NurExone Biologic: Double the speed to success?!

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To test ExoPTEN in human clinical trials (with the goal of preventing paraplegia after acute spinal cord injuries), NurExone does not need to purchase exosomes (from bone marrow stem cells).

...but NurExone Biologic Inc.* can produce them itself, using its own stem cell master bank. In this area, they have apparently developed their own process that appears to be more than twice as fast as the current method!

- Please be sure to read the complete ad hoc announcements and regulatory filings, as well as the existing conflicts of interest and disclaimer further down in the text. - Advertorial/Advertising (Client: NurExone Biologic Inc.) -

ExoPTEN from NurExone Biologic Inc.* (WKN: A3DNSU ) is being developed as an exosome-based therapy for serious neurological indications, including acute spinal cord injuries, optic nerve damage, facial nerve injuries, and other conditions. The company plans to initiate a first-in-human clinical trial in 2026 and is expanding its exosome production capabilities to support the development of these regenerative therapies. So, does NurExone Biologic Inc.* (WKN: A3DNSU ) really have the billion-dollar formula up its sleeve?!

Recent studies using the ExoPTEN active ingredient have shown unprecedented success in the restoration of damaged nerves in cases of acute spinal cord injuries (paraplegia), crushed tendon veins ("cataract"), or even damaged facial nerves (Ramsey-Hunt syndrome), in animal models!

The impression that ExoPTEN could be the future "all-purpose weapon" against many types of nerve damage is becoming increasingly apparent - a potential multi-billion dollar market!

Clinical trials in human models

In 2026, the company aims to replicate the incredible successes from the preclinical studies in the human field:

The planned study will enroll adult patients with traumatic spinal cord injuries who will be treated within 3 to 7 days of the injury.

• Phase 1 will be a dosing study to evaluate safety in up to 18 patients
• Phase 2a is a randomized, double-blind, placebo-controlled study to measure functional recovery in 10-15 patients.

And what is almost unbelievable about this already exciting situation is the fact that NurExone Biologic Inc.* (WKN: A3DNSU ) can produce the required exsosomes (derived from mesenchymal stem cells) itself by purchasing a stem cell bank - and it seems that they can do it far more effectively than others by developing a new manufacturing process that is apparently more than twice as fast as the status quo:

NurExone Strengthens Path to Clinic for ExoPTEN with New Manufacturing Process Validation

NurExone Biologic Inc.* (WKN: A3DNSU ) is pleased to announce that it presented new manufacturing process data at the 4th Annual Meeting of the Israel Society for Extracellular Vesicle Research ("ISEVR"), a cutting-edge exosome research conference, on May 22, 2025.

The Company presented promising initial data on the viability and efficacy of cells from its proprietary Master Cell Bank ("MCB"). The MCB represents a valuable and important strategic asset for the further development of GMP-compliant exosome manufacturing for the Company's lead therapeutic candidate, ExoPTEN, as well as for its subsidiary, Exo-Top Inc.

"The results indicate high economic potential and suggest that the MCB can support a larger number of production batches, thus maximizing its value and benefits."

In addition to confirming the robust growth behavior of mesenchymal stem cells ("MSCs"), the cells exhibit a population doubling time (PDT) of 20.4 ± 1.56 hours for up to 9 passages.

Cell doubling time (PDT), which refers to the time it takes for the number of cells to double, is used to study cell growth dynamics and serves as a measure for assessing the proliferative capacity of MSCs (Sci Rep. 2021;11(1):3403). The shorter the population doubling time, the greater the proliferative capacity of the cells.

NurExone intends to transfer the manufacturing process to its wholly-owned US subsidiary, Exo-Top, which will be responsible for establishing a GMP-compliant, MSC-driven exosome production facility to support both clinical trials and future commercial supply.

News conclusion:

The population doubling time (PDT) of mesenchymal stem cells derived from bone marrow stem cells is usually around 50 hours - the reactor from NurExone Biologic Inc.* (WKN: A3DNSU ) achieves it in just 20 hours.

source

This means that the ability or potential of cells to proliferate or divide is more than twice as high as normal. This metric is particularly important because these results underscore the significant economic potential and also demonstrate that MCB enables a larger number of production batches, thus maximizing both its value and utility.

