Q3 2024 Lantern Pharma Inc Earnings Call
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David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
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David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
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Speaker Change: Good afternoon and welcome to our third quarter 2024 earnings call.
Speaker Change: 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.
Speaker Change: We issued a press release after market closed today summarizing our financial results and progress across the company for the third quarter ended September 30, 2024.
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 we'll 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 Securities 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.
David Margrave, Reggie Ewesuedo
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 10-K.
for the year ended December 31st.
Speaker Change: 2023, which is on file with the SEC and available on our website.
Speaker Change: Forward-looking statements made on this conference call are as of today, November 7, 2024, and Lantern Pharma does not intend to update any of these forward-looking statements to reflect events from circumstances that occur after today unless required by law.
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 members of management.
Panna Sharma: Panna will start things off with introductions and an overview of Lantern's strategy and business model, and highlight recent achievements in our operations, followed by discussions of our financial results and our R&D efforts.
Speaker Change: I'd now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
Speaker Change: Good afternoon and thank you for joining Lantern Pharma's third quarter 2024 earnings call. Today I'll share our continued progress in advancing our AI-guided clinical programs and discuss our financial results.
The pharmaceutical industry is experiencing a fundamental transformation.
Speaker Change: AI and computational approaches are no longer optional tools. They have become essential drivers of innovation across the entire drug development spectrum.
Speaker Change: From molecular design to patient selection, from manufacturing to clinical trial execution, AI is revolutionizing how we develop life-changing therapies.
David Margrave, Reggie Ewesuedo
Speaker Change: Since our IPO in 2020, our Radar AI platform has enabled us to generate and advance 14 drug programs at a fraction of the cost of traditional drug development.
Speaker Change: More importantly, we've demonstrated the ability to consistently progress these AI-guided candidates.
Speaker Change: into actual patient trials, something very few other AI companies have done, including our ongoing phase two harmonic trial and our phase one programs for both LP184 and LP284.
Speaker Change: This quarter validates our AI-driven approach with significant clinical progress across multiple programs, including encouraging early data from our Harmonic trial and the recent FDA Fast-Track designation for LP184 in glioblastoma.
Speaker Change: These achievements underscore how our technology-first approach is accelerating the development of precision cancer therapies while maintaining capital efficiency.
Speaker Change: Our dedicated teams remain laser focused on our mission to transform cancer patients lives while dramatically reducing the time and cost of oncology drug development.
Speaker Change: A commitment that drives every aspect of our work and is reflected in the momentum we're building across our pipeline.
David Margrave, Reggie Ewesuedo
Speaker Change: Our company's leadership and the innovative use of AI machine learning to transform costs and timelines
Speaker Change: in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric and data-first approach to drug development.
Speaker Change: Let me start with a high-level view of our clinical progress. We currently have three precision oncology drug candidates advancing through clinical trials, all guided by our Radar AI platform.
Speaker Change: These include both Phase I and Phase II programs, and alongside these clinical programs, we're evaluating several promising ADC candidates in preclinical development, many of which have come from our AI-driven ADC module.
I'm particularly excited to share updates on our Harmonic trial.
Speaker Change: which is testing LP300. The initial data has been very encouraging and we detailed that in our last earnings call.
Speaker Change: In our first seven patients, we saw an 86% clinical benefit rate. To put this in perspective, these are never-smoker patients with non-small-cell lung cancer who have limited treatment options.
Speaker Change: So these early signals are particularly meaningful, especially since they cover a wide range of prior kinase mutations.
We continue to enroll additional patients across our U.S. sites.
Speaker Change: But also, we've made significant strides in expanding our monoctrial into Asia, specifically Japan and Taiwan. This expansion is strategically important because in these countries never-smoker lung cancer represents a much larger portion of all lung cancer cases. About one-third
Speaker Change: of new cases compared to what we see in Western countries, which is about 15 to 20 percent.
Speaker Change: This expansion not only accelerates our enrollment in the trial overall, but also positions LP300 in regions where the medical need is particularly high.
Speaker Change: Now, let me turn to our synthetic lethal drug candidates, LP184 and LP284. Both are first in human phase 1A trials, and they continue to show strong progress and are unrolling across centers in the U.S.
