- Successful PK/PD study confirms liver safety, sets stage for upgraded Phase II trial launch next month

- Phase II trial enhancements include placebo arm, increased sample size and adaptive design

- Ended quarter with $25 million in cash and equivalents

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to target pain and inflammation, has filed its financial and operating results for the fiscal quarter ended December 31, 2023.

“The results of November’s successful PK/PD study have empowered us to make considerable enhancements to the Phase II trial,” commented Dan Legault, Antibe’s CEO. “These upgrades may enable it to qualify as pivotal, potentially unlocking value by simplifying and shortening otenaproxesul’s remaining path to approval. Even with these enhancements, the trial remains on track to initiate next month – we’re looking forward to an exciting year.”

Business Highlights and Operational Update

The following covers fiscal Q3 2024 and subsequent events:

Progress for otenaproxesul on formulation, IP and commercial potential

• On track to launch upgraded Phase II abdominoplasty trial in March 2024; tablets manufactured and preparation of clinical sites in process
• Phase II trial enhancements include the use of a placebo arm, an increased sample size (300 patient exposures), and the use of adaptive design methodology – these enhancements may enable it to qualify as a pivotal trial for the U.S. FDA
• Completed first-in-human pharmacokinetic/pharmacodynamic (“PK/PD”) study of faster-absorbing formulation:
  • Strong safety results validated DILIsym liver safety modeling results showing acute pain treatment regimens of the new formulation to be liver-safe (DILIsym is a sophisticated software model widely used to predict liver safety in drug development)
  • Confirmed the new formulation’s linear, dose-proportional kinetics, with substantially lower doses needed to achieve target plasma levels compared to the original formulation
  • More rapid elimination also observed, expanding the drug’s safety envelope
  • Taken together, these results provide the basis for upgrading the Phase II trial
• Filed and supplemented patent applications, strengthening IP protection for new formulation to 2043
• DILIsym program underway to explore potential chronic treatment regimens

Corporate

• Arbitration with Nuance Pharma: the parties have been advised that the decision has been filed and will be released following the completion of remaining administrative matters
• Antibe named to the 2024 OTCQX Best 50, a ranking of the top performing companies traded on the OTCQX Best Market. Selected from more than 575 companies, Antibe is the only biotech to achieve this designation in the last two years
• Mayo Clinic-trained neuroscientist and pain researcher, Svetlana Kurklinsky, PhD, hired in the new role of Director of Clinical Science
• Second guaranteed payment of $875,000 received in accordance with the Citagenix sale agreement

Upcoming Milestones

The following summarizes the Company’s estimated timeline for its key upcoming milestones for otenaproxesul:

• Initiate Phase II abdominoplasty trial – calendar Q1 2024
• Deliver Phase II abdominoplasty top-line data – calendar Q3 2024
• Request End of Phase II meeting with the U.S. FDA – calendar Q4 2024

Financial Results

Cash Position: As of December 31, 2023, the Company had available cash balance and term deposits totaling $24.9 million, compared to $27.9 million as at September 30, 2023.

Net Loss: For the quarter ended December 31, 2023, Net Loss and Comprehensive Loss totaled $4.2 million ($0.08 per share), a decrease of $0.1 million compared to $4.3 million ($0.08 per share) in fiscal Q3 2023.

Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $2.3 million, compared to $2.2 million in fiscal Q3 2023.

General and Administrative Expenses: General and administrative expenses were $2.3 million, compared to $2.2 million in fiscal Q3 2023.

The Company’s unaudited fiscal Q3 2024 condensed interim financial statements and MD&A are available on SEDAR.

About Antibe Therapeutics Inc. 

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is in clinical development as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com.

Forward Looking Statements 

This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, the anticipated scope, timing, duration and completion of certain of the Company’s clinical trial programs and studies including the Phase II trial and the anticipated timing for seeking market approval for certain of the Company’s drugs and therapies for certain additional indications including chronic pain. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals or intellectual property rights related to its products and activities, the timing and outcome of the arbitration decision with Nuance Pharma, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedar.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240214672462/en/