Lantern Pharma Inc.

and welcome to our first 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 first quarter ended March 31st, 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 31st, 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, May 9th, 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, Pauna Sharma, and CFO, David Margrave. Pauna will start things off with 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.

Thanks, Maddie, and good afternoon, everyone. Thank you for joining us to hear about the productive first quarter of 2024 and our financial results, as well as other 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. At no time has this been more evident than now in early 2024, where every facet of pharma development from design of molecules to disease modeling, to simulations and even in areas like manufacturing and clinical trial recruiting are being rethought as a result of the widespread availability of computational capabilities, high quality data, and automation. 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, data-first approach to drug development. We recently demonstrated this with our newly formed collaboration with Oregon Therapeutics, where we will help them accelerate their path to the clinic and also receive upside in benefits as a result of the insights and IP from the collaboration. We expect more activity and deals where we can continue to use our AI platform radar as currency for collaborations, partnerships, and co-development opportunities. 2023 was a transformational year for Lantern Pharma across many measures, and I shared that with all of you who listened in on our March 18th earnings call. But so far in this quarter, we continue to see the pace of progress, and this includes... across our entire three AI-guided molecules that are now in clinical trials, LP184, LP284, and LP300. And each one of them is in areas of high unmet need, with LP184 on track for a clinical readout later this year. We expect in late summer or early fall. Some of the other highlights besides 184 and 284 include Obtaining regulatory allowance to begin our phase two in Japan and Taiwan, where we expect more rapid enrollments, especially since 30 to 35% of all lung cancer cases occur in never smokers in those countries. We've so far had a great safety profile with phase one clinical trials for both of our synthetic lethal drug candidates, LP184 and 284. They continue to advance in cohorts, but we see no dose limiting toxicities in any of the cohorts enrolled and dosed to date. These two drugs combined have annual global sales potential of over $12 billion. We're also advancing Starlight. It's our subsidiary focused on CNS and brain cancers with STAR-001. We filed a clinical trial protocol for the phase 1B dose optimization and expansion cohort in a very malignant form of brain cancer, recurrent IDH wild type, high-grade gliomas. We also had ongoing advancements in our AI-powered module for ADC development, where we can streamline and guide the differentiated development of new ADCs, which will be instrumental in the next generation of drug candidates, not only for our industry, but also for Lantern Pharma and our collaborators. And also, we established an AI-driven collaboration with Oregon Therapeutics, a very unique French biotech that's using a very unique small molecule to transform cancer metabolism. We'll be leveraging radar there for this novel first-in-class inhibitor. Let's talk a little bit first about our pipeline. Many of the initial observations that were 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 our three AI-guided drugs into clinical trials at a pace and cost that is traditionally unheard of in our industry. Let me walk you through some of the highlights of our portfolio before I start talking about Starlight and our emerging portfolio in ADCs. With LP184, First, many clinicians are particularly excited about and interested in the programs for these first-in-human synthetically lethal drug candidates. We've now gone through five cohorts of patients in LP184, comprised of dose levels 1 through 5. In escalating doses, we're now in dose level 6. This is a first in human phase one trial across multiple solid tumor indications. And these solid tumors are typically advanced or refractory to existing standard of care therapies. In fact, the trial is now enrolling at dose level six. And these are typically about what we've seen so far. Median prior lines of therapy have been about four lines of prior therapy for these patients. And so far, again, no observed dose limiting toxicities. The company believes that enrollment should be complete this summer and on track for a readout of the data soon thereafter. Our current enrollment efforts are focused especially on cancer patients that have DNA damage repair deficiency, or what we'll refer to as DDR deficient tumors. For those of you that have looked at the press release, you probably saw that we had a great publication focused on DDR deficient tumors and their sensitivity to LP184. But many of the genomic alterations Both, especially non-CNS solid tumors, include BRCA1 and 2, PTEN, PRK, ADC, ATR, POLL, ERCC6, ERCC3, FAN-CM, DDB1, SLX4, MLH3, MDC1. It's an alphabet soup. But what that tells us, most importantly, is there's a wide range of genomically defined tumors that that we will include as the definition of DDR deficient. And many of these are already available in mutation and expression panels that are available today. So that's great news. But also what we've done is we've submitted a supplement A and a supplement B. These are both supplements to the FDA related to LP184. Supplement A is specifically focused in non-CNF solid tumors, including TNBC. And supplement B is also dose optimization and expansion protocol in recurrent IDH wild type. And that's lantern in collaboration with Starlight. So we're already beginning to plan for the next phases. We think we'll have some results to share and move these into some very, very targeted, extremely exciting indications. Genomic identification of these patients is important, and biomarker characterization of their underlying tumor is central to our focus of personalizing treatment and, more importantly, developing efficient later-stage clinical trials. To further this effort, what we've done is also initiated the development of a PCR-based molecular diagnostic test that will help us in the identification of cancer patients with the highest likelihood of response. So I think we're making great progress with 184 across multiple measures. In 284, the initial two cohorts of patients have been dosed. And again, we see no dose limiting toxicities so far in the phase 1A clinical trial. We expect to continue opening up new sites. Phase 1 for both 184 and 284 are a little bit staggered, with 284 a few months behind where we are with 184. But 284 has shown nanomolar potency in multiple in vivo studies, including mantle cell, double-hit lymphomas, advanced NHL cancer subtypes that are fairly aggressive, and also with certain sarcomas that have DDR deficiencies. With our drug LP300, it's a very unique drug candidate, which is aimed at never smokers that have been impacted by non-small cell lung cancer. It's a growing problem, not only in the U.S., but globally. And we have been successful in achieving regulatory allowance to commence our trials in Japan and Taiwan, where the incidence rate for non-small cell lung cancer is two and a half to three times that here in the U.S., That's going to get us to accelerate the collection of patient and response data. And what that means is we'll get to some readouts quicker than we have experienced so far. We've also enrolled the help of one of the premier physicians and researchers focused on lung cancer at the National Cancer Center of Japan, Dr. Yoshio Goto. And Dr. Goto will be our lead PI and collaborator and will be leading the phase two trial in Japan. We believe that this improves the positioning for LP300 to develop collaborative and co-development partnerships with global biopharma companies, especially those that have a focus to serve the Asian markets. Let's turn quickly to Starlight. We've made some good progress on the launch of our clinical stage CNS and brain cancer-focused subsidiary, Starlight Therapeutics. It's a company that has been largely developed as a result of data. computational approaches to optimize and maximize our insights, understand mechanisms. And these insights have allowed us to create a whole, what we think is a wholly new company serving a tremendous need. Starlight and our new CMO, Dr. Chamberlain, Continued advancements, they filed a clinical trial protocol for the phase 1B dose optimization, which I mentioned earlier, supplement B, and expansion in recurrent IDH wild-type high-grade gliomas. IDH wild-type glioblastomas are the most malignant glial tumors with a median survival of about 15 months after diagnosis. So it's a really, really aggressive, poor prognosis and very poor, even worse than that, in recurrent GBMs that are IDH wild type. So in addition to the GBM clinical trial, several other indications have been published on and could be pursued as part of advancing starlight. These findings, especially in brain mets for TNBC, brain mets in non-small cell cells, lung cancer, especially those that are STK11 or KEAP mutant, and also in a number of pediatric CNS cancers, ATRT, where we've published with the NCI in a major publication in Frontiers in Cancer, and also diffuse midline gliomas, which include DIPG and other midline gliomas. Again, very poor outcomes. So for us, Starlight's pipeline isn't just focused on one indication. It's focused on what we believe could be a cornerstone and focused on multiple CNN indications. Now remember, this is a program that we've been able to develop between a million and $2 million per program. It's a milestone unheard of in the realm of oncology drug discovery, including drug manufacturing. And this is driven in large part due to our AI-centric business model. We think this is what more and more of the industry will adopt simply because it massively compresses the timeline in early stage development, indication selection, mechanistic refinement, and biomarker signature creation. These are things that historically have taken years and years and quarters, and we can compress these down. We've also made major progress in developing the next major leg of our discovery efforts, which will be focused on drug conjugates, including antibody drug conjugates. Specifically, we have a cryptofisin linked to ADC. It's a very, very novel drug, novel payload, novel mechanism, which so far we're developing in collaboration with our partners in Germany and We'll talk about that later in our call. So we believe we continue to be a leader in this AI golden age that we're hitting in medicine. It's just the beginning. It's powered by large scale, highly available computing power. It continues to morph and evolve literally every quarter. There's massive data that's available. It's being fed by more high-quality healthcare data, high-quality patient cancer biomarker data, and these capabilities are now being adopted by leading tech bio companies like ourselves, but also very importantly, biopharma is beginning to increasingly turn to it. We believe we're one of the leaders in this transformation at transforming the pace, the risk, and the cost of oncology drug discovery and development. This transformation has a promise not only to make medicines faster and cheaper, but also with greater precision for patients and change the direction of R&D productivity and more importantly, add value to groups of cancer patients that today don't necessarily always have great medicine and great therapeutic options. So let's turn our focus down to our financial update and highlights. So our CFO, David Margrave, will turn the call over to, and David will walk us through our financials.