Speaker Change: We've now dosed over 50 patients across both programs, and importantly, we haven't observed any dose-limiting toxicities in any of our patient cohorts.
Speaker Change: This safety profile is particularly encouraging as we advance these programs clinically and sharpen the indications and clinical positioning of these highly potent drug candidates.
Speaker Change: We also received exciting news this quarter regarding LP184, which many of you know will be developed as STAR-001 in CNS and brain cancer indications through our wholly owned subsidiary Starlight Therapeutics.
Speaker Change: The FDA granted us fast-track designation for glioblastoma or GBM. This designation not only demonstrates the significant unmet need in GBM, but also provides potential opportunities to expedite development and drive greater commercial value for a molecule.
David Margrave, Reggie Ewesuedo
Speaker Change: Speaking of GBM, we've been successfully enrolling recurrent GBM patients in our existing Phase 1a trial for LP184 across three sites.
Speaker Change: to prestigious academic centers, including Johns Hopkins Medicine and Indiana University, and one community site. The data we're gathering from these GBM patients is particularly valuable, as it will inform our development.
Speaker Change: for future clinical trials including phase 1b2 trials which Starlight Therapeutics expects to initiate in 2025 or any investigator-led initiatives that we undertake.
Speaker Change: This represents a significant step forward in our CMS cancer program, where effective treatment options are severely limited. At the same time, investors in Lantern will potentially benefit as we look to further develop and finance Starlight Therapeutics.
Speaker Change: I'd like to highlight now some particularly exciting opportunities, developments in our biomarker program. As many of you know, PTGR1 was initially identified to our radar AI platform as a key biomarker for LP184 response.
Speaker Change: This discovery represents one of our platform's most significant predictive insights, demonstrating how AI can identify precise biological mechanisms that drive drug response.
Speaker Change: We've now begun analyzing PTGR1 expression using qPCR in patient samples from our first seven cohorts in the LP184 Phase 1a trial.
Speaker Change: This analysis is crucial because it will help validate our AI-driven hypothesis that has been validated in vitro and in vivo and also through CRISPR experimentation. But now we can also validate it in human clinical trials.
Speaker Change: This data will allow us to better predict which patients are most likely to respond to treatment and perhaps even look at monitoring progress and sensitivity to our drug.
Speaker Change: We also received very important regulatory recognition this quarter, with three new FDA rare pediatric designations for LP184. This is in addition to the existing one for ATRT.
Speaker Change: The three new designations were all in ultra-rare childhood cancers. These designations are particularly significant because each one carries the potential to receive a Priority Review Voucher, or PRV, upon FDA approval.
Speaker Change: For those who may not be familiar with PRVs, they're transferable assets that can be sold to other pharmaceutical companies and have historically been valued in excess of 100 million dollars.
Speaker Change: We have four of these. Each PRV allows its holder to accelerate FDA review of a future drug candidate, making them highly valuable assets in the biopharma industry.
Speaker Change: The fact that LP 84 has received these designations not only underscores its potential impact in areas of high unmet need Amongst children, but particularly where these treatment options are often limited or have no options
Speaker Change: This was valuable for patients, but also potentially valuable as future value for our shareholders and our future programs.
Speaker Change: Our scientific team has been particularly productive this quarter with three significant publications and presentations and numerous insights about how to guide our drug into future combination trials.
Speaker Change: Our Chief Scientific Officer, Dr. Kishore Bhatia, will provide additional details around these and other areas that will be important for our future work.
Speaker Change: This past quarter, we published a peer-reviewed paper highlighting our novel AI-powered approach to ADC development using the Radar platform, an area of growing interest in the oncology community.
Speaker Change: We also presented new findings about our synthetic lethal drug candidate at two major conferences. The Immuno-Oncology Summit, where we shared exciting data about the role of LP-184 in synergy with anti-PD-1 drugs.
Speaker Change: and at the Society of Hematologic Oncology where we presented insights regarding LP-284.
Speaker Change: These presentations generated significant interest from collaborators, pharma companies, and also helped strengthen our AI-driven approach to drug development by giving us insights, models, and new data.
Speaker Change: We'll also get more details today from my colleague David Margrave, our CFO today, on our financial position and operations. At a top level, Lantern closed the quarter with approximately $28.1 million in cash, cash equivalents, and marketable securities.
