Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the fiscal year ended March 31, 2022, and provided an update on the Company’s strategy for fiscal 2023. All figures are stated in Canadian dollars unless otherwise stated.
“Over the past several months, we have enhanced our global partnerships and advanced our cutting-edge programs to address some of the most pressing threats in infectious disease and biodefense,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. “As we look ahead to our upcoming year, I look forward to continuing to expand our partnership with the U.S. Department of Defense's Defense Threat Reduction Agency (“DTRA”) for our biodefense vaccine candidate, ATI-1701, and, with the help of our partners, seek regulatory approval later this year for ATI-1501, designed to help patients burdened by difficult-to-treat bacterial infections.”
2022 and recent operational highlights include:
- Announcing commitment of over US$10 million in new funding from DTRA to advance our biodefense vaccine candidate ATI-1701 to help combat the bacteria Francisella tularensis, the causative agent of tularemia and a top priority biothreat.
- Expanding our agreement with Saptalis Pharmaceuticals, LLC (“Saptalis”), a New York-based specialty pharmaceuticals company, to include the European and Latin American markets where Saptalis plans to commercialize ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole.
- Announcing new late-stage clinical program ATI-1801 for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually and may be eligible for a valuable Priority Review Voucher
- Securing a non-convertible loan of US $3.6 million, and a license and distribution agreement with Long Zone Holdings Inc..
- Completing equity financing of $4,500,000
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 $25.1 million or $0.38 loss per share for the year ended March 31, 2022 was $10.8 million higher than the net loss and comprehensive loss of $14.3 million or $0.24 loss per share during the year ended March 31, 2021. This relates mainly to a $10.5 million increase in research and development (R&D) expenses, $0.2 million increase in general and administrative expenses, and $1.5 million increase in financing costs, offset by a $0.2 million increase in government assistance and $1.3 million increase in revenue.
At March 31, 2022, the Company had cash and short-term investments of $6.7 million compared to $16.1 million at March 31, 2021. In May 2022, the Company successfully completed an equity raise of $4.5 million.
As of June 23, 2022, the Company had 121,266,120 issued and outstanding Common Shares, 9,276,490 stock options and 49,817,879 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, 2022 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. The Company is currently advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic product for the treatment of a disfiguring disease, 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.
Forward looking statements
This news release contains “forward-looking statements”, including with respect to funding commitment from DTRA and the Company’s development plans with respect to ATI-1501 and ATI-1701 and potential Priority Review eligibility for ATI-1801. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and 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, 2022, 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.