Thank you for standing by. This is the webcast operator. Good evening, everyone, and welcome to Repare's Investor Event to present its recently announced worldwide license and collaboration agreement with Roche for camonsertib, also known as RP-3500. Today's call is being recorded. At this time, I would like to turn the webcast over to Steve Forte, Executive Vice President and Chief Financial Officer. Steve, please go ahead. Good evening, and thank you for joining us for today's event, where we will discuss our worldwide license and collaboration agreement with Roche for our ATR inhibitor, camonsertib, which we press released just after market close today. This press release is available on our website at www.reparerx.com. On today's call, Lloyd Segal, our President and CEO, will begin with introductory comments. Kim Seth, our EVP and Head of Business and Corporate Development, will then provide an overview of the transaction and will discuss key financial terms. Lloyd will then provide some final strategic perspective regarding today's announcement. Lloyd, Kim, and I will be available for Q&A after our prepared remarks. Due to time constraints and to ensure equitable participation, we would kindly ask that you limit yourselves to one question and one follow-up during that time. Before we begin, I would like to remind you that we will be making forward-looking statements during the call. Various remarks that we make during this call about the company's expectations, plans, and prospects constitute forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based upon our current expectations and various assumptions and are subject to the usual risks and uncertainties associated with companies in our industry and at our stage of development. There are a number of reasons why our results may differ materially from these forward-looking statements, and we refer you to our latest SEC filings, where you will find a more detailed discussion of these risks. In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change. As a reminder, the audio and slides from today's event will be made available on our website later today. I will now turn the call over to Lloyd. Thanks, Steve, and good evening, everyone. Thanks for joining us. We're very pleased to announce this strategic long-term global collaboration between Repare and Roche today. Roche is a recognized leader in oncology with a global presence in unique precision medicine capabilities. They also share our vision for maximizing the potential of camonsertib to accelerate and expand its development with the ultimate goal of benefiting patients with cancers across numerous solid tumors as a monotherapy and in combination with other agents. Camonsertib is an oral ATR inhibitor designed to treat cancers with DNA damage response, or DDR defects, and high replication stress. This was our first clinical stage asset as a company when it entered the clinic in July 2020. ATR is a critical DNA damage response protein, and it plays a central role in the regulation of cell replication stress. This concept was recently validated by Repare at [AACR-NCI-EORTC] in October of 2021 and then at AACR more recently in April this year, where we showed promising data from our TRESR Phase I/II monotherapy trial and demonstrated early human proof of concept in ovarian cancer. Noted on the left here is a summary of the compelling ovarian cancer human proof of concept data we reported at AACR in April. In addition to monotherapy clinical progress, we have multiple ongoing combination trials with PARP inhibitors and chemotherapy. We believe that there's a strong rationale for additional combinations such as radiotherapy and immunotherapy, as well as other DDR agents, including our own PKMYT1 inhibitor, RP-6306. As we highlighted at recent medical conferences, we believe that camonsertib is favorably differentiated and has the potential to be best in class in terms of safety, potency, and cell activity. We've also demonstrated the benefits derived by our proprietary patient selection insights, which allow us to expand addressable patient populations beyond the original gene of interest, ATM. As we continue to see strong rationale for monotherapy camonsertib development, much of which we shared at AACR, we also continue to believe that some or all of the combination opportunities I noted earlier could meaningfully expand the potential for camonsertib as a commercial anticancer agent. The scale and scope of both monotherapy and combination opportunities underpinned our view that the best strategy to win in ATR inhibition for patients, for our team, and for our shareholders was to partner with a best-in-class proven leader in oncology drug development and commercialization, preferably one with a global footprint and a commitment to precision oncology. We believe Roche has ticked all these boxes and more. With that backdrop, I'm pleased to hand off to Kim Seth to walk you through the partnership we've now forged with Roche. Kim, you may still be on mute. I indeed was. Thanks, Lloyd. I'm very excited to be announcing this important collaboration as it marks a meaningful value-enhancing milestone for the program and for the company. As Lloyd mentioned, we are excited about the broad potential for camonsertib to address important unmet medical needs across a range of tumor types, genotypes, and combinations. We constantly evaluate the assets in our portfolio and think about how best to maximize their value for patients and for Repare. With this in mind, we conducted an