All right. Good afternoon, everybody. Thanks for joining us for our next session at the SVB Healthcare Conference. I'm Marc Goodman, one of the biopharma analysts, and we have Satsuma Pharmaceuticals as our next company, and we are lucky enough to have the CEO, John Kollins, who is here with us. John, you know, I guess you have a presentation and you have some new information to kinda go through and stuff. Sure. Let's do it. I'm gonna turn it over to you, thanks so much for joining us. All right. Well, thank you for having us, Marc. It's great to be back at the Leerink Conference again. Just jumping right in here, I will be making some forward-looking statements during the course of the presentation. I would refer folks to our forward-looking statements, our SEC filings, and the risk factors contained therein as one considers a potential investment in Satsuma. As most of the audience, I think, knows is Satsuma is focused on developing STS101 DHE nasal powder for the acute treatment of migraine. STS101 is a very differentiated NDA stage asset. Low regulatory risk, we think significant commercial potential. We are on track to file an NDA by the end of the quarter. We believe, and are very confident that STS101 is approval despite the product not achieving statistical significance at the primary time point, two hours post-dose, in the SUMMIT trial. We think we have some very strong arguments for including the SUMMIT efficacy results and the prescribing information. Irrespective of what goes into the prescribing information, what we see in lots of market research, some of which I'll walk through with physicians, is they intend to prescribe STS101, indicate they intend to prescribe STS101 for about 30% of their patients, and that's irrespective of what the two hour efficacy is. We think STS101 uniquely addresses unmet needs of many patients, and key point here is a single dose provides sustained efficacy over time with minimal need for redosing and rescue, very convenient and easy to use, and an efficacy profile that's supported by the results of a large randomized controlled trial, the SUMMIT trial. As well, favorable safety and tolerability demonstrated more than 1,600 subjects who have treated more than 10,000 attacks. Very long exclusivity period expected as a result of just the fundamental nature of the product and the fact that we have 11 issued US patents that include patents with claims covering the formulation, the delivery device, methods of use. Those go out till the end of 2039. From a corporate standpoint, we are actively exploring alternatives to maximize value for shareholders, and we are seeking a transaction partner that'll commercialize STS101. With projected approval by January 2024, which contemplates a just standard 10-month FDA review, we believe that commercialization could commence by Q2 2024. Our cash as of the end of December was $fifty-two and a half million. This is an unaudited figure. Basic shares outstanding, 33.2 million, no debt. STS101 is the first and only DHE product with potential for broad utilization. It incorporates as the active ingredient dihydroergotamine, which is a trusted and powerful active physicians have long considered a gold standard treatment for migraine. For the very first time, we put DHE in a product that's simple to use, easy to carry, can administer a full dose in seconds. We have proven efficacy in a large randomized phase III trial, and we have favorable safety and tolerability. There's no other DHE product that has that incorporates these features. STS101 is unique, highly innovative, and designed to meet the needs of people with migraine. We combine proprietary advanced powder formulation technology in a single-use nasal delivery device. You can see it on the right. We call our technology SMART, the Simple Mucoadhesive Release Technology. Basically it allows more drug to get on board faster. Versus liquid nasal DHE sprays, we see two to three fold greater drug exposure, much less PK variability, and lower rates of almost all adverse events. Again, we're protected by multiple issued formulation device and methods patents. Administration is very, very simple and intuitive. Simply fold off a tab on the device, insert it into one nostril, and give it a squeeze to deliver. You can deliver a full dose within seconds, no priming, no assembly, no vials to open, et cetera. You can see that the PK profile falls between the PK profiles of the liquid nasal sprays, Migranal in the red, the DHE liquid nasal spray, STS101 in green, and Intramuscular DHE in blue. These data all come from our one of our phase I trials. See that STS101 rapidly achieves and sustains plasma concentrations that are expected to maximize efficacy while minimizing side effects, particularly iatrogenic nausea, which is an issue with the injected DHE. What we see from the SUMMIT trials, this PK profile translates to robust and sustained efficacy. We've superimposed the other liquid nasal spray product that has been introduced more recently, Trudhesa here, and you can see that it's only incrementally, the PK is only incrementally higher. We, you know, we get more drug on board, and that translates, we think, to a better efficacy profile without any increase in nausea. Overall, the clinical profile, and I wanna talk about this in some detail, that we see from the phase III pivotal trials is that it is one similar to injected DHE, where a single dose provides robust and sustained anti-migraine effects with minimal need for redosing or rescue, favorable to safety and tolerability. The attributes align with what the majority of patients want in an acute migraine treatment and with the American Headache Society's consensus goals for acute treatment. Showing here the primary outcome summary from the SUMMIT phase III trial, which we announced in November 1,424 subjects in the MITT population. Co-primary endpoints, freedom from pain, freedom from most bothersome symptom, were measured at two hours post-treatment. While we didn't, we fell short of achieving a p-value of 0.05 or less by three hours and at all time points thereafter through 48- hours, the p-values were less than 0.001. Very small p-values indicating that there is a real effect