Lantern Pharma Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 7, 2024

There are 4 speakers on the call.

Operator

Good afternoon, and welcome to our Q3 2024 Earnings Call. As a reminder, this call is being recorded and all attendees are in a listen only mode. We will open the call for questions and answers after our management's presentation. A webcast replay of today's conference call will be available on our website at lanternpharma.com shortly after the call. We issued a press release after market closed today summarizing our financial results and progress across the company for the Q3 ended September 30, 2024.

Operator

A copy of this release is available through our website atlanternpharma.com where you will also find a link to the slides management will be referencing on today's call. We would like to remind everyone that remarks about future expectations, performance, estimates and prospects constitute forward looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Lantern Pharma cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated. A number of factors could cause actual results to differ materially from those indicated by forward looking statements, including results of clinical trials and the impact of competition. Additional information concerning factors that could cause actual results to differ materially from those in the forward looking statements can be found in our annual report on Form 10 ks for the year ended December 31, 2023, which is on file with the SEC and available on our website.

Operator

Forward looking statements made on this conference call are as of today, November 7, 2024 and Lantern Pharma does not intend to update any of these forward looking statements to reflect events from circumstances that occur after today unless required by law. The webcast replay of the conference call and webinar will be available on Lantern's website. On today's webcast, we have Lantern Pharma CEO, Hana Sharma and members of management. Hana 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 and D efforts. I'd now like to turn the call over to Pana Sharma, President and CEO of Lantern Pharma.

Operator

Pana, please go ahead.

Speaker 1

Good afternoon, and thank you for joining Lantern Pharma's Q3 2024 Earnings Call. Today, I'll share our continued progress advancing our AI guided clinical programs and discuss our financial results. The pharmaceutical industry is experiencing a fundamental transformation. AI and computational approaches are no longer optional tools. They have become essential drivers of innovation across the entire drug development spectrum, From molecular design to patient selection, from manufacturing to clinical trial execution, AI is revolutionizing how we develop life changing therapies.

Speaker 1

Lantern has been at the forefront of this transformation. 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. More importantly, we've demonstrated the ability to consistently progress these AI guided candidates into actual patient trials, something very few other AI companies have done, including our ongoing Phase 2 HARMONIC trial and our Phase 1 programs for both LP-one hundred and eighty four and LP-two eighty four. This quarter validates our AI driven approach with significant clinical progress across multiple programs, including encouraging early data from our HARMONIC trial and the recent FDA Fast Track designation for LP-one hundred and eighty four in glioblastoma. These achievements underscore how our technology first approach is accelerating the development of precision cancer therapies while maintaining capital efficiency.

Speaker 1

Our dedicated teams remain laser focused on our mission to transform cancer patients' lives while dramatically reducing the time and cost of oncology drug development, a commitment that drives every aspect of our work and is reflected in the momentum we're building across our pipeline. Our company's leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI centric and data first approach to drug development. Let me start with a high level view of our clinical progress. We currently have 3 precision oncology drug candidates advancing through clinical trials, all guided by our radar AI platform. These include both Phase 1 and Phase 2 programs.

Speaker 1

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 HARMONICA trial, which is testing LP300. The initial data has been very encouraging, and we detailed that in our last earnings call. In our first seven patients, we saw an 86% clinical benefit rate. To put this in perspective, these are never smoker patients with non small cell lung cancer who have limited treatment options.

Speaker 1

So these early signals are particularly meaningful, especially since they cover a wide range of prior kinase mutations. We continue to enroll additional patients across our U. S. Sites, but also we've made significant strides in expanding our MARTA trial into Asia, specifically Japan and Taiwan. This expansion is strategically important because in these countries, never smoker lung cancer represents a much larger portion of all lung cancer cases, about 1 third of new cases compared to what we see in Western countries, which is about 15% to 20%.

Speaker 1

We're establishing a total of 10 sites across Japan and Taiwan, 5 in each country. We've actually already begun onboarding the sites and we expect patients to enroll this quarter. This expansion not only accelerates our enrollment in the trial overall, but also positions LP300 in regions where the medical need is particularly high. Now let me turn to our synthetic lethal drug candidates, LP184 and LP284, both are first in human Phase Ia trials and they continue to show strong progress and are enrolling across centers in the U. S.

Speaker 1

We've now dosed over 50 patients across both programs. And importantly, we haven't observed any dose limiting toxicities in any of our patient cohorts. This safety profile is particularly encouraging as we advance these programs clinically and sharpen the indications and clinical positioning of these highly potent drug candidates. We also received exciting news this quarter regarding LP-one hundred and eighty four, which many of you know will be developed as STAR-one in CNS and brain cancer indications through our wholly owned subsidiary, Starlight Therapeutics. The FDA granted us Fast Track designation for glioblastoma or GBM.

Speaker 1

This designation not only demonstrates the significant unmet need in GBM but also provides potential opportunities to expedite development and drive greater commercial value for our molecule. Speaking of GBM, we've been successfully enrolling recurrent GBM patients in our existing Phase Ia trial for LP-one hundred and eighty four across three sites: 2 prestigious academic centers, including Johns Hopkins Medicine and Indiana University, and 1 community site. The data we're gathering from these GBM patients is particularly valuable as it will inform our development for future clinical trials, including Phase 1btwo trials, which Starlight Therapeutics expects to initiate in 2025 or any investigator led initiatives that we undertake. This represents a significant step forward in our CNS cancer program where effective treatment options are severely limited. At the same time, investors in Lantern will potentially benefit as we look to further develop and finance Starlight Therapeutics.

Speaker 1

I'd like to highlight now some particularly exciting opportunities, developments in our biomarker program. As many of you know, PTGR1 was initially identified through our radar AI platform as a key biomarker for LP184 response. This discovery represents one of our platform's most significant predictive insights, demonstrating how AI can identify precise biological mechanisms that drive drug response. We've now begun analyzing PTGRL1 expression using qPCR in patient samples from our first seven cohorts in the LP184 Phase 1a trial. This analysis is crucial because it will help validate our AI driven hypothesis that has been validated in vitro and in vivo and also through CRISPR experimentation, but now we can also validate it in human clinical trials.

Speaker 1

This data will allow us to better predict which patients are most likely to respond to treatment and perhaps even look at monitoring progress and sensitivity to our drug. We also received very important regulatory recognition this quarter with 3 new FDA rare pediatric designations for LP-one hundred and eighty four. This is in addition to the existing one for ATRT. The 3 new designations were all in ultrarare childhood cancers. These designations are particularly significant because each one carries the potential to receive a priority review voucher or PRV upon FDA approval.

Speaker 1

For those who may not be familiar with PRVs, they are transferable assets that can be sold to other pharmaceutical companies and have historically been valued in excess of $100,000,000 We have 4 of these. Each PRV allows its holder to accelerate FDA review of a future drug candidate, making them highly valuable assets in the biopharma industry. The fact that LP84 has received these designations not only underscores its potential impact in areas of high unmet need amongst children, but particularly where these treatment options are often limited or have no options. This is valuable for patients, but also potentially valuable as future value for our shareholders and our future programs. Our scientific team has been particularly productive this quarter, with 3 significant publications and presentations and numerous insights about how to guide our drug into future combination trials.

Speaker 1

Our Chief Scientific Officer, Doctor. Kishore Bhatia, will provide additional details around these and other areas that will be important for our future work. This past quarter, we published a peer reviewed paper highlighting our novel AI powered approach to ADC development using the RADAR platform, an area of growing interest in the oncology community. We also presented new findings about our synthetic lethal drug candidate at 2 major conferences: the Immuno Oncology Summit, where we shared exciting data about the role of LP-one hundred and eighty four in synergy with anti PD-one drugs and at the Society of Hematologic Oncology, where we presented insights regarding LP284. 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 1

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 $28,100,000 in cash, cash equivalents and marketable securities, and we used approximately $4,500,000 in operations this past Q3. So I'm going to hand this over now to David to talk in more detail about our finance and operations. David?

Speaker 2

Thank you, Pana, and good afternoon, everyone. I will now share some financial highlights from our Q3 ended September 30, 2024. We recorded a net loss of approximately $4,500,000 for the Q3 of 2024 or $0.42 per share compared to a net loss of approximately $3,200,000 or $0.29 per share for the Q3 of 2023. For the Q3 of 2024, our R and D expenses were approximately $3,700,000 up from approximately $2,200,000 for the Q3 of 2023. This increase was largely driven by an increase in clinical trial activity.

Speaker 2

Our general and administrative expenses for the Q3 of 2024 were approximately $1,500,000 up slightly from approximately $1,300,000 for the Q3 of 2023. The increase was primarily attributable to increases in professional fees and increased patent and legal fees. Our R and D expenses continue to exceed our G and A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Our loss from operations in the Q3 of 2024 was partially offset by interest income and other income net totaling approximately $674,000 as compared to a loss offset from interest income and other income net of approximately $362,000 for the Q3 of 2023. Our cash position, which includes cash equivalents and marketable securities, was approximately $28,100,000 as of September 30, 2024.

Speaker 2

We anticipate this balance will provide us with a cash runway into at least late 2025. Importantly, we believe our solid financial position will fuel continued growth and evolution of our Radar AR platform, continue the development of our portfolio of targeted oncology drug candidates and allow us to introduce additional targeted programs and collaboration opportunities efficiently and effectively. As of September 30, 2024, we had 10,784,725 shares of common stock outstanding, outstanding warrants to purchase 70,000 shares and outstanding options to purchase 1,274,546 shares. These warrants and options combined with our outstanding shares of common stock give us a total fully diluted shares outstanding of approximately 12,100,000 shares as of September 30, 2024. Our team at Lantern continues to be very productive under a hybrid operating model.

Speaker 2

We currently have approximately 24 employees and 4 FTE consultants focused primarily on leading and advancing our research and drug development efforts. 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, RADAR has guided the rapid and efficient development of 3 AI guided drug candidates into ongoing clinical trials. As these clinical trials mature and continue to enroll patients, we expect to leverage our internal clinical operations capabilities across these trials and functions, making efficient use of our capital while lowering dependency on external higher cost providers. Additionally, we believe having more direct internal ownership not only reduces our overall financial expenditures but also gives our team greater ownership, control and access to current information, sites and day to day activity in the hospitals and cancer centers relating to our trials.

Speaker 2

This, we believe, will strengthen our company and allow us to capitalize on observations and decrease our external costs. We are fortunate to have developed a dedicated, highly motivated clinical operations team with alignment around our core values to help us in the efficient management and maturation of these clinical trials across LP300,

Speaker 1

both in

Speaker 2

the U. S. And Asia and our 1st in human drug candidates, LP184 and LP284. I'll now turn the call back to Pana for an update on Starlight and its focus on CNS and brain cancers. Pana?

Speaker 1

Thanks, David. We also continue to make significant progress on the launch of our clinical stage CNS and brain cancer focused subsidiary, Starlight Therapeutics. This is a company that has been largely developed as a result of big data and AI. The methods and computational approaches to uncover the indications and optimize the use of LP154 for brain and CNS cancers. Notably, we have started initiating site selection for the upcoming Phase Ib and Phase II trials, especially in recurrent IVH wild type high grade gliomas like GBM and are also in discussions for the use of the drug in potentially certain settings.

Speaker 1

If you have not reviewed our webinar on Webinar Wednesdays regarding Starlight, I would definitely urge you all to listen to the webinars. They provide details on the timing and focus of the trials and also provide insights from Doctor. Mark Chamberlain about how we expect to advance this both in adult and pediatric brain cancers. I'd like to take a moment to emphasize 2 significant recent developments that further validate our CNS cancer program. First, the FDA's Fast Track designation for LP-one hundred and eighty four in glioblastoma represents a crucial milestone.

Speaker 1

This designation is particularly meaningful because it recognizes both the serious nature of GBM and the significant unmet medical need. We haven't seen a new effective single agent therapy approved for GBM in nearly 20 years. Fast Track status provides us several important advantages, including more frequent interactions with the FDA, the potential for rolling review of our future NDA, and if criteria are met, could lead to accelerated approval and priority review. These benefits could potentially shave years off our development timeline in GBM and make the asset significantly more valuable in the hands of a larger biopharma partner. Equally exciting is the formation of Starlight Therapeutics' scientific advisory board, which brings together some of the most respected minds in neuro oncology.

Speaker 1

Let me share with you the distinguished members who have joined us. Doctor. Mitchell Berger from UCSF, who chairs their department of neurosurgery and directs both their Brain Tumor Center and Center For Neurological Injury and Repair. Doctor. Berger is internationally recognized for his expertise in brain mapping during tumor surgery.

Speaker 1

Doctor. Lisa Deangelis, who serves as Chief Physician Executive at Memorial Sloan Kettering Cancer Center, where she oversees all clinical operations across their network of sites. She is an internationally recognized expert in brain cancer and helped establish Memorial Sloan Kettering's Brain Tumor Center Doctor. Stuart Grossman from Johns Hopkins and Sidney Kimmel Cancer Center, who co leads their brain cancer program and brings over 22 years of experience directing NCI funded Brain Tumor Consortium. And lastly, but definitely not least, and in the least, Doctor.

Speaker 1

John Latera, also from Johns Hopkins, who co directs their brain cancer program and is internationally recognized for his work on mechanisms of brain tumor malignancy. Doctor. Latera has been an early supporter and has encouraged us to pursue this indication and has helped our research efforts and continues to help guide combination regimen ideas that we think will be significant in the clinical setting. My colleague, Doctor. Kishore Bhatia, will discuss those later today in our webinar.

Speaker 1

The Starlight Advisory Board, which includes 2 recipients of the Society For Neuro Oncology's Lifetime Achievement Award, brings unprecedented expertise to guide our CNS cancer programs. Their willingness to join our advisory board speaks volumes about the potential they see in our approach to treating these devastating cancers. Let me walk you through some of our progress now with the synthetic lethal drug candidates LP-one hundred and eighty four and LP-two eighty four. The Phase 1a basket trial for LP-one hundred and eighty four, we've now completed 9 cohorts with escalating doses. We haven't seen any dose limiting toxicities.

Speaker 1

We're actively enrolling patients across multiple solid tumor types, including those that have high PTGR1 like triple negative, GBM, and pancreatic cancer, and now we're zeroed in on tumors that have DNA damage response deficiency. Based on our pharmacokinetic analysis, we're approaching an exciting milestone. Our upcoming cohorts should reach dosage levels where we expect to see therapeutic concentrations of our drug candidate LP-one hundred and eighty four and hopefully impact on the cancers. We anticipate completing enrollment by year end or in January with initial safety and molecular correlation data expected either late this year or during early 2025. I'm particularly excited about our progress in developing a companion diagnostic for for LP-one hundred and eighty four.

Speaker 1

We're advancing a quantitative PCR based test that could help us identify the patients most likely to respond to treatment, ones that have PTGR1 above a certain threshold, which is a key aspect of our precision medicine approach. We're currently validating this assay using patient samples, but also now using them in the first seven cohorts in the Phase 1a trial. These molecular correlations will be invaluable in designing our future trials and helping us select patients. The combination of clinical progress and diagnostic development exemplifies our comprehensive approach to drug development, where we're not just advancing a therapeutic candidate, but also developing the tools to identify the right patients for treatment. Turning to our LP284 program, which targets hematologic cancers, we're making equally exciting progress.

Speaker 1

We're currently dosing our 4th cohort, again in escalating doses in the Phase Ia trial. And like 184, we're seeing favorable safety profile with no dose limiting toxicities. Let me highlight why we're excited about 284, remarkable potency in the nanomolar range for multiple blood cancer types, but specifically 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 uptick in nearly all mantle cell and double hit lymphoma patients and in general high grade B cell lymphomas, again, we received 2 orphan designations for this drug, eventually relapse after current standard treatments. The market opportunity is substantial in the U.

Speaker 1

S. And Europe alone, about 16,000 to 20,000 new patients annually, about a market exceeding somewhere in the range of $2,800,000,000 to $3,000,000,000 just in U. S. And Europe alone. We're now in the process of expanding our trial to additional hematology focused sites, which we expect will accelerate our enrollment through the end of this year.

Speaker 1

Based on our current trajectory, we believe we could advance to Phase 1b or future phases like Phase 2 by early to mid-twenty 25. When we look at both LP-one hundred and eighty four and two eighty four together, these are sister molecules, we're seeing consistent patterns that validate our synthetic lethal approach, strong safety profiles, encouraging signs of biological activity, and the potential to address significant unmet cancers where oftentimes there is no cure in the later stage setting. So these are very exciting. This kind of excitement has helped us do one very important thing, which is secure 11 FDA designations, Fast Track designations, orphan drug designations, and rare pediatric disease designations. This is a strong testament to our data driven, rapid and focused drug development initiatives.

Speaker 1

We believe this will aid in more frequent guidance and interaction with the FDA and also strengthen our commercial value in talks with partners and clinicians during adoption. With our HARMONIC trial, LP300, the data has been very encouraging. And more importantly, this is for patients where there is no real treatment options today. After they fail kinase therapy, there are very limited treatment options. So these early signals, though, in a small group are particularly meaningful.

Speaker 1

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 or monitoring as we mature the drug candidate. We continue to enroll patients across our U. S.

Speaker 1

Sites and are also expanding into Asia and Japan and Taiwan, as I've stated earlier. In East Asia, including Taiwan, Japan and South Korea, nearly 40% of new cases now in non small cell lung cancer are amongst ever smokers. This is a remarkable percentage and underscores our commitment to expand the HARMONIQ trial to where it's needed in these countries. We're opening up 10 sites in Asia, 5 in Japan, 5 in Taiwan, and very importantly, working closely with the top KOLs in each country: Doctor. Gotoh at the National Cancer Center Japan in Tokyo and Doctor.

Speaker 1

Li at the National Cheng Kung University Hospital located in Tainan City in Taiwan. In the majority of East Asia, EGFR mutations comprise a significant and overwhelming percentage of the targetable kinase mutations among ever smokers. We've already seen some early signs of efficacy in our initial cohort. Now, this is important because we think this represents an important opportunity in Asia where we've now begun discussions regarding partnering, licensing or co development of this asset in that geography. Now I'll turn the call over to our Chief Scientific Officer, Kishore Bhatia, who will provide an overview of our R and D updates and speak specifically to a number of highly promising combination regimens for LP-one hundred and eighty four, ones that have been shaped and informed and guided by RADAR, but now will help shape future clinical trials that will be very meaningful.

Speaker 1

Kishore?

Speaker 3

Thank you, Pana. As we accrue clinical data and define the MTD in our Phase I clinical trial, we are actively pursuing additional areas of R and D that will contribute to further successes of LP-one hundred and eighty four. A general consensus that has emerged from collective experiences in oncology has been that successful treatments are most likely to be based upon combination therapeutics rather than monotherapy. With this in mind, we are studying the optimal selection of potential agents to combine with LP-one hundred and eighty four, which enhance the efficacy of treatment, have little, if any, overlapping toxicity, as well as expand indications. For the past year, our RADAR, translation, and clinical teams have addressed these immediate needs.

Speaker 3

Towards fulfilling these rapidly, we have also engaged with several expert collaborators that are shown in the slide that is being displayed. And these include scientists from MD Anderson, University of Massachusetts Boston, Johns Hopkins, and the University of Texas and Antellium. Today, I'm going to talk about 3 distinct LP184 combinations, 2 of which are in accelerated protocol development by the clinical team. I won't have time to show data but can mention here that new unique combinations for LP-one hundred and eighty four are emerging from both RADAR and BEN studies, the latter including CRISPR analysis studies. So, a significant aspect of DNA damage that results from tumor specific PTGR1 heightened expression, for which now we have bioassay, which causes the bioactivation of LP184 in tumor cells, is that it ends up in the formation of double strand breaks.

Speaker 3

When threatened with LP-one hundred and eighty four, cancer cells, therefore, need to engage multiple repair factors and pathways beyond transcription coupled nucleotide excrement repair. DSPs clearly required the attention of homologous recombination repair pathways. It was therefore expected that LP-one hundred and eighty four demonstrated synthetic retinopathy in tumors deficient in such pathways, including mutations affecting BRCA1 and BRCA2. Such synthetic lethality of LP184 extends beyond the classical BRCA mutated tumors and also includes tumors with BRCA ness, such as those with mutations in additional genes involved in the homologous recombination pathway. What has been surprising has been the evidence that LP-one hundred and eighty four synergizes with PARP inhibitors, both in HRD, but also in those HRD tumors that have become PARP inhibitor resistant.

Speaker 3

This slide shows that 5 fold lower doses of LP-one hundred and eighty four are sufficient to achieve 3 to 14 fold greater regression compared to Olaparib alone in tumors mutated either in BRCA1 or BRCA2. I would particularly like to draw your attention to the synergy seen in both tumors with low doses of LP184. But if you look at the tumor on the right, which as you can see is resistant to Olaparib, it is wiped out by LP 184 at 2 milligrams per kg. And when you combine Olaparib with less than 1 fourth of this LP-one hundred and eighty four draws, this tumor now loses its refractoriness to PARP inhibitors. The likely success of this potential is further supported by similar data generated by our independent collaborators at University of Massachusetts, Boston, who also have suggested additional mechanisms involving depletion of RPA as one of the drivers of this synergy.

Speaker 3

A combination with PARP inhibitors that can make PARP resistant tumors sensitive is therefore a significant advantage for LP-one hundred and eighty four. We are particularly excited by the potential of such a combination and have developed a protocol to actively test this in our Phase Ib clinical trial arm. There are several reasons why LP-one hundred and eighty four might be an exceptional combinatorial agent for PARP inhibitors, which come from understanding the PARP inhibitor resistance factors. This next slide identifies factors that have been discussed to be associated with the resistance to PARP inhibitors. If you specifically look at row 3, much of our data suggests that LP184 effectively combats these factors.

