Aeon Biopharma Stock Price, News & Analysis

AEON Biopharma (NYSE: AEON) has successfully closed its previously announced $20.0 million underwritten public offering on January 7, 2025. The offering consisted of 40,000,000 Common Units priced at $0.50 per unit. Each unit includes one share of Common Stock and two warrants: a Series A and Series B Warrant, both with an exercise price of $0.625.

The Series A Warrants expire after 60 months following stockholder approval, while Series B Warrants expire after 30 months. Aegis Capital Corp., acting as the sole book-running manager, exercised its over-allotment option for 6,000,000 additional Series A and B Warrants. The company plans to use the net proceeds for general corporate purposes and working capital.

AEON Biopharma (NYSE: AEON) has announced the pricing of a $20.0 million underwritten public offering. The offering consists of 40,000,000 Common Units priced at $0.50 per unit (or $0.4999 for Pre-Funded Units). Each unit includes one share of Common Stock or Pre-Funded Warrant, plus Series A and B Registered Common Warrants exercisable at $0.625.

The Series A Warrants expire after 60 months, while Series B Warrants expire after 30 months following stockholder approval. Aegis Capital Corp. has been granted a 45-day over-allotment option for up to 15% additional shares and warrants.

The company plans to use the proceeds for general corporate purposes and working capital, with CEO Marc Forth stating the capital will fund operations through 2025 and support ABP-450 development as a BOTOX® biosimilar. The offering is expected to close around January 7, 2025.

AEON Biopharma (NYSE: AEON) has announced the launch of a proposed public offering of units comprising common stock (or pre-funded warrants) and warrants to purchase common stock. The clinical-stage biopharmaceutical company, focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, has appointed Aegis Capital Corp. as the sole book-running manager on a firm commitment basis.

The offering includes a 45-day option for Aegis Capital Corp. to purchase additional shares up to 15% of total shares sold to cover over-allotments. AEON plans to use the net proceeds for general corporate and working capital needs. The offering is being conducted through an effective shelf registration statement on Form S-3 and is subject to market conditions, with no guarantee of completion or final terms.

AEON Biopharma reported Q3 2024 financial results and provided a corporate update. The company held a biosimilar advisory meeting with FDA regarding ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX®. AEON plans to initiate comparative analytical studies in Q4 2024, subject to available resources. The 351(k) regulatory pathway could enable ABP-450 to reach the U.S. market under a single approval for all BOTOX's current and future therapeutic indications. The company's main limitation is current capital resources, and they are evaluating options to execute their regulatory strategy. A Biosimilar Biological Product Development Type 2 meeting with FDA is planned for 2025.

AEON Biopharma (NYSE: AEON) announced a positive outcome from its FDA Biosimilar Advisory Meeting for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). The company is aligned with the FDA on the 351(k) regulatory pathway for approval. Key points include:

1. Comparative analytical studies are expected to start in Q4 2024.
2. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to review results and confirm the proposed study package.
3. AEON aims to bring prabotulinumtoxinA to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single approval.
4. The company anticipates conducting a Phase 3 program, subject to funding, to compare ABP-450 with BOTOX®.

AEON Biopharma (NYSE: AEON), a clinical-stage biopharmaceutical company developing a botulinum toxin complex for multiple therapeutic indications, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York, NY. The event is scheduled for September 11, 2024.

Key points:

• Marc Forth, AEON's President and CEO, will present a corporate overview at 1:30 PM ET
• One-on-one meetings with institutional investors will be available
• A live webcast of the conference event will be accessible through the conference host

This participation provides AEON an opportunity to showcase its progress and engage with potential investors, potentially impacting its market position and future funding prospects.

AEON Biopharma (NYSE: AEON) reported its Q2 2024 financial results and provided a corporate update. The company is progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar to BOTOX®. AEON is scheduled to hold a biosimilar initial advisory meeting with FDA in Q3 2024. The 351(k) regulatory pathway offers potential for a single approval for all of BOTOX's current and future therapeutic indications.

Key highlights include:

• Plans to initiate a single pivotal clinical study in cervical dystonia (CD)
• Submitted a briefing package to FDA with extensive data
• Expects to start a Phase 3 CD study with ~400 patients
• Aims to demonstrate non-inferiority to BOTOX

The biosimilar approach may offer a potential regulatory pathway to bring ABP-450's differentiated economic model to the U.S. market efficiently.

AEON Biopharma has announced a strategic shift to pursue a biosimilar pathway for ABP-450, its lead candidate for treating cervical dystonia (CD). The company plans to conduct a Phase 3 study comparing ABP-450 directly with BOTOX® via the FDA's 351(k) regulatory pathway. This move follows promising Phase 2 trial results and aims to secure approval for all of BOTOX’s current and future therapeutic indications. An in-person FDA meeting is scheduled for Q3 2024 to discuss this plan. If successful, the Phase 3 study could pave the way for a Biologics License Application (BLA) filing.

AEON Biopharma announced a strategic reprioritization and cost reduction plan, aiming to extend its cash runway into Q4 2024 while evaluating funding options for its late-stage clinical pipeline. Key actions include a workforce reduction of approximately 55%, termination of CFO Peter Reynolds, and the appointment of CEO Marc Forth and Corporate Controller Jennifer Sy to additional roles as principal financial officer and principal accounting officer, respectively. The company will discontinue the Phase 2 study of ABP-450 for chronic migraine prevention due to unmet endpoints, focusing instead on analyzing interim data and maintaining patient safety.