– Completed transition to otenaproxesul’s new formulation; tablet manufacturing underway
– PK/PD study results expected in calendar Q4 2023 with Phase II initiation in Q1 2024
– Ended year with $38.9 million in cash and equivalents
TORONTO–(BUSINESS WIRE)–$ATBPF–Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation therapies to target inflammation, has filed its financial and operating results for the fiscal year ended March 31, 2023.
“We made excellent progress in the year, much of it behind the scenes,” commented Dan Legault, Antibe’s CEO. “Foremost is the successful transition to otenaproxesul’s faster-absorbing formulation, a significant step that involved launching a new production process in a new plant. With comprehensive liver safety modeling in hand, we’re making final preparations for a short PK/PD study to finalize dose selection for the Phase II bunionectomy trial. We also completed candidate selection and a patent application filing for our IBD program and identified a new family of promising anti-inflammatory compounds. With our strong balance sheet, we’re poised to deliver shareholder value in the coming year.”
Business Highlights and Operational Update
The following covers fiscal 2023 and subsequent events:
Progress for otenaproxesul on formulation, IP and commercial potential
- Transitioned to faster-absorbing formulation, including manufacturing scale up; new formulation accelerates onset of action, also enabling lower drug doses; patent application filed, strengthening IP protection to 2043
- Finalized study design and selected CRO for upcoming pharmacokinetic/pharmacodynamic (“PK/PD”) study in healthy volunteers to confirm the dosing regimens for the Phase II bunionectomy trial
- Received results from DILIsym, a sophisticated software model widely used to predict liver safety, suggesting that all envisioned acute pain treatment regimens of the new formulation are liver-safe for five-day treatment durations (including a ten day post-treatment follow up)
- Embarked on a DILIsym program with the new formulation to explore potential chronic treatment regimens
- Completed third-party commercial assessment, projecting strong market adoption rates and peak annual sales exceeding US$1 billion for U.S. market alone; pricing and reimbursement were favorable, with minimal reimbursement hurdles expected
- Concluded a comprehensive strategic positioning assessment for acute pain in the U.S. market, identifying a compelling commercial strategy and validating the drug’s best-in-class positioning in a market with few novel therapies in development
- Delivered poster presentation at the PAINWeek National Conference outlining clinical data supporting otenaproxesul’s acute pain efficacy
Emerging discovery program progressing
- Selected lead and back-up candidates for IBD program, currently undergoing evaluation in animal efficacy models; filed patent application, providing protection to 2043
- Selected lead and back-up candidates for a family of new anti-inflammatory compounds with effectiveness demonstrated in two animal models; comprehensive announcement expected in the upcoming quarter
Corporate
- Closed the previously announced sale of Citagenix subsidiary in an all-cash transaction involving a guaranteed $3.5 million, divided into four equal payments over three years, with the remaining $4.0 million subject to Citagenix achieving sales milestones over four years
- Appointed Robert E. Hoffman as new Board Chair; former Chair, Walt Macnee, and Antibe’s founder, Dr. John L. Wallace, appointed as corporate Vice Chairs
- Appointed Scott Curtis to the new position of Chief Operating Officer; since joining Antibe in 2016, Mr. Curtis has played a growing role in corporate development and strategic initiatives
- Completed in-person arbitration proceeding with Nuance Pharma; decision expected in calendar Q3 2023
Upcoming Milestones
The following summarizes the Company’s estimated timeline for its key upcoming milestones:
- Complete clinical PK/PD study for otenaproxesul – calendar Q4 2023
- Initiate Phase II bunionectomy trial of otenaproxesul – calendar Q1 2024
- Deliver Phase II bunionectomy top-line data of otenaproxesul – calendar Q2 2024
Financial Results
Cash Position: As of March 31, 2023, the Company had available cash balance and term deposits totaling $38.9 million, compared to $54.8 million as at March 31, 2022.
Net Loss: For the year ended March 31, 2023, Net Loss and Comprehensive Loss totaled $19.5 million ($0.37 per share), a decrease of $5.6 million compared to $25.1 million ($0.50 per share) in fiscal 2022.
Research and Development Expenses: Research and development expenses for the year, net of research tax credits, amounted to $11.3 million, compared to $14.4 million for fiscal 2022.
General and Administrative Expenses: General and administrative expenses were $6.1 million, compared to $5.4 million in fiscal 2022.
The Company’s audited fiscal 2023 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 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 acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. 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 under applicable securities laws, which may include, but are not limited to, the amounts, timing and receipt of the portion of the Citagenix sale price that is subject to the achievement of sales milestones, 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, Citagenix not achieving sales milestones, the Company’s inability to timely execute on its business strategy and timely and successfully complete 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 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.
Contacts
Antibe Therapeutics Inc.
Christina Cameron
VP Investor Relations
+1 416-577-1443
christina@antibethera.com