Ovid Therapeutics Inc. (OVID) Earnings Call Transcript & Summary

Good morning, and welcome to the Ovid Therapeutics Conference Call. [Operator Instructions] Please note, this event is being recorded. You may listen to a webcast replay of this call by going to the Investors section of Ovid's website. I would now like to turn the conference over to Dawn Schottlandt, Argot Partners. Please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining today's call to discuss the royalty license and termination agreement for OV935 announced earlier with Takeda Pharmaceuticals. Joining me on today's call are Dr. Jeremy Levin, Chairman and Chief Executive Officer of Ovid; Dr. Amit Rakhit, President and Chief Medical Officer; Jeff Rona, Chief Business Officer; and Jason Tardio, Chief Commercial Officer. As a reminder, during today's call, we'll be making forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this presentation may include, but are not limited to, statements about the potential benefits, clinical and regulatory development and commercialization of soticlestat; the progress, timing and trial design and results of the clinical trials regarding the company's other product candidates; the closing of this 2021 royalty license and termination agreement relating to the 2017 license and collaboration agreement; and the potential value, benefits and outcome of the collaboration with Takeda. Each of these forward-looking statements involve risks and uncertainties. These statements are based on the company's current expectations and projections made by management and are not guarantees of future performance. Therefore, actual events, outcomes and results may differ materially from what's expressed or forecasted in such forward-looking statements. Factors that may cause actual results to differ materially from these forward-looking statements include the fact that initial data from clinical trials may not be indicative and are not guarantees of the final results of the clinical trials and are subject to the risk that one or more clinical outcomes may materially change as patient enrollment continues and/or more patient data becomes available and the ability to commercialize soticlestat. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are discussed in the company's filings with the U.S. Securities and Exchange Commission, including the Risk Factors sections contained therein. Such risk may be amplified by the COVID-19 pandemic and its potential impact on Ovid's business and the global economy. Except as otherwise required under federal securities laws, do not have any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise. I will now turn the call over to Dr. Jeremy Levin, Chairman and Chief Executive Officer of Ovid.

