Lantern Pharma Inc.

Good afternoon, everyone. I am Nicole Lieber with Investor Relations here at Lantern Pharma. And welcome to our second quarter 2022 earnings call. I will be your host for today's 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 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 of 2022. Copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slides that management will be referencing on today's call. I would like to remind everyone that remarks about future expectations, performance estimates and prospectus constitute forward-looking statements for purpose 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 indicated by forward-looking statements including the impact of the COVID-19 pandemic, results of clinical trials, and the impact of competition. Additional information concerning factors that would 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, 2021, which is on file with the SEC and available on our website. Forward-looking statements made on this conference call are as of today, Monday, August 8th, 2022, and Lantern does not intend to update any of these forward-looking statements to reflect 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. Today's webcast, we have Lantern Pharma CEO, Panna Sharma, and CFO, David Margrave. Panna will start things off in a minute with an overview of Lantern's operational highlights and business activity, after which David will discuss our financial results. This will be followed by some concluding comments from Panna, and then we'll open up the call for Q&A. I'd now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.

Peter Nara, Panna Sharma, Kishor Gopaldas Bhatia, Marc Chamberlain, David Margrave Thank you very much. We're using this platform to uncover significant opportunities in cancer, opportunities that are either underserved, unmet or often overlooked. Thank you for joining us. Our unique AI platform is powered today by more than 21 billion data points and nearly 200 algorithms and computational models that can help us understand, predict and model questions that are fundamental to oncology drug development. Core to our business is our IP, not only on our drug products and the insights in how to best manufacture, utilize and direct them, but also relating to our AI platform and the methods and automation that drive the precision and growing power of radar. Lantern Pharma has entered into a major period of transformation as we evolve and mature many of our initial AI driven insights and advance our drug candidates into human clinical trials. We're continuing to make significant and meaningful progress in turning the observations and correlations generated by our AI platform radar and then validated in the lab oftentimes labs of top tier academic and research partners into actual advancements for cancer patients and potentially breakthrough or first in human clinical programs. When we went public, we had three drug programs. Today, we have nine named programs in our pipeline and several additional programs in consideration and undergoing assessment. This level of early discovery and productivity with our cash utilization and headcount is largely unheard of in biopharma companies. Today, we have several notable advancements to share with you, including updates about the launch of our phase two trial, for LP300 and lung cancer, the harmonic trial, the pathway towards phase one first in human clinical trials for LP184 and LP284, updates on the expansion of radar, as well as several operational and financial highlights. In July, we announced FDA authorization for the initiation of our harmonic trial, a phase two clinical trial evaluating our drug candidate LP300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer. The CDC defines never smoker as an adult who has never smoked or has smoked less than 100 cigarettes in his or her lifetime. Thank you very much. Thank you for joining us. Thank you for joining us. We're also engaging in global partnering discussions for regions of the world where there's a higher prevalence of never-smokers and non-small-cell lung cancer. This includes parts of Asia, South America, and Europe. Based on the present timeline, we anticipate initial interim analysis of trial results in late 2023 or early 2024, with trial completion by late 2024. Thank you for joining us. never smoker patients with non-small cell lung cancer represent a potential market size of 1.5 to 2 billion as nearly 200,000 patients worldwide are diagnosed with this cancer annually and 20 to 30,000 of those patients are in the U.S. alone. A novel and very exciting aspect of Harmonic is that we'll be collecting and analyzing liquid biopsies from patients at four points during the trial, initially at enrollment prior to treatment, and then during treatment after three treatments and six treatments and at completion of treatment. This is a very unique study since the liquid biopsies will be analyzed for both genomic and transcriptomic data. And we believe this will represent one of the largest and most comprehensive biomarker studies done on the never smoker non-small cell lung cancer population. Importantly, data from these biopsies will also provide key biomarker data for radar to help generate insights for a potential pivotal phase three trial and to further understand the response biology of never smokers with non-small cell lung cancer. In addition to the Phase 2 trial for LP300, we continue to advance multiple preclinical programs, and we also expect to launch three first-in-human Phase 1 trials over the next 12 months for our drug candidates, LP184 and LP284. Let me go into some details. For LP184, it's a unique asset that we believe can have a multi-billion dollar potential for Lantern and our shareholders. We are working on the preliminary trial design for a phase one trial of LP184 targeted for Q2 of 2023 in genomically defined pancreatic bladder cancers and other solid tumors in collaboration with Fox Chase Cancer Center and several other prestigious centers. We have also established a pathway towards a second phase one trial for LP184 in CNS cancers, including high-grade gliomas and GBN in collaboration with Johns Hopkins, which is targeted for Q2 of 2023. Conducting two Phase I trials with LP184 will allow us to maximize the potential of a compound for these different cancer types and, very importantly, generate sufficient data for partnering or licensing interest in these clinically distinct cancers. We're also planning to advance LP184 for the treatment of CNS tumors in at least two disclosed indications, GBM and brain mints. Historically, these CNS indications have very low survival rates and have few or no approved therapies. For brain mints in particular, our indications in lung and breast cancer have shown superior sensitivity, even in brain mints from HER2 positive breast cancer and also from triple negative breast cancers. Our preclinical studies have also revealed several molecular and bioavailability properties of LP184 that make it an exciting and uniquely promising agent for CNS cancers. Panna Sharma, Panna Sharma, Panna Sharma, Peter Nara, Peter Gopaldas Bhatia, Marc Chamberlain, David Margrave Thank you very much. Thank you for joining us. Our CNS indications for LP184, including GBM, ATRT, and other pediatric CNS indications represent a market potential we believe in excess of over $4 billion annually. This is something we're really excited about and investors should also be as we advance this drug candidate into phase one trials with the potential to make a significant difference in a range of CNS cancers. Moving on to LP284, Thank you for joining us. Lantern is developing LP284 for non-Hodgkin's B-cell lymphomas, where LP284 has shown nanomolar potency in cell lines and also in vivo studies, specifically in mantle cell and double-hit lymphomas. In addition to our exciting clinical developments, the radar team has been focused on making substantial improvements to our radar infrastructure, increased automation capabilities, and further refinement and improvement of algorithms. These advances will not only streamline radar insights for Lantern, but will also facilitate future commercial partnering opportunities. When we went public in the summer of 2020, radar consisted of 275 million data points, all in solid tumors. Today, we are more than 21 billion and remain on track to reach our 2022 year-end target of 25 billion. and this is across CNS cancers, pediatric cancers, solid tumors and also hematologic cancers. As we mentioned in our press release earlier this afternoon, Lantern entered into a collaboration with Actuate Therapeutics. This collaboration was penned in Q2 of 2021. That collaboration leverages radar to accelerate the identification and development of actionable clinical biomarkers for Actuate's drug candidate L-reglucid, also known as 99G41. Using advanced machine learning, ensemble-based algorithms, and other radar-aided computational approaches, we have been successful in identifying candidate predictive biomarkers. Additionally, we've been able to model clinical response to L-reglucid. These insights are being used to inform the development of L-reglucid and the design of Phase II randomized trials. These methods will be further applied to future biomarker validation, and will be expanded to incorporate modeling with additional forms of patient data in the future, including RNA, ctDNA, soluble biomarkers, and other key genomic features. Lantern has received equity in actuate therapeutics and has the potential to receive additional equity upon meeting development milestones and the application of computational models to L-raglucid based on future development efforts. and to the Actuate team, if I've mispronounced L-reglucid, I'm sorry. It's a tough word. In September, which is Childhood Cancer Awareness Month, we'll be hosting a key opinion leader webinar on LP184 in the treatment of pediatric cancer. This will feature Dr. Peter Howden, renowned professor and PI at Greedy Children's Cancer Center at UT Health Science Center, Additional details about the KOL webinar and pediatric cancer, which is currently being planned for September 22 next month, and how to participate in it will be announced in the coming weeks. I'll now turn the call over to our CFO, David Margrave, who will provide an overview of our second quarter financial results.

