Appili Therapeutics Inc.
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Appili Therapeutics Announces Closing of Second Tranche of Non-Brokered Private Placement
Globenewswire· 2026-02-18 12:19
Core Viewpoint - Appili Therapeutics Inc. has successfully closed the second tranche of a non-brokered private placement, raising gross proceeds of C$100,000 to support its drug development efforts for infectious diseases [1]. Group 1: Private Placement Details - The private placement involved the issuance of 4,000,000 units at a price of C$0.025 per unit, with each unit consisting of one Class A common share and one-half of a common share purchase warrant [2]. - Each whole warrant will allow the holder to acquire one common share at a price of C$0.05 for 36 months, pending shareholder approval [2][3]. - The company will seek shareholder approval for the warrants at the next Annual General Meeting, and if not approved, the warrants will not be exercisable [3]. Group 2: Use of Proceeds - The net proceeds from the private placement will primarily be used for working capital and to fund the development of certain product candidates [4]. Group 3: Broker Warrants - In connection with the closing, the company paid C$8,000 to finders and issued 320,000 broker warrants, which will allow holders to acquire common shares at a price of not less than C$0.02834 for 24 months, also subject to shareholder approval [4][5]. - Similar to the common warrants, the broker warrants will not be exercisable until shareholder approval is obtained [5]. Group 4: Company Overview - Appili Therapeutics is focused on developing therapies for life-threatening infections, with a portfolio that includes an FDA-approved treatment for antimicrobial resistant infections and a vaccine candidate for tularemia [7]. - The company aims to strategically develop a pipeline of novel therapies to address urgent infections with unmet needs [7].
Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2026
Globenewswire· 2026-02-12 23:15
Core Insights - Appili Therapeutics has made significant progress in advancing its infectious disease programs, with a focus on securing government funding to support its pipeline [2][4] - The company reported a net loss of CAD$1 million for the third quarter of fiscal year 2026, reflecting a decrease in government assistance and changes in expenses [14] Funding and Financials - Appili has secured over US$75 million in cumulative government funding and has an additional US$82 million in proposals under review [2] - The company received a US$40 million contract from NIAID to advance the development of VXV-01, a dual-antigen vaccine targeting multidrug-resistant Candida species [9][10] - As of December 31, 2025, Appili's cash balance was CAD$0.2 million, down from CAD$1.2 million as of March 31, 2025 [14] Product Development - ATI-1801, a topical formulation for cutaneous leishmaniasis, has a defined registration pathway following positive FDA feedback [3] - LIKMEZ (ATI-1501) has shown commercial momentum in the U.S. market, with steady sales growth since its re-launch in May 2025 [4][5] - ATI-1701, a vaccine candidate for tularemia, achieved key manufacturing milestones and may be eligible for a Priority Review Voucher upon FDA approval [6][7] Market Potential - VXV-01 addresses a critical global health need, with nearly 6.5 million people affected by invasive fungal infections annually, leading to approximately 3.8 million deaths [11]
Appili Therapeutics Announces Closing of First Tranche of Non-Brokered Private Placement
Globenewswire· 2025-12-18 12:31
Core Viewpoint - Appili Therapeutics Inc. has successfully closed the first tranche of a non-brokered private placement, raising gross proceeds of C$177,500 to support its drug development efforts for infectious diseases and biodefense [1][4]. Group 1: Private Placement Details - The private placement involved the issuance of 7,100,000 units at a price of C$0.025 per unit, with each unit consisting of one common share and one-half of a common share purchase warrant [2]. - Each warrant, subject to shareholder approval, will allow the holder to acquire one common share at a price of C$0.05 for 36 months from the closing date [2][3]. - The company has also paid C$14,200 to finders and issued 568,000 broker warrants, which will allow the purchase of common shares at a price of not less than C$0.02834 for 24 months, also subject to shareholder approval [4][5]. Group 2: Future Plans and Use of Proceeds - The net proceeds from the private placement will primarily be used for working capital and to fund the development of certain product candidates [4]. - A secondary tranche of the private placement is planned to close in December 2025 [6]. Group 3: Company Overview - Appili Therapeutics is focused on developing therapies for life-threatening infections, with a portfolio that includes an FDA-approved treatment for antimicrobial resistant infections and a vaccine candidate for tularemia [7]. - The company aims to strategically develop a pipeline of novel therapies to address urgent infections with unmet needs, positioning itself at the forefront of the global fight against infection [7].
Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2026
Globenewswire· 2025-11-13 22:21
Core Insights - Appili Therapeutics has secured a non-dilutive funding award of up to US$40 million from NIAID for the development of VXV-01, a dual-antigen vaccine targeting multidrug-resistant Candida species, highlighting the company's strategic partnerships and confidence in its execution [2][14] - The company has submitted multiple funding proposals to U.S. government agencies, with a potential combined value of approximately US$90 million, aimed at supporting critical development activities [3] - Appili has successfully re-launched LIKMEZ (ATI-1501) in the U.S. market, leading to increased sales and establishing a growing source of commercial revenue [8][9] Non-Dilutive Government Funding Strategy - Appili has secured over US$66 million in government contracts and grants, demonstrating the effectiveness of its non-dilutive funding model [4] - The company is well-positioned to advance its infectious disease and biodefense products while maintaining financial flexibility through public sector support [4] Product Development Updates - ATI-1801, a topical formulation for treating cutaneous leishmaniasis, is progressing towards NDA submission, with positive FDA feedback on its development strategy [5][6] - ATI-1701, a vaccine candidate for tularemia, has achieved key manufacturing milestones and is advancing towards IND submission with potential eligibility for a Priority Review Voucher [11][13] - The VXV-01 program is designed to address urgent needs in fungal infection prophylaxis, particularly for high-risk groups, and is supported by a significant government contract [15][16] Financial Performance - For the three months ending September 30, 2025, Appili reported a net loss of CAD 1.0 million, an increase from CAD 0.7 million in the same period in 2024, primarily due to reduced government assistance [18] - As of September 30, 2025, the company's cash balance was CAD 0.3 million, down from CAD 1.2 million as of March 31, 2025 [18]
Appili Therapeutics Announces Proposed Non-Brokered Private Placement
Globenewswire· 2025-11-05 12:16
Core Viewpoint - Appili Therapeutics Inc. is conducting a non-brokered private placement to raise up to approximately C$750,000 through the issuance of up to 30,000,000 units at a price of $0.025 per unit [1][3]. Group 1: Private Placement Details - Each unit consists of one Class A common share and one-half of a common share purchase warrant, with the whole warrant allowing the purchase of one common share at C$0.05 for 36 months from the closing date [2]. - The private placement is subject to shareholder approval for the warrants and is expected to close in November 2025 [3][4]. - Finders will receive an 8.0% cash fee on gross proceeds and broker warrants equal to 8.0% of the units issued, with similar approval requirements for the broker warrants [4]. Group 2: Use of Proceeds - The net proceeds from the private placement will primarily be used for working capital and to fund the development of certain product candidates [3]. Group 3: Company Overview - Appili Therapeutics is focused on drug development for infectious diseases and biodefense, aiming to address urgent infections with unmet needs [6]. - The company is advancing a diverse range of anti-infectives, including an FDA-approved treatment for antimicrobial resistant infections and a vaccine candidate for tularemia [6].
Appili Therapeutics to Attend BARDA Innovation Symposium 2025
Globenewswire· 2025-10-22 11:20
Core Insights - Appili Therapeutics is actively participating in the BARDA Innovation Symposium to strengthen partnerships with U.S. federal agencies and advance medical countermeasures for public health emergencies [1][2] - The company has secured a contract worth up to US $40 million from NIAID for the development of the VXV-01 fungal vaccine candidate, highlighting its capabilities in infectious disease and biodefense innovation [2][7] - Appili has submitted multiple funding proposals totaling US $94 million to U.S. federal agencies, aiming to leverage public funding for high-priority anti-infective programs [7] Government Partnerships - Government partnerships are central to Appili's mission and business model, with significant contracts and collaborations enhancing its pipeline [2][3] - The company has secured over US $66 million in government contracts and grants, providing essential non-dilutive capital to accelerate its pipeline progress [7] BARDA and Innovation Symposium - The BARDA Innovation Symposium is a platform for showcasing early-stage health security innovations and fostering collaboration among diverse stakeholders in the medical countermeasures space [5][4] - BARDA, part of the U.S. Department of Health and Human Services, plays a crucial role in funding the development of medical countermeasures against various threats, including pandemics and emerging infectious diseases [4]
Appili Therapeutics and its Partner Vitalex Biosciences Awarded Contract from NIAID Valued at up to US$40 Million to Develop Fungal Vaccine VXV-01
Globenewswire· 2025-10-01 11:17
Core Insights - Appili Therapeutics and Vitalex Biosciences have been awarded a contract worth up to US$40 million by the NIAID to develop the VXV-01 vaccine targeting invasive fungal infections [1][2] - The contract includes a 22-month base period valued at US$3.6 million and additional option periods totaling approximately US$36.3 million [2] - Appili has submitted additional funding proposals to the U.S. government, potentially worth up to US$97 million, to support the development of infectious disease products [6][7] Contract Details - The five-year contract consists of a base period of 22 months and twelve option periods, with a total value of approximately US$40 million [2] - Appili will act as the prime contractor, managing subcontractors for various technical tasks related to the vaccine's development [5] - The funding will support the development of VXV-01 through IND submission and completion of Phase 1 clinical trials [2][5] Vaccine Development - VXV-01 aims to protect against serious invasive infections caused by Candida species, which affect nearly 6.5 million people annually and are linked to approximately 3.8 million deaths [3] - The vaccine is a dual-antigen formulation designed to target antigens on broad-spectrum pathogenic fungi, representing a significant advancement in fungal disease prevention [3] - Current treatments for invasive Candida infections are not highly effective, highlighting the need for a vaccine like VXV-01 [4] Company Background - Appili Therapeutics focuses on developing therapies for life-threatening infections and has a diverse pipeline, including an FDA-approved treatment for antimicrobial-resistant infections [8] - The company has successfully raised US$34.9 million in prior government funding, establishing a strong track record in government contracting [7] - Vitalex, the partner in this project, is a start-up focused on developing technologies for hospital-acquired infections and has received over US$10 million in non-dilutive funding from NIAID [9]
