Next, we are pleased to introduce Grace Therapeutics, Inc. If you would like to ask a question during the webcast, you may drop them in the chat box button on the left side of your screen. Please type your question into the box and click "Send" to submit it. At this time, it is my pleasure to hand over the session to Prashant Kohli, CEO at Grace Therapeutics, Inc., who will lead the presentation. Sir, the floor is yours. Thank you. Hello, everyone. Welcome to the Grace Therapeutics session. I look forward to engaging with you on the Grace story. A very quick snapshot of the company. This presents our strong investment thesis. We're targeting a rare disease called subarachnoid hemorrhage. The current standard of care is a calcium channel blocker called amlodipine. The molecule has been around for a few decades now. It's completely de-risked, written in the care guidelines. The molecule is only available in the oral dosage form in the U.S., either as a capsule or a solution, and both of them have significant clinical liabilities associated with it. Our team at Grace Therapeutics has created a novel aqueous formulation of amlodipine so that it can be administered as an intravenous therapy in this critical disease, subarachnoid hemorrhage. We reported strong data meeting our primary endpoint in February of this year for our pivotal phase III trial. We believe with the other benefits that were highlighted from the trial, GTX-104, our IV formulation of amlodipine, is ideally suited to replace oral and become the standard of care therapy in SAH. It's a rare disease. The patients are treated in a finite number of hospitals in the country. With a very targeted, efficient, cost-effective commercial platform, we can bring this drug to market ourselves. We have a fantastic patent firewall, seven years market exclusivity associated with the orphan designation. On top of that, we have multiple formulation patents that take us to 2037, and our most recent method of use patent that goes until 2042. Upon approval, which we anticipate middle of next year, FDA assigned us a goal date of April 2026. We are within 12 months of a major catalyst coming up for the company. We anticipate a really strong shelf life here in terms of patent protection and the franchise itself. Amlodipine, as I mentioned, is a clinically de-risked molecule. Any new innovation will be on top of amlodipine since it's a standard of care, life-threatening condition. It's near impossible to run a placebo-controlled trial anymore in this disease state. Competitively, there's nothing in the clinic either. Very, very strong, very, very clear investment thesis around our lead program, GTX-104. In terms of what the disease is, SAH is a rare disease. Patients are unaware most of the time that they have this aneurysm that's building deep inside their brain, which all of a sudden ruptures, causing the bleed, the hemorrhagic stroke, and the disease itself has high fatality and morbidity. Eventually, 2/3 of the patients will either not survive or have long-term morbidity. Average age is less than 60 years old. It's a disease of a younger population. 2/3 of women than men get this disease. About 10% - 15% of the patients do not survive, making it to the hospital. Ideally, these patients are treated at a comprehensive stroke center where a neurosurgeon, upon confirmed diagnosis of SAH, will go in and physically secure the bleed with either a clip or coil the aneurysm, and the patient is put on amlodipine therapy. Amlodipine is written into the care guidelines by the American Heart and Stroke Association. Level 1 Class A evidence. Any patient in the U.S., high probability, will receive amlodipine therapy. The drug is indicated for up to 21 days, several times a day because of some of the liabilities that I'll talk about in the next couple of slides. The guidelines recognize the major side effect of amlodipine, which is hypotension, drop in blood pressure. It's still outlined, making sure that the patients receive as much of dose compliance as is feasible. There's a strong correlation between dose compliance of amlodipine therapy and better recovery. Amlodipine has been shown to improve neurological outcomes in this patient population. There really isn't any question whether or not the molecule works. It's baked into the care guidelines. There's a recognition that dose compliance is an issue in a clinical setting, which is where we believe GTX-104 can really address some of those shortcomings. These patients talking about the unmet clinical need, unconscious, presented to the hospital, they're dysphagic, have a hard time swallowing. Amlodipine has high first-pass metabolism, which means this drug has to be administered frequently, several times a day, up to 21 days. Patients literally have a nasogastric tube, and nurses have to shove this drug down the feeding tube. That's the only dosage form available in the U.S., as I mentioned, capsule and solution. The drug has high first-pass metabolism. It has cytochrome P450 liability. Food effects, the metabolism of amlodipine is severely impaired in the presence of other drugs and food, especially when the drug is given through the feeding tube due to gut motility and ileus issues. Sometimes it barely makes it into sufficient concentration in the blood. If it's not in the blood, it will not get to the brain. The other issue of hypotension that I mentioned earlier, the majority of the patients will end up with refractory hypotension. In fact, almost 55% - 60% of the patients do not receive the full therapeutic dose of amlodipine because of hypotension, refractory hypotension, and physicians have to withhold amlodipine therapy. The only approved drug to improve outcomes in this critical disease, patients are not getting the full dose because of a major side effect of the drug. Both of the issues, impaired metabolism and frequent dose, withholding the dose to manage hypotension, leads to suboptimal outcomes in the patient population. It's a very clear rationale for why this drug should be administered through an infusion. Our