FDA approves ATI-1501 for Metronidazole Oral Suspension 500mg/5mL and its brand name LIKMEZ™

Appili received an additional funding commitment from the U.S. Air Force Academy for ATI-1701, bringing the total program funding awarded to US$14 million

Appili Therapeutics Appoints Seasoned Biopharma Executive Mr. Prakash Gowd to its Board of Directors

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the second quarter of its fiscal year 2024, which ended on September 30, 2023. All figures are stated in Canadian dollars unless otherwise stated.

"Notably, the Company’s most advanced asset ATI-1501, received U.S. Food and Drug Administration (“FDA”) approval on September 22, 2023, along with its brand name LIKMEZ. The approval of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities, accelerate their development, and unlock value for the benefit of both patients and shareholders, ” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics, "Importantly, ATI-1701 recently received an additional funding commitment from USAFA, bringing the total program funding awarded to US$14 million. At Appili, we are proud of our strong government partnerships which enable us to advance this biodefense program towards an Investigational New Drug (“IND”).”

Operational Highlights

The Company has made significant operational progress during this quarter. The Company received FDA approval for LIKMEZ (ATI-1501) for the treatment of anaerobic bacterial infections on September 22, 2023. Appili expects to receive additional milestone payments and royalties from its partner, Saptalis Pharmaceuticals (“Saptalis”) based on this FDA approval and Saptalis’ commercialization. Saptalis is preparing for commercial launch in late 2023. On October 13, 2023, the Company’s recently issued U.S. patent related to LIKMEZ with coverage through 2039, U.S. Application No. 18/072,154 was listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.

Appili’s development program ATI-1701, for the prevention of F. Tularensis, has received awards totalling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the recently modified agreement with USAFA governing such awards, Appili will be reimbursed for subcontractor and vendor costs necessary to carry out the technical tasks. Additionally, Appili will be reimbursed for direct labour costs associated with budgeted program activities, including a portion of its overhead costs. During our second fiscal quarter, Appili progressed early-stage development activities and regulatory activities. In addition, Appili successfully completed a knowledge transfer and executed a technology transfer for the ATI-1701 drug substance manufacturing process to the Phase 1 Contract Manufacturing Organization (“CMO”).

With respect to Appili’s ATI-1801 program, for the treatment of cutaneous leishmaniasis, the Company plans to request a meeting with the FDA later this year to discuss the previously generated Phase 3 data and agree on the registration package necessary to support a New Drug Application (“NDA”) submission, which the Company expects will include available nonclinical, manufacturing, and clinical data generated to date. Appili expects to pursue non-dilutive funding and partnership opportunities with NGOs and government agencies which share the Company’s focus on tropical diseases to help complete remaining development work.

Upcoming Milestones

• Appili anticipates receiving royalty and milestone payments from its partner Saptalis, based on LIKMEZ NDA approval and commercialization.
• Appili plans to hold a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies.
• Appili expects the ATI-1701 CMO to successfully produce engineering batches.
• Appili plans to request a meeting with the FDA later this year to discuss the previously generated ATI-1801 Phase 3 data and agree on the necessary registration package to support an NDA submission.

Corporate Update

Today the company announced that it has appointed Prakash Gowd, MBA, BSc. Pharm, C.Dir., to its Board of Directors. Mr. Gowd’s career covers a broad range of commercial successes involving corporate development, fundraising, and marketing across multiple business models and therapeutic areas.

“We are very pleased to welcome Prakash to Appili’s Board. His background in corporate finance, product development and strategic planning will be very valuable as we advance our programs through multiple milestones, from ATI-1701’s IND submission, to the FDA interactions for our ATI-1801 asset,” said Dr. Armand Balboni, Chair of the Appili Board. “We are thrilled to have Prakash as a Board member and look forward to his leadership experience as we progress our candidates through these next crucial stages.”

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

The net loss and comprehensive loss of $1.0 million or $0.01 loss per share for the three months ended September 30, 2023, was $0.6 million lower than the net loss and comprehensive loss of $1.6 million or $0.02 loss per share during the three months ended September 30, 2022. This relates mainly to an increase in milestone revenue of $0.3 million, an increase in government assistance of $1.0 million, a decrease in foreign exchange losses of $0.2 million and a decrease in general and administrative expenses of $0.1 million. These decreases were offset by an increase in research and development expenses of $0.8 million and an increase in financing costs of $0.2 million.

As of September 30, 2023, the Company had cash of $0.4 million, compared to $2.5 million on March 31, 2023.

As of November 13, 2023, the Company had 121,266,120 issued and outstanding Common Shares, 7,842,000 stock options, and 44,856,874 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the second quarter of the 2024 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

About Appili Therapeutics

Appili Therapeutics is a biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infectious diseases. 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 an FDA approved ready made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. 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 the funding commitment from USAFA and expected timing of invoice payment, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, , the timing of any milestone and/or royalty payments in respect of ATI-1501, and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. 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 22, 2023, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). 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.

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