at these time points post two hours. Moreover, we've looked at a variety of clinically important endpoints. Pain freedom, MBS freedom, pain relief, total migraine freedom, no pain, no symptoms, nausea freedom, photophobia freedom, photophobia freedom. What we're showing in this plot, what I'm showing is the p-values at different time points. What you can see is that by two hours in gray, pain relief falls below the. There's a significant difference between placebo and active on pain relief. We win at two hours on pain relief. Then for every other endpoint that I just described, by three hours, we see a statistically significant effect, and that effect is sustained versus placebo through 48- hours. Moreover, when you look at on an individual patient basis, whether the effects are sustained over time, we see highly significant differences as well. Sustained pain freedom, for example, two to 24- hours, means a subject was pain free at two hours, had no relapse or use of rescue medication through 24- hours, and hence the pain free response was sustained. We see that across a variety of these endpoints. This isn't exhaustive, it's just exemplary, including sustained total migraine freedom and a significant difference in the use of rescue medications within 24 and 48- hours. What we see here, just an overall picture, is a time course and durability of anti-migraine effects that are similar to DHE administered by injection. One of the seminal papers or studies that KOLs will point to is a study that kind of underscores the long-lasting effects of DHE, is a comparative trial between DHE subQ injection and sumatriptan subQ injection. This was head to head, about a 300 patient study. It's kind of a tortoise and a hare story because sumatriptan starts off with higher rates of pain relief up to about three hours or so, by which time DHE catches up and then surpasses sumatriptan. Moreover, the recurrence that occurs following DHE is about two and a half fold less than with sumatriptan. Again, this is one of the features that physicians really, and patients really value. Recurrence is a big problem for many patients, and it occurs in up to half of all triptan treated attacks. You know, that clinicians know this. Repeated use of triptans risks medication overuse headache. Japan's recurrence is an issue we saw with Ubrelvy in 38%-50% of attacks. A second dose was taken in about half the trials. Repeated use is costly. Recurrence and redosing are leading reasons for dissatisfaction among triptan users. When you actually go out and talk to patients and survey them about what they want, a majority... When you ask them, "Would you rather have a slow acting drug with a long duration of action or a fast acting drug with a shorter duration of action?" There have been two studies published here, and the majority of patients in both cases take the slower onset, the drug with a slower onset but the longer duration of action. I think that's kind of a feature we have that aligns with what patients want. You know, when you ask people what they want, they want efficacy, they want fast onset, they want long duration without recurrence or need for redosing or rescue. They want consistency, tolerability, and convenience. We stack up, you know, we rate excellent against all these parameters with the possible exception of fast onset. We are not, at least from a statistically significant, being statistically significant versus placebo, we're a bit slower on that front. You know, when you look at the onset on an absolute basis, not placebo-adjusted, there's really not a difference between STS101 and the triptans, which sold over $1 billion for, I believe, in net sales last year. Been a very, very successful. This is what a patient would experience or a clinician would see in his or her patients because they can't apportion placebo response. What aspect of the response is based on when they're treating patients in a clinical setting is attributable to placebo. The profile also aligns with the American Headache Society's consensus goals for acute treatment. What are the goals? Rapid and consistent freedom from pain and associated symptoms without recurrence. Again, we see we rate excellent on those parameters. We rate well on restored ability to function, which we turn significant by four hours. We didn't measure that at three hours. Minimal need for repeat dosing or rescue, and minimal or no adverse events. With respect to adverse events, we compare very favorably with all other approved DHE products. Our primary market research points to a commercial opportunity and a large commercial opportunity. What we've seen consistently in our primary market research, and this aligns with our qualitative research, our discussions with physicians, is that intent to prescribe STS101 doesn't hinge on two hour efficacy results. We've done four surveys since 2021, 100 physicians each, and in which we show physicians a product profile. The product profiles really only differed in the efficacy profile that are included in them. Back in 2021, we did two surveys. One had an 8% effect size that was statistically significant at 2 hours. The other, a 16% effect size, pain-free that was statistically significant at two hours. In both cases, physicians said that they'd intended to prescribe the product to about 30% of their patients. We did a third survey after the SUMMIT readout. We did this in December, and we actually included the actual SUMMIT results. 