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spk00: and welcome to our first quarter 2024 earnings call. As a reminder, this call is being recorded and all attendees are in a listen-only mode. We will open the call for questions and answers after our management's presentation. A webcast replay of today's conference call will be available on our website at lanternpharma.com shortly after the call. We issued a press release after market closed today, summarizing our financial results and progress across the company for the first quarter ended March 31st, 2024. A copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slides management we'll be referencing on today's call. We would like to remind everyone that remarks about future expectations, performance, estimates, and prospects constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Lantern Pharma cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated. A number of factors could cause actual results to differ materially from those indicated by forward-looking statements, including results of clinical trials and the impact of competition. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in our annual report on Form 10-K, for the year ended December 31st, 2023, which is on file with the SEC and available on our website. Forward-looking statements made on this conference call are as of today, May 9th, 2024, and Lantern Pharma does not intend to update any of these forward-looking statements to reflect events from circumstances that occur after today unless required by law. The webcast replay of the conference call and webinar will be available on Lantern's website. On today's webcast, we have Lantern Pharma CEO, Pauna Sharma, and CFO, David Margrave. Pauna will start things off with an overview of Lantern's strategy and business model and highlight recent achievements in our operations, after which David will discuss our financial results. This will be followed by some concluding comments from Pauna, and then we'll open the call for Q&A. I'd now like to turn the call over to Pauna Sharma, President and CEO of Lantern Pharma. Pauna, please go ahead.
spk04: Thanks, Maddie, and good afternoon, everyone. Thank you for joining us to hear about the productive first quarter of 2024 and our financial results, as well as other corporate progress. As many of you have heard me say in the past, computational and AI driven approaches are increasing their presence and usage at both large and emerging pharma companies for all facets of drug discovery and development. At no time has this been more evident than now in early 2024, where every facet of pharma development from design of molecules to disease modeling, to simulations and even in areas like manufacturing and clinical trial recruiting are being rethought as a result of the widespread availability of computational capabilities, high quality data, and automation. Our company's leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric, data-first approach to drug development. We recently demonstrated this with our newly formed collaboration with Oregon Therapeutics, where we will help them accelerate their path to the clinic and also receive upside in benefits as a result of the insights and IP from the collaboration. We expect more activity and deals where we can continue to use our AI platform radar as currency for collaborations, partnerships, and co-development opportunities. 2023 was a transformational year for Lantern Pharma across many measures, and I shared that with all of you who listened in on our March 18th earnings call. But so far in this quarter, we continue to see the pace of progress, and this includes... across our entire three AI-guided molecules that are now in clinical trials, LP184, LP284, and LP300. And each one of them is in areas of high unmet need, with LP184 on track for a clinical readout later this year. We expect in late summer or early fall. Some of the other highlights besides 184 and 284 include Obtaining regulatory allowance to begin our phase two in Japan and Taiwan, where we expect more rapid enrollments, especially since 30 to 35% of all lung cancer cases occur in never smokers in those countries. We've so far had a great safety profile with phase one clinical trials for both of our synthetic lethal drug candidates, LP184 and 284. They continue to advance in cohorts, but we see no dose limiting toxicities in any of the cohorts enrolled and dosed to date. These two drugs combined have annual global sales potential of over $12 billion. We're also advancing Starlight. It's our subsidiary focused on CNS and brain cancers with STAR-001. We filed a clinical trial protocol for the phase 1B dose optimization and expansion cohort in a very malignant form of brain cancer, recurrent IDH wild type, high-grade gliomas. We also had ongoing advancements in our AI-powered module for ADC development, where we can streamline and guide the differentiated development of new ADCs, which will be instrumental in the next generation of drug candidates, not only for our industry, but also for Lantern Pharma and our collaborators. And also, we established an AI-driven collaboration with Oregon Therapeutics, a very unique French biotech that's using a very unique small molecule to transform cancer metabolism. We'll be leveraging radar there for this novel first-in-class inhibitor. Let's talk a little bit first about our pipeline. Many of the initial observations that were made with the help of radar are now being witnessed in the clinic. As many of you know, Radar has guided the rapid and efficient development of our three AI-guided drugs into clinical trials at a pace and cost that is traditionally unheard of in our industry. Let me walk you through some of the highlights of our portfolio before I start talking about Starlight and our emerging portfolio in ADCs. With LP184, First, many clinicians are particularly excited about and interested in the programs for these first-in-human synthetically lethal drug candidates. We've now gone through five cohorts of patients in LP184, comprised of dose levels 1 through 5. In escalating doses, we're now in dose level 6. This is a first in human phase one trial across multiple solid tumor indications. And these solid tumors are typically advanced or refractory to existing standard of care therapies. In fact, the trial is now enrolling at dose level six. And these are typically about what we've seen so far. Median prior lines of therapy have been about four lines of prior therapy for these patients. And so far, again, no observed dose limiting toxicities. The company believes that enrollment should be complete this summer and on track for a readout of the data soon thereafter. Our current enrollment efforts are focused especially on cancer patients that have DNA damage repair deficiency, or what we'll refer to as DDR deficient tumors. For those of you that have looked at the press release, you probably saw that we had a great publication focused on DDR deficient tumors and their sensitivity to LP184. But many of the genomic alterations Both, especially non-CNS solid tumors, include BRCA1 and 2, PTEN, PRK, ADC, ATR, POLL, ERCC6, ERCC3, FAN-CM, DDB1, SLX4, MLH3, MDC1. It's an alphabet soup. But what that tells us, most importantly, is there's a wide range of genomically defined tumors that that we will include as the definition of DDR deficient. And many of these are already available in mutation and expression panels that are available today. So that's great news. But also what we've done is we've submitted a supplement A and a supplement B. These are both supplements to the FDA related to LP184. Supplement A is specifically focused in non-CNF solid tumors, including TNBC. And supplement B is also dose optimization and expansion protocol in recurrent IDH wild type. And that's lantern in collaboration with Starlight. So we're already beginning to plan for the next phases. We think we'll have some results to share and move these into some very, very targeted, extremely exciting indications. Genomic identification of these patients is important, and biomarker characterization of their underlying tumor is central to our focus of personalizing treatment and, more importantly, developing efficient later-stage clinical trials. To further this effort, what we've done is also initiated the development of a PCR-based molecular diagnostic test that will help us in the identification of cancer patients with the highest likelihood of response. So I think we're making great progress with 184 across multiple measures. In 284, the initial two cohorts of patients have been dosed. And again, we see no dose limiting toxicities so far in the phase 1A clinical trial. We expect to continue opening up new sites. Phase 1 for both 184 and 284 are a little bit staggered, with 284 a few months behind where we are with 184. But 284 has shown nanomolar potency in multiple in vivo studies, including mantle cell, double-hit lymphomas, advanced NHL cancer subtypes that are fairly aggressive, and also with certain sarcomas that have DDR deficiencies. With our drug LP300, it's a very unique drug candidate, which is aimed at never smokers that have been impacted by non-small cell lung cancer. It's a growing problem, not only in the U.S., but globally. And we have been successful in achieving regulatory allowance to commence our trials in Japan and Taiwan, where the incidence rate for non-small cell lung cancer is two and a half to three times that here in the U.S., That's going to get us to accelerate the collection of patient and response data. And what that means is we'll get to some readouts quicker than we have experienced so far. We've also enrolled the help of one of the premier physicians and researchers focused on lung cancer at the National Cancer Center of Japan, Dr. Yoshio Goto. And Dr. Goto will be our lead PI and collaborator and will be leading the phase two trial in Japan. We believe that this improves the positioning for LP300 to develop collaborative and co-development partnerships with global biopharma companies, especially those that have a focus to serve the Asian markets. Let's turn quickly to Starlight. We've made some good progress on the launch of our clinical stage CNS and brain cancer-focused subsidiary, Starlight Therapeutics. It's a company that has been largely developed as a result of data. computational approaches to optimize and maximize our insights, understand mechanisms. And these insights have allowed us to create a whole, what we think is a wholly new company serving a tremendous need. Starlight and our new CMO, Dr. Chamberlain, Continued advancements, they filed a clinical trial protocol for the phase 1B dose optimization, which I mentioned earlier, supplement B, and expansion in recurrent IDH wild-type high-grade gliomas. IDH wild-type glioblastomas are the most malignant glial tumors with a median survival of about 15 months after diagnosis. So it's a really, really aggressive, poor prognosis and very poor, even worse than that, in recurrent GBMs that are IDH wild type. So in addition to the GBM clinical trial, several other indications have been published on and could be pursued as part of advancing starlight. These findings, especially in brain mets for TNBC, brain mets in non-small cell cells, lung cancer, especially those that are STK11 or KEAP mutant, and also in a number of pediatric CNS cancers, ATRT, where we've published with the NCI in a major publication in Frontiers in Cancer, and also diffuse midline gliomas, which include DIPG and other midline gliomas. Again, very poor outcomes. So for us, Starlight's pipeline isn't just focused on one indication. It's focused on what we believe could be a cornerstone and focused on multiple CNN indications. Now remember, this is a program that we've been able to develop between a million and $2 million per program. It's a milestone unheard of in the realm of oncology drug discovery, including drug manufacturing. And this is driven in large part due to our AI-centric business model. We think this is what more and more of the industry will adopt simply because it massively compresses the timeline in early stage development, indication selection, mechanistic refinement, and biomarker signature creation. These are things that historically have taken years and years and quarters, and we can compress these down. We've also made major progress in developing the next major leg of our discovery efforts, which will be focused on drug conjugates, including antibody drug conjugates. Specifically, we have a cryptofisin linked to ADC. It's a very, very novel drug, novel payload, novel mechanism, which so far we're developing in collaboration with our partners in Germany and We'll talk about that later in our call. So we believe we continue to be a leader in this AI golden age that we're hitting in medicine. It's just the beginning. It's powered by large scale, highly available computing power. It continues to morph and evolve literally every quarter. There's massive data that's available. It's being fed by more high-quality healthcare data, high-quality patient cancer biomarker data, and these capabilities are now being adopted by leading tech bio companies like ourselves, but also very importantly, biopharma is beginning to increasingly turn to it. We believe we're one of the leaders in this transformation at transforming the pace, the risk, and the cost of oncology drug discovery and development. This transformation has a promise not only to make medicines faster and cheaper, but also with greater precision for patients and change the direction of R&D productivity and more importantly, add value to groups of cancer patients that today don't necessarily always have great medicine and great therapeutic options. So let's turn our focus down to our financial update and highlights. So our CFO, David Margrave, will turn the call over to, and David will walk us through our financials.
spk03: David? Thank you, Pana, and good afternoon, everyone. I'll now share some financial highlights from our first quarter-ended March 31, 2024. We recorded a net loss of approximately $5.4 million for the first quarter of 2024 for 51 cents per share compared to a net loss of approximately $3.9 million or 36 cents per share for the first quarter of 2023. For the first quarter of 2024, our R&D expenses were approximately $4.3 million up from approximately $2.6 million for the first quarter of 2023. This increase was largely driven by an increase in clinical trial activity and clinical trial site initiations. These R&D increases in Q1 2024 were partially offset by decreases in product candidate manufacturing-related expenses of approximately $204,000. Our general and administrative expenses for the first quarter of 2024 were approximately $1.5 million, down slightly from $1.7 million for Q1 2023. The decrease was primarily attributable to decreases in payroll and compensation expense and other professional fees. Our R&D expenses continue to exceed G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Our loss from operations in the first quarter of 2024 was partially offset by interest income and other income net, totaling approximately $291,000. Our cash position, which includes cash equivalents and marketable securities, was approximately $38.4 million as of March 31, 2024. We anticipate this balance will provide us with a cash runway into at least Q3 of 2025. Importantly, we believe our solid financial position will fuel continued growth and evolution of our Radar AI platform, accelerate the development of our portfolio of targeted oncology drug candidates, and allow us to introduce additional targeted programs and collaboration opportunities efficiently and effectively. As of March 31, 2024, we had 10,758,805 shares of common stock outstanding, outstanding warrants to purchase 81,496 shares and outstanding options to purchase 1,077,292 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 11.92 million shares as of March 31, 2024. Lantern issued 20,132 shares of common stock during Q1 2024 relating to the cashless exercise of warrants to purchase 79,021 shares. Also in Q1 2024, Lantern issued 17,481 shares of common stock for aggregate proceeds of approximately $55,000 relating to the exercise of warrants for cash. With these warrant exercises, the amount of common shares covered by warrants was reduced by approximately 97,000 shares. Following these warrant exercises, Lantern now has warrants outstanding to purchase 81,496 shares and a weighted average exercise price of $16.55 per share. Our team continues to be very productive under a hybrid operating model. We currently have approximately 20 employees and 4 FTE consultants. focused primarily on leading and advancing our research and drug development efforts. We see this number expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission. I'll now turn the call back to Pana for an update on some of our development programs. Pana? David, thank you very much.
spk04: In the past three years, we've successfully developed and launched 11 additional programs, a testament to the agility, efficiency, and groundbreaking nature of our approach. On average, these programs are advancing from initial AI insights to first in human clinical trials in just two and a half years and an average cost of $2 to $3 million per program. These are metrics unheard of in oncology drug discovery. This is something even larger AI biotech companies have not been able to achieve on a consistent basis. Today, we have multiple drugs dosing patients. We're not just conjecturing about how AI could make drugs. We're actually designing drugs, developing indications, validating them, getting them patented, manufacturing these drugs, and launching them into clinical trials at a pace and cost that's really unheard of. So it's a reminder that the changes that big pharma need to make in terms of the pace can be done. And these startling figures serve as a stark reminder that the traditional model of big pharma R&D is not sustainable, it's not an effective strategy, and it's not the right approach to actually improve drug pricing or drug availability. With escalating economic and political pressures over drug prices and drug cost and drug availability, it's clear that our industry needs to rethink its approach fundamentally. And we believe that the increasing adoption of AI and data-driven technologies and computational approaches will elevate this issue into the future of drug development and pharma. The specific instances of value creation along with the development of an entirely new company, which will be at clinical stage at its birth, Starlight Therapeutics, continues to be at the forefront of a transformative approach to oncology drug discovery, and we believe can set a new standard in cancer drug development. We think Starlight really could be one of many new innovative opportunities to generate new assets and potential new long-term cancer companies. On June 26th, our CMO of Starlight, Dr. Mark Chamberlain, will be discussing the highlights of STAR-001 and discussing the future development plans as well as the upcoming trials. Please join us at 1 p.m. on June 26th. Mark is a walking encyclopedia of neuro-oncology and neurology-focused knowledge and trials and papers, and you'll find him absolutely fascinating. So let me highlight some of the things that get me excited about STAR-001. First of all, it is a uniquely potent molecule that has anti-tumor effect about 3,000 times higher than the existing standard of care drug, temozolomide. And unlike temozolomide, it actually doesn't care about the MGMT status. As you know, with MGMT, the tumors become non-responsive increasingly. Some tumors are MGMT positive at onset. Some develop MGMT methylation as a way to combat chemotherapies like temzolomide or nitrous ureas or other forms of attacking the cancer. So what we did is we looked at that very central question. Can we find temzolomide-resistant GBM cell lines? Can we find temozolomide responsive? And in both cases, our drug seems to work with super potency. In some of the studies that we did, both MGMT negative and MGMT positive, superior potency across the board, and sometimes super high potency, especially in one of the cell lines that was MGMT positive and didn't respond at all to temozolomide, which you can see on the far, I believe probably your far right on the slide. So no single therapy agent has been approved in adult GBM. We have an orphan drug designation to treat malignant gliomas, including GBM. We've shown effectiveness in both, which will actually help us with the trial. We're going to go after recurrent IDH wild type, which again, as I pointed out earlier in our discussion, there's an area of high critical need. We plan on launching this in the second half of 2024. There's also a couple of other reasons why we'd like to talk about how this drug is positioned. Actually, it's a prodrug, and we think it could be a central fixture in GBM, what they call the armamentarium. So it's got a, like I mentioned, a wonderful IC50 value, kind of ranges sometimes even sub-100 nanomolar in some cancers. Some CNS cancers, but on average, we've seen it, you know, very sub-micromolar, kind of 100 to 200 nanomolar potency, which is much more potent than some of the current mainstay approved GBMs. It works through alkylation, which is an accepted, well-understood way to create DNA breaks. And unlike most of the temzolomide and some of the nitrous ureas as well, it creates double-stranded breaks in a unique position at the adenosine position. And these double-stranded breaks can't repair themselves. And the elimination period that we've seen so far is in the kidney about 30 minutes. Now, the bioactivation, the prodrug I mentioned, this is a very unique feature because the bioactivation occurs intracellularly. That means once it's inside the cancer cell. So its ability to damage cells that are outside is pretty low. And we'll see as the safety data continues to come in from our trials. But again, as I mentioned, we haven't seen a dose limiting toxicity. But like other alkylating agents, we do think it'll probably have the typical alkylating agent, kind of nausea and vomiting potentially as we increase doses, but those can be easily managed in the clinic. So bioactivation inside the cancer cell intracellularly through PTGR1. It has a wonderful IC50 value and a well-known mechanism of elimination in about a 30-minute period. And these are some strong, unique features of this drug. It has shown to be effective also active in, like I mentioned, a number of different CNS cancers. So this drug really was born from lots of data points. And this is critical because we naturally moved from in vitro to in vivo to more advanced in vivo models. And now we're moving it to humans. In fact, in the current phase 1A safety trial, we haven't enrolled GBM patients. And so we're watching them very carefully to see what we can understand and learn about the GBM dosing, GBM response, and also the safety features early on that will guide and inform the later starlight trials. Now, another area that we've been working in is a highly promising area of antibody drug conjugates. It's a very high growth area, and this will be incorporated entirely, obviously, into our radar module. And so in the radar platform, we've been able to actually advance the development of our the current radar module, by identifying targets and indications for clinically valuable and needed indications. And that has allowed us to also rescue, I'm sorry, repurpose a lot of the code inside of our radar module. So moving on to some of the data that we saw, we announced that with the University of Belleville that we advanced our CryptoPhycin with the Magic Bullet Consortium, the CryptoPhycin ADC. And we were quite excited because we did this in a period of about six months. We were able to show picomolar potency in a wide range of solid tumors. We shared that data earlier this year in the preclinical work. We produced in the CryptoPhycin ADC an 80% cancer cell kill rate, which was much more than other commonly used ADCs. And so that got us very excited. In fact, it was also the case with medium and low HER2 expression cancers. So outside of breast, you know, HER2 does get expressed in other cancers like gastric, bladder, even some colorectal, and even ovarian. The expression level of HER2 there doesn't seem to really trigger the right kind of ADC response with some of the existing HER2 ADCs, even some of the bispecifics that are coming out. But with the cryptophycin, we get really good expression levels, about 10 times more potent than some of the existing molecules in the market. So this is exciting preclinical data. We're going to continue to develop it and go after many of these low and medium expressing HER2 cancers. But also, as I mentioned, we have several additional targets. So we've gone through thousands and thousands of targets to look at which targets we really want to go through after. And we've modeled how we can go after them, not only with cryptofycin, but actually with unique other payloads as well. And so we're really beginning to monetize this very unique asset that we've been building up with our ADC module. that we can select and characterize potent and super potent payloads, like literally overnight. We can predict the synergy of those payloads and antibodies against certain tumors, but more importantly, we can also understand what tumors it really will work on based on the microenvironment and the mutation of those tumors, because the mutations affect the availability of some of those mechanisms that we want to see in those tumors. So the target expression patterns can be very, very different, even though you have similarly expressed targets. So we think this is pretty exciting. And very importantly, the ultimate goal of doing all this isn't just to be smarter about ADCs, but to do it faster, to do it cheaper, and to develop a litany, a library of ADCs that we can bring to the clinic faster. And so in the preclinical work we've seen, we think this is very doable. We actually are now experimenting with other payloads. We're experimenting with bispecific type structures, fragment-based structures, biperitropic structures. These are all things that a year ago we couldn't do. And more importantly, this is going to be a very important area for the future of oncology drug development. We want to share a lot of these insights more widely. We think with the community, we've launched an effort called Webinar Wednesdays. It's a big part of our focus to inform, educate, and share the general public and the oncology community what we're doing. I want to share with our investors, our stakeholders, because there's a lot of details in these programs. And so every month we'll have a webinar Wednesday, which will focus on one of the efforts. We just did our very first one on LP300. We had great feedback. In fact, it actually spurred some inbound activity as a result from patient groups and also from groups that promoted it socially to various organizations. Groups like EGFR groups and groups that are focused on never smokers. What was that? Breath of Hope groups. So this is great because it lowers our cost of attracting patients to these important trials. We have a number of webinars coming up, one in pancreatic. one in bladder, both areas of high end might need. We've got global experts, KOLs from Fox Chase, Dr. Igor, who's been a great collaborator for a number of years. He's kind of a luminary in the pancreatic cancer field, and most importantly, a wonderful human being. And he'll be hosting that webinar in pancreatic cancer and followed up also with Dr. Hel Papat of the University of Copenhagen. We've had interactions with her, and she's just brilliant in GU cancer, specifically in bladder cancer, where we've seen a tremendous response. And also about 35% of bladder cancers have what's called what I referred to earlier as DNA damage repair deficiency. Very important because our drug seems to have super... in these DDR-deficient tumors, and that's a big part of bladder cancer tumors. So again, these webinar Wednesdays will give people updates, and we really look forward to sharing them. It's a major way to stay informed. Let's talk about some of our publications and posters. As I mentioned earlier in the call, we had a very exciting poster at the AACR annual meeting around our drug candidate LP284. It's a highly potent TP53 mutation agnostic DNA damaging agent. Works really well, we believe, in lymphomas, non-Hodgkin's lymphomas. And we're in a phase 1A, 1B clinical trial today. And again, we've seen no dose-limiting toxicities. We're now active in the third cohort. It's not fully enrolled, but it's beginning to be dosed. We've seen no issues in the first two cohorts. We also have published a very exciting paper. with our lantern research scientists and Georgetown University in Cancer Research Communications. And it focuses on the lethal activity of 184 against a diverse range of solid tumors and it causes double-stranded breaks in DNA in what's called HRD deficient or HR deficient, homologous repair deficient. These are basically BRCA2 or ATM. And so we've seen that our drug is up to about 12 times more sensitive than when it sees a range of these HRD, homologous repair deficiencies. Again, a subset of DNA damage repair deficiencies. A link to the publication is available in our PR, also on our LinkedIn and our website. And we're very excited about that publication because that opens up the opportunity for lots of very exciting, what do you think, combination trials. Now, BRCA drugs and HRD drugs make up a little over $2 billion in annual sales. And we think this is a very, very synergistic mechanism. In fact, the SHAP scores and the SHAP ratios for the combination of 184 plus many of these PARP inhibitors is among some of the highest that I've seen. So this is a very unique mechanism. molecule to be combining with PARP inhibitors, because the theory is that we can lower the amount of PARP dosage and reintroduce PARP to where it oftentimes becomes unusable in patients. And we can also have a complementary mechanism. PARP works by inhibiting the repair. So when the DNA tries to repair itself, it can't. and blocks that enzyme, and so it's not available to the cancer cell's DNA to try to fix it. Now, that's very complimentary because remember, LP184 and 284, they work by causing these very lethal breaks. So 184 introduces the double-stranded breaks and lower dose even of PARP. will inhibit the repair enzyme. And so we think we can create a longer, perhaps more durable and more sensitive response to these tumors. And that's a big range of tumors, about one in five to one in four tumors have some element of DNA damage repair available. So that's a big market for 184. 2023 was a pivotal year for us where we really strengthened our insights. We launched our trials. 2024 has emerged as a year of great progress where our insights are now impacting patients and their journeys to fight cancer. It's also influencing the development decisions for future trials, future drugs, and the progress of other cancer companies. Our collective efforts and dedication have fostered a transformational shift, not only for our company, but it's in a tide of transformation for the industry. We're in an exciting trajectory toward the future where we can improve the lives of cancer patients, not only today, but actually set the stage for creating affordable, effective, and more importantly, economically viable solutions faster. And that pace of innovation, I think, will continue to accelerate. So with that, I'd like to now open the call to any questions or clarifications. If you'd like to ask a question, you can do so in one of two ways. You can type your question using the Q&A tool here at the Zoom webinar. or you can click on the raise hand tool to speak directly and we'll try to unmute your line and make it available. So I'll take a break for some questions. First question from John. John, thanks for your question. As I read through it, the Oregon arrangement is another AI collaboration. That's a great question in terms of what they saw, and I think what they saw is that they have a lot of exciting opportunities with this inhibitor that they have. It works through a very unique mechanism. It's a first-in-class drug, and it inhibits cancer metabolism. And because of that, it seems to be very potent across a pretty good range of cancers. Now, these PDI... enzymes that are out there. There's lots of PDI enzymes, about 20 or so, I believe, that Oregon has talked about. But which ones do you want to inhibit and which ones? And they also have cross-purpose. So it becomes a real combinatorial problem. Now, their drug seems to inhibit four very central ones to cancer cell metabolism. and which ones they go after, and should they combine it with other drugs, are really combinatorial and data-driven questions. And so these questions will help guide the construction of a trial that could be successful or unsuccessful. So it's very, very important. And so what they see is the ability to model this data and get some in silico insights, and then rapidly go to the lab to validate very, very targeted insights. And perhaps also, most importantly, generate some new IP. So then when they go to a larger pharma partner, they've got IP around combinations, targeted IP around going after specific subtypes of cancer, and maybe even insights on what to go after in terms of the model. The benefits for Lantern are very clear. We'll own this collaboration IP alongside Oregon. We also have rights to license their drug. So if we're really excited about it, I think it could be, you know, it fits into the way we think about Some of the molecules that are exciting, it's unique, it's super potent, it can work across cancers, it has the ability to combine. So it fits a lot of the kind of key things that we'd like to see. And of course, you know, we'll have to get deeper into the collaboration, but I think it could be a good drug that gets across the finish line in a number of cancers. And so we're excited about helping Oregon and also helping the molecule. Thank you. We have a hand up, I believe, from Ashok. Ashok, we're going to let you talk. I think we can do that.
spk05: You can unmute the line if you're still available.
spk01: Can you hear me? Yes. Hi, three-part question. So the AI-driven ADC development program seems to be progressing well clinically. So what are the key inflection points and timelines to potentially advance an ADC candidate into the clinic? And then the Starlight Therapeutics, again, appears to be gaining momentum with the Phase 1B protocol filing for the STAR-1. So what are the anticipated milestones and timing to initiate adult and pediatric clinical trials? And the last part of the question is the Oregon Therapeutics represents an interesting AI collaboration opportunity. So how do you see the radar platform accelerating the drug development efforts and how might this collaboration expand over time?
spk04: Great questions. Can they hear me now? Yeah. Okay. So let's start with the ADC. We think the key inflection points for us is to zero in on if HER2 or maybe if HER2, HER3 bispecific is a better option. We're playing around the target a little bit. We've seen extraordinary data in low expressing, low and medium expressing. So we're looking at the landscape to see, you know, is that the right target? place or should we do a bispecific HER2, HER3, which is also available. So I think we've got a few more months of some preclinical analysis that we've modeled. Now we want to take it back to some wet lab studies. And then, you know, to really, we've got to get through IND studies and manufacturing. So this for us is a 2025 event in terms of getting it into the clinical. Obviously, I'd love to beat that, but manufacturing these complex biologics takes time. We are looking at some new formats that we think could change it. We're looking at fragment design. We're looking at maybe doing some things kind of more in parallel. There are some new FDA guidelines in terms of manufacturing of ADCs that we just, I think they just came out very recently, actually, which are very favorable to especially if you go after with antibodies that are already known, already characterized and already in the clinic. So we're going to look at all pathways to compress the manufacturing and IND studies. There are also opportunities for us to license some technology that gets us the clinic faster as well. So we're looking at all those, but in either case, 2024 for us is to execute on our existing trials and 2025 we think is to execute the next wave which is the ADC and other drug conjugates. In regards to Star001, we expect to hear back from the FDA on this new, what we call Supplement B to the 1B and beyond for Starlight. And we also expect to continue to recruit some people for Starlight and potentially look at some independent financing and funding for Starlight to launch. So I think those are this year events. Starlight for us is definitely this year and ADC is the next chapter. So hopefully that gives you some sense of the timelines.
