Lantern Pharma Inc.

Good afternoon and welcome to our second 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 second quarter ended June 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 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. Thank you for watching. 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, August 8, 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, Panna Sharma and members of management. 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 a discussion of the harmonic clinical trial results. I'd now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.

Good afternoon and thank you everyone for joining us to hear about our incredibly productive Second quarter of 2024. Today on the call, I have our CFO, David Margrave, and also our head VP of clinical development, Dr. Reggie Iwasudo. I'll begin the call by discussing generally the quarter and then hand it over to David to talk about the financials. And then Reggie and I will discuss the progress with our LP300 clinical trial. 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. Chemistry, biology, even now manufacturing and patient selection. And at no time has this been more evident than today, where every facet of pharma development from molecular design to disease modeling is being rethought as a result of the widespread availability of computational capabilities, Thank you for joining us. Thank you very much. and our portfolio of drug candidates and drug programs. This past quarter was a particularly busy one for Lantern and especially with our clinical operations team as we had a notable initial readout in our phase two harmonic clinical trial where we saw a preliminary but interesting 86% clinical benefit rate in the lead-in patient cohort. Our intellectual property also continues to grow Thank you for joining us. which we will discuss more in depth later in the call. Our team has also achieved significant advancement towards a key milestone in the development of a molecular diagnostic for use with our drug candidate LP184. We expect to potentially use this diagnostic to improve patient selection and stratification and the novel biomarker is PTGR1, one that we validated extensively both in the lab but also in silico and was identified through a number of in silico AI-driven screens. We also launched a very important strategic drug development collaboration using our AI platform, Oregon Therapeutics, to optimize the development of a first-in-class drug candidate, XCE853, a potent inhibitor of cancer metabolism, which we believe can have impact across multiple cancers and has a unique mechanism of action involving proteotoxicity. With Starlight Therapeutics, our wholly owned subsidiary focused on CNS and brain cancers, we advanced towards initiating site selection and feasibility for a Phase 1B, Phase 2 trial in recurrent GBM with drug candidate STAR-001. Our team also successfully launched Webinar Wednesdays, a webinar series focusing on the areas of artificial intelligence, oncology drug development, and leveraging our relationships with leading physicians, scientists, and our collaborators. We also closed the quarter with approximately 33.3 million in cash, cash equivalents and marketable securities, which our CFO will talk about later in today's call. Many of the initial observations made with the help of Radar are now being witnessed in the clinic, as many of you know. Radar has guided the rapid and efficient development of three AI-guided drugs into clinical trials over the past several years, Thank you so much for joining us. and other drug candidates that are acylfulvines, LP184 and LP284. So far, seven cohorts of patients comprised of dose levels 1 through 7 have been enrolled in escalating doses in the ongoing Phase Ia clinical trial for LP184. This is a first in human Phase I trial across multiple solid tumor indications that are advanced and refractory to the existing standard of care. Very exciting for us is there have been no observed dose-limiting toxicities to date. Now, we're at the point now in the trial where we expect to reach a dosage level in the coming cohorts where therapeutic concentrations of the drug should be attainable based on our pharmacokinetic and pharmacodynamic analysis. It's a mouthful, but all that means is we should start potentially seeing benefit in patients at these cohorts going forward. The trial is actively enrolling patients across multiple U.S. centers, These patients are relapsed, they're refractory to all existing standard of care typically, and they have advanced solid tumors such as pancreatic cancer, glioblastoma, triple negative breast cancer, and also now increasingly with solid tumor types focused on DNA damage response deficiencies. The company believes that enrollment should be complete this year and on track for an initial readout of safety and molecular correlation data by the close of the year. The dosage and safety data obtained in the Phase 1A trial for LP184 are expected to be used to advance the central nervous system indications for the Phase 1B and Phase 2 trial to be sponsored by Lantern's wholly-owned subsidiary Starlight, as well as other later-phase trials in select tumors that have shown superior responsiveness to 184 and also meet our genomically-guided criteria. AI and preclinical studies are also ongoing to further refine drug combination studies. Many of you saw the press release from yesterday, and this press release supports, at least tend to support, the improvement to durability and response with other FDA-approved drugs. Specifically, we published on PARP inhibitors earlier this quarter and yesterday in immune checkpoint inhibitors. These are two very exciting areas where the combination of our drug with some of the existing approved agents, many of which are multibillion-dollar drugs, actually we feel can benefit patients in certain solid tumors like triple negative breast cancer or others that have DNA repair deficiency. Globally, the aggregate annual market potential for LP184's target indications we believe is in excess of $10 to $12 billion, consisting of about $4 to $5 billion in CNS cancers and $7 to $8 billion for other solid tumors. For LP284, the third cohort of patients are being dosed, and no dose-limiting toxicities have been observed in this Phase 1a trial, and we expect to open additional sites throughout the quarter with the potential to advance to Phase 1b and Phase 2 by the close of this year or early 2025. LP284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell, double-hit and other non-Hodgkin's lymphomas, and especially those with DNA damage response deficiency. We published in cancers that had compromised functioning of ATM due to mutations or deletions. Now, nearly all MCL double-hits, high-grade B-cell lymphoma patients relapse from the current standard of care agents, and there's this urgent and unmet need for novel improved therapeutics for these patients. We believe the annual market potential in this group is in excess of $3 billion. We've also begun a review of some notable mechanism of action that we've observed in LP284, and we think we can actually leverage those in other diseases and conditions. Lantern expects to review those preclinical studies and findings later this quarter. Our current enrollment efforts are focused on cancer patients with tumors that have what's called DNA damage repair deficiencies. They've been observed to have higher sensitivity to 184 and even in some cases 284. So DDR genomic alterations are of interest for these trials, and we may consider other genomic alterations based on other emerging data. We also continue to make significant progress in 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. Because of the billions of data points that we had in our system, we used AI methods to look at specific indications, validated those computationally, optimized our understanding, and then took them into studies, wet lab studies with animals and mice and PDX models. And now we're actually at a point where we can start taking these indications into the clinic. Notably, we've also actually started site selection for the upcoming Phase 1b and Phase 2 trials, especially in recurrent IDH wild-type high-grade gliomas like GBM. This is very different than the most recent approval, which was an IDH mutant. So if you've not reviewed our webinar Wednesday on Starlight with Dr. Marc Chamberlain, I would definitely urge you all to listen to the webinars where we provide in detail the timing and focus of the trials and that we anticipate launching with Starlight. Now, the golden age of AI in medicine is just beginning, as witnessed even today by a discussion of today's merger among two big AI companies, Recursion in the US and Excientia in the UK. And there's a need to really use large-scale, highly available computing power, massive data storage, and the tremendous high-def biology that's available today. And that is what we're at the forefront of. But we're also, at Lantern's Way, we're harnessing those capabilities in a way we believe is much more efficient. We want to harness these capabilities in this emerging tech bio industry and be a long-term leader, not only where we create massive value for patients and also continue to drive innovation, but we're also thoughtful about the economics of cancer drug development. It's one of the first reasons many of us joined this company is we wanted to not only make drugs faster, We also wanted to make them smarter and cheaper. And Lantern is among the leaders in this transformation of the pace, the risk, and the cost of oncology drug discovery and development. This transformation has a promise not only to make medicines faster, cheaper, and with increased precision for patients, but also to help change the direction of R&P productivity and output in the cancer biopharma industry. Now let's turn our focus to our financial updates and highlights with David. I'll now turn the call over to our CFO, David Margrave, who will provide an overview of our quarter's financial results. David?

