Good morning. My name is Ashley, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences proposed acquisition of the Zynerba Pharmaceuticals conference call. All participant lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question at that time, please star one on your telephone keypad. Please be advised today's conference call is being recorded. Lastly, if you should require operator assistance, please press star zero. I will now turn the call over to Luis Sanay, Head of Investor Relations. Please go ahead. Good morning, everyone. Welcome to Harmony Biosciences conference call to discuss the proposed acquisition of Zynerba Pharmaceuticals. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO, and Sandip Kapadia, Chief Financial Officer. Following our brief prepared remarks, Jeffrey Dierks, Chief Commercial Officer, and Dr. Kumar Budur, Chief Medical Officer, will also be available for the Q&A portion of the call. As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially, and we undertake no obligation to update these statements even if circumstances change. We encourage you to review the statement set forth on slide two of our investor presentation and to consult the risk factors referenced in our SEC filings for additional details. Please note that this conference call is neither an offer to purchase nor a solicitation to sell securities. The tender offer for Zynerba's common stock described in this morning's press release has not commenced. When the tender offer does commence, investors should review our tender offer statement and related documents and Zynerba's recommendation statement, each of which will be filed with the SEC, as they will contain important information regarding the details of the tender offer and Zynerba's board's views regarding the acquisition. I would now like to turn the call over to Dr. Jeffrey Dayno. Jeff? Thank you, Luis. Good morning, everyone, and thank you for joining our call. This morning, I am very pleased and excited to announce our proposed acquisition of Zynerba Pharmaceuticals. This transaction represents an important step in our strategy to expand our pipeline and build a diversified portfolio of innovative assets beyond sleep-wake to drive long-term growth for Harmony. In addition to the strength of our core business of WAKIX and narcolepsy, along with advancement of our current lifecycle management programs with pitolisant, led by idiopathic hypersomnia, business development has always been a high priority for us. Our business development strategy has been focused on identifying assets that are complementary to our existing portfolio, where we can leverage our expertise and infrastructure. This proposed acquisition exemplifies this strategic fit in several key ways. First, our overall growth strategy. When asked about business development, we have always said that it is a high priority and we are going to be thoughtful and strategic in our approach. The acquisition of Zynerba Pharmaceuticals and its investigational product, Zygel, fits into this strategy for the following reasons. It expands our pipeline with another innovative product candidate that, similar to WAKIX, represents a portfolio and a product opportunity that could address high unmet medical needs in a number of patient populations. It diversifies our portfolio beyond sleep-wake and is also within our area of expertise in rare orphan neurology and neuropsychiatric disorders. It brings in two late-stage development programs that could launch during the WAKIX lifecycle, and it will help drive long-term growth for Harmony. Next, the product. The acquisition of Zynerba brings us another innovative product candidate called Zygel. Zygel is the first and only pharmaceutically manufactured synthetic cannabidiol, a non-euphoric cannabinoid, formulated as a patent-protected, permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zygel is manufactured through a synthetic process in a GMP facility and is not extracted from the cannabis plant. Therefore, it is devoid of THC, which is what causes the euphoric effect of cannabis and has the potential to be a non-scheduled product if approved. Zygel, for the treatment of Fragile X syndrome, has patent protection through at least 2040. Through this transaction, we are expanding our pipeline with two late-stage development programs in rare orphan neuropsychiatric disorders. Similar to WAKIX, Zygel represents a portfolio and a product opportunity, and it's currently being evaluated in a pivotal phase III clinical trial for patients with Fragile X syndrome, called the RECONNECT trial. Additionally, Zygel was studied in an open-label phase II proof-of-concept study in patients with 22q11.2 deletion syndrome, known as the INSPIRE trial. The data from this trial demonstrated clinically meaningful improvements across various symptoms of interest, including anxiety, depression, mood, and irritability, as measured by recognized scales to assess