BioNxt Signs Letter Agreement to Acquire 100% Interest in IP and to Codevelop a Sublingual Drug Formulation for Chemotherapy and Immunosuppressant Treatments

Rhea-AI Summary

BioNxt Solutions (OTCQB:BNXTF) signed a letter agreement with a European chemotherapy company to acquire 100% of IP rights to a novel sublingual high‑potency formulation for oncology and immunosuppressant uses.

Under the agreement the Codeveloper will receive a 20% royalty on license fees, capped at USD 50,000,000 aggregate. The parties plan prototype development, IP filings, preclinical and clinical studies, and regulatory filings, and aim to execute a definitive IP and collaboration agreement within 60 days. BioNxt expects to file provisional patents for the product by year‑end, positioning the program alongside its cladribine sublingual thin‑film lead program.

The release cites a market estimate: the global immunosuppressant market reaching USD 61.05 billion in 2025.

Positive

• Assignment of 100% IP rights to BioNxt
• Royalty structure: 20% of license fees, capped at USD 50,000,000
• Target to sign definitive agreement within 60 days
• Planned provisional patent filings by year‑end

Negative

• Agreement currently a letter agreement, not a binding definitive deal
• Royalty cap of USD 50,000,000 may limit long‑term revenue upside
• Project requires preclinical and clinical studies before commercialization

News Market Reaction

+4.34%

1 alert

+4.34% News Effect

On the day this news was published, BNXTF gained 4.34%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

IP interest: 100% interest Royalty rate: 20% royalty Royalty cap: USD 50,000,000 +5 more

8 metrics

IP interest 100% interest Exclusive intellectual property rights under letter agreement

Royalty rate 20% royalty Royalty on license fees payable to Codeveloper

Royalty cap USD 50,000,000 Aggregate cap on royalty payments to Codeveloper

Agreement timeline 60 days Target to sign definitive IP and Collaboration agreement

Immunosuppressant market USD 61.05 billion Estimated global market size in 2025

Share price 0.4886 Price before this acquisition news

Daily price change 2.56% 24h move heading into the announcement

Trading volume 2,300 vs 7,133 Today’s volume vs 20-day average

Market Reality Check

Price: $0.4672 Vol: Volume 2,300 vs 20-day av...

low vol

$0.4672 Last Close

Volume Volume 2,300 vs 20-day average 7,133, indicating relatively quiet trading ahead of this news. low

Technical Price 0.4886 is trading above the 200-day MA at 0.41 going into the announcement.

Peers on Argus

Peers in Healthcare/Drug Manufacturers show mixed moves (e.g., one up 30.95%, an...

Peers in Healthcare/Drug Manufacturers show mixed moves (e.g., one up 30.95%, another down 1.82%) with no clear, unified sector trend matching BNXTF.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Product development update	Positive	+1.6%	Advanced cladribine oral dissolvable film targeting MS patients with dysphagia.
Dec 01	IP acquisition agreement	Positive	+4.3%	Signed letter to acquire 100% IP and codevelop sublingual oncology/immunosuppressant drug.
Nov 20	Patent grant	Positive	+9.6%	Final Eurasian patent grant for sublingual cladribine and anticancer delivery platform.
Nov 04	Patent progress Europe	Positive	-4.0%	European Patent Office Intention to Grant for sublingual cladribine thin-film.
Oct 30	Patent notice Eurasia	Positive	+2.9%	Readiness to Grant notice from Eurasian Patent Organization for anticancer sublingual patent family.

Pattern Detected

Recent IP and development updates have mostly seen positive price alignment, with one notable divergence on a patent progress release.

Recent Company History

Over the last few months, BioNxt has focused on strengthening its sublingual cladribine platform and broader IP estate. Patent steps in Eurasia and Europe and bioequivalence study plans supported generally positive price reactions to news on Oct 30, Nov 20, and . The current IP acquisition and co-development letter for a sublingual chemotherapy/immunosuppressant product, first disclosed on Dec 01, fits this pattern of expanding its drug-delivery pipeline and global market reach.

Market Pulse Summary

This announcement expands BioNxt’s pipeline by securing a letter agreement for 100% IP interest in a...

Analysis

This announcement expands BioNxt’s pipeline by securing a letter agreement for 100% IP interest in a sublingual chemotherapy and immunosuppressant formulation, alongside its lead cladribine thin-film program. The Codeveloper’s 20% royalty, capped at USD 50,000,000, ties economics to future licensing. Investors may track progress toward a definitive agreement within 60 days, planned provisional patent filings by year-end, and how the program positions BioNxt within the projected USD 61.05 billion immunosuppressant market.

Key Terms

sublingual, immunosuppressant, preclinical, clinical studies, +1 more

5 terms

sublingual medical

"a novel sublingual drug formulation using a high-potency active pharmaceutical..."

