Lantern Pharma Inc.

Good afternoon, everybody, and welcome to the Lantern Pharma fourth quarter in fiscal year 2021 earnings 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 presentations. I am Nicole Lieber with Investor Relations at Lantern Pharma, and I will be your host for today's call. I will be joined by CEO and President Pana Sharma, CFO David Margrave, and CSO Kishore Bhatia. We issued a press release after the market closed today, summarizing our financial results and progress across the company for the fourth quarter in fiscal year 2021. And a copy of this release is available through our website at lanternpharma.com and where you can also find a link to the slides that management will be referencing for today. Following the Safe Harbor Statement, Ponna will provide an overview of Lantern Pharma's operational highlights, after which David will discuss our financial results, which will be followed by Dr. Bhatia, who will provide an update on our development programs. Finally, Ponna will offer some concluding comments, and then we'll open the call for the Q&A. I would like to remind everyone that remarks about future expectations, claims and perspectives 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 actual results to differ materially from those indicated by forward-looking statements versus the impact of the COVID-19 pandemic, results of 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 our annual report on form 10k 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 thursday march 10 2022 And Lantern Pharma does not intend to update any of these forward-looking statements to reflect events 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. And with that, I would like to turn the call over to Panna, President and CEO of Lantern Pharma. Panna, please go ahead.

Thank you, Nicole. And thank you all for joining us on our Zoom earnings call and webinar today. I'm really happy to be here with my colleagues David and Kishore in person, and we have a significant amount of updates, progress, and activity to share with you all across virtually every measure of our business. During 2021 and 2022, we've had a very productive and very fruitful time for our team, and I'm very proud of the efforts and achievements the FOCUS team has made over the past 12 and 15 months. Before I begin, I'd like to take a moment, something more serious note, and share our concerns and voice our support for the people, families and country of Ukraine. Violence and destruction in any form has no place in the economies and societies today. And I personally am joining with many other biopharma CEOs and companies in voicing my concern to the aggression in Ukraine from Russia. Coming back to Lantern Pharma, I'm extremely proud, as I mentioned, of our team's efforts and execution in the fourth quarter and throughout 2021. We made meaningful progress in multiple fronts, clinically, technically, operationally, and also on a regulatory front. Our proprietary radar AI platform also has grown. It's now surpassed 18 billion data points, and it's grown by more than 1,000% in the last year, significantly exceeding our growth expectations from earlier in the year. And we've now upped our target to 25 billion data points this year. We've also grown the number of algorithms that are powering the analysis and grown the classes of algorithms and our ability to manage the algorithms. Algorithms and data are critical pieces of driving insights that power our portfolio and help us develop new drugs faster and cheaper. This increase in the power of our platform and data points provides us with several long-term important advantages. First, it accelerates our drug development timelines by giving us ideas about the feasibility of different drug candidates or combinations. It allows us to uncover new therapeutic opportunities like we did with ATRT. It allows us to look at potentially in-licensing new compounds with a certain level of de-risk. And it allows us to find new uses for existing drugs in our portfolio like we've done now with LP100 as you look at additional tumor types. It also allows us to develop insights in terms of how we can create combination therapy programs and my colleague will talk a little bit about some of the first data we have and some combinations that we're approaching. Finally, very, very importantly, one of the biggest advantages is it expands our ability to collaborate with additional biopharma partners. We believe that the platform is now the stage where it can be used not only for our existing portfolio, but for many other drug development portfolios in oncology. This presents us with lots of new opportunities for value creation in the near term. Obviously, the goal is to reduce the cost, reduce the risk, and accelerate the timeline to develop oncology medicines by uncovering insights on drug-tumor interactions and developing companion diagnostic-type approaches, potentially signatures that can be used that are essential in understanding which patients are most likely to respond and which tumors are most likely to be sensitive to our drug programs, either mono or combination therapy. The likelihood of bringing a drug to market is on average five times higher by those that are developed with a biomarker signature than those that are not. This was a study done by Dr. Jason Parker and his team at University of Toronto. Ultimately, RADAR gives us the ability to potentially benefit and select patients that have the best option for our drug therapies or the combination therapies that we are uncovering at a fraction of the cost of traditional drug development. We plan on furthering our data expansion and the curation of this data moving forward, but in very specific areas. Let me talk a little bit about those areas. One of them was in hematologic cancers. We started campaigns in growing the number of blood cancer data points. We'll continue that focus here in 2022, and Kishore will talk a little bit about some of our insights into the blood cancer space. will also enrich our platform in pediatric and rare cancers. As you know, we announced a collaboration recently with the University of Texas San Antonio with the Grehe Children's Cancer Center. We also plan on focusing on immuno-oncology related studies and trials this year, where we expect to uncover potential new combination opportunities for 184, 284 and 100. In addition to the data points and data sets to radar, we're also focused on the growth and evolution of our library of algorithms. Algorithms are critical because they are giving us new ways to correlate the data, finding new insights. They allow us to automate the collection of data, automate the structuring of the data, and it gives us ways to make decisions in a de-risked and faster time frame. These algorithms also allow us to rapidly identify