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 (USOTC:NRXBF) (TSXV:NRX), 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 US subsidiary, Exo-Top. Recent developments include plans for US-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.
This article is disseminated in partnership with NurExone Biologic. It is intended to inform investors and should not be taken as a recommendation or financial advice.
This article is disseminated in partnership with NurExone Biologic. It is intended to inform investors and should not be taken as a recommendation or financial advice.
Ricki: It’s always a pleasure to have you with us, Dr. Lior. Let’s start with the US 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 US 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 a strong GMP and also quality system that Made has, and together with the knowledge how NurExone developed and produced our exosomes in 3D, including the raw material. Those two combined together in this strategic partnership. This is not a typical CDMO business. This is both parties that need to have a joint win here, NurExone for our development, and also Made Scientific, wanted to get access to a high quality of exosomes for the commercial use. In this case, we have a joint partnership to get it ready for even commercial and building revenue in the next nine to twelve 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, when you can start to see therapies in exosomes or cell therapy that start to be allowed on the state level, we have it few years already in Mexico. That’s considered quite an established market. To have a partner in Mexico, before even producing our 1st commercial vials, that give us the support, and the future supply needed for the market. We could secure some supply already before even start producing it. It gives us the very strong backbone of 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 other private placement that we had back in June. Those are already existing investors of NurExone, that would like to increase their position in NurExone before the activity in the US and moving to a cross-listing opportunity. We raised in the last, round that closed last week, more than one million Canadian dollars, and we are going towards using these funds in order to secure our plans to cross-list into the US together with the AGM that needs to be in September, middle of September, 15th September, in order to have a direct or cross-listing direct to the US. And it can be NASDAQ or 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 to what you just alluded to. Why is a NASDAQ listing the right next step to NurExone and what could an eventual US listing mean for the company and its investor base?
Lior: Exactly so one of the more important questions to our shareholders in the AGM, coming AGM, is the consolidation, is a preparation for a cross-listing. In order to get qualified into the US market, you need to have a minimum amount of 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’s we are a match. For example, the shareholder numbers, and numbers of years that we were reporting on quarterly basis. We are foreigner issuer in Canada. Again, we are after four years of fully publicly traded company reporting on quarterly base. We got, so to say, “mature” in Canada. One of the best way to prove it is last year that in 2025, we were elected or selected to be part of the best 50s at the TSX Venture Exchange. And I think in this point, before getting into the clinical development, when there is a major capital for at least one or two INDs, the best market to raise this amount of funds and develop the company will be in the US.
Ricki: And finally, Lior, when you put all of this together, US 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 6 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 sale will start before based on our plan. Alongside of that, we have NurExone still going into the IND. We will have tox study based on the material that we produced by Exo-Top because for the toxicity study, need to have the final exosome production in the GMP if it is scaled. We have more and more information regarding our analytic methods in order to secure our fully characterized ExoPTEN program, into the clinical development phase one.
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 www.nurexone.com. I’m Ricky Lee, and this has been The Capital Compass. Thank you for watching, and we’ll see you again next time.
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