Lantern Pharma Inc.

Good morning and welcome to our first quarter 2025 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 before the market opened today, summarizing our financial results and progress across the company for the first quarter ended March 31st, 2025. 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. We would like to remind everyone that remarks about future expectations, performance, estimates, and prospects constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Lantern pharma cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated. A number of factors could cause actual results to differ materially from those indicated by forward looking statements, including results of clinical trials and the impact of competition. Additional information concerning factors that could cause actual results to differ materially from those in the forward looking statements can be found in our annual report on form 10 K for the year ended December 31 2024. Which is on file with the SEC and available on our website forward looking statements made on this conference call are as of today may 15 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. 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, Pauna Sharma, and CFO, David Margrave. Pauna will start things off with introductions and an overview of Lantern's strategy and business model. and highlight recent achievements in our operations, after which David will discuss our financial results. This will be followed by some concluding comments from Pauna, and then we'll open the call for Q&A. I'd now like to turn the call over to Pauna Sharma, President and CEO of Lantern Pharma. Pauna, please go ahead.

Good morning. Hello, everyone. Thank you for joining us to hear about our first quarter 2025 results and corporate progress. As many of you have heard me say in the past, computational and AI-driven approaches are increasing their presence and usage at both large and emerging pharma companies for all facets of drug discovery and development. Lantern's leadership in the innovative, efficient, and pragmatic 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. The first quarter of 2025 represents a pivotal inflection point for Lantern Pharma. We've made significant advancements across our clinical stage portfolio, while simultaneously expanding the capabilities of our proprietary radar AI platform to over 200 billion oncology focused data points. These achievements position us well for multiple value creating catalysts in the coming quarters. Let me organize today's remarks around three strategic pillars. First, our clinical pipeline progress. Second, our AI platform advancements. And third, our initiatives to maximize shareholder value. Starting with our clinical pipeline, we continue to advance multiple programs that have the potential to address significant unmet patient needs for cancer patients globally. Our phase 1A trial for LP184 has progressed well with enrollment now through cohort 12. We expect to complete enrollment with 62 to 65 patients across a wide range of solid tumors by the end of June 2025. Importantly, we're beginning to see early indications of clinical activity at higher dose levels, which aligns with our preliminary pharmacokinetic data. This quarter, our safety review committee made the decision to backfill doses level 10 and 11 to ensure clarity on determining the maximum tolerated dose while maintaining patient safety. What distinguishes our synthetic lethal approach is its mechanistic precision. Unlike conventional chemotherapies and targeted agents that indiscriminately target dividing cells, LP184 and LP284 exploit specific genomic vulnerabilities in cancer cells. particularly those deficiencies in DNA damage repair pathways. The pharmacokinetic data from these trials suggest we're approaching concentration levels that correlate with the nanomolar potency observed in preclinical models. This is a critical inflection point that could demonstrate definitive proof of mechanism in patients and pave the way for future trials and partnerships. With LP184 now holding dual fast-track designations for both glioblastoma and triple negative breast cancer, plus four rare pediatric disease designations, we've positioned this molecule for accelerated development across multiple high-value meaningful indications. The FDA has also recently cleared two clinical trial protocols that can provide paths toward regulatory approvals, especially in triple negative breast cancer, where we also have a fast track designation. The first of these two protocols that has been cleared recently is a phase 1b2 study in TNBC evaluating LP184, both as monotherapy and in combination with the PARP inhibitor Olaparib. With an estimated annual market potential exceeding 4 billion in metastatic TNBC, this represents a major significant opportunity. The second, a phase 1B slash 2 study in a biomarker-defined subset of drug-resistant non-small cell lung cancer with STK11 and or KEAP1 mutations, a patient population with particularly poor prognosis, and a market opportunity exceeding 2 billion annually. Additionally, an investigator-led exploratory clinical trial for LP184 in recurrent bladder cancer is planned to begin in Denmark during Q3 2025, which could create a pathway toward commercial clinical usage in the third-line