All right, happy to be here. I'm Sten R. Sörensen, CEO of Cereno Scientific. We are pioneering a new mode of actions, new drugs that are utilizing epigenetic modulation, so the way the DNA can produce essential proteins for the body to work well. We're pioneering that development in rare diseases, and we hope to slow down, halt, and even reverse the pathogenic progression of changes in the vasculature or changes in the lung, and I'll show you where we are with those programs. We have great hopes to improve quality of life and to extend life for these patients who have a very short time to live after diagnosis, so we are working with three different programs, and we have posed the question, what if we could help these patients in a different way?
So the company was founded in 2012 on the basis of Professor Sverker Jern's research here in Gothenburg, together with colleagues and with the help of GU Ventures. We are focusing on cardiovascular and lung diseases, and we have two clinical programs with those two, and we have one preclinical program also in development. We are based here on the fourth floor. We moved here a year ago, I think, if I remember correctly. We spent eight years at AstraZeneca's BioVenture Hub first. And we run this with the competence, capacity, and passionate brains of 10 people up here, but we work globally. And we have a daughter company in Kendall Square in Boston, an office there, and we have most of our research actually in the U.S., long-standing collaboration with the University of Michigan. So 10 people, how can we develop new drugs? Ask 90,000 people, right?
We work with a lot of collaborators around the world, clinical CROs, preclinical work, CMC, lawyers, regulatory consultants, et cetera, et cetera, collaborators like Abbott and others. So about 100 people every moment is active with Cereno developing our drugs. So we've been on a growth journey since 2012. Actually, we really got going in 2015 when we put the real business plan together and financed the company through a listing in 2016 on Spotlight. We uplisted last year on NASDAQ. We have 12,000 very passionate investors in the company, and we are approaching. We've actually been above SEK 3 billion in market cap, and we are continuing to grow. We managed to do this growth without VC backing, so just retail investors actually. Why are we so interested in HDAC inhibitors?
There are over 600 articles published about the real potential that you can achieve with this mode of action. Reverse remodeling, anti-fibrotic action, anti-inflammatory action, the ability to reduce pulmonary pressure, and the ability to prevent thrombosis, blood clots without bleeding risk. We are pursuing our drugs to have an impact on pathogenic processes that are actually linked in several diseases, and we are focusing on rare diseases. PH, PH-ILD, or IPF. PH, pulmonary arterial hypertension, the pulmonary vessel between the right heart and the lung. PH-ILD and IPF are lung diseases, lung fibrosis diseases. We have three programs. CS1 is a repurposed drug. VPA has been used for epilepsy prevention before for 50, 60 years in man. We took it into a rare disease, and we completed a Phase 2 program in this pulmonary arterial hypertension.
We decided to develop a new agent, so a new chemical entity, and actually got the idea from another entity company, a neighbor to us, and we bought the idea, and that's CS014. We just completed a Phase 1 program that's targeting fibrotic diseases in the lung. CS585, we're in license from the University of Michigan. I'll talk about that another time, but that's also exciting. So what if you could prevent this progression in this disease? And here's a lady, typical patient, midlife, 50 years. She gets the diagnosis that her pulmonary artery is narrow, starting to become narrow and stiff. She has seven years to live with that diagnosis. So what happens is that the muscle inside the pulmonary artery between the right heart and the lung grows. The muscle grows, and it's also connective tissue, so it gets less elastic.
Eventually, the right heart fails because it's too much pressure to pump against. That's actually how you die. What if you could have a drug, a therapy for these patients that slow down or even reverse that remodeling? We think we have that with HDAC inhibition and CS1. Earlier this year, Lancet published in Lancet Respiratory, actually Cardiovascular Clinical Trials Consortium, which we are partly involved in. Two of the founders of that are on our scientific advisory board. They published with FDA what to do to develop new drugs to have a disease-modifying capacity to actually halt or even reverse this pathological narrowing of the artery that you can see there. You should move to improve symptoms, you should improve prognosis, and if possible, you should reduce hospitalization and prolong survival. Now, fortunately, we had already designed our Phase 2 program to study exactly that.
The Phase 2a program was really the primary objective was to study safety and tolerance of our drug in this disease, but we looked very carefully for signals of efficacy, and we wanted to capture disease-modifying capacity signals of our drug, and we really did, so we documented that the right heart and the heart actually had a better capacity to pump. We also documented that there were better quality of life of the patients and that we have an impact on prognosis in a majority of the patients beyond lowering blood pressure, et cetera. Our drug was safe, and any side effects from the drug were transient and gone in a short while, so very pleased with that data, which we released this spring, and what you don't know maybe is that the doctors and the patients asked to be kept on the drug.
They didn't want to let it go, and so we filed for extended access program with FDA, and currently, or actually, we enrolled then 10 patients in that program, and we're looking for a 12-month readout of that program. We've had an early one that's in line with what we expected, and we will have a 12-month readout in Q1. We're also doing a sub-study to that program where we're looking with X-ray on the structure of the lung vessels, and we'll see what we can find through that method. It would be exciting to see if we can impact structure with that and see it with that mode. It's called a Fluidda study, but the real big thing now for us is to get the Phase 2b trial up and running.