scientists figured out a way to crack the chemistry code and solubilize amlodipine into an aqueous formulation so that it can be administered via a simple infusion therapy. As you might be well aware, in an ICU setting, physicians prefer to stick a needle and administer a drug, especially in this disease, which is life-threatening. Patients are unconscious, dysphagic, and this drug has to be administered several times a day, deal with those limiting side effects. Oftentimes, there are medication errors as well. The IV formulation our team developed, designed elegant micellar technology using GRAS excipients. These are not exotic excipients or complicated manufacturing process. We have created a room temperature stable, sterile injectable that is relatively cost-efficient to manufacture as well. The value proposition is very clear-cut from a clinical perspective. Better dose compliance, better hypotension management. It's adhering to the care guidelines from a hospital standpoint. There are stroke certifications which have to be assessed by the Joint Commission every so often to make sure that they stick to the care guidelines, allows them to be in compliance there. Obviously, from a patient standpoint, as they're recovering and dealing with this major life-threatening event, having to be woken up every few hours just to receive this drug certainly doesn't help in their recovery. It fits in very well into the care flow, the workflow of an ICU, and from a patient convenience standpoint as well. The IV checks a lot of the boxes against the drugs that are currently available in the U.S. As I mentioned, the capsule and liquid solution are the only two formulations that are available in the U.S. There is an IV formulation available outside the U.S. Bayer, the original RLD holder, when they brought this drug to market a few decades ago, clearly recognized that IV is the best way of delivering the drug. The closest they came to solubilizing it was by using a lot of alcohol, 24% alcohol by volume. Plus, it has to be administered through a central line because of risk of precipitation. For all of those challenges, it never made it to the U.S. Where it's available in select markets worldwide, it is used sparingly, mostly as rescue therapy. The mainstay continues to be the PO route, either the capsule, the tablet, or the liquid. We align with the FDA on a regulatory pathway. Step one was to meet a pharmacokinetic bridge where we had day one Cmax and day three AUC parameters met against the oral. We successfully accomplished a scientific bridge availing the 505(b)(2) pathway, which is, as you might know, a de-risk regulatory pathway. We're not required to demonstrate efficacy in a pivotal phase III trial. The FDA guided us to a 100-patient safety trial, which is our STRIVE-ON trial I'll speak to in the next slide. What we show here is very strong pharmacokinetic data for IV relative to oral. As you can see, the box and whisker, green plot, much more tighter, predictable concentration with the IV bypasses the gut entirely, the first-pass issues that I talked about for oral. Plus, the oral has not only for across subjects, but even for the same subject, very high pharmacokinetic variability depending on the time of day that they receive the oral therapy. I'll talk about our phase III results from our STRIVE-ON trial. This is our pivotal trial, 100-patient safety trial that we successfully read out in February of this year. We dosed our first patient in October of 2023. Our last patient was enrolled in September of 2024. Less than 12 months, we were fully enrolled. Last patient, last visit was December of 2024. We read out positively in February of this year. The trial designed for the 100 patients, the treatment period up to 21 days. Our primary endpoint was hypotension, number of patients developing hypotension between IV and oral. From an FDA standpoint, our regulatory hurdle was to be equivalent. Same or better is success. We also collected additional data, efficacy measure, both physician-reported via the modified Rankin scale and patient-reported quality of life. In addition, we also collected pharmaco-economic data to demonstrate and tease out any signal from an economic perspective for IV versus oral. I'll give you a quick snapshot of the data. Clinical data, we had almost 20% patients develop fewer clinically significant hypotensive events versus oral. Almost 55% of patients had 95% or higher dose compliance as opposed to only 8% on oral. We already knew going into the trial that our pharmacokinetic was superior to oral, better hypotension management with IV, much higher dose compliance. The next question is, does it have any impact from an outcome perspective? Yes. We had almost 30% patients on IV with good recovery relative to the oral trial. Very strong data from a clinical perspective. Pharmaco-economically, we had 1.5 fewer ICU length of stay days on the IV arm versus oral, five fewer mechanical ventilation days, and 50% reduction in ICU readmission. Obviously, in a very cost-sensitive environment, given this drug will be used in an inpatient setting, having strong economic rationale for IV over oral, where there are hard dollars that could be saved, as certainly demonstrated in our STRIVE-ON trial, makes it a very compelling package addressing both clinical and pharmaco-economic. Obviously, from a dosing and administration standpoint, this fits in better, more convenient, as one neurosurgeon called it, set it, and forget it in terms of programming the dosing algorithm into the infusion pump. We were extremely pleased. Our Scientific Advisory Board is who's who of the neurocritical care space, neurosurgeons from prominent academic medical centers. We have engaged with wider thought leaders, KOLs in the community treating subarachnoid hemorrhage, and the data has been very positively received from the scientific community. We presented the data to the FDA in a pre-NDA meeting earlier this year after we read the data, aligned with them, which led to us submitting our NDA in June. Last month, the FDA