Okay, we are ready to get started. Good afternoon, and welcome back to the Virtual Investor 2024 Pitch Conference. My name is Jenene Thomas. I am CEO of JTCIR, and I will be the moderator for today's event. For this event, each presenting company will provide a five to seven minute elevator pitch followed by a Q&A session. We had a great morning session, and to kick off our afternoon session, I am pleased to be joined by J.D. Finley. J.D. is Chief Executive Officer of Palisade Bio. Welcome, J.D.
Thanks for having us, Jenene.
Happy to have you. Before we get started, I want to inform our audience that Palisade Bio is publicly listed on NASDAQ and trades under the ticker PALI. During today's discussion, the company will be making forward-looking statements. I encourage everyone to view the company's website at palisadebio.com or the SEC's website for the latest filings and information. J.D., I'll turn it over to you for your quick pitch.
Great. Thanks, Jenene, again for inviting us to present. A little bit about our company. Our focus is on advancing early stage drugs, addressing immunology and inflammatory diseases, and especially those that may have a fibrotic component. We are very excited about our lead program, which is a PDE4 inhibitor targeting ulcerative colitis and Crohn's disease. It's a small molecule that was initially developed in the Merck labs in Montreal. We really like this space because, as many of you are aware, inflammatory bowel disease is a multi-billion-dollar market, with many early stage drugs being sold to big pharma for, you know, anywhere from several hundred million dollars on the low end and up to several billion dollars on the high end. We currently have two drugs we're developing with this molecule. Our lead drug, PALI-2108, is focused primarily on ulcerative colitis.
We're finishing up our preclinical studies and plan to start our human phase I studies in just a few months. There are several aspects of this drug that I think make it very exciting. First, the science shows that patients with ulcerative colitis have an overexpression of PDE4 enzymes. This has been demonstrated to play a significant role in the inflammation of the bowel. By using our drug, which is a PDE4 inhibitor, we believe it will be highly effective in helping ulcerative colitis patients achieve remission rates that are significantly higher than other drugs currently marketed for this disease. Second, and what makes our drug unique is our pro-drug formulation, which allows for a delayed release of the active PDE4 inhibitor until it reaches either the lower end of the small intestine or the colon.
The reason this is important is because other PDE4 inhibitors that have been used in clinical studies trigger adverse effects such as headaches and nausea. That's because of the systemic exposure of the drug to the patient's central nervous system. These adverse events, you know, the headaches and nausea, lead patients to discontinue therapy. By using our pro-drug formulation, we believe we can locally deliver the active PDE4 inhibitor at the site of the disease and minimize the adverse effects that are seen with the other PDE4 inhibitors. This has been validated in our animal studies. Finally, we've been collaborating with a couple of groups and analyzing thousands of biomarkers to develop insights into which patients might be the best responders to our drug.
For those of you who might be living with ulcerative colitis or may have friends or family members living with this disease, one of the things that you'll understand is a big frustration with UC is that physicians struggle with finding a drug to treat their patients. Most drugs have a remission rate of only 10%-20%, meaning when a physician prescribes the drug to a patient, it has less than a one in five chance of working, and it usually takes about three months before you know whether the drug has worked or not. By pre-selecting patients that we believe are more likely to respond and by giving them a drug that hopefully has a much higher remission rate than 20%, it removes a great deal of uncertainty from the prescription process. So, looking at the development plan, here's a quick look at the timeline for developing PALI-2108.
As I said, we're wrapping up our preclinical studies with plans to submit our CTA filing within the next couple of months, and we're on target to kick off our phase on I-A trial in Canada before the end of the year. There's several strategic reasons why we've chosen Canada as our first, as for our first, our first study, I'm sorry. And we expect top-line readout on that trial in the first half of next year, at which point we'll kick off a phase I- B/II-A study. So, with that brief overview, let me turn it back over to you, Jenene.
Excellent, J.D. Great, great quick pitch there. A lot of exciting things happening at Palisade Bio for sure. So, you've really had an important focus with your pipeline into the UC space. And so, I'm just wondering before we open it up for Q&A, like, what was so attractive about this space to you?
Well, you know, as we've talked, it's, first of all, it's a major market that big pharma is very focused in. And second of all, and this kind of goes back to what I was saying earlier, you know, I've got, I personally have several family members who were suffering from this disease. And the process that they, the frustration is they suffer because they have to go through this trial and error process of figuring out what's the best therapy to treat them. You know, it really makes it dear to my heart to find a solution for them and for all the other millions of patients out there who are suffering from this.
Well, I appreciate that response, J.D. I have to say, you know, you've had an action-packed 2024 so far. We've seen a lot of progress, a lot of announcements just showing, you know, positive traction and moving your program, PALI-2108, towards the clinic. So, congratulations on all of your progress.
Thanks.
Sure. Enough from me. I know our audience has some questions. So, to our audience, if you have a question for J.D., just click the Q&A button at the bottom of your screen and type in your question, and we will get to as many as time allows. And J.D., I have to say, you did a great job on that quick pitch. You packed in everything in a short period of time. So, happy to hear that. So.
Thanks.
All right. Our first question is, are you engaging with the FDA currently? And then will this dictate when you will enter the clinic?
Yeah, we are, you know, alongside having discussions with Health Canada to kick off our phase I trial in Canada, we're also in discussions with the FDA. Our plan would be to do our next trial, our phase I-B/II-A trial in the United States. And so, we're in communication with the FDA and plan to go through a pre-IND meeting with them this year as well.