Speaker Change: And we used approximately $4.5 million in operations this past third quarter.
David Margrave: So I'm going to hand this over now to David to talk in more detail about our finance and operations. David? Thank you, Panna, and good afternoon everyone. I will now share some financial highlights from our third quarter ended September 30, 2024.
David Margrave: We recorded a net loss of approximately $4.5 million for the third quarter of 2024, or 42 cents per share.
David Margrave: compared to a net loss of approximately $3.2 million, or 29 cents per share, for the third quarter of 2023.
David Margrave: For the third quarter of 2024, our R&D expenses were approximately $3.7 million, up from approximately $2.2 million for the third quarter of 2023.
David Margrave: This increase was largely driven by an increase in clinical trial activity.
David Margrave: Our general and administrative expenses for the third quarter of 2024 were approximately $1.5 million, up slightly from approximately $1.3 million for the third quarter of 2023.
David Margrave: The increase was primarily attributable to increases in professional fees and increased patent and legal fees.
David Margrave: Our R&D expenses continue to exceed our G&A expenses by a strong margin, reflecting our focus on advancing our product candidates in the pipeline.
David Margrave, Reggie Ewesuedo
David Margrave: Our loss from operations in the third quarter of 2024 was partially offset by interest income and other income net.
David Margrave: totaling approximately $674,000 as compared to a loss offset from interest income and other income net of approximately $362,000 for the third quarter of 2023.
David Margrave: Our cash position, which includes cash equivalents and marketable securities, was approximately $28.1 million as of September 30, 2024.
David Margrave: We anticipate this balance will provide us with a cash runway into at least late 2025.
David Margrave: Importantly, we believe our solid financial position will fuel continued growth and evolution of our RadarAR platform.
David Margrave: continue the development of our portfolio of targeted oncology drug candidates and allow us to introduce additional targeted programs and collaboration opportunities efficiently and effectively.
David Margrave: As of September 30, 2024, we had 10,784,725 shares of common stock outstanding.
David Margrave: Outstanding warrants to purchase 70,000 shares and outstanding options to purchase 1,274,546 shares.
David Margrave, Reggie Ewesuedo
David Margrave: These warrants and options, combined with our outstanding shares of common stock.
Speaker Change: Our team at Lantern continues to be very productive under a hybrid operating model. We currently have approximately 24 employees and four FTE consultants focused primarily on leading and advancing our research and drug development efforts.
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
Speaker Change: Many of the initial observations made with the help of radar are now being brought forth into the clinic, as you can see in our portfolio slide.
that's being presented. As many of you know,
Speaker Change: Radar has guided the rapid and efficient development of three AI-guided drug candidates into ongoing clinical trials.
and these clinical trials mature and continue to enroll patients.
Speaker Change: We expect to leverage our internal clinical operations capabilities across these trials and functions, making efficient use of our capital while lowering dependency on external higher cost providers.
Additionally, we believe having more direct internal ownership
not only reduces our overall financial expenditures,
Speaker Change: but also gives our team greater ownership, control, and access to current information, sites, and day-to-day activity in the hospitals and cancer centers relating to our trials.
Speaker Change: This, we believe, will strengthen our company and allow us to capitalize on observations and decrease our external costs.
Speaker Change: We are fortunate to have developed a dedicated, highly motivated clinical operations team with alignment around our core values to help us in the efficient management and maturation of these clinical trials across LP300, both in the US and Asia.
and our first in human drug candidates, LP184 and LP284.
Panna Sharma: I'll now turn the call back to Panna for an update on Starlight and its focus on CNS and brain cancers.
David Margrave, Reggie Ewesuedo
David Margrave, Reggie Ewesuedo
Speaker Change: Thanks David. We also continue to make significant progress on the launch of our clinical stage CNS and brain cancer focused subsidiary Starlight Therapeutics. This is a company that has been largely developed as a result of big data and AI.
Speaker Change: The method and computational approaches to uncover the indications and optimize the use of LP184 for brain and CNS cancers.
David Margrave, Reggie Ewesuedo
Speaker Change: Notably, we have started initiating site selection for the upcoming Phase 1b and Phase 2 trials, especially in recurrent IDH wild types.
settings.
