Q4 2024 Lantern Pharma Inc Earnings Call
Meeting as an attendee and will be muted throughout the meeting.
Speaker Change: Good afternoon and welcome to our fourth quarter and year end 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.
Order in Year, Ended December 31, 2024
Speaker Change: A copy of this release is available through our website at lanternpharma.com where you will also find a link to the slides management will be referencing on today's call.
Speaker Change: 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 Security's Litigation Reform Act of 1995.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Onno will start things off with introductions and an overview of lanterns <unk> strategy and business model and highlight recent achievements in our operations after which David will discuss our financial results.
Speaker Change: 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 10K for the year ended December 31st, 2024, which is on file with the SEC and available on our website.
Speaker Change: This will be followed by some concluding comments from partner and then we'll open the call for Q&A.
Speaker Change: I'd now like to turn the call over to potash Sharma, President and CEO of Lantern pharma.
Speaker Change: Anna Please go ahead.
Speaker Change: Forward-looking statements made on this conference call are as of today, March 27, 2025, 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.
Matti: Matti. Thank you Hello, everyone and thank you for joining us this afternoon to hear about our fourth quarter and fiscal year 2024 results and corporate progress.
Speaker Change: 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 CFO David Margrave.
Matti: As many of you have heard me say in the past computational and AI driven approaches are increasing their presence in usage at both large and emerging pharma companies for all facets of drug discovery and development.
Speaker Change: Our leadership in the innovative use of AI and machine learning to transform the process of developing 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: 2024 was a transport transformational year for lantern pharma across many measures portfolio the platform and patient impact I'd like to highlight lantern pharma and our team's extraordinary progress across our clinical pipeline and our AI platform. These developments arent really incremental.
Speaker Change: <unk> they actually represent transformative approaches that are reshaping, how we develop precision oncology therapies for patients that usually have very limited treatment options.
And hopefully enable a much more efficient future for drug developers. Our team today is about 23 people focused and comprised of leaders in high value contributors and they have made significant strides over the past quarter actually throughout all of 2024 across all of our clinical programs.
Speaker Change: And with our AI platform radar and also in our ongoing efforts in developing an entirely new company Starlight therapeutics, which was largely possible due to our AI and data driven model, which is used to understand how and where he molecule can work best against a particular cancer and actually.
Speaker Change: If I the cancers that are going to be most sensitive to a molecule. In fact this is one of the core features of our AI.
Speaker Change: Radar, our precision oncology AI platform has guided the rapid and efficient development of three AI driven drugs into clinical trials at a pace and cost that has traditionally been unheard of in our industry. Some of our peers many of them already reported.
Speaker Change: Their burn rate and one quarter is more than our burn rate has been over the past three years.
Speaker Change: So just and in their pipeline is not all that.
Speaker Change: Advanced.
Speaker Change: So we're talking 12 to 14 quarters of our burn versus one quarter of theirs.
Speaker Change: Well our team has been very focused on executing of our mission, which is <unk>.
Speaker Change: First and foremost, which is transform oncology drug discovery and development.
Speaker Change: All of our clinical stage drug candidates are now in phase two and phase one trials, they've all dosed multiple cohorts of patients and we actually have some very exciting preclinical assets like our antibody drug conjugates that are in early development for the next generation of our portfolio.
Speaker Change: All of our clinical trials I'll be talking a little bit about today, and we will have multiple clinical readouts over the next several quarters as we get insightful data on how patients and cancers are responding to our precision drug candidates.
Speaker Change: Last year, we shared with you information from our first lead in cohort of patients in the phase two harmonic trial and I'll provide an update on that as well today. Good news is that we're continuing to see some of the remarkable results.
Speaker Change: From patients.
Speaker Change: As we've expanded the trial now.
Speaker Change: Now our team and many clinicians are particularly excited about and interested also in the programs for our first in human drug candidates L. P 184, and LP to 84.
Speaker Change: And also of course L. P 300, which is aimed at a very unique population of never smokers that had been impacted by non small cell lung cancer Dino carcinoma, but have failed other treatment options.
Speaker Change: This is a growing problem not only in the U S, but globally and we are actively screening and dosing patients not only in the U S, but in Japan, and Taiwan, where the incidence of non small cell lung cancer among ever smokers is nearly two and a half to three times than here in the U S.
Speaker Change: Our phase two asset L. P 300, which is aimed at a $4 billion to $5 billion opportunity annually.
Speaker Change: But also when it's growing has seen acceleration in enrollment.
Speaker Change: Our harmonic trial for L. P. 300 has delivered remarkable preliminary results that demand attention the leading cohort achieved an 86% clinical benefit rate and a 43% objective response rate and never smoker non small cell lung cancer patients. These arent just numbers they represent a potential change in survival.
Speaker Change: And hope for patients who have historically been underserved by conventional treatments.
Speaker Change: What makes these findings, particularly significant from a clinical perspective is it never smoke or non small cell lung cancer patients typically have showed very limited response to existing therapies. Their genomic profiles are fundamentally different from smokers with higher frequencies of actionable driver mutations, but for response to Immunotherapies.
Speaker Change: They also generally have very different genome wider genome, which much lower tumor mutation burden than smokers.
Speaker Change: Now L. P. Three hundreds mechanism, which enhances the efficacy of chemotherapy, while potentially protecting normal cells addresses this major need for.
Speaker Change: Never smokers directly are our strategic expansion to Japan, and Taiwan regions were 33% to 40% of non small cell lung cancer cases occur.
Speaker Change: Never smokers compared to just 15% in the U S positions us to accelerate enrollment this year and generate robust datasets with great powers statistical power the geographic strategy strengthens our potential for compelling 2025 readouts.
Speaker Change: That could transform treatment protocols for this distinct and growing patient population additional patient data from the expansion cohort, which is randomized two patients to one in favor of our L. P. 300 arm continues to support at the current time, a similar patient response and clinical benefit trend lantern plans and sharing.
