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246. Bull, Bear & Beyond – SynAct Pharma: executive interview image

246. Bull, Bear & Beyond – SynAct Pharma: executive interview

S1 E246 · Bull, Bear & Beyond by Edison Group
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In this interview, we speak with SynAct Pharma CEO Jeppe Øvlesen and CBO Mads Bjerregaard about the strong momentum generated at the BIO International Convention in San Diego and what it means for the partnering prospects for lead asset resomelagon. They discuss the strong interest from global pharmaceutical companies following the ADVANCE Phase IIb data, why resomelagon’s differentiated non-immunosuppressive profile is resonating with potential partners and how the asset’s opportunity extends well beyond rheumatoid arthritis. They also discuss the upcoming FDA and EMA end-of-Phase II meetings, the evolving partnering process and the key catalysts that could shape SynAct’s next phase of value creation.

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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 of Key Speakers

00:00:07
Speaker
Hello, and welcome to another Edison Executive Interview. I'm joined today by Yepe Obleson, Chief Executive Officer, and Mads Beauregard, Chief Business Officer at Cynact Pharma.
00:00:18
Speaker
Fresh from the Bio International Convention in San Diego, we'll be discussing their key takeaways from the conference, the industry's reaction to resume laban, and what it means for Cynact's partnering strategy.
00:00:30
Speaker
Welcome, both. Thank you. So I'll start with you, Jeppe.

Success at Bio International Convention

00:00:36
Speaker
um Synact has attended Bio International Convention for several years now.
00:00:41
Speaker
What made this year's conference different and what do you make of the current sentiment and partnering environment across the biotech industry? Well, basically, we had the best bio for forever, I would say. ah There is an industry that is really moving right now.
00:01:02
Speaker
Basically what happens is that the big pharmacy, a lot of their products coming off patent over the next four or five years. So there is definitely a need for new products, and especially in RA, you see a lot of products going that way.

Industry Challenges and Synact's Strong Data

00:01:19
Speaker
ah If you look at the biotech side, then over the last four five years, you have seen that the number of projects coming into clinical development has gone down.
00:01:30
Speaker
So that means that there is a kind of supply and demand that works our way. At the same time, we are coming with fresh Phase 2b data.
00:01:41
Speaker
and We're very proud of those data. We feel very comfortable. that the they are good enough to do a deal. And therefore, it was for sure a very interesting conference with lots of meetings, a lot of interactions and very qualified partners and very qualified discussions at a very high level.

Engagement with Global Pharmaceutical Companies

00:02:06
Speaker
Excellent. And turning over to you, Mads, now, Yepe mentioned that you had a number of productive meetings at BIO. What were the different kinds of pharma and biotech companies you were speaking with and did the level of engagement meet your expectations? I know you mentioned that this was the best bio ever, but just would love to learn your thoughts on this.
00:02:28
Speaker
Well, thanks. Thanks for the question. um we We spent a lot of time in building kind of the the ah the schedule for for the meeting in anticipation of the data reading out before the ah the meeting. and And we have seen a very good reception on on acceptance of building our schedules. So we basically had a full program, a full calendar with both um global pharmaceutical companies, yeah the the one the players are very active in in in the space.
00:03:03
Speaker
We have several meetings lined up with with regional players, both from European point of view and and Asian, meaning Japan, South Korea, China, point of view, yeah Latin American, and obviously also the US focused companies.
00:03:22
Speaker
The level of engagement in was stellar. um To Jeb's point, you can definitely tell something is going on. People are getting ready to ah to to act um With our data in hand, we definitely had a good card to to play and in terms of getting on the agenda and have very, very meaningful and conversations.

Interest in Study Data Without Immune Suppression

00:03:44
Speaker
Great. and And if you look at the advanced study data, now there were several positive signals. now Even though it missed the primary endpoint, the ACI 20 and biomarker data was quite encouraging.
00:03:57
Speaker
How were these results received by the pharmaceutical companies you met with and what aspects of the data set resonated most strongly with these companies? so So clearly it was the um the totality of the program in in telling what is needed to have a successful phase-free program.
00:04:20
Speaker
to meet regulatory demands and to meet the demands of uptake, meaning what what physicians would would need and what payers would need. And in that sense, it really is the the ACR response, which hit where we wanted it and fits with novel mechanisms, as seen with the TNF blockers and GAC inhibitors and so forth.
00:04:44
Speaker
um It is the reduction in in systemic inflammation markers, which is very, importantly and kind of validates the ah the mechanism. And then it's the totality of reaching very good results on those markers without suppressing the immune system.
00:05:02
Speaker
I think that element was the key trigger for all our discussions across the board of saying how this is a mechanism that does something different and hits the markers that will work in in rheumatoid arthritis.