David? Thank you, Panna, and good afternoon, everyone. I will now share some of the financial highlights from the second quarter. Our R&D expenses for the quarter ended June 30, 2022 were approximately $3 million up from approximately $1.2 million for the second quarter of 2021. This increase was primarily attributable to increases in product candidate manufacturing related expenses and increases in research studies. General and administrative expenses were approximately $1.4 million for the second quarter of 2022, up from $1.3 million in the prior year period. We recorded a net loss of approximately $4.5 million for the quarter ended June 30, 2022, or 41 cents a share. This compares to a net loss of approximately $2.3 million for the quarter ended June 30, 2021, or 21 cents per share. As of June 30, 2022, we had approximately 10.8 million shares of common stock outstanding and outstanding warrants to purchase 177,998 shares and outstanding options to purchase 939,940 shares. 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, 2022. Our cash position, which includes cash equivalents and marketable securities as of June 30, 2022, was approximately $62.2 million. This balance is expected to carry us into 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 products and collaboration opportunities in a capital efficient manner. As mentioned on prior calls, we have migrated to a hybrid work environment and I'm proud to say our team continues to be very productive under this operating model. This hybrid model removes geographic restrictions to our hiring initiatives, which gives us the ability to recruit extremely high caliber team members that otherwise might not be available in a smaller local talent pool. We currently have 18 employees who are primarily focused 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 over to Panna for some final comments. Panna. Thank you, David.