A new approach to advanced Parkinson's disease. Serina discusses SER-252's clinical progress. This presentation will be co-hosted by Steve Ledger, CEO of Serina Therapeutics. Trades on the New York Stock Exchange under the symbol SER. This format is targeted for about 30 minutes, as usual. Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina's proprietary POZ platform drug optimization technology is designed to improve the integrated efficacy and safety profile of multiple therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody- drug conjugates. The company's lead program, SER-252, is being developed as a long-acting treatment for advanced Parkinson's disease. For more information, I refer you to their website after this, which is serinatx.com, S-E-R-I-N-A-T-X.com. As many of you know, I'm the managing director and member of Tribe Public. Our website is tribepublic.com. That's T-R-I-B-E-P-U-B-L-I-C.com.
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Steve, could you please start by telling us just a little bit about yourself and what brought you here today with Serina, and then go into your presentation. Thank you so much.
Thanks, John, for hosting us today. Good morning, everyone, and thanks for your time. I'm Steve Ledger, Chief Executive Officer of Serina Therapeutics. My background is three-plus decades of experience as a principal investor, capital markets, investment banking. I started my career at Fidelity Investments as an analyst and portfolio manager and have evolved organically into my current role in helping build an early-stage company into something that is prospectively a multimodal drug delivery technology that is addressing significant clinical unmet need across multiple therapeutic areas. It's a very big vision, and it's exciting to see the project come together with an incredible board of directors that we've been able to attract and a management team to such a small company. We think there's a significant disconnect between the intrinsic value of the business today and our tiny market cap.
Let me just get right into the presentation. Serina is building better CNS medicines as of current focus, a foundational focus from proven molecules. Our POZ platform takes drugs whose biology is already well understood and re-engineers them into products patients can live better with. Today I'll focus on our lead asset, SER-252, in the clinic now in advanced Parkinson's disease. The timing of our conversation is good, John. That's why I'm here today, to give investors and prospective investors an update on Cohort one observations from our phase Ib registrational study in advanced Parkinson's patients, which we announced those observations earlier this month. For the first time, we have patient-level clinical evidence to talk about. I'll direct you to our forward-looking statements disclaimer.
The presentation contains forward-looking statements subject to risks and uncertainties. I encourage you to review our SEC filings for a full disclosure of those risk factors. Three numbers to take away here. 10 million Parkinson's patients worldwide, and that is growing at 1.5%-2% annually, with a new patient diagnosed somewhere in the world every nine minutes, and no major clinical advances in the standard of care in the past 50 years. SER-252, our lead asset, is a clever way to deliver continuous dopaminergic stimulation to these advanced patients, and has best-in-class potential for the treatment of advanced disease. The Parkinson's patient journey follows a predictable trajectory. Diagnosis in the early days leads to oral levodopa monotherapy. When motor complications ultimately present, adjunctive therapies are used.
Ultimately, all the patients end up in that advanced category, where their symptoms are typically inadequately controlled with the current oral monotherapy standard of care, levodopa, carbidopa, and the adjunctive therapies that are used to try to control symptoms. Day to day, that means more frequent off time for these patients and less predictable control. Motor fluctuations and dyskinesias that limit daily function. Morning off periods that persist when treatment is limited to waking- hour infusion. The numbers define the target population that Serina is going after with our target product profile. Approximately 250,000 advanced Parkinson's patients, inadequately controlled on oral therapy across the U.S. and the EU4 plus U.K. I've seen estimates that are twice this, but we're using this estimate, as the total available market, filtered for patients who have access to advanced care, so they're centered around movement disorder clinics in major cities.
It's estimated that only 5%- 10% of eligible advanced patients are currently on what we're defining as a device-assisted therapy, which is the current standard of care in advanced Parkinson's. I'll show you what that current standard of care looks like in terms of product profile. The gap here is the opportunity. SER-252 is positioned for patients whose disease has outgrown oral monotherapy and adjunctive therapies but who face limited attractive options. Note the reason for that gap is not a lack of clinical benefit from the current standard of care. It's that the delivery burden is too high to accept. It's a product problem, not a biology problem. A product problem is what our platform is built to solve. Let's look at those approved therapies that represent the current standard of care in advanced patients, what they validate and what they leave unsolved.
