XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

Adverum Biotechnologies Inc

Announcement: ADVM 8-K Special Filing

Form 8-K - Current report - Item 8.01 Item 9.01

Part One: Performance Analysis

As a clinical-stage company, Adverum Biotechnologies aims to establish gene therapy as a new standard of care for prevalent ocular diseases. The company's current lead product candidate, Ixo-vec, is a gene therapy product designed to deliver durable therapeutic levels of aflibercept after a single in-office intravitreal injection and is being developed for the treatment of patients with wet age-related macular degeneration (wet AMD).

Adverum Biotechnologies has made significant progress in the development of Ixo-vec. The OPTIC trial has shown strong signals of therapeutic efficacy with continuous stable aflibercept protein levels, maintenance to improvement in visual acuity and central subfield thickness, and a reduction in fluctuations in CST. Moreover, the most common adverse events have been dose-dependent and manageable. The LUNA trial, a multicenter, double-masked, randomized, parallel-group Phase 2 trial evaluating two doses of Ixo-vec, began enrollment in September 2022. The study aims to assess several prophylactic corticosteroid regimens and evaluate the effectiveness and tolerability of each.

To date, Adverum Biotechnologies has recognized the need for new treatment options for wet AMD, and the U. S. Food and Drug Administration has granted Fast Track designation for Ixo-vec for the treatment of wet AMD. Moreover, the company recently received feedback from the FDA via a Type C meeting written response regarding their Phase 2 trial of Ixo-vec. The regulatory agency aims to ensure alignment ahead of filing the Investigational New Drug amendment for the trial.

Part Two: Forward-Looking Analysis

Adverum Biotechnologies is an innovative and disruptive company in the gene therapy space focusing on ocular diseases. With a strong pipeline in place, the company aims to create a new standard of care for patients suffering from diseases affecting their vision. The company's current product candidate, Ixo-vec, has demonstrated stable efficacy and manageable side effects, which is a positive factor in the eyes of investors.

Looking forward, the company aims to initiate Phase 2 trials of Ixo-vec and assess several prophylactic corticosteroid regimens as it aims to develop a new treatment option for patients suffering from wet AMD. Moreover, the company aims to continue to make progress with its manufacturing capabilities and quality control processes.

Adverum Biotechnologies faces competition from several prominent players in the gene therapy space, such as Novartis AG, Spark Therapeutics Inc., and Biogen Inc., which could impact its future performance. However, with a strong pipeline in place and fast track designation from the FDA for Ixo-vec, the company is in a favorable position to succeed in the market.

In conclusion, Adverum Biotechnologies has strong growth prospects ahead, given the progress made so far with Ixo-vec and the initiation of Phase 2 clinical trials. The company's pipeline and innovative approach to ocular disease therapy are sure to attract investors in the future. However, investors should keep an eye on industry competition and regulatory challenges as these can impact the company's future performance.

XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT

XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Adverum Biotechnologies' Ixo-vec shows promise for wet AMD treatment

Adverum Biotechnologies (NASDAQ: ADVM) has reported their first quarter 2023 financial results, revealing strong progress in their Phase 2 LUNA trial for wet age-related macular degeneration (wet AMD). The company is on track to complete enrollment in the trial during the second half of 2023, with interim datasets for a percentage of participants at 14 weeks expected in Q3 2023, and preliminary safety and efficacy data anticipated in Q4 2023.

Adverum Biotechnologies is the only ocular gene therapy company in wet AMD to have been granted Fast Track Designation by the US Food and Drug Administration (FDA), indicating recognition of the high need for new treatment options for wet AMD. The company has also gained regulatory designations from the European Medicines Agency and the UK's Medicines and Healthcare Products Regulatory Agency.

Investors should pay attention to the progress made by Adverum Biotechnologies in developing Ixo-vec, a gene therapy product candidate utilizing a proprietary vector capsid to deliver long-term efficacy. The product has shown promise in phase 1 trials, with early aflibercept protein levels found to be therapeutic and sustained through three years.

Overall, the company's financial position looks stable, with a reported cash position of $164.6 million as of December 31, 2022, and research and development expenses decreasing due to lower compensation and laboratory expense. However, investors should keep in mind the potential risks and uncertainties associated with clinical trials and regulatory approvals.

