Mr. Dan Legault reports
ANTIBE REPORTS Q3 2024 INTERIM FINANCIAL AND OPERATING RESULTS
Antibe Therapeutics Inc. has filed its financial and operating results for the fiscal quarter ended Dec. 31, 2023.
"The results of November's successful PK/PD study have empowered us to make considerable enhancements to the Phase II trial," commented Dan Legault, Antibe's CEO. "These upgrades may enable it to qualify as pivotal, potentially unlocking value by simplifying and shortening otenaproxesul's remaining path to approval. Even with these enhancements, the trial remains on track to initiate next month - we're looking forward to an exciting year."
Business Highlights and Operational Update
The following covers fiscal Q3 2024 and subsequent events:
Progress for otenaproxesul on formulation, IP and commercial potential
On track to launch upgraded Phase II abdominoplasty trial in March 2024; tablets manufactured and preparation of clinical sites in process
Phase II trial enhancements include the use of a placebo arm, an increased sample size (300 patient exposures), and the use of adaptive design methodology - these enhancements may enable it to qualify as a pivotal trial for the U.S. FDA
Completed first-in-human pharmacokinetic/pharmacodynamic ("PK/PD") study of faster-absorbing formulation:
Strong safety results validated DILIsym liver safety modeling results showing acute pain treatment regimens of the new formulation to be liver-safe (DILIsym is a sophisticated software model widely used to predict liver safety in drug development)
Confirmed the new formulation's linear, dose-proportional kinetics, with substantially lower doses needed to achieve target plasma levels compared to the original formulation
More rapid elimination also observed, expanding the drug's safety envelope
Taken together, these results provide the basis for upgrading the Phase II trial
Filed and supplemented patent applications, strengthening IP protection for new formulation to 2043
DILIsym program underway to explore potential chronic treatment regimens
Corporate
Arbitration with Nuance Pharma: the parties have been advised that the decision has been filed and will be released following the completion of remaining administrative matters
Antibe named to the 2024 OTCQX Best 50, a ranking of the top performing companies traded on the OTCQX Best Market. Selected from more than 575 companies, Antibe is the only biotech to achieve this designation in the last two years
Mayo Clinic-trained neuroscientist and pain researcher, Svetlana Kurklinsky, PhD, hired in the new role of Director of Clinical Science
Second guaranteed payment of $875,000 received in accordance with the Citagenix sale agreement
Upcoming Milestones
The following summarizes the Company's estimated timeline for its key upcoming milestones for otenaproxesul:
Initiate Phase II abdominoplasty trial - calendar Q1 2024
Deliver Phase II abdominoplasty top-line data - calendar Q3 2024
Request End of Phase II meeting with the U.S. FDA - calendar Q4 2024
Financial Results
Cash Position: As of December 31, 2023, the Company had available cash balance and term deposits totaling $24.9 million, compared to $27.9 million as at September 30, 2023.
Net Loss: For the quarter ended December 31, 2023, Net Loss and Comprehensive Loss totaled $4.2 million ($0.08 per share), a decrease of $0.1 million compared to $4.3 million ($0.08 per share) in fiscal Q3 2023.
Research and Development Expenses: Research and development expenses for the quarter, net of research tax credits, amounted to $2.3 million, compared to $2.2 million in fiscal Q3 2023.
General and Administrative Expenses: General and administrative expenses were $2.3 million, compared to $2.2 million in fiscal Q3 2023.
The Company's unaudited fiscal Q3 2024 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 therapies to target pain and inflammation arising from a wide range of medical conditions. The Company's current pipeline includes assets that seek to overcome the gastrointestinal 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.
We seek Safe Harbor.
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