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193. Bull, Bear & Beyond – Cereno Scientific: executive interview
2 Plays5 minutes ago
In this interview, we speak with Sten Sörensen, CEO of Cereno Scientific, about the key takeaways from the company’s FY25 results and recent progress across its cardiopulmonary pipeline. Sten outlines the rationale behind Cereno’s HDAC inhibition platform and its lead programmes CS1 and CS014, which target underlying disease mechanisms in pulmonary hypertension and related conditions. The discussion focuses on CS1’s upcoming Phase IIb trial in pulmonary arterial hypertension (PAH), insights expected from the expanded access programme and recent developments in the competitive landscape, including GSK’s $950m acquisition of 35Pharma (centred on its lead asset HS235) and the recent Phase III failure of seralutinib. Sten also explains the decision to expand CS014 into pulmonary hypertension associated with interstitial lung disease (PH-ILD) and provides an update on ongoing partnering discussions. He concludes by highlighting key milestones expected over the next 12–18 months, including clinical readouts and trial initiations.
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 Q226 and Phase II for CS014 in Q127). A third asset, CS585, a prostacyclin receptor agonist, is currently under preclinical evaluation for cardiovascular indications.
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About ‘Bull, Bear & Beyond’
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Transcript
Introduction to Sereno Scientific and CEO Stan Sorensen
00:00:08
Speaker
Hello everyone and welcome to Edison TV. I'm Jyoti Prakash, healthcare care analyst here at Edison. We're delighted to be joined again by Stan Sorensen, the CEO of Sereno Scientific, a company harnessing the properties of H-Tech inhibition to develop disease-modifying treatments for rare conditions.
00:00:27
Speaker
He joins us today to discuss the company's full year 2025 results and the key clinical and strategic developments shaping its cardiopulmonary pipeline. Welcome, Stan.
00:00:38
Speaker
Thank you, Judy.
Summary of Phase 2a Data and Impact on Pulmonary Hypertension
00:00:41
Speaker
So, Stan, let's start off with your 2025 results. Can you summarize some of the key takeaways and what stands out the most for you from the results?
00:00:52
Speaker
Sure. um we I think the Phase 2a data that we presented and almost a year ago, I think, um really showed us that we have hope to have impact on these patients, a pulmonarital hypertension, with disease-modifying action. and Our objective is to slow down, halt, and possibly reverse this fatal disease. so The results we saw had impact on prognostic factors on the class of New York Heart Association. We moved patients back to a lighter disease state. And we also had an impact on the contractility of the right heart, so the function of the heart. and
00:01:45
Speaker
We had othered other types of data such as reduction of pulmonary pressure as measured with Cardiomems or wireless technology. And in addition, we impacted the quality of life as measured by a couple of technologies. So Minnesota Heart Failure Program or this Impact in PH questionnaire.
00:02:09
Speaker
There was a um an article coming out published by FDA and CVCT that highlighted what you would need to do if you have the objective of having a disease-modifying agent for these patients. It was published in Lancet Respiratory in around February, March, I think, last year. And we believe we had foresight enough to design our Phase 2a to measure these various objectives that this publication highlighted that you should aim for, and not least the quality of life of these patients as a very important part, but also the prognostic factor of these patients, so which have an average survival time of about seven, seven and a half years so um on diagnosis. And we achieved these results with only three months therapy of a drug on top of standard of care. So we're hopeful that we will be able to now in our new study, Phase 2B trial, be able to document more in that direction. and so So that was a key highlight of the year.
00:03:24
Speaker
In addition, we got then positive feedback from FDA in a type C meeting and then later fast track designation in September by FDA. So basically well aligned with the regulatory authority in the hope that we will do something really good for these patients and work with them to bring this drug as good, well and as fast as possible to to the patients.
00:03:51
Speaker
and We later in the year got our phase 2b trial accepted by FDA. and So we will now pursue the regulatory authorities in other countries where we will pursue the trial. But so all in all for our lead program CS1, which is a repurposed VPA drug into this disease with a specific and formulation.
00:04:19
Speaker
and ODD designation both in in the US and in Europe, and that program went really well, we believe, last year. and We also signed up, ah partnered with a top CRO to pursue the trial. So we are we feel we are in in good shape with this program. and That was the main highlight of last year. We have two HDAC inhibitor programs because we believe that this mode of action can be applied to a multitude of of cardiovascular par indications and We as a biotech are pursuing two rare indications and with our two programs. And the second program, which is a new chemical entity, CSO14, we completed our phase one trial and we got positive data on safety and tolerance in that trial. And not less interesting is that we got the drug exposure
00:05:21
Speaker
in humans that we have seen to be effective as a disease modifying agent agent in preclinical work. so So that was very good and we are now pursuing this drug. We changed our target indication to PHILD. And the reason is that is that that is a better fit for for the drug and for us as a company as initial target indication. So all in all, these two programs and moved well forward.