these symptoms in patients with neurobehavioral disorders. From a regulatory perspective, cannabidiol, the active ingredient in Zygel, has been granted orphan drug designation by the US Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, for the treatment of Fragile X syndrome and for the treatment of 22q11.2 deletion syndrome. Additionally, Zygel has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with Fragile X syndrome. Lastly, let me frame the market opportunity for you and highlight the important unmet medical need in these patient populations. The lead development program in phase III is in patients with Fragile X syndrome. Fragile X is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder. It is caused by a mutation in FMR1, a gene which modulates a number of systems, including the endocannabinoid system. The disorder negatively affects synaptic function, plasticity, and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. In the U.S., there are about 80,000 people living with Fragile X syndrome. There are currently no therapies approved by the FDA to treat Fragile X syndrome, and there remains a significant unmet medical need in treating patients with this debilitating disorder. The other development program is in patients with 22q deletion syndrome. This syndrome results from microdeletion in the long arm of chromosome 22 and presents with physical symptoms, including characteristic abnormalities of the palate, heart defects, immune dysfunction, and esophageal and GI issues, as well as debilitating neuropsychiatric and behavioral challenges. Anxiety is among the most common neuropsychiatric symptom and is linked to poor adaptive behaviors. Children with 22q deletion also experience social withdrawal, ADHD, cognitive impairment, and autism spectrum disorder that affect communication and social interaction. It is estimated that there are approximately 80,000 people living with 22q deletion syndrome in the U.S., and currently, there are no FDA-approved therapies to treat this disorder. As you can see, the acquisition of Zynerba Pharmaceuticals fits well into our long-term growth strategy, which is focused on developing and delivering innovative products that address areas of high unmet medical need. The innovative investigational product, Zygel, and two late-stage development programs further diversifies our pipeline and the market opportunities in patients with Fragile X and 22q11.2 deletion syndrome, each with approximately 80,000 U.S. patients, are significant. This transaction represents an important step in our strategy to expand our pipeline and build a diversified portfolio of innovative assets beyond sleep-wake to drive long-term growth for Harmony. We don't plan on stopping here. My vision for Harmony is to become the leading patient-focused CNS company by developing and delivering innovative treatments for patients living with rare orphan diseases who have high unmet medical needs. We believe that where empathy and innovation meet, a better life can begin for those patients and their families. I will now turn the call over to our CFO, Sandip Kapadia, to provide an overview of the financial terms of the proposed acquisition. Sandip? Thank you, Jeff. We're very pleased to announce our proposed acquisition of Zynerba Pharmaceuticals. This acquisition represents an important step in our strategy to expand our pipeline and build a diversified portfolio. I'd like to take a few moments to take you through the details of the acquisition. We've structured the acquisition to limit the upfront tax requirement while paying milestones primarily contingent upon advancement of the lead clinical development program in Fragile X syndrome. Starting with the transaction details, we've agreed to acquire all outstanding shares of Zynerba for a purchase price of approximately $1.1059 per share in cash, or $60 million in the aggregate payable at closing, plus one non-tradable contingent value right, or CVR, with the potential additional payments of up to $140 million, or approximately $2.5444 per share. The CVR payments will be subject to the achievement of certain clinical, regulatory, and sales milestones. Please refer to the press release in slide eight in the presentation for additional details regarding the CVR milestone payments. At a high level, payments include the following: clinical milestone payments of up to $45 million or approximately $0.82 per share upon completion of the Fragile X phase III clinical trial and dependent on the timing of the positive data readout. Regulatory milestone payments of up to $50 million, or approximately $0.91 per share, upon the FDA approval in Fragile X and a second indication. Net sales milestones of up to $45 million, or approximately $0.81 per share, after achieving certain net sales milestones. ... Given our strong cash position of approximately $430 million as of June 30, 2023, we will fund the transaction from our existing cash on