Thanks, Ahmed. Thank you for taking time today to hear our story. I'm Steve Ledger, Chief Executive Officer of Serina Therapeutics. Serina is building better CNS medicines 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. The timing of our conversation is good because we announced cohort one observations from our registrational study last week, phase I study, and for the first time, we have patient-level clinical evidence to talk about. Today, I'll focus on our lead asset, SER-252, in the clinic now in advanced Parkinson's disease, and then show how the platform extends across CNS small molecules, leaving the other modalities of LNP delivery and ADC enabling technology to another date and time. I'll direct you to our forward-looking statements.
This presentation contains forward-looking statements subject to risks and uncertainties. I'd encourage you to review our SEC filings for a full disclosure of those risk factors. Here's the current small molecule pipeline. Three assets, one platform, one development logic. SER-252 is our POZylated apomorphine asset for advanced Parkinson's disease. That's our lead. It's in a phase I-B study today. SER-270 is POZylated DHTBZ, dihydrotetrabenazine, which is a VMAT2 inhibitor, targeting the movement disorder tardive dyskinesia. It's in IND enabling planning. SER-290 is a POZ conjugate in an undisclosed CNS indication, also in IND enabling studies and planning. SER-290 has been moved ahead of SER- 270 as our next drug candidate, and we expect to publicly disclose the molecule, the TPP, clinical and commercial positioning, et cetera, in the fourth quarter. SER-252 is in a phase I-B registrational study. Cohort one is complete.
The independent safety monitoring committee has recommended advancement to cohort two, where dosing is underway. We expect single ascending dose top-line data in the first half of 2027, obviously a key value driver. Let me frame the investment case in five points. One, we are clinical stage. SER-252 is in a clinical study in advanced Parkinson's patients with a highly differentiated product profile that is potentially best in class for patients whose symptoms are no longer adequately controlled with the current standard of care. Two, we are pursuing a proven molecule strategy. Apomorphine is an example of an approved active ingredient. Investors aren't being asked to underwrite new biology. We're focused entirely on improving the product profile.
Three, we're pursuing an FDA-aligned 505(b)(2) NDA pathway, which potentially makes the current SAD/MAD study registrational, meaning FDA is open to, supported by data, of course, of going straight to an open label safety study as phase III versus another randomized controlled study. A rolling NDA submission at some point in that open label safety study. Four, near term de-risking events. The first of those has now happened. We have cohort one observations announced last week, which give us our first look at whether the design profile is showing up in patients. Five, this is a repeatable CNS model. It is a small molecule optimization platform. SER-270 and SER-290 extend the same polymer backbone and the same product optimization logic into additional opportunities. Why now? 2026 was the year SER-252 moved from regulatory alignment into clinical execution. SER-252 is in the clinic.
First patient was dosed in February of this year in the single ascending dose arm of the phase I-B study. We have cleared the first safety gate. Cohort one dosing is complete. The independent SMC completed its blinded review of cohort one safety and tolerability data and has given the go ahead to begin cohort two dosing, which will start this week. I am going to spend some time on cohort one observations in a moment because I think they are the most important thing that has happened to this program to date. The top-line data package from the SAD portion is targeted for the first half of 2027, and the balance sheet supports the work. We closed a $21 million+ private placement in April of 2026, and we reported approximately $23 million in cash at June 30th. The near term investor focus is clear.
Cohort one complete and cleared, dose escalation underway, and continued execution on the 505(b)(2) pathway. SER-252 is highly differentiated versus the current standards of care. It is designed to make continuous dopaminergic stimulation, or CDS, dramatically easy to deliver in advanced Parkinson's disease. The core insight here is that apomorphine is a clinically active dopamine agonist, but current continuous products are limited by both pump burden and by local administration site reactions. SER-252 preserves the pharmacology while improving delivery and tolerability. The four elements here, a known API, optimized delivery, POZ enabled control release, a patient-centered device, the enFuse on body system that we are partnered with from Enable Injections, and a 505(b)(2) NDA regulatory strategy, align around a target product profile that can be described in one sentence.
Continuous therapy without surgery, without daily pump set up, without skin reactions, typically associated with subcutaneous active drug release seen with the current standards of care. Parkinson's follows a predictable trajectory. Diagnosis, oral levodopa monotherapy, motor complications, adjunctive therapies, inadequate control. Finally, device-based continuous CDS, continuous dopaminergic stimulation. Day-to-day, that means more frequent off time and less predictable control of motor fluctuations and dyskinesia that limit daily function. Morning off periods that persist when treatment is limited to waking hour infusion is also one of the burdens of the current standards of care. Critically, device-based therapies remain under-penetrated because of patient and caregiver burden and invasiveness. The numbers define the target population, approximately 250,000 advanced Parkinson's patients inadequately controlled on oral therapy across the U.S., EU4, and U.K. As I mentioned, only 5%-10% of eligible advanced patients are currently on device-based therapy.
The gap is the opportunity for Serina. SER-252 is positioned for patients whose disease has outgrown oral monotherapy and adjunctive therapies, but who face limited attractive alternatives to control their symptoms. Note the reason for that gap. It is not a lack of clinical benefit from the current standard of care. It is that the delivery burden is too high to accept. That is a product problem, not a biology problem, and a product problem is what our platform is built to solve for. Here is what makes the timing favorable for Serina. Continuous dopaminergic stimulation is becoming a real commercial category. Duopa, Vyalev, Apokyn, and now SER-252 as a differentiated entrant. The market is being built by 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 caregiver burden matter to adoption. The recent Vyalev commercial trajectory is useful external valuation. Early uptake tells you the demand is real and the unmet need is significant. Even though these products remain burdensome, that is the opening we're building into. SER-252 does not need to create physician or payer awareness from scratch. The investment case is category expansion plus potential share capture if the target product profile is clinically validated. Infrastructure, clinical familiarity, and reimbursement logic are all developing ahead of us. Let's look at the approved current standards of care, and let's look at them honestly, what they validate and what they leave unsolved.
Duopa was the first in the category, established a category, established continuous levodopa carbidopa therapy as efficacious but required a surgical intestinal port, a pump and gel pack, and high maintenance administration. Vyalev is an evolution of that approach, brought a subcutaneous, continuous levodopa carbidopa product to market, but the pump is generally worn during waking hours. The label states that 62% of patients experience skin reactions, and the administration burden remains meaningful. Apokyn confirms the clinical utility of continuous apomorphine delivery but requires daily pump and tubing setup, plus a real local administration site reaction burden. Each of these products individually validates the demand. Each leaves room for SER-252, and SER-252 is designed directly around those remaining limitations. Here's the target product profile. Continuous therapy through a compact on-body system with brief wear time, in contrast to the devices and electronic pumps you saw on the prior slide.
Continuous therapy through a compact on-body system with a brief wear time. Twice weekly delivery, not continuous wear, not daily setup, approximately 10 minutes of wear time per administration, no tubing, no visible needle, no electronics, entirely mechanical operation, no programming. It's a push button experience. Consider what that means for a patient with advanced Parkinson's, often with tremor, often with-