NASDAQ:LTRN Lantern Pharma Q3 2023 Earnings Report $4.24 +0.43 (+11.15%) Closing price 03:59 PM EasternExtended Trading$4.48 +0.25 (+5.81%) As of 07:28 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Lantern Pharma EPS ResultsActual EPS-$0.29Consensus EPS -$0.46Beat/MissBeat by +$0.17One Year Ago EPSN/ALantern Pharma Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ALantern Pharma Announcement DetailsQuarterQ3 2023Date11/8/2023TimeN/AConference Call DateWednesday, November 8, 2023Conference Call Time4:30PM ETUpcoming EarningsLantern Pharma's Q1 2025 earnings is scheduled for Thursday, May 8, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Lantern Pharma Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 8, 2023 ShareLink copied to clipboard.There are 3 speakers on the call. Operator00:00:00Good afternoon, and welcome to our Q3 2023 earnings call. As a reminder, this call is being recorded and all attendees are in conference call will be available on our website at lanternpharma.com shortly after the call. We issued a press release after market close today, summarize pleased to report that we have made in the Q3 of 2019. And we are pleased to report that we have made in the Q3 of 2019. And we are pleased to report that we site at lanternpharma.com where you will also find a link to the slides management will be referencing on today's call. Operator00:00:43We 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. 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 ks for the year ended December 31, 2022, which is on file with the SEC and available on our website. Forward looking statements made on this conference call are as of today, November 8, 2023, 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. Operator00:01:53To the webcast replay of the conference call and webinar will be available on Lantern's website. On today's webcast, 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 Pana, and then we'll open the call for Q and A. I'd now like to turn the call over to Pana Sharma, President and CEO of Lantern Pharma. Panna, please go ahead. Speaker 100:02:37To the call. Thank you. Hello, everyone, and thank you for joining us this afternoon to hear about our Q3 results and corporate progress. We made significant strides over this past quarter in executing our mission of transforming the oncology drug discovery and development process, of questions. Especially now that we have all of our clinical stage drug candidates in human clinical trials that are active, 2 that are in Phase 1 now and one that is in Phase 2. Speaker 100:03:04We also continue to make significant progress in the launch of our CNS and brain cancer of our focus subsidiary Starlight Therapeutics and in developing the next major leg of our discovery and development efforts, which will be focused on drug conjugates including antibody drug conjugates. Our team and many clinicians are particularly excited about the interesting first in human drug candidates LP-one hundred and eighty four and LP-two eighty four. Both of these candidates share a mechanism called synthetic lethality. During Q2, I was able to share the news that we launched LP-one hundred and eighty four into a Phase 1 clinical trial for recurrent advanced solid tumors, especially those that are refractory to current standard of care therapies. This area is an area of especially critical need. Speaker 100:03:50During Q3, we launched the sister drug candidate LP284 into a clinical trial for recurrent non Hodgkin's lymphomas and also sarcomas. We also dosed the initial patient for LP-one hundred and eighty four this quarter. Additionally, we continue to enhance and develop our AI platform, Radar, our AI platform is revolutionizing the way we model, predict and understand drug cancer interactions, enabling us to advance our newly developed drug programs from of initial insights, the first in human clinical trials at an average of less than 2.5 years and a cost of under $2,000,000 per program. It's a milestone unheard of in the realm of oncology drug discovery. 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. Speaker 100:04:40Our leadership in the innovative use of AI and machine learning to transform of the best practices in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI centric approach to drug development. The golden age of AI medicine is just beginning and it is being powered by large of scale highly available computing, massive data storage and additionally it is being fed by healthcare and patient data and cancer data, which is more widely available and at increasing levels of quality. Companies that can harness these capabilities in the of the largest companies in the world. We believe Lantern Farm will be long term leaders that create massive value for patients, for investors and for our industry. We believe Lantern Pharma is among the leaders in this transformation of the pace, risk and cost of the development of cancer medicines. Speaker 100:05:35To the next question. This transformation has a promise not only to make oncology medicines faster, cheaper and with increased precision for patients and also for of orphan and ultra orphan groups, but also to help change the direction of R and D productivity and output in the pharma industry. In the past 2 years, we have successfully developed and launched 11 additional programs, a testament to the agility, efficiency and groundbreaking nature of our approach. As compared to the many other companies that are leveraging AI, Our productivity and efficiency on a per dollar basis is unparalleled. On average, these programs are advancing from initial AI insights to first in human clinical trials at an unheard of cost and timeline. Speaker 100:06:21In fact, in a recent study published in Drug Discovery Today, it was reported that nearly half of the largest pharma companies had negative R and D productivity for the past 20 years. These startling figures serve as a stark reminder that the traditional model of big pharma R and D is just not sustainable, not effective and is not the right approach to improve drug pricing or drug availability. With escalating economic and political pressures over drug pricing and the nature of drugs, it's clear that our industry needs to rethink its approach fundamentally, and we believe large pharma companies will increase the adoption of AI and computational approaches to elevate above this issue. These specific instances of value creation at Lantern, specifically in CNS and neuro oncology, has allowed us to develop an entirely new company, Starlight Therapeutics, and we'll be providing more data later this year early next year. Of the key drivers of the company will be setting a new standard in cancer drug development in a category that hasn't seen a new drug candidate as monotherapy in almost 17 years. Speaker 100:07:27As we continue to accelerate the pace at which we're developing and validating insights, insights that can lead to meaningful drug assets, we are then positioning these drug assets after clinical trials to partner them out with larger biopharma companies. At the same time, as David will cover shortly, We have a strong ongoing cash position, approximately $45,000,000 in cash and cash equivalents that is being carefully utilized to make meaningful progress on both our platform and our drug candidates into human clinical trials. We believe our approach is the future of developing cancer therapies where data can be used to accelerate programs, de risk the identification and progress of life changing medicines and to provide insights into which patients are most suitable for trial. Now turning to some of the specific highlights during the Q3. We received FDA clearance of our IND application for LP284, a first in human clinical trial for refractory non Hodgkin's lymphomas and sarcomas. Speaker 100:08:25We also dosed the first patient in our LP184 trial, which is for multiple advanced solid tumors. And we also expanded the number of sites in the U. S. For our LP300 non small cell lung cancer trial for never smokers. We've also started the process of expansion into East Asian countries where the demographic for this patient population is twice that of the U. Speaker 100:08:49S, about 30% to 35% of non small cell lung cancer patients are never smokers. We also developed an initial proof of concept and preclinical evidence for our novel cryptophycin based antibody drug conjugate. And we plan to share broader data from the initial exciting efficacy and scientific benchmarks achieved with that drug candidate in January of 2024. We continue to advance radar, our AI platform across several dimensions, automation, data sets, an increasing number of modules specifically designed for oncology drug development. And very importantly, we had continued ongoing fiscal discipline as clearly evidenced by our burn rate and our balance of approximately $45,000,000 in cash, cash equivalents and marketable securities at the end of the 3rd quarter. Speaker 100:09:42Of questions. We believe this provides us with sufficient cash runway well into Q3 of 2025 or beyond, as David will talk about of questions. So at this point, with