Speaker Change: If you have not reviewed our webinar Wednesdays regarding Starlight, I would definitely urge you all to listen to the webinars. They provide details on the timing and focus of the trials.
Speaker Change: and also provide insights from Dr. Mark Chamberlain about how we expect to advance this both in adult and pediatric brain cancers.
Speaker Change: I'd like to take a moment to emphasize two significant recent developments.
that further validate our CNS cancer program.
Speaker Change: First, the FDA's Fast-Track Designation for LP184 in glioblastoma represents a crucial milestone. This designation is particularly meaningful because it recognizes both the serious nature of GBM and the significant unmet medical need.
Speaker Change: Mitch Burger from UCSF with tears their department of Neurosurgery and directs both their brain tumor center and center for neurological injury and repair Dr. Berger's internationally recognized for his expertise and brain mapping during tumor surgery.
Speaker Change: Dr. Lisa Deangelis, who serves as chief physician executive at Memorial Sloan Kettering Cancer Center, where she oversees all clinical operations across their network of sites.
Speaker Change: He's an internationally recognized expert in brain cancer and help establish memorial Sloan Kettering is brain tumor center.
Speaker Change: Dr. Stuart Grossman from Johns Hopkins, and Kimmel, Sidney Kimmel Cancer Center, who co leads their brain cancer program and brings over 22 years of experience directing NCI funded brain tumor consortia and lastly, but definitely not least in the least Dr. John with Tara also from Johns Hopkins, who co director of the <unk>.
Speaker Change: Cancer program and is internationally recognized for his work on mechanisms of brain tumor malignancy. Dr. <unk> has been an early supporter. It has encouraged us to pursue this indication and has helped our research efforts and continues to help guide combination regiment ideas that we think will be significant in the clinical setting.
Speaker Change: My colleague Dr. <unk> will discuss those later today in our webinar.
Speaker Change: The Starlet Advisory Board, which includes two recipients of the society for Neuro Oncology Lifetime Achievement Award brings unprecedented expertise to guide our CNS cancer programs their willingness to join our advisory Board speaks volumes about the potential they see in our approach to treating these devastating cancers let.
Speaker Change: Let me walk you through some of our progress now with the synthetic lethal drug candidates L. P 184, and LP acuity for the phase one a basket trial for L. P. One before we've now completed nine cohorts with escalating doses, we haven't seen any dose limiting toxicities were actively enrolling patients across multiple solid tumor types, including those that have high <unk> electric.
Speaker Change: Negative GBM in pancreatic cancer and now we're zeroed in on tumor that have DNA damage response efficiency based on our pharmacokinetic analysis, we're approaching an exciting milestone our upcoming cohorts should reach dosage levels, where we expect to see therapeutic concentrations of our drug candidate L. P 184 and <unk>.
Speaker Change: <unk> impact on the cancers.
Speaker Change: We anticipate completing enrollment by year end or in January with initial safety and molecular correlation data expected either late this year or during early 2025, I'm, particularly excited about our progress in developing a companion diagnostic for <unk> four we're advancing a quantitative PCR based test that can help us identify the.
Speaker Change: <unk>, most likely to respond to treatment.
Speaker Change: The ones that have <unk> above a certain threshold, which is a key aspect of our precision medicine approach. We're currently validating this assay using patient samples, but also now using them in the first seven cohorts in the phase I trial. These electric correlations will that will be invaluable in designing our future trials and helping us select patients.
Speaker Change: The combination of clinical progress and diagnostic development exemplifies our comprehensive approach to drug development, where we're not just advancing a therapeutic candidate, but also developing the tools to identify the right patients for treatment.
Speaker Change: Turning to our LP acuity for program, which targets hematologic cancers, we're making equally exciting progress. We're currently dosing our fourth cohort again and escalating doses in the phase Iia trial in like 184 were seeing favorable safety profile with no dose limiting toxicities.
Speaker Change: Highlight why we're excited about 284 remarkable potency in animal or range for multiple blood cancer types, but specifically in mantle cell and double hit lymphomas, both very aggressive NHL subtypes, particularly those that have ATM mutations to put this opportunity in perspective, we're targeting an area of significant level.