David? Thank you, Pana, and good afternoon, everyone. I'll now share some financial highlights from our first quarter-ended March 31, 2024. We recorded a net loss of approximately $5.4 million for the first quarter of 2024 for 51 cents per share compared to a net loss of approximately $3.9 million or 36 cents per share for the first quarter of 2023. For the first quarter of 2024, our R&D expenses were approximately $4.3 million up from approximately $2.6 million for the first quarter of 2023. This increase was largely driven by an increase in clinical trial activity and clinical trial site initiations. These R&D increases in Q1 2024 were partially offset by decreases in product candidate manufacturing-related expenses of approximately $204,000. Our general and administrative expenses for the first quarter of 2024 were approximately $1.5 million, down slightly from $1.7 million for Q1 2023. The decrease was primarily attributable to decreases in payroll and compensation expense and other professional fees. Our R&D expenses continue to exceed G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Our loss from operations in the first quarter of 2024 was partially offset by interest income and other income net, totaling approximately $291,000. Our cash position, which includes cash equivalents and marketable securities, was approximately $38.4 million as of March 31, 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, accelerate 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 March 31, 2024, we had 10,758,805 shares of common stock outstanding, outstanding warrants to purchase 81,496 shares and outstanding options to purchase 1,077,292 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 11.92 million shares as of March 31, 2024. Lantern issued 20,132 shares of common stock during Q1 2024 relating to the cashless exercise of warrants to purchase 79,021 shares. Also in Q1 2024, Lantern issued 17,481 shares of common stock for aggregate proceeds of approximately $55,000 relating to the exercise of warrants for cash. With these warrant exercises, the amount of common shares covered by warrants was reduced by approximately 97,000 shares. Following these warrant exercises, Lantern now has warrants outstanding to purchase 81,496 shares and a weighted average exercise price of $16.55 per share. Our team continues to be very productive under a hybrid operating model. We currently have approximately 20 employees and 4 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 back to Pana for an update on some of our development programs. Pana? David, thank you very much.