Lantern Pharma Inc.

Good afternoon and welcome to Lantern Pharma's first quarter 2021 conference call. As a reminder, this call is being recorded and all the participants are in a listen-only mode. We will open the call for questions and answers after the presentation. I would now like to introduce your host for today's conference, Marek Piszewski with Investor Relations at Lantern Pharma. Marek, please go ahead, sir.

Thank you, Jim. and welcome everyone to the Lantern Pharma's first quarter 2021 conference call. On the call today are Panna Sharma, Lantern's president and CEO, David Margrave, Lantern's CFO and Dr. Kerry Barnhart, Lantern's vice president of clinical development. A press release was issued today with our first quarter financial results that we will be discussing in our call today. Following the safe harbor statement, Panna will provide an overview of business highlights after which David will overview our quarterly financial results and Dr. Barnhart will provide an update on our LP300 program. Panna will then offer concluding comments after which we will open this call to questions. Please also note that we have provided our link on the Investor Relations website to additional slides that we may reference in today's call. I would also like to remind everyone that remarks about future expectations, plans, 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 our actual results to differ materially from those indicated by forward-looking statements, such as the impact of the COVID-19 pandemic, results of our 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 the risk factors section in our annual report on Form 10-K, which is dated March 10, 2021, on file with the SEC. Forward-looking statements made on this conference call speak only as of today, Monday, May 3rd, 2021, and Lantern Pharma does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today. A webcast replay of the conference call will be available on the Lantern Pharma's website. And with that, I'd like to turn the call over to President and CEO, and Panna Sharma for his opening comments. Panna, please go ahead.

Marc, thank you. And good afternoon to everyone on the call today. Thank you for joining us for our first quarter 2021 conference call. We've had a number of very important progress points over the past quarter and over the past month. Very notably, as many of you probably read this morning, we announced a collaboration with Actuate Therapeutics where we will be leveraging our AI engine, Radar, to help them advance their drug candidate. As you know, Lantern Pharma is an oncology biopharma company that leverages the power of our internally developed AI and machine learning platform called Radar to develop oncology therapeutics. We believe that we are transforming the development of oncology drugs by changing the pace, the cost, the risk of drug development and opening up new doors to rescue and repurpose drugs We are one of a few pure play AI-based biopharma companies with multiple clinical stage programs as well as a rapidly growing proprietary platform for accelerating our understanding, modeling, and prediction of patient and tumor response to cancer therapies. We achieved multiple key milestones in this first quarter. I'm going to highlight a few of those that are critical. Most notably, our radar AI platform surpassed 4 billion data points in the last campaign by the end of March and over 4.6 billion as of the end of April. We also submitted an updated clinical development plan to the FDA for LP300. This is for a phase two trial in non-smokers with non-small cell lung cancer. and Dr. Barnhart will provide an update on our LP300 program later in today's call. During the quarter, we also expanded potential indications for LP184 to include atypical pteritoid rhabdoid tumors in ultra-rare pediatric brain tumor and also for LP184 in drug-resistant non-small cell lung cancer. The indication in lung cancer was published in Oncotarget This past quarter, while the ATRT work is being pursued in collaboration with Johns Hopkins. We also initiated preclinical development of LP284, an entirely new molecule, in certain hematologic cancers that have shown exceptional sensitivity to this new molecule in indications that are very different from our 184 molecule. We also strengthened our intellectual property portfolio with the filing of over 10,000 Patent Applications ranging from novel molecules to methods of use in manufacturing to identifying patients to actually those that cover fundamental technology aspects of our radar platform. Our research team published two peer-reviewed studies in Oncotarget and BNC Bioinformatics that further validate our data-driven machine learning enabled approach to drug development and also provide details and transparency on how radar is being used and implemented in our development of LP184. We think the drug development process for LP184 is actually a central hallmark in a data-driven approach. Our scientists also presented a poster at the virtual AACR this year. That poster was initially conducted in collaboration with Georgetown examining the efficacy and potency of LP184 in prostate cancers, including, and very importantly, those that had DNA damage repair mutations. And we believe that the combination of PTGR1 overexpression along with DNA damage repair confers a potential path of synthetic lethality. Very significantly, we also completed a $69 million follow-on offering in January 20th that dramatically strengthened our balance sheet It provides us multi-year runway to execute our plan to harness the power of radar to innovate precision oncology therapeutics that can bring hope and potentially increase personalization to cancer patients globally. For those of you that have listened to my prior talks and to their earnings calls, know that I believe passionately about not only changing the pace at which drugs for oncology are brought to market, but also the cost and we believe the only way to do this is to use AI and machine learning, which has absolutely smashed the product development cycle and cost curve of every other industry. The growth in radar to over 4.6 billion data points now represents a 16-fold increase since last May and a nearly four-fold growth since the beginning of the year. Let me put this differently and very simply. adding roughly a billion data points of curated biologically relevant information to guide drug development in cancer each month during the first quarter. This is a monthly pace that rivals the volume of data acquired during the entirety of our 2020 campaigns. Our campaigns are becoming larger, they're becoming more voluminous, and we're on track now to smash our previous goal of reaching 3 to 4 billion data points by the end of this year, which we've already reached, and are expecting to achieve over 10 billion during the next campaign. We also expect productivity and functionality to keep increasing as our teams collaborate more effectively and soon more in person as we end the year of the pandemic in many locations. Most importantly, the insights and knowledge that we are now able to acquire from radar is opening up to tremendous opportunities to not only develop our own pipeline of innovative oncology drug candidates, but also to collaborate with other biopharma companies to help accelerate the development of their cancer drug candidates. This kind of opportunity will yield potential equity and milestone arrangements for Lantern and for our investors. Exemplifying this aspect of our business model is the collaboration with Accurate Therapeutics that we announced earlier today. The collaboration focuses on leveraging the Radar AI platform, our machine learning methodology, and our large-scale oncology data sets to accelerate key aspects of Accurate's nine ING41 drug candidates, a best-in-class GSK3 beta inhibitor in active development in multiple Phase II clinical trials, including for pancreatic cancer. The collaboration is expected to start immediately. In fact, it has already started and will potentially generate novel intellectual property that will be jointly owned by the companies. Under the terms of the collaboration, Lantern Pharma will receive upfront equity and actuate therapeutics subject to meeting certain conditions of the collaboration, as well as development milestones in the form of additional equity if results from the collaboration are utilized in future development efforts. We think this is a great way to leverage this growing asset. Our mission remains the same, to unleash the power of Radar and our AI platform to transform the pace, risk, and cost of oncology drug discovery and development, ultimately impacting the lives of cancer patients worldwide by bringing therapies to market faster and with reduced cost. Radar has the potential to significantly accelerate our understanding of which compounds should be developed for which indications, and this may ultimately improve and personalize patient outcomes with reduced risk, decreased capital, and the increased ability to personalize therapy. During previous calls, I've spoken about how we are all experiencing and living in the beginning of a golden age of AI in medicine, an era where the availability of relevant data, computing power, cloud resources, along with on-demand sequencing, global talent pool, and the acceleration of AI and large-scale data analytics and algorithms along with investor and economic demands have aligned to make highly responsive machine-driven approaches to solving complex problems in medicine and healthcare a reality. This is especially true in drug development and especially in drug development that is earmarked by biomarkers and genomics. We are harnessing the trends and capabilities of this golden age to accelerate our expanding pipeline of oncology drug candidates, and now also those of our partners. Since our 2020 June IPO, we've grown the number of programs and active development from three. Very, very critical, both from a risk-reward standpoint, but also from a shots-on-goal standpoint. We are giving more opportunities to investors to generate upside even in the limited amount of time since we've been public. Plus, we are now also initiating development of an antibody drug conjugate program. In just 10 months, we have more than doubled these shots on goals, increased the range