Antibe Reports Q3 2024 Interim Financial and Operating Results

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– Successful PK/PD Study Confirms Liver Safety, Setting Stage for Launch of Updated Phase II Trials Next Month

– Phase II trial improvements include placebo arm, increased sample size, and adaptive design

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– Ended the quarter with $25 million in cash and equivalents

Antibes Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotech company using a hydrogen sulfide platform to treat disease and inflammation, announced financial and operating results for the fiscal quarter ended December 31, 2023.

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“The results of the successful PK/PD study in November allowed us to significantly improve our Phase II trial,” commented Dan Legault, CEO of Antibe. “These updates allow us to unlock the fundamental potential of otenaproxen by simplifying and shortening its remaining path to approval. Despite these improvements, the trial remains on track to start next month – we look forward to an exciting year ahead.”

Business highlights and operational update

The following covers fiscal 3rd quarter 2024 and subsequent events:

Advances in formulation, IP and commercial potential for otenaproxen

• On track to initiate an advanced abdominoplasty phase II trial in March 2024; prepared tablets and in the process of preparing clinical sites
• Improvements to the Phase II trial included the use of a placebo arm, an increased sample size (300 patient exposures), and the use of an adapted design methodology – improvements that may qualify it as a pivotal trial for the US FDA.
• The first human pharmacokinetic/pharmacodynamic (“PK/PD”) study of a more rapidly absorbed formulation has been completed:
  • Strong safety results confirmed DILIsym liver safety modeling results show new acute pain treatment regimens are liver safe (DILIsym is a sophisticated software model widely used to predict liver safety in drug development)
  • Linear, dose-proportional kinetics of the new formulation were confirmed, with significantly lower doses required to achieve target plasma levels compared to the parent drug.
  • Faster elimination was also observed, expanding the safety envelope of the drug
  • Taken together, these results provide a basis for updating the Phase II trial
• Filed and supplemented patent applications, strengthening IP protection for new inventions until 2043
• The DILIsym program is investigating potential chronic treatment regimens

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Corporate

• Arbitration with Nuance Pharma: The parties have been notified that an award has been made and will be issued once the remaining administrative matters are completed.
• Antibe was included in the 2024 OTCQX Best 50 list, a ranking of the best performing companies traded on the OTCQX Best Market. Chosen from more than 575 companies, Antibes is the only biotech to achieve this title in the last two years.
• Mayo Clinic-trained neurologist and disease researcher Svetlana Kurklinsky, PhD, has been hired for the new role of Director of Clinical Science
• Second secured payment of $875,000 received pursuant to the Citagenix sales agreement

Upcoming milestones

Below is a summary of the company's projected timeline for upcoming milestones for otenaproxesul:

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• Initiate phase II abdominoplasty trial – calendar 1st quarter 2024
• Provide basic data for stage II abdominoplasty – calendar 3rd quarter 2024
• Request completion of Phase II meeting with US FDA – calendar Q4 2024

Financial results

Cash position: As of December 31, 2023, the Company had cash balances and time deposits of $24.9 million, compared to $27.9 million as of September 30, 2023.

Net cost: Net loss and comprehensive loss were $4.2 million ($0.08 per share) for the quarter ended December 31, 2023, compared to $4.3 million ($0.08 per share) for the third fiscal quarter of 2023. Decreased by $1 million.

Research and development costs: Research and development expenses for the quarter were $2.3 million, excluding research tax credits, compared to $2.2 million in the third quarter of fiscal 2023.

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General and administrative expenses: General and administrative expenses were $2.3 million compared to $2.2 million in the third fiscal quarter of 2023.

The Company's unaudited condensed interim financial statements and MD&A for the third quarter of fiscal 2024 are available on SEDAR.

Antibes Therapeutics Inc. about
Antibe is a clinical-stage biotechnology company developing next-generation therapies for the treatment of pain and inflammation caused by a wide range of medical conditions using its proprietary hydrogen sulfide platform. The company's current pipeline includes assets targeting nonsteroidal anti-inflammatory drug (“NSAID”)-related gastrointestinal ulceration and bleeding. Antibe's lead drug, otenaproxen, is in clinical development as a safe alternative to opioids and current NSAIDs in the treatment of acute pain. Antibe's second pipeline drug, ATB-352, is in development for a specialized pain indication. The company's next target is inflammatory bowel disease (“IBD”), a disease in long-term need for safer, more effective treatments. Learn more at antibethera.com.

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Forward-looking statements
This news release contains certain forward-looking statements under applicable securities laws, which may include, but are not limited to, the anticipated scope, timing, duration and completion of certain of the Company's clinical trial programs and studies, including certain Phase II trials and chronic pain trials. the expected timing of seeking market approval for certain of the Company's drugs and therapies for additional indications. Any statements contained herein that are not statements of historical fact, including “will,” “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “recommend” and similar words. 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 timely implement its business strategy and the timely and successful completion of clinical trials and research. required regulatory approvals or intellectual property rights related to its products and services, the timing and outcome of Nuance Pharma's arbitration, risks associated with generic drug development and risk factors disclosed in the Company's public filings made in Canada and available as of sedar.com. The Company undertakes no obligation to update any forward-looking statements or to update any reasons why actual results may differ from those expressed in the forward-looking statements, except as required by applicable law.

Check out the original version on businesswire.com: https://www.businesswire.com/news/home/20240214672462/kz/

Contacts

Antibes Therapeutics Inc.
Christina Cameron
VP of Investor Relations
+1 416-577-1443
[email protected]

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