Lantern Pharma Inc. (NASDAQ:LTRN) Q3 2024 Earnings Call Transcript

Lantern Pharma Inc. (NASDAQ:LTRN) Q3 2024 Earnings Call Transcript November 8, 2024

Operator: Good afternoon, and welcome to our Third 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 third quarter ended September 30, 2024. A copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slide’s management will 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 31, 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, November 7, 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, Panna Sharma, and members of management. Panna will start things off with introductions and an overview of Lantern’s strategy and business model, and highlight recent achievements in our operations followed by discussions of our financial results and our R&D efforts. I’d now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.

Panna Sharma: Good afternoon, and thank you for joining Lantern Pharma’s third quarter 2024 earnings call. Today, I’ll share our continued progress advancing our AI guided clinical programs and discuss our financial results. The pharmaceutical industry is experiencing a fundamental transformation. AI and computational approaches are no longer optional tools. They have become essential drivers of innovation across the entire drug development spectrum. From molecular design to patient selection, from manufacturing to clinical trial execution, AI is revolutionizing how we develop life changing therapies. Lantern has been at the forefront of this transformation. Since our IPO in 2020, RADR AI platform has enabled us to generate and advance 14 drug programs at a fraction of the cost of traditional drug development.

More importantly, we’ve demonstrated the ability to consistently progress these AI guided candidates into actual patient trial, something very few other AI companies have done, including our ongoing Phase II Harmonic trial and our Phase I programs for both LP-184 and LP-284. This quarter validates our AI-driven approach with significant clinical progress across multiple programs, including encouraging early data from our Harmonic trial and the recent FDA Fast Track designation for LP-184 in glioblastoma. These achievements underscore how our technology-first approach is accelerating the development of precision cancer therapies, while maintaining capital efficiency. Our dedicated teams remain laser-focused on our mission to transform cancer patients’ lives, while dramatically reducing the time and cost of oncology drug development, a commitment that drives every aspect of our work and is reflected in the momentum we’re building across our pipeline.

Q&A Session

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 and data-first approach to drug development. Let me start with a high-level view of our clinical progress. We currently have three precision oncology drug candidates advancing through clinical trials, all guided by our radar AI platform. These include both Phase I and Phase II programs. And alongside these clinical programs, we’re evaluating several promising ADC candidates in preclinical development, many of which have come from our AI-driven ADC module. I’m particularly excited to share updates on our Harmonic trial, which is testing LP-300.

The initial data has been very encouraging, and we detailed that in our last earnings call. In our first seven patients, we saw an 86% clinical benefit rate. To put this in perspective, these are never smoker patients with non-small cell lung cancer who have limited treatment options. So, these early signals are particularly meaningful, especially since they cover a wide range of prior kinase mutations. We continue to enroll additional patients across our U.S. sites, but also, we’ve made significant strides in expanding our MARTA trial into Asia, specifically Japan and Taiwan. This expansion is strategically important because in these countries, never smoker lung cancer represents a much larger portion of all lung cancer cases, about one third of new cases compared to what we see in Western countries, which is about 15% to 20%.

We’re establishing a total of 10 sites across Japan and Taiwan, five in each country. We’ve actually already begun onboarding the sites, and we expect patients to enroll this quarter. This expansion not only accelerates our enrollment in the trial overall but also positions LP-300 in regions where the medical need is particularly high. Now let me turn to our synthetic lethal drug candidates, LP-184 and LP-284. Both are first in human Phase Ia trials, and they continue to show strong progress and are enrolling across centers in the U.S. We’ve now dosed over 50 patients across both programs. And importantly, we haven’t observed any dose limiting toxicities in any of our patient cohorts. This safety profile is particularly encouraging as we advance these programs clinically and sharpen the indications and clinical positioning of these highly potent drug candidates.

We also received exciting news this quarter regarding LP-184, which many of you know will be developed as STAR-1 in CNS and brain cancer indications through our wholly-owned subsidiary, Starlight Therapeutics. The FDA granted us fast-track designation for glioblastoma or GBM. This designation not only demonstrates the significant unmet need in GBM, but also provides potential opportunities to expedite development and drive greater commercial value for our molecule.Speaking of GBM, we’ve been successfully enrolling recurrent GBM patients in our existing Phase I, a trial for LP-184, across three sites, two prestigious academic centers, including Johns Hopkins Medicine and Indiana University and one community site.The data we’re gathering from these GBM patients is particularly valuable as it will inform our development for future clinical trials, including Phase Ib two trials, which Starlight Therapeutics expects to initiate in 2025 or any investigator-led initiatives that we undertake.

