Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults (COMFORTER Trial) - Protocol for a Superiority Double Blind, Randomized Controlled Trial

Dientameba Fragilis (D.fragilis) is a protozoan found in the digestive tract - in the human colon. there are disagreements regarding the preferred treatment for these cases, with several regimens tested in mostly small observational studies. Several drugs are currently recommended for D.fragilis, with metronidazole most commonly used. However, metronidazole therapy for treating dientamoebiasis in children was not associated with better clinical outcomes in a randomized, double-blinded and placebo-controlled clinical trial.
Hence, we aim to perform a double blind, randomized controlled trial, evaluating the clinical and microbiological efficacy of paromomycin versus metronidazole for the treatment of symptomatic adults with PCR positive dientamoeba fragilis.
The primary outcomes would be clinical improvement or resolution. Secondary outcomes include clinical improvement evaluated by a visual analogue scale; microbiological eradication, quality of life, and adverse events related to therapy.
We plan to include 60 patients (30 per arm)

Start Date22 Jan 2024

Sponsor / Collaborator

Sheba Medical Center

RBR-4ypn69

/ Not yet recruitingPhase 3IIT

Open, randomized clinical trial of efficacy and safety of sequential use ofsingle dose of intralesional meglumine antimoniate and topical paromomycin gelcompared to three intralesional applications of meglumine antimoniate in thetreatment of cutaneous leishmaniasis

Start Date01 Feb 2021

Sponsor / Collaborator

Fundação Oswaldo Cruz

NCT03829917

/ CompletedPhase 2/3IIT

Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis

Cure rate for L braziliensis bolivian CL has been 70%-80% for standard systemic and local monotherapies. It would benefit patients if cure rates could be consistently >90%, so testing a combination of two treatments is proposed. The most attractive systemic therapy is the only oral agent, miltefosine during 28 days, and the most attractive local therapy is application of Paromomycin cream for 28 days.

Start Date01 Feb 2019

Sponsor / Collaborator

Alfred Foundation

100 Clinical Results associated with Paromomycin Sulfate

100 Translational Medicine associated with Paromomycin Sulfate

100 Patents (Medical) associated with Paromomycin Sulfate

2,266

Literatures (Medical) associated with Paromomycin Sulfate

01 Apr 2026·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Cinnamoyl aryl hydrazones as potent leishmanicidal agents: design, synthesis, and structure–activity relationships

Article

Author: Gomes, Renan Augusto ; de Souza, Mariana Laureano ; Trossini, Gustavo Henrique Goulart ; Ferreira, Leonardo Luiz Gomes ; Heleno, Rodrigo Alves ; Dos Santos, Cleydson Breno Rodrigues ; Gatti, Fernando Moura ; Ferraz, Witor Ribeiro ; Andricopulo, Adriano Defini

Parasitic diseases like leishmaniasis and Chagas pose significant global health challenges due to limited treatment options and drug resistance. In this study, a series of novel cinnamoyl aryl hydrazone derivatives was synthesized and tested against Leishmania donovani and Trypanosoma cruzi. Four compounds showed promising antileishmanial activity (from 1.27 to 19.53 μM), with two analogues displaying superior potency compared to some current first-line treatments, such as sodium stibogluconate and paromomycin. Computational analyses revealed that activity is driven by specific electronic properties rather than steric factors, while a methyl group consistently reduced potency. The compounds demonstrated favorable predicted ADME properties and were not flagged as aggregators. This research identifies cinnamoyl aryl hydrazones as a promising scaffold for leishmanicidal drug discovery, providing a rational basis for future optimization efforts.

01 Apr 2026·International Journal for Parasitology-Drugs and Drug Resistance

Anti-cryptosporidial efficacy of tricyclic carbazole aminoalcohols in vitro and in vivo

Article

Author: Liu, Mingxiao ; Zhang, Di ; Zheng, Qi ; Wang, Weisi ; Zhu, Guan ; Duan, Liping ; Yin, Jigang ; Wang, Chenchen ; Wang, Dongqiang

