Serina Therapeutics, Inc.SER
Recorded

Serina Therapeutics, Inc. Study update

Review the key takeaways and the transcript of this earnings call.

Period 0Duration58 minParticipants2

Transcript

Preview the first fifteen paragraphs, organized by speaker.

John F. HeerdinkManaging Director and Member

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.

John F. HeerdinkManaging Director and Member

Members from 31 plus countries and all 50 states have joined Tribe Public freely to gain direct corporate access to leaders and experts that they care about via our webinar events and via 41 venue sites located across the U.S., where we regularly host in-person lunch and dinner and speaking engagements with Tribe members with many of these experts. Tribe members, furthermore, are invited to submit names of experts and leaders of industry via our free wishlist process at our website, where you simply add names of companies and subjects that span across all sectors so that you can learn more and we can possibly set up events. Please note that I'm also the managing director of Vista Partners LLC, a registered investment advisory firm in California, and its website is vistapglobal, V-I-S-T-A-P, as in Paul, global.com.

John F. HeerdinkManaging Director and Member

Please review both sets of disclaimers at each site and know that I'm currently a shareholder and advisor to Serina Therapeutics. I would also like to thank all of you for participating, and for all of your questions that you've already submitted for today's speaker. I remind you that you may send in more questions that come to mind via the Zoom chat feature during this event, and we'll do our best to get them addressed. A video of this event will be published at our Tribe Public YouTube channel and be sent out to all post this event via the Tribe This Week, which is our e-newsletter that you receive now that you've signed up for this event. Thank you also to Serina for joining us today. Now let's get started. 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.

Steve LedgerCEO

Thank you so much. Thanks, John, for hosting us today.

Steve LedgerCEO

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.

Steve LedgerCEO

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 1 observations from our phase I-B 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.

Steve LedgerCEO

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 9 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.

Steve LedgerCEO

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 adjunct 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 EU5. 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.

Steve LedgerCEO

It's estimated that only 5% to 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.

Steve LedgerCEO

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 to 24 hours a day, each validates demand, but each leaves room for significant improvement. SER-252 is designed directly around those limitations.

Steve LedgerCEO

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 APO-go 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.

Steve LedgerCEO

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.

Steve LedgerCEO

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 3 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.

Steve LedgerCEO

CMS's national coverage policy was finalized around January 2026. The 2 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 1.1 billion third-level 1 pump.

Steve LedgerCEO

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-quarters of those were on deep brain stimulation, brain surgery. Only a quarter 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.

FULL TRANSCRIPT

Continue the full translated transcript in StockNow.

Access every statement, the English original, and speaker-by-speaker history with StockNow Pro.

View the full transcript with Pro

More recent earnings calls

View earnings calendar