Q2 2024 Lantern Pharma Inc Earnings Call
The year ended December 31st, 2023, which is on file with the SEC and available on our website.
Lantern Pharma: Forward-looking statements made on this conference call are as of today, August 8th, 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.
Lantern Pharma: 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.
Speaker Change: 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 a discussion of the Harmonic Clinical Trial results.
Speaker Change: 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 everyone for joining us to hear about our incredibly productive second quarter of 2024. Today on the call I have our CFO David Margrave and also our Head VP of Clinical Development Dr. Reggie Ewesuedo.
Panna Sharma: I'll begin the call by discussing generally the quarter and then hand it over to David to talk about the financials, and then Reggie and I will discuss the progress with our LP300 clinical trial.
Panna Sharma: As many of you have heard me say in the past, computational and AI driven approaches are increasing their presence and usage at both large and emerging pharma companies for all facets of drug discovery.
Speaker Change: Chemistry, Biology, even now Manufacturing and Patient Selection.
Speaker Change: And at no time has this been more evident than today, where every facet of pharma development, from molecular design to disease modeling,
Speaker Change: is being rethought as a result of the widespread availability of computational capabilities, high-quality data, and improved automation.
Speaker Change: Our company's leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric, data-first approach to drug development.
Speaker Change: Today, we have three active clinical trials with an additional ADC-based preclinical program and a very active approach in identifying and validating combination approaches with our drugs.
Speaker Change: With our Radar AI platform, which is at the forefront of cancer drug development, we expect more activity and opportunities where we can continue to use our AI as currency for collaborations, partnerships, and co-development opportunities.
Speaker Change: We also plan to continue driving the ongoing innovation in our portfolio of drug candidates and drug programs.
Speaker Change: This past quarter was a particularly busy one for Lantern.
Speaker Change: and especially with our clinical operations team.
Speaker Change: as we had a notable initial readout in our Phase 2 harmonic clinical trial where we saw a preliminary but interesting 86% clinical benefit rate in the lead-in patient cohort.
Speaker Change: Our intellectual property also continues to grow globally, and we were awarded a very important patent in Japan directed at our LP-284 drug candidate, which is focused on the treatment of B cell cancers.
Speaker Change: So going back to our clinical trials,
Speaker Change: We have also dosed over 40 patients now in our LP184 and LP284 clinical trials. These are trials that are in phase 1A, and they have not yet seen any dose-limiting toxicities or events, which we will discuss more in depth later in the call.
Speaker Change: Our team has also achieved significant advancement towards a key milestone in the development of a molecular diagnostic for use with our drug candidate LP184.
Speaker Change: We expect to potentially use this diagnostic to improve patient selection and stratification.
Speaker Change: And the novel biomarker is PTGR1, one that we validated extensively, both in the lab, but also in silico. And it was identified through a number of in silico AI-driven screens.
Speaker Change: We also launched a very important strategic drug development collaboration using our AI platform Oregon Therapeutics to optimize the development of a first-in-class drug candidate
Speaker Change: XCE 853, a potent inhibitor of cancer metabolism which we believe can have impact across multiple cancers and has a unique mechanism of action involving proteotoxicity.
Speaker Change: With Starlight Therapeutics, our wholly owned subsidiary, focused on CNS and brain cancers, we advanced towards initiating site selection and feasibility for a Phase I-B Phase II trial in recurrent GBM with drug candidate STAR-001.
Speaker Change: Our team also successfully launched Webinar Wednesdays, a webinar series focusing on the areas of artificial intelligence, oncology drug development, and leveraging our relationships with leading physicians, scientists, and our collaborators.
CFO: We also closed the quarter with approximately $33.3 million in cash, cash equivalents, and marketable securities, which our CFO will talk about later in today's call.
Speaker Change: Many of the initial observations made with the help of radar are now being witnessed in the clinic, as many of you know. Radar has guided the rapid and efficient development of three AI-guided drugs into clinical trials over the past several years at a pace and cost that has traditionally been unheard of in our industry.
CFO: Let me walk you through some of the highlights from our AI-powered pipeline, which is, again, currently in the clinic, before I talk about other aspects of our business.
Speaker Change: Specifically, with LP184, our team and many clinicians are particularly excited about and interested in these programs for first-in-human, synthetically synthetically lethal drug candidates that are acyl-foldings, LP184 and LP284.
CFO: So far, seven cohorts of patients comprised of dose levels 1 through 7 have been enrolled in escalating doses in the ongoing Phase 1a clinical trial for LP184.
CFO: This is a first in human phase one trial across multiple solid tumor indications that are advanced and refractory to the existing standard of care.
CFO: Very exciting for us is there have been no observed dose-limiting toxicities to date.
CFO: Now, we're at the point now in the trial where we expect to reach a dosage level in the coming cohorts where therapeutic concentrations of the drug should be attainable based on our pharmacokinetic and pharmacodynamic analysis.
CFO: It's a mouthful, but all that means is we should start potentially seeing benefit in patients at these cohorts going forward.
Speaker Change: The trial is actively enrolling patients across multiple U.S. centers. These patients are relapsed.
CFO: They're refractory to all existing standard of care typically, and they have advanced solid tumors such as pancreatic cancer, glioblastoma, triple negative breast cancer, and also now increasingly with solid tumor types focused on DNA damage response deficiencies.
Speaker Change: The company believes that enrollment should be complete this year and on track for an initial readout of safety and molecular correlation data by the close of the year.
