HALIFAX - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced its financial and operational results for the second quarter of its fiscal year 2021, which ended September 30, 2020.
Second quarter and recent operational highlights include: Entering into a global partnership agreement with Dr. Reddy's Laboratories Ltd., Global Response Aid, and FUJIFILM Toyama Chemical Co. for the worldwide development and distribution of Avigan tablets (favipiravir) for the potential prevention and treatment of COVID-19 (excluding Japan, China, and Russia)
Filing a protocol with the U.S. Food and Drug Administration (FDA) for the Company's Phase 3 trial evaluating Avigan as a potential treatment for COVID-19 in the U.S.
Enrolling and dosing the first cluster of participants in our CONTROL Phase 2 trial evaluating Avigan for outbreak control against COVID-19 in Canadian long-term care facilities
Appointing senior drug development executive Don Cilla to serve as Appili's Chief Development Officer
Graduating to the main board of the Toronto Stock Exchange (TSX) and earning DTC eligibility in the U.S.
'As the world enters the next wave of COVID-19 infections, our antiviral programs are steadily advancing. We were very pleased to sign a global deal with world-class partners to develop Avigan for the potential treatment and prevention of COVID-19, to dose the first participants in our CONTROL trial, and to file a protocol with the U.S. FDA for Appili's first Phase 3 study, which is investigating Avigan for the treatment of early-to-moderate COVID-19 infections,' said Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. 'We've also staffed key positions, including the appointment of Don Cilla as Chief Development Officer, and graduated to the TSX exchange within 18 months of originally listing on the TSX Venture Exchange. We continue to work diligently to progress our clinical programs, bolster our financial position, expand our team, and drive value for our pipeline portfolio.'
The net loss and comprehensive loss of $5.1 million or $0.09 loss per share for the six months ended September 30, 2020 was $2.1 million higher than the net loss and comprehensive loss of $2.9 million or $0.09 loss per share during the six months ended September 30, 2019. This relates mainly to a $1.6 million increase in research and development (R&D) expenses, a $0.8 million increase in general and administrative expenses, offset by a $0.3 million decrease in business development expenses.
As of September 30, 2020, the Company had cash and short-term investments of $22.9 million, compared to $10.5 million on March 31, 2020. As of November 12, 2020, the Company 62,284,216 issued and outstanding Common Shares, 4,548,949 stock options and 15,011,610 warrants outstanding.
About Appili Therapeutics
Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. Appili's diverse pipeline aims to address some of the most urgent threats in global public health, including Avigan tablets, which Appili is evaluating, as part of a consortium with Dr. Reddys Labs, Global Response Aid, and FujiFilm Toyama Chemical for the global treatment and prevention of COVID-19. Appili is also evaluating ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs and ATI-1501, which employs Appili's proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies.
This news release contains 'forward-looking statements' which reflect the current expectations of the Company's management future growth, results of operations, performance and business prospects and opportunities. 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. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 24, 2020 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.