Form 8-K - Current report - Item 2.02 Item 9.01

$ADVM Reports Strong Progress in Phase 2 LUNA Trial for Wet AMD in Q1 2023 Financial Results

Part 1: Performance Analysis

Adverum Biotechnologies, Inc. is a biotechnology company that is at an early stage of development and has not yet generated any revenue from product sales. As of December 31, 2022, the company had an accumulated deficit of $802.6 million, and it expects to continue to incur substantial expenses and losses from operations as it conducts research and development efforts, advances its product candidates through nonclinical and clinical development, seeks regulatory approval, and prepares for commercialization, if approved. Adverum’s research and development expenses primarily include personnel-related costs, laboratory supplies, consulting costs, external contract research and development expenses, manufacturing clinical study materials, and overhead expenses. The company has deferred and expensed advance payments for goods or services for future research and development activities as the goods are delivered or the related services are performed.

Adverum has no operational clinical or commercial manufacturing facilities, and all of its clinical manufacturing activities are contracted out to third parties. Additionally, it uses third-party contract research organizations to carry out its clinical development and does not have a sales organization. The company will need substantial additional funding in the future to support its operating activities as it advances its product candidates. Adequate funding may not be available on acceptable terms, or at all, and if the company is unable to raise capital or form additional collaboration partnerships to support its efforts, it could be forced to delay, reduce or eliminate its research and development programs or potential commercialization efforts. As of December 31, 2022, Adverum had $185.6 million in cash, cash equivalents, and short-term investments, which it believes are sufficient to fund operations into 2025.

Part 2: Forward Looking Analysis

Adverum Biotechnologies, Inc. is focused on developing gene therapies for ocular and rare diseases, with a lead product candidate, ADVM-022, for the treatment of wet age-related macular degeneration (“wet AMD”) and diabetic macular edema (“DME”). The company plans to advance ADVM-022 through late-stage clinical development by conducting pivotal trials in wet AMD and DME and initiating a registrational trial in wet AMD. Adverum’s second product candidate, ADVM-043, is a novel gene therapy for inherited retinal diseases, with IND-enabling studies expected to complete in 2023.

Adverum’s success in developing and commercializing its product candidates depends on its ability to conduct clinical trials and obtain regulatory approvals, which is highly uncertain both in terms of the probability of success and regulatory timelines. The company will require substantial additional funding to support its research and development efforts, which may not be available on acceptable terms, or at all. Furthermore, Adverum’s ability to generate product revenue and become profitable depends upon its ability to successfully develop and commercialize its product candidates. If the company is unable to generate revenue from the sale of its products, its sales may not be sufficient to generate cash from operations, and it may be unable to continue its operations at planned levels and could be forced to reduce its operations.

Adverum operates in a highly competitive industry, and its product candidates will face competition from other treatments and therapies developed by major pharmaceutical and biotechnology companies, as well as academic and government institutions. The success of the company will also depend on its ability to attract and retain qualified personnel, protect its intellectual property, and comply with regulatory requirements. The ongoing COVID-19 pandemic may also adversely impact the company’s business and operations, and it may face delays in its clinical trials and approval processes due to the pandemic.

In the words of Laurent Fischer, Adverum’s CEO, “We remain committed to our mission of developing novel gene therapies for patients with serious eye and rare diseases. We believe that our lead program, ADVM-022, has the potential to transform the treatment of wet AMD and DME, and we remain focused on advancing this program toward registration. The fourth quarter of 2022 was an important period for Adverum with the initiation of our third dose cohort for the INFINITY trial and the progress made in preparing for our upcoming pivotal trial for ADVM-022. As we continue to move forward with our programs, we also aim to strengthen our leadership team and governance to position Adverum for its next phase of growth and success.”

Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

Announcement: ADVM 8-K Special Filing

Announcement: ADVM 8-K Special Filing

Announcement: ADVM 8-K Special Filing

Announcement: ADVM 8-K Special Filing

Announcement: ADVM 8-K Special Filing

Announcement: ADVM 8-K Special Filing

Adverum Biotechnologies' Ixo-vec shows promise for wet AMD treatment

Adverum Biotechnologies' Ixo-vec shows promise for wet AMD treatment

$ADVM Reports Strong Progress in Phase 2 LUNA Trial for Wet AMD in Q1 2023 Financial Results

$ADVM Reports Strong Progress in Phase 2 LUNA Trial for Wet AMD in Q1 2023 Financial Results

Adverum Biotechnologies: Early-Stage Gene Therapy Venture Shows Potential for Open-Minded Investors.

Adverum Biotechnologies: Early-Stage Gene Therapy Venture Shows Potential for Open-Minded Investors.