Speaker Change: Additional results, which will include data from patients enrolled in Taiwan, and Japan from the expansion cohort later this year most likely during middle to late of Q2 2025.
Speaker Change: Now the two FDA fast track designation that we received for L. P 184, and Glioblastoma in triple negative breast cancer, coupled with three additional rare pediatric disease designations represent extraordinary regulatory validation of our approach.
Speaker Change: We're going after very precise cancers precise data and these designations arent really administrative milestones there actually.
Speaker Change: Indications that are where we can expedite our clinical development timeline through enhanced FDA interactions and potential for priority review from a technical standpoint. These designations were underpinned by the mechanistic elegance of L. P 184, as synthetic modality approach its ability to exploit specific genomic.
Speaker Change: <unk> and cancer cells, while sparing normal cells, particularly through its P. T. G. R. One mediated bio activation. This offers a precision that conventional therapies cannot match the market potential across these indications exceeds $10 billion annually addressing over 150000, plus patients with limited therapeutic options across.
Speaker Change: Solid tumors.
Speaker Change: Our phase one clinical trial for both L. P 184, and 284 has successfully progressed through multiple patient cohorts systematically establishing safety profiles, while advancing toward pharmacologically active dose levels. The metallurgical dose escalation strategy has been executed with efficiency with no serious adverse.
Speaker Change: Rents related to the drug candidates observed across multiple cohorts that have been executed.
Speaker Change: What distinguishes our synthetically full approach is it's mechanistic precision unlike conventional chemotherapies that can indiscriminately target dividing cells or other alkylating agents L. P 184 acuity for exploit specific genomic vulnerabilities in cancer cells, particularly those with deficiencies in DNA damage repair.
Speaker Change: Or DNA damage repair pathways the pharmacokinetics.
Speaker Change: Kinetic data from these trials suggest we're approaching concentration levels of the drug that correlate with the nano molar potency observed in preclinical models. This is a critical inflection point that could demonstrate definitive proof of mechanism in patients and paved the way for future trials and partnerships help you want any for continued advancement through phase one trial in.
Speaker Change: Multiple solid tumors, which is targeted to finish enrollment during this coming quarter and we believe we're very close to the final set of cohorts.
Speaker Change: But now let's talk about the current phase one status.
Speaker Change: The phase <unk> results, so far for safety, Tolerability and pharmacokinetics, including the MTBE determination.
Speaker Change: We're now in cohort of 11 and have early indications of clinical activity that had been observed at these higher dose levels consistent with the preliminary PK data that we have now during Q4 of 2024 dose level 789 were cleared without safety concerns and preliminary PK data suggests dose proportionality with exposure.
Speaker Change: Enrollment and dose level nine and above we made a concentrated effort to focus that on including patients with advanced solid top advanced solid tumor patients that actually have identified DNA damage repair mutations.
Speaker Change: A broader clinical data update is slated for Q2 2025 when recruitment for this phase is expected to be completed and we will have a <unk>.
Speaker Change: Safety and dose response data available to be shared.
Speaker Change: In terms of future plant phase one b two trials were already getting to planning the future because we see that we've already submitted a clinical trial protocol to the FDA for a phase one b into study in triple negative breast cancer, where we evaluate a combination regimen with the PARP inhibitor elaborate in our preclinical.
Speaker Change: Work, we saw tremendous synergy between elaborate.
Speaker Change: And our drug L. P 184, what's again unique about the combination of PARP inhibitors and L. P. 184 is actually also very elegant now PARP inhibitors.
Speaker Change: Work by stopping the repair mechanism. So when there is DNA damage caused as a result of killing of cancer cells PARP inhibitors.
Speaker Change: Stop the ability of the cancer cell to repair that.
Our drug <unk>.
Speaker Change: It's at a different point it actually breaks apart.
Speaker Change: The DNA of.
Speaker Change: The cancer cell.
Speaker Change: They actually work and a wonderful mechanistic synergy L. P 184, breaking apart the DNA.
Speaker Change: And then PARP inhibitors.
Speaker Change: Stopping it from any attempts that repair.
Speaker Change: So we believe the synergy that we saw in preclinical models that was driven by our AI platform and also validated a number of studies done with our partners across a number of institutions.
Speaker Change: Has a very solid biological basis.
Speaker Change: So far the FDA has raised no objections to the protocol and lantern expects to initiate this trial in both the U S and a leading academic center in Nigeria subject to further funding in clinical priorities now in Nigeria, a lot of you may ask why Nigeria, Nigeria actually has been a hotbed of triple negative breast cancer.
Speaker Change: Search and studies in fact are Roche actually did a trial in T. A b C. There, but in Nigeria.
Speaker Change: <unk> occurs at a much higher rate than in many other parts of the world.
Speaker Change: And there is an active community that has done some wonderful research epidemiological reviews of T. N B C in Nigeria, and sub Saharan Africa will be working with one of the leading academic centers there.
Speaker Change: Bear in mind, the Nigerian breast cancer study.
Speaker Change: Which is published with the University of Chicago, and with Harvard has published that nearly 46% of breast cancer cases.
Speaker Change: Our triple negative breast cancer and Nigeria.
Speaker Change: And they present with mutations that many of the DNA repair genes.
Speaker Change: <unk> hundred 84, it seems to be particularly attuned to.
Speaker Change: So this is very exciting we believe that we'll be able to do our trial with group of clinicians and experts who are really zeroed in on this disease and we'll be able to get.
Speaker Change: More rapid enrollment, which is critical and again, it's critical for our highly efficient model. So we will have sites.
Speaker Change: Sites in the U S, but also sites and Nigeria will talk more about that.
Speaker Change: In the coming weeks.
Speaker Change: Additionally, an investigator led study of <unk> hundred 84, which I know many of you were excited to hear about for recurrent bladder cancer. It is planned to start in Denmark. The clinical trial will test L. P 184, as a monotherapy specifically in advanced bladder cancer with patients that have DNA damage repair mutations Doctor Hello.