00:05:53
Speaker
and And I think that's the highlight. Another aspect of last year was that we did ah refinancing and that we completed on the 27th of November, and covering a total of 665 million Swedish kronor, if fully exercised. So containing 350 million
00:06:19
Speaker
convertible loans, to two parts, and then 100 million in and an equity raise at premium, and then a couple of warrant packages that can be fully exercised on certain parameters. So all in all, the financial move last year was also a good one for Sereno. So that, I think, a completes and the major points, and unless I've forgotten something specific here.
Discussion on H-TAC Inhibition and Disease Modification
00:06:50
Speaker
Excellent. And you'd mentioned H-TAC inhibition. Both your core acids, CS1 and CSO14, are H-TAC inhibitors. For those new to Sereno, can you walk us through how H-TAC inhibition and epigenetic modulation work and why this approach makes sense cardiopulmonary conditions?
00:07:11
Speaker
Yes. H-TAC inhibition is... um an epigenetic modulator. So it's basically unlocking the DNA's ability to produce proteins the way it's supposed to do. And in certain diseases and also in relation to how you live your life, your DNA can be locked up so it doesn't function properly.
00:07:36
Speaker
and that's epigenetic impact, if you will, in general. With HTAC inhibition, we are able to unlock this this ah blockade that that there are around the carbohydrates, the histones. And and so What does this really mean? Well, if you have an HDAC inhibitor, you can impact a number of signal pathways that have a deleterious impact on the cardiopulmonary bloodstream.
00:08:10
Speaker
vessels and organs. And if you look at pulmonary otel hypertension, you have components such as inflammation, connective tissue or fibrosis development. You have myocyte, uncontrolled myocyte growth in the anterial cell wall. and you get eventually high pulmonary pressure which causes hypertrophy of the right heart which eventually fails. And you also have micro-thrombotic events in in these patients. So this is what's causing this short life expectancy upon diagnosis and also deteriorating quality of life. Now, what you'd like to do if you want to impact this disease more than just reducing pressure, which is more of a symptomatic approach, it's been very helpful with vasodilators, which is the dominant class in this indication. So you have, with those drugs, been able to extend the life expectancy from around 2.5 to 7.5 years
00:09:16
Speaker
But then it ends. So you cannot do more with the vasodilation. So the pathological process in these patients continue with or without the vasodilation.
00:09:27
Speaker
So what you'd like to do is impact these various processes that are negative. And this is exactly what we've been able and others to document with HDAC inhibition and specifically with VPA, which is our molecule that we have in c s one So it is an anti-inflammatory and anti-fibrotic. It has a slowing down of remodeling of myocyte growth. It reduces pulmonary pressure and in addition it is able to
00:10:02
Speaker
impact and prevent thrombotic episodes. This is all documented and published information. So when we decided to to select an indication, we chose PH as the most promising one to start with for Sereno and hopefully then to have a very valuable impact for these patients. So, and this is What you'd like to achieve is you'd like to slow down these processes, halt them, and maybe reverse these pathological processes. and This is exactly what has been documented in preclinical work, both prevention and reverse reversal of vessel and and cardiac pathological pathology. So we are very hopeful and we think that what we saw in the Phase II A trial was indications of of these characteristics and that this mode has.
00:10:58
Speaker
If you compare this mode of action to other new agents, such as, for instance, Sotartacept, which is a monoclonal antibody, a TGF-beta trap, molecule.
00:11:09
Speaker
It's a much more narrow approach. So it operates around TGF-beta. HTAC inhibition has an impact more upstream and on multide multitude of of pathways. And we believe that that is a more holistic approach in these patients and should be more effective when it comes to disease modification.
00:11:32
Speaker
so So that is, ah this is also why we believe that we should pursue more than one indication. do We believe we have a repeatable biology here in a small molecule that's very safe and well tolerated. It's been in man for 50, 60 years, VPA, for other diseases and much higher dosages.
00:11:55
Speaker
So we believe we can apply this mode of action to other diseases, and that's exactly what why we pursued a new chemical entity as a second generation HDAC inhibitor, and that's CSO14. And there are several proof of concept studies published in around 600 articles of VPA and and ah other and publications of proof of concept efficacy ah beyond pH is in IPF, so in lung fibrosis. There's also in liver fibrosis, kidney fibrosis, and in myocardial infarction, etc. So, We chose to pursue a second in the indication that's more into the lung tissue, pathological processes, so lung fibrosis, and we chose PHILD, pulmonary hypertension, interstitial lung disease. So so that's the target for CSO14.
