Antibe Therapeutics Reports Q3 2022 Interim Financial and Operating Results

By: Antibe Therapeutics Inc. via Business Wire

February 14, 2022 at 07:00 AM EST

- Acute pain clinical program for otenaproxesul initiating this quarter

- Ended quarter with a $59 million cash position

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 December 31, 2021.

“We’re excited to have launched otenaproxesul’s clinical program for post-operative pain and remain on track to begin Phase II in the fall. We’re also encouraged by draft guidance published last week by both the FDA and CDC, highlighting the urgent need for new non-opioid pain medications,” commented Dan Legault, Antibe’s CEO. “With our strong balance sheet, we’ve been able to advance multiple programs in parallel, including our inflammatory bowel disease program which targets a major need in an attractive market. At a corporate level, our disciplined approach to spending provides us with more than two years of cash runway. As the year progresses, we look forward to unlocking value for our shareholders as we achieve milestones across our development programs.”

Business Highlights

Launching otenaproxesul’s clinical program for post-operative pain

First human pharmacokinetic/pharmacodynamic (“PK/PD”) study underway to determine optimal treatment regimens
Preliminary third-party commercial assessment completed, confirming attractive market potential; comprehensive market opportunity and reimbursement study initiated
Ongoing investigation of alternative treatment regimens as a potential path forward for chronic indications

Other pipeline drugs advancing

Launched preclinical studies for specialized pain indication for ATB-352
Identified several inflammatory bowel disease (“IBD”) candidates with encouraging preliminary results; animal proof-of-concept studies underway to select lead candidate

Bolstering intellectual property (“IP”) position

Filed new patent application covering uses of otenaproxesul for treatment of acute pain; potential for IP protection to extend into the 2040s
Filed trademark applications in all major markets for two proprietary brand names

Upcoming Milestones

The following summarizes the Company’s estimated timeline for its key upcoming milestones (calendar quarters):

Initiate otenaproxesul PK/PD clinical studies – Q1 2022 (underway)
Complete comprehensive market opportunity and reimbursement study – Q2 2022
Identify lead IBD candidate– Q3 2022
Determine optimal treatment regimens for otenaproxesul – Q3 2022
Initiate otenaproxesul Phase II bunionectomy trial – Q4 2022

Financial Results

Cash Position: As of December 31, 2021, the Company had an available cash balance totaling $58.6 million, compared to $72.0 million as at March 31, 2021. The Company reported an available cash balance of $60.5 million for the quarter ended September 30, 2021.

Net Loss: For the quarter ended December 31, 2021, net loss amounted to $4.8 million ($0.09 per share), compared to $6.5 million ($0.17 per share) for the same period in fiscal 2021.

Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to $2.5 million for the quarter ended December 31, 2021, compared to $3.4 million for fiscal Q3 2021.

General and Administrative Expenses: General and administrative expenses totaled $1.3 million for the quarter ended December 31, 2021, compared to $1.6 million in fiscal Q3 2021.

The Company's unaudited fiscal Q3 2022 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 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.