Let's get started. I'm Scott Henry, Healthcare Analyst at Alliance Global Partners. Our next fireside chat is with Lipocine, ticker LPCN, with a market cap of approximately $20 million. Lipocine is a biopharmaceutical company that is developing treatments for Postpartum Depression, as well as the hot topic of Obesity Management. We cover the company here at AGP with a buy rating and a price target of $6.75. Stock currently trades around $3.40. Presenting for the company is Chief Executive Officer, Dr. Mahesh Patel. Mahesh, would you like to take a few minutes to tell our audience a bit about yourself and Lipocine?
Sure. Thanks, Scott, and thanks, AGP, for the opportunity. I'm Mahesh Patel. I'm the President, CEO, and Co-Founder of Lipocine. Lipocine is a biopharmaceutical company focusing on developing innovative therapies in neuro and endocrine disorders. We leverage our proprietary technology to enable effective oral absorption of molecules that historically have been very challenging to deliver orally. We have a commercial product based on our technology on the market and a robust pipeline targeting large unmet need. However, I am here to discuss our lead innovative assets, as Scott mentioned, namely 1154, positioned to change the landscape in treatment of depression, and a very promising candidate, 2401, supported by positive phase two results as an aid to GLP-1 users that may be chronic weight management patients or diabetes patients. That's the introduction. Go ahead, Scott.
That's fantastic, Mahesh. Let's kick it off. For background to investors, do you get a sense of how investors split up the pie between LPCN 1154 and LPCN 2401, the postpartum depression or the obesity management? What do you think investors place most of the value on?
I guess it's a good question. I see, or we see, both as highly valuable and important assets in their own rights, and here is why. Beginning with 1154, first, rapid relief of depression is a game changer. Postpartum depression is a subset of major depressive disorder, and it represents a significant market. 1154 is expected to have clear differentiation from currently available options, with potential for symptom relief in a matter of hours. More importantly, it's in the advanced stage of development, with phase III study ongoing, CMC work complete, and agreement with the FDA on path to NDA submission. With respect to 2401, it is also a highly valuable investment opportunity. It is targeted for an unprecedented large population of GLP-1 users for weight loss and diabetes.
It is projected that almost 30 million Americans are expected to use GLP-1, and north of 70 plus companies are working on development of an oral GLP-1. In general, weight loss in obese and overweight patients is healthy. However, it should be a quality weight loss as well as a quality fat loss. There is an unmet need to improve weight loss in terms of quality and extent. As an adjunct to GLP-1, it should not compromise weight loss achievable through GLP-1, and if any, it should improve the weight loss. We have shown with our candidate we have potential to do both, as mechanistically a product can amplify GLP-1 effects. 2401 represents a bioidentical myostatin inhibitor that works on all three relevant tissues: fat, muscle, and bone.
It is oral, it's liver friendly, and has got positive phase two results in the target GLP-1 treatment population, with respect to both body composition and weight loss. Equally important.
Okay. No, that's great. I think we'll get started first talking about 2401, the obesity compound, because investors do care so much about that category. Some of this you've already hit on, but just to flush it out, when someone looks at 2401, how would they use it in combination with the GLP-1? Is it additive? Could you get a sense of what kind of weight loss you'd have with that? Perhaps there's other reasons you take it in combination.
Yeah, sure. There are two aspects to it, right? First, as an adjunct to GLP-1, it would be an aid to improve weight loss and improve fat loss, with the potential to amplify weight and fat loss. Some of the target benefits include maintain or improve GLP-1 related weight loss. That's a must. As I mentioned, it could amplify or add on to the fat loss that we have seen with our monotherapy to date in the phase two results. What do we mean by quality fat loss? Predominant weight loss is due to fat loss and not necessarily to the lean mass loss. A high proportion of that is in the abdominal fat loss. You do not want to lose the good subcutaneous fat. You want to lose the bad fat that's in your abdominal area.
By quality weight loss, we mean preserve the lean mass and the associated functionality with the lean mass. The second aspect, right? GLP-1 users are reluctant to discontinue the use of GLP-1 because they're worried about fat and weight rebound. There are a variety of reasons why they discontinue. Of course, tolerability is one of them, and you've reached a plateau with respect to the most you could lose. This potential after stopping GLP-1 to get weight as well as fat rebound is concerning to current GLP-1 users. The expected benefit of 2401 with monotherapy post cessation to offer a ramp-off strategy would be to increase lean mass, minimize fat weight rebound, and more importantly, sustain the HbA1c improvement status and improvement in that marker achieved via GLP-1 use.
