REDWOOD CITY, Calif., March 18, 2024 (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 reported financial results for the fourth quarter and full year 2023. The company also provided recent pipeline highlights and corporate updates.
“We have made tremendous progress during 2023 and in 2024 to date in our development of Ixo-vec as a durable potential gene therapy treatment for the millions of patients suffering from wet AMD,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “We were pleased to present at Macula Society preliminary data from our ongoing LUNA Phase 2 trial of Ixo-vec, which demonstrated potentially best-in-class clinical activity at both the 2E11 and 6E10 doses of Ixo-vec, with the data trending similar to, or better than, the data in our first-in-human OPTIC trial. Importantly, the preliminary data demonstrated that Ixo-vec was generally well tolerated. We look forward to presenting the 26-week interim analysis of our LUNA Phase 2 program in mid-2024.”
Dr. Fischer continued, “In the lead-up to the data presentation at Macula Society, Adverum completed a $127.5 million private placement financing with new and existing investors that we expect to meaningfully extend our cash runway into late 2025, well beyond the anticipated presentation of topline 52-week data from our ongoing LUNA Phase 2 trial. In parallel, we are continuing to interact with regulators in the U.S. and E.U. to inform Phase 3 development of Ixo-vec, which we plan to initiate in the first half of 2025.”
Ixo-Vec Program Highlights:
Corporate Updates:
Anticipated Milestones
Financial Results for the Three Months Ended December 31, 2023
About Wet Age-Related Macular Degeneration
Wet AMD, also known as neovascular AMD or nAMD, is a VEGF driven advanced form of AMD affecting approximately 10% of patients living with AMD associated with the build-up of fluid in the macula and the retina. Wet AMD is a leading cause of blindness in people over 65 years of age, with approximately 20 million individuals worldwide living with this condition. New cases of wet AMD are expected to grow significantly worldwide as populations age. AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases. Additionally, wet AMD is a bilateral disease, and incidence of nAMD in the second eye is up to 42% in the first two to three years. The current standard of care requires frequent life-long repeated bolus injections of anti-VEGF in the eye. IVT gene therapy has the promise to preserve vision and reduce most or all injections for the life of the patient by delivering stable therapeutic levels of anti-VEGF to control macular fluid.
About Ixo-vec in Wet AMD
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), its clinical-stage gene therapy product candidate, for the treatment of wet AMD. Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require surgery to administer the gene therapy under the retina (sub-retinal approach), Ixo-vec is designed to be administered as a one-time IVT injection in the physician’s office, deliver long-term efficacy, reduce the burden of frequent anti-vascular endothelial growth factor (VEGF) injections, optimize patient compliance and improve vision outcomes for patients with wet AMD. In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for Ixo-vec for the treatment of wet AMD. Ixo-vec has also received PRIME designation from the European Medicines Agency and the Innovation Passport from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for the treatment of wet AMD.
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 potential benefits of Ixo-vec as a one-time IVT injection for the treatment of wet AMD, including its potential to improve vision outcomes, the potential best-in-class clinical activity of Ixo-vec, and anticipated timing of preliminary and interim data from the Phase 2 LUNA trial and initiation of a Phase 3 trial, and statements associated with the Company’s cash sufficiency and runway, and other statements containing the words “anticipates,” “believes,” “expects,” “intends,” “plans,” “target,” “will” and similar expressions. 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: risks associated with market conditions. 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 most recent Annual Report on Form 10-K filed with the SEC, as updated by any subsequent reports on Form 10-Q. 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.
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Adverum Biotechnologies, Inc. | ||||||
Selected Consolidated Balance Sheet Data | ||||||
(In thousands) | ||||||
December 31, | December 31, | |||||
2023 | 2022 | |||||
Cash and cash equivalents, and marketable securities | $ | 96,526 | 1 | $ | 185,589 | |
Total assets | 173,010 | 308,372 | ||||
Total current liabilities | 24,914 | 32,246 | ||||
Total liabilities | 89,541 | 126,854 | ||||
Total stockholders' equity | 83,469 | 181,518 | ||||
(1) Cash, cash equivalents, and marketable securities exclude approximately $127.8 million in net proceeds from Adverum's February 2024 private placement | ||||||
Adverum Biotechnologies, Inc. | |||||||||||||||
Consolidated Statements of Operations | |||||||||||||||
(In thousands except per share data) | |||||||||||||||
Three months ended December 31, | Years ended December 31, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
(Unaudited) | (1) | ||||||||||||||
License revenue | $ | — | $ | — | $ | 3,600 | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 15,278 | 22,199 | 77,676 | 99,277 | |||||||||||
General and administrative | 10,880 | 11,741 | 49,915 | 57,858 | |||||||||||
Total operating expenses | 26,158 | 33,940 | 127,591 | 157,135 | |||||||||||
Operating loss | (26,158 | ) | (33,940 | ) | (123,991 | ) | (157,135 | ) | |||||||
Other income, net | 1,311 | 1,223 | 5,748 | 2,673 | |||||||||||
Net loss before income taxes | (24,847 | ) | (32,717 | ) | (118,243 | ) | (154,462 | ) | |||||||
Income tax benefit (provision) | 1,133 | (19 | ) | 1,078 | (74 | ) | |||||||||
Net loss | (23,714 | ) | (32,736 | ) | (117,165 | ) | (154,536 | ) | |||||||
Net loss per share — basic and diluted | $ | (0.23 | ) | $ | (0.33 | ) | $ | (1.16 | ) | $ | (1.56 | ) | |||
Weighted-average common shares outstanding - basic and diluted | 101,213 | 99,915 | 100,824 | 99,251 | |||||||||||
(1) Derived from Adverum's annual audited consolidated financial statements. |
Last Trade: | US$6.76 |
Daily Change: | -0.06 -0.88 |
Daily Volume: | 101,425 |
Market Cap: | US$140.610M |
August 12, 2024 August 01, 2024 |
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