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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 (Nasdaq: ANNX) has outlined its 2025 outlook, emphasizing key milestones for its flagship programs. The company is advancing three major therapies:
ANX005 for Guillain-Barré Syndrome (GBS), the first targeted therapy in this area, showed promising results in a pivotal Phase 3 trial, improving muscle strength and functional recovery. A Biologics License Application (BLA) submission is planned for the first half of 2025.
ANX007 for Geographic Atrophy (GA) is the first neuroprotective therapy showing significant vision preservation in Phase 2 trials. Enrollment for the Phase 3 ARCHER II trial is expected to complete in the second half of 2025.
ANX1502, an oral C1s inhibitor, aims to treat autoimmune diseases. Clinical proof-of-concept data is expected in the first quarter of 2025. The company has a cash runway into the second half of 2026 to support these developments.
CEO Douglas Love highlighted the company's progress, noting that ANX005 could displace current GBS treatments, ANX007 could replicate significant vision protection, and ANX1502 could disrupt current autoimmune disease treatments.
Annexon, a biopharmaceutical company listed on Nasdaq under the ticker ANNX, has appointed William “BJ” Jones to its board of directors. Mr. Jones brings 30 years of experience in the biotechnology industry, focusing on U.S. and global commercial operations.
According to Douglas Love, Annexon's CEO, Mr. Jones's expertise will be important as the company advances its late-stage clinical therapies, specifically ANX005 for Guillain-Barré Syndrome and ANX007 for geographic atrophy, toward commercialization.
Mr. Jones currently serves as the Chief Commercial Officer at NewAmsterdam Pharma and has a history of successful product launches, including roles at Biohaven Pharmaceuticals, Takeda Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, and NitroMed. He has been involved in the commercialization of major brands like Nurtec® ODT, Abilify®, Farxiga®, Pradaxa®, BiDil®, and Excedrin Migraine®.
Mr. Jones holds an M.B.A from Stanford Graduate School of Business and an M.S. in Industrial Engineering from Texas A&M University.
Annexon Biosciences (Nasdaq: ANNX), a biopharmaceutical company advancing late-stage clinical therapies for neuroinflammatory diseases, announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference.
Douglas Love, President and CEO, will present on Tuesday, January 14, 2025, at 3:00 p.m. PST. The presentation will be available via a live webcast under the ‘Events & Presentations’ section on the Investors page at www.annexonbio.com. A replay will be accessible on the website for 30 days post-event.
Annexon (NASDAQ: ANNX) has granted stock options to nine new non-executive employees under its 2022 Employment Inducement Award Plan. The equity awards, approved on December 10, 2024, comply with Nasdaq Listing Rule 5635(c)(4). The grants total 901,000 shares of Annexon common stock with an exercise price of $4.44 per share, based on the closing price on December 13, 2024. The options have a ten-year term and vest over 4 years, with 25% vesting after the first year and the remaining vesting monthly at 1/48th, contingent on continued employment.
Annexon (ANNX) announced positive topline results from a real-world evidence study comparing ANX005 treatment to IVIg/PE for Guillain-Barré Syndrome (GBS). The study matched 79 ANX005-treated patients from Phase 3 trials with 79 real-world patients from the IGOS registry. Key findings showed ANX005 patients demonstrated:
- Over 10-point improvement in muscle strength by week 1 vs IVIg/PE
- Twice the likelihood of better health status on GBS-Disability Scale
- Lower mechanical ventilation needs (15 vs 32 patients)
- 12 fewer median days on ventilation and in ICU
The company plans to submit a U.S. Biologics License Application in first half of 2025. ANX005 is designed to block C1q and complement activity with a single dose, potentially offering the first FDA-approved treatment for GBS.
Annexon (NASDAQ: ANNX) announced presentations of ANX007 data from the Phase 2 ARCHER trial in geographic atrophy (GA) at the Floretina-ICOOR 2024 meeting in Florence, Italy. ANX007, a first-in-kind non-pegylated antigen-binding fragment, is designed to block C1q locally in the eye through intravitreal formulation.
The company will showcase multiple presentations focusing on vision protection and photoreceptor preservation in GA patients. The presentations will highlight the program's unique achievement in demonstrating significant vision protection in standard and low light conditions, along with preservation of photoreceptors in the fovea region. A pivotal Phase 3 ARCHER II trial is currently enrolling patients, with data expected in the second half of 2026.
Annexon (Nasdaq: ANNX) has granted stock options to seven new non-executive employees under its 2022 Employment Inducement Award Plan. The grants, approved on November 12, 2024, comply with Nasdaq Listing Rule 5635(c)(4). The employees received options to purchase 495,000 shares of common stock at an exercise price of $6.12 per share, matching the closing price on November 15, 2024. The options have a ten-year term and vest over 4 years, with 25% vesting after the first year and 1/48th monthly thereafter, contingent on continued employment.
Annexon reported Q3 2024 financial results and key milestones. The company expects topline Real-World Evidence data for ANX005 in Guillain-Barré Syndrome by year-end 2024, with BLA submission planned for H1 2025. The Phase 3 ARCHER II trial for ANX007 in Geographic Atrophy continues enrollment with topline data expected H2 2026. Their oral C1s inhibitor ANX1502 study data in Cold Agglutinin Disease is expected in Q1 2025.
Financial highlights include cash position of $340.1 million as of September 30, 2024, providing runway into H2 2026. Q3 2024 net loss was $34.8 million ($0.25 per share), with R&D expenses at $30.1 million and G&A expenses at $9.3 million.
Annexon Biosciences (Nasdaq: ANNX) has announced its participation in the upcoming Jefferies London Healthcare Conference. Douglas Love, president and CEO, will deliver a presentation on Wednesday, November 20, 2024, at 10:30 a.m. GMT. The presentation will be accessible via live webcast in the 'Events & Presentations' section of the company's investor page. A recording will remain available on the Annexon website for 30 days after the event. The company specializes in developing therapies for neuroinflammatory diseases affecting the body, brain, and eye, focusing on upstream C1q.
Annexon presented new Phase 2 data for ANX007 in geographic atrophy (GA) due to dry age-related macular degeneration (AMD) at the American Academy of Ophthalmology 2024 meeting. The study showed enhanced vision protection and greater preservation of central photoreceptor cells in patients with less advanced disease. Key findings include:
- 0% of ANX007 monthly-treated patients with less advanced disease lost 15 letters vs. 17% of sham patients
- 6% of ANX007 monthly-treated overall patients lost 15 letters vs. 21% of sham overall patients
- 61% decrease in EZ loss between ANX007 and sham in patients with <80% EZ loss at baseline
- 48% decrease in EZ loss between ANX007 and sham in patients with <98% EZ loss at baseline
These results highlight ANX007's potential for earlier intervention in dry AMD and GA. Pivotal Phase 3 ARCHER II data is expected in the second half of 2026.
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