the highlights behind us, I'll come back and talk in more details, but I'll turn the call over now to our CFO, David Margrave, who will provide an overview for the Q2 financial results. Speaker 200:10:05David? Thank you, Pana, and good afternoon, everyone. I will now share some financial highlights from our Q3 ended September 30, 2023. Our general and administrative expenses were approximately $1,300,000 for the Q3 of 2023, of down slightly from approximately $1,400,000 in the prior year period. R and D expenses for approximately $2,200,000 for the Q3 of 2023, up from approximately $700,000 in the Q3 of of 2022. Speaker 200:10:44A substantial portion of the R and D increase in 2023 relative to 2022 is related to a $935,000 payment received from a service provider in July 2022 to resolve a difference of views in the service provider agreement, which reduced our research and development expenses during the Q3 of 2022. The increase in Q3 2023 was also attributable to increases in product candidate manufacturing expenses, of increases in research studies and increases in payroll and compensation expenses. We recorded a net loss of approximately $3,200,000 for the Q3 of 2023 of $0.29 per share compared to a net loss of approximately $2,300,000 of $0.21 per share for the Q3 of 2022. Our loss from operations in the Q3 of 2023 Was partially offset by interest income and other income net totaling approximately $362,000 of our interest income and other income net increased by an aggregate of approximately $482,000 for the Q3 of 2023 compared to the Q3 of 2022. This increase was attributable to an increase in interest of approximately 194,000 of increases in dividend income of approximately $152,000 and an increase in unrealized gains on investments of approximately 102,000 As of September 30, 2023, we had approximately 10,870,000 shares of common stock outstanding of outstanding warrants to purchase approximately 177,998 shares and outstanding options to purchase of approximately 1,100,000 shares. Speaker 200:12:48These warrants and options combined with our outstanding shares of common stock Give us a total fully diluted shares outstanding of approximately 12,100,000 shares as of September 30, 2023. Our cash position, which includes cash equivalents and marketable securities, was approximately 44,900,000 of dollars as of September 30, 2023. We anticipate this balance will provide us with a cash one way 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 in a capital efficient manner. Our team continues to be very productive under a hybrid operating model. Speaker 200:13:50This hybrid model also removes geographic restrictions to our hiring initiatives, which has given us the ability to recruit extremely high caliber team members that otherwise might not be available. We currently have 21 employees 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 over to Pana for an update on some of our development programs. Pana? Speaker 100:14:24Thank you, David. This past quarter, we launched another first in human Phase 1 program with LP284, a novel synthetically lethal small molecule in refractory non Hodgkin's lymphomas and sarcomas where there is a significant patient need for improved therapies. As I mentioned on our Q2 call, we had planned to launch this trial here in Q4, and that's our current we're on track to do that. So we've launched both 184 and 284, 1 quarter after another, which is what we had talked about earlier this year. Now, 284 can work effectively both as monotherapy or in combination with other standard of care agents. Speaker 100:15:09But finding these But computational approaches are increasing their ability to predict meaningful and clinically relevant combination regimens for cancer. And our team continues to increase the value of our platform in this regard. And it helps us sharpen the focus of our existing clinical drug candidates to very specific populations. With 284, we're able to understand that advanced non Hodgkin's lymphoma cancer subtypes with DNA damage response deficiency, notably those with compromised functioning of the ATM gene, the ataxia of the ATM gene can cause a tremendous amount of sensitivity to our drug agent. In the U. Speaker 100:15:59S, Europe, of the largest B cell lymphomas are diagnosed in about 16,000 to 20,000 patients each year and have an estimated annual market potential of about $3,000,000,000 to $4,000,000,000 We also saw with this drug candidate that in PDX models of high grade B cell lymphomas, LP284 showed synergistic and significantly enhanced of anti cancer activity when used in combination with rituximab. In vivo PDX models, the synergy of rituximab with our drug LP284 of 63% more effective in destroying high grade B cell lymphomas than rituximab alone. When we put 2 84 on rituximab, we had 93% tumor growth inhibition, whereas rituximab alone only had 57%. So as many of you probably know, rituximab is a standard of care approved therapy in a wide range of B cell cancers and non Hodgkin's lymphomas. We plan on releasing additional details on this data and on the set of results in the coming month. Speaker 100:17:03Nearly all mantle cell, DHL and of high grade B cell lymphoma patients relapse from the current standard of care agent, and we believe there is an urgent and unmet need to introduce this drug either as monotherapy of 1 combination in the relapse and refractory setting for this patient group. Moving on to 184, we discussed that we dosed the first patient in the Phase 1a clinical trial. Of the first in human Phase 1 basket trial across multiple solid tumor indications. We think this the market potential for this drug is quite significant. Since 20% to 25% of solid tumors have DNA damage repair deficiency and the majority of them become refractory of the most recent study in the study. Speaker 100:17:52This trial is anticipated to enroll patients that have relapsed refractory advanced solid tumors such as pancreatic, of the U. S. And multiple other solid tumors, including GBM and brain cancers. The Lantron expects to continue Phase 1 enrollment throughout of the most recent sites and patients and potentially finish the first two cohorts of patients and also have a number of major centers like Fox Chase and Johns Hopkins Medicine and USC also joined the trial. The dosage and safety data obtained in this trial will be used to advance the central nervous system trials central nervous system cancer trials for future Phase 2 to be sponsored by Lantern's wholly owned subsidiary Starlight Therapeutics. Speaker 100:18:36Globally, the aggregate annual market potential of LP-one hundred and eighty four target indication so far is in excess of $11,000,000,000 consisting of about $4,500,000,000 to $5,500,000 plus for CNS cancers and well over $6,000,000,000 for solid tumors. So you can see why we're very excited about this drug as a potential blockbuster across multiple tumors. As we mentioned, our drug LP300 in a previous multicenter Phase III clinical trial, a subset of never of smokers and non small cell lung cancer patients who received that drug with chemotherapy showed an increased overall of survival of 91% and an increase in 2 year survival of 125%, respectively. This is compared to patients who only received the chemo doublet alone. Now we're doing that currently in a 90 patient Phase II trial and we continue to expand into multiple sites. Speaker 100:19:33Doctor. Joseph Treat, who has been appointed the lead principal investigator of the HARMONIX study. Doctor. Treat is a leading expert in lung malignancies, including non small cell lung cancer and never smokers. Additionally, he has specific experience with many Asian collaborators where this is significant where this population of the most important milestones we've seen in the past. Speaker 100:19:55So we're advancing the trial, the HARMONIC trial into Asia, specifically Taiwan, Japan and South Korea, where there's a higher incidence of never smokers in non small cell lung cancer, about double or higher than that of patients in the U. S, 32% to 35% plus. And these are largely driven by pointed and subtle mutations in EGFR or other kinases. So as I mentioned earlier in our call, we'll be sharing our preliminary work in the ADC category. This work has been accomplished in the last 6 months at a very and answer session. Speaker 100:20:40We've had very good results with our initial ADC designs and believe the cryptophycin lin conjugate has of picomolar IC50 values across multiple cancers. We've zeroed in on 5 or 6. Again, we'll be talking more about the detailed update of this program and how this program will expand. We'll plan on that update for all the investors and analysts in January of 2024. Of this past quarter, we had 2 major presentations. Speaker 100:21:07Presentations like this are important because they help highlight why we're excited about the molecules and how we're derisking them and how we're thinking about development. It also generates interest among the pharma community. So for 2 eighty four, we presented at Soho 2023. We talked about the drug having tremendous efficacy in B cell cancers, which are normally non