Appili Therapeutics and its Partner Vitalex Biosciences Awarded Contract from NIAID Valued at up to US$40 Million to Develop Fungal Vaccine VXV-01

Rhea-AI Summary

Appili Therapeutics (OTC:APLIF) and Vitalex Biosciences have secured a significant US$40 million contract from NIAID to develop VXV-01, a novel fungal vaccine. The contract includes a base period of US$3.6 million for vaccine manufacturing and additional options worth US$36.3 million to support development through Phase 1 trials.

VXV-01 is a dual-antigen vaccine targeting surface antigens of pathogenic fungi, specifically designed to combat invasive fungal infections caused by Candida species. With global fungal infections affecting 6.5 million people annually and causing approximately 3.8 million deaths, this development represents a potential breakthrough as no fungal vaccines are currently approved for human use.

The collaboration leverages Appili's expertise in vaccine development and government contracting alongside Vitalex's research capabilities to advance this promising candidate through IND submission and Phase 1 clinical trials.

Positive

• Secured significant US$40 million NIAID contract for fungal vaccine development
• Initial US$3.6 million base funding secured with potential for US$36.3 million in additional options
• Additional US$97 million in U.S. government funding proposals submitted
• Targeting large market with 6.5 million annual fungal infection cases globally
• Novel dual-antigen approach with potential first-mover advantage in fungal vaccines

Negative

• Development agreement between Appili and Vitalex still pending finalization
• Early-stage development with significant clinical trials ahead
• No approved fungal vaccines exist, indicating potential regulatory challenges

Awarded contract base period of US$3.6 million to fund vaccine manufacturing with additional option periods to advance development through Phase 1 trials

Submitted up to US$97 million in additional U.S. government funding proposals

HALIFAX, Nova Scotia, Oct. 01, 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 its partner Vitalex Biosciences (“Vitalex”) today announced that the National Institute of Allergy and Infectious Diseases (“NIAID”), part of the National Institutes of Health, has awarded up to US$40 million in funding to support the development of VXV-01, a vaccine aimed at protecting against invasive fungal infections.

The five-year contract (number 75N93025C00033) consists of a 22-month base period of performance totalling US$3.6 million, with twelve additional option periods valued at approximately US$36.3 million for a total contract value of approximately US$40 million. Under the terms of the contract, Appili will partner with Vitalex to oversee a comprehensive development program for a Vitalex vaccine, VXV-01 that includes manufacturing, nonclinical studies, clinical and regulatory activities. The NIAID funds are expected to support the development of VXV-01 through Investigational New Drug (“IND”) submission and completion of Phase 1 clinical trials.

“VXV-01 has the potential to significantly reduce serious invasive infections caused by Candida albicans, Candida auris, and other related healthcare-associated infections,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “We are excited to bring Appili’s expertise in vaccine development and government contracting to our collaboration with the Vitalex team who have deep knowledge in this field of research to move their promising vaccine candidate forward.”

“Vitalex’s second generation VXV-01 vaccine shows impressive protection against lethal invasive and mucosal Candida infections,” said Dr. Ashraf S. Ibrahim, Ph.D., Chief Executive Officer of Vitalex. “The vaccine is expected to reduce mortality rates of lethal multidrug Candida infections and reduce occurrence of mucosal Candida infections such as recurrent yeast infections.”

Recent global estimates indicate that invasive fungal infections affect nearly 6.5 million people annually and are associated with approximately 3.8 million deaths, with Candida species being a major cause of these infections. Despite this significant health burden, there are currently no fungal vaccines approved for use in humans. VXV-01 is a novel dual-antigen vaccine designed to target antigens present on the surface of broad-spectrum pathogenic fungi. This innovative approach has the potential to provide robust immunity against these challenging pathogens, representing a major advance in the prevention of serious fungal diseases.

“Invasive Candida infections are life-threatening, and the current standard of care drug treatments are not highly effective,” said Dr Gary Nabors, Ph.D., Chief Development Officer at Appili and Principal Investigator on the contract. “The VXV-01 vaccine has the potential to reduce the suffering and death that is often seen in those vulnerable people who are at risk of acquiring severe Candida fungal infections.”

Vitalex is the current owner of VXV-01, and as a condition to advancing the program, Appili and Vitalex expect to enter into an agreement for the development of VXV-01.

About NIAID Contract

Under the terms of the agreement, Appili will serve as the prime contractor and will manage an array of subcontractors performing technical tasks associated with product development. Appili will be responsible for generating the data necessary to file an IND with FDA which allows for the performance of Phase 1 clinical trials.

Update on U.S. Federal Government Funding Proposals

Not including the awarded NIAID contract described above, Appili has submitted four other funding proposals to the U.S. government representing a combined potential award value of up to US$97 million. If awarded, these funds would support the advanced development of critical infectious disease products aligned with public health and biodefense priorities.

“Having successfully raised US$34.9 million in prior government funds, Appili has built a strong track record in government contracting, and we are well-positioned to execute on innovative programs aligned with public health agencies,” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “Securing additional non-dilutive funding remains key to Appili’s strategy, enabling us to advance high-priority infectious disease products while maximizing shareholder value.”

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 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 resistant infections, a vaccine candidate to prevent tularemia, a serious biological weapon threat, and a topical antiparasitic for the treatment of cutaneous leishmaniasis, a disfiguring disease. Led by a proven management team, Appili is at the center of the global fight against infection. For more information, visit www.AppiliTherapeutics.com

About Vitalex 

Vitalex is a start-up company created to further the development of technologies discovered in the laboratory of its founder, Dr Ashraf S. Ibrahim, a senior investigator at The Lundquist Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center and a Professor at the David Geffen School of Medicine at UCLA. Vitalex has obtained >$10 million in non-dilutive funding from the NIAID to further the development of a dual antigen vaccine that targets hospital-acquired infections caused by multidrug resistant Candida albicans, Candida auris, and Gram-negative bacteria including those caused by Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Vitalex is also developing a humanized monoclonal antibody against the lethal and rare fungal infection, mucormycosis. For more infection, visit https://www.vitalexbiosciences.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. 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, (i) the risk that the Company may not be able to access all of the funding awarded with respect to the development of VXV-01, (ii) the risk that that Company may not secure any government funding in respect of any proposal submitted prior to the date hereof, (iii) risks relating to the Company’s ability to reach agreement and/or secure favourable terms with respect to the partnership with Vitalex regarding the development of VXV-01, and (iv) those listed in the annual information form of the Company dated June 25, 2025, 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

What is the total value of NIAID contract awarded to Appili Therapeutics (APLIF) for VXV-01 development?

The NIAID contract is valued at up to US$40 million, consisting of a US$3.6 million base period and additional options worth US$36.3 million over five years.

What is VXV-01 vaccine designed to treat?

VXV-01 is designed to protect against invasive fungal infections, specifically targeting Candida albicans, Candida auris, and other healthcare-associated infections.

How many people are affected by invasive fungal infections globally?

According to recent global estimates, invasive fungal infections affect approximately 6.5 million people annually, resulting in about 3.8 million deaths.

What stage of development is Appili's VXV-01 vaccine currently in?

VXV-01 is in early development, with the NIAID funding intended to support development through IND submission and Phase 1 clinical trials.

How long is the NIAID contract period for Appili's fungal vaccine development?

The contract spans five years, with an initial 22-month base period and twelve additional option periods.