Speaker 3

Even in the presence of gene conversion, LP184 has been effective. Loss of Xylem complex that allows tumors to become resistant to PARP inhibitors actually makes tumor sensitive to LP-one hundred and eighty four. Additional insights have been the agnostic feature of LP-one hundred and eighty four to SLAPAN11. Loss of SLAP-one hundred and eleven impairs prolonged S phase arrest upon PARP inhibitor exposure, thereby inducing resistance. But SLAP-one hundred and eleven loss does not affect sensitivity to LP-one hundred and eighty four.

Speaker 3

What this means in practical terms is that when used in combination with PARP inhibitors, LP-one hundred and eighty four is highly indicative not only for synergy but also for reducing the resistance to PARP inhibitors. The other molecule that we are proposing to the clinic as a combinatorial partner of LP1 hundred and eighty four is a drug that has extensive clinical experience, albeit from non oncology indications. This drug, spironolactone, is an FDA approved drug used for various indications, including hypertension and acne. What drew us specifically to this drug were multiple observations of which the most important was the serendipitous discovery that spironolactone targets ERCC3 to degrade it. The scientific rationale and reasoning of combining LP-one hundred and eighty four with spironolactone was fully justified by a battery of preclinical studies we and our collaborators conducted.

Speaker 3

In this slide, in the Box A, you can see that spironolactone increases sensitivity of GBM cell lines to LP-one hundred and eighty four 3 to 6 fold. What this specifically means is that even in settings where there is lower bioavailability of LP-one hundred and eighty four, the combination can result in sustained DNA damage, as you can see in Panel B, and that these effects correlate with the significant reduction in the repair protein ERCC3 shown in Panel C. Not surprising, therefore, the combination resulted in excellent responses in in vivo glioblastoma models. With most cures, only 1 of 5 tumors showed recurrence to the combination. In order to use this combination clinically, we need to better understand the time window where LP-one hundred and eighty four should be administered following spironolactone treatment.

Speaker 3

So, we carried out several time code studies. In this slide, we demonstrate that ERCC3 is at its lowest level in both orthotopic and subcutaneous glioblastoma xenograft at 8 hours after spironolactone administration dosed as human equivalent of 200 milligrams per kg. In addition to glioblastoma, the combination of spironolactone enhances the activity of LP-one hundred and eighty four in other select tumor types, including ATRT, pancreatic cancer and renal cancers. Given the rare pediatric orphan disease designation and the lack of any approved therapy for ATRT, we are particularly enthusiastic of the clinical studies in ATRT and are in active discussions with several pediatric neuro oncology groups, including POETIC and Children's Oncology Group. I will now shift to the 3rd combination we are exploring, which is combining LP-one hundred and eighty four with immune checkpoint inhibitors.

Speaker 3

We have previously observed during our study of DNA strand breaks the accumulation of cytodynamic DNA in tumor cells following LP-one hundred and eighty four treatment. This feature would suggest LP-one hundred and eighty four as an immune activating molecule as well. To test the potential of LP-one hundred and eighty four, combined with checkpoint inhibitors, we developed a collaboration with Doctor. Lin at MD Anderson, who has previously shown that the involvement of replication stress defect correlates with immune response in tumors. So, our thought was, could we pharmacologically induce this replication stress response defect and therefore extend the benefits of immune checkpoint inhibitors for wider patient populations.

Speaker 3

We hypothesize, therefore, that LP1A4 treatment might escalate replication stress levels, particularly in TNBC and induce replication stress response effect. As you can see in the slide, when LP-one hundred and eighty four cells were assessed for induction of replication stress effect compared to a similar defect induced by what would be expected from a cell cycle Check-one inhibitor, the results show a 60% of relative defect increase by LP-one hundred and eighty four compared to 75% with Check-one at equimolar doses. We then tested the effects of a combination of anti PD-one antibody in combination with LP-one hundred and eighty four in a murine syngetic TNBC model. The results shown in this slide evidence enhancement of tumor growth inhibition from 51% in LP-one hundred and eighty four alone treated tumors to 72% in the combination. Additional studies indicate that LP184 might actually modulate both the pure microenvironment as well as T cell function.

Speaker 3

Uniquely, it appears that LP184 reduces empty macrophages. Based upon these results, we are now in discussion with various clinical investigators towards development of a clinical study in TNBC cold tumors. Many other rationally designed combinatorial partners are emerging from a radar and CRISPR based analysis, such as inhibitors of Phen1 and REV1, but also include molecules that are outside the DNA repair pathways. One such pathway that I'd particularly like to mention, which has emerged as important, is the oxidative for fibrillation pathway. And we hope to share with you in the near future some exciting data with these combinations.