Hodgkin's lymphomas that have what's called homologous repair deficiency. This allows us then after the Phase I to perhaps serve in on of HRD focused B cell cancers. Speaker 100:21:43For 184, we presented at a joint ASCO SNOW conference showing how the molecule is activated in certain high expressing PTGR brain cancers in both adult and pediatric and it completely inhibits or kills off the cancer cells. So again, we'll take that to not only pharma companies, but also to sites that have expressed an interest. And we believe these kind of posters and presentations and data are important to help us better understand where we can point the drug to get the most effective way to market And during this coming quarter, next week in November 17, we'll continue driving awareness for our data in our platform. We'll be presenting at Society of Neuro Oncology with our to the FDA. Our next Doctor. Speaker 100:22:32John Latera is Director at the Brain Cancer Program at Johns Hopkins. Now the MGMT status is very important since by 50% to of the most important and most important and most important. This means that they either don't respond or to the current standard of care temzolomide. And that's not only in GBM, but also in many other high grade gliomas and brain cancers. On December 1, we'll be presenting at the Bengaluru Tech Summit in India on our AI platform and how we're building a future forward pharma labeled as Pharma 4.0. Speaker 100:23:08And on December 5 in Boston and at the CNS Drug Delivery Summit, we'll be presenting on how we're leveraging our AI to accelerate the development of drug candidates for CNS and brain cancers, specifically how we believe we can save 100 of 1,000 or 1,000,000 of dollars through our algorithms, which can predict the blood brain barrier permeability of any compound with 92% to 95% accuracy. Moving on to radar, we continue to advance the platform in size, scope and capabilities, and we believe it continues progressing towards becoming a potential standard for AI driven drug development in oncology for both early stage development and later stage patient biomarker of the most recent data points. We project to reach over $50,000,000,000 by the end of this year. And the scope of Raider's data has broadened with a strategic focus on additional classes of compounds, including antibodies, checkpoint inhibitors and DNA damaging agents and also additional data from clinical studies such as from liquid biopsy and combination studies. So, this data is really important because it helps us define drug interaction and optimal dosage. Speaker 100:24:19Of the key components of the platform. Now these data points and the associated advancements in automation on the platform, along with algorithms and code comprise a functional module and have advanced radars drug development capabilities. The Key modules that are being advanced right now are for predicting patient response and identifying optimal combination regimens for immuno oncology drugs, Such as mean checkpoint inhibitors, which compromise well on close to $30,000,000,000 plus in sales and also then predicting the blood brain barrier permeability of any molecule with 90 plus to 94% accuracy and doing that at a of scale and speed that allows the analysis of tens of thousands of compounds a day. And we also are continuing to advance our ADC template or ADC module for generating drug conjugate templates for the next generation of the ADCs. We expect to have additional data and perhaps posters and papers out on the ADC module. Speaker 100:25:21These three modules exemplify the type of rapid and meaningful progress the RADAR platform is expected to make by the end of this year and over the next several quarters. And we think these can become really a hallmark, but almost a backbone for oncology drug development for of many companies. And one of our primary focus during the second half of twenty twenty three has been to further accelerate the enrollment of the HARMONIC trial and also position ourselves within the patient advocacy community to drive improved awareness and enrollment in our trials for LP300, LP184, LP284. To the Q2 with groups from GBM awareness, lung cancer advocacy, and these have generated interest in our trials and are generating an enthusiastic groundswell of interest in participating with our drugs at specific trial sites. We also have an upcoming ATRT rally where our Head of Clinical Development will be speaking for an ultra rare brain cancer, ATRT, and it's a pediatric indication that we plan on pursuing through STARLIGHT, where our molecule has shown tremendous efficacy in preclinical models, specifically in ATRT since that was an insight driven from our AI platform, of proven in the lab and now also allowing us to gain a rare pediatric disease voucher. Speaker 100:26:44So 2023 is shaping into being a pivotal year where are now entering into patients and have started their journey to becoming meaningful therapies in cancer. Our collective efforts and dedication have fostered a transformational shift for our company, setting us on an exciting trajectory towards the future where we are improving the lives of cancer patients with effective and affordable targeted treatment options. In closing, I want to express my deep gratitude to our team, our partners and our stakeholders for their unwavering support. Together, we're really lighting the to the right way towards a brighter future in oncology and solving real world problems with our proprietary AI platform that is enabling the rapid development of genomically of targeted therapeutics and these are the ones that will alter the costs and timelines and drug discovery and place us at the forefront of a new era in cancer therapy and cancer medicine. Now with that, I'd like to open up the call to some questions or clarifications. Speaker 100:27:59Yes. We've got a couple of questions already teed up, which is great. We'll go first question from John. His question, I'll repeat it. As you move past of the Phase I trial for LP-one hundred and eighty four, do you anticipate refining the indication? Speaker 100:28:16What will guide efforts to narrow it down? Well, it's a great question. We will be taking liquid biopsy from the patients in Phase 1 and obviously some other PKPD data as well. And we think that will help us refine it. And since it is a basket trial, we do expect there to be a range of response. Speaker 100:28:31And that also will help us guide. Is there new higher levels of PTGR1 or does of a bigger genomic signature for homologous repair deficiency or nucleotide excision deficiency mean better response? Are we getting a muted response in certain cancers versus a higher response in others? But yes, the Phase 1 data, since it's a basket design. We allow all solid tumors that are refractory. Speaker 100:28:55We'll be obviously doing a lot of biomarker work on the what's called FFPE slides and also on liquid biopsy. So, yes, this will be very data heavy even in Phase 1. Thank you. The second question, could you provide I'll read the question, it just came in. Could you provide guidance for when you expect to share initial data from HARMONIK Phase 1 studies for LP-one hundred and eighty four and two eighty four? Speaker 100:29:26So just for clarification, Harmonic is in Phase 2. We expect to have perhaps some initial data in the first half of next of we expect that once we reach what's called 27 events, which we hope to reach by the end of next year, that we'll be able to give of data. Now of course, it could happen a lot sooner and so it will we could have 1 or 2 readouts for Harmonic next year. For Phase 1 LP-one hundred and eighty four, I expect that to be definitely in the first half of the year. And then as I mentioned earlier, LP-two eighty four is about a quarter behind that. Speaker 100:30:01So I expect data in Q1, Q2 and throughout the year, but definitely Q2, Q3 and Q4. Another question. Wow, we got a lot of great questions. This is regard to the ADC program. So in terms of the ADC program, we will be refining of some of the indications. Speaker 100:30:26We'll be sharing the data in January. So we'll talk a little bit about the timing for 2024. So we expect that of IND application to be in 'twenty four or early 'twenty five really depends on how quickly we can manufacture and get a clarity on manufacturing at GMP level. That's going to be the key driver. We think we have a super potent molecule. Speaker 100:30:48We think there's no other design like it with the cryptophycin. So we believe that it's novel and can extend to many other cancers. For us, it's really going to come down to manufacturing it. And there are some things that we're looking at that will potentially really shorten the manufacturing of the ADC, including, again, I'm stealing from the January, but we'll talk also about synthetic nanobodies that can take on the form and function of an antibody, But are easier and cheaper to manufacture. And so this might be one of the very first kind of synthetic fragment nanobody drug conjugate. Speaker 100:31:27Yes, good question. So for 184another question on 184 and 284. On 184 and 284, The question is, can you please this is from another John Heerdenck. Can you please discuss the timing of the potential Hello, John. Can you please discuss the timing potential readouts? Speaker 100:31:46Yes. So since 184 just started this past quarter, we have That designed in what's called cohorts of 3. So you have 3 patients that you dose the first level 2. And then if we see everything Green light, we go to the 2nd cohort, that's 3. And we do these cohorts of 3. Speaker 100:32:06We think about cohort 34, Maybe 5 will start seeing some really good signals. And we'll continue basically advancing the cohorts till we get to a maximum tolerated dose, and then same with 284. 284 is about a quarter behind that. But the cohort design for the first two cohorts in 284 are a little different. Those are designed as cohorts of 1. Speaker 100:32:38And so we'll be able to get through the first two cohorts pretty quickly and then take cohort 3, of just 3 patients. So again, in both, I think they're a quarter behind one another cohort. The 284 could Speed up because we plan on some outbound activity with the lymphoma community, so maybe that will help us. Again, these are fairly focused trials. We expect to see hopefully some signals as well. Speaker 100:33:00But I'm looking at Q2 and Q3 for those particular trials for 184 and 284. And if not earlier, then we'll start obviously in parallel of some partnering discussions as well. Thank you. Some more questions via e mail that we'll be talking about. One is about Starlight. Speaker 100:33:43Yes. So is our goal for Starlight, the reason we went after Starlight is when we 1st started looking at where LP-one hundred and eighty four could be pointed at best, in our AI platform, we came back with a signal for CNS cancers. Now we had kind of weren't thinking about that because we thought other solid tumors would be exceptionally more sensitive. And we didn't know enough about the blood brain barrier permeability of the molecule at the time, which is why we started creating the algorithms and now which are top in the world for that purpose. And so we realized once we got the data and signals for GBM that there's dozens and as I found out later, 120 plus other of brain cancers. Speaker 100:34:28So we sucked in all the data as we possibly could. I think in 1 quarter, we sucked in like almost $1,500,000,000 or something. And these are wide large scale genomic biomarker drug sensitivity studies. We normalize that data as quickly as we could. And Just mutation data, it was also epigenomic data. Speaker 100:34:45And we discovered that there were another wide range, other Brain cancers, secondary and primary, the drug was active in. As we went to lab to see if those in silico concepts made sense, Many of them were right on. In fact, we're even more sensitive. And so that led us to the insight that, wow, we have a lot of opportunity across of a wide range of neuro oncology. We shared that data with key thought leaders and KOLs. Speaker 100:35:14And we also published at Society of Neuro Oncology of the last 2 years and we got a lot of interest from pharmas and we realized that this is a massive market opportunity. This is exactly what we want to do is we want to change the pace of finding these kinds of insights and then generating value for patients and value for investors and generating new medicines. And so the The Starlight opportunity really took on kind of a life of its own. It went from one indication to like 5, 6, 7 indications, which obviously we can't do as one company. And since there's a lot of commercial need for patients and there's a lot of pharma of interest to develop a neuro oncology franchise. Speaker 100:35:53We think that there's interest in Anewco. And and this could be one of the very first NUCOs that spun out directly as a result of AI driven drug development. And so Starlight we'll get drug product potentially obviously just from us. We'll have a license to pursue neuro oncology indications. They won't have to worry about an AI platform and growing it. Speaker 100:36:13They won't have to worry about a lot of some of the fundamental drug product infrastructure and CMC questions. And so they'll be purely focused on execution in the CNS trials, which is great. And so we think we can make exceptional progress if we get standalone management team focused on that and fund it. So we're very excited about it. We get fairly very good and unique positive feedback. Speaker 100:36:36And for us, that's a Q1 event to raise some funding around that early part of next year, Q1, Q2, and then launch the Phase II trial for multiple indications in GBM and potentially brain mets in Q2, Q3. So, yes, very good question. I think there's any one more. Yes. So a couple more questions have come in. Speaker 100:37:04I'll take these. So a question during the Q3 of 2023, of the largest and largest companies in the world. Lantern filed 4 new patent applications relating to breast, liver and blood cancers and an additional application directed to the of lyophilized formulation for these molecules. And where does our patent portfolio sit today? David, would you like to take that? Speaker 100:37:28Sure, sure. Speaker 200:37:30We have an aggregate of over 95 issued patents and pending patent applications. We have strong patent position in each of our of lead product candidate areas. For LP-three hundred, we have claims extending into at least 2,032. For LP-one hundred and eighty four, we have claims extending into at least 2,041. And for 2,84, we have claims extending into at least of 2,039. Speaker 200:38:01I think one very interesting thing we've seen with our radar platform is that it's also a great of new insights that you can then use to further expand your IP position. And we expect to continue that. So we are of actively filing as you saw we described what we did in Q3. We will be actively filing and further building our IP position in coming quarters as Speaker 100:38:30well. Thanks, David. Another question we have from Sean. Sean, thanks for your question. His question, what are your expectations around the pace of radar data accumulation in 2024 as you look beyond the 50,000,000,000 data points anticipated by end of 2023. Speaker 100:38:51A really good question. It's a very exciting question. Well, I think we'll have of the top sometime in January or maybe early February, specifically around our radar platform. But I think we'll probably pass $50,000,000,000 in the next month or 2 easily. And we're developing internal goals, but we're thinking kind of a 3x to 4x increase for next year. Speaker 100:39:20So we're looking at we'll probably easily get to $100,000,000,000 so we'll double that number, maybe get to $150,000,000,000 $200,000,000,000 A lot of this is going to depend on how What the quality of data sets are, we have a couple of initiatives internally, again, we'll talk about them later, around engineered data sets and extracting data from data that's already available. 2nd, we're also thinking about scraping, doing large scale automated scraping from The right kind of quality publications. And we're also looking at better and automated feeds from of the existing more enlightened publications and systems that are doing machine readable data format, machine ready kind of data extractions like in through JSON files or other kind of configurations. So we have a number of things. I think we're going to crush that $50,000,000,000 number next year. Speaker 100:40:25I think it could be of at least 2 or maybe up to 4 times that. But yes, it's a great question. And more importantly, it's not just the data, it's really the of normalization and curation of the data and then of course the algorithms so you can make sense to all that data. Thank you. Well, with that, I'd like to thank everyone for participating. Speaker 100:40:47I know we had a lot of really good questions. And There being no further questions, we'd like to conclude today's call. Thank you. Thanks, everybody.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallLantern Pharma Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Lantern Pharma Earnings HeadlinesLTRN: IND Clearance for LP-184 in TNBCMay 6 at 5:03 PM | msn.comLantern Pharma Stock Short Interest Report | NASDAQ:LTRN | BenzingaMay 6 at 1:08 AM | benzinga.comBlackrock’s Sending THIS Crypto Higher on PurposeWhile everyone's distracted by Bitcoin's moves, a stealth revolution is underway. One altcoin is quietly positioning itself to overthrow the entire banking system.May 7, 2025 | Crypto 101 Media (Ad)EXCLUSIVE: Lantern Advances Breast Cancer Drug Candidate With FDA Clearance For Early-Stage TrialMay 5 at 9:52 AM | uk.finance.yahoo.comLantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC)May 5 at 8:55 AM | businesswire.comLantern Pharma (LTRN) to Release Quarterly Earnings on ThursdayMay 1, 2025 | americanbankingnews.comSee More Lantern Pharma Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Lantern Pharma? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Lantern Pharma and other key companies, straight to your email. Email Address About Lantern PharmaLantern Pharma (NASDAQ:LTRN), a clinical stage biotechnology company, focuses on artificial intelligence, machine learning, and genomic data to streamline the drug development process. Its product pipeline comprises LP-300, which is in phase 2 clinical trial in combination therapy for never-smokers with non-small cell lung cancer adenocarcinoma; LP-184, which is in phase 1 clinical trial for the treatment of solid tumor, such as pancreatic, breast, bladder, and lung cancers, and glioblastoma and other central nervous system cancers; and LP-284, which is in phase 1 clinical trial for the treatment of non-Hodgkin's lymphomas, including mantle cell lymphoma and double hit lymphoma. The company develops STAR-001, which is in preclinical development for the treatment of glioblastoma, brain metastases, atypical teratoid rhabdoid tumors, and pediatric rare disease designation. In addition, it provides ADC program, an antibody drug conjugate therapeutic approach for cancer treatment. Further, the company's artificial intelligence platform RADR uses big data analytics and machine learning for combining molecular data. Lantern Pharma Inc. has a strategic AI-driven collaboration with Oregon Therapeutics to optimize the development of its first-in-class protein disulfide isomerase inhibitor drug candidate XCE853 in novel and targeted cancer indications. The company was incorporated in 2013 and is headquartered in Dallas, Texas.View Lantern Pharma ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Disney Stock Jumps on Earnings—Is the Magic Sustainable?Archer Stock Eyes Q1 Earnings After UAE UpdatesFord Motor Stock Rises After Earnings, But Momentum May Not Last Broadcom Stock Gets a Lift on Hyperscaler Earnings & CapEx BoostPalantir Stock Drops Despite Stellar Earnings: What's Next?Is Eli Lilly a Buy After Weak Earnings and CVS-Novo Partnership?Is Reddit Stock a Buy, Sell, or Hold After Earnings Release? 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There are 3 speakers on the call. Operator00:00:00Good afternoon, and welcome to our Q3 2023 earnings call. As a reminder, this call is being recorded and all attendees are in conference call will be available on our website at lanternpharma.com shortly after the call. We issued a press release after market close today, summarize pleased to report that we have made in the Q3 of 2019. And we are pleased to report that we have made in the Q3 of 2019. And we are pleased to report that we site at lanternpharma.com where you will also find a link to the slides management will be referencing on today's call. Operator00:00:43We 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. 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 ks for the year ended December 31, 2022, which is on file with the SEC and available on our website. Forward looking statements made on this conference call are as of today, November 8, 2023, 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. Operator00:01:53To the webcast replay of the conference call and webinar will be available on Lantern's website. On today's webcast, 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 Pana, and then we'll open the call for Q and A. I'd now like to turn the call over to Pana Sharma, President and CEO of Lantern Pharma. Panna, please go ahead. Speaker 100:02:37To the call. Thank you. Hello, everyone, and thank you for joining us this afternoon to hear about our Q3 results and corporate progress. We made significant strides over this past quarter in executing our mission of transforming the oncology drug discovery and development process, of questions. Especially now that we have all of our clinical stage drug candidates in human clinical trials that are active, 2 that are in Phase 1 now and one that is in Phase 2. Speaker 100:03:04We also continue to make significant progress in the launch of our CNS and brain cancer of our focus subsidiary Starlight Therapeutics and in developing the next major leg of our discovery and development efforts, which will be focused on drug conjugates including antibody drug conjugates. Our team and many clinicians are particularly excited about the interesting first in human drug candidates LP-one hundred and eighty four and LP-two eighty four. Both of these candidates share a mechanism called synthetic lethality. During Q2, I was able to share the news that we launched LP-one hundred and eighty four into a Phase 1 clinical trial for recurrent advanced solid tumors, especially those that are refractory to current standard of care therapies. This area is an area of especially critical need. Speaker 100:03:50During Q3, we launched the sister drug candidate LP284 into a clinical trial for recurrent non Hodgkin's lymphomas and also sarcomas. We also dosed the initial patient for LP-one hundred and eighty four this quarter. Additionally, we continue to enhance and develop our AI platform, Radar, our AI platform is revolutionizing the way we model, predict and understand drug cancer interactions, enabling us to advance our newly developed drug programs from of initial insights, the first in human clinical trials at an average of less than 2.5 years and a cost of under $2,000,000 per program. It's a milestone unheard of in the realm of oncology drug discovery. 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. Speaker 100:04:40Our leadership in the innovative use of AI and machine learning to transform of the best practices in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI centric approach to drug development. The golden age of AI medicine is just beginning and it is being powered by large of scale highly available computing, massive data storage and additionally it is being fed by healthcare and patient data and cancer data, which is more widely available and at increasing levels of quality. Companies that can harness these capabilities in the of the largest companies in the world. We believe Lantern Farm will be long term leaders that create massive value for patients, for investors and for our industry. We believe Lantern Pharma is among the leaders in this transformation of the pace, risk and cost of the development of cancer medicines. Speaker 100:05:35To the next question. This transformation has a promise not only to make oncology medicines faster, cheaper and with increased precision for patients and also for of orphan and ultra orphan groups, but also to help change the direction of R and D productivity and output in the pharma industry. In the past 2 years, we have successfully developed and launched 11 additional programs, a testament to the agility, efficiency and groundbreaking nature of our approach. As compared to the many other companies that are leveraging AI, Our productivity and efficiency on a per dollar basis is unparalleled. On average, these programs are advancing from initial AI insights to first in human clinical trials at an unheard of cost and timeline. Speaker 100:06:21In fact, in a recent study published in Drug Discovery Today, it was reported that nearly half of the largest pharma companies had negative R and D productivity for the past 20 years. These startling figures serve as a stark reminder that the traditional model of big pharma R and D is just not sustainable, not effective and is not the right approach to improve drug pricing or drug availability. With escalating economic and political pressures over drug pricing and the nature of drugs, it's clear that our industry needs to rethink its approach fundamentally, and we believe large pharma companies will increase the adoption of AI and computational approaches to elevate above this issue. These specific instances of value creation at Lantern, specifically in CNS and neuro oncology, has allowed us to develop an entirely new company, Starlight Therapeutics, and we'll be providing more data later this year early next year. Of the key drivers of the company will be setting a new standard in cancer drug development in a category that hasn't seen a new drug candidate as monotherapy in almost 17 years. Speaker 100:07:27As we continue to accelerate the pace at which we're developing and validating insights, insights that can lead to meaningful drug assets, we are then positioning these drug assets after clinical trials to partner them out with larger biopharma companies. At the same time, as David will cover shortly, We have a strong ongoing cash position, approximately $45,000,000 in cash and cash equivalents that is being carefully utilized to make meaningful progress on both our platform and our drug candidates into human clinical trials. We believe our approach is the future of developing cancer therapies where data can be used to accelerate programs, de risk the identification and progress of life changing medicines and to provide insights into which patients are most suitable for trial. Now turning to some of the specific highlights during the Q3. We received FDA clearance of our IND application for LP284, a first in human clinical trial for refractory non Hodgkin's lymphomas and sarcomas. Speaker 100:08:25We also dosed the first patient in our LP184 trial, which is for multiple advanced solid tumors. And we also expanded the number of sites in the U. S. For our LP300 non small cell lung cancer trial for never smokers. We've also started the process of expansion into East Asian countries where the demographic for this patient population is twice that of the U. Speaker 100:08:49S, about 30% to 35% of non small cell lung cancer patients are never smokers. We also developed an initial proof of concept and preclinical evidence for our novel cryptophycin based antibody drug conjugate. And we plan to share broader data from the initial exciting efficacy and scientific benchmarks achieved with that drug candidate in January of 2024. We continue to advance radar, our AI platform across several dimensions, automation, data sets, an increasing number of modules specifically designed for oncology drug development. And very importantly, we had continued ongoing fiscal discipline as clearly evidenced by our burn rate and our balance of approximately $45,000,000 in cash, cash equivalents and marketable securities at the end of the 3rd quarter. Speaker 100:09:42Of questions. We believe this provides us with sufficient cash runway well into Q3 of 2025 or beyond, as David will talk about of questions. So at this point, with the highlights behind us, I'll come back and talk in more details, but I'll turn the call over now to our CFO, David Margrave, who will provide an overview for the Q2 financial results. Speaker 200:10:05David? Thank you, Pana, and good afternoon, everyone. I will now share some financial highlights from our Q3 ended September 30, 2023. Our general and administrative expenses were approximately $1,300,000 for the Q3 of 2023, of down slightly from approximately $1,400,000 in the prior year period. R and D expenses for approximately $2,200,000 for the Q3 of 2023, up from approximately $700,000 in the Q3 of of 2022. Speaker 200:10:44A substantial portion of the R and D increase in 2023 relative to 2022 is related to a $935,000 payment received from a service provider in July 2022 to resolve a difference of views in the service provider agreement, which reduced our research and development expenses during the Q3 of 2022. The increase in Q3 2023 was also attributable to increases in product candidate manufacturing expenses, of increases in research studies and increases in payroll and compensation expenses. We recorded a net loss of approximately $3,200,000 for the Q3 of 2023 of $0.29 per share compared to a net loss of approximately $2,300,000 of $0.21 per share for the Q3 of 2022. Our loss from operations in the Q3 of 2023 Was partially offset by interest income and other income net totaling approximately $362,000 of our interest income and other income net increased by an aggregate of approximately $482,000 for the Q3 of 2023 compared to the Q3 of 2022. This increase was attributable to an increase in interest of approximately 194,000 of increases in dividend income of approximately $152,000 and an increase in unrealized gains on investments of approximately 102,000 As of September 30, 2023, we had approximately 10,870,000 shares of common stock outstanding of outstanding warrants to purchase approximately 177,998 shares and outstanding options to purchase of approximately 1,100,000 shares. Speaker 200:12:48These warrants and options combined with our outstanding shares of common stock Give us a total fully diluted shares outstanding of approximately 12,100,000 shares as of September 30, 2023. Our cash position, which includes cash equivalents and marketable securities, was approximately 44,900,000 of dollars as of September 30, 2023. We anticipate this balance will provide us with a cash one way 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 in a capital efficient manner. Our team continues to be very productive under a hybrid operating model. Speaker 200:13:50This hybrid model also removes geographic restrictions to our hiring initiatives, which has given us the ability to recruit extremely high caliber team members that otherwise might not be available. We currently have 21 employees 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 over to Pana for an update on some of our development programs. Pana? Speaker 100:14:24Thank you, David. This past quarter, we launched another first in human Phase 1 program with LP284, a novel synthetically lethal small molecule in refractory non Hodgkin's lymphomas and sarcomas where there is a significant patient need for improved therapies. As I mentioned on our Q2 call, we had planned to launch this trial here in Q4, and that's our current we're on track to do that. So we've launched both 184 and 284, 1 quarter after another, which is what we had talked about earlier this year. Now, 284 can work effectively both as monotherapy or in combination with other standard of care agents. Speaker 100:15:09But finding these But computational approaches are increasing their ability to predict meaningful and clinically relevant combination regimens for cancer. And our team continues to increase the value of our platform in this regard. And it helps us sharpen the focus of our existing clinical drug candidates to very specific populations. With 284, we're able to understand that advanced non Hodgkin's lymphoma cancer subtypes with DNA damage response deficiency, notably those with compromised functioning of the ATM gene, the ataxia of the ATM gene can cause a tremendous amount of sensitivity to our drug agent. In the U. Speaker 100:15:59S, Europe, of the largest B cell lymphomas are diagnosed in about 16,000 to 20,000 patients each year and have an estimated annual market potential of about $3,000,000,000 to $4,000,000,000 We also saw with this drug candidate that in PDX models of high grade B cell lymphomas, LP284 showed synergistic and significantly enhanced of anti cancer activity when used in combination with rituximab. In vivo PDX models, the synergy of rituximab with our drug LP284 of 63% more effective in destroying high grade B cell lymphomas than rituximab alone. When we put 2 84 on rituximab, we had 93% tumor growth inhibition, whereas rituximab alone only had 57%. So as many of you probably know, rituximab is a standard of care approved therapy in a wide range of B cell cancers and non Hodgkin's lymphomas. We plan on releasing additional details on this data and on the set of results in the coming month. Speaker 100:17:03Nearly all mantle cell, DHL and of high grade B cell lymphoma patients relapse from the current standard of care agent, and we believe there is an urgent and unmet need to introduce this drug either as monotherapy of 1 combination in the relapse and refractory setting for this patient group. Moving on to 184, we discussed that we dosed the first patient in the Phase 1a clinical trial. Of the first in human Phase 1 basket trial across multiple solid tumor indications. We think this the market potential for this drug is quite significant. Since 20% to 25% of solid tumors have DNA damage repair deficiency and the majority of them become refractory of the most recent study in the study. Speaker 100:17:52This trial is anticipated to enroll patients that have relapsed refractory advanced solid tumors such as pancreatic, of the U. S. And multiple other solid tumors, including GBM and brain cancers. The Lantron expects to continue Phase 1 enrollment throughout of the most recent sites and patients and potentially finish the first two cohorts of patients and also have a number of major centers like Fox Chase and Johns Hopkins Medicine and USC also joined the trial. The dosage and safety data obtained in this trial will be used to advance the central nervous system trials central nervous system cancer trials for future Phase 2 to be sponsored by Lantern's wholly owned subsidiary Starlight Therapeutics. Speaker 100:18:36Globally, the aggregate annual market potential of LP-one hundred and eighty four target indication so far is in excess of $11,000,000,000 consisting of about $4,500,000,000 to $5,500,000 plus for CNS cancers and well over $6,000,000,000 for solid tumors. So you can see why we're very excited about this drug as a potential blockbuster across multiple tumors. As we mentioned, our drug LP300 in a previous multicenter Phase III clinical trial, a subset of never of smokers and non small cell lung cancer patients who received that drug with chemotherapy showed an increased overall of survival of 91% and an increase in 2 year survival of 125%, respectively. This is compared to patients who only received the chemo doublet alone. Now we're doing that currently in a 90 patient Phase II trial and we continue to expand into multiple sites. Speaker 100:19:33Doctor. Joseph Treat, who has been appointed the lead principal investigator of the HARMONIX study. Doctor. Treat is a leading expert in lung malignancies, including non small cell lung cancer and never smokers. Additionally, he has specific experience with many Asian collaborators where this is significant where this population of the most important milestones we've seen in the past. Speaker 100:19:55So we're advancing the trial, the HARMONIC trial into Asia, specifically Taiwan, Japan and South Korea, where there's a higher incidence of never smokers in non small cell lung cancer, about