APPILI THERAPEUTICS REPORTS FISCAL YEAR 2021 FINANCIAL AND OPERATIONAL RESULTS AND PROVIDES UPDATE ON STRATEGY FOR FISCAL 2022
Appili Therapeutics Inc. has released its financial and operational results for the fiscal year ended March 31, 2021, and has provided an update on the company's strategy for fiscal 2022. All figures are stated in Canadian dollars unless otherwise stated.
"As we enter our next fiscal year as a public company, we are excited about the pace of progress related to several of our therapies, as well as our planned future business development strategy. Our goal is to use a scientifically rigorous, and financially sound approach to identify and develop novel therapies that meet the greatest patient needs. We believe this will create enduring value for shareholders," said Armand Balboni, MD, PhD, chief executive officer of Appili Therapeutics.
"We are encouraged that an independent data and safety monitoring board has recommended continuation without modification of Appili's ongoing phase 3 PreSeCo (preventing severe COVID-19) trial evaluating Avigan/Reeqonus (favipiravir). We look forward to the completion of the PreSeCo trial and are hopeful that Avigan/Reeqonus will emerge as one of the first prescription oral medicine for newly diagnosed patients with COVID-19," continued Dr. Balboni.
2021 and recent highlights include:
Financial
- Graduated to the main board of the Toronto Stock Exchange (TSX) and received DTC (Depository Trust Company) eligibility in the United States;
- Completed equity financing of $15,525,000 and concurrent private placement of $1.44-million.
Leadership
- Appointed veteran health care executive Rochelle Stenzler to its board of directors;
- Appointed both Dr. Yoav Golan as the company's first chief medical officer, and senior drug development executive Don Cilla as chief development officer.
Development programs
- Signed a collaboration, development and supply agreement to create a global consortium with Dr. Reddy's Laboratories Ltd. (DRL) and Global Response Aid (GRA) for oral COVID-19 anti-viral candidate favipiravir.
- Received recommendation from an independent data and safety monitoring board (DSMB) to continue without modification of Appili's continuing phase 3 PreSeCo trial evaluating Avigan/Reeqonus (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19.
- Conducted a meeting with key opinion leaders to determine clinical path for the ATI-2307 program targeting resistant fungal infections. The company expects to engage regulatory authorities in 2021 and submit regulatory filings with the U.S. Food and Drug Administration and other health authorities and start phase 2 clinical trials in 2022.
- Secured an additional $6.3-million (U.S.) from the Defense Threat and Reduction Agency (DTRA) to finance the regulatory, manufacturing and pre-IND (investigational new drugs) studies for the company's ATI-1701 vaccine program.
Appili continues to work on advancing its other anti-infective programs through development. The COVID-19 pandemic, and the recent global rise of black fungal infections, has demonstrated that there are a substantial number of infectious pathogens that present serious threats to human health. "We are committed to advancing novel therapies that address unmet needs in infectious disease, and our anti-fungal ATI-2307 program is an important part of our pipeline," said Dr. Balboni. "We are continuing our cutting-edge work to advance the program, with the goal of filing a phase 2 protocol with regulatory agencies by the end of this year."
Annual financial results
The company prepares its financial statements in accordance with IFRS (international financial reporting standards) as issued by the International Accounting Standard Board and Part I of the Chartered Professional Accountants of Canada Handbook -- Accounting.
The net loss and comprehensive loss of $14.3-million or 24-cent loss per share for the year ended March 31, 2021, was $8.9-million higher than the net loss and comprehensive loss of $5.4-million or 16-cent loss per share during the year ended March 31, 2020. This relates mainly to an $8.1-million increase in research and development (R&D) expenses, $1.5-million increase in general and administrative expenses and a $60,000 increase in accreted interest, offset by a $600,000 increase in government assistance and a $300,000 decrease in business development.
At March 31, 2021, the company had cash and short-term investments of $16.1-million, and working capital of $13.6-million, compared with $10.5-million and $9.7-million, respectively, at March 31, 2020.
As of June 23, 2021, the company had 62,832,120 issued and outstanding common shares, 6,796,869 stock options and 14,625,993 warrants outstanding.
This press release should be read in conjunction with the company's audited annual consolidated financial statements for the fiscal year ended March 31, 2021, and the related management discussion and analysis, copies of which are available under the company's profile on SEDAR