Paromomycin Sulfate

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 DetailsThe 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 BoardThe 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 ArrangementAditxt’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 MetronidazoleIn 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 SubmissionCollaboration 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 ParomomycinAditxt’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 OpportunitiesAppili 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 AppiliAppili 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 AditxtAditxt, 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 STATEMENTSThis 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 ManagerAppili TherapeuticsE: JMcNeil@AppiliTherapeutics.com Investor Relations Contact: Don Cilla, Pharm.D. M.B.A.Appili TherapeuticsE: Info@AppiliTherapeutics.com

Definitive agreement with Aditxt, if approved by Appili shareholders, provides significant premium to shareholders and resources to advance key programs ATI-1701 funding commitments from U.S. Air Force Academy and interactions with the U.S. Food and Drug Administration, confirming the development pathway through IND submission U.S. Food and Drug Administration meeting request submitted to discuss ATI-1801 registration strategy HALIFAX, Nova Scotia, Aug. 13, 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, today announced its financial and operational results for the first quarter of its fiscal year 2025, which ended on June 30, 2024. All figures are stated in Canadian dollars unless otherwise stated. "In recent months, we’ve achieved significant milestones by engaging regulatory authorities for ATI-1701 and ATI-1801, and together with our partner, Saptalis Pharmaceuticals, we launched our leading asset, LIKMEZ™ (ATI-1501).” said Don Cilla, President and CEO of Appili. “These achievements, together with ATI-1701 U.S. Air Force Academy (“USAFA”) funding commitments, are expected to enable us to execute on our infectious disease programs and advance their development with the aim of bringing them to market for the benefit of both patients and shareholders.” ATI-1701, Biodefense Vaccine Candidate with Strong U.S. Air Force Academy Funding Commitments ATI-1701, a novel live-attenuated vaccine for preventing F. tularensis, has secured US$14 million in awards from the USAFA. Under the USAFA Cooperative Agreement, Appili will manage a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025. Appili has engaged with the U.S. Food and Drug Administration (“FDA”) via a pre-IND meeting, confirming the development pathway for ATI-1701, and is incorporating suggested changes into the development plan. ATI-1801, Topical Antiparasitic Product in Advanced Clinical Development ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally. Appili is currently engaging with the FDA, having submitted a type-B meeting request in 2024 to discuss linking previously generated Phase 3 data and agreeing on the necessary registration package for a New Drug Application submission. Appili aims to pursue non-dilutive funding and partnerships with NGOs and government agencies focused on tropical diseases to complete remaining development work. ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. The company is evaluating ATI-1801’s eligibility for a priority review voucher (PRV), which, if confirmed, would make it the second PRV-eligible program at Appili, alongside ATI-1701, which is potentially eligible for a PRV pending renewal of certain U.S. legislation. LIKMEZ™ (ATI-1501), FDA Approved Liquid Oral Reformulation of the Antibiotic Metronidazole In September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the approval by the United States Food and Drug Administration (“FDA”) of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, addressing the unmet need in both pediatric patients and patients with dysphagia and mitigating risks associated with drug compounding and antimicrobial resistance. LIKMEZ, with patent coverage through 2039, is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. Saptalis launched LIKMEZ in November 2023 and the product is now available to patients and doctors in the United States. Appili has the right to receive sales-based milestone payments and royalties from Saptalis based on sale of the product. Aditxt Arrangement On April 2, 2024, the Company announced that it had entered into a definitive arrangement agreement (the “Arrangement Agreement“) 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 (“Common Shares”) by way of a court-approved plan of arrangement (the “Arrangement”) under the Canada Business Corporations Act. Under the terms of the Arrangement Agreement, shareholders of the Company will receive (i) 0.002745004 of a share of common stock of Aditxt and (ii) US$0.0467 in cash, for each Common Share held at the time of the closing of the proposed Arrangement. For further details regarding the Arrangement, please see Appili’s press release dated April 2, 2024 (the “Arrangement Press Release”). Additional details of the Transaction will be described in the management information circular that will be mailed to the Appili Shareholders (the “Appili Circular”) in connection with a special meeting of the Appili Shareholders (the “Appili Meeting”) currently expected to be held in the fall of 2024 to approve the Transaction. Additional information regarding the terms of the Arrangement Agreement, the background to the Transaction, the rationale for the recommendations made by the Appili board of directors (on the basis of the recommendation of its independent special committee) and how shareholders can participate in and vote at the Appili Meeting will be provided in the Appili Circular. 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 stated in Canadian dollars unless otherwise stated. The net loss and comprehensive loss of $1.6 million or $0.01 loss per share for the three months ended June 30, 2024, was $0.1 million higher than the net loss and comprehensive loss of $1.5 million or $0.01 loss per share during the three months ended June 30, 2023. This relates mainly to an increase in research and development expenses of $0.8 million, an increase in financing costs of $0.8 million and an increase of $0.2 million in foreign exchange loss. These increases were offset by an increase in government assistance of $1.6 million, and a decrease in general and administrative expenses by $0.1 million. As of June 30, 2024, the Company had cash of $0.3 million, compared to $.1 million on March 31, 2024. As of August 13, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 11,520,281 stock options, and 41,356,874 warrants outstanding. This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the first 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 TherapeuticsAppili 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-infective s, 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 statementsThis 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, consideration to be received by shareholders in connection with the proposed Arrangement, the expected timing and process to complete the Arrangement, 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 25, 2024, 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. All statements included in this press release relating to the Arrangement are qualified by reference to the “Forward Looking Statements” section included in the Arrangement Press Release. Media Contact:Jenna McNeil, Communications ManagerAppili Therapeutics E: JMcNeil@AppiliTherapeutics.com Investor Relations Contact:Don Cilla, President and CEOAppili TherapeuticsE: Info@AppiliTherapeutics.com