extensive partnering process to identify the best global partner for camonsertib, which we believe has the potential to be a best-in-class ATR inhibitor with compelling clinical data across multiple tumor types and genetic backgrounds, and the potential for multiple combinations. In addition, we wanted to make sure our eventual partner shared our vision of leadership in the field of synthetic lethality. We concluded that Roche, with its unique expertise in precision oncology, its global reach and footprint and track record of success, was the ideal partner for this asset. Perhaps most importantly, Roche impressed us with their vision for the program, which corresponded strongly with our own ambitious goals and really signaled their commitment to making it a success. As we like to say, winning in ATR inhibition. Together, these factors convinced us that Roche was the ideal partner for us to drive the broad global development and commercialization of camonsertib. Let me go through the financial terms, briefly. We're confident that this collaboration will help Repare maximize the potential for camonsertib. The deal provides upfront cash of $125 million, with an additional $1.2 billion in potential clinical, regulatory, commercial, and sales milestones, including $55 million in potential near-term payments, in addition to royalties on sales ranging from low double digits to high teens royalties in the U.S., and high single digits to high teens royalties outside of the U.S.. Collaboration also provides Repare with the ability to opt in to a 50/50 U.S. co-development profit share arrangement, in addition to participating in U.S. co-promotion. If we do not exercise our co-development profit share co-promotion option, Repare will complete all the ongoing studies while Roche will assume leadership for future development and commercialization of camonsertib. If we do choose to exercise our co-development profit share option, we will continue to be eligible to receive clinical, regulatory, commercial, and sales milestones in addition to full ex-U.S. royalties. Steve? Steve, you may still be on mute. Sorry. Indeed I was as well. Thank you, Kim. The transaction will be subject to U.S. antitrust review and other customary conditions. We expect this transaction to close in the third quarter. Once closed, this deal would allow Repare to meaningfully extend its cash runway, providing runway into 2026, including the effects of the upfront near-term milestones and Roche's assumption of- Just to wrap up, I'd like to say how thrilled we are to have partnered with Roche in this transaction. Their unique expertise in precision oncology, their global reach, footprint, track record success, as well as their shared ambitious vision for the asset, will really be an enormous benefit to camonsertib and ultimately to patients. We set out on an ambitious effort to identify the best partner possible, and we look forward to being able to bring this vision to patients together. With that backdrop, I complete the handoff to Lloyd for some concluding thoughts. Thanks, Kim. Beyond camonsertib, we have a robust pipeline of assets with a number of interesting catalysts about which we're more excited than we ever have been in our history as a company. This includes, of course, RP6306, which is currently in the clinic, our Polθ inhibitor and other earlier stage assets that are late preclinical. We look forward to presenting phase 1 data on RP6306 later in the year and providing incremental updates on our Polθ program in the near term as we move this asset closer to clinical development. In addition, within our earlier stage pipeline programs is a new asset against a target we are not yet disclosing, which we expect to bring to IND-enabling studies in a timeline that we hope will closely resemble the timeline for our Polθ program. We anticipate unveiling more on this preclinical program in the second half of this year. With that, I'd like to leave you with a strategic perspective on this transaction for Repare. This partnership marks an important moment for us and gets us one step closer to achieving our mission to be the leading precision oncology company, delivering synthetically lethal medicines that meaningfully improve the lives of cancer patients. There are several concrete benefits to the deal we announced today, which I would like to highlight. First, this deal with Roche, a global pharmaceutical leader with deep expertise in precision oncology and molecular diagnostics, validates the strength of our SNIPRx and STEP2 platform and its clear advantages for discovery and early development. Second, it provides a vastly expanded set of resources to develop and commercialize camonsertib rapidly and on a global scale with a partner that shares our vision and ambition for the asset. Third, it further and materially strengthens our balance sheet, adding two years of cash runway in very uncertain times from a capital markets perspective. Finally, it allows us to focus on exciting opportunities across our pipeline, clinical and preclinical, including within our RP6306 program and other earlier stage assets such as, but certainly not limited to, our Polθ program. We look forward to presenting that phase 1 data later in the year for RP-6306 and providing incremental updates on the Polθ program, as it continues to move towards clinical development. With that, I'd like to turn the call over to questions. Operator? We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. In the interest of time, please limit yourself to one