This represents a significant step forward in our CNS cancer program where effective treatment options are severely limited. At the same time, investors in Lantern will potentially benefit as we look to further develop and finance Starlight Therapeutics. I’d like to highlight now some particularly exciting opportunities, developments in our biomarker program. As many of you know, PTGR1 was initially identified through our radar AI platform as a key biomarker for LP-184 response. This discovery represents one of our platform’s most significant predictive insights, demonstrating how AI can identify precise biological mechanisms that drive drug response.We’ve now begun PTGR1 expression using qPCR in patient samples from our first seven cohorts in the LP-184 Phase Ia trial.

This analysis is crucial because it will help validate our AI driven hypothesis that has been validated in vitro and in vivo and also through CRISPR experimentation, but now we can also validate it in human clinical trials. This data will allow us to better predict which patients are most likely to respond to treatment and perhaps even look at monitoring progress and sensitivity to our drug. We also received very important regulatory recognition this quarter with three new FDA rare pediatric designations for LP-184. This is in addition to the existing one for ATRT. The three new designations were all in ultrarare childhood cancers. These designations are particularly significant because each one carries the potential to receive a priority review voucher, or PRV upon FDA approval.For those who may not be familiar with PRVs, they are transferrable assets that can be sold to other pharmaceutical companies and have historically been valued in excess of $100 million.

We have four of these, each PRV allows its holder to accelerate FDA review of a future drug candidate, making them highly valuable assets in the biopharma industry.The fact that LP-184 has received these designations not only underscores its potential impact in areas of high unmet need amongst children, but particularly where these treatment options are often limited or have no options. This is valuable for patients, but also potentially valuable as future value for our shareholders and our future programs.Our scientific team has been particularly productive this quarter. With three significant publications and presentations, and numerous insights about how to guide our drug into future combination trials. Our Chief Scientific Officer, Doctor Kishor Bhatia, will provide additional details around these and other areas that will be important for our future work.This past quarter, we published a peer-reviewed paper highlighting our novel AI-powered approach to ADC development using the RADR platform, an area of growing interest in the oncology community.

We also presented new findings about our synthetic lethal drug candidate at two major conferences, the immuno-oncology summit, where we shared exciting data about the role of LP-184 in synergy with anti PD1 drugs and at the Society of Hematological Oncology, where we presented insights regarding LP-284. These presentations generated significant interest from collaborators, pharma companies and also helped strengthen our AI driven approach to drug development by giving us insights, models and new data. We’ll also get more details today from my colleague, David Margrave, our CFO, today on our financial position and operations. At a top level, Lantern closed the quarter with approximately $28.1 million in cash, cash equivalents and marketable securities, and we used approximately $4.5 million in operations this past third quarter.

So, I’m going to hand this over now to David to talk in more detail about our finance and operations. David?

David Margrave : Thank you, Panna, and good afternoon, everyone. I will now share some financial highlights from our third quarter ended September 30, 2024. We recorded a net loss of approximately $4.5 million for the third quarter of 2024 or $0.42 per share compared to a net loss of approximately $3.2 million or $0.29 per share for the third quarter of 2023. For the third quarter of 2024, our R&D expenses were approximately $3.7 million up from approximately $2.2 million for the third quarter of 2023. This increase was largely driven by an increase in clinical trial activity. Our general and administrative expenses for the third quarter of 2024 were approximately $1.5 million up slightly from approximately $1.3 million for the third quarter of 2023.

The increase was primarily attributable to increases in professional fees and increased patent and legal fees. Our R&D expenses continue to exceed our G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Our loss from operations in the third quarter of 2024 was partially offset by interest income and other income net totaling approximately $674,000 as compared to a loss offset from interest income and other income net of approximately $362,000 for the third quarter of 2023. Our cash position, which includes cash equivalents and marketable securities, was approximately $28.1 million as of September 30, 2024. We anticipate this balance will provide us with a cash runway into at least late 2025.