Speaker Change: Nearly all mantle cell and double hit lymphoma patients and in general high grade B cell lymphomas again, we received two orphan designations for this drug eventually relapsed after current standard treatments the market opportunity is substantial in the U S and Europe alone.
Speaker Change: 16% to 20000, new patients annually about a market exceeding somewhere in the range of $2 $83 billion.
Just in your U S and Europe alone. We're now in the process of expanding our trial to additional hematologic hematology focused sites, which we expect will accelerate our enrollment through the end of this year.
Speaker Change: Based on our current trajectory, we believe we can advance to phase, one b or future phases like phase II by early to mid 2025, when we look at both L. P 184, and 2004 together. These are sister molecule, we're seeing consistent patterns of Validators synthetic lethal approach strong safety profiles and encouraging signs of biological activity and the potential.
Speaker Change: <unk> to address significant unmet cancers, where oftentimes there is no cure in the later stage setting.
Speaker Change: These are very exciting.
Speaker Change: This kind of excitement has helped US do one very important thing, which is secure 11 FDA designation fast track designation and orphan drug designation and rare pediatric disease designations. This is a strong testament to our data driven rapid and focused drug development initiatives. We believe this will aid in more frequent guidance an interaction with the <unk>.
Speaker Change: D E and also strengthen our commercial value and talks with partners and clinicians during adoption.
With our harmonic trial L. P 300, the data has been very encouraging.
Speaker Change: And more importantly, this is for patients where there is no real.
Speaker Change: Treatment options today.
Speaker Change: After they fail kinase therapies that very limited treatment options. So these early signals don't have small group are particularly meaningful we also see a diverse set of patients in the U S with a varying range of kinase mutations and also with low to intermediate tumor mutation burden, we should have some interesting implications for biomarker based selection our monarch.
Speaker Change: Stirring as we mature the drug candidate, we continue to enroll patients across our U S sites and are also expanding to Asia, and Japan, and Taiwan as I've stated earlier, and East Asia, including Taiwan, Japan, and South Korea, nearly 40% of new cases now in non small cell lung cancer are amongst ever smokers. This is a remarkable percentage and underscores.
Speaker Change: Our commitment to expanding harmonic trial to where it's needed in these countries. We're opening up 10 sites in Asia, five in Japan, and Taiwan, and very importantly, working closer to the top kols in each country. Dr. <unk> at the National Cancer Center in Japan National Cancer Center, Japan in Tokyo and Dr. Lee at the National chain come University Hospital.
Speaker Change: Located in Tainan City in Taiwan, and the majority of East Asia East Asia, Egfr mutations comprise a significant an overwhelming percentage of the <unk> kinase mutations among never smokers, we've already seen some early signs of efficacy in our initial cohort.
Speaker Change: Now this is important because we think this represents an important opportunity in Asia, where we've now begun discussions regarding partnering licensing or co development of this asset and that geography, now I'll turn the call over to our Chief Scientific Officer, <unk>, <unk>, who will provide an overview of.
Speaker Change: Our R&D update and speak specifically to a number of highly promising combination regiments for LP won 84 ones that had been shaped and informed and guided by radar, but now will help shape future clinical trials that will be very meaningful for sure.
Speaker Change: Thank you Bruno.
Speaker Change: As we accrue clinical data and define the <unk> phase one clinical trial, we are actively pursuing additional areas of R&D and contribute to further successes of LP one in April.
Speaker Change: Agenda consensus that has emerged from collective experiences and oncology has been that successful treatments are most likely to be visible combination therapeutics rather than monotherapy.
Speaker Change: With this in mind, we are setting the optimal selection of potential agents to combine with <unk> hundred 84, which enhance the efficacy of the treatment have lithium if any overlapping toxicity as well as expand indications.
For the past year, our radar translational and clinical teams have advanced these immediate needs.
Speaker Change: Towards fulfilling these rapidly we are also engaged with several expert collaborators that are shown in the slide deck is being displayed and these include scientists from MD Anderson.
Speaker Change: Certain messages as Boston, Johns Hopkins, and the New CEO, Texas San Antonio.
Speaker Change: Today, I'm going to talk about three distinct LP related for combinations.