Thank you, Dawn. Good morning, everyone, and thank you for joining today's call to discuss our announcement regarding the transfer and license of our 50% share in soticlestat, or OV935, to Takeda Pharmaceuticals, and the exciting journey that lies ahead for Ovid. Let me begin with a few comments about this new agreement with Takeda. As many of you know, soticlestat was originally discovered at Takeda's Shonan, Japan research center. In 2017, Ovid recognized the potential of soticlestat. We were particularly focused on the potential to have a dual action of not just seizure reduction, but reduction in inflammation of the brain. We believe its action is unique, first and only in class, being a potent, highly selective inhibitor of cholesterol 24-hydroxylase. This action enables soticlestat to regulate the overactivation of the glutamatergic pathway. That pathway is responsible for epileptogenesis and also drives inflammation, which results in both seizures and neurotoxicity. We approached Takeda, which at the time was considering multiple options for this program, and discussed our views of the potential for the program in epilepsy. Following extensive dialogue and negotiations, Ovid acquired a 50% share in the program through an exclusive license and co-development and co-commercialization collaboration with Takeda, with Ovid providing $26 million in equity by way of upfront payment. Under this original agreement, Ovid has led the clinical development of soticlestat and would have been responsible for leading commercialization in North America, Europe and Israel. The transaction was structured with Ovid and Takeda sharing on a 50-50 basis, global development and commercialization costs and profit. In addition, Ovid was obligated to pay to Takeda up to $85 million in development and regulatory milestone payments, including a potential payment of $50 million or 8% of Ovid's stock in the initiation of Phase III trials. In the 4 years since the parties entered into the clinical collaboration agreement, Ovid and Takeda ran several clinical trials and demonstrated soticlestat's potential to treat several rare developmental and epileptic encephalopathies, including Dravet syndrome and Lennox-Gastaut syndrome. As a direct result of those trials and following meetings with the FDA and other regulatory authorities, soticlestat will now proceed into 2 pivotal Phase III trials this year. If these trials are successful, soticlestat may commercially launch in 2024. Our efforts have delivered exciting data and important scientific insight. We've worked seamlessly together to drive innovation in this novel pathway. Takeda has been a superb partner, and we at Ovid have made a seminal contribution to what we hope will be a new therapeutic class. Recognizing our joint desire to accelerate the program, Ovid and Takeda have agreed to restructure our agreement, bringing us to today's announcement. Under our new license agreement, we will terminate the original collaboration agreement, and Takeda will secure rights to our 50% global share in soticlestat in exchange for upfront development and commercial milestone payments and royalties. Takeda will assume all responsibilities for costs of both development and commercialization following closing. At closing, Ovid will receive an upfront payment of $196 million and is eligible to receive up to an additional $660 million in development, regulatory and sales milestones, for a total of up to $856 million in payments. In addition, if soticlestat achieves regulatory approval, Ovid will receive tiered royalties on worldwide sales of soticlestat at percentages ranging from low double digits to up to 20%. We believe if successfully commercialized by Takeda, soticlestat represents a multi-billion-dollar global product opportunity per annum. Lastly, Ovid's financial obligations to Takeda under our original collaboration agreement have been terminated. Following closing, Ovid will no longer be required to bear any costs associated with the development or commercialization of soticlestat, and we'll have no further obligation to make milestone payments to Takeda. The resulting savings to Ovid is estimated to be in the order of at least $250 million. Our new agreement with Takeda is expected to close by the end of Q1, subject to satisfaction of customary closing conditions, including review by the applicable regulatory authorities under the Hart-Scott-Rodino Act. Together with our existing cash balance and the $196 million upfront payment, we have the resources to develop and continue to build a very exciting pipeline and platform of technologies, which Amit will outline in a minute. Provided Takeda receives approval for soticlestat in the U.S. and Europe, and Ovid, as you know, may receive up to $85 million prior commercialization, in addition to significant milestones and royalties, as I've described on future global sales. This provides meaningful long-term cash flow and value. As Andy Plump, President of Research and Development, at Takeda noted, our collaboration demonstrates the strength of Takeda's partnership model. It also demonstrates Ovid's ability to deliver insight and drive value in a novel program. This is part of Ovid's commitment to delivering transformative medicines to patients with neurological diseases. We are now delighted to see soticlestat advance under Takeda's very able stewardship while we continue to retain substantial financial interest in the program with no obligation. We firmly believe that at this stage, Takeda's resources and expertise are ideally suited to deliver success from this program and, therefore, greatly strengthen Ovid. With that now, I'll turn the call over to Dr. Amit Rakhit to discuss the soticlestat's current clinical progress and our very exciting path from here.

Thank you, Jeremy. This agreement is a win and wonderful step forward for all parties, including, most importantly, the patients for whom it may ultimately deliver benefits. Last August, we announced positive results from the Phase II ELEKTRA study that showed a statistically significant reduction of seizures from baseline compared to placebo in the combined Dravet syndrome and Lennox-Gastaut syndrome study populations. Soticlestat was also well tolerated and demonstrated a safety profile consistent with the findings of previous studies with no new safety signals identified. The success of that trial enabled us to work with Takeda to optimize the pivotal Phase III registrational study plans, including securing endorsement from key regulatory agencies across the globe, and we're delighted that the Takeda team is moving quickly to continue the development and commercialization efforts from this point onward. With Takeda's global resources, both Phase III trials are rapidly progressing, and as Takeda has stated publicly, potentially delivering a much-needed new therapy in these conditions as early as 2024. With the close of this agreement, Ovid will have the resources to accelerate our emerging pipeline of therapeutic candidates for monogenetic and rare neuroscience conditions. We have a world-class team with a track record of identifying novel mechanisms, pioneering innovative clinical development strategies and driving new science into and through the clinic. Our future plan will leverage our internal team's capabilities along with our collaborations with key biotechnology companies and top academic institutions to optimize delivery, testing and screening technologies as we develop these next-generation therapeutics with our existing internal portfolio and complementary external assets in the neuroscience space. Before I dive into our research pipeline, let me start by stating that we continue to take a disciplined approach to evaluating, if there is a path forward for OV101, our delta selective GABAA receptor agonist, and we expect to provide an update on this at a later date. We have been building an early-stage pipeline over the past 18 months and have several exciting candidates developed in collaboration with our researchers. Our pipeline goals target 3 INDs in the coming 3 years, starting in the first half of 2022. The first of these will be OV329, which is a potent, highly selective small molecule GABA aminotransferase inhibitor in preclinical development. GABA aminotransferases enzyme inhibition is an approach that we believe will increase GABA levels, reduce neuronal hyperexcitability and ameliorate epileptic activity with a high safety margin. We anticipate that if successful, OV329 could be used to treat seizures associated with tuberous sclerosis and infantile spasms. We are currently assessing the pharmacology and nonclinical safety and have encouraging data to date. As a result, IND-enabling studies are anticipated to begin this year, and we expect to submit an IND application in the first half of 2022. Our next program, OV882, explores short hairpin RNA and its ability to interfere with UBE3A antisense that blocks UBE3A gene expression in neurons. The most common cause of Angelman syndrome is the result of the loss of functional UBE3A protein due to defect of the maternal UBE3A gene. We have deep knowledge of this area, are aware of other approaches and feel the approach we are adopting holds great promise. Our aim is to develop a noncoding RNA construct that reduces expression of UBE3A antisense and restores UBE3A expression via the paternal gene. We are working with the University of Connecticut on this program and based on the encouraging data to date, we expect to select the lead compound by the end of this year 2021 and enter IND-enabling studies with an IND filing targeted in 2023. Our third pipeline program, OV815, is a gene modulation approach focused on the kinesin family of proteins. We are initially targeting KIF1A as part of our broad collaboration with the genomics center at Columbia University. We are currently in target validation with OV815 with the lead indication targeting KIF1A-associated neurological disorder. We have additional targets that are yet to be disclosed. We look forward to sharing more on this program as it progresses towards IND in the first half of 2024. With that, I'll turn the call back over to Jeremy for closing remarks.

