Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2023
Appili completes strategic reprioritization of programs to focus on ATI-1701, a biodefense tularemia vaccine candidate, ATI-1801, a topical antiparasitic product for the treatment of a disfiguring disease, and ATI-1501, a liquid oral formulation of the antibiotic metronidazole.
“We continue to move significantly closer to being able to provide a safe and effective vaccine for the bacteria Francisella tularensis, which poses a great threat to public health and is considered by many governments to be a top-priority biothreat,” said
Second quarter and recent operational highlights include:
- Announced a commitment of over
US$10 millionin funding from DTRA to advance our biodefense tularemia vaccine candidate ATI-1701 to help combat the bacteria Francisella tularensis, the causative agent of tularemia and a top-priority biothreat. Appili expects this program may be eligible for a Priority Review Voucher (“PRV”) if approved by the United States Food and Drug Administration(“FDA”).
- Remain on track to seek FDA approval by the end of 2023 for ATI-1501, our liquid oral formulation of the antibiotic metronidazole which was designed to help patients burdened by difficult-to-treat bacterial infections.
- Presented an update, including Phase 3 efficacy data, on our cutaneous leishmaniasis product, topical paromomycin, ATI-1801 at the
WorldLeish7 Conferencein Cartagena, Colombia. ATI-1801 may be eligible for a valuable Priority Review Voucher if approved by the FDA.
The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated.
The net loss and comprehensive loss of
This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the second quarter of the 2023 fiscal year and the related management discussion and analysis (MD&A), copies of which are available on SEDAR at www.sedar.com.
Appili Portfolio Reprioritization
Appili also announced plans to focus its resources on advancing its portfolio of infectious disease and biodefense assets, including ATI-1701, ATI-1801, and ATI-1501. The Company will discontinue development of its remaining portfolio programs ATI-2307, a broad-spectrum anti-fungal, and ATI-1503, a broad-spectrum antibiotic targeting multi-drug resistant Gram-negative bacteria.
Forward Looking Statements
This news release contains “forward-looking statements”, including with respect to the Company’s development of its products and expected funding arrangements. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, risks and assumptions related to securing the full anticipated funding from DTRA and those risks, uncertainties and assumptions listed in the annual information form of the Company dated
View source version on businesswire.com: https://www.businesswire.com/news/home/20221109006155/en/
Investor Relations Contact: