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spk03: of the federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from any anticipated results. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings. Importantly, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, August 8, 2024. Except as required by law, Omniab undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. Joining me on the call today is Matt Foer, Omniab's President and CEO. During today's call, Matt and I will provide highlights on the company's operations, partner and technology updates, and our recent financial results. At the conclusion of our prepared remarks, we'll open the call to questions. And with that, let me turn the call over to Matt.
spk01: Thanks, Kurt. Good afternoon, everyone, and thanks for joining us today on our Q2 conference call. I'll pick up the presentation this afternoon here on slide number four. During the quarter, we continue to grow our business with the addition of new partnerships. Given the velocity of new deals and a growing book of business, this year has the potential to be our best year ever in new partners and licenses. In parallel, our existing partners continue to advance their programs in the clinic, thereby strengthening our pipeline this year and beyond. We're driving growth in the business with strong execution, and we're doing that within an efficient operating structure and a highly scalable business model. We intend to create further visibility for our platform through publications and by advancing our technologies. And our scientists recently published an important peer review paper in the Journal of Immunology relating to our OmniDAB single-domain antibody technology, which we launched last November and is now driving a growing number of new partner programs. And I also note that in the second quarter, we successfully demonstrated the efficient multi-site deployability of a next-generation exploration instrument across our labs. I mentioned the exploration platform here because it has the potential to drive additional efficiencies for our partner programs and to further expand our position as an industry leader in speed, throughput, reliability, and ease of use for antibody discovery screening activities. We remain committed to the continuous improvement of our technology to meet the evolving and broadening needs of our partners and to retain a leading market position. I'm proud of the achievements of our team and feel confident in our ability to execute our strategy in order to maximize value for all of our stakeholders. Now moving to slide number five, I'll start to review some of our business metrics for the quarter. We finished Q2 with 83 active partners. This includes two new platform license agreements that we signed in the quarter. Those are with Dan Bio and Topaz Therapeutics. Notably, Topaz is a company focused on radio conjugates, and they represent the first of what we expect to be multiple partners focused on this space. I note also that we mentioned in our earnings release that we issued this afternoon that we expanded our existing successful discovery relationship with Hanall Biopharma and also recently completed new deals with 92Bio and the Memorial Sloan Kettering Cancer Center. As I mentioned, given the velocity of new deals and our growing book of business this year has the potential to be our best year ever in new partner ads. Now on slide number six, you'll see that our partnership base has grown by 30% over the last two years. And these numbers I note are net of attrition. The expansion in our partnership base has been driven primarily by the validation of our platform and by new technology launches, as well as much more recently by our expanded business development efforts. On the next slide, slide number seven, you can see the distribution of our partners on a geographic basis linked to the partner's headquarters location. Although I note that many of our partner's development programs are global in scope. Our partners are predominantly based here in the US with roughly equal representation between Europe and Asia. And over the past year we've expanded our business development presence outside the US, and we expect that'll result in greater diversity within our partnership base. Slide eight shows the number of active programs at quarter end, net of attrition. With the number of active programs increasing to 333, this represents a net add of six programs on a sequential basis from Q1. During Q2, one program transitioned from discovery to the preclinical stage, one moved from preclinical to phase one, and a third program advanced from phase one to phase three. Our partners continue to align and reprioritize their therapeutic programs and pipelines in their normal course of business. In our small molecule ion channel programs, during Q2, TSA realigned elements of its portfolio and decided to discontinue their work on the small molecule NAV 1.1 sodium channel modulator program that was for rare epilepsy. GSK continues to advance a separate preclinical stage program with us for neurological diseases. And subsequent to the close of the