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BioNxt Solutions Inc. is a bioscience accelerator specializing in next-generation drug formulations, delivery systems, and diagnostic tests for various medical applications. The company has successfully completed toxicity and pharmacokinetic studies for its proprietary Cladribine product aimed at treating Multiple Sclerosis. With a focus on regulatory approval and commercialization in European markets, BioNxt is at the forefront of developing innovative medical products.
Recent achievements include finalizing a settlement agreement with a creditor, advancing to human comparative bioavailability studies, and launching a non-brokered private placement to fund research and development efforts. With a strong emphasis on innovation and collaboration, BioNxt is poised for continued growth and success in the pharmaceutical industry.
BioNxt Solutions Inc. (CSE:BNXT, OTCQB:BNXTF, FSE:BXT) has signed a statement of work (SOW) with a German-based international contract research, development, and manufacturing organization (CRDMO) for its Cladribine oral dissolvable film (ODF) development program. The SOW includes key deliverables such as technology transfer, GMP material production, stability testing, and preparation for EU submission.
BioNxt is developing a proprietary ODF Cladribine dosage form for the multiple sclerosis (MS) market, which has an expected global value of USD 41 billion by 2033. Cladribine tablets are currently approved in over 75 countries, including by the FDA and EMA, with annual sales exceeding USD 1 billion. The company has filed provisional patent applications for its Cladribine ODF, with potential protection extending to 2044.
BioNxt Solutions has signed a master services agreement (MSA) with a German international contract research, development, and manufacturing organization (CRDMO) to advance its pipeline of oral dissolvable (ODF) drug formulations.
The CRDMO, based in Munich, Germany, offers certified services and manufacturing capabilities across five countries. BioNxt aims to leverage this agreement to progress its proprietary ODF Cladribine dosage form for the multiple sclerosis (MS) market.
Cladribine tablets, already approved in over 75 countries, including by the FDA and EMA, have annual sales exceeding $1 billion. BioNxt plans to file additional patent applications for Cladribine ODF by early 2025, potentially extending patent protection to 2044.
This agreement facilitates BioNxt's regulatory, technical, and laboratory needs, setting the stage for a human comparative bioequivalence study.
BioNxt Solutions announced the closure of the second tranche of its non-brokered private placement, issuing 1,000,000 common shares at $0.27 each, raising $270,000.
The overall offering aims to issue a maximum of 6,000,000 shares to gather up to $1,620,000. Net proceeds will fund research, development, commercialization, and general working capital.
The company paid $21,600 in cash finder's fees and issued 80,000 non-transferable Common Share purchase warrants, exercisable at $0.36 per share for 24 months.
Securities issued are subject to a statutory hold period of four months plus a day.