Amylyx Pharmaceuticals - AMLX STOCK NEWS

Amylyx Pharmaceuticals has initiated its pivotal Phase 3 LUCIDITY trial for avexitide, dosing its first participant. The trial aims to evaluate this first-in-class GLP-1 receptor antagonist for treating post-bariatric hypoglycemia (PBH).

The study will involve approximately 75 participants across 20 U.S. sites, with completion expected in 2025 and topline data in first half of 2026. The FDA-approved trial will assess avexitide's ability to reduce hypoglycemic events in patients who underwent Roux-en-Y gastric bypass surgery.

Key highlights:

• Avexitide holds FDA Breakthrough Therapy and Orphan Drug Designations
• Previous five clinical trials showed consistent, positive results
• Participants will receive either 90 mg avexitide or placebo daily
• 16-week treatment period followed by 32-week open-label extension
• Company maintains cash runway through end of 2026

Amylyx Pharmaceuticals (NASDAQ: AMLX) has initiated the LUMINA Phase 1 trial for AMX0114, dosing its first participant. This multinational, randomized, double-blind, placebo-controlled study will evaluate AMX0114, an antisense oligonucleotide targeting calpain-2, in people with Amyotrophic Lateral Sclerosis (ALS).

The trial will enroll approximately 48 participants across North America, randomized 3:1 to receive AMX0114 or placebo via intrathecal administration once every four weeks for up to 4 doses. The study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, including changes in neurofilament light chain (NfL) levels.

Early cohort data from LUMINA is expected in 2025. Preclinical studies have shown improved neuronal survival and reduced extracellular NfL levels across multiple disease models. The drug targets calpain-2, a calcium-activated protease believed to be a key contributor to axonal degeneration in ALS.

Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its upcoming participation in the 24th Annual Needham Virtual Healthcare Conference. The company's management will deliver a corporate presentation on Wednesday, April 9, 2025, at 8:00 a.m. ET.

Interested parties can access a live webcast of the presentation through the 'Events and Presentations' section of the company's investor relations website at investors.amylyx.com. The presentation recording will remain available for replay on the website for 90 days after the event.

Amylyx Pharmaceuticals (NASDAQ: AMLX) reported its Q4 and full year 2024 financial results, highlighting significant pipeline progress and financial updates. The company's pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia is underway, with topline data expected in H1 2026.

Key financial metrics include:

• Q4 2024 net loss of $37.5 million ($0.55 per share)
• Full year 2024 net loss of $301.7 million ($4.43 per share)
• Cash position of $176.5 million as of December 31, 2024
• Additional $65.5 million raised through public offering in January 2025

R&D expenses decreased to $22.9 million in Q4 2024 (vs $44.9 million in Q4 2023), while SG&A expenses reduced to $17.1 million (vs $52.2 million in Q4 2023). The company expects its current cash runway to extend through the end of 2026.

Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its participation in two major investor conferences in March 2025. The company will deliver a corporate presentation and Q&A session at the TD Cowen 45th Annual Health Care Conference on March 4 at 10:30 a.m. ET in Boston. Additionally, Amylyx will participate in a fireside chat at the Leerink Global Healthcare Conference on March 10 at 2:20 p.m. ET in Miami.

Both presentations will be accessible via live webcast through the company's investor relations website under the 'Events and Presentations' section. The webcasts will remain available for replay for 90 days after the events.

Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced it will release its fourth quarter and full year 2024 financial results on Tuesday, March 4, 2025. The company's senior management will host a conference call and audio webcast at 8:00 a.m. ET to discuss financial results and company updates.

Investors can access the conference call by dialing +1 (800) 836-8184 (U.S. & Canada) or +1 (646) 357-8785 (international). A live audio webcast will be available on the company's investor website and archived for 90 days after the event.

Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management will deliver a presentation at this virtual event on Wednesday, February 12, 2025, at 2:00 p.m. ET.

Interested parties can access a live webcast of the presentation through the 'Events and Presentations' section of Amylyx's investor relations website at investors.amylyx.com/events-presentations. The presentation recording will remain available for replay on the company's website for 90 days after the event.

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced that the FDA has lifted the clinical hold on its Phase 1 clinical trial of AMX0114, an antisense oligonucleotide targeting calpain-2 for ALS treatment. The company will proceed with opening U.S. sites for screening, enrollment, and dosing.

The Phase 1 LUMINA clinical trial is expected to begin in Canada in early 2025. This multicenter, randomized, placebo-controlled trial will evaluate AMX0114's safety and biological activity, involving approximately 48 ALS patients randomized 3:1 to receive either AMX0114 or placebo via intrathecal administration once every four weeks for up to 4 doses. The trial will assess ALS biomarkers, including changes in neurofilament light levels.

The company expects to obtain early cohort data from LUMINA in 2025.

Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced the pricing of a public offering of 17,142,857 shares of common stock at $3.50 per share. The company expects to raise approximately $60.0 million in gross proceeds, before deducting underwriting costs and expenses.

The company has also granted the underwriter a 30-day option to purchase up to an additional 2,571,428 shares at the same price. The offering is expected to close around January 13, 2025. Leerink Partners is acting as the sole bookrunning manager.

Amylyx plans to use the net proceeds, combined with existing cash and marketable securities, to advance commercialization preparations, pipeline programs, working capital, and general corporate purposes.