Health, it trades on the Nasdaq under the symbol JAGX. It's a commercial stage pharmaceutical company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Happy to welcome back Founder, CEO, President, and Director Lisa Conte. Welcome back, Lisa. We look forward to hearing your update.
Thanks, Anna. Yeah, I'll jump right into it here. Nice to see you again. Okay, and we have our forward-looking statements. You know, one of my board members often says, you know, doing the same thing over and over again, expecting a different result is the definition of insanity and what he's referring to. Our stock price has been flat for some period of time. When I say to him what I think is equally crazy is changing the approach, doing something different and expecting to get the same results. We're not going to be getting the same results because of what's different and the catalysts that we have coming up literally just around the corner. We have two major programs, five clinical regulatory catalysts leading to a manifestation of three potential major business development deals.
The first catalyst here is on the rare disease side, our orphan drug program for short bowel syndrome and MVID. We now have four phase II studies started. Some of this work with key opinion leaders, regulatory agencies, trial design, endpoint definition have been almost seven, eight years in the works. Here they are with the first proof of concept data expected to come out in April of this year, literally around the corner. The patients are enrolled and that first proof of concept data will come out in April of this year. There is a major pediatric gastroenterology meeting every year in Abu Dhabi. It is run by the Head of the MENA Association, which is Dr. Mohamad Miqdady . We have been working with him for seven or eight years. He has the first two pediatric patients enrolled at Sheikh Khalifa Medical City.
The full expectation is he will be presenting that proof of concept data at this conference again in April 2025. That is what is different in the rare disease program. In the cancer program, we have for seven years been planning, executing, analyzing our phase III study to expand the indication of our FDA-approved product, Mytesi, from the current indication of HIV-related diarrhea to prophylaxis for cancer therapy-related diarrhea for patients on targeted therapy. Part of the flatness in our value has been that we did miss the primary endpoint that was announced in July of last year that was including all different solid tumor types and three different types of targeted therapies.
However, when we look at the prospectively defined subgroup of breast cancer patients, which were close to 70% of the patients, what we found is statistical significance in the responder analysis, the analysis that got crofelemer approved for Mytesi for HIV. It was presented at San Antonio Breast Cancer Conference. It has been presented to our scientific advisory board, which includes patient advocates. We will be sending a briefing package to the FDA and expect to meet with them in the second quarter of this year about the same timeframe that I previously mentioned for the rare diseases to clarify the pathway to bring crofelemer, Mytesi to approval for breast cancer patients as well. This is the diarrhea on targeted therapy. It is intense. It is life-changing. It is severe. It is chronic. It is really unacceptable. We have a non-branded advocacy program called Make Cancer Less Shitty.
I personally have interviewed 50 leaders in the patient advocacy area, most of whom are metastatic, who really are now living for five, 10, 15 years because of these targeted therapies. The keyword is living. They want to live and not just exist. This is what I call the push-push. There are now formal pathways to bring patient advocates and patient voice into discussions with the regulatory agencies. On their own, without any prompting from us, the patients, the breast cancer patients who saw our poster at San Antonio, their message is, gee, this product's already approved. It doesn't have any SAEs. We know patients who have gotten it off label. Why should it not be available to us? That's their own independent foray and meeting with the FDA.
On the doggy side, each of the programs that I just mentioned, those events that are happening in the second quarter can lead to major business development relationships, non-dilutive dollars. That is what we have been waiting for. That is what we have been teeing up for years and years. There is a convergence that is happening right now. The third one is in the dog area. We have crofelemer approved by the Center for Veterinary Medicine for chemotherapy-induced diarrhea in doggies. We would like that to be extended to all diarrhea in doggies. I know the doggy parents would appreciate that. That is not our main line of business. We are in discussions with potential large animal health partners that would be able to do that.
What's really interesting is if you are a cancer patient in the United States with diarrhea, you can get a prescription for Canalevia for crofelemer, but if you're a human, not yet. That is a major goal that we have going on this year. Last thing I will mention is Mytesi is the only oral drug approved by the FDA under botanical guidance. Under botanical guidance, there's no realistic pathway to bring a generic to market. We essentially have exclusivity to infinity and beyond. We're not dealing with any of the patent cliffs that you typically read about in the pharmaceutical industry, which is quite valuable in our business development conversations when calculating terminal value and access fees and upfront non-dilutive dollars coming into the company. Crofelemer is truly a pipeline within a product.
We just added a patent filing on a new potential indication, weight loss therapy-related overactive bowel, the GLP-1s and the GI side effects associated with those. Not something where we're doing clinical work right now, but it is an opportunity and an indication for the future. I'll stop right there and leave a few moments for questions from you, Anna.