Duodopa established the category. Continuous levodopa carbidopa therapy, but requires a surgical intestinal port, a pump, a gel pack, and high-maintenance administration. AbbVie's Vyalev was the follow-on evolution of this pioneering product, Produodopa. Vyalev brought a subcutaneous levodopa carbidopa product to market, and that product was approved by FDA in October of 2024. The pump is still part of the solution. It's generally worn only during waking hours, and the administration burden remains meaningful. The infusion site has to be moved constantly to avoid the skin reactions that are part of the product's profile. Each of these products, even though they're burdensome in terms of the platform with the SC infusion kit and the wearing it continuously 16- 24 hours a day, each validates demand, but each leaves room for significant improvement. SER-252 is designed directly around those limitations.
Continuous therapy without surgery, without daily pump set up, and without subcutaneous active moiety release. Here's what makes the timing favorable for Serina. Continuous dopaminergic stimulation, I'll refer to it as CDS in the presentation going forward, is becoming a real commercial category. Duodopa, Vyalev, and Onpgo are pioneering the space, and SER-252 is very well-positioned as a highly differentiated entrant. The market is being built by these recently approved products, and that creates a much clearer path for a differentiated follower. Existing launches do two things for us. They validate demand for continuous therapy, and they highlight exactly how much usability, tolerability, and caregiving burden matter to adoption. The recent Vyalev commercial trajectory, which I'm going to share with you in a subsequent slide, is useful external validation.
Early uptake tells you the demand is real, the unmet need is significant, and even though these products remain burdensome and less than ideal, that's the opening we're building into. SER-252, importantly, does not need to create physician or payer awareness from scratch. The investment case is pretty straightforward. It's category expansion plus potential share capture if our target product profile is clinically validated. Infrastructure, clinical familiarity, and reimbursement logic are all developing well ahead of us. I told you the category is forming, and here's what it looks like in terms of revenue. This is Vyalev, AbbVie's subcutaneous continuous levodopa product that I showed you in a prior slide, by geography. International launched first, and it has grown steadily, as you can see on a bar chart. The U.S. story is different.
Essentially zero in Q2 prior to the approval in October of 2024, $6 million in the first quarter after approval, $22 million Q2 2025. Then it inflected. $89 million Q1 2026 and $128 million in the U.S. in Q2 2026. Half of the revenue is U.S., and it is the growth driver. AbbVie is now guiding to a $1 billion annual run rate in the U.S. alone by early 2027, just three years post-approval. Importantly, this guidance is much higher than AbbVie guided to when this product was launched and where all the analysts sized the annual peak sales opportunity. Clear validation of the clinical unmet need and a much faster ramp than AbbVie had expected and the analysts expected. Why did the U.S. take off when it did? It was access. The J-code for Medicare Part B billing arrived in July 2025.
CMS's national coverage policy was finalized around January 2026. The two steps removed the structural barriers that throttled the early U.S. launch, and that matters for us. That reimbursement pathway for continuous subcutaneous Parkinson's therapy is now being built ahead of us, and it is now clearly defined what an eligible patient looks like in terms of where they are in the disease progression. SER-252 would enter a market where coding coverage, physician familiarity around CDS already exists. To be clear, these are AbbVie's numbers, not ours, but they tell you the story that when access opens, patients and physicians adopt continuous therapy, even with the burden of a continuously worn pump. If Vyalev shows demand is real, how much room is left for others? Starting with this base, about [audio distortion ].
Medicare. Claims it must be different for with demand, and it is about 500,000. We are assuming that 250,000 have access to first-line care. Before Vyalev was approved, only about 2,500 of those Medicare patients were on any device-assisted therapy at all. That's about 2%. 3/4 of those were on deep brain stimulation, brain surgery. Only 1/4 were on infusion therapy. Everyone else was managing on oral therapies alone in this advanced category. Compare that with - internationally, where penetration of device-assisted therapy is about 44% in specialist centers where a device-assisted therapy is available. We think the U.S. will follow that model. By any measure today, U.S. uptake sits in that low to mid to high single-digit range against a population where the clinical need is well established. The gap is not about benefit, it's about burden.
