Welcome back, everyone. We have an update from Jaguar Health. It's a late-stage, clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases. Happy to welcome President and CEO, Lisa Conte. Welcome, Lisa. We're happy to hear your update.
Thank you, Anna. It's a pleasure to be here and to see everybody, virtually at least, on this hopefully pleasant July day for most of you, though I certainly recognize that the Eastern Seaboard has been slammed with a lot of rain of late. Where I am, though, in Utah, it's presently beautifully sunny outside, and I wish that you all have a good rest of July. Jaguar Health just met with the agency in June. We announced this just the Fourth of July week, and that enabled a very clear plan for our analysis of neurofilament, the biomarker neurofilament. Now, I think, Anna, for your listeners, let me just give an update of that. When the disease ALS attacks the neuron, it leaves a debris field in the bloodstream, and that debris field can be measured. It's a cytoskeletal protein remainder of what's called neurofilament light.
Similar to how glucose might be a measure of diabetes problems, cholesterol might be a biomarker measure of cardiovascular problems, high neurofilament levels are a biomarker or an indicator of ALS challenges in the neuron. What you and I and all the human family rely upon for this choreography of life that enables us to move and walk and talk and eat and chew and breathe, that is driven by neurons. The FDA has proposed that we evaluate the neurofilament effect of crofelemer. That is, can it drop neurofilament in an ALS patient? If compromised neurofilament is rising because the neurofilament is leaching from destroyed neurons into the bloodstream, and our crofelemer drug that we take by mouth orally can reduce neurofilament, that's very indicative of a clinical benefit.
We have levered the $45 million that the NIH gave us, bless them, that's funding 180 subjects, individuals, participants, people who struggle with ALS, said most, you know, more specifically. It has enabled them to be on drug now for at least six months, and in many cases up to a year. Jaguar Health will be evaluating the neurofilament change of these individuals beginning next month through till September. I say that time period because we, per the FDA's request, had to get all of these individuals to at least six months of therapy, which has just happened this month. We are evaluating that, and we'll be submitting that data back to the agency.
If it is concordant, that is, says the same story, expresses the same argument that we saw in the double-blind, placebo-controlled HEALEY program, then we've asked the agency if we could submit this data consistent with HEALEY as a new drug application for the possibility of accelerated approval in ALS. Secondary to this, and not, you know, one could argue primarily to this, not secondarily, we've submitted a whole separate dossier to the FDA on survival alone because we achieved the secondary endpoint in the HEALEY point on the 30 mg dose for survival reduction. We've also announced earlier this year survival against a concurrent control, regimen A, that also showed a concordant or similar survival benefit. We've submitted this dossier to the FDA, and we have a meeting, as we announced, the Fourth of July week, also in the third quarter to discuss this.
Whether the FDA lets us put forward a new drug application based upon neurofilament or survival or both is a conversation that we'll be very much looking forward to having with the FDA over the course of the next 90 days.
Wonderful. Congratulations with that. Can you talk about when you might anticipate having new data, and a little bit more on filing that new drug application?
This data that I just spoke of is all coming to us in the very latter part of the third quarter. That data will be submitted to the FDA in the top of the fourth quarter with the ability, as we're planning and preparing, the filing of this new drug application by the end of the year. The way this works at the FDA is they would take all that data. It then becomes a review that they proceed with over the course of 60 - 70 odd days, which means that in the first quarter of 2026, we would find out if that new drug application is accepted.
It is a very busy period over the next five months at Jaguar Health and then a very busy period waiting for the FDA 's decisions in the first quarter of 2026. Within nine months from now, we will have good clarity about the possibility of whether or not our drug is accepted for a complete review in amyotrophic lateral sclerosis, that is, for the treatment of crofelemer in amyotrophic lateral sclerosis individuals.
Perfect. Talk a little bit about your plans for a phase III clinical trial in terms of timing and design for the ALS indication.
The way accelerated approval works in the U.S. Food and Drug Administration's case is there needs to be a confirmatory phase III trial. If accelerated approval is accepted based upon surrogate biomarkers, and again, the surrogate biomarkers we're talking about here are neurofilament and/or a survival conversation or both, we need to nonetheless start a phase III study. That phase III is planned to be primary endpointed on survival, that is, time to event. We've taken a page out of oncology or cancer clinical studies, a page out of cardiovascular studies, and we're literally looking to see if patients who take [crofelemer] are living longer than the placebo individuals. That's called a time-to-event study. That study we're planning to commence with first patients on drug at the latter part of this year.