Speaker Change: Pep Hot at the Copenhagen University hospitals, who focuses on prostate bladder and some renal cancers will be the Pi on this study and she is very focused on DNA damage drugs and actually molecular profiling of bladder and prostate cancers that based on work that we've done but also on published research.
Speaker Change: About 25% to 30% of bladder cancers that presentation had DNA damage repair mutations and about 40% had recurrence.
Speaker Change: So again, we think this is a great population to study.
Speaker Change: Great population that validate further the mechanism of this drug and most importantly patients that we think we can actually prolong.
Speaker Change: Their long term survival.
Speaker Change: Another great.
Speaker Change: Opportunity for MD Anderson came about with MD Anderson as our collaboration with them revealed that L. P. 184 is remarkable ability to transform immunologically cold tumors into hot tumors, it's a breakthrough with profound implications for expanding immunotherapy benefits to previously unresponsive patients this isn't really.
Speaker Change: Additive efficacy it represents a mechanistic synergy that addresses one of Immunotherapies most significant limitations the technical details here had been fascinating.
In fact, <unk> hundred 84 induces replication stress in tumor cells. This then triggers cytosol like DNA accumulation.
Speaker Change: This accumulation stimulates the immunogenic pathway.
Speaker Change: This leads to favorable remodeling of the tumor microenvironment, which we've shown in our publications.
Speaker Change: It reduces the immuno suppressive <unk> macrophages and enhances the right kind of T cell functionality in fact, it's a combination of those two factors because we have seen T cell functionality.
Speaker Change: Change with other immuno genic ermina stimulate type environments, but also the M. Two macrophage is fairly unique so we're really in preclinical T. N. B C model. This combination enhance the tumor growth inhibition from about 51% for our drug alone to over 72% when combined with anti PD, one therapy and this.
Speaker Change: As a therapeutic enhancement that was again in cold tumors and we believe this could translate into meaningful survival benefit for patients with currently very limited options are patients that basically stop responding to PD, one and PDL. One therapies. This is publicly shared at a recent poster at the ACR.
Speaker Change: Immuno oncology conference in February and also at the Io Conference last year.
Speaker Change: I owe summit this opens up significant opportunities for co development, and new indication expansion, where PD, one and PDL. One has stopped working and again. This is a massive multibillion dollar opportunity in a combination setting.
Speaker Change: Moving onto some of our very exciting new spaces at Starlight Starlight is a company that wouldn't exist if it weren't for data and AI and we unveiled a very unique innovative trial design for star double a one at the society for Neuro oncology 2024 meeting it featured a unique combination of spironolactone.
Speaker Change: This exemplifies the power of computational approaches in biomarker driven approaches in identifying non obvious therapeutic synergies spinal icons is not used in cancer. In fact, this approach exploit synthetically salary in GBM through Mechanistically elegant interaction spironolactone degrades the pro.
Speaker Change: <unk> <unk> three a critical DNA repair protein a.
Speaker Change: It creates a transient vulnerability.
Speaker Change: The drugstore double a one then exploits.
Speaker Change: And so this transient ARCC three degradation stop.
Speaker Change: Stops the cancer cell from being able to repair itself.
Speaker Change: And the way that these double stranded breaks work is at ARCC and some other proteins are needed and so it actually demonstrates that what we've seen pre clinically a 3% to six six increase.
Speaker Change: In GBM cell sensitivities sensitivity, it's pretty massive three extra six six when you combine these agents.
Speaker Change: And actually many of the tumor preclinical models in GBM and other brain cancer is actually have shown complete tumor eradication with minimal recurrence now this can be especially critical in very sensitive patients such as children. The elderly are those who have undergone multiple lines of prior therapy, even more interesting is it star double a one.
Speaker Change: As shown anti tumor activity in GBM, regardless of MGMT status and some of you had seen some of that data that we've published in the past.
Speaker Change: So not only startup of what have we.
Speaker Change: What we believe can be a great anchor molecule, but now through the use of data and biomarker driven medicine, we've actually been able to now exploit.
Speaker Change: The ability to look at and modulate ARCC three so we actually increased the potential of this therapy would make the therapeutic window much more attractive.
Speaker Change: During Q4, we also started the inaugural scientific Advisory Board, which I'm very excited about Dr. Marc Chamberlain, Dr. Kishore Bahia, both worked closely with myself and to provide strategic guidance.
Speaker Change: And and we were very excited to establish a scientific advisory board that.
Speaker Change: Is joined by experts such as doctors Mitch Burger at UCSF, Dr. Lisa Deangelis at Memorial Sloan, Kettering, and Doctor Stewart, Grossman and John Leterrier at Johns Hopkins, all four of which have deep subject matter expertise accomplished scientific experts and leaders in neuro oncology in fact two of them are.
Speaker Change: Actually the Lifetime Achievement Award winners at Society of Neuro oncology, and they're able to now help us shape the development and path for startup <unk> remind you Starlight is 100% owned by <unk> will have the potential to be a very positive impact on our investors as we monetize this unique asset the patents the insights.
Speaker Change: Its ability to work in certain brain cancers, the dosage and safety data in phase one trial will be used to advance the indications for the <unk> phase II trial, which lantern.
Speaker Change: Wholly owned subsidiary will sponsor and we think the market potential for both.
Speaker Change: This drug as startup below one and as will help you 184 will exceed 14 billion consisting.
Speaker Change: Consisting of about four plus billion in CNS cancers, both pediatric and adult and about 9% to 10 billion for other solid tumors. So we believe this has the potential to be a blockbuster.
Speaker Change: Drug across a number of indications that.
Speaker Change: Now to support a lot of this we actually we're working quite a bit on trying to understand how do we predict the blood brain barrier permeability.
