Appili Therapeutics publishes its financial and operating results for fiscal 2021 and provides an update on its strategy for fiscal 2022
HALIFAX, Nova Scotia – (COMMERCIAL THREAD) – Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company developing anti-infective drug candidates, today announced its financial and operating results for the fiscal year ended March 31, 2021, and provided an update on the Company’s strategy for fiscal 2022. All figures are in Canadian dollars, unless otherwise indicated.
“As we enter our next fiscal year as a public company, we are excited about the pace of progress related to many of our therapies, as well as our future business development strategy. Our goal is to use a scientifically rigorous and financially sound approach to identify and develop new therapies that meet the greatest needs of patients. We believe this will create lasting value for shareholders, ”said Armand Balboni, MD, PhD, CEO of Appili Therapeutics.
“We are encouraged by the fact that an independent data and security oversight committee has recommended the continuation without modification of the current PRESECO phase 3 of Appili (PREaeration SEvere COVID-19) evaluating Avigan®/ Reeqonus ™ (favipiravir). We look forward to the completion of the PRESECO trial and hope that Avigan / Reeqonus will become one of the first oral prescription drugs for newly diagnosed patients with COVID-19, ”continued Dr Balboni.
2021 and recent highlights include:
She has appointed Rochelle Stenzler, a seasoned healthcare executive, to her board of directors.
Appointed both Dr Yoav Golan as the company’s first medical director and senior director of drug development Don Cilla as director of development.
Signing of a collaboration, development and supply agreement to create a global consortium with Dr. Reddy’s Laboratories Ltd. (“DRL”) and Global Response Aid (“GRA”) for the COVID-19 oral antiviral candidate, favipiravir.
Received the recommendation of an independent Data and Safety Oversight Board (“DSMB”) to continue without modification the current PRESECO (PREventing Severe COVID-19) phase 3 trial of Appili evaluating Avigan®/ Reeqonus ™ (favipiravir) as a potential oral treatment for patients with mild to moderate COVID-19.
Organized a meeting with key opinion leaders to determine the clinical path of the ATI-2307 program targeting resistant fungal infections. The Company plans to engage regulatory authorities in 2021 and submit regulatory dossiers to the United States Food and Drug Administration and other health authorities and to begin Phase 2 clinical trials in 2022.
Obtaining an additional US $ 6.3 million from the Defense Threat and Reduction Agency (“DTRA”) to fund regulatory, manufacturing and pre-IND 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 increase in black fungal infections have demonstrated that there are a significant number of infectious pathogens that pose serious threats to human health. “We are committed to advancing new therapies that address unmet infectious disease needs, and our ATI-2307 antifungal program is an important part of our pipeline,” said Dr. Balboni. “We are continuing our cutting edge work to move the program forward, with the goal of filing a Phase 2 protocol with regulators by the end of this year. ”
Annual financial results
The Company prepares its financial statements in accordance with IFRS issued by the International Accounting Standard Board and Part I of the Handbook of Chartered Professional Accountants of Canada – Accounting.
Net loss and aggregate loss of $ 14.3 million or loss of $ 0.24 per share for the year ended March 31, 2021 was $ 8.9 million greater than net loss and loss total of $ 5.4 million or a loss of $ 0.16 per share during the fiscal year ended March 31, 2020 This is mainly an increase of $ 8.1 million in research and development expenses (R&D), a $ 1.5 million increase in general and administrative expenses and a $ 0.06 million increase in accrued interest, offset by a $ 0.6 million increase in government assistance and a decrease of $ 0.3 million in Business Development.
As at March 31, 2021, the Company had cash and short-term investments of $ 16.1 million and working capital of $ 13.6 million, compared to $ 10.5 million and $ 9.7 million. $, respectively as of March 31, 2020.
As of June 23, 2021, the Company had 62,832,120 common shares issued and outstanding, 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 year ended March 31, 2021 and the related MD&A, copies of which are available under the Company’s profile on SEDAR at address www. sedar.com
About Appili Therapeutics
Appili Therapeutics is a purpose-built, portfolio-focused, people-focused infectious disease biopharmaceutical company to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of new therapies to prevent deaths and improve lives. As part of a global consortium, Appili sponsors advanced clinical trials evaluating the antiviral Avigan® / REEQONUSMT (favipiravir) for the treatment and prevention of COVID-19 worldwide. The Company is also developing a diverse line of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious bioweapon threat, and two new antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infectious diseases. For more information, visit www.AppiliTherapeutics.com.
This press release contains “forward-looking statements” which reflect current expectations regarding the future growth of the Company’s management, results of operations, performance and business prospects and opportunities. Whenever possible, words such as “could”, “would”, “could”, “should”, “will”, “anticipate”, “believe”, “plan”, “‘wait”, “have the ‘intention to’, ‘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 Company’s annual information form dated June 23, 2021 and other documents filed by the Company with Canadian Securities Regulatory Authorities (which can be viewed at www.sedar.com). If one or more of these risks or uncertainties materialize or if the assumptions underlying the forward-looking statements prove to be incorrect, actual results, performance or achievements may differ materially from those expressed or implied by the forward-looking statements contained in this press release. Press. These factors should be carefully considered and potential investors should not place undue reliance on 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.
The Company does not make any express or implied claim that its investigational product, favipiravir, has the ability to eliminate, cure, or contain COVID-19 (or the SARS-2 coronavirus) at this time.