Speaker Change: Two of which on an excellent annotate protocol development by the clinical team.
Speaker Change: I won't have time to show data, but can mention here that new unique combinations were <unk> 84.
Speaker Change: Emerging from both radar and bend the studies, the latter including the spud analysis steady.
Speaker Change: Studies.
Speaker Change: So a significant aspect of gander damage that results from tumor specific BTG are one item. These patients while we see now we have.
Speaker Change: Baidu assay.
Speaker Change: Rich.
Speaker Change: These positive by activation of <unk> hundred 80 photo and tumor cells is that it ends up in the formation of the wholesale rates.
Speaker Change: When testing with <unk> for cancer cell, therefore need to engage multiple repair factor in parkways beyond transcription copper nickel attended feed into bed.
Speaker Change: DSP is clearly required to that pension of homologous recombination repair Barclays.
Speaker Change: It was therefore expected that there'll be 184 demonstrated synthetically facility in numerous deficient in such properties, including mutations affecting <unk> and Black Hawk.
Speaker Change: And particularly utility of LPL in April.
Speaker Change: Extends beyond the classical BRCA mutant tumors and also includes tumors with black on this such as those with mutations in at least known genes involved in the homologous recombination pathway.
Speaker Change: What has been surprising has been the evidence that <unk> hundred 84, Synergizes with PARP inhibitors, both in HRD, but also in below the target tumors that have become PARP inhibitor resistant.
Speaker Change: This slide shows that bipolar lower doses of <unk> hundred 80 before are sufficient to achieve 3% to 14 for greater regulation.
Speaker Change: Care to elaborate alone do most muted it either in <unk> or black card.
Speaker Change: I would particularly like to draw your attention to the synergies seen in both tumors with low dose <unk> Paul.
Speaker Change: I Wonder if you look at the tumor on the right, which as you can see is resistant to all up room is wiped out by the 184 at two milligrams per kg and when you combine all approved with less than one fourth of this <unk> growth. This do more no loses its effectiveness to PARP inhibitors.
Speaker Change: The likelihood of success of this potential is further supported by similar data generated by our independent collaborators at UCF, Massachusetts Boston.
Speaker Change: Also have suggested at least known Mccann event involving depletion of IPA as one of the drivers of the synergy.
Speaker Change: Our combination with PARP inhibitors.
Speaker Change: That can make spark resistant tumors sensitive is therefore significant advantage, but it will be 180 basis.
Speaker Change: We are particularly excited by the provincial of such a combination and have developed a protocol to actively test. This in a phase <unk> clinical trial.
Speaker Change: There are several reasons why <unk> might be an exceptional combinatorial agent for PARP inhibitors with come from understanding the PARP inhibitor resistant backgrounds.
Speaker Change: This next slide identified factors that have been discount can be associated with that instance, bogged inhibitors with respect to really look at where all three whatsapp or data suggests that it'll be 184 effectively combat. These factors even in the presence of gene conversion LP. When they report has been effect.
Speaker Change: Dave.
Speaker Change: Lots of helium complex.
Speaker Change: <unk> allows tumors to become resistant to PARP inhibitors actually makes chemo sensitive that'd be one in April.
Speaker Change: Edison insights have been David agnostic Regeneron will be eliminated book and slapping the 11.
Speaker Change: <unk> second 11, impairs prolong their phase I rested upon <unk> exposure, thereby reducing resistance, but slapping 11 loss does not have incentive duty to LPL in April what this means in practical films is that when using combination with bogs inhibitors LP money before it is highly indicative.
Speaker Change: Not only for synergy, but also for reducing the resistance to bump inhibitors.
Speaker Change: The other molecule that we're proposing to the clinic as a combinatorial partner of LP. What April is a drug that has extensive clinical experience, albeit from non oncology indications.
Speaker Change: This vote spironolactone.
Speaker Change: <unk> FDA approved drugs used for various indications included hypotension in acne.
Speaker Change: What you are specifically to visitor while multiple observations all with the most important was headed into business with discovery.
<unk> targets <unk> III to degrade it.
Speaker Change: The scientific rationale and reasoning of combining Elpida 184, with spironolactone was fully justified by a battery of preclinical studies Vienna collaborative conducted.