second quarter, Roche elected to return its rights to a small molecule program targeting KV7.2, following an additional internal portfolio review there. We continue to work with Roche on two additional small molecule ion channel programs for the potential treatment of CNS disorders. Consistent with our business model and our contractual terms in those deals, the KV7.2 and NAV 1.1 small molecule programs are assets that we can repartner with others in the CNS space. Now on slide nine, you can see here the growth in our partners preclinical and later stage programs, which are some of the programs that we think can be important to near term and midterm value generation in our pipeline. We've experienced 39% growth in the number of these programs over the last two years and currently have reached a total of 50 programs at these stages. Our pipeline is robust and it's growing. And we look forward to our partners' progress as they advance programs into the later stages of clinical development towards the market. As you can see here now on slide number 10, as of June 30th, we had 32 active clinical programs and approved products. During the quarter, TEVA entered the clinic with TEV56278, which is an OmniChicken-derived PD-1 with IL-2 fusion. Last week, TEVA publicly highlighted ex vivo data for this program on their earnings call. Those data showed encouraging anti-tumor T cell activity and they stated that they believe the program has potential to open up additional combo therapy approaches. Based on discussions with our partners and now with one already in the books, we continue to expect a total of four to six entries into clinical development for novel OmniAb-derived antibodies this year. This next slide, slide number 11, shows the wide and growing range of formats that our antibodies can support. And even though this list is quite broad as it currently stands, as we innovate around the platform and grow our partnership base, we continue to see the number of new formats expand. And although this slide is quite technical, it does really provide a nice illustration of the broad nature and the flexibility of our platform. The most recent new format at the clinical stage is the Adenokine multispecific with TEVA that I just mentioned and that entered the clinic in Q2. It's shown here on the lower part of the center panel. Now on slide number 12, I'll highlight a few key recent and Q2 partner updates. GenMab announced initial data from the phase two trial evaluating Acosumlumab as monotherapy and in combination with PEMBRO in patients with PDL-1 positive metastatic non-small cell lung cancer. Data from this ongoing phase two study informs their plan to launch a pre-pivotal phase three trial which is expected to launch before the end of 2024. Seastone recently announced European approval of Sugamelumab in combination with chemo as first line treatment for metastatic non-small cell lung cancer which is one of the largest cancer indications and is also among the leading causes of cancer death. Also Seastone announced that it entered into a strategic commercial collaboration with IWA Pharma. Under the terms of that agreement, IWA Pharma has the commercial rights for Sugamelumab in Switzerland and 18 central eastern European countries.
spk06: Seastone
spk01: presented preliminary data from its phase one A first in human study of CSX1004 which is an investigational antibody for prophylaxis against fentanyl related overdose. Demonstrating that CSX1004 is safe and well tolerated under the conditions tested. In addition and importantly, the exposure data were predictive of efficacy for blocking fentanyl induced respiratory depression as well. As a next step, cessation is planning a phase two proof of concept study. I mentioned Teva's work earlier and their clinical start is also highlighted here on this slide. And lastly, TALIC disclosed FDA clearance of its IMD application for ALTO2 which is a SERP alpha targeting toll like receptor agonist antibody conjugate in patients with advanced solid tumors. As you can see here on slide number 13, we look forward to numerous catalysts occurring for the balance of the year and in 2025. This is a subset of publicly disclosed events and it represents a mix of clinical readouts, clinical starts and regulatory events. And we continue to be excited about the progress that's being reported by our partners. And my last slide here, slide number 14, provides a current snapshot of the total milestone potential for our pipeline. And also calls out those 50 preclinical and later stage programs in our pipeline that I highlighted earlier as near term and midterm value drivers. As shown here on the right side of this slide, those 50 programs at preclinical stage and later have over 550 million in potential milestones on the app. And overall, our active antibody programs have over 3 billion in potential milestones. And currently, the remaining active small molecule ion channel programs with RoCH and GSK have approximately 700 million in remaining milestones. And with that, I will turn the call back over to Kurt for a discussion of our second quarter financial results. Kurt.
