Biopharmaceutical company Appili Therapeutics Inc. (APLI.TSX) has appointed Carl Gelhaus, Ph.D., as Director of Non-Clinical Research and Arthur Baran, B.Sc., MBA, PMP, as Director of New Product Development.
Baran's position heading up New Product Development will include work on ATI-1701, which has the potential to be the first of its kind vaccine against aerosolized Francisella tularensis, which can cause Tularemia, a disease that infects both animals and people. The pathogen has been classified as Category A and top-priority biothreat by the U.S. National Institutes of Health.
Dr. Gelhaus has more than 20 years of experience working in infectious disease and animal model research, with an emphasis on studying tularemia. He has worked extensively on ATI-1701 and presented positive interim data in 2020.
Arthur Baran brings more than 22 years of experience in program management, drug product development leadership, business development, and more. A news release from Appili Therapeutics said that Baran will be developing "systems, processes, and tools" that will aid business planning and decision-making.
Expert and industry veteran, Dr. Nabors, said, "The work being done in anti-infectives at Appili is important, and I am eager to help further establish us as a key player in the fight against infection."
President and CEO of Appili Therapeutics, Dr. Don Cilla, Pharm.D., M.B.A., said it's a "pivotal time" for the company and was positive about moving forward with the ATI-1701 with "Carl's expertise with Francisella Tularensis and Art's skills in program management and internal organization."
Appili Therapeutics is an infectious disease and biodefense biopharmaceutical company with the goal of solving life-threatening infections. They identify urgent infections that have previously been overlooked or those with treatment needs that are not being met and work to find a solution that will prevent deaths and improve lives.
According to its website, the company is currently working to eliminate a significant biological weapon threat, an easy-to-use liquid oral formulation that targets parasitic and anaerobic infections, and an antiparasitic that treats a disfiguring disease.
The company also recently appointed Dr. Gary Nabors, Ph.D., as Appili's Chief Development Officer. Dr. Nabor will "lead the advancement of programs through development, regulatory submission, and key commercialization milestones."
An expert and industry veteran, Dr. Nabors, said, "The work being done in anti-infectives at Appili is important, and I am eager to help further establish us as a key player in the fight against infection."
Multiple Upcoming Catalysts
The Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) for ATI-1501, which, it is hoped, will be an alternative to the traditional tablet form of the widely-used antibiotic Metronidazole for those who struggle to take it as such. ATI-1501 will be, according to Appili's website, "a proprietary taste-masked liquid suspension reformulation of metronidazole."
The company will also soon initiate IND-enabling toxicology studies for ATI-1701. IND refers to an Investigational New Drug Application, which is a request to the FDA to administer a drug to humans.
Douglas Loe of Leede Jones Gable commented, "The firm’s taste-masked oral liquid metronidazole formulation ATI-1501, for which an NDA has been submitted to the US FDA and for which regulatory review should conclude by end-of-CQ323, represents a separate suite of development milestones that we will be tracking in coming months."
Douglas Loe of Leede Jones Gable commented on this development in a March 24th research note, saying, "The firm’s taste-masked oral liquid metronidazole formulation ATI-1501, for which an NDA has been submitted to the US FDA and for which regulatory review should conclude by end-of-CQ323, represents a separate suite of development milestones that we will be tracking in coming months." Loe then gave Appili a target price of CA$0.25.
Appili Therapeutics is also working with regulatory authorities on development plans for ATI-1801, which is a paromomycin, or antimicrobial, product used in the treatment of cutaneous leishmaniasis (CL), a skin infection.
The company plans to select a Contract Drug Manufacturing Organization to produce the topical cream formulation., and anticipates being able to provide an update on the program later this year.
Streetwise Ownership Overview*
David Bautz, Ph.D., of Zacks Small-Cap Research, valued Appili Therapeutics shared at CA$0.15 per share in February 2023, based on these upcoming catalysts, "highly dependent upon the continued clinical success of the company's pipeline." The price per share at the time was CA$0.04.
Ownership and Share Structure
Appili Therapeutics Inc is headquartered in Halifax, Nova Scotia. According to its company presentation, it has CA$2.4 million in cash and cash resources as of September 30, 2022, and CA$91 million capital raised.
In terms of ownership, 71.4% of shares (around 86 million) are owned by the general public, while private companies hold 12.4% (around 15 million shares), VC/PCE firms have 11.8% (around 14 million), and 4.4% of the company is held by institutional investors.
According to Reuters, AiPharma Global Holdings LLC is the largest shareholder at 12.44%, with 15.08 million shares. Bloom Burton & Co Inc. is at 11.84%, with 14.46 million, and K2 & Associates Investment Management has 0.20%, with 0.24 million.
Market Watch reports that Appili has a market cap of CA$4.24 million and 121.27 million outstanding shares. It trades at a 52-week range of between CA$0.04 and CA$0.12.
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