Antibe Therapeutics publishes its 2021 year-end financial results and business highlights

TORONTO – (COMMERCIAL THREAD) – Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its unique hydrogen sulfide platform to develop safer pain and inflammation drugs, filed today hui its financial and operating results for the year ended March 31, 2021.

“Since the start of the year, we have made significant progress,” commented Dan Legault, CEO of Antibe. “Our Phase III preparations for otenaproxesul have passed several milestones, including the approval of its IND application to the FDA in the United States. As we continue to navigate COVID-19 restrictions, we are happy to launch our required AME study next week, which will also inform dose selection for the phase III adaptive trial. The successful merger with Antibe Holdings provides a unified intellectual property base and strengthens our position with potential partners. On this front, our ability to execute transactions has been highlighted by the US $ 100 million partnership with Nuance Pharma in China, and we are now entering confidential discussions for large markets.

Company highlights

Otenaproxesul, a leading product candidate entering Phase III trials for osteoarthritis pain

  • Completion of all Phase III reproductive toxicology and animal toxicology studies required to begin the phase III adaptive trial (10 studies in total)

  • New Investigational Drug (“IND”) Authorized with US FDA to Authorize Human Clinical Trials in the US – Opening Single Dose Study of IND underway in 24 topics

  • Obtained approval to initiate the required absorption, metabolism and excretion (“AME”) study in 90 subjects

  • Continuation of the Senior Director of Clinical Operations, Dr. Ana Stegic, to support the management and execution of clinical trials

  • Entered into a strategic license agreement with Nuance Pharma for the commercialization of otenaproxesul in the Greater China region, with milestone payments totaling US $ 100 million and a double-digit royalty

  • Beginning of the partnership process for major markets (US, EU4, UK and Japan) led by a leading global transaction company

New chemistry initiatives targeting candidates to expand and strengthen the pipeline

  • Announcement of Collaboration with Dalriada Drug Discovery to Exploit the Hydrogen Sulfide Platform in New Pathology Areas, Including Inflammatory Bowel Disease

  • Strengthening the intellectual property position for the existing pipeline

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

  • Successfully raised $ 40 million in take-over bid, providing more than two years of cash flow and fully funding the phase III adaptive efficacy trial of otenaproxesul

  • Completed merger with Antibe Holdings to unify intellectual property of drugs and company platform – eliminates significant royalty liability on future revenues

Upcoming milestones

  • Single Dose IND Opening Study Completed – Q3 2021

  • Completion of the AME study – Q4 2021

  • Request an FDA meeting prior to the start of the Phase III – Q4 2021 program

  • Initiation of adaptive Phase III trial – Q1 2022

Financial results

Treasury : As at March 31, 2021, the Company had a free cash balance totaling $ 72 million, compared to $ 6.2 million as at March 31, 2020.

Returned: For the fiscal year ended March 31, 2021, revenues totaled $ 9.7 million, a negligible increase over fiscal 2020. All revenues were owed to the Company’s subsidiary, Citagenix; sales were affected by the COVID-19 crisis in the fiscal first quarter, but recovered strongly from the second to the fourth quarter.

Net loss: For the year ended March 31, 2021, the net loss amounted to $ 26.3 million ($ 0.70 per share), compared to $ 19.3 million ($ 0.71 per share) for fiscal year 2020.

Research and development costs: Research and development expenses for the year increased to $ 13.4 million from $ 8.1 million for fiscal 2020. This increase is mainly due to higher development costs for the study. Phase IIB dosing efficacy for otenaproxesul as well as the required non-clinical studies.

General and administrative expenses: General and administrative expenses amounted to $ 7.2 million for the fiscal year, compared to $ 5.2 million for fiscal 2020. The increase is mainly attributable to an overall increase in payroll, professional and consulting fees, office expenses and other costs.

Sales and Marketing Costs: Selling and marketing expenses totaled $ 2.7 million for the year, compared to $ 3.8 million in fiscal 2020. The decrease includes lower salaries and commissions, advertising costs and promotion and travel and entertainment expenses.

With the disposal of a subsidiary of Citagenix (BMT Medizintechnik GmbH) during the year, the financial results mentioned above reflect continuing operations. The Company’s audited consolidated financial statements for fiscal 2021, the MD&A and the Annual Information Form will be available shortly on SEDAR.

About Antibe Therapeutics Inc.

Antibe is leveraging its proprietary hydrogen sulfide platform to develop safer next-generation therapies to treat inflammation resulting from a wide range of medical conditions. The Company’s current pipeline includes three assets that aim to overcome gastrointestinal (“GI”) ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s flagship drug otenaproxesul is entering phase III for the treatment of osteoarthritis pain. Additional actives under development include a safer opioid alternative for perioperative pain, and a low-dose aspirin-sparing GI alternative. The Company’s next target is inflammatory bowel disease (“IBD”), a disease that has long required safer and more effective therapies. Learn more about

Forward-looking information

This press release includes certain forward-looking statements, which may include, but are not limited to, the proposed authorization and development of drugs and medical devices. All statements contained in this document that are not statements of historical fact can be considered as forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “Expect”, “intend”, “propose” and similar terms. Forward-looking statements involve known and unknown risks and uncertainties which could cause actual results, performance or achievements to differ materially from those expressed or implied in this press release. Factors that could cause actual results to differ materially from those anticipated in this press release include, without limitation, the inability of the Company to obtain additional financing and licensing agreements on reasonable terms, or not at all, its inability to execute its business strategy and compete successfully in the market and the risks associated with the development of drugs and medical devices in general. Antibe Therapeutics assumes no obligation to update any forward-looking statements or to update the reasons why actual results may differ from those reflected in forward-looking statements, except as required by applicable law.

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