Importantly, we believe our solid financial position will fuel continued growth and evolution of our Radar AR platform, continue 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 September 30, 2024, we had 10,784,725 shares of common stock outstanding, outstanding warrants to purchase 70,000 shares and outstanding options to purchase 1,274,546 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 12.1 million shares as of September 30, 2024. Our team at Lantern continues to be very productive under a hybrid operating model.

We currently have approximately 24 employees and four FTE consultants focused primarily on leading and advancing our research and drug development efforts.Many of the initial observations made with the help of RADR are now being brought forth into the clinic as you can see in our portfolio slide, that’s being presented. As many of you know, RADR has guided the rapid and efficient development of three AI-guided drug candidates into ongoing clinical trials. As these clinical trials mature and continue to enroll patients, we expect to leverage our internal clinical operations capabilities across these trials and functions, making efficient use of our capital while lowering dependency on external higher-cost providers.Additionally, we believe having more direct internal ownership not only reduces our overall financial expenditures, but also gives our team greater ownership, control and access to current information, sites and day to day activity in the hospitals and cancer centers relating to our trials.

This, we believe, will strengthen our company and allow us to capitalize on observations and decrease our external costs.We are fortunate to have developed a dedicated, highly motivated clinical operations team with alignment around our core values to help us in the efficient management and maturation of these clinical trials across LP-300, both in the US and Asia, and our first in human drug candidates. LP-184 and LP-284.

Panna Sharma: Thanks, David. We also continue to make significant progress on the launch of our clinical stage CNS and brain cancer focused subsidiary, Starlight Therapeutics. This is a company that has been largely developed as a result of big data and AI. The methods and computational approaches to uncover the indications and optimize the use of LP-184 for brain and CNS cancers.Notably, we have started initiating site selection for the upcoming Phase Ib and Phase II trials, especially in recurrent IDH wild type-high grade gliomas like GBM. And are also in discussions for the use of the drug in potentially settings.If you have not reviewed our webinar on our reviewed our Webinar Wednesdays regarding Starlight, I would definitely urge you all to listen to the webinars.

They provide details on the timing and focus of the trials and also provide insights from Doctor Mark Chamberlain about how we expect to advance this both in adult and pediatric brain cancers. I’d like to take a moment to emphasize two significant recent developments that further validate our CNS cancer program. First, the FDA’s Fast Track designation for LP-184, in glioblastoma represents a crucial milestone. This designation is particularly meaningful because it recognizes both the serious nature of GBM and the significant unmet medical need. We have seen a new effective single-agent therapy approved for GBM in nearly 20 years. Fast track status provides us several important advantages, including more frequent interactions with the FDA, the potential for rolling review of our future NDA and if criteria are met, could lead to accelerated approval and priority review.

These benefits could potentially shave years off our development time line in GBM and make the asset significantly more valuable in the hands of a larger biopharma partner. Equally exciting is the formation of Starlight Therapeutics Scientific Advisory Board, which brings together some of the most respected minds in neuro oncology. Let me share with you the distinguished members who have joined us, Dr. Mitchell Berger — Mitch Berger from UCSF who chairs their department of neurosurgery and directs both their Brain Tumor Center and Center for Neurological Injury and Repair. Dr. Berger is internationally recognized for his expertise in brain mapping during tumor surgery. Dr. Lisa DeAngelis, who serves as Chief Physician Executive at Memorial Sloan Kettering Cancer Center, where she oversees all clinical operations across their network of sites.

She’s an internationally recognized expert in brain cancer and helped establish Memorial Sloan Kettering’s Brain Tumor Center. Dr. Stuart Grossman from Johns Hopkins and Kimbell Sidney Kimmel Cancer Center, who co leads their brain cancer program and brings over 22 years of experience directing NCI Funded Brain Tumor Consortia and lastly, but definitely not least and in the least, Dr. John Latera, also from Johns Hopkins, who codirects their brain cancer program and is internationally recognized for his work on mechanisms of brain tumor malignancy. Dr. Latera has been an early supporter and has encouraged us to pursue this indication and has helped our research efforts and continues to help guide combination regimen ideas that we think will be significant in the clinical setting.

