Appili Therapeutics Reports Fiscal Year 2021 Financial and Operational Results and Provides Update on Strategy for Fiscal 2022

Rhea-AI Summary

Appili Therapeutics (TSX: APLI; OTCQX: APLIF) reported its fiscal year results for 2021, showing a net loss of $14.3 million, up from $5.4 million in 2020. Research and development expenses rose by $8.1 million. The company has $16.1 million in cash and working capital of $13.6 million. Appili is encouraged by the independent monitoring board's recommendation to continue its Phase 3 PRESECO trial for Avigan/Reeqonus, targeting COVID-19. The company aims to advance its pipeline, including a $6.3 million grant for its ATI-1701 vaccine program.

Positive

• Independent Data and Safety Monitoring Board recommended continuing the Phase 3 PRESECO trial for Avigan/Reeqonus without modification.
• Completed a successful equity financing of $15.5 million and private placement of $1.44 million.
• Secured additional USD$6.3 million from the Defense Threat and Reduction Agency for the ATI-1701 vaccine program.

Negative

• Net loss increased to $14.3 million from $5.4 million year-over-year, largely due to rising R&D and administrative expenses.

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 fiscal year ended March 31, 2021, and 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 eligibility in the U.S.
• Completed equity financing of $15,525,000 and concurrent private placement of $1,440,000.

Leadership

• Appointed veteran healthcare 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 antiviral candidate favipiravir.
• Received recommendation from an independent Data and Safety Monitoring Board (“DSMB”) to continue without modification of Appili’s ongoing Phase 3 PRESECO (PREventing SEvere COVID-19) 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 USD$6.3 million from the Defense Threat and Reduction Agency (“DTRA”) to fund the 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 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 as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook –Accounting.

The net loss and comprehensive loss of $14.3M million or $0.24 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 $0.16 loss per share during the year ended March 31, 2020. This relates mainly to a $8.1 million increase in research and development (R&D) expenses, $1.5 million increase in general and administrative expenses and a $0.06 million increase in accreted interest, offset by a $0.6 million increase in government assistance and a $0.3 million 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 to $10.5 million and $9.7 million, respectively at March 31, 2020.

As of June 23, 2021, the Company had 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 (MD&A), copies of which are available under the Company’s profile on SEDAR at www.sedar.com

About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused 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 novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan^® / REEQONUS^TM (favipiravir) for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infectious disease. For more information, visit www.AppiliTherapeutics.com.

Forward looking statements
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 23, 2021 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.

The Company is not making any express or implied claims that its investigational product favipiravir has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.

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FAQ

What were Appili Therapeutics' financial results for the fiscal year ended March 31, 2021?

Appili reported a net loss of $14.3 million, an increase from $5.4 million the previous year, primarily due to higher research and development expenses.

What is the status of the PRESECO trial for Avigan/Reeqonus?

The independent Data and Safety Monitoring Board has recommended the continuation of the ongoing Phase 3 PRESECO trial for Avigan/Reeqonus without modification.

What financial support has Appili received for its ATI-1701 vaccine program?

Appili secured an additional USD$6.3 million from the Defense Threat and Reduction Agency to fund its ATI-1701 vaccine program.

What is Appili Therapeutics’ working capital as of March 31, 2021?

As of March 31, 2021, Appili reported working capital of $13.6 million, compared to $9.7 million in the previous year.