BioNxt Solutions Inc. Secures European Patent “Intention to Grant” for Novel Sublingual Cladribine Formulation

On 4 November 2025, BioNxt Solutions Inc. (CSE:BNXT, OTCQB:BNXTF, FSE:BXT) announced that its wholly‑owned German subsidiary, Vektor Pharma TF GmbH, has received an “Intention to Grant” notification from the European Patent Office (EPO) for European patent application no. 23 729 446.7. The application covers a sublingual, orally dispersible thin‑film formulation of cladribine designed to treat multiple sclerosis (MS) and related neurodegenerative disorders.

Why the Patent Matters

  • Patient‑friendly delivery: The sublingual thin‑film allows rapid transmucosal absorption of cladribine, potentially improving adherence in a therapeutic area that is increasingly moving toward convenient, non‑injection routes.
  • Large addressable market: The EPO decision opens protection across up to 54 jurisdictions, covering an estimated nearly 1 billion people in Europe, Eurasia, and associated validation states.
  • Competitive positioning: By securing a patent for a unique cladribine‑cyclodextrin complex, BioNxt gains a defensive moat against generic competitors and positions itself as a first‑mover in a niche that is attracting substantial investor interest.

The EPO’s “Intention to Grant” is a significant milestone. It signals that the examiner views the application as having a strong chance of eventual approval, and it allows BioNxt to proceed with strategic planning for commercialization, licensing, and potential collaborations.

Market Context

The MS market is witnessing a shift toward patient‑friendly therapies. Traditional disease‑modifying treatments often require injections or infusions, which can be burdensome for patients. Oral or sublingual options are increasingly preferred, and regulatory bodies are encouraging innovative delivery systems that enhance adherence and reduce healthcare costs. BioNxt’s sublingual cladribine thin‑film fits squarely within this trend, offering a potentially simpler, faster‑acting alternative to existing oral regimens.

Financial Snapshot

  • Close price (2025‑11‑02): 0.83 CAD
  • 52‑week high (2025‑08‑06): 1.10 CAD
  • 52‑week low (2024‑11‑19): 0.22 CAD
  • Market cap: 98.35 million CAD
  • P/E ratio: –19.16 (negative earnings reflect ongoing R&D investments)

While the company’s valuation remains modest and its earnings have yet to turn positive, the patent notification may act as a catalyst for future revenue streams and could justify a reassessment of the company’s valuation multiples.

Short‑Interest Surge and Investor Sentiment

On 3 November 2025, a separate report from aktien‑global.de highlighted a dramatic increase in short interest for BioNxt shares. The short‑selling volume rose 77.5 %, from 8 000 to 14 200 shares, indicating that a growing number of investors were betting on further price declines. This surge coincided with the market’s reaction to the patent news, which created a polarizing environment: some traders viewed the “Intention to Grant” as a long‑term growth driver, while others remained skeptical of the company’s ability to translate the patent into commercial success.

The short‑interest spike underscores the volatility that biotech firms often face when announcing intellectual‑property milestones. Investors must weigh the potential upside of a groundbreaking delivery platform against the risk that regulatory or commercial hurdles may delay or dilute the expected benefits.

Broader Industry Coverage

Additional coverage from finanznachrichten.de and ceo.ca reiterated the significance of the patent announcement, emphasizing the alignment of BioNxt’s technology with the evolving MS treatment landscape. Commentary on the company’s innovative approach highlighted its focus on natural compounds derived from plants, fungi, and bacteria—an area that has earned BioNxt several awards and recognitions.

Outlook

  • Short term: The market will likely monitor the progress of the EPO’s examination process and any updates from the U.S. and other key jurisdictions. The company’s stock may continue to exhibit volatility as short sellers and long‑term investors reassess risk and reward.
  • Long term: If the patent is ultimately granted and the sublingual thin‑film reaches clinical development, BioNxt could secure a first‑mover advantage in a patient‑centric MS market segment. Success in clinical trials, regulatory approvals, and eventual commercialization would be required to translate the intellectual‑property advantage into sustainable revenue.

In summary, BioNxt’s receipt of an “Intention to Grant” from the EPO marks a pivotal step in its pursuit of a novel cladribine delivery platform. While the announcement injects fresh optimism into a company that has struggled with shareholder sentiment, it also accentuates the inherent uncertainties of bringing an innovative therapy from the laboratory to the clinic.