Transcript
Speaker: Hello and welcome to Edison TV. We are joined to- today by Stan Sorensen, CEO of Serino Scientific. The company has released its second quarter results today and we will be discussing the key highlights from what has been a particularly active period for the company.
Speaker: Welcome Stan. Thank you, Jyoti. Pleasure. So, Stan, let's talk with ah about the Q2 results. What would you see as the most important developments and key takeaways for investors from this period? Well, I think yeah first, our readout of the extended access program was encouraging. and We know already from our phase two a data and that we have ah seen and a very positive profile of safety and tolerance for a once daily drug on top of standard of care.
Speaker: And we also saw some very encouraging ah results, efficacy signals and of function of the heart, quality of life, and reduced risk profile of mortality with the revealed risk score. so Those are all encouraging, but the EAP, which added another 12 months of use of our drug in the total of a readout of six patients, so not a lot of patients, but the majority were either stable or improved. and So, very good signals. and
Speaker: The other thing is that we um actually post-period initiated our first site for our global phase 2 B trial in PH. And that's a major effort. and We have been pursuing this ah ah trial in three continents, North America, Europe and South America.
Speaker: And the first ah site has been initiated now in the US. So we're very much looking forward to getting full on with our activities recruiting patients. Of course, the first patient in is expected within weeks. and And we are somewhat delayed with that. But there are a lot of things going on when you start a global effort like this. So we're still keeping our target of and top line readout in Q4 2028 and comfortable with that projection.
Speaker: Thanks, Stan. And it's great to know that ah the slight delay in the initiation is actually not going to impact the top line readout timelines. um So moving on, Stan, I mean, partnering has been an important part of your strategy for CS1.
Speaker: How have the discussion with potential partners progressed over the past few months? And can we expect a transaction to happen during phase two to be or is it more likely after the top line readouts are out?
Speaker: Well, and we have progressed very well with our partnering discussions, I would say. And i i actually was um outspoken at our capital markets day and said, you know, a deal could happen any day. and potentially would happen during this year. That was my expectation. And I still maintain that.
Speaker: and I also said if it doesn't happen, it you know it that will be okay. I think that our...
Speaker: first ah in class movement here with the HDAC portfolio into rare diseases, cardiovascular and pulmonary diseases, is a very attractive one.
Speaker: And we have a multiple indication opportunity here with this common biology of disease progression affecting both ah organs such as cardiovascular vessels, the heart,
Speaker: and pulmonary vessels and other ah vital organs such as the liver and the kidney, we are pursuing the rare disease pH with our first asset, CS1, and then with CSO14, the second asset, we are addressing the lung.
Speaker: And if we are successful here, this is a major opportunity. And the question really for potential partners is when they want to step in and when we want to make a collaborative deal or an exit, an M&A deal. When that is the best time. And from my perspective, that can happen any day. And the longer we pursue our programs, the more documentation of this potential we will gather, the more attractive the asset and the pipeline will be.
Speaker: So let's see what happens. We've been very active. I've been at Bio, of course, in San Diego, together with my CMO and Chairman. And we've also been to to Tokyo and China and Bio Europe, etc. over the spring. And then we are continuing those efforts and activities during the fall here, both to Asia and to Europe and and the US. s So, you know, very active and very positive discussions, but can't predict exactly when the deal will happen.
Speaker: That's excellent, Stan. And you mentioned your second asset, CSO14. Now, this asset is also at an important stage of its clinical development. You've completed the PK bridging study and the results are expected shortly.
Speaker: According to you, what would constitute a successful outcome and how will that support a direct move into phase two? Yes, so CSO14 is our new generation HDAC inhibitor, and we believe that is the drug that is pipeline in a drug opportunity, and we are pursuing PHILD, the rare disease, the lung disease, with that asset.
Speaker: And then we have had already a response from FDA that a positive readout of this bridging study ah would it enable us to move straight for a Phase IIb trial if that is deemed positive by the regulatory authority FDA when submitted. And actually, I forgot to mention that that's also a key development during the Q2 that we completed the recruitment and the trial. And we're now analyzing the bridging study results. And we have ah guided that that will come out in Q3. So targeting September here. and
Speaker: What will happen is that we will include that information in our IND that we expect to submit during this fall. and We are are also hoping that we'll get a positive response of this during this year, ah the information, and then and ah going straight for a phase 2b, and we'll complete then our protocol definition, etc. so and A positive outcome is actually the regulatory's opinion that this is good enough. And we are looking at the exposed drug exposure levels compared to the mother drug, valproic acid, with this new octoduterized generation. And we don't expect there to be any surprises.
