Marek, 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 got a number 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 RADR 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 Machine Learning platform called RADR, 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 by using our data driven machine learning enabled approach.
We are one of the 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 want to highlight a few of those that are critical. Most notably our RADR 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 LP-300. This is for our Phase 2 trial in non-smokers with non-small cell lung cancer and Dr. Barnhart will provide an update on our LP-300 program later in today's call.
During the quarter we also expanded potential indications for LP-184 to include atypical teratoid rhabdoid tumors and ultra-rare pediatric brain tumor and also for LP-184 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 pre-clinical development of LP-284, an entirely new molecule in certain hematologic cancers that have shown exceptional sensitivity to this new molecule and indications that are very different from our 184 molecule.
We also strengthened our intellectual property portfolio with the filing of over 10 patent applications ranging from de novo molecules to methods of use of manufacturing, to identifying patients, to actually those that cover fundamental technology aspects of our RADR platform.
Our research team published two peer-reviewed studies in Oncotarget and BMC Bioinformatics that further validate our data driven machine learning enabled approach to drug development and also provide details and transparency on how RADR is being used and implemented in our development of LP-184. We think the drug development process for one of these was 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 LP-184 in prostate cancers, including and very importantly those that had DNA damage repair indications and we believe that the combination of PTGR1 overexpression along with DNA damage repair confers the potential path of synthetic neutrality. Very significantly we also completed a $69 million follow-on offering in January 20, the dramatically strengthened our balance sheet, that provides us a multi-year runway to execute our plan to harness the power of RADR 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 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 machine learning, which has absolutely smashed the product development cycle and cost curve with every other industry. The growth of RADR is over 4.6 billion data points now. It 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.
We are adding roughly 1 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 drives the volume of data required during the entirety of our 2020 campaigns.
Our campaigns are becoming larger, they are becoming more voluminous, and we're on track now to smash our previous goal of reaching 3 billion 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 are in the rear of the pandemic in many locations. Most importantly, the insights and knowledge that we are now able to acquire from RADR is opening up to tremendous opportunities to not only develop our own pipeline 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 foreign investors. Exemplifying this aspect of our business model is the collaboration with Actuate Therapeutics that we announced earlier today. The collaboration focuses on leveraging the RADR AI platform, our machine learning methodology, and a large scale oncology data set to accelerate key aspects that Actuate's 9-ING-41 drug candidate at best-in-class GSK-3β inhibitor in active development and multiple Phase 2 clinical trials, including the 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 in Actuate Therapeutics subject to meeting certain conditions of the collaboration, as well as developing milestones in the form of additional equity if results in 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 RADR 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. RADR has the potential to significantly accelerate our understanding of which compounds should be developed for which indication, 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're 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 have grown the number of programs in active development from 3; very, very critical, both from a risk awards standpoint, but also from the 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 increase the number of opportunities for potentially accretive licensing and our patterning transactions.
We are 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 asset such as LP-184 and ATRT or other ultra-rare cancers directly to patients into the markets ourselves. This is an important point to note.
Let's discuss quickly our pipeline. We remain firmly on track to begin in early – in third quarter 2021, the Phase 2 trial of LP-300, a small molecule drug candidate targeting a growing, but unaddressed type of non-small cell lung cancer among non-smokers. LP-300 is now likely the most clinically advanced drug candidate anywhere for this high medical – high unmet medical need for this patient population. Dr. Kerry Barnhart will provide a detailed update review of the clinical trial protocol later in our call. LP-300 represents 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 in spent globally on therapies and drug treatment for this patient population.
Moving on to a more rapidly evolving LP-184 program that’s now in active development across four disclosed tumor types. Recall that among the central features of our business models is to collaborate in the development of our drug candidates and the specific indications with leading researchers in that area, so we can leverage their respective knowledge and experience in a given therapeutic area and their experience with therapy for that patient population. LP-184 is currently an active collaboration with Johns Hopkins in various CNS tumors including glioblastoma and ATRT. With Georgetown University we are working in the studies of LP-181 prostate cancer and with a prostate cancer center, an active study of the LP-184 in pancreatic cancer.