spk03: Thanks, Matt. So I'll provide a brief overview of our financial results for the second quarter and then we'll take some questions. On slide 16, we have our income statement for the second quarter of 2024 versus the year ago period. Total revenue for the quarter was 7.6 million compared with 6.9 million in the prior year quarter. This revenue was consistent with our expectations with the exception of higher service revenue. Matt mentioned the discontinuation of the GSK small molecule ion channel program. And this triggered an acceleration of 1.3 million dollars in service revenue above and beyond what would have otherwise been recognized in the quarter. GSK had paid for the service fees up front, which were recorded as deferred revenue and were being amortized over the life of the research term. The discontinuation resulted in the acceleration of this amortization, which would have otherwise been recognized mostly over the next two quarters. As I previously stated, we continue to project milestone payments to be weighted towards the second half of the year based on the information and statements made by our partners. In terms of expenses, our R&D expense was relatively unchanged versus the prior year. GNA expense was 8 million dollars versus last year's 8.7 million dollars, with the decrease primarily due to lower share based compensation expense, as well as non-recurring costs in the prior year associated with our ERP system implementation. The amortization of intangibles in the second quarter was higher than our recent trend. The increase was due to a 1.2 million dollar impairment related to assets associated with two legacy unpartnered ABInitio programs. In addition, other operating income for the quarter included a 2.6 million dollar reduction in contingent liabilities primarily related to changes in the ION channel programs. We have CVR obligations that expire in 2027 from our acquisition of IKGEN, and we accrue these CVR liabilities based on our projections of achieving various milestones. The recent notifications from GSK and Roche resulted in a decrease in our expected obligations for these CVRs, which was then recorded here in other operating income. Year to date, our operating expenses tracked relatively close to plan. However, we now expect total operating expenses in 2024 to be slightly less than total operating expenses in 2023. Turning to slide 17, here you'll see our balance sheet as of June 30th, 2024. We ended the second quarter with 57.2 million in cash, and as we've discussed before, we expect the first half of 24 to have a higher burn relative to the second half of the year, partly due to the milestone revenue being weighted towards the second half of the year, and partly due to the timing of cash payments from certain operating expense items that occurred in the first quarter. Given that we are still tracking close to our original plans, our cash guidance remains unchanged. And with that, I'd like to open the call for questions. Operator?
spk05: Thank you, ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press star followed by the one on your touch screen. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. First question comes from Punta Suta from Lernic Partner. Punta, go ahead.
spk04: Hi. You have Michael on for Punit. Grad for the quarter. I think for the first question, I wanted to talk a little bit about the exploration platform, and I mentioned a proof of concept study you've done. I was curious if you could talk about how this distributed format you're looking into fits into your overall offering, and if you could speak to sort of the confidence in the IP since there's been some litigation sort of the microfluidics single cell space recently. Yeah,
spk01: Michael, thanks. Yeah, thanks for the question. And yeah, the exploration platform is one that's obviously been woven into our technology offering for quite a while, you know, going back to acquiring it about four or five years ago. And it is a high throughput B cell screening platform that also has, you know, broad applicability to other areas as well. But we've focused really on B cell screening workflows. And it's one that's driven a lot of efficiencies within our business. And it's one where we've actually had some of our larger partners inquire with us about getting access to exploration instruments. And as we've invested in that platform to increase throughput and speed, we've come to realize that it's actually a form, you know, something that creates a lot of leverage in the business. You mentioned the IP landscape. You know, for us, this is a micro capillary platform. So from the way in which the equipment is run, it is quite unique. And it actually, beyond being very efficient in screening, it can be paired with deep learning and AI and other things that we've been doing for many years to really increase throughput. So we're excited about the exploration platform. It's something we've obviously have invested in over the years and continue to leverage in a variety of ways for our partners.
spk04: Okay, great. And then I was curious, you know, in conversations with new partners or existing partners, if you have any insights on, I guess, the appetite for discovery programs, given that the first half has been pretty good funding wise, but then there's also a lot of talk about sort of the large pharma prioritization isn't happening. So I wonder if you could offer some color there.
spk01: Yeah, yeah, Michael, I can comment and Kurt can add as needed. Yeah, it's obviously, as students of the industry, you know, it's clear that big pharma continues to go through prioritization exercises, which is natural. That's something that happens on a secular basis within the industry. But, you know, Q2 was quite strong for us in terms of new programs starts. And we actually have quite a variety of partners, right? It's a mix of big pharmas and startups, as well as academic partnerships as well. If I look at the landscape now, as you compare it to about a year ago, you look at some of our newer partners who are quite well funded. These are startups that have funding, you know, solid VC funding, interesting biology, differentiated ideas, and they're coming to us to get access to our platform. And we're definitely seeing that at a higher rate than we saw, say, a year or even two years ago. So that's generally good to see. And I think it is juxtaposed with prioritization exercises that go on at big pharma. But again, I think that's a natural part of the industry.
spk05: Okay,
spk04: thank you very much.
spk05: The next question will come from Chad Wiatrowski from TD Cohen. Chad, go ahead.
spk06: Hey, guys, this is Chad on for Steve Ma. Just looking at the existing programs, there's sort of large downstream milestone potential. How much visibility do you have given the bolus of upcoming partner catalysts in the next 18 months?