CFO: The dosage and safety data obtained in the Phase 1A trial for LP184 are expected to be
Speaker Change: to be used to advance the central nervous system indications for the phase 1B and phase 2 trial to be sponsored by Lantern's wholly owned subsidiary Starlight.
CFO: as well as other later phase trials and select tumors that have shown superior responsiveness to 184 and also meet our genomically guided criteria.
CFO: AI and preclinical studies are also ongoing to further refine drug combination studies. Many of you saw the press release from yesterday and this press release supports, at least tend to support, the improvement to durability and response with other FDA approved drugs.
CFO: Specifically, we published on PARP inhibitors earlier this quarter and yesterday in immune checkpoint inhibitors.
CFO: These are two very exciting areas where the combination of our drug with some of the existing approved agents, many of which are multi-billion dollar drugs, actually we feel can benefit patients in certain solid tumors like triple negative breast cancer or others that have DNA repair deficiency.
CFO: Globally, the aggregate annual market potential for LP184's target indications, we believe, is in excess of 10 to 12 billion dollars, consisting of about 4 to 5 billion in CNS cancers and 7 to 8 billion for other solid tumors.
CFO: For ELPT-P284, the third cohort of patients are being dosed.
CFO: and no dose-limiting toxicities have been observed in this Phase 1a trial, and we expect to open additional sites throughout the quarter with the potential to advance to Phase 1b and Phase 2 by the close of this year or early 2025.
CFO: LP284 has shown nanomolar potency.
CFO: across multiple published in vitro and in vivo studies, including mantle cell, double-hit, and other non-Hodgkin's lymphomas, and especially those with DNA damage response deficiency. We published in...
CFO: cancers that had compromised functioning of ATM due to mutations or deletions.
CFO: Now, nearly all MCL, double hits, high grade B-cell lymphoma patients relapse from the current standard of care agents.
CFO: and there's this urgent and unmet need for novel improved therapeutics for these patients. We believe the annual market potential in this group is in excess of three billion dollars.
Speaker Change: We've also begun a review of some notable mechanism of action that we've observed in LP284. And we think we can actually leverage those in other diseases and conditions. Lantern expects to review those preclinical studies and findings later this quarter.
CFO: Our current enrollment efforts are focused on cancer patients with tumors that have what's called DNA damage repair deficiency. They've been observed to have higher sensitivity to 184 and even in some cases 284.
CFO: So DDR genomic alterations are of interest for these trials, and we may consider other genomic alterations based on other emerging data.
CFO: We also continue to make significant progress in 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.
CFO: Because of the billions of data points that we had in our system, we used AI methods to look at specific indications.
CFO: validated those computationally, optimized our understanding, and then took them into studies, wet lab studies, with animals and mice and PDX models, and now we're actually at a point where we can start taking these indications into the clinic.
CFO: Notably, we've also actually started site selection for the upcoming Phase 1b and Phase 2 trials, especially in recurrent IDH wild-type high-grade gliomas like GBM.
CFO: This is very different than the most recent
CFO: approval, which was an IDH mutant. So if you've not reviewed our webinar Wednesday on Starlight with Dr. Mark Chamberlain, I would definitely urge you all to listen to the webinars where we provide a detail of the timing and focus of the trials that we anticipate launching with Starlight.
Speaker Change: Now, the golden age of AI in medicine is just beginning, as witnessed even today by a discussion of today's merger among two big AI companies, Recursion.
Speaker Change: in the U.S. and Excientia in the U.K. And there's a need to really use large-scale, highly available computing power, massive data storage, and the tremendous high-def biology that's available today.
Speaker Change: and that is what we're at the forefront of. But we're also, at Lantern's Way, we're harnessing those capabilities in a way we believe is much more efficient.
CFO: We're going to harness these capabilities.
CFO: in this emerging tech bio-industry and be a long-term leader.
CFO: Not only will we create massive value for patients and also continue to...
CFO: drive innovation, but we're also thoughtful about the economics.
CFO: cancer drug development. It's one of the first reasons many of us joined this company is we wanted to not only make drugs faster but we also wanted to make them smarter and cheaper.
CFO: and Lantern is up among the leaders in this transformation of the pace, the risk, and the cost of oncology drug discovery and development.
CFO: This transformation has a promise not only to make medicines faster, cheaper, and with increased precision for patients, but also to help change the direction of R&T productivity and output in the cancer biopharma industry.
CFO: Now let's turn to our focus, to our financial updates and highlights with David. I'll now turn the call over to our CFO , David Margrave, who'll provide an overview of our quarter's financial results. David. Thank you, Panna, and good afternoon, everyone.
David Margrave: I'll now share some financial highlights from our second quarter ended June 30, 2024.
David Margrave: We recorded a net loss
David Margrave: of approximately $4.96 million for the second quarter of 2024 or $0.46 per share compared to a net loss of approximately $4.75 million or $0.44 per share for the second quarter of 2023.
David Margrave: For the second quarter of 2024, our R&D expenses were approximately $3.9 million.
David Margrave: up from approximately $3.6 million for the second quarter of 2023.
David Margrave: This increase was largely driven by an increase in clinical trial activity.
David Margrave: Our general and administrative expenses for the second quarter of 2024 were approximately $1.5 million, down slightly from approximately $1.6 million for the second quarter of 2023.
David Margrave: The decrease was primarily attributable to decreases in payroll and compensation expense and decreases in insurance expenses.
