Appili Therapeutics Announces Mailing of the Management Information Circular in Connection with the Special Meeting of Shareholders

Rhea-AI Summary

Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) announces its special meeting of shareholders on November 6, 2024, to vote on the acquisition by Aditxt Inc. through its subsidiary Adivir, Inc. The arrangement offers shareholders US$0.467 in cash and 0.000686251 Aditxt shares per Appili share. Appili's board recommends voting in favor of the resolution. The deal aims to accelerate Appili's programs, enhance access to capital, and leverage Aditxt's expertise in development and commercialization.

Key highlights include:

• Advancing LIKMEZ™, an FDA-approved liquid oral reformulation of metronidazole
• Accelerating ATI-1701 development towards IND submission in 2025
• Advancing clinical development of ATI-1801 for cutaneous leishmaniasis
• Exploring additional infectious disease development opportunities

The arrangement represents a premium to Appili's recent trading price and provides immediate value to shareholders.

Positive

• Acquisition offer represents a premium to Appili's recent trading price
• Shareholders to receive US$0.467 in cash and 0.000686251 Aditxt shares per Appili share
• Potential to accelerate development of Appili's programs through Aditxt's expertise
• Enhanced access to capital and U.S. non-dilutive funding sources
• FDA approval of LIKMEZ™, a proprietary liquid suspension of metronidazole
• Potential to capitalize on two PRV-eligible programs (ATI-1701 and ATI-1801)
• Existing USAFA $14M award to support ATI-1701 development

Negative

• Shareholders will lose ownership of Appili as an independent company
• Uncertainty regarding the future value of Aditxt shares received as part of the deal

Your vote is important no matter how many votes you hold.
Shareholders who have questions or need assistance with voting their shares should contact info@appilitherapeutics.com

HALIFAX, Nova Scotia, Oct. 10, 2024 (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, announces its special meeting of shareholder date. The notice of the special meeting of shareholders (the "Meeting") and management information circular (the "Circular") will be available on the Company's website at: appilitherapeutics.com/proxy-info/ as well as under Appili’s profile on SEDAR+ www.sedarplus.ca.

Appili’s board of directors recommend that shareholders vote in favour of the resolution pursuant to which Aditxt Inc. (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company (“Appili Shares”) by way of a court-approved plan of arrangement (the “Arrangement”).

Under the terms of the Arrangement, for each Appili Share, shareholders will receive (i) US$ 0.467 in cash and (ii) 0000686251 of a share of Adixt common stock (the “Aditxt Shares”) (representing a value of approximately US$0.00013 per Appili Share based on the closing price of the Aditxt Shares on October 3, 2024 (the date immediately preceding the date of the Circular)). This Amalgamation represents a significant premium to Appili’s recent trading price, and assuming the completion of the transaction, provides shareholders with immediate value. In addition to the diversifying Appili’s shareholders’ investments, the combined enterprise should enhance access to capital and accelerate the development of Appili’s programs.

“Aditxt’s expertise in development operations and commercialization will significantly accelerate the advancement of Appili’s programs, including facilitating access to new U.S. non-dilutive funding sources, preparing ATI-1701 IND submission, and supporting manufacturing activities for ATI-1801. By leveraging Aditxt’s robust capabilities, we aim to work with partners to enhance the commercialization of LIKMEZ™ and capitalize on the strategic value of two potentially PRV eligible programs.” said Don Cilla, President and CEO of Appili. “Together, we are committed to delivering critical solutions to health challenges and accelerate innovation across early detection and healthcare delivery.”

YOUR VOTE IS IMPORTANT. VOTE YOUR SHARES FOR THE ARRANGEMENT AS SOON AS POSSIBLE.

The Company is in the process of mailing the Circular and related materials for the Meeting to Appili’s shareholders. Copies of the notice of the meeting, proxy form and Circular will be available on Appili’s investor relations website at appilitherapeutics.com/proxy-info/.

Shareholder Meeting Details
The Company's Meeting will be held virtually via a live teleconference hosted through the facilities of Chorus Call at 11:00 a.m. (Toronto time), on November 6, 2024 (as more particularly described in the Circular). Shareholders are encouraged to read the Circular and vote their shares as soon as possible. The deadline for voting your shares is 11:00 a.m. (Eastern time) on November 4, 2024.

Appili’s board of directors recommends that shareholders vote FOR the resolution approving the Arrangement (the “Arrangement Resolution”).

Shareholders representing approximately 11.9% of the outstanding Appili Shares have entered into support and voting agreements to vote in favour of the Arrangement Resolution. It has also been communicated to the Company that shareholders holding an additional approximately 17.1% of the outstanding Appili Shares intend to vote in favour of the Arrangement Resolution.

