Antibe Therapeutics Reports Q1 2022 Interim Financial and Operating Results

By: Antibe Therapeutics Inc. via Business Wire

August 17, 2021 at 07:00 AM EDT

- Ended quarter with a strong $67 million cash position

- AME study on required pause; data expected in October

Antibe Therapeutics Inc. (TSX:ATE, OTCQX:ATBPF), a clinical stage company leveraging its unique hydrogen sulfide platform to develop safer medicines for pain and inflammation, has filed its financial and operating results for the fiscal quarter ended June 30, 2021.

“We made progress across all activities during the quarter,” commented Dan Legault, Antibe’s CEO. “However, subsequent to the quarter, we placed otenaproxesul’s AME study on a required pause because a pre-specified safety threshold was exceeded. As announced earlier this month, we are collecting and analyzing additional data to understand the cause and implications of the events, and to determine the optimal plan for otenaproxesul’s continued development. We will update our shareholders in October when we expect this work to be complete. In parallel, development of fresh IP continues for the rest of our pipeline, including our pursuit of a novel candidate for inflammatory bowel disease. While there is much to be done to address recent events, our dedicated team and cash position put us in a strong position to move forward.”

During the course of the absorption, metabolism and excretion (“AME”) study, the Company conducted twice-weekly blood draws and collected other specimens to measure key biomarker and pharmacokinetic data. More than 6,200 samples will be analyzed at five specialized labs in Canada and internationally, providing insight on the drug’s behavior and the potential for effectiveness at lower doses.

Business Highlights

Otenaproxesul, lead product candidate in clinical development for osteoarthritis pain

Cleared Investigational New Drug (“IND”) filing with U.S. FDA to allow human clinical trials in the United States – IND-opening single-dose study completed with analysis underway
Completed Phase III-enabling animal long-range and reproductive toxicology studies (10 studies in total), one further study to conclude in calendar Q4
Received approval to commence the absorption, metabolism and excretion (“AME”) study in 90 subjects; subsequent to the quarter, the AME study was placed on a required pause (see August 3, 2021 press release)
Retained senior clinical operations director, Dr. Ana Stegic, to support clinical trial management and execution

New chemistry initiatives targeting candidates to expand and bolster pipeline

Initiated collaboration with Dalriada Drug Discovery to exploit hydrogen sulfide platform in new disease areas including inflammatory bowel disease (“IBD”)
Stepped up pace of new chemistry initiatives to fortify intellectual property position for existing pipeline, including peri-operative pain and aspirin-based drug candidates

Fully funded for over two years with 100% ownership of underlying intellectual property

Successfully raised $40 million in a bought deal public offering, providing over two years of cash runway
Completed amalgamation with Antibe Holdings to unify the intellectual property ownership of the Company’s drugs and platform – eliminates significant royalty liability on future revenues

Financial Results

Cash Position: As of June 30, 2021, the Company had an available cash balance totaling $66.8 million, compared to $72 million as at March 31, 2021.

Revenue: For the quarter ended June 30, 2021, revenue totaled $2.7 million, compared to $1.1 million for the same period in fiscal 2021. All revenue was due to the Company’s subsidiary, Citagenix; sales were higher as the impact of COVID–19 caused dental clinics to close for a significant part of the prior year’s quarter.

Net Loss: For the quarter ended June 30, 2021, net loss amounted to $6.3 million ($0.13 per share), compared to $4.9 million ($0.16 per share) for the same period in fiscal 2021.

Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to $3.2 million for the quarter ended June 30, 2021, compared to $2.1 million for the same period in fiscal 2021. The increase was primarily due to higher salaries and wages, professional and consulting fees costs, research and clinical trial costs partly offset by SR&ED rebates.

General and Administrative Expenses: General and administrative expenses totaled $1.6 million for the quarter ended June 30, 2021, a negligible decrease compared to the same period in fiscal 2021. The difference was primarily due to decreased professional and consulting fees partly offset by higher overall payroll, office expenses and other costs.

Sales and Marketing Expenses: Selling and marketing expenses amounted to $0.7 million for fiscal Q1 2022 compared to $0.4 million for the same period in fiscal 2021. The increase consisted of increased salaries and wages, commissions, advertising and promotion, and travel and entertainment costs.

With the divestiture of Citagenix’s subsidiary (BMT Medizintechnik GmbH) during the 2021 fiscal year, the above-stated financial results reflect continuing operations. The Company's unaudited fiscal Q1 2022 condensed interim financial statements and MD&A are available on SEDAR.

About Antibe Therapeutics Inc.

Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to address inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes three 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 for the treatment of osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-sparing alternative to low-dose aspirin. 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, which may include, but are not limited to, the proposed licensing and development of drugs and medical devices. 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 secure additional financing and licensing arrangements on reasonable terms, or at all, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics 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.