Thank you, Panna, and good afternoon, everyone. I'll now share some financial highlights from our second quarter into June 30, 2024. We recorded a net loss of approximately $4.96 million for the second quarter of 2024, or 46 cents per share, compared to a net loss of approximately $4.75 million or 44 cents per share for the second quarter of 2023. For the second quarter 2024, our R&D expenses were approximately $3.9 million, up from approximately $3.6 million for the second quarter of 2023. This increase was largely driven by an increase in clinical trial activity. Our general and administrative expenses for the second quarter of 2024 were approximately $1.5 million, down slightly from approximately $1.6 million for the second quarter of 2023. The decrease was primarily attributable to decreases in payroll and compensation expense and decreases in insurance expenses. 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 second quarter of 2024 was partially offset by interest income and other income net totaling approximately $449,000 as compared to interest income and other income net totaling approximately Our cash position, which includes cash equivalents and marketable securities, was approximately $33.3 million as of June 30, 2024. We anticipate this balance will provide us with a cash runway into at least Q3 of 2025. Importantly, we believe our solid financial position will fuel continued growth and evolution of our Radar AI platform and continue the advancement of our portfolio of targeted oncology drug candidates. As of June 30, 2024, we had 10,758,805 shares of common stock outstanding, so about 10.75 million shares of common stock outstanding. We had outstanding warrants to purchase 81,496 shares of common stock and outstanding options to purchase 1,063,548 shares of common stock. These warrants and options combined with our outstanding shares of common stock give us a total fully diluted shares outstanding of approximately 11.9 million shares as of June 30, 2024. Our team continues to be very productive under a hybrid operating model. We currently have approximately 22 employees and four FTE consultants focused primarily on leading and advancing our research and drug development efforts. We see this number expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission. I'll now turn the call over to Reggie for a review of initial Phase II patient results and future directions for our harmonic trial. Reggie?