Surgery, tubing, pumps, daily setup, that's exactly the problem that SER-252 is designed to solve with our twice weekly, roughly 10 minutes of wear time, no tubing, no surgery, no skin reactions. Large population, very low penetration, a category that is now reimbursed, and SER-252 emerging as a highly differentiated product. That's the opportunity. What is SER-252? Those of you who have heard the story have seen the product profile, but it is a pozylated version of apomorphine. It leverages our half-life extension, drug delivery, product optimization technology that we call POZ, that is designed to make continuous dopaminergic stimulation dramatically easier to deliver in advanced Parkinson's.
The core insight, apomorphine is a clinically active dopamine agonist, but current continuous products from Supernus, called Onpgo, and other apomorphine-approved products that are more rescue therapies, like Apokyn and Kynmobi, are highly limited by pump burden in the case of Supernus's Onpgo, and by local administration site reactions by all apomorphine that is used therapeutically or as a rescue therapy. SER-252 preserves the pharmacology of the active moiety apomorphine while improving delivery and tolerability. Four elements are the key takeaways here. A known API, very low biology risk for our asset because apomorphine is well-characterized. Optimized delivery, POZ-enabled controlled release. A patient-centered device. We are partnered with Enable Injections on this device. It is a very clever on-body mechanical device, no electronics. It is a push-button operation.
A regulatory strategy and alignment with the FDA on what is called a 505(b)(2) NDA pathway, where Serina can rely on the data that exists in the real world and in clinical studies on apomorphine as part of our clinical program, supporting data to support an accelerated path to an NDA submission. The target product profile in one sentence. POZ enables SER-252 as a continuous therapy without surgery, without daily pump setup, and without subcutaneous active moiety release that causes skin reactions. Here is the target product profile more concisely. Continuous therapy through a compact on-body system with a brief wear time, twice- weekly delivery, not a continuous wear, not daily setup, about 10 minutes of wear time per administration. No tubing, no visible needle. It is delivered through a 30-gauge needle that goes about an eighth of an inch into the subcutaneous compartment.
Patients do not feel the needle. They are not exposed to the needle. No tubing, no electronics. It is a mechanical push-button operation with no programming required. Consider what that means for a patient with advanced Parkinson's, often with tremor, often with dexterity limitations, often reliant on a caregiver. Twice a week, 10 minutes, push a button, done. The product is designed to keep an advanced patient in an always-on state of good on time and very limited periods of off time. If we can titrate a patient precisely, we can dial out off time nearly completely. If the clinical data support the PK, the tolerability, excuse me, and the usability differentiation, this is a potentially best-in-class profile. What that means is a significant market opportunity. Our base case is a $1.8 billion peak annual sales opportunity. Our upside case is $2.7 billion annually if SER-252 expands the market.
The base case assumes share capture within that currently device-eligible population defined by that Medicare Part B coding. The upside case reflects category expansion, where our twice-weekly, 10-minute self-administered therapy pulls forward patients who would never accept a pump, a tube, or a surgical port, and perhaps introduces the opportunity to clinicians to treat moderate patients, moderate to advanced patients. U.S. pricing is benchmarked to the recently approved continuous infusion products, so no heroic product assumptions in our modeling. This is the slide that really frames the differentiation argument. What I will point to in the interest of time is that Vyalev's focus on the skin reactions, the site reactions. Vyalev's label reports 62% of patients experience infusion site reactions, and 28% are actual infections. Nodules and erythema are common with Onpgo, and tube-related complications are common with all of these products.
Because our technology, excuse me, dials out the actual active moiety from reacting with the subcutaneous compartment, our active moiety apomorphine is not released until it is in the plasma, circulating in the plasma. We dial out that interaction with the subcutaneous compartment and the skin tolerability issue. In NHP, in monkeys, and we have done a lot of them over the years to support our preclinical data submission, we have never seen injection site reactions in monkeys related to either our polymer or the active moiety apomorphine. Will that translate to patients? That is what our study is designed to read out on. One of the readouts is that tolerability. The phase Ib registrational study is underway. First patient was dosed in February. I will go back to this slide to frame it. The Cohort one, which we completed in July of 2026, we have read out.