hand. Zynerba's cash and cash equivalent balance was approximately $36 million as of June 30, 2023. The final cash balance will be dependent on the timing of the close and transaction costs. The transaction is expected to close by the fourth quarter of 2023, subject to customary closing conditions, including that the holders of at least a majority of the outstanding shares of Zynerba common stock tender such shares to Harmony in connection with the tender offer. Finally, we continue to be active in our business development efforts to look for additional opportunities to expand our pipeline and build a diverse portfolio. We also retain ample financial capacity to pursue additional business development and execute on our share repurchase program as we look to deploy capital to maximize shareholder value. With that, I'd like to turn the call back to the operator to facilitate any Q&A. Operator? Certainly. Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. If you wish to remove yourself from the queue, you may do so by pressing star two. We remind that you pick up your handsets and please limit yourself to first question and one follow-up question. We will take our first question from Charles Duncan, Cantor Fitzgerald. Please go ahead. Hey, good morning, Jeff, and team, congratulations on this proposed acquisition. It's pretty interesting. We know, we know the Zygel product and Zynerba folks pretty well, having been diligent on it for a while. I had a couple of quick questions. I guess I wonder, with regard to the enrollment rate of the ongoing RECONNECT study, and, you know, implications to payments in 2024. I guess I'm wondering, how is that enrollment going, and what is your, call it, probability of having to pay either $35 million with the completion of it next year on positive data or, excuse me, $35 million or $35 million the following year, depending on the timing? The second question I have is regarding FDA communication, if you've had an opportunity to review that and, you know, kind of the FDA feedback in terms of methylation being an important part of enrolling Fragile X patients, in that study. Thank you. Yeah. Good morning, Charles, and thank you for your questions. Yeah, you know, we're aware that, you know, you have been following Zynerba. For your first question, Charles, you know, with regards to the enrollment in the RECONNECT trial and timing, so, you know, at this point, we, you know, cannot commit with regards to the, you know, the Fragile X development timeline that was previously disclosed. We will provide an update, you know, on our view of the program and timeline after the closing of the transaction, you know, when we get sort of a closer look at everything. You know, that being said, and with regards to your second question in FDA interactions, yes, you know, we did thorough diligence, obviously, and have seen, you know, all of the FDA communications interactions. I, I think at a high level, we're very excited about the potential of, you know, the Fragile X phase III RECONNECT trial, that development program, as well as the potential of the 22q development program based on positive signals and data from the phase II proof of concept study. You know, we think this expands our pipeline, diversifies our portfolio, and, and very excited for the potential opportunity here, as well as an opportunity to bring, you know, new treatment options for patient populations with unmet medical needs. Okay. If I could just follow up, any, any impact on the interim study for pitolisant in idiopathic hypersomnia, do you feel like that is still on track, or, or could this modulate your efforts there? No impact at all, Charles. That, you know, that trial is absolutely on track and no impact on our current life cycle management development programs. You know, we have a full capacity, experienced team to continue with our LC, you know, life cycle management programs in idiopathic hypersomnia, Prader-Willi, as we previously discussed, and then bringing these programs in and adding to our pipeline. Okay. Thanks for the taking the questions. Thanks. Yep. Thank you, Charles. Thank you. We will take our next question from François Brisebois with Oppenheimer. Please go ahead. All right. Thanks, taking the questions. Just a couple here. In terms of the data you talked about, can you just maybe tell us your, you know, what makes you confident about the open label INSPIRE data? Was there data, you know, on the Fragile X side, not just the 22q, but on the Fragile X side, that that was encouraging, as of phase II? Thank you. Yeah. Thank you, François. Good morning. Let me ask Kumar Budur to, you know, respond with regards to our view of the data of those programs. Sure. Hey, good morning, François. Thanks for the question. Let me start with Fragile X syndrome. The data from the CONNECT-FX study, which was a large study in Fragile X syndrome with over 200 subjects enrolled in that study. The data was