Annexon, Inc. - ANNX STOCK NEWS

Annexon Inc (ANNX) has initiated patient dosing in the global Phase 3 ARCHER II trial for ANX007, a C1q inhibitor targeting geographic atrophy (GA). The trial aims to evaluate ANX007's potential to protect vision in GA patients, with topline data expected in H2 2026. New data from the Phase 2 ARCHER trial showed:

1. Significant vision protection in standard and low light conditions
2. Structural protection in key retinal areas for visual acuity
3. Up to 60% protection of photoreceptors in the central fovea
4. 29% protection of photoreceptors across the full retinal field

ANX007 is the only GA therapy candidate to receive PRIME designation in the EU and Fast Track designation from the FDA. The Phase 3 trial will enroll approximately 630 patients, using best corrected visual acuity (BCVA) protection against ≥15-letter loss as the primary outcome measure.

Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on novel therapies for neuroinflammatory diseases, has granted an inducement award to a new non-executive employee. The equity award, approved on July 11, 2024, under the 2022 Employment Inducement Award Plan, includes an option to purchase 6,200 shares of Annexon common stock. The option has a ten-year term with an exercise price of $6.17 per share, equal to the closing price on July 15, 2024. It vests over 4 years, with 25% vesting on the first anniversary and 1/48th monthly thereafter, subject to continued service.

Annexon will present additional data from its Phase 2 ARCHER trial on ANX007 at the 42nd ASRS Annual Scientific Meeting in Stockholm, Sweden from July 17-20, 2024. The presentations will highlight the protective effects of ANX007 on visual acuity and anatomical measures in patients with geographic atrophy (GA), a condition causing irreversible vision loss. Dr. Glenn J. Jaffe and Dr. Joel Pearlman will discuss the trial's findings, showcasing ANX007's impact on the central macula's ellipsoid zone and retinal pigment epithelium. This trial is important for advancing therapies for neuroinflammatory diseases affecting vision.

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.