SpyGlass Pharma, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Thank you. Thank you all for being here today. I'm going to take you through the story on SpyGlass Pharma. First, our standard disclaimers. We'll have forward-looking statements. Big picture, what are we looking at? We're solving for cataracts and glaucoma at a single point when a patient's undergoing cataract surgery. This is a $13 billion addressable market, and I'll take you through the background on how we get here. We've been treating cataracts and glaucoma at that time of cataract surgery for over a decade now. We know that about 20% of patients that are undergoing cataract surgery also have glaucoma or ocular hypertension, which is elevated IOP and a precursor to glaucoma. That means one in five patients undergoing cataract surgery could benefit from this product. In the U.S., that's 1 million patients of the 5 million undergoing cataract surgery.

There's a similar product in market today, the iDose, which delivers a prostaglandin analog for up to three years. It currently has a wholesale acquisition cost of $13,950. When we multiply that WAC times the addressable market, that's where we get this $13 billion opportunity. What's unique about the SpyGlass product is it's designed in a way that all cataract surgeons can use it without changing how they do their surgery. No new tools or techniques. They literally load two drug pads onto the intraocular lens that they would typically use during cataract surgery and implant it through their standard incisions and injectors. So, we're accessible to 100% of cataract surgeons. We have two studies that have read out with long-term data.

Our first-in-human study, we've released three-year data on. We have 95% of patients that have reached that three-year mark and aren't taking any additional therapies at 3 years, with 37% mean IOP lowering. By far, best in class for a product like this, and on par with some of the more invasive glaucoma surgical techniques. We followed that up with a phase I/II trial. We expanded to 22 sites and over 100 patients and showed similar results with 98% of patients off of topical IOP lowering therapy and 34% mean IOP reduction at 12 months with our 78 microgram dose, which is the dose that we're taking into phase III and intend to commercialize. Clear regulatory and reimbursement pathways. The product will be approved as a 505(b)(2) on an NDA, and it'll get reimbursed with existing Category I CPT codes.

It is just cataract surgery, and a J-code for the drug component of it. Focus pipeline. Besides the BIM-IOL, which is our lead product, we also have a drug ring system which uses the same delivery technology as we have in the BIM-IOL with a different form factor. This form factor allows the product to be used any time after cataract surgery. If a patient needed additional replenishment years down the road, this product could go in also in a procedure that all cataract surgeons know how to do. It actually goes just on top of the existing lens in the ciliary sulcus, which is where you would put an add-on IOL post-cataract surgery if you need additional refractive correction. Strong IP lasting well beyond 2039 and strong financial position. We have $234.2 million cash on hand at the end of Q2, which will last us through 2028.

If you look at our team, I will not go through the details, but what you will see here is decades of experience across the board in ophthalmology, whether commercial expertise, product development expertise, financial expertise, knowing how to launch, buy, and build drug products in the space and devices in cataract surgery. What are we really solving for? Every day, over 80 million people around the world are fighting to save their sight from glaucoma. We talk about this as the silent thief of vision because you do not feel the elevated intraocular pressure. You do not feel anything until you start losing the vision, and it collapses slowly from the periphery and goes down. Once it is lost, it is irreversible. Typically, patients are treating this with topical drops, prostaglandin analogs, first-line therapy.

The issue is, even though you are not feeling the disease, you feel the negative impacts of the drops, right? Whether it is the financial impact of having to go and get these drops monthly, whether it is the redness or irritation that affects a third of the patients, what this all results in is by six months, half of patients are not filling their prescriptions, and this is a chronic disease. They need to take these drops to preserve their vision. For whatever reason, by six months, regardless of the class of medication, over half of patients are not filling their prescriptions. We have a different vision for the patient's journey. Initial diagnosis would be the same. Initial management would be the same. You are diagnosed with ocular hypertension. You get put on drops.