Perfect. Thank you, Lisa. All right. Yeah, tell me a little bit more about the company's development focus, excuse me, on rare diseases and about the benefits of an orphan drug rare disease business model for the ultra rare diseases like MVID.
Sure. Thank you for the question. Short bowel syndrome is about 40,000 patients around the world. Classic rare disease products that are in that area that are not standard of care because of the side effects, GLP-2s, are typically reimbursed at the rate of about $500,000 a year. You're talking about high mortality, high morbidity, high patient access, a lot of complications in taking care of these patients. MVID, ultra rare, is a couple of hundred patients around the world. Each patient is a bit of a unicorn.
We have already met with the agencies in Europe, for example, where there is an opportunity for PRIME, which is like an accelerated approval in the United States, literally off of benefit that could be seen in a couple of patients or this proof of concept that I mentioned coming around the corner in April, and also reimbursed early patient access in Europe, a program that does not exist in the United States. Because of that, we do have a footprint, Napo Thera, in Europe that is gearing up to be able to take advantage of that opportunity and get this product, assuming it is showing benefit, to these really fragile MVID patients who have absolutely no alternative whatsoever out there, nothing in development, nothing available to them.
On December 11th at the San Antonio Breast Cancer Symposium, your company presented statistically significant positive results from the pre-specified subgroup of adult patients with breast cancer from the company's recently conducted phase III OnTarget trial of crofelemer for cancer therapy. Tell me about the response to this poster presentation. How was it?
You know, San Antonio is a fabulous conference for everyone in the breast cancer community. Of course, the oncology community was there and asking a lot of questions. Two things really stuck out. The first is, I would say almost every, I think every manufacturer of a targeted therapy had somebody from medical affairs who came around because there are limitations in how these drugs can be utilized at full dose or without any interruption or without any resistance that is developing because of interruption, because of the side effects. One of the most prominent, of course, is diarrhea. In fact, as more potent agents, targeted agents are being developed, we are talking, you know, 60 or 70 of them or 80 are approved right now. The side effects, and in particular, the secretory diarrhea is becoming more intense. That was quite notable.
We are helping patients stay on their cancer therapy, and everybody has to be for that. They are actually helping educate and promote about the novel paradigm-shifting mechanism of action of crofelemer or Mytesi. The other thing was the patients, of course, that I mentioned and the advocacy that has organically grown there as they are seeking to have comfort, relief, ability to stay on their drugs. In particular, in this case, it was also the early stage patients who are very concerned about having a recommendation to start at a subtherapeutic dose because of the fear of diarrhea. They do not want to start at a subtherapeutic dose. They have got cancer. They have got an early diagnosis. They want to hit it the right way.
Absolutely. Lisa, do you have any closing remarks for our viewers?
This is the year. It's showtime. It's catalyst time. There is really a convergence of catalysts that coincidentally are all happening this year. This is the year we need it.
Wonderful. Thank you for this update. We appreciate it. We look forward to seeing you again real soon.
Thanks a lot. Appreciate it.
All right, everyone, we'll be right back. Welcome back, everyone. We have an update from Regen BioPharma. It trades on the OTC Pink Sheets under the symbol RGBP. It's a biotech company focused on developing innovative treatments using autologous cell therapies, RNA, DNA-based immunotherapy, and small molecules in the immune, oncology, and autoimmune disease space. Please welcome President and CEO David Koos and Harry Lander, Senior Scientific Consultant. Welcome back, gentlemen. I know you have a great update for us today.
Yeah, I'm excited. I think it represents a big milestone for us. Without further ado, I'll just jump right into that and we'll kick it off and roll it out the door.
Perfect.
First of all, Harry, any thoughts on how excited you are over this agreement with ClinDatrix?
Yeah, I think I agree with you. It's a milestone, a long time coming in terms of, you know, we haven't quite kicked off the clinical trial, but it's the penultimate step. I think it's a great opportunity for us. I think we found the right partner in terms of CRO, both in terms of experience and user-friendliness. I think these guys will be a terrific partner for this clinical trial.
Good, good, good. If you hadn't seen the, they call them tweets now, since it's X, no longer Twitter. Anyway, I posted up on X about this agreement that we signed over the weekend with ClinDatrix. They're basically going to step up and do the phase I clinical trials for us on HemaXellerate , which is the safety study, which is very exciting. This is the first step into the clinical stage of Regen BioPharma's existence. We're now a clinical and not a wannabe preclinical company. That's very exciting. Now, with the contract, there's a lot of things that are moving parts in terms of needing to discuss. The first step was executing what they call a master services agreement, which details what they're going to do for us.
