IRVINE, Calif. - AEON Biopharma, Inc. (NYSE: AEON), a clinical-stage biopharmaceutical company, reported today that its Phase 2 trial for ABP-450, a botulinum toxin complex aimed at preventing chronic migraines, did not meet its primary efficacy endpoint. In the trial, the treatment arms showed a reduction in monthly migraine days (MMD) comparable to a placebo, failing to demonstrate statistical significance.
The interim analysis of the trial, which included 325 patients, revealed an 8.5-day reduction in MMD for the 150 U dosage group and a 7.7-day reduction for the 195 U dosage group. These results were overshadowed by an 8.4-day reduction in the placebo group. The lack of significant difference (p=0.9132 for 150 U and p=0.3611 for 195 U) suggests no clear advantage of ABP-450 over placebo.
AEON's management expressed surprise at the high placebo response, which deviated from expectations based on prior studies. The secondary endpoints of the trial also did not reach statistical significance. In response to these findings, AEON has initiated cash conservation measures and will explore strategic options moving forward.
Marc Forth, President and CEO of AEON, acknowledged the outcome was unexpected but noted that the active treatment arms performed within the anticipated range for reducing MMD. The company plans to conduct further analysis to understand the unexpected placebo effect and to determine the future of ABP-450's development.
ABP-450, which is also marketed by Evolus (NASDAQ:EOLS) under the name Jeuveau for cosmetic uses, is developed and distributed by AEON for therapeutic indications in various international territories, including the U.S., Canada, and the European Union.
AEON has not disclosed the next steps for ABP-450 but has stated its commitment to evaluating the complete data set from the trial. The information reported is based on a press release statement from AEON Biopharma.
InvestingPro Insights
Following the disappointing trial results for AEON Biopharma's ABP-450, the company's financial health and stock performance have come into sharp focus. According to InvestingPro data, AEON's market capitalization stands at a modest $130.31 million, reflecting the challenges the company faces in the market. The stock's recent performance paints a stark picture, with a one-week price total return of -33.73% and a one-month price total return of -58.47%, indicating significant investor concerns following the trial news.
AEON's financial stability is also under scrutiny, as the company is quickly burning through cash, and its short-term obligations exceed its liquid assets. These concerns are compounded by the fact that AEON operates with a moderate level of debt and has a return on assets of -415.73% for the last twelve months as of Q4 2023. The InvestingPro data also reveals that the company's stock is trading near its 52-week low, at only 19.57% of its 52-week high, and has not been profitable over the last twelve months.
With the next earnings date approaching on May 14, 2024, AEON investors and analysts will be keenly watching for signs of strategic shifts or further cash conservation efforts. For those looking to delve deeper into AEON's financials and stock performance, InvestingPro offers additional insights and metrics. There are 12 more InvestingPro Tips available at https://www.investing.com/pro/AEON, which can provide a more comprehensive understanding of the company's position. Readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, gaining access to a wealth of financial analysis and expert commentary.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.