We've already received permission in the first regulatory market to proceed with that study, and we'll be having an investigator meeting shortly. That study will continue more broadly in a global fashion in 2026.
Our viewer, Matt, asks for how long does the neurofilament remain in the bloodstream, and after the reduction, has there been any regeneration?
To answer the first question, neurofilament elevation shows up before individuals who struggle with ALS start presenting clinical symptoms. In other words, if you were to measure my neurofilament right now, I would pray that my neurofilament would be undetectable. That is, that my neurons are doing their job. If I'm still functional, more or less, I can do everything I'd like to do. I just hit 59, so I have the inevitable, you know, nearly almost 60 aches and pains. Other than that, I'm doing fine. If my neurofilament was rising and I had that blood test, I would think, uh-oh, batten down the hatches. Clinical effects are about to hit me. To answer Matt's question, yes, neurofilament does still stay elevated unless Jaguar Health remains, by the way, the only drug in a phase II double-blind, placebo-controlled study that has shown a reduction in neurofilament.
The second part of Matt's question?
For how long does it remain in the bloodstream? After the reduction, has there been regeneration?
We don't know the regeneration in the case of ALS yet, but we've just presented data at the American Academy of Neurology in April that suggests that we're both remyelinating a damaged neuron and we are protecting the neuron that has been compromised. We've seen return of effect through paraclinical biomarkers using MRI and visual evoked potentials in the MS population. We have not yet concluded that same work in ALS. We've been focused, frankly, on all the things we're doing in ALS otherwise, but we do see it in MS. There could be a correlation in ALS as well, but we don't know for sure scientifically.
Can you talk a little bit more about the [crofelemer] , what it's being investigated primarily for? Is it one indication or multiple indications?
The way we think about this is a little bit of a pipeline in a product, as we call it, because the MS data is actually being discussed with the agency also this quarter. We mentioned that as well in our June 30, 2023 update. In other words, we have three meetings with the F DA that are face-to-face on either of ALS, two meetings, or MS, one. The MS discussion is what's called an end of phase II meeting. We've just sent them all of our dossier on our multiple sclerosis program. It was the same dose, same drug that we're talking about in the case of ALS. That's why we talk about this a little bit as a pipeline in a product.
Mechanistically, the way this drug is working is it's driving the energetic return to the flailing or failing mitochondria, which is the energy powerhouse of the neuron or the cell, and that's driving what the neuron's doing. To be able to provide back the energetic metabolite support that the mitochondria needs to basically get its gas and its engine going, speaking colloquially, is very important. We also have concluded Parkinson's work already. We did Rett syndrome and early preclinical data a year ago. There is a whiteboard down the hall in my office here that has Huntington's and frontotemporal dementia, et cetera, all as possibilities. I can go into other neurodegenerative diseases. At the moment, our key clinical focus has been MS and ALS with this early insight also into Parkinson's.
Fantastic update. Great work. Please continue to do this important work. For all of our viewers, it's Jaguar Health on the NASDAQ JAGX. Rob, thank you for your update today.
Thank you.
All right, everyone. We'll be right back. We have an update from Sono Group NV. It trades on the OTCQB under the symbol SEVCF in its wholly owned subsidiary Sono Motors GmbH. They're on a pioneering mission to accelerate the revolution of mobility by making every commercial vehicle solar. Happy to welcome back Managing Director, CEO, and CFO, George O' Leary. Welcome back, George. What's your update today?
Hi, Anna. How are you? Thank you very much for having me. I will go through it now. First is our forward-looking statement disclaimer, and I think that's really important today because I'm actually going to be giving some Q3 and Q4 guidance. For anyone who's listening for the first time, a little bit about me and my background. I started my career at Peat, Marwick, Mitchell, which is now KPMG, so I'm dating myself a little bit. I was Vice President of Operations for Cablev ision Industries, ran $125 million worth of business for Cablev ision. We sold to Time Warner. I became CEO of Communications Resource Incorporated. I started a cable installation business, grew it from $5 million to $40 million in four years, and sold it to a public company. I founded SKS Consulting, where I provide executive-level consulting currently. Let me tell you about the company.