promising, and especially when we looked at the data in patients with complete methylation, there was a significant separation, patients who had complete methylation when compared to placebo versus Zygel. The ongoing phase III study, the RECONNECT study, is designed based off of the learnings from the CONNECT-FX study. For example, we are focusing on complete methylation patients, but it's also important to note that about 20% of the patients also have partial methylation. If the data in partial methylation patients are supportive and consistent with the data on the full methylation patients, then we have a potential for broader label indication. That's on the efficacy side. From the safety perspective, Zygel was, in general, safe and well tolerated. The only case of note was application site reaction, like skin irritation, and that was seen in about 6.4% of the patients who were on Zygel, compared to 1% of patients who were on placebo, and most of these were mild, transient, and resolved on their own. That's Fragile X syndrome. Regarding 22q deletion syndrome, it was a small proof of concept, open label study in 20 patients, we saw promising signals on several parameters of interest like mood, anxiety, and irritability, which are the most prominent and bothersome symptoms for the patient and the caregiver. We are very encouraged with the data that we saw, both in 22q deletion syndrome and also Fragile X syndrome in the CONNECT-FX study, we are hopeful that the ongoing RECONNECT study will be positive, and it will be sufficient for regulatory approval. Thanks so much. Thank you very much. Can you, can you just maybe touch on, Jeff, when you talk about the prevalence of Fragile X, just maybe the understanding of what percentage of that is partial versus full, methylation? Yeah, sure, François. It's about 60% of the patients with Fragile X, you know, have full methylation. Of the estimated 80,000 patients with Fragile X in the U.S. Thank you. Sure. Thanks, François. Thank you. We'll take our next question from David Amsellem with Piper Sandler. Please go ahead. Hey, thanks. Pardon my, my ignorance here, if you could call it ignorance. Can, can you talk about the extent to which you would look at the product more broadly in or in a broader epilepsy population over, over time? I, I know you have the, the lead indications, but, you know, we've, we've seen with the, the other CBD product that's, that's available, that there's a lot of off-label use. How do you think about that over time, and how do you think about where you want to take this product over time? Thank you. Yeah, sure, David. Good morning, and thanks for your question. You know, I, I think that we're aware, obviously, of, you know, the other products in terms of the cannabidiol, you know, based products and, and their application in, in the rare epilepsies. I think obviously our initial focus is on the programs we talked about, where we have significant opportunity in the rare neuropsychiatric disorders, you know, as we mentioned, led by Fragile X in phase III and potentially 22 q, which would be, you know, phase III-ready. In terms of other additional indications, I think it's too early for us to, you know, comment on where we would take that with regards to our overall portfolio. You know, potentially as a synthetic cannabidiol, potentially in terms of a, a different overall benefit-risk po... you know, proposition, there could be opportunity there. I, I obviously, will comment more after the closing and as we advance the initial development efforts, if there's additional opportunities going forward. Okay, that's helpful. If I may sneak in a follow-up. As, as you think about the dev and M&A, more, more broadly, and I know this gets you out of, gets you out of the, sleep medicine and more into, you know, squarely, more squarely in, in neurology, do you think about, over time broadening beyond rare neurological diseases, or is this something that... Is this a, a space where, you know, you're continuing to be squarely comfortable, in playing in? How do you think about that, just sort of longer term? Yeah, I think for the long term, as, as we've said, you know, our, our focus, you know, internal expertise and infrastructure in the rare orphan sort of neurology, neuropsychiatry space, we, you know, and we leverage that expertise and, and infrastructure in an efficient commercial footprint. We are open, you know, as we look broadly at the BD landscape, we would be open to, you know, adjacencies and other broader opportunities. For the right, potential BD deal, we obviously strong balance sheet, the ability to transact, ability to additional capital. Maybe Sandip can comment on that. I think we, we keep our eyes, you know, wide open for opportunities that would, would be a good strategic fit. You know, in the near term and reflective, you know, of this proposed acquisition, you know, orphan rare space and it is, is kind of where, you know, our