Antibe Reports 2023 Year-End Results and Business Highlights

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation therapies to target inflammation, has filed its financial and operating results for the fiscal year ended March 31, 2023.

“We made excellent progress in the year, much of it behind the scenes,” commented Dan Legault, Antibe’s CEO. “Foremost is the successful transition to otenaproxesul’s faster-absorbing formulation, a significant step that involved launching a new production process in a new plant. With comprehensive liver safety modeling in hand, we’re making final preparations for a short PK/PD study to finalize dose selection for the Phase II bunionectomy trial. We also completed candidate selection and a patent application filing for our IBD program and identified a new family of promising anti-inflammatory compounds. With our strong balance sheet, we’re poised to deliver shareholder value in the coming year.”

Business Highlights and Operational Update

The following covers fiscal 2023 and subsequent events:

Progress for otenaproxesul on formulation, IP and commercial potential

• Transitioned to faster-absorbing formulation, including manufacturing scale up; new formulation accelerates onset of action, also enabling lower drug doses; patent application filed, strengthening IP protection to 2043
• Finalized study design and selected CRO for upcoming pharmacokinetic/pharmacodynamic ("PK/PD") study in healthy volunteers to confirm the dosing regimens for the Phase II bunionectomy trial
• Received results from DILIsym, a sophisticated software model widely used to predict liver safety, suggesting that all envisioned acute pain treatment regimens of the new formulation are liver-safe for five-day treatment durations (including a ten day post-treatment follow up)
• Embarked on a DILIsym program with the new formulation to explore potential chronic treatment regimens
• Completed third-party commercial assessment, projecting strong market adoption rates and peak annual sales exceeding US$1 billion for U.S. market alone; pricing and reimbursement were favorable, with minimal reimbursement hurdles expected
• Concluded a comprehensive strategic positioning assessment for acute pain in the U.S. market, identifying a compelling commercial strategy and validating the drug’s best-in-class positioning in a market with few novel therapies in development
• Delivered poster presentation at the PAINWeek National Conference outlining clinical data supporting otenaproxesul’s acute pain efficacy

Emerging discovery program progressing