Design and Endpoints of Phase 2B Study
00:13:00
Speaker
Right. And just talking about your primary asset, CS1, it's about to commence phase 2B studies. and And the phase 2B design is quite different from what we've historically seen in PAH.
00:13:15
Speaker
What was the strategic rationale behind the longer duration and the endpoints which has been chosen for the studies? Well, first maybe I should say that the investigators and patients didn't really want to stop the Phase 2A trial treatment. So we were asked to submit a to FDA and ask for extended access program. and we got that accepted immediately by FDA. So we have run one-year extended access program for 10 patients that were about half of the patients in the phase 2a trial into this longer program which primarily has as an objective to look at safety and tolerance over the longer term.
00:14:05
Speaker
We of course are interested to see if this each individual patient journey here is a good one rather than a negative one. So we will see it's a very small material, but but in any case it's a longer period with our drug in patients. That data, top line analysis will come out in Q1 and more analysis in Q2. So we're excited about that. We're also looking at potential impact on structure with a specific CT scan technology.
00:14:38
Speaker
app so So that's been going on last year, and we've had the last patient, the last visit. So analysis is so are ongoing. and When it comes to the design of the Phase 2b trial, we have, of course, taken notice of the FDA's and and the experts' and publication and also view on ah what should be pursued in new trials in this indication. and if you is especially are interested in disease modification. So we have constructed the design that way. And for a disease modifying agent that is not primarily a dilating agent, but a
00:15:22
Speaker
expect to have impact on the pathological processes, it's beneficial to have a longer period when you study this drug on top of standard of care. And that's exactly what we have done. So we have 36 weeks in in the third first therapeutic process window, so to speak, on top of standard of care. And then we swap the patients from placebo to active therapy, and then we continue the trial until 60 weeks.
00:15:53
Speaker
And there is a smaller window where they are are not on drug. and And the reason for this design is that so the longer period, but it's also and for patients in this trial to all of the patients to get active drug. There's also a possibility to see if the drug therapy has a lingering effect, which it hopefully should have after these 36 weeks. And that would highlight and to some extent the disease modifying capacity of the drug.
Positioning CS1 in the Pulmonary Hypertension Market
00:16:32
Speaker
Right. and And if you just look at the competitive landscape, there has been some important news flow in the space recently, including the seralutinib phase three trial outcome.
00:16:44
Speaker
How do you interpret the implication of the results on the pH field and what kind of read across do you see for CS1? Well, I think yeah first and foremost, ah you know, we are in this business to help patients and we are passionate about it. So we'd love ah drugs to succeed in their, you know, vision and a ambition to help these patients. So it's always negative when when a drug program fails to to prove what it's aimed to do, we we think. and
00:17:18
Speaker
I've been in the heart failure space most of my life and been able to add therapy to standard of care and improve survival with 30% plus in two previous journeys with beta blockers and MR antagonists. And at that time, there were a couple of agents, now there are seven.
00:17:37
Speaker
So if you have a deadly disease with a really bad prognosis and pathological deterioration, there is room for a multitude of of of therapies to help these patients and probably also needed. So and in heart failure, traditional heart failure, that was the case. and And we believe that pH is research on pH, probably due to this orphan nature, is 30 years behind the heart failure research. And we are one of the movers here.
00:18:13
Speaker
and When it comes specifically to the field, until a couple of years ago, it was purely vasodilating mode of action drugs. And then Sotardacept, TGF-beta that we talked about before here, came as a new agent.
00:18:30
Speaker
It's always difficult with new agents because you don't know if they're going to be safe and well tolerated and effective. And in the case of TGF-beta, it has its drawbacks when it comes to safety and on bleedings and also pericardial effusion and also on tolerance. But it seems it's effective at least up to six months.
00:18:55
Speaker
and Whether or not it's a disease modifying agent, I think, has to still be documented and proven. And this is a very narrow approach.
00:19:05
Speaker
with solutinib failing in phase three was one of the newer mode of actions that it didn't seem to be effective enough in that trial. So we'll see if if that program will continue to stop completely. We also saw last year Keras Therapeutics wanting to pursue a second generation, if you will, after Sotartacept with a better profile then sort when it comes to safety intolerance, and and then Sotartacept or WinRiver, but failed in phase 2B due to exactly pericardiac effusion, which is very dangerous.
00:19:44
Speaker
So and I'm a bit surprised actually that GSK are going for the same axis. I think it's if if they're able to be safer and more tolerant, that is a great thing, I think, but it' the jury will be out on that one, on on the b thirty five acquisition that was made last week, I think.