main footprint is at this point in time. Sandip, any further thoughts? No, I think, I think like you said, we have ample financial capacity to pursue business development, you know, whether it's a, a broad indication or, or orphan rare indications. Okay, that's helpful. Thanks, guys. Thanks, David. Thank you. We will take our next question from Danielle Brill with Raymond James. Please go ahead. Hi, guys. Good morning. Thanks for the question. Two quick ones from, from me. I'm curious, will you need a second phase III trial to support a filing for Fragile X? Is methylation screening routinely performed in medical practice, given you may have a restricted label? Thank you. Yep. Good morning, Danielle. Thanks for your question. Kumar, Sure. Take that one? Good morning, Danielle. Once again, thanks for the question. The phase III pivotal registration study, the ongoing RECONNECT study, is designed based on the input from the FDA on the study design, primary endpoint, and other aspects. Typically, in a rare orphan indication, what FDA requires is a single, adequate, and well-controlled study, especially if the data are statistically significant and clinically meaningful. The ongoing RECONNECT study is an adequate and well-controlled study, and we believe this 1 study, if it is statistically significant, clinically meaningful, should be sufficient for registration. We don't believe there will be a need for the second pivotal study. Kumar, in terms of the question about methylation, is that routinely done in clinical practice? Yes, it is. It has become a routine standard clinical practice now. Understood. Thank you. Thanks, Danielle. Thank you. We will take our next question from Ami Fadia with Needham. Please go ahead. Hi, good morning. Thanks for taking my question. Could you elaborate a little bit more on the primary and secondary endpoints of the phase II study? You know, what is the subset analysis of patients that have full methylation show for the primary endpoint as well as the secondary endpoint? If the FDA, based on your read of their interactions, is looking for signs of efficacy beyond the primary endpoint for approval of the product. Secondly, you've mentioned that 20% of the patients in the phase III study that will be enrolled have partial methylation. What was that percentage in the phase II study? You know, is that what you're gonna continue as you take on kind of this program? Thank you. Sure. Good morning, Ami. Thanks for your questions. Yeah, Kumar can respond to those. Good morning, Ami. I know there were lots of questions there, so I'll try to see if I can answer all of them. The CONNECT-FX study was a large study, Ami. In fact, there were over 200 patients with Fragile X syndrome that were enrolled in that study. In that particular study, about 65% of the patients had complete methylation, and the rest of them had partial methylation. When we looked at the data, the patients who had complete methylation showed statistically significant difference compared to placebo. The patients who had partial methylation, although the efficacy, the change from baseline, was very similar, there was also a significant placebo response, and therefore it was not statistically significant. Going forward, the phase III study was designed based on the learnings from the CONNECT-FX study, including the primary endpoint, the duration of the study, 18 weeks versus 14 weeks, and also the dosing paradigm, where we also introduced a higher dose of 750 mg for patients who weigh greater than 50 kg. In terms of, what other questions you asked, Ami? There was a question- About the secondary endpoints. me start with the primary endpoint. The primary endpoint was something that was designed with input from the FDA. The primary endpoint is the Aberrant Behavior Checklist, community version in Fragile X syndrome, specifically measuring Social Avoidance. In terms of secondary endpoints, we are also looking at other endpoints like ABC, Aberrant Behavior Checklist in general, specifically irritability as well. Also, we are looking at the Aberrant Behavior Checklist, various symptom domains across both complete methylation and partial methylation patients. From a registration perspective, what we are looking for is a statistically significant difference on the primary endpoint, which is ABC-3 Fragile X syndrome, Social Avoidance. Does that answer your question? One last piece, which is what% of the patients, well, I guess I've gotten all the answers. Thank you. Sorry about that. Thank you, Ami. Yeah. I think, yeah, the, we've got 65% with full methylation in the phase II in the CONNECT-FX trial. By design, the phase III will have, 80%. Of the full methylation. Complete methylation, and 20% with partial methylation. Thank you. Thank you. We will take our next question from Graig Suvannavejh with Mizuho Securities. Please go ahead. Hey, good morning. Thanks, so much for taking my questions. Congrats on the