Clean Inc. and Sono Group NV at Emerging Growth Conference: Strategic Innovations

On Thursday, 17 July 2025, Clean Inc. (NASDAQ:JAGX) and Sono Group NV presented their strategic advancements at the Emerging Growth Conference 84. Clean Inc. is making strides in ALS treatment, while Sono Group NV is expanding its solar mobility solutions. Both companies are navigating regulatory and commercial challenges to drive growth.

Key Takeaways

• Clean Inc. is advancing ALS treatment with CNMAU8, aiming for FDA accelerated approval.
• Sono Group NV projects doubling revenue from Q3 to Q4 with solar technology for vehicles.
• Clean Inc. plans a Phase 3 trial focusing on survival rates for ALS patients.
• Sono Group NV is pursuing uplisting to a major national exchange to enhance visibility.
• Both companies focus on innovation in their respective sectors: healthcare and sustainable mobility.

Financial Results

Clean Inc.

• Leveraged $45 million from the NIH for ALS study
• Planning to submit data to the FDA by the end of the year

Sono Group NV

• Revenue for July exceeded all of Q1 2025
• Average revenue per unit expected to reach €8,000 by Q4

Operational Updates

Clean Inc.

• Focused on improving mitochondrial health to treat ALS
• Secondary endpoint in Healy trial showed a survival reduction with 30mg dose

Sono Group NV

• Orders from six large OEMs
• Projected unit sales: 60% refrigeration units, 40% buses in Q3/Q4

Future Outlook

Clean Inc.

• Anticipates FDA clarity on drug review within nine months
• Plans to expand Phase 3 study globally in 2026

Sono Group NV

• Pursuing uplisting to Nasdaq or NYSE American
• Aims for 50 orders in Q3 and over 100 in Q4

Q&A Highlights

• Rob Etherington emphasized the busy period ahead for Clean Inc. with FDA decisions expected in early 2026.
• George O’Leary highlighted solar technology as a bridge to future electric vehicle adoption.

For more detailed insights, please refer to the full conference call transcript.

Full transcript - Emerging Growth Conference 84:

Anna, Host/Operator: Welcome back, everyone. We have an update from Clean Inc. It trades on the NASDAQ under the symbol CLNN. 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 Rob Etherington.

Welcome, Rob. We’re happy to hear your update.

Rob Etherington, President and CEO, Clean Inc.: 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. CLEAN just met with the agency in June. We announced this, just the July 4 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. So similar to how glucose might be a measure of diabetes problems, cholesterol might be a measure, a biomarker measure of cardiovascular problems, high neurofilament levels is a biomarker or an indicator of ALS challenges in the neuron. So what you and I and all the human family relies 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.

And so what we’ve done is the FDA has proposed that we evaluate the neurofilament effect of cnMaUA, that is can it drop neurofilament in an ALS patient? So if compromised neurofilament is rising because the neurofilament is leaching from destroyed neuron into the bloodstream, and our CNMAU8 drug that we take by mouth orally can reduce neurofilament. That’s very indicative of a clinical benefit. And so we have levered the $45,000,000 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, and CLEAN will be evaluating the neurofilament change of these individuals beginning next month through till September. Why I say that time period is 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.

And so what we’re doing is evaluating that and we’ll be cement sending submitting that data back to the agency. And if it is concordant, that is, it says the same story, expresses the same argument that we saw in the double blind, placebo controlled Healy program, then we’ve asked the agency if we could submit this data consistent with Healy as a new drug application for the possibility of accelerated approval in ALS. Now 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 Healy point on thirty milligram dose for survival reduction, and we’ve also announced earlier this year, survival against a concurrent control regimen a that also showed a concordant or similar survival benefit. So we’ve submitted this dossier to the FDA, and we have a meeting as we announced, the July 4 week also in the third quarter to discuss this. So 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 ninety days.

Anna, Host/Operator: 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?

Rob Etherington, President and CEO, Clean Inc.: This data that I just spoke of is all coming to us in the very latter part of the third quarter, and so 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. And so the way this works at the FDA is then they would take all that data, it then becomes a review that they conclude that they proceed with over the course of sixty to seventy odd days, which means that, in the first quarter of twenty twenty six, we would find out if that new drug application is accepted. So literally, that’s a very busy period over the next, five months at clean and then, a very busy period waiting for the FDA’s decisions in the first quarter of twenty twenty six. So 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 ALS, that is, for the treatment of CMAU8 in ALS, individuals.

Anna, Host/Operator: Perfect. Talk a little bit about your plans for a phase three clinical trial in terms of timing and design for the ALS indication.

