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Antibe Therapeutics Inc (2)
Symbol ATE
Shares Issued 52,637,091
Close 2023-06-29 C$ 0.47
Market Cap C$ 24,739,433
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Antibe spends $11.3-million on R&D in fiscal 2023

2023-06-29 13:00 ET - News Release

Mr. Dan Legault reports

ANTIBE REPORTS 2023 YEAR-END RESULTS AND BUSINESS HIGHLIGHTS

Antibe Therapeutics Inc. 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 chief executive officer. "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 modelling 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, intellectual property 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 contract research organization for coming 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 10-day posttreatment 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 $1-billion (U.S.) for U.S. market alone; pricing and reimbursement were favourable, 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 backup candidates for IBD program, currently undergoing evaluation in animal efficacy models; filed patent application, providing protection to 2043;
  • Selected lead and backup candidates for a family of new anti-inflammatory compounds with effectiveness demonstrated in two animal models; comprehensive announcement expected in the coming 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-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.

Coming milestones

The following summarizes the company's estimated timeline for its key coming 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 totalling $38.9-million, compared with $54.8-million as at March 31, 2022.

Net loss: For the year ended March 31, 2023, net loss and comprehensive loss totalled $19.5-million (37 cents per share), a decrease of $5.6-million compared with $25.1-million (50 cents 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 with $14.4-million for fiscal 2022.

General and administrative expenses: General and administrative expenses were $6.1-million, compared with $5.4-million in fiscal 2022.

The company's audited fiscal 2023 consolidated financial statements, management discussion and analysis, and annual information form are available on SEDAR.

About Antibe Therapeutics Inc.

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulphide 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 non-steroidal 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.

We seek Safe Harbor.

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