I guess there's an unmet need in terms of providing patients an off-ramp option that's currently not available. So these are some of the.
Yeah. It sounds like it can give a longer life cycle management treatment to the disease that could really bring some benefits to a very hot category, but always could use improvement as it continues to grow. Could you talk a little bit about the upcoming trial? When you expect that to start and what kind of design that should have?
A little bit first on the design. The study objective is to assess weight loss and fat loss as an adjunct to GLP-1 in stage one. The second stage would be to assess once you stop the GLP-1 use, the weight and fat rebound potential, or can you maintain the weight loss and attenuate the lean mass loss or muscle loss. We're planning to initiate a phase two proof of concept study as an adjunct to GLP-1. That's the first stage. We expect the first patient dosing to occur in the third quarter of this year, so next quarter.
When do you expect that we could get our first look at the data from that trial? Perhaps on top of that, could you just tell us why you're optimistic in the results? Perhaps some of the earlier clinical data is indicative, just to get your sense of how to look at that trial.
Yeah. When I mentioned positive phase two results from our NASH trial in the population that's consistent with the chronic weight management population, we saw favorable changes in weight change, as well as for body composition. Given that mechanistically our androgen receptor agonist can amplify GLP-1 effects, both genomically and non-genomically, we believe there is huge excitement for us to do this study. In terms of what investors would focus on in our upcoming phase II trials, as we all know, healthcare providers, investors, patients currently want more quality weight loss at a faster rate. I mean, that's the race is on. We believe investors would like to know if 2401 users as an adjunct can address the shortcomings of the GLP-1 while not compromising its benefits.
Besides improvement in body composition, I believe investors should look out for whether 2401 has potential for effects that are adverse or additive to GLP-1 effects, right, with respect to weight loss and fat loss. You do not want to reverse the benefits of GLP-1, and you want something that is tolerable. We believe our candidates should mechanistically help in both fronts in terms of weight loss and fat loss based on the positive GLP-1 effects we have seen. We have not seen any tolerability issues, so we should not believe there will be additive tolerability issues. The other focus might be for investors would be that the weight loss should predominantly be from the fat loss. That is the bad actor here and not lean mass or bone loss. Moreover, as an aid in GLP-1, can it attenuate loss of lean mass and associated functionality?
This is particularly relevant for sarcopenic as well as elderly population, where they have low lean mass to begin with. The other thing to note is that the investors should look for confirmation of superior tolerability relative to other active-in myostatin modulators, like Injectable Monoclonal Antibodies, and the SARMs, Selective Androgen Receptor Modulators, in terms of liver tolerability, muscle spasms, GI effects, which we have not seen to date in our phase II trials. We are pretty optimistic that we will have favorable benefit of risk profile. Investors will and should also be interested from a regulatory perspective, confirmation of unmet need in the vulnerable elderly population, because that would be the appropriate population from a regulatory standpoint, and the results of our 2401 intervention as it is related to patient functionality, because the guidance clearly says that the impact on patient, how they feel, survive is quite important.
Like I mentioned, based on positive phase II results, we're confident we have potentially improved weight loss and amplified fat loss while increasing muscle mass.
Okay. When should we look for that data once the trial's underway? I believe middle of 2026, is that correct?
I think it could be assuming we have first patient dose in the third quarter. I think recruiting should go pretty fast. I would say a late first quarter next year for the stage one result in conjunction with GLP-1. That's 24 weeks treatment duration. The stage two will be about six-eight months later. It will be third quarter.
Great. Have you thought about this is an expensive category to develop. Would you consider partnering it after proof of concept has been developed?
Absolutely. Each of our assets in our pipeline are partnering candidates. I'm glad you asked. Yeah, 2401, we're already seeking partnership to even proceed downstream because that's the plan after the proof of concept. We have already started discussions with interested parties.
