Paromomycin Sulfate

Assets include the FDA-approved LIKMEZ™, the ATI-1701 tularemia vaccine defense program that has been awarded a USD $14 million non-dilutive award from the DoD, and the ATI-1801 topical formulation MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Aditxt, Inc. (“Aditxt” or the “Company”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, today announced that it has entered into a definitive arrangement agreement ("Arrangement Agreement") to acquire Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (“Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures. Under the Arrangement Agreement, Aditxt’s wholly owned subsidiary, Adivir, Inc. (“Adivir”) agreed to acquire all issued and outstanding Class A common shares of Appili (the “Appili Shares”) through a court-approved plan of arrangement under the Canada Business Corporations Act ("Transaction"). Since its inception in 2015, Appili has developed a diverse portfolio, including the FDA-approved LIKMEZ™ (previously ATI-1501), ATI-1701 biodefense program supported by a USD $14 million non-dilutive award from the U.S DoD., and ATI-1801, a topical formulation targeting cutaneous leishmaniasis, a painful and disfiguring disease. LIKMEZ, FDA-Approved Taste-Masked Oral Suspension for Bacterial Infections Appili developed LIKMEZ, a new formulation of the antibiotic metronidazole, specifically tailored to improve patient experience and adherence, particularly in patients who have difficulty swallowing large tablets. The patent-protected LIKMEZ is a reformulated taste-masking technology containing metronidazole, which makes it easier to swallow and better tasting, increasing patient compliance. The U.S. FDA's approval of LIKMEZ highlighted Appili’s capacity to identify and develop significant opportunities within the infectious disease domain. Appili licensed the manufacturing and commercialization rights in the U.S. and other selected territories to Saptalis Pharmaceuticals, LLC (“Saptalis”). Appili, in collaboration with Saptalis, continued the product's development, ultimately achieving FDA approval in the United States. With FDA approval, future revenue is expected to be derived from milestone payments and royalties from Saptalis under the license agreement. ATI-1701, Live Attenuated Vaccine for Francisella Tularensis Appili is developing ATI-1701 as a live attenuated vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health due to its high rate of infectivity and ability to cause lethal pneumonia and systemic infection. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack. Appili's strategic alignment with governmental and public health priorities has secured non-dilutive funding of USD $14 million from the U.S. DoD for its ATI-1701 biodefense program. This funding has been crucial in advancing the development of ATI-1701, including support for manufacturing, non-clinical studies, and regulatory activities through the submission of an Investigational New Drug (IND) application. ATI-1701 may be eligible for a Priority Review Voucher (PRV) if the U.S. Government extends the Medical Countermeasures PRV program. A PRV enables its recipient to expedite the review process for future drug applications upon issuance. While no assurance can be provided that ATI-1701 will be deemed eligible for a priority review voucher or, what its ultimate worth will be if approved, and recent secondary market transactions involving PRVs have ranged from USD $80 million to USD $100 million, their strategic value extends beyond the secondary market, offering significant advantages in accelerating the development timeline of new treatments. ATI-1801, Topical Formulation for the Treatment of Cutaneous Leishmaniasis (CL) ATI-1801 represents Appili’s innovative approach to combating cutaneous leishmaniasis (CL), a devastating skin infection classified by the World Health Organization (WHO) as a Neglected Tropical Disease (NTD) that impacts hundreds of thousands of individuals globally. This topical product is formulated with paromomycin, a previously approved antibiotic available in oral or injectable form. The topical formulation allows a more direct and comfortable application for patients who suffer from painful CL lesions. Having undergone evaluation in a Phase 3 study, ATI-1801 targets CL infections that manifest through skin lesions and ulcers, leading to potential scarring, disfigurement, and societal stigma. Appili is committed to collaborating with stakeholders worldwide to advance the development of ATI-1801 and to obtain regulatory approvals, ensuring global access to this critical treatment. Additionally, Appili is assessing the potential for ATI-1801 to qualify for a Priority Review Voucher (PRV), a step that could further expedite bringing this essential therapy to those in need. Synergy with Aditxt’s Programs This acquisition will enhance Aditxt’s portfolio of subsidiaries and create synergies with its existing programs, particularly precision diagnostics. Integrating Appili’s expertise and product lines would pave the way for a comprehensive approach to population health, from early detection and prevention to treatment. The potential for collaboration within the Aditxt ecosystem can streamline patient care, from early detection through precision diagnostics to developing tailored treatment strategies. Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, elaborated on the significance of this acquisition, stating, “The acquisition of Appili would represent another step in Aditxt’s journey towards advancing promising innovations in health. Our mission is to accelerate some of the most promising health innovations, like those developed by Appili, to reach their full potential and to have a lasting impact. The urgency for innovative and effective public health solutions is unprecedented. The need to discover and bring new treatments to the market or to enhance existing ones to combat public health challenges has never been more critical. By integrating Appili’s proven expertise and diverse portfolio in the infectious disease and biodefense domain, Aditxt can substantially contribute to advancing public health solutions.” “This transaction with Aditxt aligns with our goals on multiple levels. We see this as an opportunity for growth, innovation, and collaboration. Our shared vision and combined expertise will undoubtedly accelerate our mission to develop innovative treatments and solutions for some of the most challenging health threats facing the world today. Appili can now leverage Aditxt’s proven research and development, operations, and commercialization expertise to accelerate the development of our three programs. Secondly, as a NASDAQ-listed company, we believe Aditxt can facilitate capital access in this challenging economic environment. We welcome this new chapter, confident that together, we will achieve even greater heights in deploying innovative healthcare solutions,” said Dr. Don Cilla, President and CEO of Appili Therapeutics. Transaction Details: The Transaction will be effected through a court-approved plan of arrangement under the Canada Business Corporations Act. Under the terms of the Arrangement Agreement, Adivir will acquire all of the issued and outstanding Appili Shares, with each Appili Shareholder receiving (i) 0.002745004 of a share of common stock (each whole share, an “Aditxt Share”) of Aditxt (the “Share Consideration”) and (ii) US$0.0467 for each Appili Share held (the “Cash Consideration” and together with the Share Consideration collectively, the “Transaction Consideration”) representing total consideration per Appili Share of approximately US$0.0561 based on the closing price of Aditxt stock on March 28, 2024 After giving effect to the Transaction, Appili Shareholders will hold approximately 19.99% of the issued and outstanding Aditxt Shares (on a non-diluted basis) based on the currently issued and outstanding Aditxt Shares (calculated on a non-diluted basis). In connection with the Transaction, each outstanding option and warrant of Appili will be cashed out based on the implied in-the-money value of the Transaction Consideration. In connection with the Transaction Aditxt will: (i) agree to repay no less than 50% in outstanding senior secured debt at the closing of the Transaction (the “Closing”) and to repay the remaining outstanding senior secured debt by no later than December 31, 2024; (ii) acquire all of Appili’s remaining outstanding liabilities and indebtedness; and (iii) agree to satisfy certain payables of Appili at Closing as further detailed in the Arrangement Agreement. The Transaction is subject to the approval of at least two-thirds of the votes cast at the special meeting of the Appili Shareholders, which is expected to be held before the end of calendar Q2 2024 to approve the Transaction. Appili's directors, officers, and certain shareholders holding approximately 11.9% of the total voting power of the issued and outstanding Appili Shares have entered into voting support agreements with the Buyer to vote in favor of the Transaction. The Transaction is conditional upon Aditxt raising at least US$20 million in financing (the “Aditxt Financing”) prior to Closing. In addition, completion of the Transaction is subject to other customary conditions, including the receipt of all necessary court, regulatory and stock exchange approvals. Subject to receiving all required approvals, Closing is expected to occur not later than early Q3 2024. The Arrangement Agreement contains customary terms and conditions, including non-solicitation provisions, which are subject to Appili's right to consider and accept a superior proposal subject to a matching right in favor of Aditxt. The Arrangement Agreement also provides for paying a termination fee of Cdn$1.25 million in certain circumstances. None of the securities to be issued pursuant to the Arrangement Agreement have been or will be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and any securities issued in the Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act and applicable exemptions under state securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities. If the Transaction is completed, the Appili Shares will be delisted from the TSX and the OTCQX and Appili will apply to cease to be a reporting issuer. Advisors Aird & Berlis LLP acted as Canadian legal counsel to Aditxt. Sheppard, Mullin, Richter & Hampton LLP acted as US securities counsel to Aditxt and Nelson Mullins Riley & Scarborough LLP acted as US M&A counsel to Aditxt. Dentons Canada LLP acted as legal counsel to Appili. Bloom Burton & Co. acted as financial advisor to the Appili Board and BDO Canada LLP acted as independent financial advisor to the Appili Special Committee. About Aditxt, Inc. Aditxt, Inc.® (“Aditxt”) (NASDAQ: ADTX) is an innovation platform dedicated to discovering, developing, and deploying promising 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. Aditxt has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing national and population health and impacting public health globally. Pearsanta™, Inc., delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, led by its CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA. For more information see: 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 aims 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 a vaccine candidate to eliminate a severe biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Appili is at the epicenter of the global fight against infection, led by a proven management team. For more information, visit . Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s ability to close the proposed transaction, including but not limited to, the Company’s ability to raise the necessary capital to close the transaction; the ability of both companies to secure all required regulatory, third-party and shareholder approvals for the proposed transaction; the Company’s expectation that shares of its common stock will remain listed on the Nasdaq Stock Market; the anticipated timing to close the transaction; the anticipated financial performances of the Company and Appili both before and after the proposed transaction; the anticipated benefits of the proposed transaction including synergies to Aditxt’s business following the proposed transaction; Appili’s ability to secure PRV vouchers for one or more of its programs; Aditxt’s ability to leverage Appili for subsequent product acquisitions and license agreements subsequent to the transaction; Appili’s ability to secure and maintain requisite regulatory approvals; costs related to the transaction; and changes to the potential market size and the size of the patient populations utilizing LIKMEZ. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the each company’s SEC filings, including Aditxt’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April 17, 2023 as amended April 28, 2023 and July 12, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 14, 2023, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. View source version on businesswire.com: Contacts Media Relations Contact: Mary O’ Brien mobrien@aditxt.com (516) 753-9933 Source: Aditxt, Inc. View this news release online at:

FDA approved LIKMEZ™ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL Additional USAFA funding commitment from the U.S. Air Force Academy, intended to advance the ATI-1701 program toward an IND submission to the FDA Engaging regulatory authorities to align on ATI-1801 development plans HALIFAX, Nova Scotia, Feb. 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 biodefense products, today announced its financial and operational results for the third quarter of its fiscal year 2024, which ended on December 31, 2023. All figures are stated in Canadian dollars unless otherwise stated. In recent months, we've achieved significant milestones by solidifying ATI-1701 government partnerships, engaging regulatory authorities for ATI-1801, and bringing our most advanced innovative asset, LIKMEZ™ (ATI-1501) to market through our partner. Beginning 2024, Appili’s skilled team stands with a clear vision, and committed funding enabling us to execute on our infectious disease program priorities, said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “Additionally, the issuance of the patent claims for ATI-1701, shortly after receiving an additional funding commitment from USAFA, strengthens the programs position in biodefense and the new methods are expected to allow Appili to further develop a valuable vaccine that is urgently needed on the market”. Operational Highlights LIKMEZ™ ATI-1501: FDA Approved Product, In September 2023, Appili announced the FDA approval of LIKMEZ™ (ATI-1501), our proprietary taste-masked liquid suspension reformulation of metronidazole, through our U.S. partner, Saptalis Pharmaceuticals LLC. LIKMEZ 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 commercial sales in the United States are ongoing. 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 earned US$600,000 in milestone payments in fiscal 2024. Appili expects to receive sales-based milestone payments and royalties from Saptalis based on sale of the product. ATI-1701, our Biodefense Vaccine Candidate with Strong Government Support ATI-1701 is a novel, live-attenuated vaccine for the prevention of F. Tularensis, has received awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the USAFA Cooperative Agreement, Appili oversees a comprehensive development program for ATI-1701, which includes nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities to support an IND submission in 2025. Appili was granted a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies and expects to receive feedback in early 2024. ATI-1801, our Licensed 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 January 2024, Appili requested a meeting with the FDA to discuss the previously generated Phase 3 data and agree on the necessary registration package to support a New Drug Application submission, which the Company expects will include available nonclinical, manufacturing, and clinical data generated to date. Annual Financial Results The Company prepares its financial statements in accordance with IFRS 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 $0.2 million or $0.00 loss per share for the three months ended December 31, 2023, was $2.4 million lower than the net loss and comprehensive loss of $2.6 million or $0.02 loss per share during the three months ended December 31, 2022. This relates mainly to an increase in milestone revenue of $0.5 million, an increase in government assistance of $2.0 million and a decrease in general and administrative expenses of $0.9 million. These decreases were offset by an increase in research and development expenses of $0.9 million and an increase in financing costs of $0.2 million. As of December 31, 2023, the Company had cash of $0.6 million, compared to $2.5 million on March 31, 2023. As of February 13, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 7,957,000 stock options, and 44,856,874 warrants outstanding. This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for the third quarter of the 2024 fiscal year and the related MD&A, copies of which are available under the Company’s pro SEDAR+ at . 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 infectious diseases. 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 . 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, 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, 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 22, 2023, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at ). 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, Communications Manager Appili Therapeutics E: JMcNeil@AppiliTherapeutics.com Investor Relations Contact: Don Cilla, President and CEO Appili Therapeutics E: Info@AppiliTherapeutics.com