spk03: Yeah, I think, you know, it's kind of a combination of public and private information that we get in terms of our forecast. A lot of our partners have made public statements about when they expect to start, you know, a phase two or a phase three program. So obviously, you know, you can observe that. And then in some cases, the partners have provided us, you know, more detailed information of their plans. So I would say that we have, you know, maybe a little bit more visibility than the outside world is based on some information that we get, although the information is not perfect. And, you know, we find out sometimes things change, right? Partners say that they're going to start something in the next quarter and that moves. But we do get some additional information other than what's said publicly.
spk01: And I'll add just a little bit to that, Chad, as well, that generally speaking, as things enter the clinic is when they start to become a lot more public and visible to investors. And, you know, I think this quarter, the TEV 56278 is an example, right? That's a program for which there was not really public visibility until the program started. And it was great to see last week TEVA highlighting it on their earnings call. But again, that's a program that was probably under the radar from a public perspective. But generally, as things progress out of preclinical and into phase one is when there starts to be a lot more visibility for the outside world on specific programs.
spk06: Great. And yeah, this is obviously a benefit of your business model today is like an R&D sharing platform. But regarding the exploration, would you ever sell instruments directly to partners, just given the majority of the R&D investment has already taken place?
spk01: Yeah, look, Chad, it's a great question. I think it's a topic that we would discuss, kind of discuss those plans transparently as they would form. We have been approached by people who would like exploration instruments. We know it's deployable. We know it has broad application. We know it drives efficiencies. So those are all things that I think create optionality in the business and things we can think about in the future.
spk05: Thanks
spk06: for the questions,
spk05: guys.
spk07: Thanks,
spk05: Chad. The next question will be coming from Stephen Wiley from Stifle. Stephen, go ahead.
spk02: Yeah, good afternoon, guys. Thanks for taking the questions. I was just kind of wondering where the potential repartnering of these CNS assets you're getting back from GSK and Roche fit within your current list of priorities. And were these development candidates that were in the IND enabling studies, is that the right way to think about where they were from a development stage? And I know you mentioned that you maintain co-ownership of the IP associated with the Glaxo small molecule, but is that also the case for the Roche asset as well?
spk01: Yeah, Steve, thanks for the question. I characterize these from a stage perspective as kind of discovery class preclinical, right? I mean, especially in that small molecule space, they're being tested in animal models and that sort of thing. So that's kind of how I would describe the stage. We now have the ability to repartner them. Again, these are both in the CNS space. And that's certainly something we have done in the past. If you look at our history, obviously our core focus is technology innovation and development and licensing our technologies. But often programs do come out of our technology development. And we've successfully licensed individual assets in the past. We have some assets now that are available for license for which we pursue that. And so that's kind of a byproduct. We don't plan on developing assets ourselves, but we do see these as prime candidates for potential repartnering. There's growing interest in some of these ion channel spaces. Obviously, we're more focused on the antibody side now, but there are folks who are focused on small molecules as well. So yeah, hopefully that gives you a little more color. Okay.
spk02: And then maybe just kind of going back to the macro for a second. Just kind of curious. I mean, obviously you talked about how some of these prioritization efforts within big pharma tend to be cyclical. There was obviously a large CRO out yesterday with some pretty cautious commentary around big pharma spending just on the discovery and outsourcing front. Do those happenings influence kind of where you spend your time from a BD perspective?
spk01: You know, interesting. It's an interesting question, Steve. And obviously, as I said, we see these cycles. You know, a lot of our BD efforts, right, or I kind of maybe answer it in two ways. A lot of our BD efforts are now, you know, we're doing more and more outreach, but there's still a lot of inbound interest on our platform, which I think is a lot about as we continue to expand the platform, as it becomes more validated, as we publish more papers and peer-reviewed journals, that tends to attract inbound interest. We have a nice mix in our portfolio now with our 83 partners of big pharmas, of startup companies, of academics. So we kind of have an interesting vantage point on kind of where people are going. And so the way I would answer it is it not only informs our relationships, not only inform the BD that we do, but the innovation that we do as well. And I think that drives interest. One of the reasons I think we've been able to grow the business, both from partners and programs net of attrition, is because there's an understanding that we are continuing to innovate, and that I think attracts partners as well. So our dialogue obviously is, you know, there's a lot of forward-looking discussions with our partners, especially the larger ones. So, and they're kind of thinking downstream in a much more long-term discovery mindset, you know, despite a firm that might be looking differently at its existing portfolio or reprioritizing it.