Thank you, Amit. We're very excited about today's announcement, both for what it delivers to Ovid and our future and for what it delivers to patients and our shareholders. The upfront payment alone in this transaction represents approximately 4x the cash investment we made in soticlestat over the last 4 years since we began the collaboration with Takeda. If the program succeeds, with a potential launch as early as 2024, additional milestones and royalties may provide a long-term source of capital for the company, and our efforts to deliver a next generation of therapies in the round neurological conditions. Our team possessions a unique, demonstrated ability to identify, assess and develop therapies in this area, and we believe our early pipeline is well positioned to deliver on our goal. We also believe our platform and expertise represents an attractive proposition to potential partners with complementary programs, which we will continue to actively pursue. That concludes our prepared remarks. Operator, please open the line for Q&A.

[Operator Instructions] Your first question comes from the line of Brian Abrahams of RBC Capital Markets.

Congratulations on the transaction. A couple of questions for me. I guess, maybe first, just on the terms of the agreement. Can you speak a little bit more about the regulatory and commercial milestones, the $660 million? And just broadly speaking, how should we think about those breaking down across -- over the next few years? And then I had a follow-up question.

Super. Well, Brian, just as you think about everything, start -- good morning to you, first of all. Sorry, that was a bit rude of me. Start first of all, by thinking about the date that Takeda has announced that it will be commercializing the product because the milestones obviously start to come in there. So as we -- you point out, that's -- it is 2024 that they have stated publicly that they intend to launch this. Now backing off that, between now the closing when we get $196 million, we then have another $85 million of regulatory milestones before it launches. Once it launches, there are tiered royalty, and there are tiered milestones of $660 million of them as they go up through the sales milestones. Those are global sales. So I'll just leave you to -- those are not going to be disclosed, but they are substantial. And then once it hits the royalties, the royalties are equally tiered. So there is a cash flow behind those milestones. But the key point that you should be thinking about really is the launch targeted for 2024 because you get regulatory before that, relatively small compared -- smaller than compared to these sales milestones and then sales milestones on global sales. And finally, obviously, royalties underpinning that.

Got. Got it. That's really helpful clarification. And then just on the Phase III plan for Dravet and LGS. Can you maybe talk a little bit about the potential design there? Any -- I guess, how comparable the design will look like to the Phase II? Any sort of stringency around drop seizures or seizure counts that could potentially further enhance your ability to -- your and Takeda's ability to demonstrate benefits there and the sort of regulatory path -- sorry, the regulatory feedback that you received on the path forward in those 2 indications.

Thanks, Brian. I'll hand over to Amit in a second, but just let me start by saying, this -- as a partnership, we're not -- we will continue to be involved in this until we get approval for closure. We have been intimate in the design of this. Remember, Ovid was responsible for leading development, right the way through to this point when we hand over. So evidently, with the Phase III first, imminently starting where we know exactly what we are designed and what has been designed, but it comes from our approach to this disease area and based on what we did previously in the ELEKTRA trial. So Amit, would you be kind enough to take on the -- Brian's question?