Since these MCB-derived cells form the essential biological basis for exosome production, maintaining high cell quality is critical for consistent, scalable, and reliable therapeutic production. These initial production data indicate that these proprietary cells will contribute to building a strong US manufacturing infrastructure to advance NurExone's clinical programs. This could also position the new US subsidiary, Exo-Top, as a leading provider of clinical-grade exosome production and supply.

In short: The technology for producing exosomes will not only provide its own research with high-quality material – NurExone Biologic Inc.* (WKN: A3DNSU ) also intends to subsequently meet the exosome demand of third parties! This should be a lucrative venture due to the apparently superior technology (more than twice as fast).

NurExone Biologic Inc.* ISIN: CA67059R1091 , WKN: A3DNSU , TSXV: NRX , Valor: 119876063

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NurExone Biologic Inc.* (WKN: A3DNSU ) is a TSX-V-listed pharmaceutical company developing a biologically guided exotherapy platform using exosomes as a next-generation drug delivery system. The company's first product, ExoPTEN, targets neuronal regeneration and recovery in patients who have suffered an acute spinal cord injury.

Notably, ExoPTEN has received orphan drug designation from the Food and Drug Administration, underscoring its potential importance for these patients. The company holds an exclusive worldwide license from the Technion and Tel Aviv University for the development and commercialization of the technology.

The Eureka Commission seems equally enthusiastic:

Eureka was launched in 1985 as an agreement between 18 countries and the European Commission to promote competitiveness and market integration and support cooperation in research and development. Since then, Eureka has expanded to include 47 countries, supporting organizations with national funding.

Source: Börse-Express

Developing future medicines with exsosomes

Exosomes, the technology used by NurExone Biologic Inc.* (WKN: A3DNSU ), are particles that are produced, among other things, during the proliferation of stem cells. A remarkable property of exosomes is their ability to stimulate the body's own regenerative processes after injuries or during acute phases of disease. For example, exosomes from mesenchymal stem cells have been found to activate several processes important for the repair of bone fractures and wound healing. These exosomes are also involved in the regulation of immune-mediated reactions and anti-inflammatory processes. Exosome research is considered the holy grail for numerous diseases, and therefore significant capital is being invested:

• Roche ( SIX: ROG ) invests USD 36 million in Puretech ( NASDAQ: PRTC ) – up to USD 1 billion in milestone payments and royalties
• Takeda ( TOKYO: 4502 ) will pay USD 44 million for the collaboration with Evox - up to USD 838 million in milestone payments and royalties
• Eli Lilly ( NYSE: LLY ) will pay USD 20 million for the collaboration with Evox - up to USD 1.2 billion in milestone payments and royalties

Nurexone - ExoPTEN nasal spray cures paraplegia?

In NurExone Biologic Inc.'s (WKN: A3DNSU ) technology, exosomes are used as "carriers" containing modified siRNA. Simply put, the exosomes locate the damaged nerve fibers, and the modified siRNA is responsible for the healing process.

In preclinical animal studies with a completely transected spinal cord, intranasal administration of ExoPTEN resulted in significant motor improvement, sensory recovery, and faster recovery of the urinary reflex.

Functional restoration

The MRI clearly shows the almost complete recovery of the severed spinal cord. This can also be seen in a stunning video. The rat, whose spinal cord had previously been severed, regained its motor function after treatment with the ExoPTEN.

Conclusion:

Now that you've seen the video and the facts, wouldn't you be tempted to call this technology a miracle? I think so – but a miracle is often a one-time occurrence, and NurExone Biologic Inc.* (WKN: A3DNSU ) is working to make this miracle reproducible as often as needed. I firmly believe this can be achieved and that ExoPTEN can become the standard treatment for spinal cord injuries.

Consider for yourself whether the prospect of such an unprecedented procedure/drug might be worth the risk of investing in this penny stock!

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