My colleague, Dr. Kishore Bhatia, will discuss those later today in our webinar. The Starlight Advisory Board, which includes two recipients of the Society for Neuro Oncology’s Lifetime Achievement Award, brings unprecedented expertise to guide our CNS cancer programs. Their willingness to join our advisory board speaks volumes about the potential they see in our approach to treating these devastating cancers. Let me walk you through some of our progress now with the synthetic lethal drug candidates LP-184 and LP-284. The Phase 1a basket trial for LP-184, we’ve now completed nine cohorts with escalating doses. We haven’t seen any dose limiting toxicities. We’re actively enrolling patients across multiple solid tumor types, including those that have high PTGR1 like triple negative, GBM and pancreatic cancer, and now we’re zeroed in on tumors that have DNA damage response deficiency.

Based on our pharmacokinetic analysis, we’re approaching an exciting milestone. Our upcoming cohort should reach dosage levels where we expect to see therapeutic concentrations of our drug candidate LP-184 and, hopefully, impact on the cancers. We anticipate completing enrollment by year end or in January with initial safety and molecular correlation data expected either late this year or during early 2025. I’m particularly excited about our progress in developing a companion diagnostic for LP-184. We’re advancing a quantitative PCR-based test that could help us identify the patients most likely to respond to treatment, ones that have PTGR-1 above a certain threshold, which is a key aspect of our precision medicine approach. We’re currently validating this assay using patient samples, but also now using them in the first seven cohorts in the Phase 1a trial.

These molecular correlations will that will be invaluable in designing our future trials and helping us select patients. The combination of clinical progress and diagnostic development exemplifies our comprehensive approach to drug development where we’re not just advancing a therapeutic candidate, but also developing the tools to identify the right patients for treatment.Turning to our LP-284 program, which targets hematologic cancers, we’re making equally exciting progress. We’re currently dosing our fourth cohort, again in escalating doses in the Phase Ia trial. And like 184, we’re seeing favorable safety profile with no dose limiting toxicities.Let me highlight why we’re excited about 284. Remarkable potency in the nanomolar range for multiple blood cancer types, but specifically in mantle cell and double hit lymphomas, both very aggressive NHL subtypes, particularly those that have ATM mutations.

To put this opportunity in perspective, we’re targeting an area of significant nearly all mantle cell and double hit lymphoma patients and in general high grade B cell lymphomas, again we received two orphan designations for this drug, eventually relapse after current standard treatments.The market opportunity is substantial in the US and Europe alone, about 16,000 to 20,000 new patients annually, about a market exceeding somewhere in the range of $2.8 billion to $3 billion just in US and Europe alone. We’re now in the process of expanding our trial to additional hematology focused sites, which we expect will accelerate our enrollment through the end of this year. Based on our current trajectory, we believe we can advance to Phase Ib, or future phases like Phase II by early to mid- 2025.When we look at both LP-184 and 284 together, these are sister molecules.

We’re seeing consistent patterns that validate our synthetic lethal approach, strong safety profiles, encouraging signs of biological activity, and the potential to address significant unmet cancers where oftentimes there is no cure in the later stage setting. So, these are very exciting. This kind of excitement has helped us do one very important thing, which is secure 11 FDA designations, fast track designations, orphan drug designations and rare pediatric disease designations. This is a strong testament to our data driven, rapid and focused drug development initiatives. We believe this will aid in more frequent guidance and interaction with the FDA, and also strengthen our commercial value in talks with partners and clinicians during adoption.

With Harmonic Trial, LP-300, the data has been very encouraging. And more importantly, this is for patients where there is no real treatment options today. After they failed kinase therapy, there are very limited treatment options. So, these early signals though in a small group are particularly meaningful. We also see a diverse set of patients in the US with a varying range of kinase mutations and also with low to intermediate tumor mutation burden. We should have some interesting implications for biomarker-based selection or monitoring as we mature the drug candidate. We continue to enroll patients across our US sites, and are also expanding into Asia and Japan and Taiwan, as I’ve stated earlier. In East Asia, including Taiwan, Japan and South Korea, nearly 40% of new cases now in non-small cell lung cancer are amongst ever smokers.