spk02: And then maybe just on the startup side, you know, when you're engaging with these earlier stage companies and perhaps these companies are even being formed around assets that are being discovered off your platform, how do you think about, you know, the economic return as it comes down to taking like a founder stake in equity versus trying to maximize downstream economics? Or do you feel like you can accomplish both of those things within a specific deal structure?
spk01: Yeah, we do feel like we can accomplish both of those things. I will say, and as we commonly say, you know, we have NPVs in mind for how we structure deals, but no two deals are alike, right? And so we pride ourselves on finding flexible structures that work for us and our stakeholders, but also work for the partners as well. We are certainly open to things like taking equity stakes and those kinds of things. Certainly, I've had a history of that in our past management team as so we are open to those sorts of things. But yeah, we're excited about our mix of partners. You know, we've added some pretty exciting startup companies in recent months here who really have, you know, interesting ideas, novel biology, proven management teams, and so all of those things kind of inform how we're thinking as we're finalizing a deal with a partner, but we are open to multiple kinds of structures. I think there's a lot of different ways that we can create value in a model like ours.
spk02: Okay, thanks for taking the questions. Thanks, Steve.
spk05: The last question is going to come from Connor McNamara from RBC Capital Markets. Connor, go ahead.
spk07: Great, thanks for the questions, guys. And just a question about 2025. In the press release, you talked about cash use going down significantly. How should we think about where the revenue step up comes from? Is that going to be, you know, do royalties start becoming more meaningful in 2025, or is it going to be a similar mix with just more of the milestones coming through? Is there any comment you can make on how we should think about that in 2025?
spk03: Yeah, so there's two parts to that, Connor. You know, the first is, as I've talked about, the leverage that's built into this business. So we've kind of built the business to where it needs to be. We're staffed where we need to be. And so, you know, you won't see really any sort of increase in operating expense barring inflation. In fact, you know, this year, based on our latest projections, operating expense will actually be down here in 2024 relative to 2023. But in terms of, you know, what drives a substantial drop in the cash burn, it's a function of revenue and more specifically milestone revenue. So royalties, you know, right now we're generating royalties from a couple of products over in China. We do note that one of the programs or one of those compounds just got approval in Europe. And so, you know, there could be something that comes there. But our projection for kind of the change is really a function of increased milestones. As you think about those 50 things or so that Matt talked about that are currently in preclinical or clinical stages, as those move to the next stage, they'll trigger milestones. And that's what we think will be the primary driver of that.
spk07: Okay, great. And by the way, the disclosure, thanks for that. And the disclosure on the absolute dollar amount, I think it's the first time you've broken it out by stage, right? The 3 billion is broken out. So I think that's helpful. Or have you shown that data before?
spk03: No, this was the first time we put that out there. So thanks for noticing. Yeah, that's the opposite.
spk07: Well, thanks for the cover. That's really helpful. And then just quickly on the, you mentioned the European approval. Should we, I mean, does that have any royalty revenue that flows through in 2024? Is that a smaller opportunity for you guys? Is there any way to quantify that?
spk03: It's hard to know right now. I mean, Suga Malamad, it carries a 3% royalty on worldwide sales. You know, right now that's, you know, Seastone says they're looking for a partner for what I would sort of say EU. They do have a partner for Switzerland and Central Eastern Europe. In EUA-FARMA, they announced that. But, you know, they don't actually, you know, they're not going to launch this themselves. They're looking for a partner. And they said that, you know, they would have updates soon. So I don't know, Connor, in terms of, we'll have to wait and see based on, you know, what partner they can line up. But I would say that that could drive incremental royalty income, but that's not part of sort of what we're forecasting at this moment.
spk07: Great. All right. Well, thanks for the question, guys. I really appreciate it. And congrats on the solid order.
spk01: Yeah.
spk03: Thanks, Connor.
spk01: Great. Thanks, Connor. So it looks like that's our last question. So I'd like to thank everyone for participating on today's call and for your questions and engagement. We look forward to keeping you updated on our progress and speaking to you again in a few months. We will be at some upcoming conferences, including the H.C. Wainwright Conference in New York City next month. And look forward to seeing some of you then. So thanks again for your interest in Omniav and have a great day.
spk05: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
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