaluate a single Ixo-vec injection compared to on-label aflibercept 2mg in both treatment-naïve and previously treated patients REDWOOD CITY, Calif., March 03, 2025 (GLOBE NEWSWIRE) ...

REDWOOD CITY, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the company will present at the Cowen 45th Annual Healthcare Life Sciences Conference on Tuesday, March 4 at 11:50 a.m. ET. The webcast of the presentation may be accessed under Events and Presentations in the Investors section of Adverum’s website. A replay of the ...