We have kept that cohort blinded. The design of the study is randomized, double-blind, placebo-controlled in advanced patients in both a single ascending dose and a multiple ascending dose arm as components of the study. You can see here five cohorts of eight patients randomized three to one in the SAD arm and 48 patients in the MAD arm, with the three cohorts representing what we hope to tease out as the three commercial doses that we take forward in the study. The dose escalation is overseen by a safety monitoring committee, and the study is running currently across sites in the U.S. and Australia, with South Korea and Taiwan about to come on board. The outputs of the study are safety and tolerability and characterization of pharmacokinetics, defining that curve. We also have MDS- UPDRS, motor scoring, so preliminary assessments of efficacy, so structured motor state assessments.
Importantly, these are all in the targeted patient population, these advanced patients. These are challenging patients to bring into a study like this. It is challenging to find phase I sites that want these patients because they are challenging to work with. Our study design has another feature that is particularly informative. Patients are withdrawn from their background medications in accordance with the protocol. They are washed out of all their medications, their levodopa, their adjunct therapies, when they come into the clinic. We can get a relatively clear look at what SER-252 is doing by itself as a monotherapy. The FDA really liked this study design and had really been collaborative in thinking about how do we get a known active apomorphine as a better product to patients where there is a significant clinical unmet need right now.
Let me tell you what we saw in Cohort one. Cohort one, again, enrolled eight patients with Parkinson's advanced disease and motor fluctuation, and it evaluated the lowest dose level in the single ascending dose portion, the SAD portion of the study. I want to underline that this was a starting dose. FDA requires you to start these studies at a dose that is a very small fraction of the allowed dose that you sort of tease out, a maximum allowed dose in your preclinical work. Going in, our objectives were to establish safety around skin reactions and other measures of tolerability, and to categorize pharmacokinetics. We were not expecting this cohort to tell us much about therapeutic activity. Three things came out of Cohort one. First, the PK. Blinded observation showed a sustained PK profile consistent with the prolonged apomorphine exposure that SER-252 is designed to provide.
That is the platform doing exactly what it was engineered to do, now measured in advanced Parkinson's patients. This is the observation that changes the conversation. Blinded Cohort one observations included sustained periods of improvement in motor function in individual patients on exploratory clinical measures. We haven't unblinded the study, so the study is still blinded, so we can't say for sure that clinical activity at the lowest dose tested with patients washed out of their background Parkinson's medication was related to active study drug. But because of the study design, it is unlikely that those patients were placebo patients that showed the clinical activity. The findings supported the independent safety monitoring committee's recommendation to advance to the next dose level. Let's be disciplined about how much weight to put on this, because the framing matters as much as the finding.
These are preliminary, blinded, exploratory observations in a small number of patients. They may not be evidence of a treatment effect, and they may not be predictive of future results. That being said, at a high level, we're beginning to see evidence that the sustained apomorphine exposure that SER-252 was designed to deliver can translate into a clinical effect. Seeing that at the starting dose gives us a meaningful foundation as we evaluate higher exposures. We're now advancing Cohort two, with the top-line on our single ascending dose study targeted for the first half of 2027. What should you watch for? There are five questions. Let me find the five questions. Here we go. There are five questions that our near-term data has begun to answer and will continue to answer. One is the safety and tolerability. Will the early cohort show an acceptable safety profile?
Two, is the PK profile as designed? Does the product candidate generate controlled exposure consistent with CDS? Because that's what we're up against, competing against continuous infusion products with a twice-a-week long-acting injectable. Three, skin tolerability. Does the human primate injection site differentiation translate into patients? Four, usability. Can the enFuse support a materially easier patient and caregiver experience? Five, the regulatory pathway. Does the data continue to support FDA alignment around an accelerated path to NDA submission? This is the value creation roadmap, and here's what's different about the conversation today versus six months ago. We've begun to answer questions on the first three, and with favorable observations. I want to close the clinical argument on the single most important question, and that is apomorphine clinically active? That's not in dispute. Is continuous infusion the only way to deliver CDS? That is in dispute today.