Jaguar Health is a pioneer in gastrointestinal health. We're headquartered in the United States. Our management board and our supervising board are all based in the U.S., so we became a U.S. filer January 1, 2023. As Anna mentioned, we're quoted on NASDAQ under the symbol JAGX. We're focused on developing and commercializing novel, plant-based prescription medicines for people and animals with GI distress, including our lead product, Mytesi. Mainly, we're looking at large pharmaceutical partners and expanding our reach. We have a patent portfolio of nine granted patents and over 30 pending patents. Our end-to-end solution includes proprietary plant-based medicines, our clinical research, our regulatory expertise, and our commercial infrastructure. For our lead product, Mytesi, which is approved for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, our proprietary formulation is unique and different, allowing for maximum efficacy and safety.
Our commercial focus is on tomorrow's GI market. Our solution works across multiple patient populations, whether it's HIV, cancer therapy-related diarrhea, or rare diseases. Immediate operational impact, we lower healthcare costs, improve patient quality of life, and provide instant symptom relief to reduce the burden of GI distress. Easy scalable adoption, oral plant-based medicines, plus our established distribution network, allow for rapid expansion directly through specialty pharmacies or hospital systems, which is where we're focusing, or through global partnerships. Our product portfolio focuses on Mytesi, crofelemer, GELCLAIR, and other pipeline products for gastrointestinal health. What I'll be talking about in Q3 and Q4 is mostly refrigeration trailers and buses. Here is how our solar solution works for a solar bus kit example. We have 16 solar panels on the top of a bus. We connect it to our solar charge controller, as I mentioned, with eight zones.
That connects into the low-volt battery. We also have telematics providing useful insights for both the driver and for the fleet operators as well. Last year in November at our Italy trade show, we won a prestigious Green Innovation Award for excellence in sustainable innovation. In January of this year, we became the first national type certification for solar bus kits in Germany. What's really great about that is because they use the European standard, anywhere in Europe that we want to do installations, it'll simplify our installation process. Instead of getting every single bus certified, we actually can do an entire fleet with one certification. This definitely provides a competitive advantage, certainly in Germany. Because it's European standards, it'll adopt throughout Europe. In March of this year, we partnered with Merlin Solar Technologies to expand our global reach.
The way I like to describe it is best-in-class co-marketing partnership with Merlin Solar Panels and our solar charge controller and integration know-how. It provides us scope both in Europe as well as in North America. Strong commercial momentum is driving Q3 and Q4 expected revenue growth. Proven demand across sectors. We have orders from the six large OEMs, a diverse client base, including global leaders in refrigeration trailers, buses, and trucks. We're building on delivered results. The half a month of July's revenue exceeds all of Q1 2025 revenue. Existing framework agreements are in place with the large OEMs where we're in final discussions for much larger deployments. Our average revenue per unit is trending up by the fourth quarter to €8,000 per unit. The breakout for Q3 and Q4 would be about 60% refrigeration units and about 40% buses.
We're looking to have approximately 50 orders in Q3 going to over 100 orders in Q4. Our revenue should double from Q3- Q4, which is very exciting. It's what we've been waiting for. Working with OEMs takes a long time, and we're finally getting there. With our business, as I mentioned, we combine U.S. growth and entrepreneurship with German technology, innovation, and know-how. As I mentioned, our management board and our supervising board are all based here in the U.S. We're now a U.S. filer, and our Managing Directors are based in Munich, Germany, where our subsidiary Sono Motors resides. I always like to talk about our most valuable resource, which is our management, our employees in Munich, Germany. They're really, really focused on changing the world.
Matter of fact, they're all vegan, and they also ride their bicycles to work rather than driving their vehicles, focusing on reducing the carbon footprint. Our focus on the remaining part of 2025 and 2026 outlook, we're building on our 24-hour momentum on focusing on our OEM strategy, really focused on getting on the production line with our large OEMs, expanding our global partnerships like we did with Merlin, and expected revenue growth in Q3 and Q4 totaling 150 units for the two quarters. Pursuing an uplisting to a major national exchange, we're in talks with both NASDAQ and the New York Stock Exchange American. We're looking to improve visibility and enhance liquidity, drive long-term value for our shareholders, and create much larger business opportunities through M&A once we get onto a national exchange. The time for solar mobility is now. Three things: momentum, market, and timing.
