- Completed successful PK/PD study for otenaproxesul’s new formulation

- Phase II initiation on track for upcoming quarter

- Ended quarter with $28 million in cash and equivalents

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to develop next-generation therapies to target inflammation, has filed its financial and operating results for the fiscal quarter ended September 30, 2023.

“Last quarter capped two years of preparation for otenaproxesul’s successful PK/PD study,” commented Dan Legault, Antibe’s CEO. “With human safety addressed and encouraging PK data in hand, we’re excited to be nearing another inflection point in otenaproxesul’s value and partnering potential. We’re looking forward to the Phase II trial, on track to launch in calendar Q1 2024.”

Business Highlights and Operational Update

The following covers fiscal Q2 2024 and subsequent events:

Progress for otenaproxesul on formulation, IP and commercial potential

• Completed first-in-human pharmacokinetic/pharmacodynamic (“PK/PD”) study of faster-absorbing formulation, enabling selection of treatment regimens for the upcoming Phase II trial
• Strong PK/PD safety results validated DILIsym liver safety modeling results showing envisioned acute pain treatment regimens of the new formulation to be liver-safe
• PK/PD data confirm linear, dose-proportional pharmacokinetics
• Filed and supplemented patent applications, strengthening IP protection for new formulation to 2043
• DILIsym program underway to explore potential chronic treatment regimens

Emerging discovery program progressing

• Filed patent applications covering a family of new anti-inflammatory compounds with effectiveness demonstrated in three animal models; announcement expected in calendar Q1 2024

Corporate

• Arbitration decision with Nuance Pharma expected in calendar Q4 2023
• Dr. Joseph Stauffer, Antibe’s Chief Medical Officer, to chair the USA Clinical Trials Innovation & Outsourcing Programme conference on November 15, 2023 (New York, NY)
• Second guaranteed payment of $875,000 received in accordance with the Citagenix sale agreement

Upcoming Milestones

In light of the strong safety and PK data from otenaproxesul’s recent clinical PK/PD study, Antibe is upgrading the design of the upcoming fully-funded Phase II trial. While trial initiation remains set for calendar Q1 2024, the Company now anticipates top-line results in calendar Q3 2024.

Financial Results

Cash Position: As of September 30, 2023, the Company had available cash balance and term deposits totaling $27.9 million, compared to $34.3 million as at June 30, 2023.

Net Loss: For the quarter ended September 30, 2023, Net Loss and Comprehensive Loss totaled $5.0 million ($0.10 per share), a decrease of $1.1 million compared to $6.1 million ($0.12 per share) in fiscal Q2 2023.

Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $3.5 million, compared to $3.9 million in fiscal Q2 2023.

General and Administrative Expenses: General and administrative expenses were $1.9 million, compared to $1.7 million in fiscal Q2 2023.

The Company’s unaudited fiscal Q2 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 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 Information

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. 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, 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.

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