Lantern Pharma Inc.

Good afternoon and welcome to our third quarter 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 third quarter ended September 30, 2024. 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. 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, 2023, which is on file with the SEC and available on our website. 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, Pana Sharma, and members of management. Pana 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. I'd now like to turn the call over to Pana Sharma, President and CEO of Lantern Pharma. Pana, please go ahead.

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. 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. 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 II harmonic trial, and our Phase I programs for both LP184 and LP284. 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. These achievements underscore how our technology-first approach is accelerating the development of precision cancer therapies while maintaining capital efficiency. 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 three precision oncology drug candidates advancing through clinical trials, all guided by our Radar AI platform. These include both phase one and phase two 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, 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. 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 monotrial into Asia, specifically Japan and Taiwan. This expansion is strategically important because in these countries, never-smoking lung cancer represents a much larger portion of all lung cancer cases, about one-third of new cases compared to what we see in Western countries, which is about 15% to 20%. We're establishing a total of 10 sites across Japan and Taiwan, five 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 1A trials, and they continue to show strong progress and are unrolling across centers in the U.S. 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 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. 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 our molecule. Speaking of GBM, we've been successfully enrolling recurrent GBM patients in our existing phase 1A trial for LP184 across three sites, two 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 for future clinical trials and including Phase 1B2 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 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. 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 PTGR1 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. 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 three new FDA rare pediatric designations for LP184. This is in addition to the existing one for ATRT. 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. 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 million. 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. 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 three significant publications and presentations and numerous insights about how to guide our drug into future combination trials. Our chief scientific officer, Dr. 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 two major conferences, the Immuno-Oncology Summit, where we shared exciting data about the role of LP184 in synergy with anti-PD-1 drugs, and at the Society of Hematological 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. 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. And we used approximately $4.5 million in operations this past third quarter. So I'm going to hand this over now to David to talk in more detail about our finance and operations. David?

Thank you, Pana, and good afternoon, everyone. I will now share some financial highlights from our third quarter ended September 30, 2024. We recorded a net loss of approximately $4.5 million for the third quarter of 2024 or 42 cents per share compared to a net loss of approximately $3.2 million or 29 cents per share for the third quarter of 2023. For the third quarter of 2024, our R&D expenses were approximately $3.7 million or up from approximately $2.2 million for the third quarter of 2023. This increase was largely driven by an increase in clinical trial activity. 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. The increase was primarily attributable to increases in professional fees and increased patent and legal fees. Our R&D expenses continue to exceed our G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Our loss from operations in the third quarter 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 third quarter of 2023. Our cash position, which includes cash equivalents and marketable securities, was approximately $28.1 million as of September 30, 2024. 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 RadarAR 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 12.1 million shares as of September 30, 2024. 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. 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 three 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. 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, both in the U.S. and Asia, and our first 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?