Panna Sharma
Analyst · Colliers Securities. Go ahead. Your line is open
Marek, 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 Lantern Pharma's 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 RADR. We're 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're 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 milestone for our platform and for developing insights for new indications that will power future therapies. Shortly after we began trading last June of 2020, we announced that our proprietary AI platform for precision oncology drug development RADR surpassed 450 million data points. That was roughly six months ahead of our plans. Now, we plan to cross the 3 billion mark during 2021. We closed 2020, we're 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 and -- of a biomarker enabled signature that can be used for both patient selection and prediction of tumor response. Our process for selecting clean, 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 RADR 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 RADR 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. RADR's growing genomic drug sensitivity and patient outcome datasets, 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 RADR 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 industry 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 is small molecule oncology assets and antibody drug conjugate asset includes new compounds that we have identified to our biomarker discovery efforts, as well as potential therapies of extensive prior clinical experience that we acquired after previous owners abandoned development efforts following Phase 3 setbacks. In all regards, we own the therapeutic rights or developmental rights to all the assets that were developing. Our RADR 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, each -- some -- many of which are highlighted in the press release that was issued earlier today -- 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 for a 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 high -- for creative 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 it also -- we also grew the number of data points that fuel our AI platform by over 5x past year, initiated manufacturing, research and development, collaboration with leading cancer research institutions; these include Johns Hopkins in glioblastoma, Georgetown University in prostate cancer; Fox Chase Cancer Center in pancreatic cancer; and also their solid tumors were nucleotide excision 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 LP-184 in solid tumors, in particular, solid tumors that overexpress 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 over expressed 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 the X models, it will pinpoint the specific mechanism, seek confirmatory validation on the role of PTGR1 and other genetic mutations and the research will complete the acquisition of detailed genomic information in prostate cancers, and potentially, other related to your genital cancers. The second phase goal 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 a lot of 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. 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 LP-184 in pancreatic cancer, and this collaboration advances the targeted use of LP-184 in genetically-defined subtypes of pancreatic cancer. Again, those are the right gene signature and of course, to be able to use that gene signature, biologically relevant and naturally -- 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 thereafter one of the cancers that has very poor overall survival. The program at Fox Chase Cancer Center is being led by Dr. Igor Astsaturov in the molecular therapeutics program at Fox Chase. Igor is an internationally recognized researcher in GI cancers, specializing investigating signaling pathways and informed choice of biomarkers and innovative therapy combinations and clinical trials. In the fourth quarter, we announced another collaboration and research agreement with Johns Hopkins as the Sidney Kimmel Comprehensive Cancer Center. This program is focused on further development of one -- LP-184 in glioblastoma. Johns Hopkins is a leading research center for brain cancers, one of the largest brain tumor treatment and research centers in the world and they focus on treating extremely large number of patients affected by all types of brain tumors. In fact, after finding that LP-184 crossed the blood brain barrier exquisitely, we've been at the forefront of enriching our RADR 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, LP-184, especially as monotherapy. The goal of this collaboration is to develop a clinically ready program that has characterized the drug candidate 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 these needed population. This kind of research we believe is at 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 RADR engine. The RADR 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 then are used to do additional work. And this process is continuing now -- several cancers and several cancer areas at Lantern, and this feeds millions of data points of additional insight -- proprietary data-driven insight into our RADR platform. Our GBM program is being led by Dr. John [Indiscernible], an internationally recognized researcher in neurology, oncology, and neuroscience. During our last call, we talked about how LP-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 [Indiscernible] cells. This opens up a potentially high value opportunity to help patients in many other brain cancers and the ability to cross the blood brain barrier is of critical importance and 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 didn't genomically-define subtypes of CNS cancer should be prioritized for development, using in-silico tools and also in-vitro data from neuronal cell plates, neurospheres, LP-184 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 -- we have identified several additional brain cancers where LP-184 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 brain cancer that occurs primarily in pediat -- 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 LP-184 as a potential therapy in this ultra-rare indication and have a potential treatment for these patients. So, we're working -- that we validated this both in the lab as well as in-silico. We're seeking collaborators to further to the syndication. So, we believe with a 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 a ATRT, validated blood brain barrier permeability, identified several additional indications that we're in the process of validating, and we've really developed a very unique portfolio of brain cancer indications for LP-184. We believe this basket of brain cancer indications can be a very important tool to then partner with the right biotech or pharma. Looking to other development programs, LP-100 is currently being managed by our partner for the treatment of genetically defined metastatic castration resistant prostate cancer, while LP-300 small molecule candidate also is preparing to enter a Phase 2 trial in non-small cell lung cancer as a combination therapy for non-smokers. For LP-300, we have made significant progress and better understanding the mechanisms involved in LP-300 activity and in-lining the usage of LP-300 with the chemo doublet therapy that is more commonly used today, namely carboplatin and pemetrexed. This is accomplished through a recently completed non-clinical bridging study that showed the LP-300 is with carbo and pemetrexed is as safe as cisplatin and paxi capsule and doesn't cause any additional toxicity or adverse events. We plan on sharing this with the FDA as part of a process to reenter Phase 2 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 LP-184 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 LP-184, 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 Dr. [Indiscernible] on Califia 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. ADC is an emerging class of highly potent drugs and have seen several approvals over the last two years, and a lot of interest from big biotech and pharma and 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 ADC program. Working closely with the 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 the 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 over our AI drug development or data-driven approach. Together our current portfolio of drug candidates and our RADR AI platform has the potential for multiple shareholder value milestones in 2021 and 2022. In addition, our RADR platform is mature to the point where we're going to begin to focus increasingly on collaborating with other biotechs and pharma companies to further develop RADR and to develop opportunities through RADR for our investors. Now, I'll hand the call over to David Margrave, our CFO for review in the fourth quarter and year end results. David?