Rob Etherington, President and CEO, Clean Inc.: So the way accelerated approval works in the FDA’s case is there needs to be a confirmatory phase three. So if accelerated approval is accepted based upon surrogate biomarkers, and again, the surrogate biomarkers we’re talking about here is neurofilament and or a survival conversation or both, then we need to nonetheless start a phase three study. And that phase three is planned to be primary and pointed on survival, that is time to event. So 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 CNMA-eight living longer than the placebo individuals. That’s called a time to event study, and 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 investigator meetings shortly. And then that study will continue more broadly in a global fashion in 2026.

Anna, Host/Operator: Our viewer Matt asks, for how long does the neurofilament remain in the bloodstream? And after the reduction, has there been any regeneration?

Rob Etherington, President and CEO, Clean Inc.: So to answer the first question, neurofilament elevation shows up before actually individuals who struggle with ALS start presenting clinical symptoms. So 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 you I’m still functional, more or less. I can do everything I like to do.

I just hit 59, so I have the inevitable, you know, nearly almost 60 aches and pains. But other than that, I’m doing fine. And, but if 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. So to answer Matt’s question, yes, neurofilament does still stay elevated unless clean remains, by the way, the only drug in a phase two double blind placebo controlled study that has shown a reduction in neurofilament.

And then the second part of Matt’s question.

Anna, Host/Operator: For how long does it remain in the bloodstream? And after the reduction, has there been regeneration?

Rob Etherington, President and CEO, Clean Inc.: So 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. So we’ve seen return of effect through paraclinical biomarkers using MRI and visual vote 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. So it it it there could be a correlation in ALS as well, but we don’t know for sure scientifically.

Anna, Host/Operator: Can you talk a little bit more about the CNMA U8? What it’s being investigated primarily for? Is it one indication or multiple indications?

Rob Etherington, President and CEO, Clean Inc.: 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 our our June 30 update. So in other words, we have three meetings with the FDA that are face to face on either of ALS two meetings or MS one. And the MS discussion is what’s called an end of phase two 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. So that’s why we talk about this a little bit as a pipeline and a product. And 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. And so to to be able to provide back the energetic metabolite support that the energy that the mitochondria needs to basically get its gas and its engine going, speaking colloquially, is very important. And so 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, etc, all as possibilities. I can go into other neurodegenerative diseases. But at the moment, our key clinical focus has been MS and ALS with this early insight also into Parkinson’s. Parkinson’s.

Anna, Host/Operator: Well, fantastic update. Great work, and please continue to do this important work. For all of our viewers, it’s clean on the NASDAQ CLNN. Rob, thank you for your update today.

Rob Etherington, President and CEO, Clean Inc.: Thank you.

Anna, Host/Operator: All right, everyone. We’ll be right back. One, we have an update from Sono Group NV, trades on the OTCQB under the symbol SEVCF, and 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?

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Hi, Anna. How are you? Thank you very much for having me. I will go through it now. So first is our forward looking statement disclaimer, and I think that’s really important today because I’m actually gonna be giving some q three and q four guidance.

So for anyone who’s listening for the first time, a little bit about me and my background. I started my career at Pete Marrick and Mitchell, which is now KPMG, so I’m dating myself a little bit. I was vice president of operations for Cablevision Industries, ran a $125,000,000 worth of business for Cablevision till we sold to Time Warner. Then I became CEO of Communication Resource Incorporated. I started a cable installation business, grew it from five to forty million in four years, and sold it to a public company.

And then I founded SKS Consulting and where I provide executive level consulting currently. So let me tell you about the company. So Sono is a pioneer in solar mobility. We’re headquartered in Munich, Germany. Our management board and our supervisory board are all based in The US, so we became a US filer January 1.

As Anna mentioned, we’re quoted on the OTC under the symbol SEVCF. We’re focused on integrating proprietary solar technology onto commercial vehicles. Mainly, we’re looking at the large OEMs and getting on their production line, and we have a patent portfolio of nine granted patents and over 30 pending patents. So our end to end solution, we have solar panels. We have our solar charge controller, which is proprietary, our vehicle integration, and our software and data analytics.

For our solar bus kit where we have 16 solar panels on the top of a bus, our solar charge controller operates in eight zones, which is very unique and different, allowing for maximum efficiency of the use of the sun. Ace commercial fleets with tomorrow’s EV market. So one, our our our solution works across all commercial vehicles, whether it’s diesel, whether it’s hybrid, whether it’s a EV. Immediate operational impact, we lower fuel and energy cost. We, extend the battery life, and we provide instant c o two reduction to reduce the carbon footprint.

Easy scalable adoption, lightweight solar panels plus our multi zone controller installation one to two days directly on the OEM factory production lines, is we’re focusing on, or commercial fleet retrofits. So our product portfolio, we focus on buses, trucks, and vans, recreational vehicles, and refrigeration trailers. What I’ll be talking about in q three and q four is mostly refrigeration trailers and buses. So how our solar solution works for a solar bus kit example. So we have 16 solar panels on the top of a bus, then we connect it to our solar charge controller, as I mentioned, with eight zones, that connects into the low volt battery.

