- NurExone Biologic (TSXV:NRX / OTCQB:NRXBF) is advancing its exosome-based therapeutic platform while developing a separate commercial exosome supply business through Exo-Top.
- A strategic relationship with Made Scientific is intended to establish U.S.-based GMP exosome manufacturing for both NurExone’s ExoPTEN program and potential commercial applications.
- NurExone is targeting Mexico as an early commercial market for Exo-Top and says it is working toward its first commercial exosome revenues.
- The company is preparing for a potential U.S. cross-listing, with a proposed share consolidation intended to help satisfy applicable listing requirements.
Can exosomes support both a new generation of regenerative therapies and a commercial business in their own right?
NurExone Biologic (TSXV:NRX / OTCQB:NRXBF) is pursuing both opportunities as it advances its lead therapeutic candidate, ExoPTEN, while building a commercial exosome platform through its U.S. subsidiary, Exo-Top.
This content has been prepared as part of a partnership with NurExone Biologic Inc. and is intended for informational purposes only.
In the latest episode of The Capital Compass, NurExone CEO Dr. Lior Shaltiel joins Stockhouse’s Ricki Lee to discuss the company’s U.S. manufacturing strategy, expansion into Mexico, recent financing and plans to pursue a potential U.S. exchange listing.
Building U.S. exosome manufacturing capacity
NurExone recently signed a memorandum of understanding with Made Scientific focused on establishing GMP-grade exosome manufacturing in the United States.
Shaltiel describes the arrangement as a strategic partnership rather than a conventional contract development and manufacturing relationship. NurExone brings its knowledge of 3D exosome production, while Made Scientific contributes GMP manufacturing and quality systems.
The manufacturing capability is intended to support NurExone’s ExoPTEN development program while also creating potential commercial opportunities for Exo-Top.
Management is targeting production of a commercial batch and says it aims to begin generating commercial revenue within the coming months.
Mexico forms part of commercial strategy
Alongside its U.S. manufacturing plans, NurExone is expanding Exo-Top’s commercial footprint into Mexico.
Shaltiel describes Mexico as an established market for exosome and cell-based applications and says securing a local partner before beginning commercial vial production could provide an important foundation for future supply.
The commercial strategy is developing alongside NurExone’s therapeutic work, with ExoPTEN continuing toward the investigational new drug, or IND, stage.
Preparing for a potential U.S. listing
NurExone is also strengthening its financial position ahead of the next stage of development.
The company recently completed a private placement that Shaltiel says raised more than C$1 million, with existing investors increasing their positions. Management expects part of the capital to support preparations for a potential U.S. cross-listing.
Shareholders are also expected to consider a proposed share consolidation. Shaltiel says the measure is intended to help NurExone satisfy minimum share-price requirements associated with a potential listing on a major U.S. exchange.
Looking ahead, investors will be watching for progress in U.S. manufacturing, Exo-Top’s first commercial sales, development work supporting ExoPTEN and further steps toward a possible U.S. listing.
Watch the full interview above for more from Dr. Lior Shaltiel on NurExone’s therapeutic and commercial exosome strategy.
Transcript
This transcript has been lightly edited for clarity and readability.
Ricki: Can exosomes become both the foundation of a new regenerative therapy and a commercial business in their own right?
Hello, I’m Ricki Lee, and this is another episode of The Capital Compass. Today, we’re checking back in with NurExone Biologic (TSXV:NRX / OTCQB:NRXBF), a biotech company developing exosome-based therapies for central nervous system injuries.
Alongside its lead therapeutic candidate, ExoPTEN, NurExone is building the commercial side of its exosome platform through its U.S. subsidiary, Exo-Top. Recent developments include plans for U.S.-based manufacturing and distribution in Mexico as the company looks to expand its footprint across North America.
NurExone is also strengthening its financial position and taking steps toward a potential future Nasdaq listing.
Joining me today to walk us through these developments and what comes next is Dr. Lior Shaltiel, CEO of NurExone Biologic. Lior, welcome back. Great to have you with us.
Lior: As usual, thank you for having me.
Ricki: It’s always a pleasure to have you with us, Dr. Lior. Let’s start with the U.S. manufacturing strategy, if we can. You recently signed an MOU with Made Scientific around GMP manufacturing of exosomes in the United States. How important is establishing that domestic manufacturing capability, both for NurExone’s therapeutic pipeline and for building a commercial exosome supply business?