double or higher than that of patients in the U. S, 32% to 35% plus. And these are largely driven by pointed and subtle mutations in EGFR or other kinases. So as I mentioned earlier in our call, we'll be sharing our preliminary work in the ADC category. This work has been accomplished in the last 6 months at a very and answer session. Speaker 100:20:40We've had very good results with our initial ADC designs and believe the cryptophycin lin conjugate has of picomolar IC50 values across multiple cancers. We've zeroed in on 5 or 6. Again, we'll be talking more about the detailed update of this program and how this program will expand. We'll plan on that update for all the investors and analysts in January of 2024. Of this past quarter, we had 2 major presentations. Speaker 100:21:07Presentations like this are important because they help highlight why we're excited about the molecules and how we're derisking them and how we're thinking about development. It also generates interest among the pharma community. So for 2 eighty four, we presented at Soho 2023. We talked about the drug having tremendous efficacy in B cell cancers, which are normally non Hodgkin's lymphomas that have what's called homologous repair deficiency. This allows us then after the Phase I to perhaps serve in on of HRD focused B cell cancers. Speaker 100:21:43For 184, we presented at a joint ASCO SNOW conference showing how the molecule is activated in certain high expressing PTGR brain cancers in both adult and pediatric and it completely inhibits or kills off the cancer cells. So again, we'll take that to not only pharma companies, but also to sites that have expressed an interest. And we believe these kind of posters and presentations and data are important to help us better understand where we can point the drug to get the most effective way to market And during this coming quarter, next week in November 17, we'll continue driving awareness for our data in our platform. We'll be presenting at Society of Neuro Oncology with our to the FDA. Our next Doctor. Speaker 100:22:32John Latera is Director at the Brain Cancer Program at Johns Hopkins. Now the MGMT status is very important since by 50% to of the most important and most important and most important. This means that they either don't respond or to the current standard of care temzolomide. And that's not only in GBM, but also in many other high grade gliomas and brain cancers. On December 1, we'll be presenting at the Bengaluru Tech Summit in India on our AI platform and how we're building a future forward pharma labeled as Pharma 4.0. Speaker 100:23:08And on December 5 in Boston and at the CNS Drug Delivery Summit, we'll be presenting on how we're leveraging our AI to accelerate the development of drug candidates for CNS and brain cancers, specifically how we believe we can save 100 of 1,000 or 1,000,000 of dollars through our algorithms, which can predict the blood brain barrier permeability of any compound with 92% to 95% accuracy. Moving on to radar, we continue to advance the platform in size, scope and capabilities, and we believe it continues progressing towards becoming a potential standard for AI driven drug development in oncology for both early stage development and later stage patient biomarker of the most recent data points. We project to reach over $50,000,000,000 by the end of this year. And the scope of Raider's data has broadened with a strategic focus on additional classes of compounds, including antibodies, checkpoint inhibitors and DNA damaging agents and also additional data from clinical studies such as from liquid biopsy and combination studies. So, this data is really important because it helps us define drug interaction and optimal dosage. Speaker 100:24:19Of the key components of the platform. Now these data points and the associated advancements in automation on the platform, along with algorithms and code comprise a functional module and have advanced radars drug development capabilities. The Key modules that are being advanced right now are for predicting patient response and identifying optimal combination regimens for immuno oncology drugs, Such as mean checkpoint inhibitors, which compromise well on close to $30,000,000,000 plus in sales and also then predicting the blood brain barrier permeability of any molecule with 90 plus to 94% accuracy and doing that at a of scale and speed that allows the analysis of tens of thousands of compounds a day. And we also are continuing to advance our ADC template or ADC module for generating drug conjugate templates for the next generation of the ADCs. We expect to have additional data and perhaps posters and papers out on the ADC module. Speaker 100:25:21These three modules exemplify the type of rapid and meaningful progress the RADAR platform is expected to make by the end of this year and over the next several quarters. And we think these can become really a hallmark, but almost a backbone for oncology drug development for of many companies. And one of our primary focus during the second half of twenty twenty three has been to further accelerate the enrollment of the HARMONIC trial and also position ourselves within the patient advocacy community to drive improved awareness and enrollment in our trials for LP300, LP184, LP284. To the Q2 with groups from GBM awareness, lung cancer advocacy, and these have generated interest in our trials and are generating an enthusiastic groundswell of interest in participating with our drugs at specific trial sites. We also have an upcoming ATRT rally where our Head of Clinical Development will be speaking for an ultra rare brain cancer, ATRT, and it's a pediatric indication that we plan on pursuing through STARLIGHT, where our molecule has shown tremendous efficacy in preclinical models, specifically in ATRT since that was an insight driven from our AI platform, of proven in the lab and now also allowing us to gain a rare pediatric disease voucher. Speaker 100:26:44So 2023 is shaping into being a pivotal year where are now entering into patients and have started their journey to becoming meaningful therapies in cancer. Our collective efforts and dedication have fostered a transformational shift for our company, setting us on an exciting trajectory towards the future where we are improving the lives of cancer patients with effective and affordable targeted treatment options. In closing, I want to express my deep gratitude to our team, our partners and our stakeholders for their unwavering support. Together, we're really lighting the to the right way towards a brighter future in oncology and solving real world problems with our proprietary AI platform that is enabling the rapid development of genomically of targeted therapeutics and these are the ones that will alter the costs and timelines and drug discovery and place us at the forefront of a new era in cancer therapy and cancer medicine. Now with that, I'd like to open up the call to some questions or clarifications. Speaker 100:27:59Yes. We've got a couple of questions already teed up, which is great. We'll go first question from John. His question, I'll repeat it. As you move past of the Phase I trial for LP-one hundred and eighty four, do you anticipate refining the indication? Speaker 100:28:16What will guide efforts to narrow it down? Well, it's a great question. We will be taking liquid biopsy from the patients in Phase 1 and obviously some other PKPD data as well. And we think that will help us refine it. And since it is a basket trial, we do expect there to be a range of response. Speaker 100:28:31And that also will help us guide. Is there new higher levels of PTGR1 or does of a bigger genomic signature for homologous repair deficiency or nucleotide excision deficiency mean better response? Are we getting a muted response in certain cancers versus a higher response in others? But yes, the Phase 1 data, since it's a basket design. We allow all solid tumors that are refractory. Speaker 100:28:55We'll be obviously doing a lot of biomarker work on the what's called FFPE slides and also on liquid biopsy. So, yes, this will be very data heavy even in Phase 1. Thank you. The second question, could you provide I'll read the question, it just came in. Could you provide guidance for when you expect to share initial data from HARMONIK Phase 1 studies for LP-one hundred and eighty four and two eighty four? Speaker 100:29:26So just for clarification, Harmonic is in Phase 2. We expect to have perhaps some initial data in the first half of next of we expect that once we reach what's called 27 events, which we hope to reach by the end of next year, that we'll be able to give of data. Now of course, it could happen a lot sooner and so it will we could have 1 or 2 readouts for Harmonic next year. For Phase 1 LP-one hundred and eighty four, I expect that to be definitely in the first half of the year. And then as I mentioned earlier, LP-two eighty four is about a quarter behind that. Speaker 100:30:01So I expect data in Q1, Q2 and throughout the year, but definitely Q2, Q3 and Q4. Another question. Wow, we got a lot of great questions. This is regard to the ADC program. So