of cancers that we can have an impact on, and significantly increased the number of opportunities for potentially accretive licensing and or partnering transactions. We're particularly excited by the fact that we're opening into areas where there's massive clinical need for improved therapies, especially in certain rare and ultra rare cancers. This may enable us to bring certain assets such as LP184 and ATRT or other ultra rare cancers directly to patients and to the market ourselves. This is an important point to note. Let's discuss quickly our pipeline. We remain are firmly on track to begin in third quarter of 2021 the phase two trial of LP300, a small molecule drug candidate targeting a growing but unaddressed type of non-small cell lung cancer among non-smokers. LP300 is now likely the most clinically advanced drug candidate anywhere for this high unmet medical need for this patient population. Dr. Kerry Barnhart will provide a detailed update and review of the clinical trial protocol later in our call. LP300 represents a potentially first-in-class combination therapy for non-small cell lung cancer patients who are non-smokers, a histologically defined adenocarcinoma that accounts for approximately 20% of new non-small cell lung cancer cases globally and actually even more in certain geographies. We believe that each year about $2.5 billion is spent globally on therapies and drug treatments for this patient population. Moving on to our more rapidly evolving LP184 program that's now in active development across four disclosed tumor types. Recall that among the central features of our business model is to collaborate in the development of our drug candidates in specific indications with leading researchers in that area. so that we can leverage their respective knowledge and experience in a given therapeutic area and their experience with therapies for that patient population. LP184 is currently in active collaborations with Johns Hopkins in various CNS tumors including glioblastoma and ATRT. With Georgetown University, we're working in studies of LP184 in prostate cancer and with Fox Chase Cancer Center in active studies of LP184 and Pancreatic Cancer. We continue to explore additional opportunities for collaboration and development and we expect to announce additional collaborations with leading institutions in the coming months. The scope of work being done at each of our collaborations is to prepare the drug, LP184 or other candidates for clinical development and targeted clinical trials where we have a clear indication of the patient need and the mechanism of action and a driving genomic or biomarker-based signature. We believe that we can gain relevant insight, expertise, and experience from these KOLs, and we remain firmly on track to leverage this model to potentially begin phase one clinical trials in each of these collaborations and their respective indications in 2022. We will continue to provide regular updates on each of these programs as appropriate. In fact, we have data we expect in this quarter and next quarter for all of these programs. Among the goals of the ongoing collaboration is to help guide the development and validation of a signature of disease that can potentially serve as a companion diagnostic and thereby more clearly define the commercial potential of each of our innovative cancer drug candidates. It's important also to note that in fact there was a recent publication done by University of Toronto researchers that indicated that clinical trials in cancer that used a biomarker or used a biomarker-based signature were five times more likely to receive regulatory approvals. In certain cancers like breast cancer, the increase was more notable, such as 12X. In other cancers like pancreatic and prostate, it was a little bit lower, like 6 to 7X and 4X in colorectal. These collaborations allow us to get there, I believe, in a very cost-effective and very efficient manner. For example, our collaboration with Georgetown is currently focused on validating the role of PTGR1 and the genetic mutations that drive the DNA damage repair pathways that make LP184 highly potent in certain prostate cancers. Ultimately, the goal of the collaboration is to create a more biologically relevant and robust gene signature in preparation for clinical trials with the objective of allowing future prostate cancer patients to experience the benefit of a personalized treatment approach. We believe that Lantern's AI-driven approach could save millions of dollars in drug development costs while significantly accelerating the path to personalization and commercialization of therapy. We also have a similar research and collaboration agreement with Fox Chase Cancer Center for the further development of LP184 in pancreatic cancer This collaboration advances the targeted use of LP184 in genetically defined subtypes of pancreatic cancer and also the development of robust gene signature. We believe this could open up a pathway to a more personalized therapy option that has the potential to improve survival. This program is being led by Dr. Igor Astestorov at the Molecular Therapeutics Program at Fox Chase. We also announced