Sure. Brian, sure. So we've been working with the Takeda team and have had multiple positive interactions with regulatory bodies across the globe, so including the FDA, EMA and Japanese PMDA, all of whom aligned with our Phase III study design. So both the Phase III Dravet study and Lennox-Gastaut studies are -- there is 2 separate studies. They're global, double-blind, randomized, placebo-controlled studies, similar to other epilepsy studies. And that, there is a 4- to 6-week prospective baseline screening period followed by 16 weeks of treatment, which consists of a 4-week titration and 12-week maintenance. The Dravet study is approximately 140 patients, mostly in the pediatric, young adult age group. And the LGS study is approximately 230-plus patients in the pediatric -- adult age group. The patients who complete the study will have the opportunity to enroll into the long-term open-label extension study, which is also ongoing. This is a global study. The end points that we're using primary in the Dravet study is convulsive seizures as previous, and that's consistent with other Dravet syndrome programs, and major motor drop seizures for the Lennox-Gastaut program. Overall, both these studies are in study initiation modes, and the Takeda team will have further updates about the study start, but they're all on track to initiate this year, probably by midyear. And Takeda actually commented publicly that it plans to launch the drug in 2024.

Great. Maybe one more, if I could just squeeze it in real quick. Strategically speaking, with the substantial infusion of capital, it does sound like the early-stage programs you described are advancing very well. Any other plans to deploy the capital in terms of additional business development opportunities? Or I guess, how are you guys weighing whether to move forward with 101 in FXS or anything else?

Yes. It's important to know, number one, we do not have any future financial obligations underlying the relationship with Takeda. So it's not just an infusion of capital, it's a reduction in expense. And we anticipated that, that reduction, as I said, is about $250 million before we get to commercialization. So with that in mind, we have very, very disciplined approach as to how we will build the platform and augment the pipeline. So hold fire on that. We'll be prepared to discuss that further. But one thing you should be very clear on, we are extremely disciplined and thoughtful and strategic about this. Advancing our programs, building our pipeline and making jolly sure that what we do is what we're really good at.

Make sense. Congrats again.

Your next question comes from the line of Charles Duncan of Cantor Fitzgerald.

Jeremy and team, congratulations on this transaction. So I had a quick question regarding this, I guess, transaction going forward. In terms of the deal or in terms of the possible royalties, could you earn that on sale of the drug for any indication or only for epilepsy indications? Or more specifically, for Lennox-Gastaut and Dravet?

All indications. Charles, good morning, not being rude in answering your question, not seeing both.

No. No worries. So any indication -- so if Takeda develops a drug beyond Lennox-Gastaut and Dravet you'll earn royalties on the sale of -- for those indications as well?

Yes.

Okay. And then just a clarification on Brian's -- on the answer to Brian's question. I thought total were $660 million milestones, but you mentioned $85 million before commercialization. So is that on top of the $660 million? Or should we subtract from the $660 million?

No, it's not on top. Sorry, I just want to make sure that you have that clear. That's before -- I just divided them between what is pre-commercial and then what is commercial milestones. My apologies if that wasn't clear.

Okay. And then with regard to the pipeline, I had 2 questions. One is rate limiting steps, if you will, for forward motion on 329. And then on Angelman, have you met with the agency? And could you provide an update perhaps in the first half or in the second half of this year with regard to a route forward on Angelman?

Super. Let me hand you over to Amit, and he can discuss his plan. Again, as I said to you, once this all closes, we will have another occasion to discuss in far greater depth. But Amit, why don't you take that as it stands today?

Sure. So for OV329, we are already in nonclinical safety and exploring different models that we have, and we believe we can move this into tuberous sclerosis complex and infantile spasms. So some of the things that we're working on are, of course, understanding the biology, the safety in the preclinical setting and the manufacturing. And those are the pieces that we're working on right now as we gear up for our kind of IND-enabling studies as well as to the manufacturing perspective. Everything looks to be so far on track, and we're expecting and anticipating an IND to be filed next year. So the first half of 2022. In terms of the Angelman program, so now we're still, as we mentioned, exploring the possibilities for OV101 in Angelman syndrome. And we are anticipating data from ELARA study this year as well as evaluating our complete package of data that we have from Angelman syndrome as well as the Fragile X program. And so we'll have a further update on that as soon as we can see the ELARA data and then anticipate an interaction with the FDA to see if there's a path forward. The other Angelman syndrome program we have now, which I mentioned also, is our OV882 program. That is much earlier. That is a program that I mentioned that we're working with the University of Connecticut, and that's the short hairpin RNA as kind of an approach that a set of others are looking at in terms of genetic and molecular approaches to Angelman syndrome. That's a little bit further out in terms of our IND scheduled in 2023, but we're working rapidly towards lead identification by the end of this year and initiating IND-enabling studies for that program next year.