Lior: Made is our strategic partner in the U.S. that will serve the demand for the company for our drug substance, part of ExoPTEN. We need the exosomes in a GMP grade, and Made Scientific is a perfect strategic partner in this because we are combining forces with the strong GMP and quality system that Made has, together with the knowledge of how NurExone developed and produced our exosomes in 3D, including the raw material.
Those two combine together in this strategic partnership. This is not a typical CDMO business. Both parties need to have a joint win here: NurExone for our development, and Made Scientific wants to get access to a high quality of exosomes for commercial use.
In this case, we have a joint partnership to get it ready for commercial use and build revenue in the next nine to 12 months.
Ricki: You’re also expanding the commercial side of the business, as we touched upon, into Mexico through Exo-Top. What opportunity do you see in that market, and how does distribution in Mexico fit into the broader North American growth strategy?
Lior: Mexico is an established market. What we see now in Florida and other states, where you can start to see therapies in exosomes or cell therapy being allowed on the state level, we’ve had for a few years already in Mexico. That’s considered quite an established market.
To have a partner in Mexico before even producing our first commercial vials gives us the support and the future supply needed for the market. We could secure some supply already before we even start producing it. It gives us a very strong backbone for our commercial arm.
Ricki: You’ve also recently closed a private placement. How did that financing go, and where do you expect to put that additional capital to work as you advance both the therapeutics and commercial sides of the business?
Lior: This private placement was relatively unique. It’s combined with another private placement that we had back in June. Those are already existing investors of NurExone who would like to increase their position in NurExone before the activity in the U.S. and moving to a cross-listing opportunity.
We raised, in the last round that closed last week, more than C$1 million, and we are going towards using these funds in order to secure our plans to cross-list into the U.S., together with the AGM that needs to be in September, in the middle of September, September 15, in order to have a direct or cross-listing to the U.S. It can be Nasdaq or the New York Stock Exchange.
Ricki: Another in what seems to be a long list of major developments is the proposed share consolidation, which is expected to go before shareholders at a special meeting as part of your plans to pursue a Nasdaq listing, which you just alluded to.
Why is a Nasdaq listing the right next step for NurExone, and what could an eventual U.S. listing mean for the company and its investor base?
Lior: Exactly. One of the more important questions to our shareholders in the coming AGM is the consolidation, which is preparation for a cross-listing.
In order to get qualified into the U.S. market, you need to have a minimum share price. This is why it’s a technical procedure that we need to ask our shareholders to do in order to meet the criteria.
The rest of the criteria, we are a match. For example, the shareholder numbers and number of years that we were reporting on a quarterly basis. We are a foreign issuer in Canada. Again, we are after four years of being a fully publicly traded company, reporting on a quarterly basis.
We got, so to say, “mature” in Canada. One of the best ways to prove it is that last year, in 2025, we were selected to be part of the TSX Venture 50.
I think at this point, before getting into clinical development, when there is major capital needed for at least one or two INDs, the best market to raise this amount of funds and develop the company will be in the U.S.
Ricki: And finally, Lior, when you put all of this together — U.S. manufacturing, commercial exosome sales, geographic expansion, new capital and the potential Nasdaq listing — what are the key milestones that investors should be watching over the next six to 12 months?
Lior: The development can be on the commercial part, what the activity will be done in Exo-Top together with Made Scientific. Engineering-wise, first a commercial batch to be able to sell and showing the first revenue in the next nine months or even before. The sales will start before, based on our plan.
Alongside that, we have NurExone still going into the IND. We will have a tox study based on the material that we produced by Exo-Top because, for the toxicity study, we need to have the final exosome production in GMP if it is scaled.
We have more and more information regarding our analytical methods in order to secure our fully characterized ExoPTEN program into clinical development Phase 1.
Ricki: Well, Dr. Lior Shaltiel, thank you for joining us and updating us on the NurExone Biologic story.
Lior: Thank you again for the stage, and looking forward to our next time.
Ricki: Indeed. For more information, you can visit nurexone.com. I’m Ricki Lee, and this has been The Capital Compass. Thank you for watching, and we’ll see you again next time.
