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226. Bull, Bear & Beyond – Cereno Scientific: executive interview
5 Plays11 minutes ago
In this interview, we speak with Sten Sörensen, CEO of Cereno Scientific, about the company’s strong start to 2026 and the key takeaways from the Q126 results. He provides updates on CS1 ahead of its planned Phase IIb trial in pulmonary arterial hypertension (PAH), discusses the advancement of CS014 in PH associated with interstitial lung disease (PH-ILD) and the ongoing pharmacokinetic bridging study, and explains the rationale for selecting antiphospholipid syndrome (APS) as the lead indication for CS585. Sten also highlights how the company’s clinical programmes are aligned with the evolving regulatory landscape, helping to de-risk development, and comments on growing interest from potential pharmaceutical partners. He concludes by outlining the key milestones and catalysts investors can expect over the coming months, setting the stage for a newsflow-rich period.
Cereno Scientific (STO: CRNO-B) is a clinical-stage biotech focused on developing innovative treatments for rare diseases in the cardiovascular and pulmonary fields. Its pipeline is led by CS1 and CS014, HDAC inhibitors with disease-modifying potential in PAH and PH-ILD, respectively. Both candidates are supported by encouraging clinical data and are advancing towards later-stage clinical trials (Phase IIb for CS1 in June 2026 and Phase II for CS014 in Q127). A third asset, CS585, a prostacyclin receptor agonist, is currently in preclinical development for APS.
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About ‘Bull, Bear & Beyond’
Bull, Bear & Beyond': features candid conversations with senior executives and from our own team of experts from across industries, exploring strategy, innovation, and the opportunities shaping their markets and 60-second pieces are a compressed summary of content designed to convey our message in a single, easily shareable hit.
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Transcript
Introduction and Q126 Results Discussion
00:00:07
Speaker
Hello and welcome to another episode of Edison TV. I'm Jyoti Prakash, Director of Healthcare at Edison. Joining us today is Ten Sorensen, CEO of Servino Scientific.
00:00:19
Speaker
The company has reported some interesting news flow recently and announced its Q126 results today, which we will be discussing in more detail during this interview. Welcome, Ten.
00:00:30
Speaker
Thank you.
Progress Highlights and CS1 Trial Plans
00:00:31
Speaker
So Sten, just to kick off, 2026 has already been a very active year for Serino and you reported your Q1 26 results today. What would you identify as the key milestones and main takeaways from the year so far?
00:00:46
Speaker
Well, we have seen really good progress in the start of 2026 for Sereno. And ah obviously the um key milestone that we're looking ahead to to kick in is the start of our phase 2b trial for a lead program, the HDAC inhibitor CS1 in PH, the rare disease.
00:01:10
Speaker
pulmonary arterial hypertension, and we're targeting that for June, so very soon. We've also seen good progress on our second HDAC program, the novel CSO14, and that's a very capital efficient and fast strategy that we're implementing and we're currently doing a study to fast forward this program to a phase 2b trial and starting and next year.
00:01:41
Speaker
And of course, we have also increased the visibility of our third program, the preclinical asset CS585 into the rare disease space, and we've increased the visibility of that target. So and all in all, a good progress for the company.
00:02:00
Speaker
Great. and And clearly the biggest upcoming catalyst is the phase 2B initiation for CS1.
CS1 Trial Preparations and Approach
00:02:07
Speaker
You mentioned that the trial is expected to commence in June.
00:02:11
Speaker
But what are the key remaining steps ahead of initiation for you? Well, we started the year by communicating that we have a fantastic and gravity into our program from the top 10.
00:02:24
Speaker
thought leaders in the space in PH and in cardiology. So we announced the clinical steering committee consisting of Mark Kumbair, Sandeep Sajar and others, including Deepak Bath, the cardiologist running Mount Sinai.
00:02:40
Speaker
and So we have a a very good leadership of our program and ah Professor Mark Kumbair is also the chairman of this steering committee. and So that was the start. We also and moved on our patient-centric approach and made an agreement in alignment with PH Europe Global and for the input into the steering committee, Halskore,
00:03:08
Speaker
who is a long surviving PH patient actually and very active in that organization. And we believe very much in a patient-centric approach. So provision of thoughts into our clinical program and then also awareness and possibly improve their patient recruitment recruitment through that collaboration. So very happy with that.