Speaker Change: And our team did a fantastic job at our patent pending blood brain barrier permeability predictive algorithm. It represents what we believe what we believe is a computational breakthrough with exceptional significance with five of the top 11 rankings in the therapeutic data Commons leader board and the ability now to be a very high performing algorithm, we can do maybe.
Speaker Change: 100000 molecules in our.
Speaker Change: Translate that translated can mean a million molecules are more in a workday. So we've developed an AI system that outperforms industry standards in terms of accuracy and throughput for a CNS drug therapeutic development. This will also be in fact, when the first a gentex is that will be made publicly available for drug developers who were going to open this up.
Speaker Change: And partner this is precision medicine groups to help guide their development and also potentially for therapy selection and patients. So we're in fairly advanced discussions now with a number of institutions and.
Speaker Change: A brain tumor group to actually use this algorithm as part of their work now. This technological advantage has profound implications for accelerating CNS drug discovery are notoriously challenging domain, where over 98% of small molecules fail to effectively penetrate the blood brain barrier and where some of the traditional algorithms.
Speaker Change: Have been kind of in the two thirds to 70 mid Seventy's maybe percent accuracy now, we're seeing a whole new generation of algorithms, including ours, which had taken that up into the low to high <unk> and so this unprecedented accuracy allows us to identify promising CNS penetrant compounds with.
Speaker Change: Jordan area efficiency now again I'd also mentioned ours is also high performing so we've taken some very unique engineering steps.
Speaker Change: So that actually.
Speaker Change: The decrease.
Speaker Change: The amount of time required and the computational capability doesn't merely enhance our existing programs. It actually opens up entirely new therapeutic possibilities across multiple neurological indications from not only us but also for other drug developer teams.
Speaker Change: Now our AI powered antibody drug conjugate development module also represents a fundamental reinvention a traditionally resource intensive high risk development process, our AI module for ADC development identify 82, very promising targets and over 290 target indication combinations and many of these are actually validated.
Speaker Change: Because some of them are already in preclinical and clinical trials.
Speaker Change: So this is one of oncology as most rapidly growing therapeutic modalities and the technical implications for this ADC module frame using AI is pretty substantial.
Speaker Change: Traditional ADC development requires a lot of iterative testing.
Speaker Change: Antibodies antibodies.
Speaker Change: Any kind of maybe by specific and then the linker and various payloads.
Speaker Change: And a process that can take years and millions or maybe given tens of millions of dollars just in early stage work.
Speaker Change: Our computational approach reduces these timelines, we believe by third half and preclinical costs by even more than half while simultaneously enhancing the target selection process.
Speaker Change: So this efficiency advantage positions us to rapidly advance multiple ADC candidates with exceptional selectivity profiles and potential for superior therapeutic windows.
Speaker Change: <unk> enables us to allow others to take advantage of this AI now this will be one of the many AI modules, we place into what we call. It a gentex framework, which is really good.
Speaker Change: The kind of the vanguard of the AI work today and once you put into an agenda framework. We can allow it to be used by collaborators and partners and I'll talk more about this later in today's call.
The radar platform expansion beyond 100 billion oncology specific data points represents a computational resource of unprecedented scale and specificity and precision oncology. The vast repository of molecular clinical pharmacological data enables increasingly sophisticated analysis that traditional approaches simply cannot match, but very important.
Speaker Change: Right.
Speaker Change: Don't have the underlying data and curation already that we've done now.
Speaker Change: Now the technical sophistication of radar enables multi dimensional analysis that identified non obvious relationships between genomic features drug responses in potential combination strategies. This capability has directly enabled our biomarker discovery initiatives, including <unk> signature.
Speaker Change: <unk> underlying synergistic combinations, such as checkpoint inhibitors, or spirolactone with 184, or even rituximab with 284.
Speaker Change: And as we continue to refine the methodologies that can feed data from studies back into the platform radar involved evolves from just an analytical platform to a predictive engine capable of identifying promising therapeutic approaches.
With unprecedented efficiency and precision and ultimately in the next generation with its own level of automation.
Speaker Change: So through the integration of advanced AI, computational biology, and precision medicine approaches we're systematically addressing some of oncology is most challenging domains with an unprecedented level of efficiency and scientific rigor.
Speaker Change: Our burn rate is a fraction of that of other companies yet or.
Speaker Change: Advancements across multiple molecules, putting them into patients and advancing the platform is something I'm quite excited about financially we closed the year with $24 million in cash cash equivalents in marketable securities, which I believe will give us runway to execute on our business this year and take our programs to inflection points with data and outcomes David.
Speaker Change: David Margrave or CFO will discuss this in more detail in a moment our.
Speaker Change: Our continued execution across these clinical trials and with our precision oncology programs positions us for multiple value creating milestones.
Speaker Change: Throughout this year and with the potential to deliver transformative therapies for patients with limited treatment options.
David Margaret: Now I'll turn the call over to David Margaret.
Speaker Change: Talk about are.
David Margaret: Talk about our financials and other key metrics David.
Speaker Change: Thank you Panna.
Speaker Change: And good afternoon, everyone I'll now share some financial highlights from our fourth quarter and full year ended December 31 2024.
Speaker Change: I'll start with a review of the fourth quarter.
Speaker Change: Our general and administrative expenses were approximately one $6 million for the fourth quarter of 2024.
Speaker Change: Up from approximately $1 3 million in the prior year period.
Speaker Change: R&D expenses were approximately $4 3 million for the fourth quarter of 2024 up from approximately $3 $6 million in the fourth quarter of 2023.
Speaker Change: We recorded a net loss of approximately $5 9 million for the fourth quarter of 2024 or <unk> 54 per share.
Speaker Change: Compared to a net loss of approximately $4 2 million or <unk> 39 per share for the fourth quarter of 2023.
Speaker Change: For the full year 2024, our R&D expenses were approximately $16 $1 million.