setting. Based on work we have done with Dana-Farber and the Danish Cancer Research Group and in other published research, about 25% to 30% of bladder cancers have DNA damage repair mutations at presentation and over 40% at recurrence. Now, turning to our harmonic phase two trial for LP300, we continue to make strong progress with enrollment in Japan and Taiwan, where never smokers represent about 33 to 40% of new non-small cell lung cancer cases, compared to about 15 to 17% in the U.S. Following our compelling preliminary data showing an 86% clinical benefit rate and 43% objective response rate in the safety lead-in cohort, additional patient data from the expansion cohort continues to support a similar positive trend. We look forward to sharing updated results, including data from patients in our Asian expansion cohort during Q3 and data from the ongoing benefits from our initial lead-in cohort. Through our wholly-owned subsidiary, Starlight Therapeutics, we're advancing Star001 for indications in CNS and brain cancers. Recently, our collaborators at Johns Hopkins have provided independent confirmation of hypersensitivity in rare pediatric brain tumors to LP184, supporting our planned clinical trial with the pediatric consortium focused on CNS tumors. A Phase 1b2 trial in recurrent GBM is anticipated to begin in late 2025. subject to successful additional protocol clearance and funding. Also bear in mind that LP184 has multiple pediatric disease designations that upon approval in that indication can yield a priority review voucher, which can then be marketed and sold for 100 to $150 million each. And Lantern and Starlight have the potential and pathway for four of those opportunities. Starlight, which is 100% owned by Lantern, will have the potential to be another very positive impact on our investors as we monetize this unique asset, the patents, and the clinical indications and insight. The dosage and safety data obtained in the phase one trial For LP184, it will be used to advance the central nervous system indications as STAR-001 for future Phase 1B and Phase 2 trial, sponsored by Lantern's wholly-owned subsidiary, Starlight Therapeutics. Globally, the annual market potential for LP184's target indications is estimated to be about $14 billion, consisting of $4 to $5 billion for CNS cancers, both primary and secondary, and about $10 billion for other solid tumors. Turning now to our second pillar, which is our AI platform, let's talk about the expansion and commercialization now of our radar AI platform. This quarter, our proprietary radar platform grew to approximately 200 billion oncology-focused data points. The platform continues to deliver value across multiple dimensions, from drug candidate optimization and developing combination strategies to biomarker signature development and mechanism of action clarification. We've made an important and exciting decision to open up the Radar AI platform on a module by module basis to the broader scientific and research community. We expect to initially do this as a freemium type approach, which will be expected to drive collaborations and economics to Lantern. The large scale and highly inexpensive evolution of RAG and agentic technologies has completely changed the ability for small emerging companies like Lantern to use cloud infrastructure to open up algorithms and unique processes to a broader community at a scale cost and level of complexity unimaginable in the past. A milestone this past first quarter was a strengthening of our AI intellectual property portfolio with the PCT publication of our proprietary blood-brain barrier penetration prediction patent application. This technology received a favorable PCT search report indicating no significant prior art. And our algorithms currently hold five of the top 10 positions on the Therapeutic Commons leaderboard, a remarkable achievement demonstrating our leadership in AI drug development. This will be one of the first modules that we make publicly available in the coming quarters. Our BBB permeability prediction tool can process up to 100,000 molecules per day with industry-leading accuracy, and the algorithm continues to evolve and improve. This technological advantage has profound implications for accelerating CNS drug discovery and the ability to predict in a domain that's been notoriously challenging, but 98% of small molecules historically have failed to effectively penetrate the blood brain barrier. And our algorithms unprecedented accuracy enables us to identify promising CNS penetrant compounds and also optimize existing compounds with extraordinary efficiency, potentially reducing traditional discovery timelines by months while dramatically increasing success probabilities. This computational capability doesn't merely enhance our existing programs. It opens up entirely new therapeutic development possibilities across not only cancer, but other neurological indications for many other drug development teams. We're particularly excited about our plans to make this and other radar AI modules commercially available to the scientific and research community this year. This represents a new potential revenue stream and opportunity to foster collaborative open source innovation in cancer drug development. We've also expanded radar with an innovative AI-powered module to