David Margrave: Our R&D expenses continue to exceed our G&A expenses by a strong margin.
David Margrave: reflecting our focus on advancing our
David Margrave: Our loss from operations in the second quarter of 2024 was partially offset.
David Margrave: by interest income and other income net.
David Margrave: totaling approximately $449,000 as compared to interest income and other income net totaling approximately $444,000 for the second quarter of 2023.
David Margrave: Our cash position, which includes cash equivalents and marketable securities, was approximately $33.3 million as of June 30, 2024.
David Margrave: We anticipate this balance will provide us with a cash runway into at least Q3 of 2025.
David Margrave: Importantly, we believe our solid financial position will fuel continued growth and evolution of our radar AI platform and continue the advancement of our portfolio of targeted oncology drug candidates.
David Margrave: As of June 30, 2024, we had 10,758,805 shares of common stock outstanding.
David Margrave: So about 10.75 million shares of Common Stock Outstanding. We had outstanding warrants to purchase 81,496 shares of Common Stock and outstanding options to purchase 1,063,548 shares of Common Stock.
David Margrave: These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 11.9 million shares as of June 30, 2024.
David Margrave: Our team continues to be very productive under a hybrid operating model.
David Margrave: We currently have approximately 22 employees and four FTE consultants focused primarily on leading and advancing our research and drug development efforts.
David Margrave: We see this number expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission.
David Margrave: I'll now turn the call over to Reggie for a review of initial Phase 2 patient results and future directions for our harmonic trial. Reggie?
Reggie Iwasudo: Thank you, David.
Reggie Iwasudo: I will start off by reviewing the study design for the harmonic trial.
Reggie Iwasudo: There are two stages.
Reggie Iwasudo: in the Harmonic Trial.
Reggie Iwasudo: The stage one is the safety leading, and then the randomization and expansion stage of the study.
Speaker Change: It is worth noting at this point, though, that investigators are completely satisfied and aligned with this strategy.
Reggie Iwasudo: because it aligns very well with current dosing intervals for the standard of care regimen.
Reggie Iwasudo: as well as the disease evaluation intervals.
Speaker Change: I was spending many of my time really going over the data.
Speaker Change: The safety leading is now completed with a total of seven patients enrolled, and the preliminary data is the subject of my presentation in most of the subsequent slides.
Speaker Change: The study started with geographically dispersed sites in the United States with Dr. Treat at Fox Chase as the global lead investigator.
Reggie Iwasudo: The number of sites have now been extended to the Asia-Pacific region and includes renowned investigators like Dr. Godo at the National Cancer Center Hospital in Tokyo, as well as other experienced and reputable investigators both in Japan and Taiwan.
Reggie Iwasudo: The obvious needs for this expansion of science should be pretty obvious.
Reggie Iwasudo: This is due to the fact that relatively high prevalence of the patient population in that part of the world.
Reggie Iwasudo: So let me now present the clinical data as it relates to safety when LP300 is combined with a standard of care chemotherapy doublet.
Reggie Iwasudo: To summarize,
Reggie Iwasudo: The safety profile is in keeping with what is expected for the standard of care regimen.
Reggie Iwasudo: overall
Reggie Iwasudo: The events observed were primarily grade 1 or 2 adverse events.
Reggie Iwasudo: Now, most of these events
Reggie Iwasudo: Seen in this presentation, we are attributable to a single patient.
Reggie Iwasudo: who entered the study with multiple comorbidities.
Reggie Iwasudo: Of note, however, having completed this stage of the program, there were no dose-limiting toxicities.
Reggie Iwasudo: Severe adverse events, or more importantly, new unexpected toxicities reported.
Reggie Iwasudo: And no patient has discontinued any of the treatment due to toxicity. Now this is key to a new regimen because it speaks to the tolerability of the triplet regimen.
Reggie Iwasudo: I will now hand over the presentation to Panna, the CEO , to review the key takeaways from the clinical data, and I will join him as part of that presentation.
Panna Sharma: Thanks Reggie. I want to review for everyone the key patient characteristics and our studies endpoints and obviously these will remain the same as we go now from the lead-in to the expansion phase.
Speaker Change: The patients are all never smokers.
Speaker Change: that have histopathological evidence of stage 3 or 4 primary lung adenocarcinoma. They have to have TKI molecular alterations such as EGFR, METXON-14, ROS1, BRAF, ALK, and TRAC fusions.
Speaker Change: and they have to have relapsed after one or more lines of therapy with those TKIs.
Speaker Change: So obviously, these are identified TKIs, which we believe are...
Speaker Change: a small family of all the potential TKI mutations that can possibly occur. That's an important note because our drug, we believe, has effects on the TKI receptors.
Speaker Change: The study endpoints are progression-free survival and overall survival and we'll give you a little discussion what we've seen as benchmarks for those toward the end.
Speaker Change: and the secondary endpoints...
Speaker Change: which we had some of
Speaker Change: some of which today are objective response rate, duration of response, and clinical benefit rate.
Speaker Change: And again, it's very surprising oftentimes that those who stop responding to those TKIs that are never smokers actually have very poor duration of response and after they go to chemo doublets, in fact, usually well under five and six months.
Speaker Change: So, there's a very urgent need for targeting this population.
Reggie Iwasudo: Reggie, you want to talk a little bit about some of the patient highlights so far?
Reggie Iwasudo: Yes, absolutely.
Reggie Iwasudo: So maybe if we go on to the next slide.
