Gameto’s Post

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From NASDAQ market site, I'm your host, Christina Iranian. And joining me today is Dina Radakovich, CEO and cofounder of Comido. Dina, thank you so much for joining. Welcome. Thank you so much for having me today. Excited to be here. Very excited to be here and very excited to dive in. Tell me about Comido and the company's mission. Yeah. So Jamie is the Women's Health biotechnology company leveraging the advances of induced proponent stem cell and cell engineering. We come from the premise that we actually never had good models to study the female reproductive system and therefore. Develop novel and better treatments. So with Kamito, we build this induced proponent stem cell or I PSC derived over is in a dish and we use it to study the diseases of the human productive system and develop novel treatments. And the idea behind all of our treatments is not only that he was cutting edge science, but they keep the female patient journey at the core. Wow, that's amazing. Your main product is for Tilo. Tell me about that and how is it transforming the fertility treatment space? Yeah, absolutely. So IVF. Make freezing. So obviously you've been a a miracle in size. Over 10 million babies have been born worldwide and a Nobel Prize in medicine was received for the discovery. But the female patient journey hasn't changed since the first IVF baby was born in 1978 in the UK, right? Women still today have about two weeks of twice daily hormone injections that are today still urine derived from urine of other women or recombinant hormones. So the patient journey is difficult emotionally, physically, financially. Psychologically and it obviously leads to fewer people accessing the the treatment and doing on average 3 cycles that most people need to get a baby as as per the data in the US. So with Portillo, we changed their process into a technology more people can do. In a fertile cycle, a woman would have just about two or three once daily injections followed by the eggs being kept in the coculture system with their Fertilia product. Which are young ovarian support cells. So kind of imagine using a bit of growth inside your body and then doing the maturation outside of the body in a young over in a dish. Because these cells were stem cell derived. And therefore you changed A2 week process into a two or three day process. And you remove the basically the difficult unwanted side effects from giving systemic hormone injections. You remove some of the other issues that women have during stimulation such as inability to exercise to have intercourse. Travel and certain risk like hyperstimulation syndrome risk of ovarian torsion after retrieval when the ovary twists. So it it's really is a much simpler shorter and what we hope is to be more accessible solution for people wanting to access assisted reproductive technologies. That's amazing. It really sounds like it is simpler and more effective and you recently had your first baby born on fertile and December congratulations thank you yes so for Tilo is or do you receive clearances in several markets where the 1st. To be born in December of last year, which was a huge milestone, I mean for medicine and for the field of induced for potent stem cells, right Cincinnati Yamanaka won a Nobel Prize for that in 2012. Kamito was actually I believe the first phase three that won Ind clearance from the FDA to start a phase two trial of an IPC therapy. We were very proud to see a biomedical first, but this time happens to be in Women's Health where historically was very much lacking behind other areas of of medicine where we have so much more modern. Precision medicine engineering techniques so fertile has already cleared in Australia where there with IFA and versus health Mexico, Peru, Argentina, Japan and we are now in starting our phase three trial in the United States. We got the Ind clearance to initiate the trial and the more information about our face to trial is now available in clinicaltrials.gov if you search for terms for Tilo Gemito. Or in vitro maturation, that's amazing. Congratulations on all your success. What is the technology behind for TILO that makes it different and essentially more effective than traditional IVF? Yeah. So I think like so far our data from pregnancy cycle is showing that for a broad patient groups were at parity with IVF. We are more effective than previously approved IBM solutions, right. This concept of kind of maturing inside of body part literally. Or, or in full. And that is because, well, kind of the basic biology in our ovaries is that eggs need this supports our environment to mature. They need that signaling, right? They're a little bit like a human baby when it's born, you throw it out, right? I, I'm a mom, I still have a 14 month old, right? Like I definitely remember how how much help and nourishment they needed. So similarly for eggs, they need the nourishment of the support cell environment. So currently IVF when woman injects the hormones. You kind of give the obviously the dose systemically to act on the ovaries and on her own ovarian support cells, right. The eggs themselves don't even have receptors for the hormones we give. We try to give her own support social environment and hyper stimulated to try and mature more eggs, which doesn't normally happen. So in the fertile cycle, you essentially can you, you time it with the right phase of the menstrual cycle to have a bit of growth of follicles. You give a little bit of simulation to grow the follicles to ease the retrieval procedure, which is basically. Extracting the eggs out of the body and then the final step of maturation can have an outside of the body and there there's no like competition in that in a dish. It is much more regulated control. And as I mentioned, because our ovarian supports us, our stem cell derived, they're young. So you essentially give every woman a young ovary in a dish. The previous FDA approved solutions for