And then we also have telematics providing useful insights for both the driver and also for the fleet, operators as well. So last year in November at our Italy trade show, we won a prestigious green innovation award for excellence in sustainable innovation. And in January, we became the first national type certification for solar bus kits in Germany. And what’s really great about that is because they use the European standard, so anywhere in Europe that we want to do installations, it’s it’ll simplify our installation process where instead of getting every single bus certified, we actually can do an entire fleet with one certification. Definitely providing a competitive advantage certainly in Germany.

And because it’s European standards, it it’ll adopt throughout Europe. So in March, 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. So strong commercial momentum driving q three and q four expected revenue growth.

So proven demand across sectors. We 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 the q one, 2025 revenue. Existing framework agreements in place with the large OEMs.

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, and the breakout for q three and q four would be about 60% refrigeration units and about 40% buses. We’re looking to have approximately 50 orders in q I’m going to over a 100 orders in q four, so our revenue should double from q three to q four, which is very exciting. And, really, it’s what we’ve been waiting for. You know, working with OEMs takes a long time, and we’re finally getting there.

So with our business, as I mentioned, we combine US 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 US, so we’re now a US filer. And our managing directors, are based in Munich, Germany where our subsidiary Sono Motors resides. So I always like to talk about our most valuable resource, which is our management our our employees, in in Munich, Germany. They 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. So our focus on the remaining part of 2,025 and 2026 outlook, We’re building on our ’24 momentum on focusing on our OEM strategy, really focused on getting on the production line with our large OEMs, expand our global partnerships like we did with Merlin, and expected revenue growth in q three and q four totaling a 150 units for the two quarters. Pursuing and 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 and a once we get onto a national exchange. And 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 q three and over a 100 units in q four with an average of €8,000 per unit by q four. Sonos 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 c o two reductions and other cost benefits including fuel for 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, and and as these large OEMs start building EV commercial vehicles, you know, we provide a solution immediately for them. And then our uplisting prep with Nasdaq and New York Stock Exchange American to boost liquidity and visibility, broaden investor base, and create much larger m and a growth opportunities. So key takeaways in 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 two thousand twenty five expected revenue growth is substantial reflecting significant interest in the large OEMs. And by the way, that’s taken a lot of time, and a lot of energy and effort, from our team. So I’m very excited about that, and 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. And Sono Group NV is on track for a planned uplisting to a national exchange, hopefully, by the end of this year or sooner, and, you know, 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.

Anna, Host/Operator: Great job. Congratulations, George. Yes. A few questions, and you you pretty much answered this. But, Ian asks, are you gonna eventually drop the f or get a new stock symbol?

What’s your plan?

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Well, yes. So, the stock symbol from basically, what our focus is on the OTCQB, that’s our stock symbol. And, the, 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.

Anna, Host/Operator: A few questions about your panels. Michela asks, where are you sourcing them?

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Mhmm. So with our partnership with Merlin Solar, they provide what I call best in class panels. So we source them from The US. They also have manufacturing in other places as well, but we also have existing manufacturers of both local and in Asia. So so we have three sources for our solar panels, but our focus is with Merlin and The US.

Anna, Host/Operator: And Dmitry asks, can those panels be positioned on the side to generate any energy?

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Yeah. Great question. So with our refrigeration units, are much larger vehicles, we 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.

Anna, Host/Operator: Our viewer asks, who are your customers? Where are they located? Specifically, what countries? And why are they buying from you versus the alternatives out there?

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Great. So they’re 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. So some are based in Germany, and others, are definitely in Europe or The UK.

But with our partnership with Merlin, 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, and 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.

Anna, Host/Operator: And assuming you hit your q four targets, what kind of volume are you planning for early twenty twenty six, and how scalable is your current operation to support that?

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Yep. So, that’s a great question. You know, we have a good team of hardworking people. We should be able to cover certainly q three and q four. Our business will continue to scale based on the six large OEMs and growing.

Our sales pipeline is growing fairly substantially now. We expect much larger volumes to continue the growth we’re projecting in in q three and q four. We expect that to continue through 2026 and 02/1927. We expect, one, to be significantly larger than we are today and also to be profitable by then as well.

Anna, Host/Operator: 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.

George O’Leary, Managing Director, CEO, and CFO, Sono Group NV: Thanks, Anna. Great to see you. We’ll talk soon.

Anna, Host/Operator: Take care. Everyone. That was Sono Group, OTCQB. 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 conferences will be on our YouTube channel, youtube.com/emerginggrowthconference, or follow us on x at emerginggrowthc. Reserve your spot early, stay on, and we’ll see you next month. Thanks, everyone, for watching.

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