Reggie Iwasudo: As required, one of what we do in clinical trials is to look at the data from different angles.
Speaker Change: The first thing we did here was to look at the spider plant.
Reggie Iwasudo: which goes over the preliminary data, but with the intent to really understand the attributes of the regimen.
Reggie Iwasudo: What you see on this slide or presentation is the onset of the clinical benefit.
Reggie Iwasudo: This is rapid and it will appear durable.
Reggie Iwasudo: Now this is key. So what we're expecting is from the regimen if a patient is treated within the first three cycles
Speaker Change: If you're going to derive clinical benefit, that should be sustainable.
Speaker Change: And that's what we are beginning to observe.
Speaker Change: So we'll go on to the next slide.
Speaker Change: And we'll look at the data from another perspective, which is the waterfall plan.
Speaker Change: Now, this gives us the magnitude of the clinical benefits, and as you can see on this presentation, it's quite impressive.
Speaker Change: The response is just after three cycles, and this has been seen virtually for all the patients.
Speaker Change: in this cohort.
Speaker Change: The emerging durability of the clinical benefits, however, is presented on the next slide, which is the SWMAS plot.
Speaker Change: So again, you begin to get a sense from this presentation.
Speaker Change: that 86% disease control rate in this patient population with a 43% objective response rate, which includes one patient maintaining a 50% reduction in tumor size over 14 months.
Speaker Change: Clearly we are encouraged by these preliminary results. We share the results with investigators. They all with that exception are very encouraged with whatever what we are seeing here with this regimen.
Speaker Change: So I'll now go on to the next slide, which talks about really the demographics of this patient. And we want to pay particular attention to where we think we're seeing these benefits in the patients.
Speaker Change: We are closely monitoring the patients.
Speaker Change: But it is very clear from this that there are a couple of encouraging observations while accessing the demographics and specifics.
Speaker Change: One, the patient population is relatively more heterogeneous than would be the case with typical studies in this space.
Speaker Change: which tend to be restricted to one-driver mutation populations.
Speaker Change: Two, the tyrosine kinase receptor genomic alterations at baseline is other than EGFR or EGFR alone. So they're one or two patients with co-mutation at baseline.
Speaker Change: We know those patients don't tend to do well with TGFR and targeted therapies.
Speaker Change: But you will also notice that after three cycles,
Speaker Change: The tumor response is remarkably exaggerated on metabolic lesion sites.
Speaker Change: leading to complete disappearance or resolution to normalcy in size in the case of lymph nodes.
Speaker Change: Patients with low or intermediate tumor mutational burden are deriving clinical benefit, which is very exciting for us because we believe this will pave the way for a more acceptable and adaptable biomarker selection strategy.
Speaker Change: since this assessment is already part of routine clinical practice.
Speaker Change: My next slide relates to the prior lines of cancer treatment and the response we're observing so far.
Speaker Change: Looking at this data, the median number of prior lines of therapy is 2 with a range of 1 to 4, notwithstanding
Speaker Change: The preliminary efficacy data suggests that regardless
Speaker Change: of the number of prior lines of treatment or type of prior tyrosine kinase inhibitor treatment.
Speaker Change: LP300, when used in combination with standard of care regimen, is likely to provide clinical benefits.
Speaker Change: Now, it's important to point out that one of the patients in this cohort had already been exposed to carboplatin chemo doublet, but still derived remarkable and durable response.
Speaker Change: We strongly believe that, based on the mechanism of action of LP300,
Speaker Change: What we have seen is what we've always come to know about the drug, which is that the drug is known to resensitize tumor cells to the effect of chemotherapy through a mechanism where it resets the redox cycle.
Speaker Change: So this is a very encouraging set of data for us.
Speaker Change: And again, all the investigators, including Dr. Treat, that we've shared the data with are very excited, and we look at this as being very promising.
Speaker Change: Next slide.
Dr. Panna: So I will just review the top part of this slide, and I will invite the CEO , Dr. Pannara, to review the latter part of this slide. So to summarize, we have seven patients that have been enrolled in the Stage 1 or the safety leading phase of the study.
Dr. Panna: Six out of seven patients have derived clinical benefits. Three of those are partial responders, which are really significant in magnitude of response, including very remarkable reduction in metastatic lesion sites.
Speaker Change: with an average of tumor size reduction of about 51%. There are three noticeable stable diseases which have resulted in an average of about 13% tumor size reduction. But overall,
Dr. Panna: With a clinical benefit rate of 86% and an overall response rate of 43% from this initial cohort, we believe that this is very promising.
Dr. Panna: Notably, from a safety perspective, there are no DLTs.
Dr. Panna: No serious adverse events in excess of what one would expect from the standard of care chemotherapy regimen.
Dr. Panna: But more importantly, no new added toxicity to the Double F regimen, which tells us very clearly that after three cycles, this is a regimen that is very tolerable and most welcome in the space.
Dr. Panna: I'll hand it over to Panna to review the last part of this slide.
Panna Sharma: Yeah, thanks Reggie. So obviously the key ongoing consideration is really the measuring for the durability of response for going forward and that's going to be very important for us.
Speaker Change: You know, we are considering, we believe, to file for a breakthrough therapy designation if we continue to see
Panna Sharma: the types of trends that we're seeing, which again isn't just the clinical benefit rate, but also, as Reggie pointed to, that there's no increase
Reggie Iwasudo: in toxicity or adverse events which is very important because oftentimes in this patient group again you're looking at
Reggie Iwasudo: some serious adverse events.