Momentum from early-stage pilots to now scalable commercial deployments with six global OEMs. Our unit volumes are expected to increase to 50 units in Q3 and over 100 units in Q4, with an average of €8,000 per unit by Q4. Sono is one of the few companies offering a full end-to-end solution specifically built for commercial vehicles between our multi-zone controller, solar panels, and analytics and dashboard. Whether it's diesel, hybrid, or electric vehicles, we provide immediate CO2 reductions and other cost benefits, including fuel for diesel. Timing, the commercial vehicle market's looking for a practical cost-effective solution today, not years from now, as the EV infrastructure still lags. As these large OEMs start building EV commercial vehicles, you know, we provide a solution immediately for them.
Our uplifting prep with NASDAQ and New York Stock Exchange American to boost liquidity and visibility, broaden investor base, and create much larger M&A growth opportunities. Key takeaways and closing. Solar is the largest and most affordable renewable energy source. As I like to say, solar bridges the gap between conventional vehicles of today and the electric vehicles of tomorrow as charging stations catch up to the EV demand. The second half of 2025 expected revenue growth is substantial, reflecting significant interest in the large OEMs. By the way, that's taken a lot of time and a lot of energy and effort from our team. I'm very excited about that. I'm excited to be able to finally share some guidance. Our patent portfolio, as I mentioned, nine granted patents, our data-driven dashboard, and our solar mobility know-how set us apart from our competition.
Sono Group NV is on track for a planned uplifting to a national exchange, hopefully by the end of this year or sooner. I am personally focused on driving that. With that said, let me turn it over to the audience for any questions that anyone might have.
Great job. Congratulations, George. Yes, a few questions, and you pretty much answered this, but Ian asks, are you going to eventually drop the F or get a new stock symbol? What's your plan?
The stock symbol from basically what our focus is on the OTCQB, that's our stock symbol. Going forward, when we get to a national exchange, obviously the stock symbol will change, and our focus is really getting there sooner than later.
A few questions about your panels. Michela asks, where are you sourcing them?
With our partnership with Merlin Solar Technologies, they provide what I call best-in-class panels. We source them from the U.S. They also have manufacturing in other places as well. We also have existing manufacturers both local and in Asia. We have three sources for our panels. Our focus is with Merlin Solar Technologies and the U.S.
Dimitri asks, can those panels be positioned on the side to generate any energy?
Great question. With our refrigeration units, which are much larger vehicles, we have the solar panels on the top of the roof, obviously, but also on the sides as an option to actually create more efficiencies and more solar energy.
Our viewer asks, who are your customers? Where are they located? Specifically, what countries? Why are they buying from you versus the alternatives out there?
Right. There are global large OEMs that we're focused on with our customer base. We're looking to get on the production lines. They're obviously global companies, but we're focused on the European market. Some are based in Germany, and others are definitely in Europe or the U.K. With our partnership with Merlin Solar Technologies, we're also starting to get some traction in North America as well. Why they look to us versus others is we have experience with really specific solar mobility like no one else has. That's why these large OEMs are looking at us, even though we're a fairly small company, to provide the solar solutions for their commercial vehicle markets.
Assuming you hit your Q4 targets, what kind of volume are you planning for early 2026? How scalable is your current operation to support that?
That's a great question. We have a good team of hardworking people. We should be able to cover certainly Q3 and Q4. Our business will continue to scale based on the six large OEMs and growing. Our sales line is growing fairly substantially now. We expect much larger volumes to continue the growth we're projecting in Q3 and Q4. We expect that to continue through 2026 and 2027. We expect one to be significantly larger than we are today and also to be profitable by then as well.
Wonderful. Great update, George. Happy to have you back with this good news. Congrats, and please continue to come back on the conference with some more good news like this.
Thanks, Anna. Great to see you. We'll talk soon.
All right, everyone. That was Jaguar Health. I went mute. Thank you all for watching the Emerging Growth Conference. Thank you to our presenters and attendees for making this a great success. Remember, a complete replay of our conferences will be on our YouTube channel, youtube.com/emerginggrowthconference, or follow us on X at Emerging Growth C. Reserve your spot early. Stay on, and we'll see you next month. Thanks, everyone, for watching.