– Otenaproxesul new formulation tablets manufactured for upcoming PK/PD study
– PK/PD study results expected next quarter with Phase II initiation in calendar Q1 2024
– Ended quarter with $34.3 million in cash and equivalents
TORONTO, CANADA — (August 14, 2023) – 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 quarter ended June 30, 2023.
“With tablets in hand, we’re excited to be approaching several near-term catalysts,” commented Dan Legault, Antibe’s CEO. “We’ll kick off our otenaproxesul clinical program in the fall with a short PK/PD study to confirm liver safety and inform the doses for the Phase II trial, which is slated to start in the first quarter of 2024. Top-line Phase II data are expected late next spring – positive results would set the stage for an End of Phase 2 meeting with the FDA later in 2024. All of this reflects a tremendous behind-the-scenes effort by our scientific, manufacturing and regulatory teams, supported by our global manufacturing partner. The opportunity to capture share in a market roiled by the opioid epidemic has never been greater.”
Business Highlights and Operational Update
The following covers fiscal Q1 2024 and subsequent events:
Progress for otenaproxesul on formulation, IP and commercial potential
- Completed transition to faster-absorbing formulation, including manufacturing scale up and production of tablets for upcoming PK/PD study; new formulation accelerates onset of action, also enabling lower drug doses
- Finalized study design and selected CRO for upcoming PK/PD (pharmacokinetic/ pharmacodynamic) study in healthy volunteers to confirm the dosing regimens for the Phase II bunionectomy (foot bone surgery) 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 of the new formulation to explore potential chronic treatment regimens
Emerging discovery program progressing
- Selected lead and back-up candidates for IBD program, currently undergoing evaluation in animal efficacy models; filed patent application, providing protection to 2043
- Selected lead and back-up candidates for a family of new anti-inflammatory compounds with effectiveness demonstrated in two animal models; comprehensive announcement expected in the current quarter
- Annual General Meeting set for September 8, 2023; materials have been mailed to shareholders
- Completed in-person arbitration proceeding with Nuance Pharma; decision now expected in the upcoming quarter
The following summarizes the Company’s estimated timeline for its key upcoming milestones:
- Complete clinical PK/PD study for otenaproxesul – calendar Q4 2023
- Initiate Phase II bunionectomy trial of otenaproxesul – calendar Q1 2024
- Deliver Phase II bunionectomy top-line data of otenaproxesul – calendar Q2 2024
Cash Position: As of June 30, 2023, the Company had available cash balance and term deposits totaling $34.3 million, compared to $38.9 million as at March 31, 2023.
Net Loss: For the quarter ended June 30, 2023, Net Loss and Comprehensive Loss totaled $5.8 million ($0.11 per share), an increase of $0.3 million compared to $5.5 million ($0.10 per share) in fiscal Q1 2023.
Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $3.6 million, compared to $3.8 million for fiscal Q1 2023.
General and Administrative Expenses: General and administrative expenses were $2.2 million, compared to $1.1 million in fiscal Q1 2023.
The Company’s unaudited fiscal Q1 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 PK/PD study, 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 related to its 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.
Antibe Therapeutics Inc.
VP Investor Relations
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