Reggie Iwasudo: And so far, we've been fortunate not to have that, but more importantly, we're not seeing any that are above the normal standard of care, which is critical.
Reggie Iwasudo: So, we believe the types of clinical benefit coupled with the safety profile that we've observed to date
Reggie Iwasudo: make us very excited to look at if these statistics continue to hold over the next few cycles.
Reggie Iwasudo: to apply for breakthrough therapy designation. We've also observed, which is very important to note, this has been hypothesized early on and we'll begin to see some good data, is that tumor mutation burden or TMB levels are measured as either low or intermediate.
Reggie Iwasudo: are responsive to this therapy, TRIPLID. And these are typically patients that are not responsive to immunotherapies or checkpoint inhibitors. Usually high TNB or high PD-L1 is associated with an improved response to PD-L and PD-1.
Reggie Iwasudo: So, all signs point to that we really need to accelerate.
Reggie Iwasudo: for the enrollment of this trial.
Reggie Iwasudo: And we've begun sharing the observations to date with the sites and with our Asian colleagues and that we believe we'll be able to get to some significant enrollment over the next several months as the trial now goes into the expansion phase. Let's go to the next slide, please.
Reggie Iwasudo: So let me conclude my part of the presentation and to put the Harmony Trial in context. I think there are several studies you see on this slide.
Reggie Iwasudo: pertaining to the impact or lack thereof of immunotherapy in the nervous smoker population, which is the population targeted here.
Speaker Change: The never smokers with advanced lung adenocarcinoma clearly do not respond well to immunotherapy.
Speaker Change: either when used alone or in combination with a standard of care double-platinum dose.
Speaker Change: aware groups
Speaker Change: The preliminary profile and activity we're seeing in this study would seem to suggest that this subgroup of patients
Speaker Change: who tend to have low or intermediate tumor mutational burden.
Speaker Change: who potentially benefit from this harmonic cryo regimen.
Speaker Change: The study is currently enrolling in the randomization and expansion phase, and as Panna pointed out, more data in the near future will further define and or validate the clinical activity that we've observed so far.
Speaker Change: Could we go on to the next slide, please?
Speaker Change: This just summarizes at a very high level the key highlights about LP300. In a previous study, this laid down the scientific rationale for the current design where we saw very impressive improvement in clinical benefit in terms of survival when we looked at nervous smokers versus
Speaker Change: and Smokers.
Speaker Change: So it does the scientific basis.
Speaker Change: for using LP300 in combination.
Speaker Change: with the current doublet standard of care. The mechanism of action are reflected on this slide, but one thing that is very fundamental in terms of the regimen, which we are beginning to observe, is that well over a thousand patients have been dosed with this drug, either alone, even in healthy volunteers, or in combination.
Speaker Change: with different chemotherapy regimens. So the safety profile is well-established, no surprise from this study that we have currently, and is welcomed by all the investigators as we have looked at the first cohort of patients from a safety and tolerability perspective.
Speaker Change: I just thought I should share with you all the comparative data, the historical benchmark for what we are talking about.
Speaker Change: The next phase of this study, obviously, is combining LP300.
Speaker Change: plus the panotrexate carboplatinum dogwood.
Speaker Change: versus carboplatin and permetrexate doublet. Now, this is the benchmark. When you look at overall response rate in these studies.
Speaker Change: You're going anywhere from about 26 percent to probably on the very high end recently with the Myripoza 2 study, about 36 percent.
Speaker Change: Right now, with the data that we have, sharing with, this is the opinion of the investigators, we are clearly above what, you know, the historical data is, and I think we can attest to that.
Speaker Change: But more importantly, as the data matures, we are keen on understanding the median duration of response, as well as the PFS, which obviously is the primary endpoint of this study, co-primary endpoint with survival.
Speaker Change: But all these studies, either with I.O. agents or by specifics, as you look at this particular set of the standard of care regimen, right now, preliminary data obviously is looking better than what has been known in this space.
Speaker Change: So I will conclude by saying that the data that we have, the clinical data, from a safety perspective,
Speaker Change: His father is on the standard of care regimen as expected.
Speaker Change: and Safety Profile. And in terms of the preliminary and emerging
Speaker Change: clinical efficacy profile, I think we're encouraged by what we're seeing.
Speaker Change: Thank you.
Speaker Change: [inaudible]
Speaker Change: Reggie, thank you and thank you to our clinical colleagues and of course patients for the first phase.
Speaker Change: Moving back to other aspects of our portfolio, I know people are very excited about Starlight.
Speaker Change: We've seen some really good movement this year in brain cancers.
Speaker Change: obviously initially in pediatric brain cancers with the results from day one pharmaceutical and now more recently with the result in IDH mutant gliomas.
Speaker Change: And so it's an exciting time, and I think, as we stated before, we want to further monetize Starlight.
Speaker Change: because Starlight is pointed at...
Speaker Change: some very important and significant indications.
Speaker Change: who's now started site selection for the upcoming Phase 1B and 2 trials. We'll make several announcements in the coming months on the progress on those fronts and also on additional talent and leadership that we plan on leveraging at Starlight.
Speaker Change: For those who have not listened in, on the backdrop of Starlight or on the details of the trials, we have some webinars that we invite you to listen to.
Speaker Change: Additionally, a major part of our business obviously is to inform, educate, and share with the general public and investors and the oncology community the details of our programs and our efforts.