Cryptosporidiosis is a major cause of diarrheal disease in humans and animals, yet there are no fully effective drugs, particularly for immunocompromised patients. Carbazole aminoalcohols (CAAs) are a relatively unexplored chemical class with reported broad-spectrum antiparasitic activities. Here, we systematically evaluated 36 CAA derivatives for anti-cryptosporidial efficacy. In vitro screening using a 44-h Cryptosporidium parvum infection assay identified eight compounds with low-micromolar EC₅₀ values (1.53-6.86 μM). The three most potent hits (H1402 at 25 mg/kg/d, and YFM1 and YFM3 at 15 mg/kg/d) were selected for in vivo evaluation in a chronic C. tyzzeri mouse model. Daily oral treatment with these compounds for 7 days reduced fecal oocyst shedding by 55.9-59.1 % compared with a 247.5 % increase in vehicle controls (P < 0.01). Paromomycin at 1000 mg/kg/d, used as a positive control, produced an 84.2 % reduction. All three CAAs were generally well tolerated, with only minor weight loss observed in H1402-treated mice. Together, these results demonstrate that CAAs possess reproducible in vitro activity and significant in vivo efficacy against cryptosporidial infection, supporting their potential as lead scaffolds for anti-cryptosporidial drug development. Structural optimization to improve potency, selectivity, and pharmacokinetic properties is warranted to advance CAAs toward preclinical development.

01 Mar 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Skin pharmacokinetics and pharmacodynamics in patients with post-kala-azar dermal leishmaniasis

Article

Author: Carrillo, Eugenia ; Kumar, Ashish ; Madhukar, Major ; Solana, Jose ; Younis, Brima Musa ; Kumari, Poonam ; Sundar, Shyam ; Musa, Ahmed Mudawi ; Chaubey, Rahul ; Mondal, Dinesh ; Ali, Mujahid Ahmed ; Singh, Abhishek Kumar ; Torres, Ana ; Pandey, Krishna ; Noureldin, Ali ; Singh, Om Prakash ; Roseboom, Ignace C ; Chu, Wan-Yu ; Maruf, Shomik ; Verma, Deepak Kumar ; Kumar, Vinod ; Dorlo, Thomas P C ; Khalil, Eltahir Awad Gasim ; Bernardo, Lorena ; Moreno, Javier ; Chakravarty, Jaya ; Saeed, Mohammed Abdelrahim ; Alves, Fabiana ; Sanchez, Carmen ; Das, Pradeep ; Raja, Sheeraz ; Rode, Joelle ; Topno, Roshan Kamal ; Ahmed, Anas Elbashir ; Rashid, Md Utba ; Ghosh, Prakash

BACKGROUND:

Treatment regimens and clinical outcomes for post-kala-azar dermal leishmaniasis (PKDL) vary across South Asia and Eastern Africa. We evaluated the skin target site pharmacokinetics (PK) of miltefosine, liposomal amphotericin B (LAmB) and paromomycin and associated pharmacodynamics (PD) on skin parasite reduction and lesion healing, to determine PK/PD factors driving regional differences in clinical outcomes.

METHODS:

In South Asia, participants (n = 126) received LAmB alone or with miltefosine. In Eastern Africa, participants (n = 110) received LAmB or paromomycin with miltefosine. Skin drug concentrations were compared to the in vitro EC₅₀ of Leishmania donovani to assess PK target attainment, then correlated with skin parasite load and lesion score to evaluate pharmacokinetic-pharmacodynamic (PK-PD) relationships.

RESULTS:

Antileishmanial drug distribution varied in skin. Miltefosine showed the highest skin-to-plasma ratio, with medians of 1.19 (IQR: 0.78-1.88) in South Asia vs. 1.58 (1.1-2.08) in Eastern Africa (P < 0.05). Combining paromomycin or LAmB with miltefosine improved PK target attainment and reduced variability. In South Asia, macular or mixed (macular and papular/nodular) lesions predominated (93%) and were associated with ≥6-fold higher baseline parasite load and lesion score versus Eastern Africa, where papular and maculopapular lesions were more common (97%). By treatment end, parasite loads dropped ≥99% in both regions, with ≤7% above the transmission threshold. Lesion scores decreased by 11% in South Asia and 93% in Eastern Africa.

CONCLUSIONS:

Similar skin PK target attainment and relative parasite reduction were achieved for all regimens. Regional differences in parasite load and lesion score at baseline and lesion healing rates, suggest disease presentation is the primary factor affecting clinical outcomes.