Where we meet the patients is at single point in time when you go for cataract surgery, and cataract surgery is the most common procedure performed in surgery centers at that tune of 5 million procedures a year. In these pre-op consultations, the discussion from the doctor to the patient would be, "Hey, we are going to take care of your cataracts, and at the same time, we could try to get you off your drops. Would you like me to investigate your benefits and see if insurance will pay for this?" It is an easy choice for both the surgeon and the patient because it does not take any significant additional effort, and we are not creating any significant new risk. The drug that we are using, bimatoprost, is a prostaglandin analog that has been on the market for over 25 years, and the surgery, as mentioned earlier, is just cataract surgery.

Procedure's done, then the patients will experience some amount of time without needing drops. One of the other really cool things about the product is when we talk about follow-up options. At any point post-surgery, the BIM-IOL doesn't take any of the existing options off the table. You could go back on drops. You could do lasers. You could do other drug delivery products. You could have any of the other glaucoma surgical techniques because we're not using any of the other tissues that are commonly used for those products. We're also working on a follow-up option, which is the BIM-DRS or Drug Ring System. This would allow for the retreatment of patients if years down the road they need additional therapy. They could go back to the OR, and it leverages the same drug delivery technology as what we have in our initial product.

I'll take you through a short animation on our product, starting with the intraocular lens. This is a lot like standard intraocular lenses that you would see from the large strategics in our industry. The only changes are right here where the haptics and optic come together, we have features to retain the drug pads. This product would be assembled in the OR at the time of surgery. Typically, a technician will load the two drug pads onto the intraocular lens. From this point forward, it's just cataract surgery. They load it into an off-the-shelf intraocular lens injector, and typically the surgeon will finish removing the cataract and reach back, grab the injector with the intraocular lens, put it through standard incisions, inject it into the capsular bag. It unfolds just like a normal IOL.

The materials we use is a hydrophobic acrylic, just like all the larger strategics. Our material's previously been FDA approved. You can notice the drug pads on the periphery of the lens right there, and the only way even a doctor can see them is if the pupil is fully dilated. Once they leave and the pupil comes back down, you can't notice the pads even at a slit lamp. This is going back to the millions of patients, so 20% of the 5 million, so 1 million patients in the U.S., another 5.4 million in the rest of the world. That's where we get the $13 billion total addressable market. As mentioned earlier, the option for a lot of patients today, if they're going to treat glaucoma at the time of cataract surgery, is a minimally invasive glaucoma surgical procedure.

That would be stents in the angle or something else, typically in the angle of the eye where the iris and cornea come together. What's interesting is only about a third of cataract surgeons are routinely performing these procedures in the angle, and so that leaves another two thirds that are not addressing glaucoma at the time of cataract surgery. As mentioned earlier, SpyGlass is accessible to 100% of cataract surgeons. Registration pathway, we've had a ton of meetings with the FDA. They've been tremendously helpful in defining this pathway to approve both the IOL and the drug pads under a single 505(b)(2). On the reimbursement side, this is another place where SpyGlass has a simple answer. We are cataract surgery, so we're using the same Category I CPT codes that get reimbursed millions of times a year.

We do have an add-on Category III CPT code that we were just issued in May of this year. For that, we are currently in our phase III, and we are studying the amount of time a surgeon spends in a standard of care case with their typical IOL and the amount of time that they spend with the SpyGlass IOL on that procedure. Once the product gets approved, that is when we will go back to the MAC and negotiate exactly what that amount of time and effort from the surgeon is worth. That is not key to the procedure. Even when we did our physician surveys, they came back with, the surgeon does not need anything else because they are really just doing cataract surgery, and anything above zero is a win for them.

We will just make sure that they are compensated fairly once we know exactly how much time that is. The drug itself will be reimbursed through a J-code, which is typically reimbursed at ASP plus 6%. I will take you through a little bit of our non-clinical and clinical data, first grounding you in why our product works so well. What you are looking at here is an in vitro release curve. While we took the numbers off of the y-axis, what you will notice is how consistent the drug release is from year 1 to year 2 to year 3. Very consistent delivery, and we know that we can go out beyond 7 years. In fact, that is the product that we took into our first in human study.