Speaker Change: In this slide and the bulk sale you can see that spironolactone increases sensitivity of GBM cell lines to help you on 94 three to six fold.
Speaker Change: While this facility means that even in settings, where then we lower bioavailability of LP dollars 80 for the combination can result in sustained DNA damage as you can see in bandwidth b and that these effects poorly with a significant reduction in the reserve booking <unk> shown in panel <unk>.
Speaker Change: Not surprising therefore.
Speaker Change: The combination resulted in excellent responses in in vivo Glioblastoma models with most skills.
Speaker Change: Only one of five two months showed recurrence to the combination.
Speaker Change: In order to use this combination clinically we need to better understand the time window will help you when they report should be administered.
Speaker Change: Following spironolactone treatment. So we gathered over several time gold studies.
Speaker Change: In this slide we demonstrate that <unk> is at its lowest level.
Speaker Change: Both our total <unk> and subcutaneous <unk>.
Speaker Change: <unk> zero graft at eight hours after spironolactone administration relative human equivalent of 200 milligrams per kg.
Speaker Change: In addition to the Durban Soma.
Speaker Change: Communist on spironolactone enhances activity of LP when they report in other select humor types, including <unk> pancreatic cancer in vivo Kansas.
Speaker Change: Even though we have began to often do you do.
Speaker Change: <unk> designation and the lack of any approved therapy for <unk>, we are particularly enthusiastic of the clinical studies in the PRT and are in active discussions with several pediatric neuro oncology groups, including loyalty and children's oncology group.
Speaker Change: Yeah.
I will now shift to the third population, we are exploring which is combining <unk> with immune checkpoint inhibitors.
Speaker Change: We have previously observed.
Speaker Change: And our studio DNA strand breaks the accumulation of cycle really in DNA <unk> sales volume is <unk> hundred 84 treatment.
Speaker Change: This figure would suggest SB 184, as an immune activating molecule as well.
Speaker Change: To test the potential of LP wondering before combine checkpoint inhibitors being developed in collaboration with Dr. Lin at MD Anderson.
Speaker Change: As previously shown that involvement of replication threat defense.
Speaker Change: Lifts with immuno responsive tumors.
Speaker Change: Patois could be pharmacologically induce this replication steps.
Speaker Change: In response to your bank and therefore extend the benefits of immune checkpoint inhibitor from a wider patient population.
Speaker Change: Haplophase, therefore that LP when it for treatment.
Speaker Change: Scalade replicating fast level, working with E&P in BDC and induce replications responsive.
Speaker Change: As you can see on the slide when L. P 184 cells assessed for induction of replication, Japan compared to a similar effects induced by what would be expected from a cell cycle checkpoint inhibitor.
Speaker Change: Result showed a 60% of related deferred increase.
Speaker Change: <unk> increased by <unk> 84, compared to 75% with tech won at equal amyloidosis.
Speaker Change: We then tested the effects of a combination of empty PD one antibody in combination with <unk> in a murine syndromic.
Speaker Change: CNBC modeling the.
Speaker Change: The results shown in this slide.
Speaker Change: Evidence enhancement of Cumulus growth inhibition from 51% in opioid April alone <unk> tumors to 72% in the formulation.
Speaker Change: Additional studies indicate.
Speaker Change: That <unk> might actually modulate bone.
Speaker Change: Fewer micro environment as well as T cell function uniquely it appeared that <unk> reduces empty macrophages.
Speaker Change: Based upon these results we are now in discussion with video clinical investigators towards development of a clinical study in Dnb's equaled two months.
Speaker Change: Many other rationally designed combinatorial partners that are emerging from a rebound in disposable analysis set.
Speaker Change: Such as inhibitors of <unk> and Revlon, but also include molecules that are outside of the VA has been a bad Barclays one.
Speaker Change: First Barclays event, particularly like to mention because amongst demand is important.
Speaker Change: Is the oxidative phosphorylation buffet.
Speaker Change: And we hope to share with you in the near future exciting dws combinations and.
Speaker Change: And now I'll turn back to bundle.
Speaker Change: Sure. Thank you very much.
Speaker Change: As you can see we're already turning our attention now to the next phase of clinical development and pathway for our exciting drug L. P 184.