question and one follow-up. At this time, we will pause momentarily to assemble our roster. The first question today comes from Jeff Hung with Morgan Stanley. Please go ahead. Hey, congratulations on the partnership announcement, and thanks for taking my questions. For the $1.2 billion in potential milestones, you've highlighted $55 million that could be near term. Can you provide additional color on what the $55 million would be for and how it breaks out? I have a follow-up. Steve, will you tackle that one? Sure. As you note in your question, Jeff, we called out the first $55 million from the total of $1.2 billion of potential milestone action. These are clinical milestones that, while are contingent, we believe could become payable within a year from the close of the transaction. In addition, there are more milestones that could become payable over their cash runway, but we haven't factored them into the valuation, and would only disclose these ones, Roche's. Okay, great. Thanks. Mm-hmm. For the opt-in for the 50/50 U.S. co-development and profit sharing, when would you need to make that decision? If you do exercise that option, which milestones would you forgo? Thanks. Kim, I think you're best positioned to answer that one. Yeah. No, it's exercisable prior to the commencement of the first pivotal clinical trial for cancer. You know, as you can imagine, the U.S. milestones are the ones that would be affected. Jeff, we haven't yet, you know, given the early nature of this partnership, agreed with Roche on how we'll describe what will be, you know, their clinical program. We're gonna have to be quite cautious in giving more details than that on, for example, when exactly we expect them to start, when that milestone could potentially be hit and how that's made up. I note, though, that in the next four business days or less, a redacted version of the definitive agreement will be posted on EDGAR. Okay. Yeah. Great. Thanks. Just one. Mm-hmm. Comment there. The redacted version would be filed with our next 10-K. Just... Sorry about that. Yeah. Thanks, and congrats again. Thanks, Jeff. The next question comes from. Steve, I assume you mean 10-Q, not 10-K. That's right. Sorry, 10-Q. Yeah. Great. The next question. Next question. Comes from Chris Shibutani from Goldman Sachs. Please go ahead. Chris, your line is open. You may ask your question. Thank you. Congratulations on the deal, guys. Perhaps if you could comment a bit about how Roche views and is committed to an essential part of your platform, which is really pursuing the step two opportunities. It appears that that would be an opportunity for some of your clinical plans to change with this partnership. Secondly, you know, Seth, as you think about this, I know, you know, the work that you've been doing going back to the discovery partnership with Bristol, we have some additional assets that are advancing. Comment about how you're seeing this type of partnership strategy in the context of perhaps some of the additional assets that you have. Thanks. Thanks, Chris. I'll tackle the second, but hand the tougher first question off to Kim. In terms of the BMS partnership, this is a very distinct partnership in that it's focused on an advanced clinical asset with early clinical proof of concept. There is, as Kim will describe better than I can, a really nice baton handing to the global clinical development team over the next little while at Roche from us. The BMS partnership, as we spoke about in May of 2020 when we announced that deal, is really focused on delivering to BMS validated targets for them to prosecute internally and develop pre-clinically the chemistry and discovery work and heavy lifting to get DCs and ultimately clinical candidates there. The overlap is really, you know, almost completely non-existent. It, you know, I guess as BMS in time drives the candidate drugs that they develop off the targets that we deliver to them into the clinic, you know, I guess a theoretical overlap depending on how they prosecute their drugs, but we view that as virtually nonexistent. With that, I'll hand it to Kim to answer the tougher question. Yeah, no, thanks for the question. In terms of the vision and the appreciation for Repare's work with our STEP2 platform and how we've approached precision oncology, I think one of the great things about Roche is that we didn't feel like we had to explain precision oncology to them, right? They have a number of, you know, capabilities in the space, arguably deeper than anyone in many ways. We didn't feel like we were having to convince them that a precision approach, such as what we're doing with STEP2, needs to be recognized. I think, you know, again, won't speak for Roche's development plans, but I can say that one of the things that really impressed us the most about Roche was their precision oncology sophistication, and their appreciation for what we've been able to build. Next question. The next question comes from Joe Catanzaro with Piper Sandler. Please go ahead. Thanks for taking my question and congrats, of course, on a very nice deal here. Maybe I was wondering if you could speak to the rest of your pipeline and how that played a role in your decision to move forward with this licensing deal. Maybe along those lines, whether this deal changes how you think about the scope of 6306 near-term clinical development strategy. Thanks, maybe I'll have a follow-up. Yeah. Thanks, Joe. It's a great question. I think. If I could rephrase that as in why now and how do we look at this in the context of