TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies to target inflammation, has filed its financial and operating results for the fiscal quarter ended September 30, 2022.
“We’ve made significant progress since launching otenaproxesul’s acute pain program a year ago,” commented Dan Legault, Antibe’s CEO. “The last few months have been particularly productive, with the transition to otenaproxesul’s faster-dissolving formulation, its strengthened IP protection to 2042 and attractive third-party sales projections. And we remain on track to initiate the Phase II bunionectomy study in the first half of next year. Especially with the momentum we’ve gained, we’re excited to be advancing a novel non-opioid pain drug in a market that’s seen limited innovation since the late 1990s.”
Business Highlights and Operational Update
Progress for otenaproxesul on formulation, IP and validation of commercial potential
- Announced faster-dissolving formulation that accelerates onset of action; also enables lower dose, providing additional safety buffer and a potential pathway to address chronic pain indications
- Filed patent application for new formulation, strengthening IP protection to 2042
- Initiated animal de-risking studies for new formulation; saved resources by bypassing previously planned molar extraction clinical study
- Completed third-party commercial assessment, indicating potential robust sales and strong market adoption rates (see accompanying MD&A for further details)
- Delivered poster presentation at the PAINWeek National Conference outlining clinical data supporting otenaproxesul’s acute pain efficacy
- Continued investigation of alternative formulations and treatment regimens as potential paths forward for chronic pain indications
Inflammatory bowel disease program lead selection
- Completed animal gastric damage model with positive results – lead candidate to be selected in the current quarter
- Closed the previously announced sale of Citagenix subsidiary in $6.5 million all-cash transaction involving a guaranteed $3.5 million, divided into four equal payments over three years, with the remaining $3.0 million subject to Citagenix achieving sales milestones in that period
- 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
The following summarizes the Company’s estimated timeline for its key upcoming milestones:
- Select lead candidate for inflammatory bowel disease – calendar Q4 2022
- Initiate Phase II bunionectomy trial – calendar H1 2023
Cash Position: As of September 30, 2022, the Company had an available cash balance and term deposits totaling $45.4 million, compared to $54.8 million as at March 31, 2022. This provides the Company with over two years of runway, including the cost of the upcoming Phase II bunionectomy trial.
Net Loss: For the quarter ended September 30, 2022, Net Loss and Comprehensive Loss totaled $6.1 million ($0.12 per share), a decrease of $2.6 million compared to $8.7 million ($0.17 per share) in fiscal Q2 2022.
Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $3.9 million, compared to $5.2 million in fiscal Q2 2022.
General and Administrative Expenses: General and administrative expenses were $1.7 million for the quarter, compared to $1.7 million in fiscal Q2 2022.
The Company’s unaudited fiscal Q2 2023 condensed interim financial statements and MD&A 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 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 acute 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 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.