kind of this way of in vitro maturation have been mostly media and just kind of providing basic nutrients. Just maturation to spontaneously happen but what we have seen in biology in this research was conducted at Harvard Medical School, but it's every other centers were researching this is that the eggs need that support cell signals. So really the difference is IVF realized her to kind of boost your own but it's does it gives us systemic side effects this you can replicate that in addition a controlled faction and user young over at technology really kind of my my cofounder Mark Martin Varshavsky who's a himself. A serial entrepreneur built 5 unicorns. He's the founder, chairman of Inception Prelude, one of the largest clinic chains here. He called us a young ovary company. So really our young over in a dish is a fertility program. And then we leverage similar technology of these young ovarian support cells for the implants for our menopause program, right? For which we last year also received 10 million non diluted funding to hopefully bring it to Phase 1. So it's really leveraging that young over in addition technology. That's amazing. How long does the process take end to end? Well, from the fertile cycle, it depends what type of stimulation is given. There is variation that is usually determined based on women's own ovarian reserve. But it could, you know most of the time. And there is one consultation where if you where you have the consultation, you have the ultrasound, you get your treatment prescribed and then maybe three days later you come for retrieval. And that is when you go home the same day. And then they would just call you later and tell you about, you know, the number of. Eggs or embryos, whatever the purpose of the cycle was. So in general, the woman usually just has a one kind of appointment and then the retrieval. No monitoring in most kind of standard, OK, RBF there is a monitoring every two to three days, even though women do inject at home and you know, maybe one or two days off, once a day injections. We've had and we've published papers which showed that 92% of women would repeat the cycle, which is very important. Again, giving this is very much a numbers game and as I mentioned. People do need often two or three cycles to, to get a baby and that's why people do this, right? Nobody's doing it for fun. And so it is really a a much shorter process and much easier to integrate into everyday life. I personally participated into one of our egg freezing trials here in New York City and it was, you know, even in my busy CEO of startup CEO lifestyle and back then there were loads more things going on. It was I was able to integrate it into. My lifestyle without any significant side effects. That's amazing and great to hear your personal story as well. Well, it is important because honestly, when they came up with the fertile ID, I was also thinking about from a perspective, OK, like, how does you know, women go through this egg freezing? And why haven't we solved this? And some people will tell me, yeah, well, when women want to become mothers, they would jump from the roof. So why bother, you know, doing this? Like, is this a real company? And I was like, excuse me. Right. Like women absolutely deserve better solutions. And like, just across Women's Health. Contest fertility, but this was kind of the first area where we felt we had the science and we can really create a game changing product that is is definitely more empowering, right? Like we've, you know, this process of IVF hasn't changed. The advertising around that has changed, right? Like it has become egg freezing, for example, is marketed to women, almost an area of self empowerment, but a process still very difficult, right. So I think I felt that, you know, there is a need for a change and there are so many more women that would potentially consider it if you know. It was a shorter and more convenient for them. And obviously this is for everyone, right. Like we talked about the female patient journey, but you know, all all all people are relying on this. You know, one in five heterosexual couples have infertility. Even more same sex couples rely on science to build their families. So it is, you know, really everyone's problem and it's getting attention so much as in even issue of geopolitical importance would fertility rates and governments are starting to intervene. So in Japan. For example, the governments are now paying for IVF cycles and I think, you know, we will see, see more. So this is really just one of the innovations that will hopefully allow people to to build the families they want. That's amazing. It's a very mission driven company and sounds like there's a lot of opportunity for growth. So what's next? Well, right now we're be launching so you can follow us on our on our website for the 15 announcement of 15 sites where you can for patients that are interested to learn more about our. Way through trial, again, the trial will be across 15 top IVF clinics. It is the fertile cycle versus the short medical IVM and there will be a stipend towards your next cycle for patients who don't get pregnant. So that will be starting to recruit and in the United States and then for patients outside of the United States, we keep adding more and more partners and jurisdictions where we are cleared we're also under regulatory review in numerous. Under jurisdiction, so for international audience, again, on our website, they can link to these clinics and and learn more about the product. And then on the broader pipeline side, as I mentioned, we're kind of doing the ID enabling animal work in the menopause. So we'll see. That's a much earlier science product, but hopefully if it goes well, you know, we will be looking to to bring that product to the clinic as well. That's amazing. Well, the work you're doing is absolutely incredible and we're so excited to continue following. Dina, thank you so much for joining. Thank you so much for having me again.