Antibe Therapeutics Reports 2022 Year-End Results and Business Highlights

Rhea-AI Summary

Antibe Therapeutics Inc. has announced its financial results for the fiscal year ended March 31, 2022. The company holds $55 million in cash, ensuring over two years of financial runway. Antibe is advancing its lead drug, otenaproxesul, through a Phase II program targeting acute pain, with developments planned for bunionectomy and molar extraction trials. The company also reported a net loss of $25.1 million for the fiscal year, slightly improved from $26.3 million last year.

Positive

• Cash position of $55 million supports operations into 2024.
• Initiation of Phase II acute pain program with promising clinical data.
• Binding agreement to sell Citagenix for $6.5 million.

Negative

• Net loss increased to $25.1 million in FY 2022.
• Research and development expenses rose to $14.4 million.

- Phase II acute pain program to initiate in early calendar Q4 2022

- Ended year with $55 million in cash and equivalents, providing over two years of runway

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.”

Business Highlights
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

Upcoming Milestones
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

Financial Results

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220630005297/en/

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-577-1443

christina@antibethera.com

Source: Antibe Therapeutics Inc.

FAQ

What are the key highlights from Antibe Therapeutics' press release on March 31, 2022?

Antibe announced a cash position of $55 million, a net loss of $25.1 million, and advancements in its Phase II acute pain program.

How much cash does Antibe Therapeutics have for its operations?

Antibe Therapeutics reported a cash position of $55 million, providing over two years of financial runway.

What is the status of Antibe's otenaproxesul drug development?

Antibe is advancing otenaproxesul through its Phase II acute pain program with a molar extraction study set to begin in early Q4 2022.

What was the net loss for Antibe Therapeutics in fiscal year 2022?

Antibe Therapeutics reported a net loss of $25.1 million for the fiscal year ended March 31, 2022.

What is the impending milestone for Antibe Therapeutics in Q4 2022?

Antibe plans to initiate its Phase II molar extraction trial in early Q4 2022.