Speaker Change: Up from approximately $11 9 million for 2023.
Speaker Change: This increase was primarily attributable to increases in research studies of approximately $2 $95 million.
Speaker Change: Relating to the conduct in support of our clinical trials.
Speaker Change: As well as increases in research and development payroll expenses of approximately $897000.
Speaker Change: And increases in consulting expenses of approximately 376330 $6000.
Speaker Change: Our general and administrative expenses for 2024 were approximately $6 1 million up slightly from approximately $6 million for 2023 the.
Speaker Change: The increase was primarily attributable to increases in other professional fees.
Speaker Change: Our R&D expenses continued to exceed our G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline.
Speaker Change: Net loss for the full year 2024 was approximately $28 million.
Speaker Change: Our $1 93 per share compared to approximately $16 million for $1 47 per share for 2023 or.
Speaker Change: Our loss from operations in the 2024 calendar year was partially offset by interest income and other income net totaling approximately $1 $4 million.
Speaker Change: Our cash position, which includes cash equivalents in marketable securities was approximately $24 million as of December 31, 2024.
Speaker Change: Based on our currently anticipated expenditures in capital commitments.
Speaker Change: We believe that our existing cash cash equivalents in marketable securities as of December 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements for.
Speaker Change: For at least 12 months from today's date.
Speaker Change: We expect that we will need substantial additional funding in the near future and one of our key objectives for the remainder of 2025 will be <unk> to pursue additional funding opportunities.
Speaker Change: As of December 31, 2024, we had $10 million and 784725 shares of common stock outstanding outstanding.
Speaker Change: Outstanding warrants to purchase 70000 shares and.
Speaker Change: An outstanding options to purchase $1 million 245694 shares.
Speaker Change: These warrants and options combined with our outstanding shares of common stock gives us a total fully diluted shares outstanding of approximately $12 1 million shares.
Speaker Change: As of December 31, 2024.
Speaker Change: Our team continues to be very productive under our hybrid operating model. We currently have 24 employees focused primarily on leading and advancing our research and drug development efforts and I will now turn the call back over to partner for an update on some of our development programs.
Speaker Change: Thank you David.
Speaker Change: So our leadership in the use innovative use of AI and machine learning in many ways AI for good to transform costs and timelines in the development of precision oncology therapies as allowed us to have a pretty exciting pipeline.
Speaker Change: So allowed us to bring three molecules to market.
Speaker Change: With teams cost and efficiency.
Speaker Change: That continues to make massive year over year improvements.
Speaker Change: And we have L. P 300, and phase two again, we plan on having another readout.
Speaker Change: During the second quarter.
Speaker Change: We've accelerated enrollment because of our expansion into Japan, and Taiwan specifically.
Speaker Change: Specifically there the disease occurs in nevers with and never smokers.
Speaker Change: But a two X two to three X higher rate.
Speaker Change: So this is particularly important because it will also use that to leverage the phase II data to look at partnerships, perhaps geographic partnerships as well, which have already begun having conversations with.
Speaker Change: Our phase one trials for <unk> for NLP acuity for both really potent synthetic lethal agents one for solid tumors.
Speaker Change: Has advanced to over 50 patients, we expect to enroll we expect to enroll about <unk>.
Speaker Change: 60 patients. So we're getting very close to what we believe will be the completion of the trial.
Speaker Change: <unk> hundred 84, slightly different dosing schedule, but similar cohorts structure.
Speaker Change: As a few months behind and we think we'll be able to have.
Speaker Change: That 30 patient enrolled later this year. So all three trials, we'll have data.
Speaker Change: But very importantly, we also expect.
Speaker Change: To have great ideas and how to pinpoint the use of these molecules in specific.
Speaker Change: Therapeutics.
Speaker Change: Areas.
Speaker Change: This is why we have over 11.
Speaker Change: Orphan.
Speaker Change: Rare pediatric and fast track designations, it's very important to note. So for a small company. We have 12 designations across 11 different programs, a TRT, having both orphan and rare pediatric.
Speaker Change: So that's really almost we have for every head count we almost have a half a designation and in fact, it's the only molecule that I know that actually has four designations for a rare pediatric.
Speaker Change: So pinpointing, how our molecule work is really one of the most challenging things and so this is really about not only understanding your molecule, but also actually knowing where and how to use it.
Speaker Change: We've achieved this in a very very short period of time remember L. P. 284 did not even exist. When we were when we raise money to go public LP 184 wasn't in the clinic L. P 300.
Speaker Change: We're just beginning to Peel the onion in terms of its mechanistic potential.
Speaker Change: So during 2024, we achieved our goal of reaching 100 billion data points.
Speaker Change: <unk> cancer focused data more than one year that we had in the prior three years and more of this data growth and data ingestion campaigns will be automated freeing up our team to focus on intelligent curation and analysis of data and also on creating upstream engineered datasets to solve more specific problems and these problems, we think in mid start making us.
Speaker Change: Of certain types of generative AI AI that will transform our analytic capabilities to actually autonomous agents.
Speaker Change: So today I'd like to share with you our vision for the next evolution of our radar platform, a future where adjourn take AI and autonomous intelligence dramatically accelerates our ability to transform oncology drug development not only in Atlanta, but also for other drug companies at.
Speaker Change: In Atlanta, and we've consistently demonstrated how our proprietary platform has revolutionized our approach, but we believe also traditional oncology drug development paradigms and as we've shared in previous quarters. Our AI guided approach has enabled us to advance all these candidates into the clinic at a fraction of the traditional cost and actually have more pinpointed in more precise trials.
Speaker Change: It takes us an average of about two to $2 5 million for program from scratch to get it into a trial, whereas the industry standard is somewhere in the range of $10 million to $15 million.
Speaker Change: Now, we're entering a transformative phase where radar where leverage the agenda, we're going to start leveraging a gentex AI capabilities. So autonomous systems capable of making complex decisions analyzing intricate biological datasets and executing sophisticated workflows without constant human supervision.
