4D Molecular Therapeutics, Inc. Common Stock Investor Day 2026
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Transcript
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Hey, guys. We're getting started. Thanks for all being here today. Sorry for those online, we're running a couple minutes late, but just want to make sure folks filtered in. My name is Julian Pei. I'm the head of investor relations for 4D Molecular Therapeutics, and we're really excited to have you here today for our first ever Investor Day. We're going to handle Q&A today via the QR code, so please scan that on your devices and submit those questions, and we'll get to those at the end with our great panel we have for you today. As usual, I'll remind you of our forward-looking statements. If you want to see more details, please go to our investor relations website or the SEC. With that in mind, it is my distinct pleasure to welcome to the stage Dr. David Kirn, our co-founder, president, and CEO.
All right. Thanks, Julian. Well, it's a pleasure to be here, and welcome. Thanks for being here. We really appreciate it. I'm Dave Kirn, co-founder, CEO, and president of 4D Molecular Therapeutics. I've been in the industry for about 30 years as a physician scientist, a drug developer, serial entrepreneur, and CEO. We started 4D a little over a decade ago with a clear and compelling vision, and that was to boldly innovate and execute to bring great genetic medicines to millions of patients. Standing here today, it's remarkable to say that we are on the cusp of achieving that vision today with 4D-150. And we believe that 4D-150 has potential to establish a whole new treatment paradigm in wet AMD, as you'll see today.
I'd like to start out with four key takeaways for you today that we'll work through the course of the presentations. First of all, we believe that 4D-150 can be a backbone therapy for all patients with wet AMD, not just the most severe. What do we mean when we say backbone therapy? What we mean is a continuous, lifelong therapy after one single injection, with supplements being used as needed for supplementation of patient's care. Number two, our target product profile addresses the two most important needs in this disease today, preservation of vision and treatment burden reduction, with the added opportunity for some patients to, in fact, be injection-free for many years, if not lifelong. Number three, we believe our clinical data, our phase III design, and our phase III execution has positioned us for great success in 2027 and beyond.
And finally, what you'll hear from us today is that our stakeholders, our patients, physicians, and payers, we believe, have come together and given us great confidence in our ability to commercialize this product broadly and see broad adoption. These are today's speakers. I think you're going to find them very interesting. They're all experts. They've been selected very carefully to give very diverse perspectives on the opportunity for 4D-150. So we think that you'll walk away from here today with a much more holistic understanding of the opportunity in front of us. This is our agenda. It's going to follow that flow I started with in the beginning with the four key points. Let's just take a step back and say, why are we here today? We're here today because the current treatment paradigm in wet AMD is simply not good enough.
Why can I say that definitively? Well, I spent the last 5 plus years having hundreds of conversations with physicians, patients, their caregivers, clinic staff, and I hear over and over again, "It's not good enough." Why do we think it's not good enough? Let's start with the way treatment is currently administered. It's episodic. It's bolus treatment where patients are beautifully treated for a finite window of time, and then they're left fundamentally untreated and have treatment lapses repeatedly over and over again for the rest of their life. Why is that a problem? Wet AMD is chronic, it's continuous, it's relentless. It doesn't take a day off. Imagine having this very serious disease in your retina that's not being treated in repeated blocks throughout the rest of your life. That just doesn't make sense. Number 2, high treatment burden.
The burden on patients, their caregivers, and on the medical system is enormous with these repeat injections, as you'll see today. Finally, I'd like to leave you with the most important point is that because of this episodic treatment being mismatched with the disease biology, and despite all this burden and cost on the system, patients still lose vision. Let me say that again. Patients in the U.S. with wet AMD, the majority will lose vision. Many will still go blind. Outside of the U.S., where treatment's not available to the extent that it is here, the problem is much worse. This simply isn't a good enough situation, and patients deserve better. What could the future look like? Our vision is that 4D-150 can serve as the backbone therapy for all patients with wet AMD.
Again, not just the most severe. What does that look like? Single routine injection in the clinic, continuous disease treatment, potentially, we believe, for the rest of the patient's life. A significant reduction in treatment burden, and most important, since treatment's on board at all times, 24 hours a day, 7 days a week, 365 days a year, we believe we're going to preserve patients' vision. What's the result of that? They will be liberated. They will be free to go off and live their life and spend their time with loved ones and family, and really enjoy their golden years. I'd like to briefly remind you how we can achieve this paradigm shift. It's not magic, and it's certainly not luck. This is by design. When we started the company over 10 years ago, the first order of business was to invent a novel capsid.