Okay. We'll wrap up that part of the discussion. I would just highlight that is one of the main reasons we wanted to have you here today, Mahesh, because investors are always looking for obesity management companies given the considerable growth there. This is one that I think a lot of people are not aware of. It has some potential additive events as patients start looking for longer life cycle management. This could be one of the solutions. Even if it got a little more attention, it could do a lot for the stock price.
Yeah. Thanks for the opportunity.
Yeah. Let's shift over and talk a little bit about LPCN 1154. This is the postpartum depression treatment. Perhaps you just want to talk a little bit about the mechanism of action and how it's kind of an improvement on something we're already familiar with.
Yeah. So we're talking about Brexanolone, also known as Allopregnanolone. It's a bioidentical hormone with significant levels in the third trimester of pregnancy. Post-delivery, there's a precipitous drop of that mood-stabilizing hormone. Mechanistically, it's a GABA positive allosteric modulator that has potential for a variety of neuropsychiatric effects. Just to kind of give you a flavor on the design and the regulatory perspective, we have a phase three study that has started. It's a two-arm study, outpatient study in women with severe postpartum depression. It's a 48-hour treatment duration and plans to enroll approximately 80 patients. Also want to let you know that due to the bioequivalence that we have established with the injectable Brexanolone, FDA is recommending a single phase three study should suffice for NDA submission. We expect the first patient dosing to be very soon. Enrollment rate is going to be the determining factor.
The current projections are that NDA filing would be approximately a year from now. We are focused on selecting quality sites to expedite enrollment. Also, I want to mention that the clinical risk profile for 1154 is quite low in terms of phase three study risk because Brexanolone, the molecule is the same, has established efficacy in multiple studies with the IV infusion. We have comparable levels with that IV infusion. Also, the study size, duration, and population are very similar to the positive IV infusion studies. In terms of labeling risk, we have not seen any excessive sedation rate with the oral 1154 in several studies. We presented that data to the FDA. FDA is not requiring us to do an inpatient study. They have allowed us to do an outpatient study with no healthcare provider monitoring needed.
This bodes well in terms of product labeling if all goes well. That's the clinical plan.
Okay. Great. Because I know you originally had hoped to file on the PK data, but they did ask for more. And perhaps refresh my memory a little bit. When Sage took Brexanolone through the clinic, was that a pretty statistically significant trial?
Yeah. They were very successful with the, I mean, with the PPD indication in both of the pivotal trials. Yeah, I think the B values were pretty good. The treatment effect was good. We took that into account in terms of following our study. Yeah, the data was pretty clear. In fact, it was efficacious even at a 60 microgram per kilogram per hour, so at a lower dose. In fact, a touch better than the labeled dose.
If I recall correctly, Zulresso was a good product, but it required, I think it might have been a couple of days inpatient hospital treatment, which for a new mother could be a deal breaker in many situations. It is very challenging. Your product will be oral so, in theory, could be outpatient. Could you talk about where you think peak revenue potential for this product could be?
First of all, I want to remind PPD is a first indication in depression we are targeting. The postpartum depression is a significant market with about a quarter million mothers suffering from this debilitating disease. Currently, 60,000-80,000 are seeking intervention. This is going up as we speak as the diagnosis rates are going high thanks to the Sage and Biogen effort. Also, ACOG is kind of recommending perinatal screening for depression as well as postpartum screening. We believe LPCN 1154 can be a first-line option given its short treatment duration, expected robust efficacy, and good tolerability. We believe 30%-50% share market is within reason. The market is being approximated by some analysts in the range of $500 million to as high as $1 billion in the US alone.
Okay. So a significant product. We are starting to run out of time here, but I want to make sure I ask every company given the current environment. Can you talk about your balance sheet as far as the cash on hand and the runway we should be comfortable with?
Yeah. We remain measured and frugal with our spend. We expect while we conduct the study with 1154 and 2401, our burn rate is to be in the same range as it has been historically, $3 million-ish per quarter. This is exclusive of any non-diluted cash inflow. We have cash for at least 12 months and more. This is pretty measured spending and focused spending or investment, I should say.
Okay. Mahesh, that's great. Thank you for being with us today. As we mentioned, this is a name we wanted to have at the conference because you've got two shots on goal that we think are both exciting. One, different investors may prefer different lead programs, but both exciting and glad to have you here. Thank you for participating.
Yeah. Thanks, Scott. Thanks to you as well. And thanks everyone for.