00:03:34
Speaker
Of course, we are operatively a very intense period with our CRO partner, a leading actor in the field of PH. And it's intense and work and with in relation to getting everything aligned. So and a lot going on with that program.
PK Bridging Study for CSO14
00:04:00
Speaker
Moving on to your second asset, CSO14, and this was recently repositioned towards PHILD. And you also mentioned recently there was an announcement that the PK bridging study has been initiated. Now, can you just walk us through the study design and and also explain how this will help de-risk the pathway towards the planned phase 2B study, which is expected to start in early 2027?
00:04:28
Speaker
Yes, so normally when you have pursued and and gotten your preclinical package in order, you submit IND or similar to the authority where you pursue your first phase one study, which we have done in Sweden with CSO14 in Uppsala, where we've done many studies.
00:04:48
Speaker
and so But then when you want to move on from that, you align with the proper regulatory authority. We did so initially with FDA, and we got feedback that if we pursue the bridging study relative to the old molecule VPA that's been in man for 60 years in various dosages and and so much is known about the concentration in in the human body, et cetera. So if we did a bridging study versus that with our new asset, which is actually a modified version of VPA, we could move straight for a phase IIb trial rather than what you usually do, a phase IIa trial. and So that it by itself would save Sereno a fair amount of capital and a fair amount of time, up to two years time, if we succeed with that trial. And the trial is actually PK-PD. So we are looking at drug exposure levels versus VPA in in man.
00:05:53
Speaker
And if those are appropriate, which we believe they will be, and we will avoid additional safety studies and can move directly to the Phase IIb stage. So we're very happy with that. And it's a two-dose exposure over in 14 patients over a two-week period, if I now remember correctly.
00:06:16
Speaker
Very useful information. Thank you,
Focus on APS and CS585 Strategy
00:06:18
Speaker
Sten. And you also have a third asset in your portfolio, CS585. And you recently selected antiphospholipid syndrome or APS as the lead indication for this asset.
00:06:30
Speaker
What drove you to prioritize APS as the target indication? and And then what kind of commercial opportunity do you see in this indication? Well, Jotje, as you know, Sereno Scientific is focused initially with our efforts into rare and ah orphan or rare disease space and because we believe there is ah a very high unmet need in many indications there and we could be most useful there initially. It also is a good strategy for a biotech because and normally it's less capital intensive and it requires less time.
00:07:06
Speaker
So for CS585, we announced APS because it's such an indication. And we have already a longstanding and research agreement with University of Michigan. We actually inlicensed CS585 from University of Michigan, and we collaborate since that deal with the inventor and professor Mike Hollenstad, who's active at University of Michigan. And in the work that we have done there, we have documented in a variety of vessels that CS585 is able to prevent trebosis without increasing bleeding risk. This was covered in JTH, in editorial and podcasts, etc. about this work. so
00:07:56
Speaker
Now we have increased the strategic direction and also the visibility of that by announcing APS as our target. So that's the background.
00:08:08
Speaker
Commercially, and we're looking at a very large market, actually. So 18 billion U.S. dollars and growing. so And there isn't very good technology. treatment there at this time. And we hope we will deliver this drug and be able to deliver a lot of value to patients and and treating physicians. That's great. And Tim, if you look at your entire portfolio, ah you are targeting rare, often conditions with significant unmet
Regulatory Alignment and Drug Repurposing
00:08:41
Speaker
need. But how closely are you aligned with the regulatory authorities on these programs?
00:08:47
Speaker
Well, it's it's an interesting question, which I actually like a lot because I've spent my career ah repurposing drugs into new indications. and So this is the third or fourth time, actually.
00:09:01
Speaker
I did it initially with MR antagonists in heart failure in the mid-90s and then moved on to do it with beta blockers in the mid-90s. And they both increased survival with more than 30% in heart failure. and quality of life, published in New England Journal of Medicine.