News (Medical) associated with Paromomycin Sulfate

12 Feb 2026

·www.biospace.com

Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2026

US$82 Million in Pending Proposals Across Multiple Infectious Disease Programs US$40 Million NIAID Funding Award Supports VXV-01 Development Through Phase 1 LIKMEZ® (ATI-1501) Commercial Momentum with Increased U.S. Market Adoption HALIFAX, Nova Scotia, Feb. 12, 2026 (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 third quarter of its fiscal year 2026, which ended on December 31, 2025. All figures are in Canadian dollars unless otherwise stated. “During the past quarter, we made important progress in advancing multiple U.S. federal funding proposals that, if awarded, could meaningfully support our key pipeline and collaborator programs.” said Dr. Don Cilla, President and CEO of Appili. “With the recent award up to US $40 million for VXV-01 and continued access to non-dilutive capital, Appili is steadily strengthening its funding base to drive infectious disease assets forward.” Non-Dilutive Government Funding Model Delivering Results Appili continues to leverage strategic government partnerships to advance its infectious disease and biodefense pipeline. The Company has secured over US$75 million in cumulative government funding since inception and has an additional US$82 million in proposals in active review across multiple programs. Non-dilutive funding sources enable Appili to advance critical development activities, including manufacturing, preclinical studies, regulatory activities, and clinical trial preparation and conduct, while preserving shareholder value. ATI-1801 – Topical Antiparasitic Program with an Aligned Regulatory Path Following positive feedback from the U.S. Food and Drug Administration (“FDA”) on its scientific bridging strategy, ATI-1801, a topical formulation of paromomycin for cutaneous leishmaniasis has a clearly defined registration pathway to support an NDA submission. Appili is actively pursuing non-dilutive funding from global health organizations and government agencies that share the Company’s focus on tropical diseases to execute this strategy and complete the remaining development work. Appili’s ATI-1801 is potentially eligible to receive a Priority Review Voucher (“PRV”) upon FDA approval, which is anticipated as early as the fourth quarter of 2029 subject to securing the requisite funding. Recent PRV transactions have reached US$200 million, representing meaningful non-dilutive value creation LIKMEZ® (ATI-1501), Commercial Momentum Building in U.S. Market Saptalis Pharmaceuticals, Appili’s manufacturing and commercialization partner, continues to commercialize LIKMEZ (metronidazole oral suspension, 500 mg/5 mL), the first and only FDA-approved liquid oral formulation of metronidazole. Since the re-launch in May 2025, LIKMEZ has demonstrated steady sales growth, reflecting strong clinician and patient demand. Under the agreement with Saptalis, Appili is eligible to receive sales-based milestone payments and royalties, providing a growing source of commercial revenue. In April 2025, additional patents protecting LIKMEZ's composition and preparation methods were published in the U.S. and Mexico, with patent protection extending through 2039. ATI-1701 – Biodefense Vaccine Candidate Achieves Key Manufacturing and Scientific Milestones ATI-1701, a live-attenuated vaccine candidate for tularemia, achieved a key operational milestone during the fiscal year with the successful GMP manufacture of drug substance and drug product. The GMP drug product may be formally dispositioned for use in Phase 1 clinical trials. Subject to renewal of certain pending legislation in the U.S., Appili believes that ATI-1701 may be eligible for a PRV, if approved by the FDA. VXV-01 – Advancing Through NIAID-Funded Development Program During the third quarter, Appili was awarded a contract by the U.S. National Institute of Allergy and Infectious Disease (“NIAID”) valued at up to US$40 million to advance VXV-01, Vitalex Biosciences’ (“Vitalex”) first-in-class, dual-antigen vaccine targeting multidrug-resistant Candida species. Appili leads development as the prime contractor, with Vitalex providing asset development and scientific expertise as subcontractor. Under an agreement with Vitalex, Appili retains an exclusive option to acquire worldwide rights to VXV-01. This structure positions Appili to transition from development lead to asset owner with minimal upfront investment risk. VXV-01 is targeted at addressing a critical global health need. Nearly 6.5 million people annually are affected by invasive fungal infections, resulting in approximately 3.8 million deaths. Currently, no fungal vaccines are approved for human use, highlighting the potential for VXV-01 to emerge as a highly promising first-in-class candidate for the prevention of serious fungal diseases. Lender Extensions Pursuant to the terms of such extensions, all amounts owing under the Bloom Burton Loan, together with all accrued and unpaid interest, will be due on March 31, 2026. All amounts owing under the Long Zone Holdings Loan, together with all accrued and unpaid interest, unless Appili completes an equity financing with minimum gross proceeds of at least CAD$450,000 by February 28, 2026, in which case the extension will continue in full force and effect until March 31, 2026. 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 in Canadian dollars unless otherwise stated. For the three months ending December 31, 2025, the Company reported a net and comprehensive loss of $1 million ($0.01 per share), representing an increase of $0.5 million compared to the net loss of $0.5 million ($0.004 per share) for the same period in 2024. The higher loss was mainly driven by a $2.6 million reduction in government assistance, partially offset by a $1.2 million decrease in research and development expenses, $0.2 million decrease in general and administrative expenses and a $0.7 million increase in foreign exchange gains. As of December 31, 2025, the Company’s cash balance was $0.2 million, down from $1.2 million as of March 31, 2025. As of December 31, 2025, the Company had 128,366,120 issued and outstanding Common Shares, 11,910,281 stock options, and 39,048,000 warrants outstanding. This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the second quarter of the 2026 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 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 resistant 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 potential for partnered projects to be developed, the potential that Appili will receive government awards and / or contracts related to its proposal submissions, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701, ATI-1801 and VXV-01, the timing of any milestone and/or royalty payments in respect of ATI-1501, the potential PRV eligibility of ATI-1701 and ATI-1801 and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. (ii) ,. 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 secure any government funding in respect of any proposal submitted prior to the date hereof, (ii) risks relating to the ability of the Company to repay the LZH Loan and the Bloom Burton Loan as and when they become due (including the risk that any waivers the Company may require thereunder will not be provided), and (iii) those risks 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 ). 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