Speaker Change: So, last Wednesday of every month.
Speaker Change: We'll focus on our trials, our publications, our collaborations.
Speaker Change: and on our AI developments. Our next webinar will be the end of this month, August 28th on Wednesday, where Reggie will dive deeper into some of the data and clinical readouts, and that'll be followed up with.
Speaker Change: additional data from our AI platform in September and some insights about our efforts in immuno-oncology with 184 in September , so all very very relevant.
Speaker Change: We've also had additional publications highlighting the clinical value of our radar work.
Speaker Change: We had a great publication that showed the potential for LP184 to be synergistic with PARP inhibitors in a wide range of solid tumors. This was published at AACR Journal's Cancer Research Communications.
Speaker Change: And again, this is in a wide range of solid tumors that are what's called HRD.
Speaker Change: homologous repair deficient and this is a very under addressed large category that's generating billions in drug sales annually.
Speaker Change: The preclinical findings in the paper illustrate the potential of LP184 to be a pan-HRD cancer therapeutic, which could be the first drug of this type in this class.
Speaker Change: So it's a really great observation and we believe help us establish a combination trial in this group of patients once we've established the MTD in the phase 1A for LP184.
Speaker Change: Also, as we communicated yesterday, we have new data and scientific findings conducted in conjunction with Drs. Young-Doo and Fabius Lin at MD Anderson, and these were presented at the Immuno-Oncology Summit just yesterday by our colleagues.
Speaker Change: And these findings showcase what Lantern believes to be the role of LP184 to be combined with checkpoint inhibitors to provide greater response
Speaker Change: in triple negative breast cancer due to the synergy, but also we believe because of the mechanism where LP184 can transform triple negative breast cancer tumors that are unresponsive or what's called cold.
Speaker Change: too responsive or hot to checkpoint inhibitors.
Speaker Change: and we believe that it reshapes the tumor microenvironment both through heightened T-cell aggregation and also by decreasing M2 macrophages. Both are really, really critical in heightening
Speaker Change: the potential for Iotherapies to work. The poster can be found on our website under our posters section
Speaker Change: Now 2024 has emerged to be a year of progress for us where we've accelerated ideas and AI driven insights now to the clinic.
Speaker Change: And these insights are now not just good publications and great...
Speaker Change: theory, but they're impacting patients and their journey to fight cancer.
Speaker Change: and also influencing the development decisions of other people in the cancer category.
Speaker Change: I think our collective efforts and dedication have fostered a transformational shift, not only for our company, but actually for groups of our industry, and it's setting us on a very exciting trajectory.
Speaker Change: where we can not only improve the lives of cancer patients, but also do it in ways that is more effective.
Speaker Change: and more scalable. We believe that our business model will drive affordable, more personalized treatment options in cancer. Now with that, I'd like to now open the call to any questions or clarifications. If you'd like to ask a question, you can do so in two ways.
Speaker Change: One, you can raise your hand under the participant category. I think there's a hand raised already. And or you can also type it in and we can look at questions that way.
Speaker Change: So before we get into questions, I'd like to take a moment to personally thank our team for helping to prepare us for these calls and to gather all this. It takes a lot of work, so thank you for our team for taking time out of their normal day-to-day to help make this happen. So let's take some questions from our audience.
Speaker Change: I think our first question is from Keith at Chardin. Keith, please go ahead.
Speaker Change: I think you're muted, Key.
Speaker Change: David Margrave, Panna Sharma, Ashok
Speaker Change: [inaudible]
Speaker Change: Okay, let's go on to take a question from John .
John: Hello, am I coming through? Yep. Great. I thought I'd start with a question on just what kind of threshold you're looking for that shows LP300 merits a breakthrough candidacy status.
Speaker Change: I think if we see the current trajectory.
Speaker Change: in the next, let's say,
Speaker Change: 12 to 20 patients, plus we get some durability data. I think that's that would give us comfort level, but we'd have to see the totality of the data. Seven patients is a good start, but it's preliminary. We'd love to see 21 patients.
Speaker Change: You know, if we had 14 patients out of 21, that would give us a lot of, you know...
Speaker Change: He was pretty excited.
Speaker Change: 16 patients, I mean, but the...
Speaker Change: Overall clinical benefit rate of 86% is largely unheard of in this group, so
Speaker Change: we want to make sure that's durable. And so more patients, drive the end number, and then some durability of response, which I'm sure the FDA will want to look at for breakthrough.
Speaker Change: Okay so about a two-thirds clinical benefit rate is kind of what you'd be looking for.
Speaker Change: We'd have to take a look at the totality of the data, but yes, I mean metastatic lesion improvement, no safety issues, those all skew us.
Speaker Change: towards some positive as well, right? And then looking at the safety profile that you've seen, you know, from the first seven harmonic patients.
Speaker Change: and comparing it to some of the other NSCLC populations that were using EGFR, TKIs, and checkpoint inhibitors, kind of how does that safety profile compare to some of those other
Speaker Change: molecules out there or biologics out there.
Speaker Change: Well, a letter of safety expert.
Reggie Iwasudo: Reggie, take that question on. Hi Reggie. Hi John . That's a very great question. I would just tell you off the bat, what is unheard of in this space is for patients to go on to about 9 weeks or 9 to 10 weeks of treatment with any kind of dosing interruption or discontinuation of the regimen.
Speaker Change: I mean, that is very common, you know, with the TKS in combination.