Speaker: So and we're hopeful that this will be positive and positive in the views of FDA. Great. And Sten, we also noted in your Q2 release that the phase two timelines are now expected in Q3 27 instead of Q1 27 previously.
Speaker: um What are the steps which remain to be completed prior to the phase two initiation? Well, first, of course, we need to analyze the data of the bridging study, and then we have a full investigative new drug application to write up. We've already started that work, of course. and We will include this analysis, and we'll also include the definition of a protocol for PHILD, a Phase IIb protocol. So that's ah that work that needs to be done. And then we need to have that feedback from from the FDA.
Speaker: And then we are on our way. Of course, we need to contract the CRO and we need them to get all the information. and administrative and regulatory activities in the centers that will be allocated or involved in this trial. But more than that, you actually need to have clinical trial material ready for such a trial. And because we're moving here,
Speaker: as a target directly to phase 2b, we have a larger need of clinical material, and there are steps involved in scaling up, stability testing, etc. that takes more time than it would have done originally. So and we were still they're quite tight on our type timelines and our objectives here, and with the move to phase 2b and the clinical material and that needs to be produced here, and we need more time. So that's why we have pushed this timeline now to 2027. That's
Speaker: that's great. And thanks for the updates, Stan. And if you talk about your third acid, CS585, you've recently selected antiphospholipid syndrome as the target indication.
Speaker: Could you brief us on how the preclinical work is progressing and when can we expect phase one to begin? Yeah, so as you know, we have a long-standing collaborative ah collaboration and and with the University of Michigan and Professor Mike Hollenstedt, specifically in the ah blood a disease area, is a professor there and has a big department and is a world-renowned name in the field. And our first work with CS585 was published in JTH, got its own editorial, a podcast, and and its article and for this very important work in preventing thrombosis without increasing bleeding risk. That was the first work that we did.
Speaker: And now we have initiated and targeted the and indication of the disease APS. So studies, preclinical studies are ongoing with that kind of disease model. and And we're also looking at how to best formulate the drug to bring it into man. So those are the two steps that are most important. Of course, we also and need to do tox work or safety study work. before we move this into MAN. So this is all yeah either planned or ongoing. The preclinical work is ongoing. The safety studies will commence eventually. That's great. And Sen, my final question relates to funding, which is always important. ah You ended the second quarter with around 39 million Swedish Kronan cash and also raised subsequently another 60 million in a directed issue.
Speaker: How should investors think about CERNOS funding needs over the next 12 to 18 months, given the phase 2B trial is going to ramp up and also CSO14 is going to progress towards phase 2?
Speaker: And just following up from that, what role could partnering play in meeting those requirements? And yeah, so of course, when you move ah three drug programs towards either and as now initiating a phase 2b trial for CS1, a global trial, and then moving for a phase 2b, hopefully approval in PHILD and initiation by Q3 next year, and then our third asset, moving ah in preclinical still, they all need funding.
Speaker: CS1 needs most now, and CSO14 needs ah most when you start recruitment in a major trial, but there are funding needs for that also as you move towards that. and so We ah had 39 million, we raised 60 that came in post that.
Speaker: And we are always working and looking and evaluating what is the best financing strategies moving forward for Sereno. We had a market cap of a plus 3 billion last year in May, and now we have half of that. So one has to think carefully about how much funds are being brought into the company and how. Of course, always, and if you can get a good...
Speaker: a partnering deal in place that will take care of either all the funding or partial funding of one or several of the programs. So that's always attractive on the right terms and with the right partner. But a company such as ours and other biotechs can't depend on those negotiations. So we always have to have a strategy that or several that you can implement as you go. And we have those in place and we are working on those. So I'll let you know more when I have more to say about that. But you can expect Soriano to do some kind of fundraising within the next six to nine months.
Speaker: That's great. Very insightful, Stan, and look forward to progress on these plans. Thank you for speaking with us today. Thank you. Thank you, Jyoti. Bye-bye.
