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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 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.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on developing therapies for neuroinflammatory diseases, has announced the granting of inducement awards to seven new non-executive employees. These equity awards were approved on October 10, 2024, in compliance with Nasdaq Listing Rule 5635(c)(4).
The awards consist of options to purchase a total of 643,500 shares of Annexon common stock. The options have a ten-year term and an exercise price of $7.45 per share, which was the closing price of Annexon's stock on October 15, 2024. The options will vest over 4 years, with 25% vesting on the first anniversary of the grant date and an additional 1/48th vesting monthly thereafter, subject to continued employment.
Annexon, Inc. (Nasdaq: ANNX) will present new analyses of ANX007 from the completed Phase 2 ARCHER trial in geographic atrophy (GA) at the American Academy of Ophthalmology (AAO) 2024 annual meeting and the Eyecelerator conference at AAO. ANX007, a first-in-kind, non-pegylated antigen-binding fragment (Fab), is designed to block C1q locally in the eye with an intravitreal formulation.
Key highlights include:
- ANX007 demonstrated significant vision protection in standard and low light conditions
- Significant photoreceptor preservation was observed in the fovea region critical for visual acuity
- Phase 3 data from the ongoing ARCHER II pivotal program is expected in the second half of 2026
Presentations will be made by Dr. Rahul N. Khurana and Douglas Love at the respective events in Chicago, Illinois.
Annexon (Nasdaq: ANNX), a biopharmaceutical company focused on developing novel complement therapies for neuroinflammatory diseases, has granted stock options to six new non-executive employees under its 2022 Employment Inducement Award Plan. The equity awards, approved on September 13, 2024, comply with Nasdaq Listing Rule 5635(c)(4). In total, the new employees received options to purchase 1,015,000 shares of Annexon common stock. These options have a ten-year term and an exercise price of $7.20 per share, matching the closing price of Annexon's stock on the grant date. The options vest over 4 years, with 25% vesting after one year and the remainder vesting monthly, subject to continued employment.
Annexon (Nasdaq: ANNX) will present analyses of ANX007 from the Phase 2 ARCHER trial in geographic atrophy (GA) at two major ophthalmology conferences. ANX007, a novel C1q-blocking Fab, demonstrated significant vision protection in standard and low light conditions, and preservation of photoreceptors in the fovea region. The company has initiated the Phase 3 ARCHER II pivotal trial, with data expected in the second half of 2026. Presentations will highlight ANX007's potential to be the first treatment to protect vision in GA, focusing on its mechanism of action and clinical results from the ARCHER trial.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on novel complement therapies for neuroinflammatory diseases, has expanded its senior leadership team with three key appointments:
1. Shikhar Agarwal, M.B.A. as SVP, Head of Commercial
2. Sunil B. Mehta, Pharm.D as SVP of Medical Affairs
3. Myoung Kim, Ph.D., M.A., M.B.A. as VP of Health Economics and Outcomes Research
These appointments aim to strengthen Annexon's commercial development for flagship programs in Guillain-Barré Syndrome (GBS) and geographic atrophy (GA). The new leaders bring extensive experience in product strategy, successful launches, and market development across various therapeutic areas.
Annexon Biosciences (Nasdaq: ANNX), a biopharmaceutical company focused on developing novel complement therapies for neuroinflammatory diseases, has announced its participation in two upcoming investor conferences in September 2024. Douglas Love, the company's president and CEO, will engage in fireside chats at the following events:
1. Wells Fargo Healthcare Conference on September 4, 2024, at 9:30 a.m. ET in Boston, MA
2. Cantor Global Healthcare Conference on September 17, 2024, at 3:05 p.m. ET in New York, NY
Live webcasts of both presentations will be available on the Annexon website under the 'Events & Presentations' section of the Investors page. Replays will be archived for 30 days following each presentation.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on developing novel complement therapies for neuroinflammatory diseases, has announced the granting of inducement awards to two new non-executive employees. These equity awards, approved on August 15, 2024, were granted under the company's 2022 Employment Inducement Award Plan in compliance with Nasdaq Listing Rule 5635(c)(4).
The new employees received options to purchase a total of 83,000 shares of Annexon common stock. These options have a ten-year term and an exercise price of $5.98 per share, which was the closing price of Annexon's stock on the grant date. The options will vest over 4 years, with 25% vesting on the first anniversary and an additional 1/48th vesting monthly thereafter, subject to continued employment.
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