Clene Inc. Common Stock Lytham Partners Fall 2026 Investor Conference

Good day everyone, and thank you for joining us today for the Lytham Partners Fall 2026 Investor Conference. My name is Joe Diaz. I am a managing partner at Lytham Partners. I would like to welcome Clene Inc., which trades on the NASDAQ under the ticker CLNN. Today, I will be moderating a fireside chat with Rob Etherington, Chief Executive Officer. Let's get started. Rob, welcome.

Thank you, Joe. It is a pleasure to be here. Thanks for the invitation. We appreciate your time.

Can you provide us a brief overview of Clene and what makes the company unique? Is there an obvious differentiator from your most direct peers?

Clene actually is remarkably unique. We are not a small molecule. We are not a biologic. We are the world's first, for neurodegenerative disease especially, oral nanotherapeutic suspension. In fact, I am holding it here in my hand rather, but it is taken by mouth. That is a little slip of my tongue, because indeed it goes down the tongue for ALS patients, multiple sclerosis patients, and Parkinson's patients who are taking our medicine, CNM-Au8, every morning in not just five clinical studies, but in a very extensive, in fact, numbering four expanded access protocols enabling compassionate use. Clene's unique because this is a intersection of physics and material science into biology, and our asset is a proprietary gold nanocrystal suspension, as I mentioned.

Would you describe that as Clene's competitive edge in neurodegeneration, particularly given the novelty of nano catalytic therapeutics?

Well, let's talk a little bit about ALS and what our real, I think, competitive edge is. That is that ALS is a progressive fatal disease, extraordinarily complex, extraordinarily devastating. Progressive and fatal. Patients are passing away in 2 to 4 years. There is an estimated 100-plus new people in America diagnosed every week, and unfortunately, there's about the same number of deaths every week. ALS is kind of thought to be relatively rare, but all of us have recognized ALS touching us in some way or the other. The challenge is that everybody's passing away.

The advantage we have is that since Lou Gehrig famously lent his name to this disease in the 1930s with his diagnosis and his retirement from professional baseball, and for many decades we called it Lou Gehrig's disease, but it took 60 years for the first drug to be approved. That drug is called riluzole, generically, and it's pretty much the only drug that patients can take worldwide in many countries. In this country, patients can take another asset too. But there's very few therapies. They do, unfortunately, very little, and there's not been any approvals in heterogeneous sporadic disease, which is to say most of the ALS condition, 98% of ALS is heterogeneous sporadic, that has been approved in the last number of years. In other words, since 2005. That's 20 years of no development really.

Our asset is coming forward to a new drug application shortly. I think the unique thing is that people living with ALS experience extraordinary burden, that there's this massive, significant unmet need, despite, as I've just expressed, the standard current of care. What Clene is doing is working to extend survival for people living with ALS, and to do so with oral administration of this proprietary gold nanocrystal therapeutic suspension.

What is the biggest misconception about Clene or your candidate, CNM-Au8, that you think this conversation can help to clarify?

Well, unfortunately, multiple, numbering now in the many dozens, we also missed our primary endpoint on ALSFRS. This is ALS Functional Response Scale. Let me give a little context. For decades, standard of care in clinical studies in ALS was a survival endpoint, but that could not be achieved, save for riluzole. The ALS community rallied around another measure as a primary endpoint called ALSFRS, and also because the disease is uniformly fatal, clinical studies for far too long were short, 6 months or so. It makes total sense. ALSFRS is a functional response. It is on 12 domains of function. How I move and walk and talk and eat and chew and breathe. It also makes sense that clinical studies be only 6 months for double-blind placebo in the history of this because patients are passing away.

But the fundamental fact is that everybody keeps missing the primary endpoint, including Clene. Clene missed the primary endpoint ALSFRS in the HEALEY study. But what is unique here is that only Clene achieved a survival benefit. Only Clene achieved, in these large studies, a clinical worsening statistically significant benefit, and only Clene achieved an improvement in what is called CAFS, Clinical Assessment of Function and Survival, and only Clene achieved, in a double-blind, placebo-controlled study, a neurofilament light change. That is of, in the HEALEY program, 8 different regimens. What we are doing is taking all this collective data, despite a missed primary endpoint, to the U.S. FDA, and going down what is called a surrogate possible approval path. There is the misconception that despite a missed primary endpoint, does Clene have any chance? We think so, and we have had a series of dialogues with the FDA.

Our asset is precisely designed and scientifically shown to support mitochondrial function, to enhance the neuron resilience that this disease requires. Excuse me. I mentioned neurofilament light. This is something very relevant because another drug in a very small slice of ALS, a genetically compromised patient population that constitutes a few hundred people in this country, the FDA approved that drug on neurofilament light reduction. Our data is more modest in this broader set of heterogeneous disease, sporadic ALS. The question is, I think that investors may ask, is if Clene has missed its primary endpoint, and if their neurofilament reduction is modest, is there an opportunity? We would argue yes, because we have seen that neurofilament trajectory, that is a change in neurofilament, is associated with mortality risk.

Clene remains, as I've stated, the only drug that in double-blind placebo control studies achieved a nominally significant, nominally meaning the primary endpoint was missed, but it was nonetheless a relevant change in neurofilament. The FDA has asked us to prove that neurofilament reduction with CNM-Au8 administration is connected to survival. We've announced, in the last couple of months, a lot of data that says exactly that ALS neurofilament trajectory is in fact connected, in Clene's case, reproduced across independent studies, and shown that the evidence framework supports neurofilament response as a surrogate biomarker likely to predict clinical benefit. That's a phrase that comes directly from the statute, likely to predict clinical benefit, and that what we've seen with CNM-Au8 is that indeed we have shown that CNM-Au8 treatment has a neurofilament response and improved survival.

Do you consider that to be the most important point for investors to focus on?