in terms of the ADC program, we will be refining of some of the indications. Speaker 100:30:26We'll be sharing the data in January. So we'll talk a little bit about the timing for 2024. So we expect that of IND application to be in 'twenty four or early 'twenty five really depends on how quickly we can manufacture and get a clarity on manufacturing at GMP level. That's going to be the key driver. We think we have a super potent molecule. Speaker 100:30:48We think there's no other design like it with the cryptophycin. So we believe that it's novel and can extend to many other cancers. For us, it's really going to come down to manufacturing it. And there are some things that we're looking at that will potentially really shorten the manufacturing of the ADC, including, again, I'm stealing from the January, but we'll talk also about synthetic nanobodies that can take on the form and function of an antibody, But are easier and cheaper to manufacture. And so this might be one of the very first kind of synthetic fragment nanobody drug conjugate. Speaker 100:31:27Yes, good question. So for 184another question on 184 and 284. On 184 and 284, The question is, can you please this is from another John Heerdenck. Can you please discuss the timing of the potential Hello, John. Can you please discuss the timing potential readouts? Speaker 100:31:46Yes. So since 184 just started this past quarter, we have That designed in what's called cohorts of 3. So you have 3 patients that you dose the first level 2. And then if we see everything Green light, we go to the 2nd cohort, that's 3. And we do these cohorts of 3. Speaker 100:32:06We think about cohort 34, Maybe 5 will start seeing some really good signals. And we'll continue basically advancing the cohorts till we get to a maximum tolerated dose, and then same with 284. 284 is about a quarter behind that. But the cohort design for the first two cohorts in 284 are a little different. Those are designed as cohorts of 1. Speaker 100:32:38And so we'll be able to get through the first two cohorts pretty quickly and then take cohort 3, of just 3 patients. So again, in both, I think they're a quarter behind one another cohort. The 284 could Speed up because we plan on some outbound activity with the lymphoma community, so maybe that will help us. Again, these are fairly focused trials. We expect to see hopefully some signals as well. Speaker 100:33:00But I'm looking at Q2 and Q3 for those particular trials for 184 and 284. And if not earlier, then we'll start obviously in parallel of some partnering discussions as well. Thank you. Some more questions via e mail that we'll be talking about. One is about Starlight. Speaker 100:33:43Yes. So is our goal for Starlight, the reason we went after Starlight is when we 1st started looking at where LP-one hundred and eighty four could be pointed at best, in our AI platform, we came back with a signal for CNS cancers. Now we had kind of weren't thinking about that because we thought other solid tumors would be exceptionally more sensitive. And we didn't know enough about the blood brain barrier permeability of the molecule at the time, which is why we started creating the algorithms and now which are top in the world for that purpose. And so we realized once we got the data and signals for GBM that there's dozens and as I found out later, 120 plus other of brain cancers. Speaker 100:34:28So we sucked in all the data as we possibly could. I think in 1 quarter, we sucked in like almost $1,500,000,000 or something. And these are wide large scale genomic biomarker drug sensitivity studies. We normalize that data as quickly as we could. And Just mutation data, it was also epigenomic data. Speaker 100:34:45And we discovered that there were another wide range, other Brain cancers, secondary and primary, the drug was active in. As we went to lab to see if those in silico concepts made sense, Many of them were right on. In fact, we're even more sensitive. And so that led us to the insight that, wow, we have a lot of opportunity across of a wide range of neuro oncology. We shared that data with key thought leaders and KOLs. Speaker 100:35:14And we also published at Society of Neuro Oncology of the last 2 years and we got a lot of interest from pharmas and we realized that this is a massive market opportunity. This is exactly what we want to do is we want to change the pace of finding these kinds of insights and then generating value for patients and value for investors and generating new medicines. And so the The Starlight opportunity really took on kind of a life of its own. It went from one indication to like 5, 6, 7 indications, which obviously we can't do as one company. And since there's a lot of commercial need for patients and there's a lot of pharma of interest to develop a neuro oncology franchise. Speaker 100:35:53We think that there's interest in Anewco. And and this could be one of the very first NUCOs that spun out directly as a result of AI driven drug development. And so Starlight we'll get drug product potentially obviously just from us. We'll have a license to pursue neuro oncology indications. They won't have to worry about an AI platform and growing it. Speaker 100:36:13They won't have to worry about a lot of some of the fundamental drug product infrastructure and CMC questions. And so they'll be purely focused on execution in the CNS trials, which is great. And so we think we can make exceptional progress if we get standalone management team focused on that and fund it. So we're very excited about it. We get fairly very good and unique positive feedback. Speaker 100:36:36And for us, that's a Q1 event to raise some funding around that early part of next year, Q1, Q2, and then launch the Phase II trial for multiple indications in GBM and potentially brain mets in Q2, Q3. So, yes, very good question. I think there's any one more. Yes. So a couple more questions have come in. Speaker 100:37:04I'll take these. So a question during the Q3 of 2023, of the largest and largest companies in the world. Lantern filed 4 new patent applications relating to breast, liver and blood cancers and an additional application directed to the of lyophilized formulation for these molecules. And where does our patent portfolio sit today? David, would you like to take that? Speaker 100:37:28Sure, sure. Speaker 200:37:30We have an aggregate of over 95 issued patents and pending patent applications. We have strong patent position in each of our of lead product candidate areas. For LP-three hundred, we have claims extending into at least 2,032. For LP-one hundred and eighty four, we have claims extending into at least 2,041. And for 2,84, we have claims extending into at least of 2,039. Speaker 200:38:01I think one very interesting thing we've seen with our radar platform is that it's also a great of new insights that you can then use to further expand your IP position. And we expect to continue that. So we are of actively filing as you saw we described what we did in Q3. We will be actively filing and further building our IP position in coming quarters as Speaker 100:38:30well. Thanks, David. Another question we have from Sean. Sean, thanks for your question. His question, what are your expectations around the pace of radar data accumulation in 2024 as you look beyond the 50,000,000,000 data points anticipated by end of 2023. Speaker 100:38:51A really good question. It's a very exciting question. Well, I think we'll have of the top sometime in January or maybe early February, specifically around our radar platform. But I think we'll probably pass $50,000,000,000 in the next month or 2 easily. And we're developing internal goals, but we're thinking kind of a 3x to 4x increase for next year. Speaker 100:39:20So we're looking at we'll probably easily get to $100,000,000,000 so we'll double that number, maybe get to $150,000,000,000 $200,000,000,000 A lot of this is going to depend on how What the quality of data sets are, we have a couple of initiatives internally, again, we'll talk about them later, around engineered data sets and extracting data from data that's already available. 2nd, we're also thinking about scraping, doing large scale automated scraping from The right kind of quality publications. And we're also looking at better and automated feeds from of the existing more enlightened publications and systems that are doing machine readable data format, machine ready kind of data extractions like in through JSON files or other kind of configurations. So we have a number of things. I think we're going to crush that $50,000,000,000 number next year. Speaker 100:40:25I think it could be of at least 2 or maybe up to 4 times that. But yes, it's a great question. And more importantly, it's not just the data, it's really the of normalization and curation of the data and then of course the algorithms so you can make sense to all that data. Thank you. Well, with that, I'd like to thank everyone for participating. Speaker 100:40:47I know we had a lot of really good questions. And There being no further questions, we'd like to conclude today's call. Thank you. Thanks, everybody.Read morePowered by