Okay. Last question. That's very helpful. Last question is back to the idea of strategy. I guess I'm kind of wondering if this transaction is the start or the -- or perhaps, the end of the beginning with regard to your discipline and diligence. Do you focus more on rare CNS disorders that have a site component or a neurology component? Any particular color -- and would you hope to bring in another asset this year? Or do you think that, that's not critical to moving forward?

So there's a couple of things that you should be -- that we've been thinking about as, look, since we got into this business of rare neurology, it's exploded. It -- both technologically and in companies. It's the area that is probably the most interesting. In 2014, for example, in Angelman, there was only Ovid. And we've learned a hell of a lot about what goes on in that disorder and what that has implications for autism type or other types of disorders like that. During that period of time, there's also been a fundamental shift in the technology base of being able to address the disorders themselves. So you've got several things going on. In Angelman, one company. Now there is somewhere upwards of 14, okay, something like that. That's not dissimilar to many other areas. And I would say, you probably know better than me, but we've probably had a tenfold increase in the number of areas of interest. So what we really are interested in here is: Number one, very carefully defining what is a measurable end point. That's really the key for any asset that we have. We've learned a lot about end points. So again, our tutorial that we had, which was a hard and disappointing one in children in Angelman is that the end point works in adults and adolescents, not so good in children, but we defined an end point. That end point now is being promulgated across all companies using -- in Angelman. So each asset, as it comes in, will be assessed by what is its flexibility. Does it fit with our abilities to define an end point that is measurable and meaningful clinically? And from there, we'll then ask the question, can we as a team, make a difference to it. We have the team that has been assembled is really knows it stuff. It knows it stuff in epilepsy. It knows its stuff in the autism spectrum disorder. So we have the opportunity to move either/or. However, we'll be focused on that end point big time, and I'll ask Amit if he wants to add to that. We will also be focused on the fact that what we're really interested in is what we've learned about. We just -- we're one of the pioneers in this area. We have really studied what it's going to take to make a difference in rare disorders of the brain technologically, manufacturing-wise, clinically, regulatory-wise. So we are poised to take advantage of that experience -- hard experience, Chaz, hard experience. We're very disappointed about the results last year. But biology is biology, and we don't -- you don't gain say that. So Amit, perhaps you'll describe what we -- our thinking of the kinds of assets that we're going to be looking at and the kind -- and by the way, Chaz, it's also platforms that we're looking at. I would say to you that don't -- we're not going to be held to a time when we do a transaction, though. We definitely will look at them. We'll be very, very disciplined. Yes. Amit, do you want to add to that?

I'll just add briefly, Chaz, that -- so not necessarily just neuropsych conditions, right? So we, I think, have a lot of expertise now in this very high unmet need area. Neurodevelopmental conditions are very difficult. I think we have a very good understanding of how to create novel end points, how to work with the regulators, how to work with the patient communities to develop end points and clinical strategies that make sense in the neurodevelopment, neuropsych space. But beyond that, I think we are looking at areas, as Jeremy mentioned, monogenetic conditions or conditions that have a molecular pathophysiology that's understood or at least thought to be understood that we can focus in on that is driving some of our early research pipeline, focused on either a genetic or molecular therapy, like the RNA therapeutics I mentioned or the gene modulation approach I mentioned for OV815 or platforms that are -- enable us to target rare conditions in the brain. And so more to come on that as we explore some of those opportunities that are ahead of us already.

Your next question comes from the line of Yigal Nochomovitz of Citi.

Congrats on the transaction, Jeremy. The press release didn't specifically mention duplication 15q and CDKL5. I just want to confirm that the transaction includes those indications. And obviously, you had some promising data last year in the -- both those indications. Just wondering what is Takeda's plan with respect to further development there.