our portfolio? I think on one hand, as Kim outlined nicely in the talk, you know, we saw a really rich opportunity set, with camonsertib clinically. While our balance sheet was strong yesterday, there's a question of whether, you know, we could have been as ambitious as we wanted to in this capital market context and kept our pedal to the metal on the rest of the portfolio for a long period of time. You know, our view was, on one hand, this is a win for camonsertib as a global program that we started. I mean, the discussion with Roche started long before the current market environment evolved to how it did. As paradoxical as this may sound, we were a bit concerned with how nice the rest of the pipeline was looking, and therefore the investment that that was going to take with sixty-three oh six, but also with every other program behind it, Polθ, and the program that we mentioned earlier coming up behind Polθ, all of which are gonna take significant investment at a time where, you know, we were highly cognizant of the capital environment, capital markets environment in which we were making these decisions. As I said earlier, we're more excited about the pipeline, including 63 oh six than we ever have been. I think this just gives us an opportunity to have our cake and to eat it too, in the sense that we have a high degree of certainty on prosecution of camonsertib globally and having a very substantial part of the upside there and being able to focus a lot of energy and resource on the rest of the portfolio. Okay. Got it. Maybe if I could squeeze in one quick follow-up. Lloyd, you alluded to the new program once again there. I'm wondering if maybe you could just characterize it at a high level, whether it's a novel target in a similar vein as PKMYT1 or maybe something more similar to ATR, where you're pursuing, you know, best in class, but maybe not first in class. As I think I said, later in the second half of this year, we're going to hopefully share more about that one. Much like we did with PKMYT1, and because you guys all know Mike so well, we are likely to share more about that when it's closer to or about to be into the clinic. You know, what I will say is there's a lot of novelty and it's like everything else, it's something for which we aim to be best in class. I'll leave it at that, 'cause we're not disclosing more this time. Okay, fair enough. Thanks, thanks for taking my question. Great, Joe. Thank you. The next question comes from Marc Frahm with Cowen and Company. Please go ahead. Hi. Thanks for taking my questions and congrats on the deal with Roche. Maybe just, Lloyd, to follow up with some of your comments to start the whole call on, you know, the RP-3500 has a real path with combinations, you know, some of which you've started to prosecute with chemo and PARP. You had some ideas beyond that. Are there specific assets or pathways that, you know, Roche is being active in with the what's obviously a very broad pipeline that were particularly attractive relative to potential other partners? Kim, do you want to tackle that one? We're not talking about Roche's, you know, portfolio or again, how they're gonna pursue things. I think at the end of the day, what we were excited about was the commitment to this program. You know, it is worth mentioning that we did keep our right to combine with PKMYT1, RP-6306, and we control that program entirely. There are obviously a lot of opportunities. We've talked about in the past, you know, for opportunities of combinations and for, you know, areas to go. I think it goes without saying that those are ones that we've been excited about. Roche will be able to fill in, you know, folks on their development strategy at a later date. Okay, thanks. Are you able to provide any sort of breakdown of the longer-term milestones just between development stage versus kind of regulatory and commercial? Steve, I'm not sure what we can share. Yeah. Sorry, can you hear me okay? Yeah. Yeah. Yeah. As you imagine, both we and our current counterparts at Roche are pretty sensitive to those disclosures. For obvious competitive reasons. What I can tell you is the following. The $125 million upfront payment is payable upon closing, which, as we mentioned earlier, we anticipate in the third quarter. The first $55 million in development milestones are attributable to the achievement of clinical development milestones by Roche, which we believe could occur within the first 12 months from closing. There are additional clinical development milestones in the agreement that are significantly larger than the ones that we're disclosing as near-term. The remaining structure is, I'd say, quite typical of deals in our industry with additional regulatory commercial milestones and commercial milestones. Okay, thank you. The next question comes from Charles Zhu with Guggenheim. Please go ahead. Hey, good evening, guys. You know, first of all, I wanted to repeat what others have said and congratulations on the big deal with Roche. I didn't see this on your press release, but I noticed two items that you mentioned on your 8-K that came out at the same time. One, you noted that your right to opt into a co-promotion in the U.S. would follow regulatory approval for quote, "A specified major indication." I assume it's within ovarian cancer, but you know, is there any additional color you could provide around that? Does this mean that you know, either you or Roche have identified a registration-directed path? What does this mean for how we should think about any potential