Speaker Change: So our enhanced radar platform will feature autonomous intelligence.
Speaker Change: And we'll modularized these into agents in these agents, we will continuously monitor and integrate real time data from relevant biomarker in cancer studies and publications, enabling dynamic protocol insight that can be used in real trials and to make precision medicine decisions. The autonomously identify potential combination regimens by analyzed.
Billions of unique molecular interactions across multiple therapeutic modalities similar to our recent.
Significant insights on 184, and checkpoint inhibitors that demonstrated transformation of an immunologically cold tumors to hot tumor, but with a totally different level of scale imagine being able to do thousands of these molecules in a week and we will also deploy advanced reinforced reinforcement learning algorithms that will optimize lead compounds.
Speaker Change: Election, or elucidate target characterization across for antibody drug conjugate development, our peptide or drug drug conjugate development and again, we've already identified 82, promising targets and over 290 target indications many of which are already validated in the clinic from other companies.
Speaker Change: Now this next generation of our platform represents a fundamental shift in drug development methodology, moving from human limited analytics and reactive to proactive continuously self learning systems.
Speaker Change: Capable of identifying non obvious patterns and opportunities and benchmarking does across multiple therapeutic dimensions. So for us though it is we had certain dimensions specifically in oncology are specific in neuro oncology, but while our current platform has already proven exceptional with over 100 billion data points.
Speaker Change: Oncology focus by deploying a gentex Arctic protector and interfaces on top of very specific modules. We will have the potential to create systems that reduce key development decision timelines and compress compress complex data gathering and analytics, creating unprecedented deficiency advantages.
Speaker Change: Rack rapid biomarker identification and validation in our case P. T. G R. One and others autonomous design and automation of combination regimens instantaneous evaluation and molecular libraries the.
Speaker Change: The financial implications for this are pretty substantial potentially reducing preclinical development costs by 67% to 80% by site, while simultaneously increasing successful transition rates in early development and perhaps later development phases. So we're strategically positioning our <unk>.
Speaker Change: Architecture with radar platform to not only drive our internal pipeline, but also as a valuable collaborative asset for Biopharma partners.
Speaker Change: To overcome drug development bottlenecks we've.
Speaker Change: <unk> had very successful collaborations with the Oregon Therapeutics and Actuate therapeutics, both collaborations where we target we offer targeted radar modules.
Speaker Change: For these partners and we believe we will generate some near term commercial traction as a result of that.
Speaker Change: We anticipate launching our first agentic AI around the blood brain barrier permeability prediction algorithm, that's now being commercialized as a module that will be publicly.
Speaker Change: Coming and that will leverage our unprecedented performance metrics and also have the algorithm hopefully guide actual treatment decisions being made in a number of trials.
Speaker Change: Additionally, our ADC development module, which is already demonstrated capabilities.
Speaker Change: As compared to traditional approaches will also become more broadly available later this year and along with another project that will be publicly facing.
Speaker Change: Probably in early summer call projects data now.
Speaker Change: Now all three of these will be leveraging a <unk> architectures.
Speaker Change: Wildly very different but they will put into the public face the ability to actually start thinking about drug development at a level of scale and data access thats usually unheard of.
Speaker Change: So the Golden age of AI in Medicine isn't just beginning its accelerating exponentially by integrating a gentle capabilities. We believe our AI radar will transform from an analytical platform to a true.
Speaker Change: Development partner, one that is a wait 24 hours a day one that's capable of operating continuously at a scale that's unprecedented across multiple research dimensions and constantly grows connecting insights across previously siloed areas of cancer biology, and ultimately, helping us deliver life changing therapies to patients.
Speaker Change: Faster.
Speaker Change: We are just building better tools were actually fundamentally re imagining what's possible in precision oncology and as we continue this journey, our <unk> radar platform.
Speaker Change: Positions us at the forefront of an entirely new paradigm and drug development, one in which AI doesn't really assist human researchers, but actively participates alongside through autonomous continuous learning and insights that can be tested and recur back into the system and hopefully deployed into the clinic faster.
Speaker Change: So this golden age is actually accelerating and it's being driven by large scale highly available computing power incredibly massive data storage and also.
Speaker Change: Great people at the end of the day, you have to have great imaginations and wonderfully dedicated people.
Speaker Change: To be able to deliver this.
Speaker Change: Ultimately for patients and to improve.
Speaker Change: Human life and so we're at levels of quality and data that has never been imagined before companies harness. These capabilities are really the future of the tech bio industry.
Speaker Change: Believes will become long term leaders that create massive value for patients and investors.
Speaker Change: And we think of course industries go through their cycles, and ups and downs, but I've never been more bullish on the potential for AI to really transform and change outcomes for patients, but also it will make our medicines faster cheaper and with increased precision I think it'll help us change the direction of R&D productivity.
Speaker Change: And output in the pharma industry. So we believe our approach is the future of developing cancer therapies, where data can be used to accelerate programs derisked identification identify combinations in patient populations faster and get life changing medicines into actual trials. So I want to express our deep credit my deep gratitude to our team are.
Speaker Change: Partners, our stakeholders for their unwavering support and especially to our clinical trial sites and to the patients participating in our trials I think together, we're lighting a way towards a brighter future in oncology and solving real world problems.
Speaker Change: That enable rapid development.
Speaker Change: Precision therapies that can alter the cost and timelines in drug discovery and very importantly place land are at the forefront of a new era of unprecedented insights.
Speaker Change: Now with that I'd like to now open the call to any questions or clarifications, but also as we do so I'd like to take a quick moment to thank our team for helping us to prepare for these calls and to prepare for a quarterly finding filings. So again, let's go ahead and take questions from our audience.
Speaker Change: I ask you to do so in one of two ways you can type your question directly into the QA tool or you can click on raise the hand.