Good morning, Yigal. Good to hear from you. What I'll do is, I'll ask Amit to walk you through that. Yes, very promising data, and we are very encouraged by it. Amit, perhaps, what you'll do is walk through how Takeda is thinking about sequencing trials and while the Dup15q and CDKL5 in context of the other trials that have been designed.

Right. So the CDKL5 deficiency disorder and Dup15q syndrome. As you know, we conducted the ARCADE study last year, which was a Phase II open-label exploratory study in both those conditions, and we saw encouraging signals on both those cohorts in that program. Upon closing, Takeda will actually have full control of the development path for soticlestat. And currently, the plan is to advance soticlestat in the pivotal Phase III studies for Dravet syndrome and Lennox-Gastaut. They haven't advised us the additional plans, but we believe that the profile of the program holds promise for other areas like CDKL5 and Dup15q and others beyond that. But ultimately, the decisions on those steps will be Takeda's development decisions, either as part of a registrational strategy or as part of life cycle. And you'll probably hear more of that as they continue to speak about the program and the opportunities that are going to come up for this development.

And just -- regarding the previous comments on Fragile X. Could you just clarify whether there's some question as to whether that program will or will not continue? Is there a future go, no-go decision on Fragile X that we should be expecting?

Amit, would you be kind enough to answer that, if that's okay?

Yes. Sure. Sure. So as you know, we had our Phase II ROCKET study and OV101 in Fragile X, which also showed very, I think, data that was encouraging. Right now, what we're doing is looking at the totality of information that we have with OV101, including the Angelman syndrome program; the Fragile X Phase II; the ELARA data, which is the long-term data and really want to be thoughtful and disciplined about our approach for next steps. And we should have that soon. So I just don't have that answer for you right now, but we'll be getting back to publicly about what's next steps for OV101 in the near future.

Okay. Perfect. And just one technical question on how is the accounting going to work with the $196 million? Is that all recognized immediately? Is there some schedule there?

I'm going to ask, if you don't mind, Jeff, if you can step in and answer that.

Sure. Thank you, Jeremy, and nice to talk to you, Yigal. So we are still working through that. We don't have an exact guidance on that, but I think one of the key things there clearly is that we don't have any further commitments post-closing other than to deliver documents. So we'll be back to you with that, but my expectation is that it's not going to get hung up on the balance sheet for very long.

Your next question comes from the line of Jason Butler of JMP Securities.

Let me add my congrats on the transaction. I guess I had a question from me on OV329. There's been some success with drugs associated to increase GABA levels, thinking about things like vigabatrin or valproic acid. Can you just talk a little bit about the mechanism here, how you think about the differentiation for 329? And how that fits into your decision around the initial indications or epilepsy settings you'll move into first?

Sure, Jason. Sure. So OV329, I think you mentioned the indication that I mentioned earlier, tuberous sclerosis complex and infantile spasm, vigabatrin is a current therapy that's on the market, but it has its -- a profile that has a benefit risk profile that potentially could be improved, right? So OV329 functions by reducing the activity of GABA aminotransferase. So this is a key enzyme that's responsible for the degradation of GABA, which is the brain's major inhibitory neurotransmitter. So by inhibiting the metabolism of GABA, OV329 leads to an increased concentration of GABA. And given that epilepsy and these conditions are characterized by excessive neural excitation, these increased levels of GABA may thus suppress excitatory signaling and thereby reduce seizure. So that's why we are encouraged by this mechanism, especially that's what some of the data we've seen from our preclinical models as well, which we'll share in a scientific forum. But if successful, we look at OV329 as being able to treat seizures that are associated, like I mentioned, infantile spasm and tuberous sclerosis complex. There may be other opportunities as well as we're kind of assessing this different approach. And as I mentioned earlier, the areas that we're looking at now are IND-enabling activities, which we anticipate IND for this program in the first half of 2022.

And Jason, if I could just add. Amit just brushed over the vigabatrin. Vigabatrin, despite its very, very mixed profile has very severe side effects. The whole design of this program, which we collaborated with Rick Silverman, who's the discoverer of Lyrica, was designed to approach the idea that we really could find -- we would have something that would have a profile which would be safe and effective and would address a major market despite its side effect. I know that vigabatrin was a $1 billion drug. And so we feel we have an approach based on our understanding, again, of this whole area of epilepsy, again of the understanding of the GABA system of really uniquely being able to put a target exactly the profile that we want.