proposed acquisition. Two questions, if I may. First, on the M&A in itself, it does change the overall risk profile of your company, and I, I guess I'm just trying to get a better appreciation of the considerations of, of this this transaction relative to perhaps other deals or, or potential transactions that you contemplated. Was this really more about the revenue opportunity or the size of the transaction, which led you to choose the proposed acquisition of Zynerba? My second question just has to really do about the transaction value, you know, from a market cap perspective. If I have my numbers right, Zynerba is about an $18 million market cap company, and so for $60 million upfront and then, another $140 or so in, a potential CVR payments, just wondering, how you came to, the transaction value of this deal. Thanks. Yes, great. Thanks for your question. In, in terms of, overall, you know, with regards to this, potential acquisition, you know, we see it as a, a, a really good strategic fit, you know, with regards to consistent with, you know, our strategy in, you know, orphan rare, you know, neurologic and neuropsychiatric disorders. You know, as well as another innovative product, you know, expanding our, our pipeline and diversifying our, our portfolio. I, I think that would be at a high level, you know, the thinking of the opportunity here. In, in terms of the, you know, the, the terms of the proposed transaction, I think Sandip, I'll ask him to comment on that. Sure. Greg, thanks, thanks for the question. Clearly, look, we've structured the transaction in a manner that we, we feel appropriately values the opportunity. You know, as, as I mentioned in the call, you know, we, you know, upfront cash, we try to minimize the upfront cash, which is about $60 million. As, as I also mentioned, Zynerba's, you know, cash on hand at the end of June was about $36 million. We based the balance, really based on success of the programs, going forward. I, we feel that we've, you know, appropriately valued it based on the overall opportunity, as, as Jeff mentioned, not only in Fragile X, but potentially many other indications that we may be able to pursue that maybe the team previously wasn't able to pursue. Clearly, obviously, we looked at it from a NPV perspective, and we felt it was good value, just even from the Fragile X program by itself. Thanks, Sandip. Thank you. We will take our next question from Pavan Patel with Bank of America. Please go ahead. Hey, guys. Congratulations on the announcement of the deal this morning. In terms of the treatment of Fragile X patients, can you describe if there's any off-label treatments that those patients may be getting? Can you share your thoughts on what they, what that may look like in the clinic? What do you see as the onset of action for Zygel with the transdermal delivery, and how does that compare to the potential off-label treatments that Fragile X patients may be getting? Thank you. Sure. Thank you for your question. Kumar, you want to respond to that? Yeah. Good morning. Thank you for the question. Currently, there are no FDA-approved treatment for any symptom cluster in Fragile X syndrome. Right now, the clinicians are using off-label treatments, depending on the predominant symptoms. Some of the medications that are commonly used include SSRIs, sometimes to take the edge off of the anxiety. Sometimes they also use some benzodiazepines, items, and sometimes some low-dose antipsychotics as well. As you can see, I mean, clearly, there is a significant high unmet need in this patient population because none of the off-label medications are neither suitable, nor the side effect profile is appropriate for this particular patient population. To answer your second question, in terms of, Zygel itself, Zygel is the first and the only pharmaceutically produced permeation-enhanced transdermal gel. The advantage of a transdermal gel, where the drug is delivered directly into the circulatory system, is that it bypasses the GI system, therefore, the significant GI side effects that are associated with oral cannabidiol preparations are avoided, and also it bypasses the first-pass metabolism, which means that the adverse impacts on the liver system are also minimized. In terms of efficacy itself, what we have seen in the CONNECT-FX clinical trial is that we do start seeing some improvement starting between week one and week two, and the improvement continues up to about 12 to 14 weeks. What is more important is the sustained improvement that we have seen with Zygel, especially in FX, Fragile X syndrome. In fact, one piece of information I do want to share is that in terms of safety profile, some of the patients with Fragile X syndrome have now completed over six years of treatment, and the efficacy is sustained. The persistence rate is really impressive, especially in a neuropsychiatric condition like Fragile X syndrome. Thank you. If I can have a follow-up question. In