Speaker Change: And speak directly and we will try to and mutual line. Thank you.
Okay.
Speaker Change: So you've got the first question I'll repeat the question before I answer it. Thank you John for your question.
Speaker Change: The question is from John is how is the pace and quality of enrollment and Asia compared to the U S.
Speaker Change: It is about two to forex faster they got ramped up.
Speaker Change: Faster some sites are slower than others, but in terms of output just in this past.
Speaker Change: Few months, we saw.
Speaker Change: An equal amount of output from Asia as we saw in the U S. But of course their timeline from.
Speaker Change: From Onboarding to first patient was phenomenally faster.
Speaker Change: And it's just accelerating so I think.
Speaker Change: It'll be three to four X faster ultimately this year because of Asia great question.
Next question is.
Speaker Change: From.
Speaker Change: John also.
Speaker Change: In the ADC realm.
Speaker Change: And with help from radar what are the opportunities for Adcs.
Speaker Change: That substitute the toxic payload.
Speaker Change: Another immunotherapy.
Speaker Change: So with another with a minimum.
Speaker Change: Well it depends on what kind of.
Speaker Change: Immunotherapy, whether it's in modulating agent or binding.
Speaker Change: I think doing an antibody antibody con.
Speaker Change: Conjugate is potentially challenging.
Speaker Change: But if you do it with a small molecule that's in immuno modulating agent like an IL agent or others.
Speaker Change: Yes, it's possible you're going to start seeing many of those youre going to see that one of the things that we're actually looking at its a great question John is actually.
Speaker Change: Things that have multiple payloads, so more than one payload. So that's actually very exciting it's a space that.
Speaker Change: Probably not on our plate right now, but I do think that design of multi payload mulct by a multi payload in bi specifics with multi payloads is definitely going to be in the future. You may have payloads that are.
Speaker Change: Both immuno modulating and also.
Speaker Change: <unk>.
Speaker Change: Toxic so I think you're going to see a lot of innovation now.
Speaker Change: The challenges of course always then testing those because right now one of the most expensive points and testing Adcs is testing them in the nonhuman primates.
Speaker Change: So how you test in nonhuman primates for some of these more complex architectures that are being imagined.
Speaker Change: We will be something that we got to sort out, but yes, theoretically that's definitely doable I requires a level of precision biology and data collection that is just beginning to happen. So that's perfect area for AI. Some wonderful question.
Speaker Change: I'm going to turn it over.
Chad: Too Chad.
Chad: Yeah, Hi, Todd Thank you.
Chad: Just wondering for the harmonic update and.
Chad: Later this year that we expect to get if you could just set the stage.
Chad: Or where do you guys think you're going to be how much do you think youre going to have what should look what we should look for.
Chad: That update.
Chad: Okay.
Chad: Sir your question was on harmonic data correct.
Chad: Correct.
Chad: Yeah. So we are in.
Chad: Enrolled.
Chad: A nice chunk of patients in Asia and also in the U S. In the last few months so.
Chad: We are continuing to seeing the same kind of trend in terms of the clinical benefit.
Chad: We hope to have a <unk>.
Chad: Nice chunk of patients that will have multiple.
Chad: <unk>.
Chad: Yeah.
Chad: Scans in terms of the resist criteria. So I think sometime in mid to late Q2, we'll have the next readout, but the key one will come at 30 events. So if we have 30 events.
Chad: That will probably be closer to the end of the year and that'll be an important time, because then we'll be able to decide do we take this into a larger larger trial and also will give confidence that we'll have data enough data to partner out the asset, but we will probably do something.
Chad: More near term to kind of showcase that the trends that we saw in the early cohort are continuing.
Chad: And the existing cohort, which has included a lot of patients from Japan and Taiwan.
Chad: Okay, and then if I may just.
Chad: A follow up in a different direction on your ADC programs.
Chad: What should we be looking for next.
Chad: Obviously, yes, there'll be two things.
Chad: We've talked about that we made a conscious effort on this call not to focus on it because we wanted to focus more on the the clinical assets and.
Chad: Some of the other AI features but we've got some exciting preclinical data that we're validating we put out some data last year in terms of her too low in her two medium, but definitely hurt too low expressing cancers, where we saw tremendous potency several fold higher than existing FDA approved agents.
Chad: With our crypto <unk> linked.
Chad: ADC that we've designed we also have another one that's in the.
Chad:
Chad: Allude in Nassau fulfill family that we're working on some.
Chad: Very exciting new payloads that are Super Super potent 100 to 500 times more potent than <unk> 84.
Chad: And we have some targets in mind, so we'll have more preclinical data as the year progresses and.
Chad: And we also will announced a couple of partnerships with groups that are using our ADC AI platform.
Chad: As an analytical tool.
Chad: So those are the two things to expect.
Chad: Thank you.
Chad: We've got a great question.
Chad: From play Eitan.
Chad: So clay asked a question about providing results and L. P 184 in Q4.
Chad: And it was pushed one will you provide results. That's a great question on the 184 data clay. So the 184 data originally it was expected in Q4.
Chad: Because we expected to see.
Chad: MTGE around dose level minor 10, what's mostly changes that the enrolment has gone to a higher dose levels and so that's basically added to the time so.
Chad: The calculations for PK and availability of the drug seem to end up more like rats than dogs. So our thought was.
Chad: Probably end up somewhere in between but were definitely much more like rats in terms of the.
Chad: The amount of drug that humans can take.
Chad: That's actually a good thing because we're seeing higher therapeutic.
Chad: Sorry, a higher likelihood of having therapeutic doses at these higher cohorts these double digit cohorts, where now <unk>.
Cohort of 11, 12, and so each cohort takes about a month and so that's exactly why.
Chad: We see that so nothing other than the.
Chad: The dose levels have gone higher and we haven't seen any.
Chad: Significant.
Chad: Serious adverse events.
Chad: And we're now just beginning to see therapeutic levels of efficacy so.
