TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies that target inflammation, has filed its financial and operating results for the fiscal year ended March 31, 2022.
“Since its launch last fall, we’ve been encouraged by the results of otenaproxesul’s acute pain program, and it remains very much on track,” commented Dan Legault, Antibe’s CEO. “Our data suggest that the drug can deliver the onset of action and pain relief required for commercial success in acute pain indications – an exciting prospect in a massive market that’s seen minimal innovation over the last 20 years. To further de-risk the dose selection for the planned bunionectomy trial, we’ve added a short molar extraction study to the Phase II program – with no impact on cashflow. With a balance sheet that funds us well into 2024, we’re continuing to focus our efforts and expenditures on creating value for our shareholders.”
The following covers fiscal Q4 2022 and subsequent events:
Launched otenaproxesul’s clinical program for post-operative pain
- Completed two pharmacokinetic/pharmacodynamic (“PK/PD”) studies; loading dose study suggests viable onset of action for acute pain relief
- Augmented plan replaces remaining healthy volunteer PK/PD studies with Phase II molar (wisdom tooth) extraction study to obtain more informative data in post-operative patients
- Phase II molar extraction study slated for initiation in early calendar Q4 2022 with top-line results expected within three months – to be followed by Phase II bunionectomy (foot bone surgery) study
- Ongoing investigation of alternative treatment regimens as a potential path forward for chronic indications
Other drugs advancing
- Evaluating two promising molecules to select lead candidate for inflammatory bowel disease program
- Filed patent for specialized pain indication for ATB-352, with potential for IP protection to extend into the 2040s
Corporate and governance
- Signed binding agreement to sell Citagenix in a $6.5 million all-cash transaction, including milestones
- Appointed Robert E. Hoffman as new Board Chair; outgoing Chair, Walt Macnee, and Antibe’s founder, Dr. John L. Wallace, appointed as corporate Vice Chairs
The following summarizes the Company’s estimated timeline for its key upcoming milestones (calendar quarters):
- Phase II third molar extraction trial initiated – Q4 2022
- Identify lead candidate for inflammatory bowel disease – Q4 2022
- Phase II bunionectomy trial initiated – H1 2023
Cash Position: As of March 31, 2022, the Company had an available cash balance and term deposits totaling $54.8 million, compared to $72.0 million as at March 31, 2021.
Net Loss: For the year ended March 31, 2022, net loss totaled to $25.1 million ($0.50 per share), compared to $26.3 million ($0.70 per share) for fiscal 2021.
Research and Development Expenses: Research and development expenses for the year, net of research tax credits, amounted to $14.4 million, compared to $13.4 million for fiscal 2021.
General and Administrative Expenses: General and administrative expenses were $5.4 million for the year, compared to $6.0 million in fiscal 2021.
Sales and Marketing Expenses: Selling and marketing expenses totaled $0.2 million for the year compared to $0.1 million in fiscal 2021.
The Company’s audited fiscal 2022 consolidated financial statements, MD&A and AIF 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 post-operative pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s anticipated 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 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 compete 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 www.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.