APLI Appili Therapeutics Inc

Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the third quarter of its fiscal year 2025, which ended on December 31, 2024. All figures are in Canadian dollars unless otherwise stated.

“As we move into 2025, I want to extend my deepest gratitude to our supporters and partners who have stood by us through both challenges and progress,” said Dr. Don Cilla, President and CEO of Appili. “The past year highlighted global concerns surrounding public health and biosecurity, reaffirming the urgent need for infectious disease solutions. With strong government partnerships, promising near-clinical stage programs, and a dedicated team, we are well-positioned to accelerate the development of critical infectious disease treatments.”

“Building on our expanded government partnerships, and the commercial launch of LIKMEZ™, Appili continues to make significant strides in our pipeline programs targeting critical infectious diseases for which effective treatments are currently unavailable,” Dr. Cilla added. “This year, we will continue to outline the vital role these programs play in protecting patients and the value they bring to our stakeholders.”

ATI-1701, our Biodefense Vaccine Candidate with Strong Government Support

Appili’s ATI-1701 development program, focused on the prevention of Francisella tularensis infection, has secured awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). Under this cooperative agreement, Appili is leading a comprehensive development initiative that includes nonclinical studies, manufacturing, clinical preparatory work, and regulatory activities, all supporting an Investigational New Drug (“IND”) submission planned for 2025. To date, Appili has been reimbursed for subcontractor and vendor costs, as well as labor costs for budgeted program activities, totaling US$8.9 million.

In October 2024, Appili presented positive findings at the Military Health System Research Symposium and IDWeek 2024™ demonstrating that a single dose of ATI-1701 provided full protection against lethal tularemia one year after vaccination. These results, combined with research highlighting the elevated risk of tularemia outbreaks in conflict zones, underscore ATI-1701’s potential as a critical tool in protecting military personnel and addressing global biodefense needs.

ATI-1801, our topical antiparasitic product

ATI-1801 is a novel topical formulation of paromomycin (15% w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually.

In October 2024, Appili announced alignment with the U.S. Food and Drug Administration (“FDA”) on ATI-1801 development requirements, providing a clear path towards an NDA submission. In response to Appili’s recent Type B meeting request, the agency agreed with our proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches, enabling Appili to leverage key results from the clinical dossier for ATI-1801, including successful Phase 3 study outcomes.

ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. We are evaluating its eligibility for a priority review voucher (“PRV”), which, if confirmed, would make it the second potentially PRV-eligible program at Appili, alongside ATI-1701.

LIKMEZ™ ATI-1501: FDA Approved Product,

Through Appili’s commercialization partner Saptalis Pharmaceuticals LLC (“Saptalis”), LIKMEZ launched in the U.S., and the product is available to patients. LIKMEZ is the first and only FDA-approved liquid formulation of metronidazole providing a novel prescribing option for patients with difficulty swallowing or experiencing taste-related hurdles.

The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges. LIKMEZ was developed to address these issues.

The FDA approval of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities and develop and monetize them for the benefit of both patients and shareholders. Collaborating with Saptalis, Appili is eligible to receive sales-based milestone payments and royalties based on sale of the product. Saptalis is currently in the process of identifying an alternative commercialization partner.

Shareholder Support and Strategic Transactions

On November 6, 2024, shareholders of the Company overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”).

For further details regarding the Transaction, please see Appili’s press release dated April 2, 2024 and Appili’s management information circular (the “Circular”) dated October 4, 2024, a copy of which is available under Appili’s profile on SEDAR+ (sedarplus.ca).

Among other customary closing conditions, the Transaction remains subject to Aditxt securing sufficient financing to complete the Transaction. In this regard, on January 31, Appili granted a waiver to Aditxt to extend the outside for the Transaction to February 28, 2025 in exchange for a payment by Aditxt of US$250,000 (payable in the month of February 2025).

Subject to satisfaction or waiver of the remaining closing conditions, Appili expects the Transaction to close in the first quarter of calendar 2025.

Looking Ahead

Dr. Cilla added: “It is a tremendous privilege to lead the company towards new stages of growth, and I’m excited to steer Appili towards new milestones. This year holds significant importance, marked by advancing funded ATI-1701 activities to IND submission and engaging regulatory authorities to align on ATI-1801 development plans.”

Financial Results

The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are in Canadian dollars unless otherwise stated.

The net loss and comprehensive loss for the three months ended December 31, 2024, totaled $0.5 million ($0.00 loss per share), reflecting a $0.4 million increase compared to the $0.1 million net loss ($0.00 loss per share) reported for the same period in 2023. This increase was primarily due to a $0.08 million rise in financing costs, a $0.6 million increase in foreign exchange losses, and a $0.4 million decrease in revenue. However, these factors were partially offset by a $0.1 million reduction in general and administrative expenses, a $0.5 million increase in government assistance, and a $0.05 million decrease in both business development and research and development expenses. As of December 31, 2024, the Company had cash of $0.2 million, compared to $0.09 million on March 31, 2024.

As of February 14, 2025, the Company had 121,266,120 issued and outstanding Common Shares, 10,910,281 stock options, and 37,139,874 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the third quarter of the 2025 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 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 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, advancing program towards IND, 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, the expected timing and process to complete the Transaction, 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 (i) the annual information form of the Company dated June 25, 2024, (ii) the Circular, and (iii) 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.

All statements included in this press release relating to the Transaction are qualified by reference to the “Forward Looking Statements” section included in Appili’s press release issued on April 2, 2024 announcing the Transaction.

Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: Info@AppiliTherapeutics.com