Chad: That's added to the time.
Chad: Hopefully that answers your question.
Chad: Next question.
Chad:
Chad: Is on the.
Chad: Dosing cohorts <unk> 11, and 12 I believe the dose is.
Chad: As a 0.61.
Chad: Mg.
Chad: I believe it's six one.
Chad: I will have to.
Chad: I'll get back to them or their dominance looked at ups and Mike.
Chad: But I believe it's <unk> six <unk>.
Chad: Per kg, but let's let's find that out right now.
Chad: We looked at up I'm going to take another question.
Speaker Change: From anonymous attendee, when we'll likely we see star for pediatrics.
Chad: Wonderful question.
Speaker Change: We're working very closely with the poetic.
Speaker Change: The consortium, we're very close to getting a protocol that everyone can agree too for pediatrics.
Speaker Change: Brain cancers, Dr. Marc Chamberlain and <unk>.
Sandra: Sandra leading up to it efforts to interact with the poetic consortium.
Speaker Change: I think.
Speaker Change: We will probably see that.
Speaker Change: Mid to late this year.
Speaker Change: So we do have a protocol that seems to have enough people around the table.
Speaker Change: And we'll be able to then exploit the rare pediatric disease designations and hopefully march towards.
Speaker Change: Getting our drug to patients and part of that also has to have a.
Speaker Change: Clear signal in adult.
Speaker Change: Gliomas.
Speaker Change: We think those two factors will be easily checkmark.
Speaker Change: And so we will then launch into pediatrics horizontal subject to.
Speaker Change: The right approvals.
Speaker Change: Our next question is.
Luka: Oh from Luka Luka. Thank you very much for your question and I'll answer it says.
Luka: What is missing to sign deals with other firms to discover new drugs.
Luka: Yes, great question.
Luka: Luca.
Luka: We constantly look for deals I think if there are deals out there I think we'd love to do it. There is you know I think partly is it does take a lot of.
Luka: Financial but really actual people resources, if you want to do this for others, they're going to pay you on an hourly or as a target amount.
Luka: And so as a small company.
Luka: Bear in mind.
Luka: Our scientists and data engineers are somewhat limited.
Luka: So we have focused on our own pipeline, but yeah, we'd like we'd love to focus more on other people's pipeline long as theyre willing to pay us for it I don't think our shareholders want us to do a lot of work unless we get either equity and the drug or and get reimbursed significantly so.
Luka: I think we're happy to have discussions.
Luka: So yeah. Thank you great question I mean, I think if there are there are definitely conversations we had they usually tend to breakdown.
Luka: Really around.
Luka: Are they willing to give us enough equity in the molecule or enough upside to make it worth our while for us to stop.
Luka: <unk> working on our programs.
Luka: But again one of the things that we're doing now is using a gentex AI architecture to take some of these more simple initial analytic modules and put them out to the public. So that's something that we plan on doing with three or four of these modules the blood brain barrier module.
Luka: ADC module or aspects of the ADC module.
Luka: Some of the modules around differential gene expression and transcript gnomic analysis, and a very exciting project codenamed data that we'll be talking more about in the next 45 to 60 days.
Luka: Thank you.
Luka: Yes.
Speaker Change: Great question from Michael <unk>, Michael asked the question have we reached out to Amazon.
Speaker Change: Yeah, we've had a lot of discussions with Amazon.
Speaker Change: Unfortunately, probably not at the right levels, but we've done a lot of education of Amazon about how big pharma needs are very different from drug developer kind of needs.
Speaker Change: And they're you know, they're very good at kind of thinking about data storage in making data available but the.
Speaker Change: The problems that we solve tend to be more.
Speaker Change: Computation, rather than compute intensive rather than necessarily just data intensive and data storage intensive, but yeah I think <unk>.
Speaker Change: Groups like Amazon like Nvidia are beginning to understand the potential this has but again, we're looking for people who would love to help us have those conversations with big Tech and part of our goal in making the <unk> architecture is publicly available is to drive those conversations.
Speaker Change: Thank you for that question.
Speaker Change: So again, please raise your hand, if you have a question.
Speaker Change: We can put you live like we did with Chad or please enter into the chat window.
Speaker Change: I think we have a question on the dose levels. So that was from just to respond to the cloud So do what you want.
Speaker Change: Yeah Clay I think you'd asked a question about the dose levels for 184, and the current dose level 12.
Speaker Change: Is 0.61 milligrams per kilogram. So that's that's where we are now.
Speaker Change: Hopefully that answers your question.
Speaker Change: Raise your hand right.
Speaker Change: And we're at what percentage dose level.
Speaker Change:
Speaker Change: We're increasing from dose of it as a 25%.
Speaker Change: Because that's what the ROE at 25% level. So I think it was 150 and 33% or 20, I think we're at 25% increase.
Speaker Change: Okay, well I would love to.
Speaker Change: Answer.
Speaker Change: Answer any other questions as they come in.
Speaker Change: We think we're well positioned for the year, we've got multiple Readouts. We believe we're getting very close to some of the.
Speaker Change: Final cohorts for both 184.
Speaker Change: And approaching $2 four later this year.
Speaker Change: We will have data at least once maybe twice for 300.
Speaker Change: Once as we get the next big chunk of it.
Speaker Change: Data from the current subjects that have been enrolled.
Speaker Change: We will also have.
Speaker Change: In that update will Usher also have updates from the initial lead in cohort.
Speaker Change: So we'll have some exciting data report on those initial patients where we saw.
Speaker Change: The 86% clinical benefit rate as well, so that'll be coming more near term and then the larger.
Speaker Change: Report on 300, probably later in the year as we get 30.
Speaker Change: Events.
Speaker Change: So thank you everyone.
Speaker Change: And I look forward to talking with many of you in upcoming meetings for one on ones.
Speaker Change: Thank you for your time today and thank you to the landrum team as well thanks very much.