Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2022

Rhea-AI Summary

Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) reported its financial results for Q1 2022, ending June 30, 2021. The company incurred a net loss of $7.4 million ($0.12 per share), up from $2.6 million ($0.05 per share) in Q1 2021, largely due to increased R&D expenses. Operationally, it completed an interim analysis for the Phase 3 PRESECO trial of Avigan®/Reeqonus™ for COVID-19, receiving a recommendation to continue. The trial has expanded into Latin America, and the company secured $3.5 million in funding for its pipeline.

Positive

• Recommendation to continue PRESECO Phase 3 trial for Avigan®/Reeqonus™.
• Expansion of PRESECO trial into Latin America.
• Secured $3.5 million in funding to support pipeline.

Negative

• Net loss increased to $7.4 million, up from $2.6 million YOY.
• Increase in R&D expenses by $4.5 million compared to last year.

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 first quarter of its fiscal year 2022, which ended on June 30, 2021.

“As COVID-19 cases surge in many parts of the world, the need for safe and effective oral antivirals to contain outbreaks and stay ahead of variants has never been more clear,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “With our PRESECO Phase 3 trial rapidly approaching a top-line read-out and our clinical stage antifungal on track for Phase 2 initiation next year, we are well-positioned to deliver urgently needed medicines for COVID-19 and other life-threatening infections.”

First quarter and recent operational highlights include:

• Completing an interim analysis 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 and receiving a unanimous recommendation from an independent Data Safety and Monitoring Board (“DSMB”) to continue the study without modifications
• Expanding the PRESECO Phase 3 trial to Latin America in June with the addition of several clinical research sites in Mexico and Brazil
• Entering into an agreement in August with the Lind Partners for $3.5 million in funding to support PRESECO and the broader Appili pipeline
• Building out our preclinical data package and working with leading investigators/advisors to set our Phase 2 protocols for our lead anti-fungal clinical trial, scheduled to begin early next year

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. All figures are stated in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss of $7.4 million or $0.12 loss per share for the three months ended June 30, 2021, was $4.8 million higher than the net loss and comprehensive loss of $2.6 million or $0.05 loss per share during the three months ended June 30, 2020. This relates mainly to an increase in research and development expenses by $4.5 million, an increase in business development of $0.23 million, an increase in general and administration expenses by $0.09 million, an increase in accreted interest of $0.02 million, and an increase in income tax expense of $0.02 million. These increases were offset by an increase of government assistance of $0.14 million.

As of June 30, 2021, the Company had cash and short-term investments of $9.33 million, compared to $16.1 million on March 31, 2021. As of August 13, 2021, the Company had 62,832,120 issued and outstanding Common Shares, 6,793,536 stock options, and 14,326,276 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the first quarter of the 2022 fiscal year and the related management discussion and analysis (MD&A), copies of which are available 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™(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 infection. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements”, including with respect to the expected interim data read-out timetable for the PRESECO study, 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 ). 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 product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210813005185/en/

FAQ

What were Appili Therapeutics' Q1 2022 financial results?

Appili reported a net loss of $7.4 million ($0.12 per share) for Q1 2022, an increase from $2.6 million in Q1 2021.

What is the status of the PRESECO trial for Appili Therapeutics?

The PRESECO Phase 3 trial for Avigan®/Reeqonus™ received a recommendation to continue and has expanded into Latin America.

How much funding did Appili Therapeutics secure in August 2021?

Appili secured $3.5 million in funding to support the PRESECO trial and its broader pipeline.