It will be global, and we have signed up, we think, the best CRO to get the job done worldwide for us, and we're working on that protocol, and we'll submit it to the FDA and other regulatory authorities shortly. We have had alignment meetings with FDA, and we actually also got Fast Track designation by FDA, which means that they really see potential of this drug, and they will work with us to get it to the market as soon as we can together. That Fast Track designation we got very recently. So big market, a lot of patients in need. We think we can do something really useful here. So we also are developing another HDAC inhibitor. We call it CS014, as I mentioned.
So if you have the capacity to impact fibrosis development in cardiovascular disease, you would potentially also have it in lung diseases with fibrosis growth, connective tissue growth, such as IPF. Between three to five years life expectancy after diagnosis, mostly men in this case. So what if we could impact this patient group with the same mode of action, but now in a rare disease with lung fibrosis growth? And we just completed a Phase 1 trial which was very safe, very well tolerated, and we also had the drug exposure in that trial, which was similar to what we saw was enough to get impact on both muscle and fibrotic growth in animal work. So very happy with that study. We're now pursuing the design of the protocol of this drug, and we hope to bring it into the clinic in a Phase 2 trial next year.
So we have two programs that will be pursued into Phase 2 programs with a start next year. Yeah, so we're very excited about this, and we think that we will be successful. You never know with science, but we think there's enough evidence in the preclinical work. We think we have seen enough in the clinical work, and we believe we will have safe drugs that are oral, which is not unimportant, as you know, and that will be well tolerated compared to all the other drugs that are there. We also believe we'll have a drug in both PH and in IPF that can be added to the current therapies and add value, both quality of life value and life extension. So yeah, we feel that we are attractive for investors. Retail investors seem to like us.
We have had a 20%-25% growth of investors over the first nine months this year. The market cap has been growing, and we have been fortunate to work with partners to finance the company with debt financing and share issues that worked well so far. And we also have a process to potentially do a deal with big pharma, which is our objective eventually. So we are running business development track and are having talks with various pharma companies around the world, and we'll see where those discussions eventually end. And maybe you don't know, but around between 50% and 75% of all new drugs are developed by biotechs, not by pharma, right? But most of the drugs are launched by pharma. So somewhere in between the innovation and early development, there's a deal struck, licensing or acquisition to then bring it onto the market.
All right, hope this was okay. Thank you, everyone.
Thank you very much, Sten, and please raise your hand if you have any questions. Okay, then I start off. You have two parallel Phase 2, and are you going to fund those projects by yourselves, or are you looking to get a partner funding?
Driving biotech companies normally always involve to be prepared to finance your programs as long as needed, and we are working on that, and we're also working on partnering discussions, and we are prepared for both scenarios, I would say.
Okay, exciting times. If we go to CS1 and the study, it will be a global study, you said?
Yeah, so we expect these studies are normally somewhere between 100 and 150 patients, probably run around 40-50 sites in most parts of the world, the Western world at least. So U.S. is 60% of the market, so a lot of companies have their centers there, but you also branch out to many other countries in Europe and elsewhere in Asia.
Yeah, sure. And the initiation is in the first half of next year, right?
Yes.
For how long do you think the study will go on?
Well, we haven't really released that information, so we'll see where we end up eventually. We'll come back to that.
We go to the other Phase 2. Will that also be a global study, or could you elaborate a little bit?
We don't know really yet. So we have the choice to pursue phase 2a or Phase 2b trial with that eventually. We need to have our talks with the FDA, do our own homework, and then we'll see what we actually decide to pursue. But a Phase 2 trial it will be.
Yeah.
Size and specifics, we will get back to.
Yeah, of course. And in August, you had the news about the fast track, and how important is that for a company like Cereno?
I think there are at least three various importance of that. One is the recognition so that the regulatory authorities actually recognize that you have a potential to change therapy for the better despite what's out there, and that they will work with you actively to help you. So that recognition spills over to the shareholder market and to the investor market. So there's a regulatory recognition, there's a shareholder impact, and then there's actually speed and cost. So it's good in many ways.
Yeah, I understand. And you just mentioned it quickly, I think, but when it comes to the study, you work with a partner to get the patients enrolled, right? Or how?
We work with many things with the partners. You saw the, I mean, the various partners we have. We've had, when you work with a global program, you need to work very early with your partner to define the protocol together, we believe, and also work on the regulatory processes. It's really a partnership early on to get the program, the regulatory processes, et cetera, and the whole design going, and then you implement the trial. The trial is implemented through ethical approvals, first regionally like U.S., Europe, et cetera, but then you have local approvals, and then you have contracting that you need to do with every site.
So if you have 50 sites in every part of the world, there's a lot of work to get done, and then you recruit the patients under protocol, and then this has to be managed well so you have quality assurance of that that's done, et cetera, and then you have the analysis, et cetera, et cetera. So yeah, a lot of things.
Yeah, a lot of things to do. Time flies. Thank you very much for the presentation.
Thank you.