We wanted that capsid, that delivery vehicle, to have the following characteristics. We wanted to be able to deliver it by routine injection in the clinic, just like a bolus anti-VEGF. We achieved that. We wanted to use a very low dose, so we had low cost of goods and lower risk of any toxicities. We achieved that. We wanted a vector that targeted the retina, particularly the macula, very efficiently with a single injection, so we could get our treatment right to the site of disease where it needed to be. We wanted to design this vector to minimize any sort of risk of significant toxicities or inflammation. I think as you see today, from the data that we've generated in the clinic, we believe we've achieved that with this proprietary and unique vector. The vector's just a delivery vehicle.
The actual treatment here is aflibercept and an RNAi for VEGF C. We hit four VEGF family members. Let's remember, aflibercept is the market leader in wet AMD over the last decade. It has been used in over 64 million doses in humans. 64 million, and it has shown great efficacy and a very excellent safety profile. That is our treatment. That is completely de-risked. What we are doing is delivering it in a much better way, and that is having it expressed from the retina itself, right at the site of disease, continuously, 24 hours a day, seven days a week, 365 days a year, for the rest of the patient's life. It is a fundamentally better way to use this amazing molecule. With that background, I would love to invite Dr. Arshad Khanani to the stage.
Arshad has been with us through this entire journey, from inception to the treatment of the first patient with 4D-150, and we are thrilled to have him here. Arshad? Good to see you, man.
Thank you, David. Good morning, everybody. It is great to see you. I am Arshad Khanani, I am a medical and surgical retina specialist based out of Reno, Nevada. I have been involved with over 150 clinical trials as a PI, and I have been involved with many gene therapy programs throughout this journey. I have been in practice over 16 years. Today is a very emotional day for me, because when I started the journey with 4D, it was in December 2021. I had the honor and pleasure to inject the first human patient. At that time, I do not think we would get a full room like this about a gene therapy. We have gone through a lot of learnings for gene therapy, and it is so exciting, as David said, that we now have pivotal data reading out next year from two global phase III trials looking at naive patients with neovascular AMD.
My goal today in the next five minutes or so is to take you through the journey of wet AMD patients and what we are seeing in clinic with those patients. I think in numbers and graphs, we actually miss the patient perspective. Before I get started, I want to ask the audience, how many in the audience have been to a retina clinic beside the doctors? None. How many of you have somebody that actually suffers from a chronic, relentless, heterogeneous, blinding disease? That is what it is. I think the perspective of patients, the fear in the eyes of patients, the anxiety they have every time they come in our clinic, the emotions that we see or our staff sees on a daily basis when they get the news that you have a chronic disease that can blind you.
A chronic disease that can blind you, and you have to come to this clinic, sit for the doctors for 3 hours, get this injection in your eye, be out of commission for 24 hours because of irritation. I think in these graphs, we don't see that. I think this is something that excites me as a physician. When you have a single intravitreal injection in clinic that can eliminate the need for injections or reduce that burden, it's a huge achievement for the field. This is a monumental, paradigm-shifting treatment that we hope we can deliver to the patients in the near future. David covered the problem at hand. We're treating a chronic disease with bolus injections, and they work great. I was in training when anti-VEGFs came out.
I had a patient who was blind in one eye from wet AMD, had a dog and a cane while her other eye was still seeing, but she had wet AMD. She said, "I know what this disease is going to do to me. I'm getting ready to go blind." Then came out the anti-VEGF, and she didn't go blind. This is what anti-VEGF did for those patients. But we know the real problem. Bolus injections are not an answer for a chronic disease that needs sustained delivery, and this episodic treatment is a problem long-term. We will treat the patients, they'll gain the vision, and then life comes in the way. They fall and break a hip. They're in rehab for 6 months. What happens? They come back, and they're blind. We start treating them. We cannot recover the vision.
We are trying to change this with 4D-150. Real-world outcomes, many of you have seen these graphs. Me and many of our colleagues in the audience have published on it. Behind each number is a patient that went blind. Behind this number is a patient that has to be taken care of by their family. They have to navigate, they have to do groceries, they have to cook for themselves. I think this is what we are missing. I think we want all of these patients not to lose vision. The number of injections go down over time. They're not sustainable. I think what we need to do is come up with something that can give them that backbone treatment so that if they miss injection, if life comes in the way, I have very motivated patients.
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