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Annexon, Inc. (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company that focuses on developing novel therapeutics aimed at treating complement-mediated neurodegenerative and autoimmune diseases. The company's unique scientific approach targets C1q, the initiating molecule of the classical complement pathway, to halt the inflammatory cascade before it starts, providing significant potential benefits across a range of diseases affecting the body, brain, and eye.
Annexon’s primary product candidates include:
- ANX005: A monoclonal antibody designed to block C1q, currently in pivotal Phase 3 trials for Guillain-Barré Syndrome (GBS) and showing promising results in reducing muscle strength loss and nerve damage.
- ANX007: An antigen-binding fragment aimed at treating geographic atrophy (GA) in the eye, demonstrating notable protection against vision loss and retinal damage in Phase 2 trials.
- ANX1502: An oral small molecule inhibitor targeting autoimmune diseases, expected to generate proof-of-concept data in the second half of 2024.
In recent developments, Annexon announced positive top-line results from their Phase 3 trial of ANX005 in GBS, showing significant improvements in clinical outcomes and muscle strength. This trial marks a major milestone as ANX005 could become the first targeted treatment for GBS in the U.S. The company also showcased ANX007's potential in preserving retinal structures and vision in GA patients, with Phase 3 trials set to commence in 2024.
Financially, Annexon maintains a robust balance sheet with approximately $260 million in cash and equivalents, providing a runway into mid-2026. The company recently completed a public offering to raise additional capital, further strengthening its financial position to advance its clinical programs.
Annexon continues to advance its pipeline rigorously, with multiple upcoming milestones that have the potential to generate substantial value for patients and shareholders alike.
Annexon, a clinical-stage biopharmaceutical company (Nasdaq: ANNX), announced that its CEO, Douglas Love, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 3:45 p.m. ET. The presentation will focus on their innovative complement medicines targeting autoimmune and neurodegenerative disorders. A live webcast will be available on their website, with a replay accessible for 30 days post-event.
Annexon's pipeline includes product candidates like ANX005, ANX007, and ANX009, designed to disrupt the C1q pathway.
Annexon announced positive safety and dose-response results from its Phase 1 trial of ANX009, designed to block C1q in autoimmune diseases. The study, involving 48 healthy volunteers, showed no serious adverse events and effective C1q inhibition, supporting further trials. Additionally, preclinical findings presented at the ASH Annual Meeting indicated the classical complement pathway's role in warm autoimmune hemolytic anemia (wAIHA), with ongoing evaluations of ANX005 in a Phase 2 trial for this condition.
Annexon reported a net loss of $35.6 million or $0.93 per share for Q3 2021, compared to $15.6 million or $0.77 per share year-over-year. As of September 30, 2021, the company had $271.4 million in cash and investments, supporting operations into 2024. The FDA granted Orphan Drug designation for ANX005, aimed at treating Huntington's disease. The company is advancing three clinical-stage candidates in five trials, with initial data from ANX005 expected in Q4 2021. The leadership team has strengthened with new appointments, enhancing the company's research efforts.
Annexon, a clinical-stage biopharma company, has appointed Ted Yednock as Chief Innovation Officer and Larry Mattheakis as Chief Scientific Officer. Yednock, previously Chief Scientific Officer since 2013, will focus on strengthening scientific collaborations while remaining on the executive committee. Mattheakis brings extensive drug development experience from Protagonist Therapeutics, aiming to enhance Annexon’s therapeutic pipeline for complement-mediated diseases. The company is currently progressing three drug candidates across seven clinical trials, focusing on autoimmune, neurodegenerative, and ophthalmic disorders.
On September 23, 2021, Annexon (Nasdaq: ANNX), a biopharmaceutical company, announced that its CEO, Douglas Love, will speak at the 2021 Cantor Virtual Global Healthcare Conference on September 30, 2021, at 12:40 p.m. ET. The event will be available via a live webcast on Annexon's Investors page and will be archived for 30 days post-presentation. Annexon focuses on developing complement medicines for autoimmune, neurodegenerative, and ophthalmic disorders, with a pipeline that includes innovative products like ANX005, ANX007, and ANX009.
On September 20, 2021, Annexon (Nasdaq: ANNX) announced its upcoming virtual C1q Series event scheduled for September 27, 2021, at 10:00 a.m. ET. This event will focus on the company's neurodegeneration franchise and will include presentations from the executive team and key opinion leaders. A live webcast will be accessible through the Investors section of annexonbio.com. Annexon specializes in developing complement medicines for autoimmune, neurodegenerative, and ophthalmic disorders, leveraging its technology to target diseases caused by C1q activation.
Annexon (Nasdaq: ANNX) announced its second quarter 2021 financial results and business updates, highlighting progress in its autoimmune and neurodegenerative therapeutic franchises. The company advanced its clinical candidate ANX009 in treatment of autoimmune diseases and reported data from ANX005 trials in Huntington’s and Amyotrophic Lateral Sclerosis. Financially, Annexon reported a net loss of $31.3 million for Q2 2021, up from $12.2 million in Q2 2020, with R&D expenses rising to $24.6 million. The company appointed William D. Waddill to its Board, enhancing its strategic capabilities.
Annexon has announced advancements in its autoimmune pipeline, moving ANX009 into a Phase 1b program for Lupus Nephritis and expanding ANX005 to a Phase 2 trial for Multifocal Motor Neuropathy (MMN). ANX009 was well-tolerated in a Phase 1 trial and demonstrated robust C1q inhibition, leading to its selection for Lupus Nephritis patients. Meanwhile, ANX005 is expected to address unmet needs in MMN, which is characterized by progressive muscle weakness due to immune-mediated nerve damage. The company is poised to enhance its C1q inhibitor portfolio, targeting significant autoimmune conditions.
Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company, will have its President & CEO, Douglas Love, present at the Raymond James Human Health Innovation Conference on June 23, 2021, at 1:20 pm EDT. The conference will focus on the company's pipeline of novel therapies targeting classical complement-mediated autoimmune and neurodegenerative disorders. Investors can access a live webcast under the 'Events & Presentations' section on the Investors page of www.annexonbio.com, with an archived replay available for 30 days.
Annexon reported its first-quarter 2021 financial results, highlighting key developments in its clinical pipeline. The Phase 2 trial of ANX005 for Huntington’s Disease is fully enrolled, with data expected in 2H 2021. Additionally, the first-in-human study of ANX009 has been completed, with results anticipated by summer 2021. The company is advancing drug candidates ANX105 and ANX1502, aiming for IND submissions by year-end 2021. As of March 31, 2021, Annexon holds $326.7 million in cash, sufficient to fund operations through 2023, despite a net loss of $26.0 million this quarter.
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