This is a remarkable percentage and underscores our commitment to expand the Harmonic Trail to where it’s needed in these countries. We’re opening up 10 sites in Asia, 5 in Japan, 5 in Taiwan, and very importantly working closely with the top KOLs in each country. Doctor, Goto at the National Cancer Center Japan in Tokyo, and Doctor Li at the National Tengkang University Hospital located in Tainan City in Taiwan. In the majority of East Asia, EGFR mutations comprise a significant and overwhelming percentage of the targetable kinase mutations among ever smokers. We’ve already seen some early signs of efficacy in our initial cohort. Now, this is important because we think this represents an important opportunity in Asia where we’ve now begun discussions regarding partnering, licensing or co-development of this asset in that geography.

Now I’ll turn the call over to our Chief Scientific Officer, Kishor Bhatia, who will provide an overview of our R&D updates and speak specifically to a number of highly promising combination regimens for LP-184, ones that have been shaped and informed and guided by Lantern, but now will help shape future clinical trials that will be very meaningful. Kishor?

Kishor Bhatia : Thank you, Panna. As we accrue clinical data and define the MTD in our Phase I clinical trial, we are actively pursuing additional areas of R&D that will contribute to further successes of LP-184. A general consensus that has emerged from collective experiences in oncology has been that successful treatments are most likely to be based upon combination therapeutics rather than monotherapy. With this in mind, we are studying the optimal selection of potential agents to combine with LP-184, which enhance the efficacy of treatment, have little if any overlapping toxicity, as well as expand indications. For the past year, our radar, translational, and clinical teams have addressed these immediate needs. Towards fulfilling these rapidly, we have also engaged with several expert collaborators that are shown in the slide that is being displayed, and these include scientists from MD Anderson, University of Massachusetts Boston, Johns Hopkins, and the University of Texas and Antellium.

Today, I’m going to talk about three distinct LP-184 combinations, two of which are in accelerated protocol development by the clinical team. I won’t have time to show data, but can mention here that new unique combinations for LP-184 are emerging from both RADAR and BEM studies, the latter including CRISPR analysis studies. So, a significant aspect of DNA damage that results from tumor specific PTGR1 HITEN expression for which now we have bioassay, which causes bioactivation of LP-184 in tumor cells is that it ends up in the formation of double strand breaks. When threatened with LP-184, cancer cells therefore need to engage multiple repair factors and pathways beyond transcription coupled nucleotide excision repair. DSPs clearly require the attention of homologous recombination repair pathways.

It was therefore expected that LP-184 demonstrated synthetic lethality in tumors deficient in such pathways, including mutations affecting BRCA 1 and BRCA 2. Such synthetic lethality of LP-184 extends beyond the classical BRCA mutated tumors and also includes tumors with BRCA ness such as those with mutations in additional genes involved in the homologous recombination pathway. What has been surprising has been the evidence that LP-184 synergizes with PARP inhibitors, both in HRD, but also in those HRD tumors that have become PARP inhibitor resistant. This slide shows that fivefold lower doses of LP-184 are sufficient to achieve three to 14-fold greater regression compared to Olaparib alone in tumors mutated either in BRCA1 or BRCA2. I would particularly like to draw your attention to the synergy seen in both tumors with low doses of LP-184.

But if you look at the tumor on the right, which as you can see is resistant to olaparib, it is wiped out by LP-184 at two milligrams per kg. And when you combine Olaparib with less than 1/4 of this LP-184, draws this tumor now loses its refractoriness to PARP inhibitors. The likely success of this potential Is further supported by similar data generated by our independent collaborators at University of Massachusetts, Boston, who also have suggested additional mechanisms involving depletion of RPA as one of the drivers of this synergy.A combination with PARP inhibitors that can make PARP resistant tumors sensitive is therefore a significant advantage for LP-184. We are particularly excited by the potential of such a combination and have developed a protocol to actively test this in Phase Ib clinical trial arm.

There are several reasons why LP-184 might be an exceptional combinatorial agent for PARP inhibitors, which come from understanding the PARP inhibitor resistance factors. This next slide identifies factors that have been discussed to be associated with the resistance to PARP inhibitors. If you specifically look at row three, much of our data suggests that LP-184 effectively combats these factors. Even in the presence of gene conversion, LP-184 has been effective. Loss of shielding complex that allows tumors to become resistant to PARP inhibitors actually makes tumor sensitive to LP-184. Additional insights have been the agnostic feature of LP-184 to SLFN11. Loss of SLFN11 impairs prolonged S phase arrest upon PARP inhibitor exposure, thereby inducing resistance.