Speaker Change: You can look at the current Mariposa 2 trial for example which is the most recent with the biospecific combination.
Speaker Change: with the TKI by the way for patients in the same population versus the same standard of care.
Speaker Change: It shouldn't surprise anybody in this field to know that certainly up to 80% of the patients discontinue treatment for one reason or the other because of toxicities, and they had to interrupt treatment, and a third or more of those patients literally discontinue treatment.
Speaker Change: So this, again, presenting this preliminary safety data with no new toxicity to these investigators was really exciting because for this length of time, none of the patients have required those discontinuation for any of the, certainly not LP300.
Speaker Change: Okay, great. And just one more question on your collaborations.
Speaker Change: When you look at the Oregon therapeutics and also Actuate and TTC, how will you determine if this is a success? I mean what kind of milestones are you looking for kind of internally to show that these are kind of working and they're valuable?
Speaker Change: Yeah, each one is a little bit different. I'll take that question. Unique, I mean Actuate has filed an S1.
Speaker Change: and I think that the work our team did was definitely helpful for them in terms of understanding their patient population and developing.
Speaker Change: some specific insights related to people who are refractory to PD-1 therapy that would have potential to benefit from their drug or lagu, or lagericin, yeah.
Speaker Change: Elragulisib. It's a little hard. Yeah, hard to say, but so we think it's, you know, we think that's on track to be...
Speaker Change: successful because we've helped the company and if they do go public and are able to raise additional capital we definitely think it's because of the focus around understanding the patient profile.
Speaker Change: With regards to TTC, that came a little after, so that one.
Speaker Change: We're still working, we do have some very good ideas. TTC is out raising capital or looking for grant money for the next phase, but that one is not as well capitalized as Actuate has been, so they're slower. Oregon is the newest one.
Speaker Change: And I already am pretty excited about what we're doing for Oregon, and it's not, it's barely two months old, so it's very early, but we have some very clear milestones in terms of
Speaker Change: developing some collaborative IP together that we can monetize, specifically helping them
Speaker Change: define combinations and define indications that they haven't thought of. So, and I think we'll be able to accomplish that.
John: Eventually, the IP has to be monetized for it to be a success for everyone, but you got to have good, strong, valid ideas and do them inexpensively, which is part of the magic of AI. Yeah, and just adding very quickly to that, John , in simple terms, I think
Speaker Change: It's a question of are we able to allow them to see things and do things that they wouldn't be able to do otherwise and this goes beyond our collaborations in terms of radar and AI and we're seeing just more and more evidence in these collaborations in other ways.
Speaker Change: that's showing insights that wouldn't have arisen without that additional insight.
Key: Great. Thank you guys. Appreciate it. Thank you. We'll try Key again. I don't know if he's back on the line. Can you hear me now? Yeah, we can hear you, Key. Great. Yeah, it's Key.
She: I appreciate all the detailed patient data.
Speaker Change: I guess the first question is, again, with a huge caveat, this is small numbers, but the patient with the RET mutations, you know, had a nice response. Not sure if they were re-challenged with subartatinib or not, but was that a surprise to you based on your pre-clin data?
Speaker Change: Maybe I'll take that one. It wasn't really a surprise because, again, if you, maybe one of the highlights for LP300 and what we understand of the mechanism of action.
Speaker Change: One of the, you know, set of data we've been able to generate preclinically is understanding that the drug really binds to cysteine residues and, you know, of different tyrosine kinase receptors, including rats.
Speaker Change: So, seeing this kind of clinical data is very exciting to us.
Speaker Change: and that's why in the presentation I made sure to emphasize that it's not just
Speaker Change: you know, a driver mutation of interest, as you've seen other clinical trials in this space, but rather the protocol is designed to really capture any driver mutations for those patients to come in as far as they are nervous smokers.
Speaker Change: So this is very encouraging for us. It didn't come as a surprise.
Speaker Change: And then with respect to patient 107002 who had progressive disease, anything about their baseline?
Speaker Change: that maybe might have predicted a less than favorable response there.
Speaker Change: You know this was the first patient enrolled in the trial. A lot of things going on with the protocol at that time, but this patient really accounted for most of the toxicities you've seen because of comorbidities. So the patient one would say wasn't an ideal patient for a clinical trial.
Speaker Change: Okay, great, thanks.
Speaker Change: We have a question in the chat window.
Speaker Change: that I'm going to go ahead and answer. I'll read it out for everyone. Can you please go deeper into checkpoint inhibitors?
Katrina: and the market they currently garner, specifically Katrina, and why LP184 may be a great and synergistic partner.
Speaker Change: Good question. Now I'm not a Katruda rep or I'm not a Merck rep.
Katrina: But having done a lot of work for Merck in my prior career, I can tell you that the 57 patient trial that they had that got them on the map had remarkable results.
Speaker Change: The market today for checkpoint inhibitors, including Keytruda, is somewhere close to $40 billion.
Speaker Change: 2 to 48 billion dollars.
Speaker Change: David Margrave, Panna Sharma, Ashok
Speaker Change: So, it's a significant market.
Speaker Change: Now, we all know that Gertrude has cut some of these early stage PD-L1s that are coming off market, and there's some new PD-L1s already out, or PD-1s, you know, Coe Harris has one of those already out, I believe, that's a...
Speaker Change: BioSimilar. Pricing isn't great, but I've heard that the efficacy is very, very good. It's a clean BioSimilar. So the market, you know, I think will remain fairly robust. Analysts project it'll grow about 15 to 17 percent because there's a whole new wave of new
Speaker Change: So it's a good market. Now we're not going after that whole market. What we're going after is we believe that there's even a larger group of patients.