terms of when I look on CT.gov, I see the September 2023 primary completion date. In terms of NDA filing, could we see that by year-end? If not, maybe if you can have some color on timing of this product. Thank you. You know, it is, first of all, I have to say we are very excited about having this opportunity at Harmony to help tens of thousands of patients with Fragile X syndrome, especially when there are no FDA-approved treatments for this condition. It is a bit too early to comment on the timeline, and we intend to provide further update after the closure of the deal. Yeah. Thanks, Kumar. Yeah. As Kumar said, you know, after the closing of the deal and when we, you know, have a closer look at the program and progress to date, we'll, we'll provide updates with regards to, you know, timing and other, you know, regulatory milestones. Thank you, guys, and congrats again. Yeah, thank you. Thank you. We will now take our last question from Corinne Jenkins with Goldman Sachs. Please go ahead. Good morning, everyone. Maybe a couple from us. I'm curious which data you were able to access ahead of kind of going forward with this deal. Was there, for example, any interim analysis of the phase III? Were you able to kind of look at the earlier stage PK/PD data that I don't think the street has seen? I have maybe one other follow-up. Sure, Corinne. Good morning. Thanks for your question. I think Kumar can respond to that. Obviously, we, we've done deep diligence, you know, taking us to this point and, a close assessment of, of the data. Okay. Thank you, Corinne. Good morning. As part of the due diligence, obviously, we looked at all the data, starting from the non-clinical data to clinical pharmacology and the clinical data. Obviously, the most important data set of the clinical data, the CONNECT-FX study, where more than 200 patients, as I mentioned earlier, with Fragile X syndrome, were enrolled, and where we saw a signal, really a stronger signal in patients with complete methylation compared to patients with partial methylation. In fact, we saw about 40% median improvement in the symptoms of Fragile X syndrome on the primary endpoint, which is social avoidance scale, which is pretty significant. The RECONNECT study, is based on the learnings of the CONNECT-FX study, and we have made some data-driven changes in the RECONNECT study, thereby increasing the confidence in the probability of success of RECONNECT study. Hopefully, that answers your question, Corinne. Yeah. Corinne, what I'll also add, I think, you know, what we've been seeing is also the, you know, the consistency of the data, you know, across both the, you know, the Fragile X and 22q deletion syndrome, you know, program. The consistency of the data, the sustained, you know, response over time, over long periods of time in the open label extensions. The other, interesting data set that was, was published also is the, you know, exposure through this transdermal preparation, you know, achieving similar exposures as some of the oral preparations of cannabidiol, along with steady plasma levels. Yeah. One, one more thing to add, Corinne, is the safety profile. In fact, we have over 750 patients exposed to Zygel across various phase II and phase III studies in various indications. I mentioned earlier, some of the patients with Fragile X syndrome have been exposed to Zygel for over six years now, and we are impressed with the consistency rate and the continued sustained efficacy. Understood. Maybe could you just help us understand the nature of the patent suite, like the existing patent portfolio? I think you can't get composition of matter patents for any cannabidiol-based products, so I'm curious what they've established and your confidence in kind of the, the strength of the patent portfolio. Sure, Corinne. Yeah. You know, from what we've seen in our assessment, you know, we're confident in the strength of the, the portfolio and, mainly based on, Zygel for the treatment of Fragile X syndrome, is patent protected, you know, through at least 2040. It gives us, you know, sort of long, you know, long runway and opportunity with regards to, you know, that program. Also method of use for 22 Q, if we choose to pursue that indication as well. Okay, it's a method of use patent? Correct. Okay, thanks. Yeah. Thank you. There are no further questions at this time. I'll turn the call back over to Dr. Dayno for closing remarks. Thank you, operator. I just want to thank everyone for joining our call today. We're, you know, very excited about, you know, this proposed acquisition that will, you know, we see as a strategic acquisition to expand our pipeline, diversify our portfolio, and drive long-term growth for Harmony Biosciences. Thanks, everyone. Have a great day. Thank you. This does conclude today's Harmony Biosciences proposed acquisition of the Zynerba Pharmaceuticals conference call. You may now disconnect your line and have a wonderful day.