TORONTO--(BUSINESS WIRE)--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, today filed its financial and operating results for the fiscal year ended March 31, 2021.
“Since the beginning of the year we’ve made significant progress,” commented Dan Legault, Antibe’s CEO. “Our Phase III preparations for otenaproxesul achieved several milestones, including the clearance of its IND application with the FDA in the United States. While we continue to navigate COVID-19 restrictions, we’re pleased to launch our required AME study next week which will also inform the dose selection for the Phase III adaptive trial. The successful amalgamation with Antibe Holdings provides a unified intellectual property base and strengthens our position with potential partners. On that front, our ability to execute deals was highlighted by the US$100 million partnership with Nuance Pharma in China, and we’re now entering confidential discussions for the large markets.”
Otenaproxesul, lead product candidate entering Phase III trials for osteoarthritis pain
- Completed all Phase III-enabling animal long-range and reproductive toxicology studies required to commence the Phase III adaptive trial (10 studies in total)
- Cleared Investigational New Drug (“IND”) filing with U.S. FDA to allow human clinical trials in the United States – IND-opening single-dose study underway in 24 subjects
- Received approval to commence the required absorption, metabolism and excretion (“AME”) study in 90 subjects
- Retained senior clinical operations director, Dr. Ana Stegic, to support clinical trial management and execution
- Completed a strategic licensing deal 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
- Commenced partnering process for the large markets (United States, EU4, UK and Japan) led by a leading global transaction firm
New chemistry initiatives targeting candidates to expand and bolster pipeline
- Announced collaboration with Dalriada Drug Discovery to exploit hydrogen sulfide platform in new disease areas including inflammatory bowel disease
- Fortifying intellectual property position for existing pipeline
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 and fully funding otenaproxesul’s Phase III adaptive efficacy trial
- 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
- Completion of single-dose IND-opening study – Q3 2021
- Completion of AME study – Q4 2021
- Request FDA meeting prior to start of Phase III program – Q4 2021
- Initiation of Phase III adaptive trial – Q1 2022
Cash Position: As of March 31, 2021, the Company had an available cash balance totaling $72 million, compared to $6.2 million at March 31, 2020.
Revenue: For the year ended March 31, 2021, revenue totaled $9.7 million, a negligible increase compared to the fiscal 2020 period. All revenue was due to the Company’s subsidiary, Citagenix; sales were adversely affected by the COVID-19 crisis in fiscal Q1 but recovered strongly in fiscal Q2 through Q4.
Net Loss: For the year ended March 31, 2021, net loss amounted to $26.3 million ($0.70 per share), compared to $19.3 million ($0.71 per share) for fiscal 2020.
Research and Development Expenses: Research and development expenses for the year increased to $13.4 million compared to $8.1 million in fiscal 2020. The increase was primarily due to higher development costs for the Phase IIB dose-ranging, efficacy study for otenaproxesul as well as required non-clinical studies.
General and Administrative Expenses: General and administrative expenses amounted to $7.2 million for the year compared to $5.2 million for fiscal 2020. The increase was primarily due to higher overall payroll, professional and consulting fees, office expenses and other costs.
Sales and Marketing Expenses: Selling and marketing expenses totaled $2.7 million for the year compared to $3.8 million in fiscal 2020. The decrease consisted of lower salaries and commissions, advertising and promotions costs and travel and entertainment costs.
With the divestiture of a Citagenix subsidiary (BMT Medizintechnik GmbH) during the year, the above-stated financial results reflect continuing operations. The Company's audited fiscal 2021 consolidated financial statements, MD&A and AIF will be available shortly 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 entering Phase III 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.