Continuous infusion, while it's limited by short half-life, daily pump burden, local administration site reactions, is generating efficacy. These patients are being helped. The key translation question is, can SER-252 avoid those limitations? Again, the skin reactions are a significant reason why apomorphine, as an approved product in Europe called APO-go, prior to Supernus's approval of Onpgo in the U.S., never did more than $300 million or $400 million in annual sales. That's because patients and clinicians abandoned it, even though it was efficacious, because of the skin reactions you see here, which this level of skin reactions was seen in about 30% of patients. Those patients discontinued the therapy. The human confirmation that you see on the right demonstrated in monkeys where we've seen no skin issues needs to be confirmed in humans. Cohort one, so far, so good.
The safety monitoring committee has not halted the trial based on any safety or tolerability issues. The whole story in four sentences is patients with advanced Parkinson's need alternatives to oral therapy that can provide reliable control. Oral therapy inevitably stops providing oral reliable control. Early uptake of the recently approved device-assisted therapy proves the demand, but those products remain burdensome. SER-252 is designed to deliver sustained APO exposure in a simpler format, and cohort one may be the first clinical evidence that the approach is working in patients. The sequence of value inflection milestones lines up accordingly. Cohort one, check. First half of 2027, the SAD top-line data package, where we will unblind the study. We believe internally that that will attract interest from prospective partners about co-developing this asset, prospectively be a catalyst for raising non-dilutive capital to take this program forward.
Into 2028, when we launch the MAD study, where we are doing repeat dosing, durability of repeat dosing, dose selection, exploratory efficacy, clinical signals, all of that will be teased out. Again, we are dealing with a molecule that is well understood. It is well understood to be efficacious. We are delivering it in a different format. The clinical risk of our program, we believe relative to typical clinical development programs that get to phase II and phase III, is relatively modest. You can see the timelines of rolling out to an NDA submission package. We are tracking these timelines from every aspect of clinical operations to CMC readiness. To close, Serina builds better CNS medicines from proven molecules. SER-252 is the first clinical proof of that model, and here is why that matters. Cohort one is complete. We are dosing Cohort two.
We saw, we believe, a sustained PK profile and clinical activity at the lowest dose tested. SER-252 was engineered to achieve this PK profile. These observations strengthen our confidence in SER-252, and they are consistent with the profile the program was designed to achieve. It is SER-252 first as proof of concept of not just our ability to get this asset to an NDA submission on a 505(b)(2) NDA pathway that is highly differentiated and embraced. It is proof of principle on the platform itself, whether this is a rinse-and-repeat small molecule platform that can optimize other molecules. We do not have time to talk about those other molecules today, but we are really excited about the pipeline in a platform that is implicit in what we are building. Thank you all for your time today, and hopefully, we still have time for questions.
We have got a couple of questions. Reminder, if you do have anything else you would like addressed, just send it through the Zoom chat feature here on this webinar. A couple of questions that lead with, one is on the financial side. Can you give us a little bit of a picture of your cap structure? What does that look like today, and any significant shareholders, insider ownership? Can you give us that picture?
Yeah. Happy to. As of our most recent SEC financial report, our Form 10-Q for 2Q June 30th, I believe we were reporting approximately 25 million shares outstanding, and we have a very large percentage of that that is owned by insiders. Our lead investor is a very successful biotech investor called Greg Bailey. Greg was an early investor in two very successful company builds in biotech. Both were acquired by Pfizer. One was called Medivation, the other was called Biohaven. Greg is still a director at Biohaven. Biohaven still exists as a publicly traded company in oncology, but they sold their CNS portfolio to Pfizer for $11 billion. I believe that was in 2024. Medivation was sold to Pfizer about a decade ago for $14 billion, and that was also an oncology drug.
