Aeon Biopharma Stock Price, News & Analysis

AEON Biopharma (NYSE: AEON) has reported its Q4 and full-year 2024 financial results, highlighting significant progress in its biosimilar development program for ABP-450. The company has initiated analytical studies in Q4 2024 to prepare for a potential Biosimilar Biological Product Development Type 2a meeting with the FDA in H2 2025.

The company is pursuing a 351(k) regulatory pathway using BOTOX as the reference product, which could enable market access for all of BOTOX's current and future therapeutic indications under a single FDA approval. AEON has commenced primary analytical studies for the comparative analytical assessment (CAA).

In January 2025, AEON strengthened its financial position through an underwritten public offering raising $20.0 million in gross proceeds. The company expects these funds, combined with existing cash, to support operations through 2025. Notably, approximately 89% of the Series B warrants from this offering have been exercised.

AEON Biopharma (NYSE: AEON), a clinical-stage biopharmaceutical company developing a botulinum toxin complex through a 351(k) biosimilar pathway, has announced its participation in the upcoming Leerink Global Healthcare Conference. The event will take place from March 10-12, 2025 in Miami, FL.

Marc Forth, the company's President and Chief Executive Officer, will deliver a corporate overview during the conference. Interested parties can arrange one-on-one meetings with management through their Leerink representatives.

AEON Biopharma (NYSE: AEON), a clinical-stage biopharmaceutical company, has announced a 1-for-72 reverse stock split of its common stock, effective February 26, 2025. The decision was approved by the company's Board of Directors following stockholder authorization at a Special Meeting on February 24, 2025, where shareholders approved a split ratio range of 1-for-5 to 1-for-150.

The reverse split aims to increase the selling price of AEON's common stock to maintain compliance with NYSE American requirements. Trading will continue under the symbol 'AEON' but with a new CUSIP number [00791X 209]. Stockholders' ownership percentages will remain unchanged, except for fractional shares, which will be rounded up to the nearest whole share.

AEON Biopharma (NYSE: AEON) has received a notice of non-compliance from NYSE American on February 3, 2025, due to failing to meet continued listing standards. The company reported a stockholders' deficit of $32.1 million as of September 30, 2024, and losses in two of its three most recent fiscal years, violating Section 1003(a)(i) which requires minimum stockholders' equity of $2.0 million.

AEON must submit a compliance plan by March 5, 2025, to regain compliance by August 3, 2026. While the stock continues trading under 'AEON' with an added '.BC' designation indicating 'below compliance', failure to submit an acceptable plan or meet compliance deadlines could result in delisting proceedings. The company maintains its SEC reporting requirements and intends to submit its compliance plan.

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®.