Sublingual describes a way to take a drug or supplement by placing it under the tongue so active ingredients are absorbed through the thin tissue there directly into the bloodstream. Like taking a shortcut compared with swallowing a pill, this can produce faster effects, simpler dosing and sometimes more predictable delivery. Investors watch for sublingual formulations because they can affect a product’s market appeal, regulatory pathway, pricing and competitive positioning.

immunosuppressant medical

"for oncology and immunosuppressant treatments.BioNxt and the Codeveloper will..."

An immunosuppressant is a medicine that reduces the activity of the body's immune system so it won't attack transplanted organs or itself in autoimmune diseases. Investors pay attention because these drugs can generate substantial sales but also carry clear safety and regulatory risks (like higher infection rates and long-term side effects); like a thermostat that turns down a furnace, they must be carefully balanced, which affects clinical development, pricing, and a company’s financial outlook.

preclinical medical

"including prototype development, IP filings, preclinical and clinical studies..."

Preclinical describes the stage of drug or medical-product development when researchers test a candidate in the lab and in animals to see if it is safe, reaches intended targets, and shows basic effectiveness before any human trials begin. For investors, preclinical status signals an early, higher‑risk opportunity where positive lab results can increase value but significant work, time, and regulatory hurdles remain — like proofing a prototype in a workshop before road testing.

clinical studies medical

"IP filings, preclinical and clinical studies, and regulatory filings..."

Clinical studies are structured tests carried out with human volunteers to evaluate whether a medical treatment, drug or device is safe and effective. Investors watch their design and results the way a buyer watches product testing: clear positive results can unlock approvals, sales and higher company value, while failures or safety concerns can halt progress and sharply reduce expected returns.

regulatory filings regulatory

"preclinical and clinical studies, and regulatory filings. 100% of intellectual..."

Regulatory filings are official documents a company must submit to government or securities agencies to report its financial results, major business developments, governance practices, and legal or compliance matters. They matter to investors because they provide verified, timely information—like a vehicle inspection report—that reveals a company’s health, risks and changes that can affect stock value, helping investors make informed decisions and compare companies on a level playing field.

AI-generated analysis. Not financial advice.

VANCOUVER, BC / ACCESS Newswire / December 1, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce it has signed a letter agreement with a European-based chemotherapy company (the "Codeveloper") for the exclusive intellectual property rights to a novel sublingual drug formulation using a high-potency active pharmaceutical ingredient for oncology and immunosuppressant treatments.

BioNxt and the Codeveloper will work together to plan and manage the project, including prototype development, IP filings, preclinical and clinical studies, and regulatory filings. 100% of intellectual property rights will be assigned to BioNxt and the Codeveloper will receive a 20% royalty on license fees paid to BioNxt from third-party licensees, capped at USD 50,000,000 in aggregate royalty payments. BioNxt and the Codeveloper are working toward a definitive IP and Collaboration agreement to be signed in the next 60 days.

"This chemotherapy and immunosuppressant product opportunity is an excellent complement to our lead development program, which is a sublingual thin-film formulation of cladribine for multiple sclerosis," said Hugh Rogers, CEO of BioNxt Solutions. "We expect to file provisional patents for our new sublingual product by year-end, which will expand our growing intellectual property portfolio and product pipeline."

The immunosuppressant market is growing rapidly due to a surge in organ transplants and autoimmune disorders. Statista estimates that the global market for immunosuppressants will reach USD 61.05 billion in 2025.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next‐generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin‐Film), Transdermal (Skin Patch), and Oral (Enteric‐Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.

With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient‐centric solutions that enhance treatment outcomes worldwide.

BioNxt is listed on the Canadian Securities Exchange:BNXT, OTC Markets:BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact

Hugh Rogers, Co‐Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt‐solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward‐Looking" Information

This news release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Forward-looking information in this news release includes the anticipated filing date of the Annual Filings. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

FAQ

What did BioNxt (BNXTF) agree to acquire on December 1, 2025?

BioNxt agreed to acquire 100% of IP rights to a novel sublingual high‑potency formulation for chemotherapy and immunosuppressant treatments.

How is the Codeveloper compensated in the BioNxt (BNXTF) agreement?

The Codeveloper will receive a 20% royalty on license fees paid to BioNxt, capped at USD 50,000,000 in aggregate.

What timeline did BioNxt (BNXTF) provide for finalizing the collaboration?

BioNxt and the Codeveloper are working toward a definitive IP and collaboration agreement to be signed within 60 days.

Will BioNxt (BNXTF) file patents for the new sublingual product?

Yes; BioNxt expects to file provisional patents by year‑end for the new sublingual product.

What development steps will BioNxt (BNXTF) and the Codeveloper undertake?

They plan to manage prototype development, IP filings, preclinical and clinical studies, and regulatory filings.

How large is the cited immunosuppressant market referenced in the announcement?

The announcement cites an estimate that the global immunosuppressant market will reach USD 61.05 billion in 2025.