Lantern Pharma Inc.

Good afternoon and welcome to Lantern Pharma's fourth quarter 2020 conference call. As a reminder, this call is being recorded and all participants are in 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, Malrick Teshefsky with Investor Relations at Lantern Pharma. Malrick, please go ahead.

Thank you very much, Christy, and thank you for joining us for Lantern Pharma's fourth quarter 2020 conference call. On the call today are Prana Sharma, Lantern's President and CEO, and David Margrave, Lantern's CFO. A press release was issued this afternoon with our fourth quarter financial results that we will be discussing here today. Following the safe harbor statement, Pana will provide an overview of after which David will share our quarterly financial results. Pana will then offer concluding comments after which we will open this call to questions. Please also note that we have provided our link on our IR website to the slide that we will be referencing 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 cautioned that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as the impact of COVID-19 pandemic, the 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 and be found in the risk factors section in our annual report on Form 10-K for the year ended December 31st, 2020, which was filed with the FCC on March 10th, 2021. Any forward-looking statements made on this conference call speak only as of today's date, Wednesday, March 10th, 2021. And Lent and PhRMA does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today. Please refer to today's press release for replay information. And now, I turn the call over to Parna Sharma, President and CEO of Lent and PhRMA. Parna Sharma, President and CEO of Lent and PhRMA. Parna Sharma, President and CEO of Lent and PhRMA.

Mark, thank you. And good afternoon to everyone on the call today. Thank you for joining us for our fourth quarter and year-end 2020 conference call. For those of you that are new to the Lantern Pharma story, we are a unique company, an oncology biotech that leverages the power of artificial intelligence and machine learning to both rescue and develop oncology therapies. We do this through our internally developed proprietary AI platform called Radar. We are one of the few AI-based biotechs that has multiple clinical stage programs in development as well as a rapidly growing proprietary platform. for accelerating our understanding, modeling, and prediction of patient and tumor response to cancer therapies. In this regard, we are a very unique company at the forefront of the data and machine-enabled transformation happening in drug development and drug discovery today. Our team has been working very hard this past quarter, advancing our collaborations, developing meaningful lab data, advancing our manufacturing, onboarding new team members, both employees and consultants, while also hitting major new milestones for our platform and for developing insights for new indications that'll power future therapies. Shortly after we began trading last June of 2020, we announced that our proprietary AI platform for precision oncology drug development radar surpassed 450 million data points. That was roughly six months ahead of our plans. Now we plan to cross the three billion mark during 2021. We closed 2020 with a little over 1.1 billion data points. These data are highly curated data sets specifically for oncology drug development and drug response prediction. Our team has made tremendous progress in this front and has recently announced a publication in BMC Bioinformatics which showcases some of the processes that our platform enables for drug development, in particular preclinical work for selection of indications, and the development of a biomarker-enabled signature that can be used for both patient selection and prediction of tumor response. Our process for selecting, cleaning, curating, and tagging the data has gotten significantly more efficient and powerful, and this will allow our company and particularly our partners to develop cancer therapies and better understand where and how certain compounds work with even greater precision, reduced risk, and a much more rapid pace. We will be seeking and developing select partnerships with biopharma companies where our radar AI platform can help in the development of their programs and generate rewards and upside for Lantern and our investors. Beyond merely the sheer amount of data, the quality and relevance of our data and functionality continues to grow, as evidenced by the increase in the number of indications and programs we have developed since our IPO. In June, it was three, and now it's seven programs. And this is all in the span of the last nine months. Our radar AI platform stands at the core of our business model alongside a targeted and accelerated drug development path. The growth in the quantity and quality of our data and also our functionality is an important driver of the value of our franchise. Radar's growing genomic drug sensitivity and patient outcome data sets combined with our AI and machine learning enable us to streamline the drug development process while also identifying patients and patient populations that will benefit from our oncology therapies. We are confident the power of radar will enable us to add at least one additional biomarker or genetically defined program or indication to our pipeline every 12 to 18 months. During previous calls, I've spoken extensively about how we are now beginning to experience and live in the beginning of a golden age of artificial intelligence, an era where the availability of relevant data, computing power, cloud resources, on-demand sequencing, talent, and the acceleration of AI and large-scale data analytics and algorithms, along with shifting economic and investor demands, have aligned to make large, data-driven, highly responsive, machine-driven approaches to solving complex, sometimes unknown problems a reality. This is especially true in drug development. We are harnessing the trends and capabilities of this golden age to accelerate our pipeline and, most importantly, to benefit cancer patients and to bring down the costs associated with the risky and lengthy process of cancer drug development. For those of you that are still new to the story or learning about Lantern, our pipeline of small molecule oncology assets and an antibody drug conjugate asset includes new compounds that we have identified through our biomarker discovery efforts, as well as potential therapies with extensive prior clinical experience that we acquired after previous owners abandoned development efforts following phase three setbacks. In all regards, we own the therapeutic rights or developmental rights to all the assets that we're developing. Our radar AI platform underpins each development or rescue efforts, and we are confident that this will help us achieve a scale and transformation to the oncology drug development process. 