improve the precision, cost, and timeline of antibody drug conjugate development. This multi-omic approach leverages proprietary algorithms to design and optimize target selection, payload efficiency, and tumor selectivity, addressing a rapidly growing segment of the oncology market that has been notoriously difficult and very time-consuming. Our AI-powered antibody drug conjugate development module represents a fundamental reinvention of a traditionally resource-intensive high-risk development process. By identifying promising targets and target indication combinations, we've established a robust pipeline of opportunities in one of oncology's most rapidly growing therapeutic modalities. The technical implications for this are substantial. Iterative testing of antibodies, linkers, and payloads, which can take years and consume tens of millions of dollars, can be narrowed down, streamlined, and de-risked. Our computational approach, we believe, can reduce these timelines by 30% to 50% and preclinical costs by up to two-thirds, while simultaneously enhancing target selection and understanding of real-world target availability in an involved cancer environment. This efficiency advantage positions us to rapidly advance our own candidates with exceptional selectivity profiles, but also to enable other companies to take advantage of this. This module will also be one of the many modules we place into an agentic interface and framework for use by our collaborators and partners. We'll talk about this more later this quarter and probably host a specific call talking about the evolution of our AI platform to a more public-facing commercial opportunity. AI and platform-driven insights continue to guide our clinical development strategy. For LP184, we've also developed a qPCR assay for PTGR1, which as we know is the bioactivation agent for LP184. And by measuring PTGR1 levels, we can help guide patient stratification and also at the same time identify indications that may be very promising. For LP284, we've also used our platform to identify promising combination strategies, for example, the Rituximab, which have shown compelling preclinical synergy. Moving on to our third strategic pillar to maximize shareholder value, we've done this now through disciplined capital management and a number of strategic initiatives. We've maintained our disciplined approach to capital deployment, ending the quarter with approximately 19.7 million in cash, cash equivalents, and marketable securities, providing an expected operating runway through at least middle of May next year. Our quarterly net loss decreased to approximately 4.5 million compared to 5.4 million in the same period last year, reflecting our continued focus on operational efficiency. We want to bear in mind that the company's last capital raise was in January of 2021. So we've maintained tremendous fiscal discipline in getting our molecules into clinical trials, into meaningful inflection points, and executing on our dual strategy of advancing clinical programs while expanding vastly our AI platform capabilities. And now we're going to enter into, we believe, productive discussions with potential biopharma partners whether through licensing agreements, technology partnerships, or co-development. Now, I'll turn the call over to our CFO, David Margrave, who will provide more details on the financial results for the quarter.

Thank you, Pana, and good morning, everyone. I'll now share some financial highlights from our first quarter of 2025, ended March 31, 2025. Our general and administrative expenses were approximately $1.51 million for the first quarter of 2025, compared to approximately $1.48 million in the prior year period. R&D expenses were approximately $3.3 million for the first quarter of 2025, down from approximately $4.3 million in the first quarter of 2024. The decrease was primarily due to reductions in CRO and clinical site costs for LP184, which also reflected our objective to accomplish more with our internal clinical operations team. We recorded a net loss of approximately $4.5 million for the first quarter of 2025, or 42 cents per share, compared to a net loss of approximately $5.4 million, or 51 cents per share, for the first quarter of 2024. Our cash position, which includes cash equivalents and marketable securities, was approximately 19.7 million as of March 31, 2025. Based on our currently anticipated expenditures and capital commitments, we believe that our existing cash, cash equivalents and marketable securities as of March 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from today's date, May 15th, so until at least mid-May 2026. We will need additional funding in the near future, and one of our key objectives is to pursue additional funding opportunities. As of March 31, 2025, we had 10,784,000 725 shares of common stock outstanding, outstanding warrants to purchase 70,000 shares, and outstanding options to purchase 1,242,378 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 12.1 million shares as of March 31, 2025. Our team continues to be very productive under our hybrid operating model. We currently have 23 employees focused primarily on leading and advancing our research and drug development efforts. I'll now turn the call back over to Pana for additional updates and closing remarks. Pana. Thank you.