Speaker Change: that don't respond to checkpoint inhibitors that could benefit from them. And there's a whole group of people whose lives have been wonderfully prolonged, but their cancer is not cured.
Speaker Change: So they stopped responding to checkpoint inhibitors.
Speaker Change: and the tumor microenvironment reshapes itself.
Speaker Change: So that's where LP184 we believe can be a great and synergistic partner. The first one of course we have some data on that we're excited about is in triple negative breast cancer.
Speaker Change: and triple negative breast cancer can be rapidly...
Speaker Change: evolving in terms of its clonal evolution, so it's also part of the reason why.
Speaker Change: be good to go after. And so we think that TNBC would be a great initial target to get an early win.
Speaker Change: and then potentially go after other places where checkpoint inhibitors can be improved, which will be many of those tumors where you have complex tumor microenvironments.
Speaker Change: and you have rapid clonal evolution.
Speaker Change: And so that, to me, can be...
Speaker Change: multiple, multiple billions of dollars of potential over time. But the key is to pick one where we know that we could have a good, good effect and potential win and TNBC looks like one where we've seen synergy, we've demonstrated clinical evidence.
Speaker Change: We see two of the most important hallmarks. One is we're bringing and recruiting the right kind of T cell environment.
Speaker Change: and we're also decreasing the number of M2 macrophages, both which have been very, very correlated with reducing response to immunotherapies.
Speaker Change: Thank you for that question, John .
Speaker Change: Another question in the chat window that just popped up.
Speaker Change: Michael's question I'll read is, are you open to small pharma partnership opportunities?
Speaker Change: Well, Michael, being a small pharma ourselves, yeah, absolutely. Yeah, we're a small biopharma that acts like a big pharma, but we are a small pharma. I mean, we're very, we're always looking for partnership opportunities and
Speaker Change: welcome you to send myself or members that you know in the company and an email and we will get back to you quickly. Time for one more question. I don't know if there's any more questions.
Speaker Change: David Margrave, Panna Sharma, Panna Sharma, Ashok
Speaker Change: There's one more question So I'll go ahead and take this one. The question is given the market cap of the company Do you think Lantern is still relevant to be a major player in the industry?
Speaker Change: That's a great, it's a good fundamental question as an investor, I think. So thank you for being involved. I think there's room for big companies and small and I always like to urge everyone that with the exception of a few handful of companies, every big company started small.
Speaker Change: except LabCorp, which started because of Roche and U.S. Labs, but very, I mean even Regeneron and Biogen. Now is that what we're going to be in the future? Who knows, but I do think
Speaker Change: That very likely that our approach and our drugs will be partnered, licensed, and sold. That's what we're doing. Or we'll spin out the assets.
Speaker Change: So, I think that we are very relevant to the industry, and I've seen a lot of companies try to copycat our approach.
Speaker Change: A lot of companies are very interested, so I think we will be very relevant, and I think
Speaker Change: you will see ups and downs in this industry, just like every other industry. I like to remind people that even Amazon, before it became the huge behemoth, not that we're gonna become Amazon, saw 80 and 90% reductions in stock price about four or five times on their way up.
Speaker Change: So, stock prices and everything, I think it's a huge indicator of how much your cost of capital will be, but I think we're probably the cheapest company with a phase two drug and two phase one drugs that are first in class.
Speaker Change: So that does get me at times concerned and frustrated, but, you know, and we're not spending 60 to 80 million dollars a quarter like some other companies who are in the press today.
Speaker Change: for their merger. So, you know, it's, you got to do things differently, but you also really have to think about how to do them differently. You can't say you're going to use AI and then spend like Eli Lilly or
Speaker Change: Rush.
Speaker Change: So, you know, I think we can do things differently with AI, pick the right kind of very select focused bets and opportunities and try to develop those with a tremendous amount of operational efficiency. And so I think that'll pay a lot of dividends to to our investors, but also
Speaker Change: will allow us to be very relevant in the industry.
Speaker Change: And just adding to that very quickly, we're beginning to see some great momentum on multiple fronts.
Speaker Change: We talked a lot today about Harmonic, but there are some very exciting things going on with our other candidates as well, and then Radar in addition to that. So we're building some great momentum that we think will be value driving in multiple ways.
Speaker Change: Thank you. So, in closing, I want to express my
Speaker Change: Thanks and a gratitude to our team, our partners, our stakeholders.
Speaker Change: and those who are following the company for their support and interest. Together, I think we are really lighting the way toward a brighter future in oncology and solving real world problems for patients with proprietary AI solutions and insight. And we think we're gonna radically alter the potential to.
Speaker Change: changed the cost structure and timelines in drug discovery. So thank you everyone for your time this afternoon. With that, I'd like to adjourn the call today.
Speaker Change: Thanks a lot. Thank you.
Speaker Change: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
Larry Weaver: www.larryweaver.com www.larryweaver.com
Larry Weaver: www.larryweaver.com www.larryweaver.com
Panna Sharma: Thank you. Thank you. Thank you.
Panna Sharma: David Margrave, Panna Sharma, Ashok [inaudible]
Panna Sharma: www.larryweaver.com www.larryweaver.com
Speaker Change: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
Speaker Change: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
Speaker Change: www.larryweaver.com www.larryweaver.com