The next step we get into will be them coming back with the milestone points and breaking that down financially for us, what that means. We'll be in a position that we can have a bird's eye view of what time they expect things to take, how much each segment is going to cost, and where we are in terms of making progress towards completing the phase I clinical trial. Now, once we complete that, we anticipate applying for a, what is the additional.
Indication.
Indication for the therapy. That'll be to treat the side effects for chemotherapy. That way, we see that as being a huge market for us. What do we estimate? Like $8 billion.
It's a very big market, yeah.
We see that being extremely exciting. I think that I'm just excited that we're in a place where we're finally kicking off clinical trials. It makes us feel, makes me feel like everything we've done to this point is justified and that we're now at a maturational level that suggests the effectibility of the biotech initiative. I think that moving forward, I expect to see, the first thing I'm looking for is the first phase of the trials, which they're going to outline for me, that detail what our expenses are, their time constraints, things of that nature, so that we really start feeling immersed in what's taking place and it all becomes real. That's very exciting. I don't know if you have anything to add to that, Harry.
No, I mean, you know, a clinical trial has many, many moving parts. Of course, the CRO will take care of all of them. You can imagine like a menu at a restaurant, you know, there's just many line items that are part of a clinical trial, whether it's at the beginning of a clinical trial when you're setting it up, when you're recruiting patients, when you're going through the protocol and treating the patients, and even after you're done treating the patients as you're analyzing the data and doing statistical analyses and things like that. There are, as you can imagine, many, many elements to the clinical trial. The ClinDatrix group are very good.
You know, they have a very nice methodology to put all these processes in place and to let us know what the pricing is going to be in the next three months, next six months, things like that.
Yeah. I'm excited. I've been on the phone with them several times over the last three, four days. It's all getting real. That's the important thing. We worked hard to get to this point. It's just nice to see it all coming together. Now, I know I actually set my timer to see where we're at. We're running a little thin on time. I don't know if we have questions out there. I think this would be a good time to jump in and let's hit those things.
Okay, great. Yeah, we do have some questions about your Reg A, if you want to talk about that, how much money has been raised for Reg A financing so far, and how much do you expect to be raised before the end of first quarter?
Yeah, I think the Reg A has had several moving parts of its own. We had to qualify it with the Securities and Exchange Commission. We had to qualify it in states that we've had indications of interest in. Now we're in a position that we actually are ready to raise money. In fact, we got our first wire in today. We're kicking it off. We've got interest. I've had many phone calls with both private and institutional investors that have a great deal of interest in the company. I think we'll start seeing it rapidly fill up.
Great. We have a few questions about phase I trials for HemaXellerate . How much money is needed to conduct that? When do you expect the phase I trials to commence?
With this agreement that we just signed, you know, this kind of kicks the door open. Now it's a matter of setting things up, getting the, what do they call it, the working protocols for how we do, what we do, when we do it, and how much it costs. That's in the process of being developed. They will send it over to me to review. I'll execute it and send it back to them. Overall, the first part of phase I should cost us somewhere between $100,000 and $110,000. The overall clinical phase I will be somewhere around $550,000.
Can you talk a little bit about your plan to scale up your research efforts to accelerate the development timeline?
I don't know that there's anything you can do to really accelerate the timeline. The timeline is pretty much what it is based on the protocols and what has to be accomplished within each protocol. You know, it can go very fast. If you get lucky, you get the sample population that you want immediately. The likelihood is that that doesn't usually happen overnight. That could take a little bit of time to pull that together. That's on the CRO now, the contract research organization. They have to find the population. They have to put it in place. From there, you move things along as accomplishments are made.
Wonderful. David, Harry, do you have any closing remarks for our viewers today?
No. Harry?
No, I mean, I just want to reiterate that it is, you know, you can feel that the company is now shifting into a new phase. And it's a nice thing to see.
I feel that everything in the air seems to have a different vibe to it. You know, you start entering into clinical phase I. It just feels like we're a fresh new company, that we're entering a new stage in our career. That's exciting.
Wonderful. Good. This is a great update. Happy to hear this. We will continue to follow along at the next conference. We are looking forward to it.
All right. Appreciate it, Anna.
All right. Thank you both. Thank you, Wolf. Yeah, great way to end. Concluding our conference today. This completes day one. We'll see you back here tomorrow at 9:00 A.M. Eastern for day two of our Super Virtual Investor Conference. We'll see you tomorrow.