Speaker 3

And now I'll turn it back to Parna.

Speaker 1

Kishore, thank you very much. As you can see, we're already turning our attention now to the next phase of clinical development and pathway for the exciting drug LP-one hundred and eighty four. We know that many of these combinations are with drugs that are a part of the meaningful arsenal in cancer, especially PD-one, anti PD-one and PARP. And we expect there to be a lot of excitement in the clinical community as there has been so far in the research community, but also very importantly in the biopharma community, given the number of PARPs and their limited range of extended use in some of these tumors and also the same with PD-one. When you have a drug like LP-one hundred and eighty four 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 1

Let's now talk a little bit about Webinar Wednesday. We've had a lot of exciting webinars, about 1 a month. For those that have not listened in on the backdrop of these webinars or the details, our last webinar Wednesday for the year will be held on December 11th, not the last Wednesday of November, not the last Wednesday of December, but we know it's a challenging time. So we try to pick right the middle of the month. That webinar will focus on the power of AI in drug development, specifically around the use of molecular features to predict blood brain barrier permeability with radar.

Speaker 1

The webinar will discuss also future development plans we have and the potential commercialization and commercial availability of this RADAR platform module, which leverages extensive molecular feature analysis, enriched with proprietary models and proprietary data. According to the Therapeutic Data Commons, one of our early According to the Therapeutic Data Commons, a coordinated initiative to access and evaluate artificial intelligence capability across therapeutic modalities and across stages of discovery, Lantern's BBB algorithms are 5 of the top 10 performing algorithms on the leaderboard. So that's very exciting. That was some of our early algorithms. In fact, they continue to mature and get refined and have actually matured significantly in some of their future discrimination.

Speaker 1

So we're pretty excited to talk about that on December 11 with one of our data scientists who's been working on those models. As you know, 2024 has been a year of progress, accelerated progress where our insights are impacting patients in their journey to fight cancer and also influencing the development decisions and progress actually of other cancer companies. Our collective efforts and dedication have fostered a transformational shift for our company, setting us on an exciting trajectory towards the future where we are improving the lives of cancer patients with effective and affordable treatment options. As you can see, the work being done by Kishore and his team and also our clinical operations team is focused on meticulous execution, but constantly with one hand on the wheel of innovation. During the Q4 and into next year, we will have several clinical readouts and milestones to share with our investors as we advance our pipeline and company.

Speaker 1

As I've said before, the golden age of AI in medicine is just beginning, and it is being powered by large scale, highly available computing power, massive data storage, massive data collaborations, and it is being fed by healthcare, patient and cancer data, which is more widely available and at increasing levels of quality, much more so than ever before. Companies that harness these capabilities in the biotech and biopharma arena will be long term leaders in this biotech or really now becoming more tech bio industry. And we think these are companies that are well poised to create massive value for patients long term and ultimately for investors in our industry. I'd like to take a moment right now to personally thank our team for helping to prepare us for these calls, to prepare the materials, gather the data, provide insight, and to their amazing dedication. If it wasn't for them, we probably would have a very handicapped call.

Speaker 1

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 in one of 2 ways. You can type your question using the Q and A tool, or you can click on the raise hand tool to speak directly and we will unmute your line. Regarding LP300, Yes, I'll go ahead and answer the first question. The first question asked is when do we expect additional data regarding our HARMONIC and LP300 trial?

Speaker 1

As we just opened up the sites in Asia, our goal is to gather another 14 to 20 patients actively. And for Harmonic, we'll know a lot more once we see the impact of the trial expansion in Asia and also the data from the planned interim analysis, which will take place at 31 patients. So those two events will really guide us in terms of the next big clinical readout regarding the HARMONIC trial. And we expect that around mid of next year, if not earlier, but middle of next year is when we're expecting it. Any updates on how Radar is growing and collaboration efforts?

Speaker 1

Great question. As you know, we announced last quarter our collaboration of Oregon Therapeutics, which is going very well. We expect the first phase of that collaboration to finalize sometime during the next month, probably before the end of the year, where we will be able to answer several questions and set the framework for some good joint IP in regards to indications and perhaps biomarker signatures that correlate to response for their drug, for their PDI inhibitor. We are looking at additional collaborations. As you know, we've had 3 very important ones with emerging biopharma companies.

