Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2021

Rhea-AI Summary

Appili Therapeutics (TSX: APLI; OTCQX: APLIF) released its financial results for Q3 of FY2021, reporting a net loss of $9.34 million, up from $4.13 million in the same period the previous year. Key operational highlights include a collaboration with Dr. Reddy’s Laboratories to advance the COVID-19 antiviral favipiravir, and the initiation of clinical trials for its PRESECO study. As of December 31, 2020, the company had cash and short-term investments of $20.29 million. Appili remains committed to addressing COVID-19 through its antiviral programs.

Positive

• Collaboration with Dr. Reddy’s Laboratories to advance favipiravir for COVID-19 treatment.
• First participant dosed in the Phase 3 PRESECO study for favipiravir.
• Received a 'No Objection Letter' from Health Canada for a new Phase 3 trial evaluating favipiravir.

Negative

• Net loss increased to $9.34 million for the nine months ended December 31, 2020, up from $4.13 million in the prior year 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 third quarter of its fiscal year 2021, which ended December 31, 2020.

Third quarter and recent operational highlights include:

• Signing 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
• Working with partner DRL to support the filing of an application under Health Canada’s interim order for favipiravir oral tablets (REEQONUS in Canada) on behalf of the global consortium
• Dosing the first participant and activating over 50% of the planned sites in the U.S. for its Phase 3 PRESECO study evaluating favipiravir for the early treatment of mild-to-moderate COVID-19 infections.
• Receiving a 'No Objection Letter (NOL)' from Health Canada to initiate the Phase 3 PEPCO study evaluating favipiravir for the prevention of COVID-19 in exposed individuals in the community setting.
• Appointing Don Cilla to the role of Chief Development Officer and veteran healthcare executive Rochelle Stenzler to its Board of Directors.

“With COVID-19 infections soaring across the globe, we believe that a multifaceted approach, including vaccines, oral antivirals, and effective public health strategies are necessary to reduce the spread and the impact of these serious infections,” said Dr. Armand Balboni, Chief Executive Officer of Appili Therapeutics. “We are committed to being part of this solution. Our team has made considerable progress, working with Health Canada, the US FDA, and our clinical and consortium partners to accelerate our favipiravir program. We look forward to continued progress, including an expected interim data readout from our PRESECO study in the coming months, in our mission to address this pandemic.”

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 dollar figures are $CAN unless otherwise noted.

The net loss and comprehensive loss of $9.34 million or $0.16 loss per share for the nine months ended December 30, 2020 was $5.21 million higher than the net loss and comprehensive loss of $4.13 million or $0.13 loss per share during the nine months ended December 30, 2019. This relates mainly to an increase in research and development expenses by $4.38 million, an increase in general and administration expenses by $1.15 million, an increase in accreted interest of $0.05 million. These increases were offset by a decrease of $0.41 million in business development expenses and an increase of government assistance of $0.09 million.

As of December 31, 2020, the Company had cash and short-term investments of $20.29 million, compared to $10.54 million at March 31, 2020. As of February 12, 2021, the Company had 62,578,194 issued and outstanding Common Shares, 4,538,538 stock options and 14,879,919 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for December 31, 2020 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^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 infection. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements”, including with respect to the expected interim data readout 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 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.

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/20210212005534/en/

FAQ

What were Appili Therapeutics' financial results for Q3 FY2021?

Appili reported a net loss of $9.34 million, significantly higher than the $4.13 million loss in Q3 FY2020.

What collaborations has Appili Therapeutics established recently?

Appili announced a collaboration with Dr. Reddy’s Laboratories to advance favipiravir as a COVID-19 treatment.

What is the status of Appili's clinical trials for favipiravir?

As of the latest update, the first participant has been dosed in the Phase 3 PRESECO study evaluating favipiravir.

How much cash does Appili Therapeutics have as of December 31, 2020?

Appili reported cash and short-term investments of $20.29 million as of December 31, 2020.