But, S phase arrest level SLFN11 loss does not affect sensitivity to LP-184. What this means in practical terms is that when used in combination with PARP inhibitors, LP-184 is highly indicative not only for synergy, but also for reducing the resistance to PARP inhibitors. The other molecule that we are proposing to the clinic as a combinatorial partner of LP-184 is a drug that has extensive clinical experience albeit from non-oncology indications. This drug, spironolactone, is an FDA approved drug used for various indications, including hypertension and acne.What drew us specifically to this drug were multiple observations of which the most important was the serendipitous discovery that spiral electron targets ERCC3 to degrade it. The scientific rationale and reasoning of combining LP-184 with spironolactone was fully justified by a battery of preclinical studies we and our collaborators conducted.In this slide, in the box A, you can see that spironolactone increases sensitivity of GBM cell lines to LP-184, three to six-fold.

What this specifically means is that even in settings where there is lower bioavailability of LP-184, the combination can result in sustained DNA damage as you can see in panel B and that these effects correlate with the significant reduction in the repair protein ERCC3 shown in panel V.Not surprising, therefore, the combination resulted in excellent responses in in vivo glioblastoma models. With most cures, only 1 of 5 tumors showed recurrence to the combination. In order to use this combination clinically, we need to better understand the time window where LP-184 should be administered following spironolactone treatment. So, we carried out several time code studies. In this slide, we demonstrate that ERCC 3 is at its lowest level in both orthotopic and subcutaneous glioblastoma xenograft at 8 hours after spironolactone administration dosed as human equivalent of 200 milligrams per kg.

In addition to glioblastoma, the combination of spironolactone enhances the activity of LP-184 in other select tumor types, including ATRT, pancreatic cancer, and renal cancers. Given the rare pediatric orphan disease designation and the lack of any approved therapy for ATRT, we are particularly enthusiastic of the clinical studies in ATRT and are in active discussions with several pediatric neuro oncology groups, including POETIC and children’s oncology group. I will now shift to the third combination we are exploring, which is combining LP-184 with immune checkpoint inhibitors. We have previously observed during our study of DNA strand breaks, the accumulation of cytogenic DNA in tumor cells following LP-84 treatment. This feature would suggest LP-184 as an immune activating molecule as well.

To test the potential of LP-184 combined with checkpoint inhibitors, we developed a collaboration with doctor Lin at MD Anderson who has previously shown that involvement of replication stress defect correlates with immune response in tumors. So, our thought was could we pharmacologically induce this replication stress response defect and therefore extend the benefits of immune checkpoint inhibitors to wider patient population. We hypothesize therefore that LP-184 treatment might escalate replication stress levels, particularly in TNBC and induce replication stress response effect. As you can see in the slide, when LP-184 cells were assessed for induction of replication stress defect compared to a similar defect induced by what would be expected from the cell cycle checkpoint inhibitor, the results show a 60% of relative defect increase by LP-184 compared to 75% with checkpoint at equimolar doses.

We then tested the effects of a combination of anti PD-1 antibody in combination with LP-184 in a murine syngetic TNBC model. The results shown in this slide evidence enhancement of tumor growth inhibition from 51% in LP-184 alone treated tumors to 72% in the combination. Additional study indicate that LP-184 might actually modulate both the pure microenvironment as well as T cell function. Uniquely, it appeared that LP-184 reduces empty macrophages. Based upon these results, we are now in discussion with various clinical investigators towards development of a clinical study in TNBC cold tumors. Many other rationally designed combinatorial partners are emerging from a radar and CRISPR based analysis such as inhibitors of FEN1 and REV1, but also include molecules that are outside the DNA repair pathways.