Recommendation of Appili’s Special Committee and Appili’s Board
The special committee of the board of directors of Appili and the board of directors of Appili have recommended that shareholder vote in favour of the Arrangement Resolution.

Aditxt Arrangement
Aditxt’s strategy is anchored in accelerating promising health innovations. With two subsidiaries in immune health and precision diagnostics already established, the proposed acquisitions of Evofem Biosciences, Inc., and Appili seek to further extend Aditxt’s presence into women’s health and public health, supporting its continued expansion.

Support from Aditxt may enable Appili to accelerate clinical and commercial stage innovations and activate the strategic value of potentially PRV eligible products.

LIKMEZ™ (ATI-1501), Expansion of FDA Approved Liquid Oral Reformulation of the Antibiotic Metronidazole
In September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the FDA approval of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ addresses the unmet need in both pediatric patients and elderly patients with dysphagia and mitigating risks associated with drug compounding and antimicrobial resistance.

LIKMEZ, the first FDA-approved ready-made suspension of metronidazole with patent coverage through 2039, is expected to expand accessibility to patients in need.

ATI-1701, Accelerate Development to IND Submission
Collaboration within the Aditxt ecosystem has the potential to facilitate access to new U.S. non dilutive funding sources and accelerate the development of the program.

Existing funding including the Company’s USAFA $14M awards, along with new non-dilutive funding sources facilitated by Aditxt are expected to advance Appili’s ATI-1701 biodefense program toward an Investigational New Drug submission to the U.S. FDA in 2025.

ATI-1801, Advance Clinical Development of Paromomycin
Aditxt’s presence, established in public health and women’s health areas, is expected to accelerate the advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

Appili also expects to capitalize on the strategic value of potentially PRV eligible ATI-1801, which, if confirmed, would make it the second PRV-eligible products at Appili, alongside ATI-1701, pending renewal of certain U.S. legislation.

Additional Infectious Disease Development Opportunities
Appili has partnered with other companies to explore additional infectious disease development opportunities in the fungal disease and viral disease space. By collaborating with these partners, the development programs benefit from prior work on the asset by the partner and leverage Appili’s government contracting expertise to solicit non-dilutive funding to fund the programs infectious disease development. This allows Appili the opportunity to lead in the development of new infectious disease assets. Through these partnerships, Appili can potentially access additional government funding, and potentially gain substantial benefit on commercialization.

About Appili
Appili 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. Appili 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 about Appili Therapeutics Inc., visit www.AppiliTherapeutics.com.

About Aditxt
Aditxt, Inc.® is an innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.

Shareholder Questions 
Shareholders who have any questions or require assistance with voting may contact Appili Therapeutics info@appilitherapeutics.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Forward-looking statements in this news release include, but are not limited to: statements with respect to the anticipated completion of the Arrangement, shareholders voting in favour or the Arrangement Resolution, anticipated effects of the Arrangement on Aditxt, the Company and the combined company’s strategy going forward and statements with respect to the anticipated benefits associated with the acquisition of Appili. Actual results and developments may differ materially from those contemplated by these statements.

Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the Arrangement, anticipated benefits from the Arrangement, and expected growth, results of operations, performance, industry trends and growth opportunities. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect.

Among other things, there can be no assurance that the Arrangement will be completed or that the anticipated benefits from the Arrangement will be achieved.

Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information, including those set out in the Circular. Consequently, readers are cautioned not to place undue reliance on the forward-looking statements and information contained in this press release.

The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither IIROC nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release.

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

When is Appili Therapeutics' special shareholder meeting for the Aditxt acquisition?

Appili Therapeutics' special shareholder meeting for the Aditxt acquisition is scheduled for November 6, 2024, at 11:00 a.m. (Toronto time).

What will Appili Therapeutics (APLIF) shareholders receive in the Aditxt acquisition deal?

Appili Therapeutics (APLIF) shareholders will receive US$0.467 in cash and 0.000686251 Aditxt shares for each Appili share they own.

What is the deadline for Appili Therapeutics shareholders to vote on the Aditxt acquisition?

The deadline for Appili Therapeutics shareholders to vote on the Aditxt acquisition is 11:00 a.m. (Eastern time) on November 4, 2024.

What is LIKMEZ™ and when was it approved by the FDA?

LIKMEZ™ is a proprietary taste-masked liquid suspension formulation of the antibiotic metronidazole. It was approved by the FDA in September 2023.