Greg is a huge believer in the platform, and essentially was the sponsor of our going public transaction through a reverse merger into a shell he controlled. So, the bulk of our controlling owner's ownership, Greg Bailey, and his platform company, Juvenescence, came from their ownership of the shell. They owned about 25% post-reverse merger of the combined company, with Serina's original shareholders owning 75%. Then commenced with the reverse merger, and subsequently, almost all of our capital has been committed by Greg and Juvenescence. We have never marketed a funding. We have not gone out with an S-1, marketed any sort of funding to the street, and that is a feature of our company build, and the capital stack associated with that.
Our game plan has been to fund the company most efficiently, even while we've been presented with opportunities to take on large boluses of capital from the name brand biotech specialist funds. We believe that we've got an opportunity to generate data in multiple programs across multiple modalities that will get Serina the valuation that is closer to the intrinsic value of what we've built and what we're building. So I think we have a float of about 30%, John, on that 25 million shares outstanding. We have a relatively clean capital structure. We have a $5 million convertible note that is held by Greg Bailey. But everything else is essentially common stock.
We do have a relatively small warrant component, about 965,000 in warrants, attached to a PIPE funding that we did in the first quarter of this year, where we raised $21 million in a PIPE funding, again, led by Greg Bailey, and it was all insiders, no outsiders in that round. We had an ATM vehicle that we used in that first quarter to raise an additional $10 million. So our balance sheet at the end of June was $23 million in cash, and a very clean payables profile. That's given us the working capital to keep moving forward to the milestones.
The next milestone, we would love to have a bigger bolus of capital go on offense across all of the opportunities that are in front of us. It is my job, and the team's job, to continue to solve for getting that most efficiently from a dilution standpoint and a strategic standpoint.
Thanks, Steve. Two questions we have left here unless something else pops up. One is, do you expect to conduct additional trials after the MAD results are announced?
Great question. I would say to be determined with a caveat. When we had our Type B meeting with FDA back in August of 2025, we believed that was an extraordinary outcome where FDA aligned around a real patient-centric view of the unmet need in this patient population of advanced Parkinson's, and worked with us in terms of a study design that could get our TPP, again, data-driven, to patients sooner rather than later. The idea that we presented to them was to go from this sort of phase Ib to consider the SAD/MAD, the phase Ib study, as really a phase Ib/IIb study, that the MAD is the phase Ib portion, excuse me, the SAD is the phase Ib portion, and the MAD is the phase IIb portion. Internally, we refer to them as phase I and phase II studies, even though that is not technically what the protocol aligns with.
The idea with FDA was if those two arms of that phase I study give us the data that we are looking for, then we could prospectively do some time, maybe in parallel to those two studies going on, but maybe after, what is called a PK bridging study or a relative bioavailability study, where we do a comparator study to Apokyn. This would not be a placebo-controlled study. It would be bringing a patient who is on Apokyn on one of the three commercial doses into the clinic. We would take them off Apokyn and put them on SER-252 at the three doses we believe are our commercial doses that line up with the efficacy or the non-inferiority of that Apokyn-approved product. FDA really liked that study design. Again, data-driven, data being supportive of what is next.
We got alignment around what's next being a phase III open label safety study, not another phase III randomized controlled study, placebo-controlled study, or a double dummy, double-blinded comparator placebo study, which are complex and expensive. But we got them to align around this is really going to be a safety issue once we've characterized PK. That just chronically dosing the POZ-apomorphine conjugate over time is the final readout to an NDA submission, and that we could submit the NDA sometime as we had enough data in that open label safety study. So that is the case that we hope would lead to an NDA submission in 2030.
Again, it'll be data-driven, but the framework and the alignment around the understanding of apomorphine as an active, approved molecule, and what we're doing with it, I think really is a unique case of how FDA is really taking a really priority-like review of real world evidence, patient-centric view, and really looking to create better products from existing biology that's well-characterized.
Okay. Thank you, Steve. Actually, another question popped up here. Again, in this world of AI, it's not surprising there's one to deal with artificial intelligence here. But it says, "Given the comprehensive data accessible to you and your peer models regarding the molecular structure, mechanism of action, and delivery methodology, how many iterations of artificial intelligence models have you developed and disseminated across the network of models to progressively refine the most efficient direct approaches, thereby providing you with the most direct pathway toward achieving your objective? Have you learned anything from it? Are you continuously using AI in any way in the journey?
