Appili Therapeutics Announces Submission of U.S. Federal Government Funding Proposals and Provides Corporate and Aditxt Transaction Update

Rhea-AI Summary

Appili Therapeutics (APLIF) has submitted four new federal funding proposals totaling US$117.5 million to advance infectious disease treatments. Two proposals to NIAID seek US$46.3M for fungal infection vaccine development and US$36.4M for antifungal antibody development. Two additional proposals to MCDC request US$34.8M for viral infection treatments.

The company has joined the Medical CBRN Defense Consortium and received modifications to its USAFA Cooperative Agreement, including an increased G&A overhead recovery rate. However, due to budget constraints, no additional funds beyond the US$11.6M already allotted for ATI-1701 are expected, potentially delaying FDA submission.

The company's going-private transaction with Aditxt has been extended to March 31, 2025, with Aditxt providing a US$250,000 waiver payment.

Positive

• Submitted new funding proposals worth US$117.5M for infectious disease treatments
• Joined Medical CBRN Defense Consortium, which has awarded over US$7B in project funding
• Received increased G&A overhead recovery rate for USAFA agreement
• Successfully secured US$33.2M in prior government funding awards

Negative

• No additional funding expected beyond US$11.6M for ATI-1701 program due to budget constraints
• Likely delay in FDA submission for ATI-1701 program
• Going-private transaction completion still uncertain, pending Aditxt securing sufficient financing

Four new funding proposals, totalling US$117.5 million, have been submitted for review
Modifications received to U.S. Air Force Academy Cooperative Agreement
Outside date for going-private transaction extended to March 31, 2025

HALIFAX, Nova Scotia, March 18, 2025 (GLOBE NEWSWIRE) -- 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 that, the Company along with its partners, have submitted applications for four new federal funding opportunities. The funding, if awarded, would total up to US$117.5 million and support the company’s efforts to advance urgent infectious disease treatments aligned with critical public health priorities.

Funding Opportunities

By leveraging Appili’s proven government contracting expertise, the Company and its partner have applied for two solicitations announced by the National Institute of Allergy and Infectious Diseases (“NIAID”). The first proposal seeks US$46.3 million in funding to develop a vaccine aimed at protecting against invasive fungal infections. The second proposal requests US$36.4 million to develop an antifungal monoclonal antibody targeting a rare fungal infection. If awarded, the NIAID funds are expected to support development of both products through to Investigational New Drug (“IND”) applications and Phase 1 clinical studies.

Appili also submitted two proposals to the US Medical CBRN Defense Consortium (“MCDC”) seeking a total of US$34.8 million. The first proposal seeks US$20.1 million to develop a potential broad-spectrum host-directed treatment for viral infections. This project, developed in collaboration with partners, aims to address the critical medical needs for warfighters at high risk of exposure to dangerous viral infections. The second proposal submitted to MCDC, seeks US$14.7 million to develop a broad-spectrum direct-acting antiviral, potentially useful for treating patients infected with RNA viruses such as influenza, coronavirus, West Nile, Zika, and other severely pathogenic viruses. If awarded, the funding is expected to support the advancement of both projects through manufacturing, non-clinical development and regulatory activities necessary to support an IND application.

Medical CBRN Defense Consortium Membership

The Company was recently selected to join the MCDC, further demonstrating Appili’s commitment to U.S. preparedness and biodefense. With the consortium having awarded over US$7 billion in project funding to date, Appili is solidifying its position as a key player in developing cutting-edge medical countermeasures.

Through the consortium, Appili plans to engage government stakeholders, collaborate with industry partners, and pursue funding opportunities that align with the priorities of the U.S. Department of Defense.

US$33.2 million received in non-dilutive funding awards to date

Appili has successfully raised approximately US$33.2 million in prior government funding awards, showcasing its ability to develop compelling research proposals for groundbreaking technologies and form strategic partnerships to compete for government funding. The funds from prior awards helped advance development activities, for pipeline programs including, ATI-1701, a vaccine candidate to eliminate a serious biological weapon threat, and LIKMEZ™ (ATI-1501), an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections.

Update to USAFA Awards

Appili has received an update to its arrangement with the United States Air Force Academy (“USAFA”) for ATI-1701, a biodefense vaccine candidate. Previously, ATI-1701 was awarded a total of approximately US$14 million from USAFA, of which US$11.6 million was allotted to pay for services under the agreement.

In the recent modification to the USAFA Cooperative Agreement, Appili received an increased General & Administrative (G&A) overhead recovery rate. This rate was applied retroactively to the start of the Cooperative Agreement, resulting in an increase to the reimbursement for all past and future invoices. The increase in the allowable G&A overhead recovery rate is a significant benefit to Appili. While the total awarded amount is approximately US$14 million, due to ongoing U.S. Defense Department budget constraints and other factors, the Company does not anticipate additional funds to be allotted beyond the US$11.6 million that has been funded to date for ATI-1701. Without additional funding, Appili does not expect to be in a position to submit an Investigational New Drug Application for ATI-1701 to the U.S. Food and Drug Administration by the end of this year, as originally expected.

Appili has received US$9.7 million in USAFA reimbursements to date, covering labor expenses, subcontractor and vendor costs, as well as other direct and indirect costs for budgeted program activities. The company remains committed to advancing ATI-1701 and will continue to invoice USAFA for program expenses, utilizing the existing funding.

Update on Going-Private Transaction with Aditxt

The Company also wishes to provide an update on its proposed going-private transaction pursuant to which Aditxt Inc. (NASDAQ: ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. (“Adivir”) 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”).

As previously announced, shareholders of the Company overwhelmingly voted in favour of a special resolution approving the Transaction. The Company has also secured all necessary court approvals to affect the Transaction.

Among other customary closing conditions, the Transaction remains subject to Aditxt securing sufficient financing to complete the Transaction. In this regard, on February 28, 2025, Appili granted a waiver to Aditxt to extend the outside for the Transaction to March 31, 2025 in exchange for a payment by Aditxt of US$250,000 (the “Waiver Payment”). The parties have also agreed that, if a termination fee becomes payable to the Company by Aditxt or Adivir at any time, the Waiver Payment would be credited towards any such termination payment.

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

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).

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 potential for partnered projects to be developed, the potential that Appili will receive government awards and / or contracts related to its proposal submissions, the availability of future funding under the USAFA cooperative agreement, the Company’s development plan with respect to ATI-1701 and the expected timing and process to complete the Transaction. 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) 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. 

Media Contact: 

Jenna McNeil, Corporate Affairs and Communications Manager 
Appili Therapeutics 
E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact: 

Don Cilla, Pharm.D. M.B.A. 
Appili Therapeutics 
E: Info@AppiliTherapeutics.com 

FAQ

How much federal funding has Appili Therapeutics (APLIF) applied for in their latest proposals?

Appili Therapeutics has submitted four new federal funding proposals totaling US$117.5 million, split between NIAID (US$82.7M) and MCDC (US$34.8M).

What is the status of Appili Therapeutics' (APLIF) ATI-1701 biodefense vaccine program?

Due to Defense Department budget constraints, no funding beyond the current US$11.6M allocation is expected, likely delaying the FDA Investigational New Drug Application submission.

When is the new deadline for Appili Therapeutics' (APLIF) going-private transaction with Aditxt?

The outside date for the going-private transaction has been extended to March 31, 2025, with Aditxt providing a US$250,000 waiver payment.

How much non-dilutive funding has APLIF secured to date?

Appili Therapeutics has successfully secured approximately US$33.2 million in prior government funding awards.