Great. Okay. Our next question is, what is the total addressable market?
Total addressable market is around 8 million patients worldwide.
Okay. Great. Our next question is, oh, this is a good one. Is management investing in the company?
Absolutely. And as I mentioned in my brief remarks, I have been and will continue to buy shares in the open market because, as I mentioned, I think there's a huge disconnect between the value of this company and where we could be in a very short period of time.
Our next question. Current therapies aren't great with sub 20% remission rate. That really sets a low bar. What do you think would be success? What do you think would be success to get approval?
Well, to get approval is one thing. To be successful, in our view, is another thing. To get approval, I think we need to demonstrate a placebo-adjusted remission rate of 20% or higher. Quite frankly, some drugs are being approved at as low as a 15% placebo-adjusted remission rate. Our target is much higher than that. We think, given the data we've seen, that we're hopeful that we'll see remission rates of greater than 30% with this drug.
Okay. Our next question. Hi, J.D. Great progress this year. My question is about patient selection. How can PALI narrow down specific patients who can benefit the most?
Well, and that's what we were just talking about with the precision medicine approach, some of the biomarkers that we're gathering data on. And by the way, one thing that I didn't mention, but it's worth mentioning now, is that in our first trial, our phase I-A, there will be we're actually labeling it a I-A/B trial because we plan to select 20 patients at the tail end of that study and, using the biomarkers that we're developing, narrow that down to probably the top four to six patients that we think will be the best responders to our drug. We'll gather some great pharmacodynamic data from those disease patients to help us hopefully identify that these biomarkers, that there's a strong correlation between these biomarkers and our drug and our ability to address those patients.
Okay. Our next question. You recently announced a scientific advisory board. How active are they in your development process?
Very active. In fact, two weeks ago, we met at Digestive Disease Week in Washington and had a meeting with them. They continue to advise us on trial design and the like. These two guys are, you know, some of the best in the world in this area. We're very lucky and grateful to have them on our clinical advisory board.
Excellent. So, our next question. Why do you think remission rates are so low with existing approved drugs for IBD? Is it tolerability of these drugs, or are they just not great targets for the disease?
Yeah, I think it's a combination of things. Tolerability certainly is one of them. You know, if you look at, and I guess this is another aspect of our drug that we're excited about. We are, because we're oral, we're one of few drugs that are oral. The ones that are oral, either, I think there are four current drugs in the market that are oral. Two of them have black box warnings because of the side effects. And the other two have remission rates of like 15%, something like that. So, the market is, you know, desperately looking for an oral therapy that has much higher remission rates and fewer side effects. And that's the importance of us developing this as a pro-drug, is that it limits the systemic exposure to the central nervous system and hopefully will eliminate a lot of those, a lot of those side effects.
Okay. Our next question. Apremilast seems to be very effective PDE4. Why do you think they are not going after UC?
Well, that's, you know, seven years ago, they ran phase II studies in UC. And again, the problem is, if you look at the, if you look at the data from that study, as they increased the dosage, the effectiveness went down, the remission rates went down. And a lot of that is because patients discontinued the use of the drug because of the side effects. So, I think what they've concluded is that they could not get the tolerability to where it needed to be in order for that to be a commercial solution to UC.
Right. This is a rapid-fire Q&A. I love it. So, we've got some good questions. Okay. So, our next question. You had some very interesting data in May showing high activity of the drug in the lower GI tract. Can you talk about how this might mitigate some of the side effects common with other oral agents for UC?
Yeah, well, that's the whole point of the pro-drug formulation, where the drug, the active ingredient, doesn't get released until the bacteria of the lower GI tract basically releases the pro-drug or releases the active drug from the pro-drug. That way, the drug is getting to where it needs to be to treat the disease as opposed to being exposed to the central nervous system in levels that cause all those side effects we've talked about.
Great. All right. That seems to be all the questions. Done and done in 15 minutes. I love it.
I love it.
But before you go, J.D. So, you've had a lot of exciting progress. And, you know, we've seen a lot of really good milestones being hit just even this year so far. So, if we think about, we're at a quick pitch conference. You have investors that are, you know, watching this right now. So, what would you tell investors why you think it makes sense for investors to look at Palisade Bio as an opportunity right now?
Well, first, thanks again for allowing our company to present today. To answer your question, I couldn't be more excited about our lead drug and the clear pathway to bringing this much-needed therapy to patients. Janine, you've heard me say this many times, but I believe there's a major disconnect between our current market cap and the intrinsic value of our company. I know this is a fate shared by many micro-cap companies in today's market environment. You know, we're currently trading at half our cash. I believe the downside of investing in the stock is very limited while the upside is virtually unlimited. This is why, as I said, I've been buying and will continue to buy Palisade shares in the open market.
Excellent. Well, J.D., great way to end this session. Really appreciate your participation. So, this does conclude the Palisade Bio quick pitch session. What a tongue twister, right? I'd like to thank J.D. Finley, CEO of Palisade Bio, for joining us today. I'd also like to thank our audience for your time, attention, and great questions as always. And look forward to you joining us again at 1:00 P.M. for our next session. And be sure you stay up to date on Palisade Bio by signing up for email alerts on their website at palisadebio.com and follow along on their social channels. Once again, as a reminder, you can access the full schedule of presenting companies at the 2024 Quick Pitch Conference at virtualinvestorco.com. I'd like to thank everyone and see you back shortly.
Thanks, Janine. Thanks, everyone.
Thanks, JD.