2020 was a pivotal year for Lantern Pharma, marked by a series of financial, operational, and drug development achievements, many of which are highlighted in the press release that was issued earlier this afternoon. But these achievements validate something that's very unique about our business. Not only are we capital efficient, and leveraging the power of AI, but we also are combining that with the knowledge and experience of our scientific team to rapidly take these insights and march forward in our drug development programs. In the short time since our June 2020 IPO, we've more than doubled the number of programs that we have in active development. This increases the number of opportunities for accretive licensing deals, partnering opportunities, and generating upside for our investors. We also initiated a highly differentiated antibody drug conjugate program. This leverages some very unique linker technologies developed by Califia, and we also grew the number of data points that fuel our AI platform by over 5x this past year. We initiated manufacturing, research, and development collaborations with leading cancer research institutions. These include Johns Hopkins and Glioblastoma. Georgetown University in prostate cancer, Fox Chase Cancer Center in pancreatic cancer, and also other solid tumors where nucleotide exclusion repair mechanisms can be exploited. These are all very targeted programs, and many of these programs and collaborations are now entering their second stage, including the one with Georgetown. The first stage of joint research activities began in the fourth quarter of 2019. and generated compelling evidence of efficacy of LP184 in solid tumors, but in particular solid tumors that overexpressed PTGR1. This anti-tumor activity was linked in a dose-dependent fashion, and we validated it in very specific subtypes of prostate cancer where PTGR1 is naturally overexpressed as a form of it becoming metastatic. This research has helped us guide specific development of that signature and more importantly, correlates to increased response among certain subtypes of cancer, including cancers that are DNA damage repair gene deficient. The next phase of collaboration will focus on a larger set of PDX models. It'll pinpoint the specific mechanism, seek confirmatory validation on the role of PTGR1 and potentially other genetic mutations, and the research will complete the acquisition of detailed genomic information in prostate cancers and potentially other related urogenital cancers. The second phase goal is to create a biologically relevant, robust gene signature that we can take into clinical trials and will prepare us to select patients with the objective of allowing future prostate cancer patients to experience the benefit of a more personalized cancer treatment approach. Ultimately, we believe that our AI-driven approach could save millions of dollars in drug development costs, perhaps tens of millions, while significantly accelerating the path to commercialization, but more importantly, personalized treatment towards select populations that are most likely to benefit from the therapy. The work that we're doing at Georgetown is being led by Dr. Partha Banerjee, a world-renowned expert in molecular oncology and prostate cancer. We also have collaboration research agreements with Fox Chase Cancer Center for the development of LP184 in pancreatic cancer, And this collaboration advances the targeted use of LP184 in genetically defined subtypes of pancreatic cancer. Again, those with the right gene signature and, of course, to be able to use that gene signature biologically relevant and occurring naturally in pancreatic cancers to guide the development of clinical trial. If successful, we believe that we can develop a more personalized therapy option that has the potential to improve survival and go after one of the cancers that has very poor overall survival. The program at Fox Chase Cancer Center is being led by Dr. Igor Astyashirov in the molecular therapeutics program at Fox Chase. Igor is an internationally recognized researcher in GI cancer specializing in investigating signaling pathways that inform the choice of biomarkers and innovative therapy combinations in clinical trials. In the fourth quarter, we announced another collaboration and research agreement with Johns Hopkins at the Sidney Kimmel Comprehensive Cancer Center. This program is focused on further development of one LP184 in glioblastoma. Johns Hopkins is a leading research center for brain cancers and one of the largest brain tumor treatment and research centers in the world, and they focus on treating an extremely large number of patients affected by all types of brain tumors. In fact, after finding that LP184 cross the blood-brain barrier exquisitely. We've been at the forefront of enriching our RADAR database with several dozen million data points in brain cancers. And again, the collaboration today with Hopkins is focused on defining the subtypes of GBM, but also clarifying the most promising clinical application for the drug candidate, LP184, especially as monotherapy. The goal of this collaboration is to develop a clinically ready program that has characterized the drug candidate with the most biologically relevant and robust biomarker signature and using that signature to identify the patients that have the highest potential for response. This way we can shorten future trials and bring the drug to the benefit of this needed population. This kind of research we believe is the forefront of translational cancer medicine and very importantly allows us to develop physiologically relevant models using patient-derived material and then understand the biology of what is actually happening inside the cancer tumor and use that to feed our radar engine. The radar engine allows us to generate more precise biomarker signatures that provide data-driven insight into additional mechanisms. So we believe this is a very essential, very important feedback loop as data from physiologically relevant experiments feeds back into our AI engine. Our AI engine generates