VaccineLicense out/inFinancial Statement

14 Nov 2024

·www.globenewswire.com

Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2025

Overwhelming shareholder support in favour of take-private transaction with Aditxt Studies presented at IDWeek 2024™ demonstrate ATI-1701 provides full protection against lethal tularemia in animal models after one year Alignment with U.S. Food and Drug Administration on development requirements for ATI-1801 NDA Submission HALIFAX, Nova Scotia, Nov. 14, 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 second quarter of its fiscal year 2025, which ended on September 30, 2024. All figures are stated in Canadian dollars unless otherwise stated. “During fiscal year 2025, Appili shareholders voted overwhelmingly in favor of the transaction with Aditxt, facilitating our access to capital and activating promising opportunities for Appili,” said Dr. Don Cilla, President and CEO of Appili. “The shareholder vote is an important milestone for Appili and brings us one step closer to ‘Making Promising Innovations Possible Together’ through Aditxt’s social incubator platform.” 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 previously secured US$14 million in awards from the United States Air Force Academy (“USAFA”). Under the cooperative agreement with USAFA, Appili manages a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025. Recent data presented by Appili's scientific team at the Military Health System Research Symposium and IDWeek 2024™ demonstrated strong efficacy results. Studies showed that a single dose of ATI-1701 provided full protection against lethal tularemia in animal models, with protection for one year after vaccination. Additional research highlighted the heightened risk of tularemia outbreaks in conflict zones and positioned ATI-1701 as a potentially valuable tool in protecting warfighters. Appili has recently had positive interactions with the United States Food and Drug Administration (“FDA”) in the form of a pre-IND meeting, confirming the development pathway for the majority of Appili’s proposed development plan. Appili is currently in the process of implementing suggested changes in its development effort. ATI-1801, Demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies 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. In a recent response to Appili’s Type B meeting request, the FDA agreed with the Company’s proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches. The approach enables Appili to leverage key results from the clinical dossier for ATI-1801 licensed from U.S. Army Medical Materiel Development Activity, including the successful results of a Phase 3 study, and allows the completion of an New Drug Application much sooner than if additional clinical data were required. 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 FDA of LIKMEZ™ (ATI-1501), LIKMEZ® is the first and only FDA-approved liquid formulation of metronidazole providing a novel prescribing option for patients with difficulty swallowing or experiencing taste-related hurdles. LIKMEZ, with patent coverage through 2039, addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. In November 2023, Saptalis, through a commercialization partner, launched LIKMEZ in the U.S. and the product is now available to patients and doctors. Appili earned milestone payments from Saptalis and is entitled to receive additional sales-based milestone payments and royalties from Saptalis based on sale of the product. Saptalis is currently in the process of identifying an alternative commercialization partner. Aditxt Arrangement On November 6, 2024, shareholders of the Company overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. 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”). Approximately 29.50% of the outstanding Appili Shares were voted by shareholders and the Transaction was approved by 99.79% of the votes cast. 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). Appili and Aditxt are in the process of satisfying the remaining closing conditions, which include: (1) the Company obtaining final court approval for the Transaction, and (2) Aditxt securing sufficient financing to complete the Transaction. Subject to satisfaction or waiver of the remaining closing conditions, Appili expects the Transaction to close in December 2024. 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 $0.8 million or $0.01 loss per share for the three months ended September 30, 2024, was $0.2 million lower than the net loss and comprehensive loss of $1 million or $0.01 loss per share during the three months ended September 30, 2023. This relates mainly to an increase in research and development expenses of $1 million, an increase in financing costs of $0.1 million and a decrease in revenue of $0.3 million. This increase was offset by a decrease in general and administrative expenses by $0.1 million, an increase in government assistance of $1.3 million, and an increase of $0.2 million in foreign exchange gain. As of September 30, 2024, the Company had cash of $0.7 million, compared to $0.1 million on March 31, 2024. As of November 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 second 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-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 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 Transaction, the expected timing and process to complete the Transaction, 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 (i) the annual information form of the Company dated June 25, 2024, (ii) the Cicular, and (iii) 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

