– Recent animal data on otenaproxesul’s new formulation confirm rapid drug uptake and potential for effective pain management
– Targeting first clinical dose in calendar Q3 2023; Phase II top-line data within 12 months
– Ended quarter with $42.4 million in cash and equivalents, providing over two years of runway
TORONTO, CANADA — (February 15, 2023) – Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies to target inflammation, has filed its financial and operating results for the fiscal quarter ended December 31, 2022.
“As we prepare for the Phase II bunionectomy trial, we’re increasingly excited about the potential of otenaproxesul’s new formulation,” noted Dan Legault, Antibe’s CEO. “Recent animal data have confirmed both its potential for effective pain management at dramatically lower doses and a rapid onset profile ideally suited for acute pain. To de-risk the translation of this data to human doses, we’ve planned a confirmatory study in healthy volunteers upon release of the new drug tablets. We look forward to delivering Phase II top-line data in the next 12 months.”
The Company also announced that its founder, Dr. John L. Wallace, has decided to retire from the Board of Directors. Dr. Wallace will remain a corporate Vice Chair, enabling the Company to continue to benefit from his wisdom and expertise. Robert E. Hoffman, Antibe’s Board Chair, commented: “From elucidating how today’s NSAIDs injure the digestive tract to conceiving our novel hydrogen sulfide platform, John’s pioneering science has underpinned our emergence as a publicly traded biotech pursuing a major advance in anti-inflammatory therapeutics. We thank him for his extraordinary service as a Director.”
Business Highlights and Operational Update
Progress for otenaproxesul on formulation and IP
- Transitioned to faster-dissolving formulation that accelerates onset of action; also enables treatment regimens with lower drug doses, providing additional safety buffer and a potential pathway to address chronic pain indications
- Filed patent application for new formulation, strengthening IP protection to 2043
- Initiated animal de-risking studies for new formulation; saved resources by bypassing previously planned molar extraction clinical study
- Finalized study design for upcoming pharmacokinetic/pharmacodynamic (“PK/PD”) study in healthy volunteers to confirm dose selection for upcoming Phase II bunionectomy trial; PK/PD study anticipated to take 2 – 3 months
- Results from DILIsym, a sophisticated software model widely used to predict liver safety, suggest that all envisioned acute pain treatment regimens of the new formulation are liver-safe for five-day treatment durations (including ten days post treatment follow up)
- Retained Klick Health, a leading life science-focused marketing and commercialization agency, to conduct a comprehensive strategic positioning assessment of otenaproxesul for acute pain in the U.S. market; based on the recent third-party commercial assessment projecting U.S. market peak annual sales exceeding $1 billion, the purpose of the current study is to validate the drug’s positioning and formulate a commercial launch strategy to support partnering discussions
- Continued investigation of alternative formulations and treatment regimens as potential paths forward for chronic pain indications
Inflammatory bowel disease program lead selection
- Completed animal colitis model with positive efficacy results for several potential candidates
- Lead and back-up candidates selected with patent application filing expected next quarter
- Closed the previously announced sale of Citagenix subsidiary in an all-cash transaction involving a guaranteed $3.5 million, divided into four equal payments over three years, with the remaining $4.0 million subject to Citagenix achieving sales milestones over four years (the milestone formula was amended subsequent to the closing, including a one-year term extension and an additional $1.0 million of potential milestone payments; the amendment is available on SEDAR)
The following summarizes the Company’s estimated timeline for its key upcoming milestones:
- Ready tablets of otenaproxesul’s new formulation – calendar Q2 2023
- Initiate clinical PK/PD study for otenaproxesul – calendar Q3 2023
- Initiate Phase II bunionectomy trial of otenaproxesul – calendar Q4 2023
- Deliver Phase II bunionectomy top-line data of otenaproxesul – calendar Q1 2024
Cash Position: As of December 31, 2022, the Company had available cash balance and term deposits totaling $42.4 million, compared to $54.8 million as at March 31, 2022. This provides the Company with over two years of runway, which includes the cost of the upcoming Phase II bunionectomy trial.
Net Loss: For the quarter ended December 31, 2022, Net Loss and Comprehensive Loss totaled $4.3 million ($0.08 per share), an decrease of $0.5 million compared to $4.8 million ($0.09 per share) in fiscal Q3 2022.
Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $2.2 million, compared to $2.5 million in fiscal Q3 2022.
General and Administrative Expenses: General and administrative expenses were $1.6 million for the quarter, compared to $1.3 million in fiscal Q3 2022.
The Company’s unaudited fiscal Q3 2023 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 safer 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 (“GI”) 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 amounts, timing and receipt of the portion of the Citagenix sale price that is subject to the achievement of sales milestones, the anticipated scope, timing, duration and completion of certain of the Company’s clinical trial programs and studies 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, Citagenix not achieving sales milestones, 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 and medical device 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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