2.9% effect size, not statistically significant. They came back and said 30% of our patients we'd intend to prescribe. Some people, you know, people said, "Look, you may not get your data in the label. You may get the Migranal efficacy data." I said, "Okay, let's go out and do the survey again." This time we excluded from participation anyone who had participated in the December survey. So we included just the Migranal label efficacy data in the product profile. Again, 30% intent to prescribe. What this is telling us is that the key drivers of interest are, you know, the fact that we incorporate in STS101, DHE is the active ingredient, that patients or physicians really respond to the ease of use and convenience of STS101, and its favorable safety and tolerability profile. Finally, we believe STS101 has high probability of FDA approval. We have strong arguments for including the SUMMIT efficacy results in the label. The FDA has consistently told us that the product is approvable with just PK data that builds a scientific bridge to the reference product, injectable DHE and liquid nasal spray, and the open label safety results. They have indicated that the efficacy trial results are optional, but that they could potentially be included in the label. We've spent the last couple months talking with expert regulatory advisors, both council and former FDA officials, in crafting the arguments for including the SUMMIT trial data in the label, and we believe we have strong arguments. Finally, the timeline for submission and potential approval, commercial introduction are shown down below. Conclusions. STS101 has a very unique and differentiated clinical profile. Single dose provides robust and sustained efficacy with minimal need for redosing at rescue. Very convenient and easy to use. Favorable safety and tolerability. That profile is supported by the highest quality clinical evidence generated in a large randomized controlled trial and a large safety trial. The profile aligns with what the majority of patients want in an acute treatment. It aligns with the American Headache Society's goals for acute treatment. Our market research tells us that the product has significant commercial potential, and that physicians who are surveyed consistently tell us that they intend to prescribe STS101 to about 30% of their patients. We have a high probability of approval with very strong arguments for including SUMMIT results in the label. I'll close it there. Thank you very much. John, let me just ask a quick question. Sure. T he market research that you just were speaking of. Right. W hat did the, what did the market research look like, you know, five years ago, before you went about working on the phase III study, the original one, in the first place? You know what I mean? I. Which leads to the second question, which is why did you go about-. Right. Working on the phase III in the first place. Right all this time if we're kind of back where we started? Right. Right. You know, the market research is You know, people have consistently responded to the fact that DHE is the active ingredient, and the, you know, and the ease of use and convenience aspect of the product. It's a fair question as to, like, did you really need the phase III efficacy trial? I think in a perfect world, I think ideally, yes, because I think it gives you the Had we been successful, it would have given us the strongest ammunition to secure reimbursement for the product from payers. Now, we've done payer research as well, and, you know, I think we'll have to push a little bit more with the payers, given that we missed the two hour endpoint. Given the, you know, again, given the effect that we see, the fact that we did a large trial, that we have a very strong data set that clearly shows effect, I mean, we've got very strong arguments still to take forward with the payers. Right. You know, as you know, Marc, I mean, it's. You know, you've got to market, if you will, a product to payers as much as you, and get them to cover the product, to, you know, as well as marketing it to physicians and patients. When you were quoting the 30% was pretty consistent, right? Yeah. P eople describing the 30%-. R emarkably consistent. What was it like five years ago, before you even went down the path? Was it 30% as well? You know, I don't remember off the top of my head. I mean, I'm just. Well, was it 20-something? Was it five to 10? Yeah. I don't. Do you have any-. I don't. You know, the only reason I ask is if it was 30 then, it's kind of like, wow, okay. That's a pretty high number. I mean-. Yeah. Well, physicians have always, you know, they've always wanted a DHE product that consistently gets enough drug on board to have a robust effect, and that's very easy to use, and doesn't result in side effects. There's no other product that meets that need, Marc. Right. T hat's the issue. A skeptic would say, "Well, that may be the case, but, you know, if you look at Impel, and they launched a DHE, they're not, you know, they're not killing it. I mean, obviously they're growing, you know, small numbers, but. Yeah. What's your view of that product? Yeah. Well, that product is, you know, kind of Migranal with a you know, a bigger sprayer that jams more liquid up into the nose, basically takes the volume of drug liquid that Migranal delivers in four sprays over 15- minutes, and delivers it in two sprays. As a result, they get more congestion. Congestion is a big problem with Trudhesa, as is the difficult assembly and preparation procedure. It's not a convenient product. I think the root, you know, the root problem with Impel and the reason that they've not performed that well is it's not a great product. Yeah. Period, full stop. Just so we're clear, right now, the company is burning what kind of cash, and what are you seeing going forward? Well, all our clinical work is basically done, you know, our expenses have gone down significantly. Right. We had a little over $50 million as of the end of the year. Right. Okay. That's where we are. You are currently speaking with. We are certainly engaged in partner discussions. P otential partners. I suppose the next question is give us a sense of what these types of discussions are like, and maybe second part is, you know, are these small companies? Are they big companies? Yeah. A cross the board, or do you-. We've engaged with a variety of companies, and I can't, you know, really give more color than that at this point. It's fair to say that there is interest? Yes. That that interest is in a product that will not be, doing another phase III study, but instead filing with what you have today? That's correct. That's the discussion point? Yep. Got it. Okay. Okay. All right. Well, thank you so much for. Great. Well, thank you. G iving us an update. It's always- All right, thanks. Mm-hmm. You know, good questions, and we'll see how things go. Right. Right. Okay. Thank you. All right. Take care. Take care, Marc. Bye. Bye. Bye-bye.