00:09:19
Speaker
And when I met Sereno, I had a gut feeling that this could be another time where actually HDAC inhibition could be repurposed in to new indications, such as cardiopulmonary diseases. And we believe that Sereno is pioneering that effort with our programs. And interestingly, in Lancet pulmonary lt respiratory, and both FDA and our chairman of our steering committee published with other thought leaders that if you want to pursue pulmonary tail hypertension, you should design your trials in a way and ah to look at prognostic impact, to look at function, and to look at quality of life.
00:10:07
Speaker
so And that's exactly what we're doing with our trial. So we have aligned it with FDA. We have ah actually the chairman and also author of that program is is well aligned with Serena, of course. And and we also obtained a fast track designation by FDA last September. So CS1 is very much aligned. Our repurposing effort and Actually, recently FDA made a public call to investors, pharma, and the thought leaders to look for indications or repurposing mode of action agents that are being used for something today and could be useful in new indications. And I've been doing it most of my life, and we are doing it at Sereno. So very much aligned on that one, too.
International Engagement and Partnership Interests
00:10:58
Speaker
then just Just moving on to the next question, and we've we've seen that s Serino has become highly active at international scientific and investor conferences more recently.
00:11:09
Speaker
So what kind of interest are you seeing from potential pharma partners? And following up from that, what type of collaborations would be most strategically relevant for Serino at this stage?
00:11:22
Speaker
Well, we have you know we we are very happy that our efforts are being acknowledged by various parts of the sector. When it comes to specifically partnering and pharma, we have been very active and since ah two years, a one and a half year, I would say. And so we are present at things like JP Morgan, Bio Europe. and This year, i was active in Tokyo, a bio-Nordic event in Tokyo, and then on to bio-China in Shanghai. And we see a lot of interest around what we do. We believe we are in a sweet spot for interest, and and that means
00:12:08
Speaker
actually coincides with the appetite increasing by pharma, both global, region regional or local players, I would say. So a clinical mid to late stage and program, and rare de disease space, first mover, ah repeatable biology into multiple indication possible, that's something that pharma is looking for.
00:12:34
Speaker
um We are in several discussions and contacts with various players, and local players in Japan, for instance, ah regional players in Europe, which have been quite active actually and recently, and also global players. So let's see what will come out of that. Those relationships are normally not short before a deal is made, so but we are on our way.
00:13:02
Speaker
I would say also that when it comes to a deal, we are looking at all three, local, regional and global. And and I wouldn't rule out any of those, but they have to fit with Sereno's ambitions here. So let's see where we end up. We're happy for the interest in the company. That's great and all the best for these discussions, Stan. And just to wrap up, as we progress through 2026, what can investors look forward in the coming months from
Upcoming 2026 Milestones Overview
00:13:33
Speaker
Sereno?
00:13:33
Speaker
So we have, of course, the and first patient in, in our global phase 2B program in the rare disease PH. And that's expected, targeted for June. We really hope we can keep that target. And that's a a US site.
00:13:49
Speaker
and And then we have ah the analysis of our extended access program for CS1, looking at if we can see anything in a quite small number of patients on the efficacy side. We also have a sub-study in that the in collaboration with Fluida, and looking at and structures of of the lung vessels.
00:14:13
Speaker
and So that's coming out also targeted for June. And what else is that we are doing the bridging study communicated yesterday and that we have the first patient in. So that's a little later. we conclude that in mid-summer, sometime in the in the mid-year, and then results coming out just after the summer.
00:14:34
Speaker
And then we are moving with CSO 14 to um a apply for an IND in PHILD, the rare disease, lung disease, and hope to get that accepted by regulatory authorities within the year. And then we will have two programs in phase 2B, actually. One and a ready to start, if you will. So that's really what I...
00:15:02
Speaker
you know Those are some really key milestones for the company, and I hope investors will enjoy them. That's great. And lots going on and lots to look forward to as well. Thank you, Stan, for speaking with us today. Thank you, Jyoti. I appreciate it and have a good day. Thank you.