a new collaboration research agreement with Johns Hopkins to explore the development of LP184 in atypical teratoid rhabdoid tumors, or ATRT, an ultra-rare and fast-growing cancerous tumor of the brain that presents primarily in children. ATRT, notably, also is marked by SMARCB1 deletion, either entirely or in part. So SMARCB1 mutated cancers represent another category for LP184. Hopkins, as many of you know, is a leading research center for brain cancers, and one of the largest brain tumor treatment research centers in the world with a focus on treating patients affected by all types of brain tumors. ATRT currently has no effective therapies and the urgency of directing this drug towards helping children battle this particularly aggressive cancer was self-evident, as was the opportunity to collaborate with John Hopkins pediatric oncologist, Dr. Eric Rabb, who has devoted his career to studying these pediatric brain cancers. Pediatric brain cancer is the second leading cause of pediatric cancer death, with the incidence rate growing, unfortunately, at approximately 2.7 to 2.9% per year. We believe that the rarity of the incidence of ATRT in the U.S., actually globally, and its prevalence in children supports the potential for LP184 to qualify in the future for a possible grant by the U.S. FDA for a rare pediatric disease designation If we're successful in receiving the rare pediatric disease designation and if it receives ultimate approval, we could qualify for getting a priority review voucher. That review voucher would represent a significant value-enhancing milestone for Lantern Pharma. These research programs, such as the ones I've highlighted with Hopkins, Georgetown, and Fox Chase, are at the forefront of translational cancer medicine. They will use patient-derived cancer cells that are studied using physiologically relevant in vitro and in vivo models. This innovative approach allows the researchers to more precisely understand the biology of the tumor, guided, of course, by early-stage work that's done in a cycle with our radar AI platform. This allows us to more accurately establish the precise signature in a cyclical manner. This data-driven insight also gives us insight into additional mechanisms that can be leveraged in creating combination programs and in creating potentially new targets or new molecules. Our mission is to transform and accelerate the cancer drug development process. If we can compress the time to clinical trials and de-risk our drugs, such as LP184, we can save years of research and tens of millions of dollars in developing treatments for GBM, ACRT, Pancreatic, and other potential rare or ultra rare cancers such as the ones we're currently evaluating. Also, in talks about what our team has also published, we've also published manuscripts describing the efficacy of our drug in a variety of different models such as the one we published in OncoTarget just over two weeks ago where there's a clear clinical need for LP184 for non-small cell lung cancer patients that are ineligible for targeted therapy or have developed resistance to other forms of therapy. For us, this is a very interesting target because of our complementary approach with LP300 where we're targeting non-smokers that have a very different molecular profile. Similarly, LP184 goes again for a very unique subset of non-small cell lung cancer patients that aren't responding to targeted therapy or are no longer eligible. So meaning existing targeted therapies such as EGFR or ALK inhibitors will only work in genetically defined patient sets. And there's about 30 to close to 40% that don't have those targetable alterations such as EGFR, ALK, CNET, or have developed resistance to the current standard of care therapies. That leaves those patients without additional therapeutic options and actually not a very good prognosis. We believe that LP184 could potentially be effective in that patient class. We're now working pre-clinically to show how LP184 inhibits tumor growth. We've shown that now in a mouse xenograft model of KRAS and PF1 mutant lung cancers. And co-occurring KRAS and PF1 mutation occur in about 17% of lung adenocarcinoma cases. and are a very aggressive form of lung cancer that is believed to be usually undruggable. We've developed a genomic signature that is believed to predict response in tumors that will be responsive to 184 and guide in further development of the drug. Using this data-driven approach, we've shown that not only we can find unique biomarkers that link drug response and mechanism, but we can also rapidly uncover clinically meaningful patient subgroups that can benefit from our portfolio of therapies. In the past 10 months of being public, our team has accomplished a significant amount in terms of advancing our portfolio, uncovering new indications, and very importantly, advancing our radar AI platform. We believe that together, this will provide the potential for multiple shareholder value, enhancing milestones over the next 2021 and 2022. And we have sufficient capital to achieve those milestones. Now I'll hand over the call to David Margrave. are CFO for a review of our first quarter financial results.