Speaker Change: We know that many of these combinations are with drugs that are part of the meaningful Arsenal and cancer, especially PD, one anti PD, one and PARP.
Speaker Change: And we expect there to be a lot of excitement in the clinical community as there has been so far in the research community, but also very importantly in the Biopharma community given the number of parts and Theyre limited range of extended use in some of these tumors and also the same with PD one.
Speaker Change: When you have a drug like <unk> 184 that can widen the therapeutic window and potentially open up new avenues, there should be a lot of excitement and potential for partnering opportunity.
Speaker Change: Let's now talk a bit about webinar Wednesday, we've had.
A lot of exciting webinars about one a month for those that have not listened in on the backdrop of these webinars have the details our last webinar Wednesday for the year will be held on December 11th not the last Wednesday of November or not the last Wednesday December but we know it's a challenging time, so we try to pick.
At the middle of the month that webinar will focus on the power of AI and drug development specifically.
Speaker Change: The use of molecular features to predict blood brain barrier permeability with radar. The webinar will discuss also future development plans, we have and the potential commercialization and commercial availability of this radar platform module, which leverages leverages extensive molecular feature analysis and enrich the proprietary models.
Speaker Change: And proprietary data according to the therapeutic data comments one of our early.
Speaker Change: Sorry, according to the therapeutic data comments.
Speaker Change: Coordinated initiative to access and evaluate artificial intelligence capability across therapeutic modalities and across stages of discovery land turns BBB algorithms are five of the top 10 performing algorithms on the leader Board.
Speaker Change: So that's very exciting that with some of our early algorithms in fact, they continue to mature and get refined and have actually matured significantly in some of their future discrimination.
Speaker Change: So we're pretty excited to talk about that on December 11th with one of our data scientists who has been working on those models.
Speaker Change: As you know 2024 has been a year of progress and accelerated progress where our insights are impacting patients in their journey to fight cancer and also influencing the development decisions and progress actually of other cancer companies, our collective efforts and dedication have fostered a transformational shift for our company setting us on an exciting trajectory.
Speaker Change: Rectory towards the future, where we are improving the lives of cancer patients with effective and affordable treatment options. As you can see the work being done by <unk> and his team and also our clinical operations team is focused on meticulous execution, we're constantly with one hand on the wheel of innovation during the fourth quarter and into next year.
Speaker Change: We will have several clinical readouts and milestones to share with our investors as we advance our pipeline and company size.
Speaker Change: <unk> said before the Golden age of AI in Medicine is just beginning and it is being powered by large scale highly available computing power massive data storage massive data collaborations and it is being said by health care patient in cancer data, which is more widely available and at increasing levels of quality.
<unk> more so than ever before.
Speaker Change: Companies that harness these capabilities in the biotech and Biopharma.
Speaker Change: Arena will.
Speaker Change: It will be long term leaders and this biotech are really now becoming more tech bio industry and we think these are companies that are well poised to create massive value for patients long term and ultimately for investors in our industry.
Speaker Change: I'd like to take a moment right now to personally thank our team for helping to prepare us for these calls to prepare the materials gathered the data provide insight and to there.
Speaker Change: Amazing dedication.
Speaker Change: It wasn't for them, we probably would have a very handicap call. So with that I'd like to now open the call to any questions or clarifications, if you'd like to ask a question you can do so one of two ways. You can type your question using the Q&A tool, where you can click on the raise hand tool to speak directly and we will and mute your line.
Speaker Change: Okay.
Speaker Change: Internally operationally, which is very important we've begun to slowly bring in but very step by step aspects of clinical operations to try to build really a world class Ninja team and clinical operations that we can use across our trials and one pool across the various functions and we think that gives us a lot of synergy reduces our external spend.
Speaker Change: But as David pointed out brings us closer in contact with our patients our clinical sites and our data. So again I think we're doing right things operationally and are very focused on maintaining.
Speaker Change: The burn rate and.
Speaker Change: In the same range that we have historically.
Speaker Change: With that I'd like to thank everyone for their time today.
Speaker Change: And I want to express my deep gratitude to our team for our partners and our stakeholders for their support and also to realize that together, we are really trying to light the way for a brighter more scalable future and oncology care and oncology drug development.