I'll answer the last piece of that first. Yes. That is a very detailed question of, and description of how a drug development company would deploy, employ AI, and iterate it. If you look at our algorithm that we're solving for, we've built a chemistry platform that we believe is rinse and repeat, and it really is about, what is the opportunity set of small molecules that lend themselves to our attachment chemistry, where we can control PK, where we can create a near zero-order release profile, PK profile, for a small molecule. Remember, small molecules are some of the most challenging compounds to deliver. They almost are always delivered orally or infused because they have bioavailability challenges of high first pass metabolism in the liver, low bioavailability to escape the gut.
They have to be dosed on a phasic peak and trough basis, so that pulsatile sort of treatment effect can create Cmax-related side effects and Cmin efficacy challenges. We have expanded using AI as well as wet lab work in the trenches, the chemistry platform, the IP, the foundational IP around the funnel of molecules that we can actually control. It is a massive opportunity set, right? How does this drug sponsor with a platform like this select molecules to develop themselves versus prospectively partner? That is really the secret sauce of how we are using AI to vet molecules, not just from a chemistry standpoint, but from a competitive landscape, clinical unmet need. Who will care about the product profile? Clinicians, strategic pharma partners.
We have built a pretty robust model around hardcore chemistry, and chemistry that advances our IP and our platform and expands our funnel of molecules that we can work with, but also bringing in the commercial assessment, the clinical unmet need pieces of it, to identify pipeline candidates and partnering candidates. It is unexplored right now, boiling the ocean of molecules that pharma is working with that would benefit from a technology like that, this on a partnering perspective. We believe once we have proof of principle on the platform with this lead asset, that pharma should care about our platform. I point to the acquisition back in, I think it was 2015, by Teva of a company called Auspex, which had a revolutionary, quote unquote, small molecule prodrug platform called deuterium chemistry. They could deuterize molecules and rinse and repeat, and create multiple clinical assets really efficiently.
That was the promise of deuterium chemistry. Teva paid $3.5 billion for the platform, which had, I think, one clinical asset at the time. That clinical asset is Austedo, a drug for tardive dyskinesia that did $1.5 billion in 2024, so a successful acquisition. But the fact that no other clinical assets came out of that platform really reinforced how difficult it is to do what Serina is doing, and really how much more elegant our platform is versus deuterium chemistry in terms of the dials that we have to work with, to work with an expanded opportunity set of molecules and really control PK versus that chemistry. But if we can get there, this technology is incredibly valuable. It is our belief.
Okay. Thank you. You got time for a couple more? They just popped up. People are very interested in what you are saying today.
Yeah. I'm good.
Okay. Here's the next one. In your opinion, you've already touched on this, but it's a good summary question. What are the next three major milestones on your horizon, along with dates, and what are the major conferences in your vertical that you or any member of your team are participating in them in some fashion?
Yeah, those are all great questions. I'll take it in pieces here. When you have human data, and you're ready to talk about that, it's not easy to get into neuroscience conferences, the one you want to be in, right? Having data opens that up for us, right? We've got a great advisor panel of KOLs in Parkinson's. Folks that, Bob Hauser, who was the PI on Vyalev, folks like that just know the space, and actually are still treating patients, right? They have their own movement disorder clinics in major cities. We'll be doing on the scientific comms, that type of stuff. Talking about our data, the SAD top-line data, and beyond will be a real key value inflection point. First half of next year, this company could inflect in terms of value dramatically, right?
Once you have a de-risked chance of success that goes from whatever analysts and prospective partners are putting on it today to what it would look like after a SAD TFL. That is probably the biggest key inflection point. But certainly, other programs that we're working on, particularly SER-290, which is in stealth mode right now, is our undisclosed third molecule. Internally, we've advanced that molecule ahead of SER-270, the disclosed molecule, in terms of priority. I think that will be an interesting conversation with prospective investors and KOLs when that reveal happens. We plan on picking up the scientific comms around Parkinson's and new molecules. Those are really where we're headed. We do have to capitalize this company more aggressively to do everything that we would like to, and we're always solving for that.
Additional fundings from investors that are not insiders would be sort of important validation from the investment community of our platform and our assets.