Clinical ResultDrug ApprovalVaccineOrphan DrugPhase 3

06 Nov 2024

·www.globenewswire.com

Appili Therapeutics Announces Results of Special Meeting of Shareholders

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES HALIFAX, Nova Scotia, Nov. 06, 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 the results from its special meeting of shareholders held earlier today (the “Meeting”). Shareholders of the Company (the “Shareholders”), overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. will acquire all of the issued and outstanding Class A common shares of the Company (the “Appili Shares”) by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”). A total of 35,770,287 Appili Shares were voted at the Meeting, representing approximately 29.50% of the outstanding Appili Shares. The Transaction was approved by (i) 99.79% of the votes cast by Shareholders at the Meeting and (ii) 99.65% of the votes cast by Shareholders at the Meeting (excluding the votes cast by persons whose votes may not be included in determining minority approval of a “business combination” in accordance with Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions). The successful close of this transaction is an important milestone for Appili as it focuses on advancing its pipeline of anti-infective therapies and delivering on its mission to protect patients from severe infectious diseases. “The alignment with Aditxt will facilitate our access to capital and activates promising opportunities for Appili across multiple fronts. Through Aditxt’s social incubator platform, we can amplify our impact and reach in the infectious diseases and medical countermeasure landscape.” said Dr. Don Cilla, President and CEO of Appili. “By leveraging Aditxt’s mission to "Make Promising Innovations Possible Together", we aim to prepare ATI-1701 for IND submission, implement FDA’s agreed upon strategy for ATI-1801, and enhance commercialization for LIKMEZ™ and capitalize on the strategic value of two potential PRV eligible programs.” The Transaction is conditional upon certain customary closing conditions and Aditxt raising at least US$20 million in financing. The Transaction is expected to close in Q4 2024. The Company has filed a report of the voting results on the resolution voted on the Meeting on the Company’s SEDAR+ profile at www.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. 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. Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close. For more information, www.aditxt.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 closing of the Transaction and the timing thereof. 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 conditions precedent of the Transaction. 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 Transaction will be completed. 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. 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 CIRO 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

Vaccine

100 Deals associated with Paromomycin Sulfate

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KEGG	Wiki	ATC	Drug Bank
-	Paromomycin Sulfate	A07AA06	DB01421

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Amebiasis	Japan	Pfizer Japan, Inc.	25 Dec 2012
Cryptosporidiosis	-	-	01 Jan 1959
Giardiasis	-	-	01 Jan 1959