accepted our NDA for review and assigned us the PDUFA goal date of April 23, 2026. Very, very strong data, clear rationale in terms of the unmet need. The molecule is clinically de-risked. We check a lot of the boxes just to give you a flavor of the patients that were recruited. Average age, as you can see, is way less than 60 years old, 2/3 women than men. UTNHEST is a grade that stratifies the severity of subarachnoid hemorrhage when patients are admitted to a hospital. One is the lowest grade, and five is the worst grade associated with 70%, 80%+ mortality. We just ended up with patients that were far worse off in the IV arm relative to oral. Still ended up with very strong data. Great signal from a hypotension perspective, favoring the GTX, the IV arm. Much higher dose compliance, as I mentioned. Majority of the patients in the IV arm had 95% or higher dose compliance as opposed to only 8% on oral. Modified Rankin scale is a 90-day outcome measure that we collected. We had assessments at day 30 and day 90. Unfortunately, in this disease, day 90 is considered to be long-term. We had 30% patients with good recovery in the IV arm. Patients came back to the hospital day 90 to be physician-assessed on MRS, which is the neurological assessment scale. We also collected patient-reported outcomes at day 90. We had zero patients, for example. There were zero patients that were bedridden at day 90 versus 12% on oral. One patient that could not manage their personal hygiene as opposed to 12% on IV. Very consistent, strong outcome, efficacy signals both physician as well as patient-reported outcomes. Safety data was very comparable between the two arms. Amlodipine has been on the market for decades. There is an IV available outside the U.S. for decades as well. There's no new safety signal that came out of the STRIVE-ON trial. In terms of, I mentioned the pharmaco-economic benefit, very high confidence with tight standard deviation on ICU length of stay and mechanical ventilation. We collected eight pharmaco-economic parameters related to disease severity as well as cost for the hospital. Every single of the eight parameters favored GTX-104. External ventricular drain, for example, the majority of the patients received an EVD drain, which is a hole that gets drilled into the brain to relieve hemodynamic pressure, better fluid management. By day 14, we had a significantly higher number of patients with an EVD drain versus the oral amlodipine arm. Commercial, about 50,000 cases a year in the U.S. We did extensive market research after we read out the trial and very, very well received by clinicians who are excited about the improved efficacy potential over the oral, better dose compliance, better hypotension management. The hospital administrators, the PMT committee cited the strong pharmaco-economic benefit on the IV versus oral that could potentially pay for the therapy. Obviously, the route of administration fits very well with the care flow, workflow of an ICU. About 250 hospitals in the country that treat the majority of the patients. With a highly experienced 15- 20 sales force, we can bring this drug to market. We're not talking about deploying massive boots on the ground, an army of sales force typically required to commercialize. In our instance, it's a very concentrated, focused market to commercialize GTX-104. I mentioned our strong patent firewall, seven years market exclusivity with our orphan drug designation. Our patents, the formulation patents go into 2037, and our newest method of use patent goes to 2042. Strong firewall. We have $20 million cash that we reported at the end of June. Our cash runway with the current cash on hand is way past goal date, PDUFA approval into Q3 of next year. We have two tranches of warrants. One that is going to expire October of this year for $7.6 million potential proceeds coming into the company. The second one, $15 million on approval. When you factor in about $23 million of those proceeds from those two warrant exercises, that takes us deep into revenue territory in 2027. Strong management team, experienced, bench to bedside. I've launched multiple drugs, both in an acute care setting and in a chronic care setting. Our Chief Medical Officer is a world-renowned neurosurgeon and exceptional CMC expertise, product formulation, and development expertise as well. With that, I'll end the formal presentation. In a nutshell, strong investment thesis, molecule is de-risk. We are nearing a major inflection point for the company. We have cash to take us past that inflection point in a commercial market that is rare and very, very attractive as well. I'll pause here and see if there are any questions. Thank you, Prashant, for the wonderful presentation. If anyone has questions, please feel free to type your question into the Q&A box, and Prashant will address them right away. Thank you so much. While we wait for any questions to come in, I'll try and maybe address some ones that are fairly typical. In terms of the NDA package itself that we submitted to the FDA, we made sure that during our pre-NDA meeting, we aligned on all components of an NDA. By that, I mean clinical, non-clinical, CMC. The regulatory pathway that we have taken has been blessed by the FDA on numerous occasions. We don't expect there to be any high risk there. The FDA has not said anything about having an adcom either for us, which we think that would be highly unlikely as well for a 505(b)(2) approach. You know from our perspective, we believe the regulatory hurdles are relatively straightforward. Okay. It doesn't look like we have any questions. I will pass it on to the operator. All right. Thank you so much. Since there is no question came in, we will now close this session. Thank you so much for your time, Prashant, and have a great day. Thank you. Bye. That concludes Grace Therapeutics, Inc.'s Presentation. You may now disconnect. For details on upcoming presentations, please refer to the conference agenda. Thank you for your participation, and we look forward to welcoming you to the next session.