Speaking of funding, The Michael J. Fox Foundation organization reports that they've invested more than $3 billion in Parkinson's research since its founding and are determined to push this effort forward. Do any organizations like The Michael J. Fox Foundation, or The Michael J. Fox Foundation, are they in your line of sight? Can you speak to that in any way?
Yes. They are in our line of sight. Debbie Brooks, their CEO, who was their founding CEO, she went away for a bit, and she's now back. In the interim, it's common knowledge that The Fox Foundation, the majority of their capital in recent years has come from Sergey Brin, one of the Google co-founders. It's public knowledge that Sergey has the LRRK2 mutation that is believed to potentially be the mechanism that leads to a higher incidence of Parkinson's in about 10% of the Parkinson's patients, right? It's a mechanism that is somewhat linked to Parkinson's. His funding has moved The Fox Foundation in a direction of looking for disease-modifying therapy early, right? Sort of moonshots, right?
None of those are going to help the 10 million patients that have the disease today, but maybe down the line, in a few years' time, to a decade or maybe never, some of these mechanisms will bear fruit. So a quality of life, best in class for advanced patients whose symptoms are inadequately controlled is really not in their sweet spot. But we do have direct communication, and we've proposed some ways to collaborate on what we're doing. Sort of day in the life of an advanced Parkinson's type documentary, docuseries sort of content around really helping the Parkinson's community attract more research dollars to the mid and advanced patient segments.
Got it. Thank you, Steve. One last question in regards to your SER-290 that says undisclosed on your pipeline chart on the site. Can you speak to that? Let us know a little bit about that.
Yeah. We have a third program, as I've alluded to, SER-290, that's undisclosed. SER-290 represents our third POZ-enabled small molecule program targeting an undisclosed CNS indication. What I can share today is that, again, it's a POZ conjugate with roughly a one-week PK profile via subcutaneous injection. What I can also say is it's a POZ conjugate of a recently, within the last year or so, approved CNS drug that analysts believe is a potential multi-billion dollar blockbuster. We're making great progress in identifying our lead candidate. We've got multiple paths to optimization on multiple lead candidates that we would take into IND-enabling studies, and we expect to initiate IND-enabling studies in 2027. We haven't specifically said when.
The strategic rationale sort of follows our established playbook. Take a clinically de-risked molecule, mechanism has been validated, and FDA-approved with no limitations in delivery or tolerability, and use the POZ platform to create a differentiated product that may have superior PK and patient convenience for a segment of a market, not necessarily the whole market. The CNS focus aligns with the core expertise we're building within the company and within our ecosystem of advisors and KOLs and subject matter experts, both clinically and on a regulatory basis. We have an extraordinary advisory panel that's informing this program. We haven't announced that yet, but we expect to come out of stealth mode on this program with a series of KOL events and scientific communications as well around the value proposition for our approach in this big area.
That's all I can say at this point, but I would say this is a sooner rather than later reveal, because I think it could be a catalyst for raising substantial capital more efficiently than our current market cap would suggest.
Got it. Well, I'm going to call it here. I want to thank you for joining us and addressing all of these questions. I want to thank all for the Tribe from around the world that joined us as well. I also like to thank you for the Tribe expressing, today especially, expressed that they would like to see you in one of their cities in the near future. As many of you know, we've hosted these corporate-sponsored events, and there are cities like Salt Lake City, Orange County, there's Dallas, Houston, Atlanta, that a representative asked to meet you. So at some point, hopefully, we can organize that, as people are very interested in your company and the topic.
I also mention again, a video of this event will be published at the Tribe Public YouTube channel later today, and we'll include it in the Tribe Public e-newsletter that will go out on Friday, the Tribe This Week, and we'll do our best to get that out to everyone. Again, if you have additional questions that come to mind after this, please reflect them to me, and we'll get them to management, or we'll see if we can get Steve and Serina back on at some point to address any further questions as they make progress. Again, thanks to Serina. The New York Stock Exchange symbol is SER. Thank you, Steve. Thank you everyone for joining us, and hope you have a great rest of the week.
Thanks, everybody. Thanks, John.