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Appili Therapeutics Inc. (APLIF) is a biopharmaceutical leader focused on infectious disease treatments and biodefense solutions. This page provides investors and stakeholders with timely updates on the company’s clinical developments, regulatory milestones, and strategic initiatives.
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Aditxt (NASDAQ: ADTX) announced that Appili Therapeutics (TSX: APLI; OTCPink: APLIF) will hold a special meeting on November 6, 2024, for shareholders to vote on Aditxt's proposed acquisition. Appili's board recommends voting in favor. Appili has raised CAD $100M for developing infectious disease and biodefense therapeutics. Its portfolio includes:
1. LIKMEZ™: FDA-approved liquid antibiotic
2. ATI-1701: Tularemia vaccine with $14M in funding
3. ATI-1801: Topical treatment for cutaneous leishmaniasis
Two programs may be eligible for FDA Priority Review Vouchers. The acquisition aims to expand Aditxt's reach in addressing infectious diseases and public health challenges.
Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) announces its special meeting of shareholders on November 6, 2024, to vote on the acquisition by Aditxt Inc. through its subsidiary Adivir, Inc. The arrangement offers shareholders US$0.467 in cash and 0.000686251 Aditxt shares per Appili share. Appili's board recommends voting in favor of the resolution. The deal aims to accelerate Appili's programs, enhance access to capital, and leverage Aditxt's expertise in development and commercialization.
Key highlights include:
- Advancing LIKMEZ™, an FDA-approved liquid oral reformulation of metronidazole
- Accelerating ATI-1701 development towards IND submission in 2025
- Advancing clinical development of ATI-1801 for cutaneous leishmaniasis
- Exploring additional infectious disease development opportunities
Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF), a biopharmaceutical company focused on infectious diseases and medical countermeasures, held its annual and special meeting of shareholders on September 17, 2024. All tabled resolutions were approved, including the election of six directors: Don Cilla, Brian Bloom, Theresa Matkovits, Juergen Froehlich, Armand Balboni, and Prakash Gowd. The shareholders also approved the re-appointment of PricewaterhouseCoopers, LLP as the independent auditor, and passed special resolutions for the Company's continuation from the Canada Business Corporations Act to the Ontario Business Corporations Act (OBCA). Additionally, shareholders authorized the board to set the number of directors within the limits set in the Company's articles, in accordance with the OBCA.
Aditxt Inc. (NASDAQ: ADTX) has announced a third amendment to its arrangement agreement with Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF). Key changes include:
1. Extending the Outside Date to November 19, 2024
2. Requiring Appili to convene a shareholder meeting promptly
3. Changing the deadline for Aditxt's financing completion to October 18, 2024
4. Making the Continuance a condition for completing the arrangement
The transaction remains subject to Aditxt raising at least $20 million in financing and other customary conditions. Upon completion of the Appili and Evofem Biosciences transactions, Aditxt plans to introduce two new programs focused on public health and women's health, expanding its current immune health and precision health programs.
Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) reported its Q1 FY2025 financial results, ending June 30, 2024. Key highlights include:
1. A definitive agreement with Aditxt, offering a premium to shareholders if approved.
2. ATI-1701 secured $14 million in USAFA funding commitments.
3. FDA engagement for ATI-1801's registration strategy.
4. LIKMEZ™ (ATI-1501) launched in the US market.
5. Net loss of $1.6 million ($0.01 per share), slightly higher than Q1 FY2024.
6. Cash position of $0.3 million as of June 30, 2024.
The company is advancing its infectious disease programs, focusing on ATI-1701, ATI-1801, and LIKMEZ™, aiming to benefit patients and shareholders.
Aditxt (NASDAQ: ADTX) has signed a second amendment to the arrangement agreement with Appili Therapeutics, targeting a September 30, 2024 closing date for the acquisition. The deal involves Aditxt acquiring all issued and outstanding Class A common shares of Appili through a court-approved plan. Key conditions include Aditxt raising at least US$20 million in financing before closing.
Appili has raised over CAD $100 million since 2015 for developing therapeutics in the global infectious disease and biodefense markets. Their portfolio includes LIKMEZ™, an FDA-approved antibiotic suspension, ATI-1701, a tularemia vaccine, and ATI-1801, a topical antiparasitic product. Two programs are potentially eligible for FDA Priority Review Vouchers, subject to legislation renewal.
Appili Therapeutics reported its fiscal year 2024 results, highlighting the FDA approval and commercial launch of LIKMEZ (ATI-1501) for metronidazole oral suspension. The company secured funding from the U.S. Air Force Academy to advance ATI-1701, a biodefense vaccine, and is engaging with regulatory authorities regarding ATI-1801, a topical antiparasitic product.
Financially, Appili experienced a net loss of $3.8 million, an improvement from the $9.2 million loss in the previous year, aided by an increase in government assistance and revenue. The company reported cash reserves of $0.1 million as of March 31, 2024, compared to $2.5 million the prior year, and highlighted a going concern note due to reliance on closing a transaction with Aditxt and other funding.
Appili entered an agreement with Aditxt, where shareholders would receive a combination of cash and stock, contingent on Aditxt raising additional capital. The deal is expected to finalize by Q3 2024.