Beyond Rheumatoid Arthritis: New Opportunities

00:05:17
Speaker
um and and doing that without the side effects that are usually associated with therapies in this area that is the key excellent and turning back to you lepe from a commercial perspective uh were the discussions mainly centered on rheumatoid arthritis or did companies also recognize rhizomalocon's broader potential across inflammatory diseases for sure an interesting angle and um Basically a lot of focus is on r RA, but with these companies you move quite quickly into other discussions about all ah other programs and other opportunities. The good thing about especially the bigger companies is that they have the strengths, they have the money and the resources to drive ah our our project into into a lot of other indications.
00:06:09
Speaker
So in all these discussions, we are normally discussing three, four, five other programs that could be could be relevant. ah What is the real key factor here is that we need to make sure that in ah in a potential agreement, we are we are paid ah for those indications as well.
00:06:31
Speaker
So that is, of course, a lot on on on the agenda as well. So no, for sure, ah many other opportunities varying a little bit from company to company, but I think we are reasonable dressed for taking the discussion.
00:06:46
Speaker
And as you know, we have some data on other indications as well. We also have some animal day animal data to support that as well. So we think we're in a reasonable good situation to to discuss those with potential partners.
00:07:03
Speaker
And we look forward to hearing more about that.

Crucial Meetings with FDA and EMA

00:07:06
Speaker
um So ye the next major milestone for Resimiligon is the FDA and the EMA end of phase two meetings. How important were these to your discussions and are they viewed as the next key value in inflection points for CENACT?
00:07:23
Speaker
It's an important point and we have already started a preparation for taking those discussions. The good thing about it is that we are we are very convinced, but our partners in discussion were also quite convinced that we are phase three ready.
00:07:43
Speaker
And that's of course ah an important factor for us. um And therefore, all attention is to to get those meetings established and come out with the right result.
00:07:55
Speaker
But we are quite confident and it was nice to see that the partners share our confidence.

Strategic Partnership Structures and Timing

00:08:01
Speaker
So I'll probably direct the next one to you, Mads. How have your discussions at BIO influenced your thinking in terms of the timing or the structure of a potential partnering deal? And what would be an ideal partnership for you?
00:08:16
Speaker
Okay, that that's a little little hard to answer straightforward because um so there there is no deal on you know on before the ink is dry, so to speak. right so So I have to be very careful what the what how to relate to that. um It's very clear the discussions we've had on buyer you know that sets a direction that is is is based on on those structured discussions. From a timing point of view, we definitely want to make sure that that partners are joining us towards the discussion with authorities to design face-free. That's a priority of of of ours. So from a timing point of view, the next 6-12 months, that's really going to focus in on
00:09:10
Speaker
getting the right partners on board, and making sure that we that we join forces in in how to address the authorities and and and then take it from there. But again, is so hard to predict the timing of these these discussions. So so i'm I'm not going to do that at all. um the The perfect opportunity here um you know This caters to both global ah deals that you know that that can can be done in ah in in parallel.
00:09:44
Speaker
We are also open up for discussion for more regional-based deals, meaning that you can do one area in the world to start with and then find another partner for another area of the world and will be the kind kind of coordinating partner in that. So we're open for a lot of various types of of of deals.
00:10:06
Speaker
um I don't think I should, we should probably not go into much more detail at this point in time and and really leave it to the discussions that are ongoing right now. Excellent. and And I'll wrap this up with Yepe.

Future Plans and Investor Updates

00:10:20
Speaker
Following the momentum you've seen at Bio, what are the next steps for Synact? And I have to ask you this again, when might investors expect an update on the part-leding discussions?
00:10:33
Speaker
We are moving we're moving now the the different companies into various levels of discussions, ah many of them under CDA already.
00:10:43
Speaker
And then we're going into different processes and due diligence. Quite a few of the companies, they know us from the past, so they can go quite quickly. That's of course good.
00:10:55
Speaker
We would love to update the market as as soon as we have something that is of substance. But there's a little bit of a balance. you know We also need to make sure that we don't give out too much information because potential partners would of course look at Where are they?
00:11:13
Speaker
Where are we? and How is the process going forward? So it's a little bit of a balance. So I hope that during the during the autumn we can give a bit of an update and show that we are progressing.
00:11:28
Speaker
But we also need to make sure that we keep our statistical strengths ah in in those discussions and not reveal too much of where we are. Thank you both for talking to us today and we look forward to hearing more on the progress with Resume Lagon. For our viewers interested to learn more about Cynact, please refer to EdisonGroup.com for our ongoing coverage of the company.
00:11:52
Speaker
Thank you again. Thank you. Take care. Thank you very much.