One such pathway that I’d particularly like to mention which has emerged as important is the oxidative fotillation pathway. And we hope to share with you in the near future some exciting data with these combinations. And now I’ll turn back to Panna

Panna Sharma: Kishor, thank you very much. As you can see, we’re already turning our attention now to the next phase of clinical development and pathway for our exciting drug LP-184. We know that many of these combinations are with drugs that are a part of the meaningful arsenal in cancer, especially PD-1, anti PD-1 and PARP.And we expect there to be a lot of excitement in the clinical community as there has been so far in the research community. But also, very importantly in the biopharma community given the number of PARPs and their limited range of extended use in some of these tumors and also the same with PD-1. When you have a drug like LP-184, that can widen the therapeutic window and potentially open up new avenues. There should be a lot of excitement and potential for partnering opportunity.Let’s now talk a little bit about Webinar Wednesday.

We’ve had a lot of exciting webinars, about one a month. For those that have not listened in on the backdrop of these webinars or the details. Our last Webinar Wednesday for the year will be held on December 11, not the last Wednesday of November, not the last Wednesday of December, but we know it’s a challenging time. So, we try to pick right the middle of the month. That webinar will focus on the power of AI in drug development, specifically around the use of molecular features to predict blood-brain barrier permeability with RADR. The webinar will discuss also future development plans we have and the potential commercialization and commercial availability of this RADR platform module, which leverages extensive molecular feature analysis enriched with proprietary models and proprietary data.According to the therapeutic data commons, one of our early – sorry according to the therapeutic data commons, a coordinated initiative to access and evaluate artificial intelligence capability across therapeutic modalities.

And across stages of discovery, Lantern’s BBB algorithms are 5 of the top 10 performing algorithms on the leaderboard. So that’s very exciting. That was some of our early algorithms. In fact, they continue to mature and get refined and have actually matured significantly in some of their future discrimination. So, we’re pretty excited to talk about that on December 11 with one of our data scientists who’s been working on those models.As you know, 2024 has been a year of progress, accelerated progress where our insights are impacting patients in their journey to fight cancer and also influencing the development decisions and progress actually of other cancer companies. 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 treatment options.

As you can see, the work being done by Kishore and his team, and also our clinical operations team is focused on meticulous execution but constantly with one hand on the wheel of innovation. During the fourth quarter and into next year, we will have several clinical readouts and milestones to share with our investors as we advance our pipeline and company. As I’ve said before, the golden age of AI in medicine is just beginning. And it is being powered by large scale, highly available computing power, massive data storage, massive data collaborations. And it is being fed by healthcare, patient and cancer data, which is more widely available and at increasing levels of quality, much more so than ever before.Companies that harness these capabilities in the biotech and biopharma arena will be long-term leaders in this biotech or really now becoming more tech bio industry.

And we think these are companies that are well poised to create massive value for patients long-term and ultimately for investors in our industry. I’d like to take a moment right now to personally thank our team for helping to prepare us for these calls, to prepare the materials, gather the data, provide insight, and to their amazing dedication, if it wasn’t for them, we probably would have a very handicap call.

A – Panna Sharma: Regarding LP-300. Yeah, I’ll go ahead and answer, take the first answer to the first question. The first question asked is when do we expect additional data regarding our HARMONIC and LP-300 trial? As we just opened up the sites in Asia, our goal is to gather another 14 patients to 28 patients actively. And for Harmonic, we’ll know a lot more once we see the impact of the trial expansion in Asia and also the data from the planned interim analysis, which will take place at 31 patients. So those two events will really guide us in terms of the next big clinical readout regarding the HARMONIQ trial, and we expect that around mid of next year, if not earlier. But middle of next year is when we’re expecting it. Thank you.

Next question. Repeat the question. Any updates on how Radar is growing and collaboration efforts? Great question. As you know, we announced last quarter, our collaboration with Oregon Therapeutics, which is going very well. We expect the first phase of that collaboration to finalize sometime during the next month, probably before the end of the year, where we will be able to answer several questions and set the framework for some good joint IP in regards to indications and perhaps biomarker signatures that correlate to response for their for their drug, for their PDI inhibitor. We are looking at additional collaborations. As you know, we’ve had three very important ones with emerging biopharma companies. We’re now focused on larger biotech companies, I would say, more midmarket and more, ones with much more diverse portfolios.