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leishmaniasis, Cutaneous	Phase 3	United States	Appili Therapeutics, Inc.	13 Apr 2022
Acquired Immunodeficiency Syndrome	Clinical	United States	Genetics Institute LLC	31 Aug 2001
Optic Atrophy, Autosomal Dominant	Preclinical	China	Shantou University	30 May 2025
Optic Atrophy, Autosomal Dominant	Preclinical	China	The Chinese University of Hong Kong	30 May 2025
Optic Atrophy, Autosomal Dominant	Preclinical	Hong Kong	The Hong Kong Polytechnic University	30 May 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03399955 (Pubmed)	Phase 2	Post-Kala-azar dermal leishmanioid IFN-γ \| TNF \| IL-1β ... View more	-	paromomycin plus miltefosine	qokrqxwnry(dqvolznnxf) = lbucelmcxi nrtzzikloc (mchoenlqvt )	Positive	15 Jul 2024
				liposomal amphotericin B plus miltefosine	qokrqxwnry(dqvolznnxf) = nwrovpzndl nrtzzikloc (mchoenlqvt )
NCT03399955 (not available, Pubmed \| PLoS Negl Trop Dis)	Phase 2	Post-Kala-azar dermal leishmanioid	110	Paromomycin/Miltefosine	jtbamyqbwq(eqwleysnqp) = zjgrqcpcfk lcozzqjjsh (qdwiwibqgb, 90.3 - 100)	Positive	21 Nov 2023
				Liposomal Amphotericin B/Miltefosine	jtbamyqbwq(eqwleysnqp) = ubtsibkqfe lcozzqjjsh (qdwiwibqgb, 70.2 - 91.9)
NCT03129646 (Pubmed)	Phase 3	Leishmaniasis, Visceral	439	Paromomycin plus Miltefosine	lipxatdodf(rfnuxoftfj) = bmxybpqcsp ekuzvauhnx (pdciltmlrz, -6.2 to 7.4)	Positive	27 Sep 2022
				Sodium Stibogluconate plus Paromomycin	lipxatdodf(rfnuxoftfj) = txnnvpytww ekuzvauhnx (pdciltmlrz, -6.2 to 7.4)
NCT03759886 (Pubmed 1 \| Pubmed 2 \| Int J Colorectal Dis)	Not Applicable	-	120	Intervention group (oral paromomycin and metronidazole)	qqixvpvwvp(yrdnokfntm) = showed a tendency towards decreased frequencies in the intervention group rudbnjzxdc (mpglrkslvb )	-	25 Apr 2021
				paromomycine (Control group (no intervention))
NCT03096457 (Pubmed \| Clin Infect Dis)	Phase 2/3	Leishmaniasis, Cutaneous	80	15% Paromomycin-Aquaphilic	vornobfzcy(hchizmdcrg) = rewzdffsvy osxsuxpafc (nuqsilvwhn, 62.5 - 88)	-	15 Feb 2019
				Aquaphilic vehicle	vornobfzcy(hchizmdcrg) = meymwpewkh osxsuxpafc (nuqsilvwhn, 3 - 30)
NCT01328457 (Pubmed \| PLoS Negl Trop Dis)	Not Applicable	Leishmaniasis, Visceral	120	Paromomycin Intramuscular Injection (PMIM)	qgmplogojr(bvcrczjxmt) = Injection site pain was the most commonly reported adverse event itnbuouufu (znohqxpesl ) View more	Positive	01 Jan 2015
NCT00255567 (Pubmed \| PLoS Negl Trop Dis)	Phase 2	Leishmaniasis, Visceral	42	Paromomycin 20 mg/kg/day for 21 days	lfshtitofc(ghjuhxuaeb) = wwzmwpygum fgdwltgizp (xvirjtszlz, 63.7% - 97.0%)	-	26 Oct 2010
				Paromomycin 15 mg/kg/day for 28 days	lfshtitofc(ghjuhxuaeb) = nsikdixrzp fgdwltgizp (xvirjtszlz, 69.6% - 98.8%)
NCT00629031 (Pubmed \| Clin Infect Dis)	Phase 3	Leishmaniasis, Visceral	329	paromomycin (Group A)	ziimqdsxon(kmsieyujwb) = Mild grade injection site pain was the most common adverse event thxclztzkr (yshnvemznb ) View more	-	15 Sep 2009
				paromomycin (Group B)
NCT00216346 (Pubmed \| N Engl J Med)	Phase 3	Leishmaniasis, Visceral	667	Paromomycin	rckglpreua(jryjonlgkq) = fevers jqpdkawgve (hmpwhbgowc ) View more	Positive	21 Jun 2007
				Amphotericin B

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