FDA feedback that you may or may not have received so far on the TRESR data, including from Module 2? The second item I noticed was that you've called out retaining the right to conduct combination studies for camonsertib with RP-6306. Could you just also, you know, talk a little bit about your rationale for retaining those rights as well as the potential importance of that combination? Thanks. I'll let Kim handle the second one, again and just on the first, just simply, Charles, don't read too much into that. I don't think you should expect that Roche or we will be, you know, giving any guidance or even hints in the very near term about the direction and regulatory path and registrational path. I think this is a brand-new program for them, and I think they've earned the right to take a bit of time. Of course, they'll be setting the tone for disclosures and sharing clinical strategies, themselves. I'm sure you understand that's typical for a partnership at this stage. The latter, I'll hand off to Kim. Yeah, thanks for the question. In terms of the RP-6306 combination, you know, one of the opportunities we've seen, for both programs is the combination. As it's been disclosed, we've started the combination study in the clinic. It was important for us to retain the right to pursue that and to control that combination path in the clinic. You know, that was certainly something that we secured in this deal is retention of that right. Did that answer your question? Yes, it indeed does. Thanks for answering my questions and congrats again. Thanks, Charles. Next question. The next question comes from David Martin with Bloom Burton. Please go ahead. Thanks for taking the questions, and congratulations. That's a great deal. First quick question. Does Roche get any equity in Repare? No, there is no equity component whatsoever. Okay. This deal is entirely, you know, non-dilutive. Okay, great. Second question. The near-term milestones, is it a matter of Roche would have to pay to stay in the deal, or are there thresholds that they could say, "Didn't meet the threshold, we're not gonna pay, but we're still in the deal? Kim? Yeah. No, I don't think there's that, you know, there's any kind of unusual trigger like that. It's a sort of a standard licensing structure where we're committed partners together. You would expect, David, typical diligence requirements, with the typical limitations. I don't think there's anything outside the norm in that respect. Okay. Okay, that's it for me. Congratulations. Thanks, Dave. The next question comes from Ben Burnett with Stifel. Please go ahead. Thank you very much. I'll also add my congrats. I wanted to ask, is there anything you can say just about the nature of what drove Roche to the table? I guess, was it really just built around the monotherapy data or do they also have access to the PARP inhibitor combination data? I'll answer in terms of access and then hand it off to Kim, maybe to give you as much color as we can. The last part, I think you should assume that Roche had the opportunity to diligence broadly and deeply, you know, public and non-public data that we have that would be normal and typical for a deal of this scale. On the latter, Kim. Yeah, thanks for the question. You know, what got Roche to the table, what drove them ultimately is a question for Roche. I can say from our perspective, what we think really was from the get-go, a clear positive sign was the sort of resonance between our clinical teams and the way that they work together. It was evident from the get-go, and I think there was a lot of mutual respect. You know, that certainly was a signal that this could be a great partner. You know, I think they, as Lloyd just said, they had access to all the data and were aware of what we're up to. They liked what they saw and, you know, based on the outcome. I think really this cultural fit is really. It's hard to quantify it, but there was a really strong fit between the clinical teams and a sort of just as we talked about Roche sharing the vision. It also worked its way down into, you know, less macro kinds of things, you know, in terms of how to think about developing the asset. Okay, that's fantastic. Can I also ask, does this agreement change kind of the guidance around timing for the PARP inhibitor combination disclosure? I think previously targeted for Q3. Yes. I think we'll get some clarity out as soon as we have a chance to let the dust settle, but the answer to your very good question, Ben, is yes. I think you should expect now that the program will ultimately be handed off to Roche, that the timing for any disclosure in a very competitive ATR inhibitor market, which they wanna win in as much as we do, if not more, they'll take into considerations that a big pharma would normally take at this stage of the game. Understood. Great. Thank you so much. Thanks, Ben. This concludes our question and answer session. I would like to turn the conference back over to Lloyd Segal for any closing remarks. I just wanna thank you all for your insightful questions. Today's announcement with Roche is a significant milestone for Repare. We're excited to work with Roche, and we look forward to updating all of you on the continued progress on development of camonsertib and this partnership in the future. That concludes our call. Thanks for taking the time with us on a busy evening. Good night and have a good ASCO for those of you who are going. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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