So, our attention now is increasingly to larger companies given that the platform has matured quite a bit over the last year and a half. I’ll take the next question coming in the Q&A panel. Can we speak to any partnership interest? Although it’s probably too early to speak to partnership interest for the [Indiscernible] trial, we have gotten some conversation started. Obviously, this is, as I mentioned, from a epidemiological basis, never smokers account for 33% to 40% plus of non-small cell lung cancer cases in East Asia. Again, primarily Japan, Taiwan, and South Korea, many of the major regions in China are similar. But so, you can expect that we’re in discussions with pharma larger pharma companies in Japan now. So that’s very early, but we are receiving interest given the focus and given the prevalence of the disease there.The other thing that I’d like to add is, obviously, we did hint at a biomarker signature correlating to lower intermediate tumor mutation burden.

Now we’re obviously chasing that down clinically. We’ve had very good initial data.We’re looking to support this data as more patients get enrolled, and we understand the tumor mutation burden status of those patients. And that also could mark a very important turning point in terms of interest with all the companies that are going after high tumor mutation burden whereas this is for lower tumor mutation burden. Thank you. Very good question. Next question is on Starlight Therapeutics. As you can see, every quarter, we continue — The next question is about Starlight Therapeutics and the Scientific Advisory Board members. We’re quite thrilled about the decisions for Doctors DeAngelis, Berger, Latera and Grossman to join the Scientific and Clinical Advisory Board, and these guys are among the most preeminent in their field.

And for them to be interested in the drug and the indications, again, speaks volumes of we think of the potential for this very novel site-activated alkylating agent to potentially transform the lives of both pediatric and adult brain cancer patients.My personal feeling, and this is very important, is that we’re making progress each quarter. We’re opening up sites. We’re enrolling patients. We think the biotech market is fundamentally getting stronger. I think there’ll be a lot of interest we’ve had in both private and public financing, and we’ll find the best route to capitalize Starlight independently. So, it can grow and develop its own trials. We believe that the trials for Ib and II, or for some other unique trials should be launched sometime in early 2025 for Starlight.

But in the meantime, we try to maintain a lot of fiscal discipline. And again, those are planned trials. We’ll see how the financing events go. And we try to use a lot of the existing Lantern infrastructure and people to advance Starlight in parallel. So, there’s a lot of work for our team. And again, this work creates a lot of value for our investors long-term. But we think this could be one of several planned spinouts from Lantern where the portfolio is more focused. The portfolio is in a certain modality and is aimed at a certain group of cancers or in a certain population. Very good question. Thank you. With that, we’re coming up against about an hour, 50 minutes into the call, long call today. But I want to thank everyone. We got a good overview of what’s next in the combination trials.Again, we’re very far into the Phase Ia for LP-184, where we expect to get to at MTD in the next few cohorts and that should correlate with what we believe is going to be something we can go into future planned Phase Ib and Phase II planned trials with as well.

And we continue to make very solid progress with our AI platform, both with our collaborators and internally with new functionality, and we now will be expanding rapidly into Asia with our LP-300 trial. Very importantly, as David pointed out, we continue to be very meticulous about execution and cost conscious. We do think that our existing capital and balance sheet allows us to take us through significant events, but we’re watching the markets carefully. If there’s opportunities to partner our assets out or to access the capital markets, we’ll do so if it makes sense. But we’re also very prepared to continue executing. And at the same time, we do think the markets will probably improve, but more importantly, we’ll have opportunities to partner our assets and leverage our capabilities.

Internally, operationally, which is very important, we’ve begun to slowly bring in a very step by step aspects of clinical operations to try to build really a world class ninja team in clinical operations that we can use across our trials and more importantly across the various functions. And we think that gives us a lot of synergy, reduces our external spend, but as David pointed out, brings us closer in contact with our patients, our clinical sites, and our data. So, again, I think we’re doing right things operationally and are very focused on maintaining, kind of the burn rate, in the same range that we have historically. So that, I’d like to thank everyone for their time today, and I want to express my deep gratitude to our team, our partners, and our stakeholders for their support.

And, also, you know, to realize that together, we are really trying to light the way for a brighter, more scalable future in oncology care and in oncology drug development.

Panna Sharma: So, thank you very much for joining us at the forefront of a new era for drug discovery and joining our listening to an aura team that we believe is bringing us to this new era. Thank you. Thank you.