Appili Therapeutics and Colleagues Publish Manuscript Demonstrating Efficacy of ATI-1701 Tularemia Vaccine
GlobeNewswire News Room· 2025-08-06 11:21
Core Viewpoint - Appili Therapeutics has announced a peer-reviewed publication supporting the efficacy of its vaccine candidate ATI-1701 against tularemia, highlighting its robust protection in multiple animal models [1][2][3]. Company Overview - Appili Therapeutics is a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, with a mission to address life-threatening infections [7]. - The company is advancing a diverse range of anti-infectives, including ATI-1701, which is aimed at preventing tularemia, a highly contagious bacterial disease [7]. Vaccine Candidate Details - ATI-1701 is a live attenuated strain of Francisella tularensis, being developed as a first-in-class vaccine for tularemia, which currently has no approved vaccine in major markets [2][5][6]. - The vaccine is considered a top biodefense priority due to the severe illness it can cause and its high infectiousness, being over 1,000 times more infectious than anthrax [6]. Study Findings - The publication details studies showing that ATI-1701 provided 100% survival in rats challenged with aerosolized SCHU S4 up to one year post-vaccination, even at doses exceeding 10,000 times the median lethal dose [8]. - In cynomolgus macaques, the vaccine demonstrated up to 100% protection, reduced disease severity, and improved histopathological outcomes, with robust antibody responses correlating with survival [8]. Development and Partnerships - The study reinforces ATI-1701's potential as a leading candidate for tularemia prevention and supports continued development in partnership with the U.S. Department of Defense [4].
Appili Therapeutics Reports Fiscal Year 2025 Financial and Operational Results
Globenewswire· 2025-06-25 22:04
Core Viewpoint - Appili Therapeutics has successfully re-launched LIKMEZ™ (ATI-1501), a metronidazole oral suspension, and is actively pursuing funding opportunities to support its development programs and enhance its market position [2][3][14]. Group 1: Product Development and Market Position - LIKMEZ™ (ATI-1501) is the first FDA-approved, ready-to-use liquid oral suspension of metronidazole, specifically designed for patients who have difficulty swallowing tablets or are sensitive to taste [3][4]. - The re-launch of LIKMEZ follows new patent coverage extending to 2039, marking a significant milestone for the company and its partner, Saptalis Pharmaceuticals [2]. - Appili is focused on driving continued sales of LIKMEZ while advancing other product candidates, including ATI-1701 and ATI-1801 [3]. Group 2: Funding and Financial Performance - The company has submitted five non-dilutive funding proposals to the U.S. government, with a total potential value of up to US$125 million, aimed at supporting the development of critical infectious disease products [3][14]. - For the fiscal year ended March 31, 2025, Appili reported a net loss of CAD 2.6 million, which is an improvement from a net loss of CAD 3.8 million in the previous year, primarily due to increased government assistance and other income [19][20]. - As of March 31, 2025, the company had cash reserves of CAD 1.2 million, a significant increase from CAD 0.1 million a year earlier, indicating improved liquidity [21]. Group 3: Research and Development Progress - ATI-1701, a biodefense vaccine candidate for tularemia, has received approximately US$11.6 million in funding from the U.S. Air Force Academy and has shown promising results in providing protection against lethal tularemia [5][6]. - The company is actively pursuing additional funding and partnership opportunities for ATI-1801, a topical antiparasitic product that has received Orphan Drug Designation from the FDA [10][13]. - Appili has successfully completed technology transfer for the ATI-1701 manufacturing process, supporting future development activities [8].
Appili Therapeutics Announces Formal Termination of Arrangement Agreement with Aditxt Inc.
Globenewswire· 2025-05-30 11:17
Core Viewpoint - Appili Therapeutics Inc. has formally terminated its arrangement agreement with Aditxt Inc. and is entitled to a termination fee of USD 1,250,000, with USD 1,000,000 remaining payable after adjustments [1][2]. Group 1: Termination of Arrangement Agreement - The termination of the arrangement agreement with Aditxt is effective as of May 30, 2025 [1]. - Appili is entitled to a termination fee of USD 1,250,000, which has been reduced by previous payments made by Aditxt [2]. - The remaining amount of USD 1,000,000 is still payable to Appili [2]. Group 2: Financial Arrangements - In connection with the termination, Appili has secured 3-month extensions on amounts due under its secured loan agreement with Long Zone Holdings Inc. and unsecured promissory notes with Bloom Burton & Co. Inc. [3]. - All amounts owed under these loans, including accrued interest, will be due on August 31, 2025 [3]. Group 3: Company Overview - Appili Therapeutics is focused on developing therapies for infectious diseases and medical countermeasures [4]. - The company aims to address urgent infections with unmet needs and is advancing a diverse range of anti-infectives, including an FDA-approved treatment for antimicrobial-resistant infections [4]. - Appili is led by a proven management team and is positioned at the forefront of the global fight against infections [4].