spk05: We have another question.
spk04: Do you want to? John, are you raising your hand or answering the questions? Okay. Let me read the question out for everybody. His question is, does the Oregon Therapeutics Partnership... serve as a template for other potential partnerships? I think it does. You know, we always like to think of being able to stamp something, but we've got one with Actuate. We have one with TTC. We have one now with Oregon, each of those very unique molecules and each good teams. Because as you get into collaboration, you're not only collaborating, betting on your capabilities, you're also betting on the partner. You know, these are real partnerships. And so, you know, we like the teams in all companies. We like the molecule. We like their path because if they don't succeed, we don't succeed, right? We're getting upside inequity in those molecules. So we're pretty focused on making sure we pick the right kind of chances to win. And our platform helps us do that, right? We can really understand a lot about the molecule and the indication and the unmet need just even during conversations because we start doing that modeling and analysis with radar even prior to looking at their data. Now, tech companies, you know, as I mentioned in the last call, we are in discussion with tech companies for partnerships. I don't know how long those take, but we are, you know, we're having discussions with many of the ones you can imagine. Those things just take time. I think, you know, we're not one of the big names like a recursion, you know, or an ex-scientia. Unfortunately, they had some issues with their management. or benevolent. Again, there's some business model issues, but there's some great big companies that suck up all the air in the room. So I think as we show our proof points and have more discussions with the Amazons and Apples and NVIDIAs and Googles and others, there's a whole range of tier two players as well. I think they can be suitable long-term tech partners. to enable our platform to get to a scale that can be monetized independently longer term. Another question from John is a great question, John. Do you want to ask it or do you want me to read it? Okay. So when will the sites be finalized for the harmonic trial in Asia? And will we see any sites outside of Japan and Taiwan? I think we'll do that in a phased manner. I mean, I think we've got some very good sites now in Japan, five that we've identified. I believe, is that right, David? Five. David will be visiting those sites along with our head of clinical development next month. along with Dr. Goto and getting those sites up and running. And then we have five additional sites, I believe also in Taiwan. So it'll be 10 sites. And those 10 sites can really give us the bulk of the patients that we need so far. We do have a couple of other countries that I mentioned earlier. In prior calls, we are looking at South Korea as well. Unfortunately, South Korea is going through some issues with their doctors striking in some of their major hospitals. So it's not an ideal time for, I think, a foreign new clinical trial from a small company to enter. But we have a lot of excitement in South Korea because the numbers in South Korea for never smokers with lung cancer is actually even higher than Japan's. So we had a lot of very initial excitement, but the doctors that are going on strike in South Korea gave us pause because we didn't want to be spending time and energy and money if, in fact, our trial was going to be stalled. So we kind of backed off of South Korea near term. even though it looks very, very promising because the number of patients and the centralization of patients. But we think we can get similar kind of activity just as easily in Japan and actually just as easily in Taiwan and even more cost effective in Taiwan than Japan. So I think we will look at new sites, but we have 10 coming on board in those two countries that could be very, very productive activities. and could supply us the bulk of what we need for the trial. But thank you for that question, John. So in closing, we're coming up on 50 minutes. I want to express my deep gratitude, first of all, to our team for making this happen. I know these webinars and these slides and the scripts, it's not easy. You've got to gather a lot of information. You've got to deliver. You've got to understand it. And of course, broadcast is great. You know, people get to look at it anytime. So I want to, Thank my team for the constant support and information, but also to our partners and stakeholders for their unwavering support. I think together we're really building a much, much better, scalable, brighter future in oncology. You know, we're solving real-world problems with proprietary AI solutions and with a real pragmatic approach. I think, you know, the rapid development of genomically guided targeted therapies is can alter the costs and timelines in oncology drug development. And I think it's going to place us long-term at the forefront of a new golden age of unprecedented productivity in the development of medicines. Thank you, everyone, for your time today.
spk03: Thanks very much.
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