Antibe Therapeutics Reports Q1 2023 Interim Financial and Operating Results

By: Antibe Therapeutics Inc. via Business Wire

August 15, 2022 at 07:00 AM EDT

- Phase II acute pain program to initiate in September

- Ended quarter with $50 million in cash and equivalents, providing over two years of runway

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 quarter ended June 30, 2022.

“We are really pleased with our progress,” commented Dan Legault, Antibe’s CEO. “The data we’ve collected supports otenaproxesul’s target profile as a GI-safe, non-opioid oral analgesic for acute pain – a multi-billion dollar market devoid of innovation and in great need of novel therapies. We’re particularly excited to launch the Phase II molar extraction study next month, enabling us to collect data in post-operative patients for the first time. The results of this study should allow us to identify the optimal dosing regimens for the larger Phase II bunionectomy trial next year.”

Business Highlights and Operational Update

Preparations on track for otenaproxesul’s Phase II program for acute pain

Completed loading dose pharmacokinetic/pharmacodynamic (“PK/PD”) study in the quarter; results suggest viable onset of action for acute pain relief
Upcoming Phase II molar (wisdom tooth) extraction study to obtain PK/PD data and exploratory pain endpoints in post-operative patients – study to initiate in September with results expected by January 2023
Ongoing investigation of alternative treatment regimens as a potential path forward for chronic indications

Inflammatory bowel disease program nearing lead selection

Identified three additional promising candidates for inflammatory bowel disease program – lead candidate to be chosen next quarter

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; former Chair, Walt Macnee, and Antibe’s founder, Dr. John L. Wallace, appointed as corporate Vice Chairs

Upcoming Milestones

The following summarizes the Company’s estimated timeline for its key upcoming milestones:

Phase II third molar extraction trial initiation – calendar Q3 2022
Identify lead candidate for inflammatory bowel disease – calendar Q4 2022
Phase II third molar extraction trial results – early calendar Q1 2023
Phase II bunionectomy trial initiation – calendar H1 2023

Financial Results

Cash Position: As of June 30, 2022, the Company had an available cash balance and term deposits totaling $50.2 million, compared to $54.8 million as at March 31, 2022.

Net Loss: For the quarter ended June 30, 2022, Net Loss and Comprehensive Loss totaled $5.5 million ($0.10 per share), compared to $6.3 million ($0.13 per share) for fiscal Q1 2022.

Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $3.8 million, compared to $3.2 million for fiscal Q1 2022.

General and Administrative Expenses: General and administrative expenses were $1.1 million for the quarter, compared to $1.3 million in fiscal Q1 2022.

The Company’s unaudited fiscal Q1 2023 condensed interim financial statements and MD&A will be available shortly 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 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.