Your next question comes from the line of Michael Higgins of Ladenburg.

Congratulations, Jeremy, Amit and rest of the team on the news this morning. A follow-up question on the indications outside of Dravet, LGS. So specifically, CDKL5, Dup15 maybe tuberous sclerosis, if Takeda decides to develop in those indications, is the current terms of the agreement include -- in terms of the cash payments, include additional development in those indications? Or does allow for possibly an amendment, if they choose to develop sequentially, it sounds like, in those indications with one follow-up question.

Michael, nice to hear. We -- the agreement covers all, whether it be CDKL5, Dup15. If Takeda goes into, for example, epilepsy in general, and obviously, that's -- given the profile of the drug in the future, but we leave that up to them to make that decision. Clearly, they -- very strong neurosciences, commercial capabilities and our -- part of our decision-making here, Michael, was to ensure that they could put the most muscle behind developing this for as many different indications as they feel, and the agreement takes account of all of those indications.

So just to follow up on that. For example, if they go into CDKL5 in advance and has success, the additional milestones of $660 million, that includes CDKL5?

These milestones include our -- global sales irrespective of [indiscernible].

Okay. Then one follow-up on the CRP, the complex regional pain syndrome Phase II that Takeda was running. I believe it finished up last fall. Do you know if they've discussed that publicly, the results? And do you know if that -- if not, is the trial completed?

Well, first of all, we didn't participate in that -- consequence of that, any commentary about that has to come from Takeda -- so just for that discussion with them [indiscernible].

Understood. Appreciate it. Congrats again.

And the final question comes from the line of Tim Lugo of William Blair.

Congratulations on the transaction. I guess looking back a bit, you previously had partnered with a lot of larger organizations that maybe didn't have the expertise in rare neurologic disorders, and now the Takeda kind of come to fruition. And with 329 and 882, are you now moving forward, looking more towards the academic kind of area for your assets? Or are you still looking at maybe some assets that might be buried within a large pharma that could have a potential in the rare disease world?

Tim, thanks for the question. Look, the bottom line here is that it's going to depend on the asset. Our interest is, we have refined our interest significantly in what we're interested in. We're not interested in revisiting compounds that have either been put aside or been used elsewhere and some other things. We're -- in some of the disorder. We're really interested in novel, first-in-class, genetically focused mechanisms. Some of these are obviously in smaller biotechs, private companies, other of them actually are in large pharmaceutical companies. One of the struggle that many of these companies have is that they have these interesting constructs, they are really able to drive the early research. But what they can't do is understand how they translate that into a product that you can develop. And we really understand that. So now we're going to -- in the academic arena, we're looking at novel platforms that will help us build our own full baked capabilities, which we're close on. And then secondarily, as we look at these academics, we -- as we have in Columbia. Columbia is a wonderful example of that. We sought out the leading neuroscience lab or one of the leading neurosis labs in the world with an intent to be able to explore a deep pipeline of targets. How you then drug that target is down to us. And that's kind of the early stage one. In the case of UConn, there, we had a deep understanding of what people were thinking about around Angelman. We had a real understanding of the different approaches that were being adopted, ASOs, small molecule, et cetera. And so there, we had weeks went out and looked for someone who actually had a construct that was beyond the target because we knew what the target was, but the construct suited our abilities and our -- what we knew the future will want or we believe that you too all want. So that's a little different from Columbia. And now there is a couple of others that we have like that, but in addition to which, we have the opportunity to talk with some of the more innovative biotech companies who simply don't have the ability to do what we can do, both because of our internal intrinsic understanding, our experience and our knowledge in the area. So that's -- it's a depends answer. I'm sorry, it's not as more definitive, but it is quite specific in what we're looking for. It won't be like an OV101 when we started the company. We may have an insight into something, but we're looking for really -- we want to break open the seal. That is what we're going to do. We have the ability to do it, we have the knowledge to do it, and we are going to do it.

Fair enough. Congratulation on the transaction.

And I'll now turn it over to Jeremy for his concluding remarks.

Thank you very much for everybody for listening to us today. I greatly appreciate the time that you've spent with us. I know that this has been a very busy day for all of you. And from our perspective, I want to just say how very grateful I am for you for supporting us or listening to us, and we look forward to a really exciting time ahead. So thank you very much, everyone.

This concludes today's conference call. You may now disconnect.