signatures, those signatures that are used to do additional work. And this process is continuing now across several cancers and several cancer areas at Lantern, and this feeds millions of data points of additional insight, proprietary data-driven insight, into our radar platform. Our GBM program is being led by Dr. John Letera, an internationally recognized researcher in neurology, oncology, and neuroscience. During our last call, we talked about how LPA-184 has demonstrated high nanomolar potency and the ability to cross the blood-brain barrier, something that very few small molecules can do. But more importantly, as it crosses the blood-brain barrier, it keeps neuronal cells intact and viable while really focusing the damage on the cancer or the glioma cells. This opens up potentially a high-value opportunity to help patients in many other brain cancers. and the ability to cross the blood-brain barrier is of critical importance in treatment outcomes for CNS and other brain cancers. Our AI platform, along with algorithms tuned to predict blood-brain barrier permeability, played an important role in helping determine which CNS cancers and which genomically defined subtypes of CNS cancer should be prioritized for development. Using in silico tools and also in vitro data from neuronal cell plates, neuro spheres, LP184 demonstrated permeability that was in line with TMZ and other therapies while also demonstrating nanomolar potency. This data is extremely significant. Building on this data, we believe we can identify, well, we have identified several additional brain cancers where LP184 can play a major role as a potential therapy, and we're pursuing one of the validated indications in atypical teratoid rhabdoid tumors. This is an ultra-rare tumor. brain cancer that occurs primarily in children, especially children under the age of four. And there's typically between 50 and 70 or 80 cases a year, so very ultra rare cancer without any therapies today. And so we believe we can compress the timeline to bringing LP184 as a potential therapy in this ultra rare indication. and have a potential treatment for these patients. So we're working now that we validated this both in the lab as well as in Silico. We're seeking collaborators to further sue this indication. So do we believe with the franchise now that 12 months ago was just beginning where we observed the potential for 184 to target GBM? And after GBM, we now also have found ATRT, validated blood-brain barrier permeability, identified several additional indications that were in the process of validating, and we've really developed a very unique portfolio of brain cancer indications for LP184. We believe this basket of brain cancer indications can be a very important tool to then partner with the right biotech or pharma provider. Looking to other development programs, LP100 is currently being managed by our partner for the treatment of genetically defined metastatic castration-resistant prostate cancer, while LP300, a small molecule candidate, also is preparing to enter a phase two trial in non-small cell lung cancer as a combination therapy for non-smokers. For LP300, we have made significant progress in better understanding the mechanisms involved in LP300 activity and in aligning the usage of LP300 with the chemotherapy that is more commonly used today, namely carboplatin and pemetrexid. This was accomplished through a recently completed non-clinical bridging study that showed that LP300 with carboplatin and pemetrexid is as safe as cisplatin and Paxitaxel and doesn't cause any additional toxicity or adverse events. We plan on sharing this with the FDA as part of a process to re-enter Phase II clinical trials later this year. Most recently we also announced something that is very unique and that is the launch of our antibody drug conjugate program. This was developed by leveraging the AI platform by understanding where L184 could potentially work best by synergizing with other optimal targets. And many of these targets were antibody targets and we also then were able to work with Califia Pharma to leverage a patent-protected linker library that we can conjugate with our unique DNA-damaging compounds like LP184 and potentially other payloads. According to industry analysts, the global ADC cancer therapy market is expected to exceed $10 billion by 2026, $15 billion by 2030, and it's driven by innovations in protein targeting, which is what our platform does. We're really targeting linker technologies, which we now have access to through Dr. Kalanur and Kalifia, and conjugation processes. So ADCs bring together the ability to target specific antibodies on very specific types of cancer cells and then link that antibody targeting capability to delivering our potent molecule or payload to that cell. ADCs are an emerging class of highly potent drugs that have seen several approvals over the last two years and a lot of interest from big biotech and pharma in partnering. The portfolio of technologies and library linkers at Califia has meaningfully progressed with a specific focus on our class of drugs and we believe this optimization coupled with the identification of cancer subtypes and molecular targets has allowed us to save several quarters if not years in the development process and allows us to enable targeting very specific cancers. This way we can enter the clinical trials at a speed that we believe has not been achieved in the ADC category. So again, we believe this is another major franchise portfolio of value with the agency program. Working closely with innovators and world leading drug developers is an essential part of our strategy to leverage and develop new platforms that can transform the timeline and effectiveness of cancer drug development. By implementing antibody drug conjugate approaches, we aim to offer cancer patients an additionally highly targeted platform that can make meaningful contributions and also benefit from the synergies of our AI drug development or data-driven approach. Together, our current portfolio of drug candidates and our Radar AI platform has the potential for multiple shareholder value milestones in 2021 and 2022. In addition, our Radar platform has matured to the point where we're going to begin to focus increasingly on collaborating with other biotechs and pharma companies to further develop Radar and to develop opportunities through RADAR for our investors. Now, I'll hand the call over to David Margrave, our CFO, for review of the fourth quarter and year-end results. David?