Annexon, Inc. - ANNX STOCK NEWS

Annexon announced positive results from its Phase 3 trial of ANX005, an immunotherapy targeting C1q for Guillain-Barré Syndrome (GBS). Presented at the 2024 PNS Annual Meeting, data showed faster and more complete recovery for ANX005-treated patients compared to placebo.

Significant improvements were noted in primary and multiple pre-specified endpoints from Week 1 through Week 26. Two and a half times more ANX005-treated patients returned to a normal/pre-disease state of health by Week 26 compared to placebo.

Patients with North American and European baseline characteristics experienced larger benefits in disability and muscle strength measures. A single infusion of ANX005 was generally well-tolerated, with a safety profile similar to placebo.

These findings underscore the potential of ANX005 to become the first targeted immunotherapy for GBS, offering a new treatment option for a significant unmet need in the GBS landscape.

Annexon will present pivotal Phase 3 data on ANX005, a novel C1q blocking antibody for Guillain-Barré Syndrome (GBS), at the 2024 Peripheral Nerve Society Annual Meeting from June 22-25 in Montréal, Canada.

The data shows significant improvements in multiple functional and prognostic measures, indicating expedited recovery for GBS patients. ANX005 has the potential to become the first targeted therapy approved for GBS treatment.

Presentations will include an oral session on June 25, a lunch symposium, a flash oral presentation on June 23, and two poster presentations on June 23 and 24.

Annexon, a clinical-stage biopharmaceutical company, announced inducement grants to two new non-executive employees. These equity awards were made under the 2022 Employment Inducement Award Plan and approved on June 14, 2024, in line with Nasdaq Listing Rule 5635(c)(4). The new employees received options to purchase 109,300 shares of Annexon common stock. The exercise price is $5.62 per share, matching the closing stock price on the grant date. The options have a ten-year term and vest over four years, with 25% vesting after the first year and the remaining shares vesting monthly thereafter.

Annexon announced the pricing of its public offering of 13,001,120 shares of common stock at $6.25 per share, potentially raising $125 million before underwriting discounts and commissions. Additionally, pre-funded warrants for 7,000,000 shares at $6.249 per share were also part of the offering. The proceeds aim to further the company's late-stage clinical platform targeting neuroinflammatory diseases. The offering is expected to close on June 7, 2024, subject to customary conditions. J.P. Morgan, Jefferies, TD Cowen, BofA Securities, and Wells Fargo Securities are joint book-running managers for the offering. More details are available through the SEC's website.

Annexon announced a proposed public offering of $125 million in common stock. The company may also grant underwriters an option to purchase an additional $18.75 million in shares. The offering's completion is uncertain and subject to market conditions. J.P. Morgan, Jefferies, TD Cowen, BofA Securities, and Wells Fargo Securities will act as joint book-running managers. Shares will be offered under a shelf registration statement filed with the SEC. The final terms will be disclosed in a forthcoming final prospectus supplement.

Annexon announced positive results from its Phase 3 trial of ANX005 in Guillain-Barré syndrome (GBS). The trial showed a significant 2.4-fold improvement in the GBS-disability scale at week 8 with a 30 mg/kg dose (p=0.0058). Secondary endpoints, including muscle strength and nerve damage, also improved. ANX005 was well-tolerated with mild side effects. A real-world evidence study and regulatory submissions are expected by 2025. The company plans to present detailed data at an upcoming conference.

Annexon Biosciences, a clinical-stage biopharmaceutical company focused on complement-based medicines, will host a conference call and webcast on Tuesday, June 4, 2024, at 8:30 a.m. ET. The event will discuss the results of their Phase 3 clinical trial for a treatment targeting Guillain-Barré Syndrome (GBS). Interested parties in the U.S. and Canada can dial 1-877-407-0784, while international participants can use 1-201-689-8560. The conference ID is 13747058, and a live webcast and replay will be available on Annexon's website.

Annexon, a clinical-stage biopharmaceutical company, announced inducement grants for two new non-executive employees under its 2022 Employment Inducement Award Plan. Approved on May 11, 2024, in line with Nasdaq Listing Rule 5635(c)(4), these equity awards include options to purchase 52,590 shares of Annexon’s common stock. These options have a ten-year term, an exercise price of $4.50 per share (the closing price on May 15, 2024), and vest over four years. Specifically, 25% of the shares vest on the first anniversary of the grant date, with an additional 1/48th vesting monthly thereafter, provided the employees continue their service through the vesting dates.

Annexon, Inc. reported its first quarter 2024 financial results, highlighting multiple value-creating catalysts in their portfolio. Key anticipated milestones include Phase 3 data for ANX005 in Guillain-Barré Syndrome, Phase 3 trial initiation for ANX007 in Geographic Atrophy, and proof-of-concept data for ANX1502 in Chronic Autoimmune Conditions. The company boasts a strong balance sheet with cash of $264.9 million as of March 31, 2024.