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July 25, 2024

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BioNxt Solutions (BNXT.C) to spark marketing as ODF human studies begin

Biotech companies are notoriously difficult to find investor love for in Canada, at least historically, so it’s no surprise that BioNxt Solutions (BNXT.C) is headquartered in Germany.

That proximity to German investors is likely to come in handy as the company seeks to start cranking out marketing coverage after several months of prepping their Oral Dissolvable Film (ODF) product for human studies in conjunction with the drug Cladribine.

Cladribine is an existing drug for treatment of Multiple Sclerosis (MS) with longstanding approval for commercial sale, but the existing delivery vehicles for the drug are difficult for MS patients, who often have poor gag reflexes, to swallow.

BioNxt’s oral dissolvable film product removes that barrier, with the idea being that it will make the drug more bioavailable, easier to dose, and have better outcomes with patients.

BioNxt has three drug products in the pipeline, but the ODF is the focus.

Those are:

  • Rotigotine patch (transdermal system for Parkinson’s disease)
  • ODF-based proprietary Cladribine product (for Multiple Sclerosis)
  • Various thin film drug formulation products at early stages

Using our proprietary discovery platform, we peg BioNxt as a company at Level 8: (FDA Approval), from a 10 level system.

Those include:

MILESTONE TIMELINE:
Level 1: Concept and Feasibility – Initial studies on Rotigotine and other formulations.
Level 2: Preclinical Testing – Laboratory testing of drug formulations.
Level 3: IND Application – Submission of Investigational New Drug application for clinical trials.
Level 4: Phase I Clinical Trials – Initial human trials for dosage and safety assessment (this is where Cladribine ODF sits currently).
Level 5: Phase II Clinical Trials – Extended testing for efficacy and side effects.
Level 6: Phase III Clinical Trials – Large-scale trials, confirming effectiveness.
Level 7: NDA Submission – Submission of New Drug Application.
Level 8: FDA Approval – Approval received (this is where Rotigotine sits currently).

Level 9 and 10 involve commercialization, so BioNxt has been to this dance before and knows how to progress through the system.

Let’s look at the tale of the tape:

CLADRIBINE ODF

  • TREATS: Multiple Sclerosis
  • DEVELOPMENT STAGE: Advanced to human comparative bioavailability studies as of 2024.
  • PATENT HELD: Yes, preliminary patent applications filed, with potential protection until 2044.
  • CLINICAL TRIAL PARTNERS: Not specified.
  • LICENSED FROM: Co-developed with European parties.
  • QUARTERLY REVS: Not yet commercialized.

From the company:

On Feb. 7, 2024, Bionxt announced positive animal toxicity study results with no adverse clinical abnormalities or indications of toxicity observed in any participants after consecutive days of dosing. On March 13, 2024, the company announced positive animal PK study results that demonstrated highly comparable rapid absorption and bioequivalence between the company’s ODF (oral dissolvable film) product and the name-brand reference drug for all administered samples. The coming planned human comparative bioequivalence study will be carried out by a European contract research organization in accordance with European Union medical regulatory guidelines.

Hugh Rogers has been the longstanding CEO of this company since back when it first emerged as a cannabis focused bio-play. It’s since evolved several times, picking up IP along the way, which has brought us to today, where the company sits on the precipice of having the ability to replace a drug that is given to as many as 2.3 million people globally.

Getting to that commercialization will take time, but moving from human trials through to extended efficacy and side effects trials is a big deal, and shouldn’t be too hard of an ask considering the effets of cladribine are already well understood.

The company has filed cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.

The company realized $1.5 million in warrant exercises last year, and raised over $2.5 million in financings.

Now they’re beginning marketing, both in North America (including yours truly) and in Germany.

Add it to your watchlist.

— Chris Parry

FULL DISCLOSURE: Client company, as press released on 28/06/24. We own stock in the company and have for several years.

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