00:20:07
Speaker
So this leaves the field quite open for a once daily, very safe and well tolerated in man in much higher dosages. And so far, very well and and safe, and tolerated and safe in the PH trial we have pursued so far. And we are pursuing it in much lower dosages than has been in man for these 60 years.
00:20:31
Speaker
So once daily safe, well tolerated drug If it's now effective and a disease-modifying agent, it would be able to add to all the other standard of care drugs, including WinRiver. And I think it would be a preferred choice eventually to be added very early after diagnosis to get the full impact of the disease-modifying capacity.
Focus Shift to PHILD and Asset CSO14
00:21:00
Speaker
So, Sten, turning to your second asset, CSO14, you recently broadened the clinical focus towards PHILD, and you touched on this a bit. But what drove this decision and what should investors look for as the next key milestone from this program?
00:21:20
Speaker
Well, we believe that we already have very strong signals in PH. So we... with with our CS1 drug in phase 2A and in preclinical work. And and in addition, with CSO14, we had impact on plexiform lesions and fibrosis in a pH model.
00:21:44
Speaker
So we have a good standing, we believe, with our drug and remembering that CSO14 is a deuterized version of EPA, so new generation and improved and molecule. and We felt that ah the hurdle in IPF is quite high for new agents. A lot of agents have failed. The programs are very long and large.
00:22:11
Speaker
and And we felt that PHILE, there's even higher unmet need when it comes to agents. So from a scientific platform point of view, we believe that PHILD is closer to the data we have and that the hurdle in in terms terms of time and cost is lower and the need is higher. So these three components play for PHILD for our agent as the first indication. That doesn't preclude IPF as we move forward ah later with with this drug and in in expansion of indications, of course. We are and now pursuing our documentation work, if you will, the paperwork, and eventually discussions with regulatory authorities.
00:23:02
Speaker
and experts around the world to bring forward a Phase II program to FDA and other regulatory authorities for the program for CSO14 in PHILD. And we expect to have that submitted and accepted by the end of this year and start a trial, a Phase II program next year.
00:23:26
Speaker
Excellent. And Stinn, during the CMD, which was recently concluded, you mentioned that partnering discussions are ongoing.
Global Partnership Discussions
00:23:35
Speaker
Where are you in that process now? And what would be an ideal partnership look like for Sereno?
00:23:43
Speaker
and So we have been exposing, so to speak, and telling the world and the potential partners around the world, both global players, specialty players into the orphan disease or PH specifically, as well as local or regional players in, for instance, Japan, Asia, et cetera, about Serena, what we're doing and what that what we're doing is a pioneering effort with this new mode of action. and So these discussions have are with some partners closed and with other partners they're still ongoing and they're shifting compared to and what stage we are with the company and as we're moving forward, and discussions continue or change direction. so
00:24:37
Speaker
And I would say that we are in an exciting phase now. A lot of things, as you heard before, are happening in the pH field with the drugs that are there. We saw an acquisition of B35 last week by GSK. and A drug program failed in phase two last year and in phase three this year. So two mode of actions that didn't really come out well in the trials. And and so there is a strong...
00:25:08
Speaker
need and a strong appetite we believe for drugs that can make a difference and we've we sense that in our discussions and that's where we are basically and it's a changing field so i i said in in the on the capital markets day that i think that we will do some kind of deal this year with between sereno and and a partner and But let's see, the jury is still out on that. i think we have very good discussions.
00:25:41
Speaker
That's excellent, Stan. And it seems like a lot is going on with the company and and we look forward to the progress over the coming
Upcoming Milestones and Developments
00:25:49
Speaker
periods. But as we look ahead, can you quickly summarize the most important upcoming milestones for Sereno, which would be of greatest interest to investors?
00:26:02
Speaker
So and the first milestone that's coming up is actually some readout of the extended access program for el lead program CS1 in PH. So we'll get some information out in this quarter and some more information in Q2. That's the first information and milestone, I think. It's going to be really interesting. The second milestone of very high importance is the first recruitment into our Phase 2b trial, which we expect to happen in Q2. towards the end of Q2, I would say. And then that program is rolling. And remember, we are going to run this program on three continents, so US, and Europe and South America. and so so it's a
00:26:56
Speaker
sites and program with around 125 patients around the world. So there will be several milestones as this program progresses over the year that we will be able to report on.
00:27:10
Speaker
So those are the two and major milestones this year. And then, of course, the submission and acceptance by regulatory authorities of the phase two program for CSO 14. Those are the key things this year.
00:27:27
Speaker
And of course, I hope to be able to report something in relation to partners. Thank you, Stan, for your time and for sharing these insights into Serino's strategy and upcoming catalysts.
00:27:40
Speaker
For our audience keen to learn more about Serino Scientific, please refer to edisongroup.com for our ongoing coverage of the company. Thank you again, Stan.