We continue to explore additional opportunities for collaboration and development and we expect to announce additional collaboration with leading institutions in the coming months. The scope of work being done at each of our collaborations is to prepare the drug, LP-184 or other candidates for clinical development and targeted clinical trials where we have a clear indication that the – 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 1 clinical trials in each of these collaborations and their respective indications in 2022.
We will continue to provide regular updates in 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 collaborations is to help guide the development and validation of a signature of disease that can potentially serve as a companion diagnostics and thereby more clearly defines the commercial potential of each of our innovative cancer drug candidates. It’s important also to note that the fact there was a recent publication done by the University of Toronto Researchers that indicated that clinical trials in cancer that used to biomarkers 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, other cancers like pancreatic, prostate, it was lower like 6x to 7x and 4x in colorectal. These collaborations will 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 LP-184 highly potent across a 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 the future prostate cancer patients to experience the benefits of a personalized treatment appropriate. We believe the Lantern’s AI driven approach could save millions of dollars in drug development costs, while significantly accelerating the path to personalization and commercialization of therapies.
We also have a similar research in collaboration agreement with Fox Chase Cancer Center for the further development of 184, LP-184 in pancreatic cancer. This collaboration advances the targeted uses to LP-184 in genetically defriend subtypes of pancreatic cancer, and also the government robust gene signature. We believe this could open up the pathway to a more personalized therapy option that has the potential to improve survival. This program is being led by Dr. Igor Astsaturov at the Molecular Therapeutics Program at Fox Chase.
We also announced a new collaboration research agreement with Johns Hopkins for the development of the 184 in Atypical Teratoid Rhabdoid tumors or ATRT and ultra-rare and fast growing cancers tumors of the brain that presents primarily in children. ATRT notably also is marked by SMARCB1 deletion, either entirely or in part.
So SMARCB1mutated cancers to represent another category for LP-184. Hopkins as many of you know is the leading research center for brain cancer 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 therapy 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 Johns Hopkins Pediatric Oncologist Dr. Eric Raabe, 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 to approximately 2.7% to 2.9% per year. We believe that the rarity of the incidents of ATRT in the U.S. and actually globally, and its prevalence in children supports the potential for LP-184 to qualify in the future for a possible grant by the U.S. FDA for rare pediatric disease designation. If we are 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 one that highlighted with Hopkins, Georgetown and Fox Chase are the forefront of translational cancer medicine. They'll use patient derived cancer cells that are studied using physiologically relevant in vitro and in vitro models. This innovative approach allows 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 RADR AI platform. This allows us to more actively establish the precise signature in a cyclical manner. This data driven insight also gives insight into additional mechanisms that can be leveraged in creating combination programs and in creating potentially new targets from new molecules.
Our mission is to transform and accelerate the cancer drug development process. If we can compress the time to clinical trials and derisk our drugs such as LP-184, we can save years of research and tens of millions of dollars developing treatments for GBM, ATRT, pancreatic and other potential rare or ultra-rare cancers such as the ones we're currently evaluating. Also it talks about what our team has also published, who has 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 LP-184 for non-small cell lung cancer patients that are ineligible for targeted therapies or have developed resistance to other forms of therapy.
For us this is a very interesting target because of our complementary approach with LP-300 where we are targeting non-smokers that have been a very different molecular profile. Similarly LP-184 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. There’s about 30%, close to 40% that don't have those targetable alterations such as EGFR, ALK seeing that and all 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 LP-184 could potentially be effective in that patient class.
We are now working pre-clinically to show how LP-184 inhibits tumor growth, we’ve show that now in mouse xenograft model of KRAS and KEAP1 mutant lung cancers and co-occurring KRAS and KEAP1 mutations occurring in about 17% lunch and in carcinoma cases, and are a very aggressive form of lung cancer that is believed to be usually undrugable. We’ve developed a genetic signature that is believed to predict response in tumors that will be responsive to 184 and guiding further development of the drug. Using this data driven approach, we’ve show that we not only can find unique biomarkers that link drug response to 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 RADR 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, our CFO for a review of or first quarter financial results. David.