Speaker 1

We're now focused on larger biotech companies, I would say more mid market and more ones with much more diverse portfolios. So our attention now is increasingly to larger companies given that the platform has matured quite a bit over the last year and a half. I'll take the next question coming in the Q and A panel. Although it's probably too early to speak to partnership interest for the NeverSmoker trial, we have gotten some conversation started. Obviously, this is, as I mentioned, from an epidemiological basis, NeverSmokers account for 33% to 40 plus percent of non small cell lung cancer cases in East Asia, again, primarily Japan, Taiwan and South Korea.

Speaker 1

Many of the major regions in China are similar. But so you can expect that we're in discussions with pharma larger pharma companies in Japan now. So that's very early, but we are receiving interest given the focus and given the prevalence of the disease there. The other thing that I'd like to add is obviously we did hint at a biomarker signature correlating to lower intermediate tumor mutation burden. Now we're obviously chasing that down clinically.

Speaker 1

We've had very good initial data. We're looking to support this data as more patients get enrolled. And we understand the tumor mutation burden status of those patients. And that also could mark a very important turning point in terms of interest with all the companies that are going after high tumor mutation burden, whereas this is for lower tumor mutation burden. Thank you.

Speaker 1

Very good question. Next question is on Starlight Therapeutics. As you can see, every quarter, we continue the next question is about Starlight Therapeutics and the Scientific Advisory Board members. We're quite thrilled about the decisions for Doctors Deangelis, Berger, Latera and Grossman to join the Scientific and Clinical Advisory Board. And these guys are among the most preeminent in their field.

Speaker 1

And for them to be interested in the drug and the indications, again, speaks volumes of, we think, of the potential for this very novel site activated alkylating agent to potentially transform the lives of both pediatric and adult brain cancer patients. My personal feeling, and this is very important, is that we're making progress each quarter. We're opening up sites. We're enrolling patients. We think the biotech market is fundamentally getting stronger.

Speaker 1

I think there'll be a lot of interest we've had in both private and public financing, and we'll find the best route to capitalize Starlight independently so it can grow and develop its own trials. We believe that the trials for 1b and 2 or for some other unique trials should be launched sometime in early 2025 for Starlight. But in the meantime, we try to maintain a lot of fiscal discipline. And again, those are planned trials. We'll see how the financing events go.

Speaker 1

And we try to use a lot of the existing Lantern infrastructure and people to advance Starlight in parallel. So there's a lot of work for our team. And again, this work creates a lot of value for our investors long term. But we think this could be one of several planned spinouts from Lantern where the portfolio is more focused, the portfolio is in a certain modality and is aimed at a certain group of cancers or in a certain population. Very good question.

Speaker 1

Thank you. With that, we're coming up against about an hour, 50 minutes into the call, long call today. But I want to thank everyone. We got a good overview of what's next in the combination trials. Again, we're very far into the Phase 1a for LP-one hundred and eighty four, where we expect to get to at MTD in the next few cohorts.

Speaker 1

And that should correlate with what we believe is going to be something we can go into future plan to Phase Ib and Phase II planned trials with as well. And we continue to make very solid progress with our AI platform, both with our collaborators and internally with new functionality. And we now will be expanding rapidly into Asia with our LP300 trial. Very importantly, as David pointed out, we continue to be very meticulous about execution and cost conscious. We do think that our existing capital and balance sheet allows us to take us through significant events, but we're watching the markets carefully.

Speaker 1

If there's opportunities to partner our assets out or to access the capital markets, we'll do so if it makes sense. But we're also very prepared to continue executing. And at the same time, we do think the markets will probably improve. But more importantly, we'll have opportunities to partner our assets and leverage our capabilities. Internally, operationally, which is very important, we've begun to slowly bring in, but very step by step aspects of clinical operations to try to build really a world class NINJA team in clinical operations that we can use across our trials and more importantly across the various functions.

Speaker 1

And we think that gives us a lot of synergy, reduces our external spend, but as David pointed out, brings us closer in contact with our patients, our clinical sites and our data. So again, I think we're doing right things operationally and are very focused on maintaining kind of the burn rate in the same range that we have historically. So that I'd like to thank everyone for their time today. And I want to express my deep gratitude to our team, our partners and our stakeholders for their support. And also to realize that together we are really trying to light the way for a brighter, more scalable future in oncology care and in oncology drug development.

Speaker 1

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

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Earnings Conference Call
Lantern Pharma Q3 2024
00:00 / 00:00