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AEON Biopharma Announces Strategic Resource Reprioritization and Cost Reduction Plan

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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.

Positive
  • Current cash and cash equivalents expected to support operations into Q4 2024.
  • Strategic cost reduction plan implemented to preserve cash.
  • Workforce reduction and executive appointments aimed at cost efficiency.
  • Potential for a revised clinical development strategy upon securing additional capital.
Negative
  • 55% workforce reduction, including termination of CFO Peter Reynolds.
  • Discontinuation of Phase 2 study of ABP-450 for chronic migraine prevention due to unmet endpoints.
  • Uncertain future funding for the late-stage clinical pipeline.

Insights

AEON Biopharma's strategic cost reduction plan and workforce reduction have significant implications for stakeholders. By reducing 55% of its workforce and making strategic adjustments, AEON aims to extend its cash runway into the fourth quarter of 2024. The company's ability to secure additional financing is important as it impacts the further development of their clinical pipeline.

The termination of the CFO and other employees is a sign of the company's efforts to streamline operations and cut expenses. However, such significant workforce reductions may affect AEON's operational capacity and could delay project timelines. Investors should closely monitor AEON’s cash flow and financing activities to gauge the company's future prospects.

In the short term, these cost-cutting measures may stabilize the company's financial position. However, if additional financing isn't secured, the long-term viability of AEON's operations could be in jeopardy. Given the discontinuation of the Phase 2 study for ABP-450 due to not meeting endpoints, this adds layers of uncertainty about the success of future clinical developments.

The termination of the Phase 2 study for ABP-450 in preventing chronic migraine is noteworthy. Discontinuing a trial based on interim results that didn't meet primary or secondary endpoints suggests that the therapeutic potential of ABP-450 in this area may be limited. This decision reflects the importance of data-driven evaluations in clinical trials but also signals a setback in AEON's research pipeline.

For investors, it's essential to understand that clinical trials are inherently risky and discontinuations, while disappointing, can redirect resources to more promising research areas. Monitoring AEON's future strategic directions and their ability to pivot towards other indications for ABP-450 will be key. The company's continued analysis of interim data could still yield valuable insights for future development efforts.

AEON's announcement of their strategic reprioritization indicates the company's proactive approach to financial management amidst challenging clinical trial outcomes. However, the market's reaction may lean towards cautiousness given the uncertainty associated with future funding and the halting of pivotal clinical trials.

The reduction in workforce and halting of certain studies may lead to a temporary dip in investor confidence. However, it's also important to note that cost reduction measures are often necessary for early-stage companies to extend their operational runway. Investors should focus on how effectively AEON can communicate their revised clinical development strategy and secure additional capital.

In the long term, if AEON successfully navigates these financial and operational challenges, they may emerge more resilient. Investors should keep an eye on AEON’s strategic updates and their ability to attract new investments or partnerships.

Current cash and cash equivalents expected to be sufficient to support corporate operations into Q4 2024; evaluating options to fund future advancement of late-stage clinical pipeline

IRVINE, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced a strategic reprioritization and cost reduction plan as the Company evaluates all financing options to support next steps across its late-stage clinical pipeline for ABP-450 that targets multiple indications. The Company’s actions are expected to be sufficient to extend its cash runway into the fourth quarter of 2024.

“Following a strategic review of our resources, we made the decision to implement several cost reductions that will preserve cash while still supporting corporate activities. Upon securing additional capital, we would be positioned to announce a revised clinical development strategy for our pipeline of ABP-450 programs. We look forward to keeping shareholders apprised of our progress,” commented Marc Forth, AEON’s president and chief executive officer.

As part of the cash preservation strategy, AEON has reduced its workforce by approximately 55%. This includes the Company’s termination of Peter Reynolds as the chief financial officer, principal financial officer and principal accounting officer, effective as of May 17, 2024. Concurrently, the Board appointed Mr. Forth as principal financial officer and Jennifer Sy, the Company’s corporate controller, as principal accounting officer, each effective as of May 17, 2024. Mr. Forth and Ms. Sy will continue in their prior roles. These cost reduction actions will also include efforts to reduce additional operating costs and are expected to be substantially completed by June 2024.

“We are grateful for Peter’s contributions to the Company and wish him success in his future endeavors. Peter effectively guided AEON’s finance and accounting functions through multiple important milestones, including our business combination that resulted in AEON being publicly listed,” stated Mr. Forth.

In addition, subsequent to evaluating the topline interim analysis, which did not achieve its primary or secondary endpoints, the Company has discontinued the Phase 2 study of ABP-450 for the prevention of chronic migraine, which had previously completed enrollment and dosing of patients, and ceased enrollment and dosing of patients in the Company’s migraine open label extension study (the “OLE Study”). Patients in both studies will be monitored for safety purposes through the 12-week period following their last treatment. The Company will continue its analysis of interim data from the study.

About AEON Biopharma

AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding the closing of each installment of the Private Placement, AEON’s expected capital resources and liquidity needs and the anticipated timing of AEON’s clinical results are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements, including with respect to potential obligations pursuant to the forward purchase agreements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.

Contacts

Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Source: AEON Biopharma


FAQ

What is AEON Biopharma's latest strategic plan?

AEON Biopharma announced a reprioritization and cost reduction plan to extend its cash runway into Q4 2024 and evaluate financing options for its late-stage clinical pipeline.

What changes did AEON Biopharma make to its workforce?

AEON Biopharma reduced its workforce by approximately 55% and terminated CFO Peter Reynolds, appointing Marc Forth and Jennifer Sy to additional roles.

What is the status of AEON Biopharma's Phase 2 study for ABP-450?

AEON Biopharma discontinued its Phase 2 study of ABP-450 for chronic migraine prevention after it failed to meet primary and secondary endpoints.

How long can AEON Biopharma's current cash support its operations?

AEON Biopharma's current cash and cash equivalents are expected to support operations into the fourth quarter of 2024.

What are AEON Biopharma's plans for additional funding?

AEON Biopharma is evaluating options to fund the future advancement of its late-stage clinical pipeline.

AEON Biopharma, Inc.

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Biotechnology
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