cancer subtypes that may have gone unnoticed or have been poorly understood, and they provide insight into potential drug target interactions. These algorithms can also help further our ability to uncover patient groups that can respond to specific drugs, not only initially, but perhaps even over the course of treatment. Now, with such an incredible assortment of both data and algorithms as it grows, we've also embedded in our management of the algorithms a DevOps environment, a machine learning development operations environment. This is important because the management of algorithms becomes much more complex, especially when you're using multiple algorithms with thousands of potential parameters and you're using what we're beginning to use increasingly, which is an ensemble approach where algorithms are used together. So we multiply our ability to get into greater precision or make up for weaknesses that certain algorithms have by using other algorithms. All of this is critical because it helps us define and develop the strategy of bringing a drug to market and develop a potential combination approach or a companion diagnostic. And this allows us to have a higher chance of approval and a faster route to getting to patients. We think this will be a long-term strategic advantage as we deepen our capabilities in two very important areas, both antibody drug conjugates and combination therapies. We believe that this will help an increasing number of patients and ultimately add significantly more value for investors. Now turning to our biomarker signatures, we think this is an area of real importance. As I mentioned, there was a recent study about a year ago that was published a few years ago by Dr. Jason Parker, University of Toronto. He and his team reviewed over 10,000 clinical trials. and across about 745 drug programs. And this study showed that biomarker-based trials had success rates that were four to 12 times higher than those clinical trials that did not use biomarkers. The study team also concluded that there was clear evidence that biomarkers increased clinical trial success rates in multiple indications, many of those which we're going after. And this is a hallmark of our development process. This further encourages us that utilizing our radar platform with our drug candidates and potentially with other drug candidates can have a very meaningful way of reducing costs and accelerating our ability to get our drug candidates to patients. As you know, we've begun to witness firsthand growing industry interest in AI machine learning solutions, especially ones that help innovate or de-risk the development of precision therapies and combination therapies. We believe that there's a growing appetite for these kinds of solutions. Many of the solutions are data powered or powered by AI approaches or machine learning techniques. And we think these techniques will increasingly be adopted by bigger biopharma companies and ultimately yield greater investor value for us. Now, before passing the call over to David to discuss our financial results, I want to briefly talk about some of the highlights in 2021 and into this year of our drug development candidates. During 2021, we had multiple areas where we advanced our drug programs. We reported positive preclinical data for LP184 in patriotic cancer, in glioblastoma, and also in a rare pediatric cancer, ATRT. We also advanced LP300 toward a phase two clinical trial, a harmonic trial, for never smokers and non-small cell lung cancer. This will be a 90-patient randomized phase two clinical trial with two arms where LP300 will be co-administered along with a chemo doublet to patients that have failed or have stopped responding to TKI therapy. And we will be looking at the co-endpoints of overall survival and progression-free survival. The Armonic clinical trial is actually looking at sites today. Again, one arm will be 60 patients. It's a two-to-one ratio. One arm will be 30, the control arm. We began an assessment also of the next phase of our other phase two program, LP100, in metastatic castration resistant prostate cancer. We've actually also found that there are several other cancers that could be very sensitive to this drug. And we'll talk about that a little bit later and also share more of the data from that trial. The trial has dosed nine patients. in a target of 27, and the median overall survival for that initial cohort has been 12.5 months, which is higher than other fourth and fifth line trials that have been done in metastatic castration-resistant prostate cancer. We also presented positive data late last year at ASH for our new drug LP284 in hematologic cancers, including several rare blood cancers such as mantle cell lymphoma and double-hit lymphomas. We plan on sharing additional data on this drug program later this year and also announce research collaborations in that program. As a result of the encouraging results in 184 in regards to glioblastoma and pancreatic cancer, we were granted orphan drug designation in both and also in ATRT, where we additionally got rare pediatric designation. This not only allows us to have tax credits for the trials being done here in the U.S., waiver of marketing registration application fees, reduced annual product fees, but these are all massively important because they reduce our burden of development, they give us increased commercial protection, and they potentially give us a voucher that, upon approval, we can actually sell for $100 to $110 million. Also, these orphan drug designations give us validation of our AI-driven approach. All three of these orphan drug designations were achieved quite rapidly based on the data and insight driven from our machine learning algorithms and our AI approach. We also submitted an abstract with Fox Chase Cancer Center researcher Dr. Igor Astrosarov. He's an established NCI-funded physician scientist who's also co-leader of the Greenberg Pancreatic Cancer Institute at Fox Chase. And it was also presented for a virtual conference at AACR. The data showed that LP100 showed was very effective and potentially as a synthetically lethal agent in pancreatic cancers that had DNA damage repair deficiency. This is an area that we're particularly excited about and we believe gives us a roadmap for prioritizing additional cancers where we can develop first-in-class solutions and show significant improvement over the existing standard of care outcomes. We also showed that in GBM, we also had a very good response. This work was done in conjunction with Kennedy Krieger and Johns Hopkins University. This is a multibillion dollar indication. And in both. pancreatic and for GBM. We're now in IND enabling studies, which are already quite long, and these IND studies will allow us to file the IND for this year and then get into phase one human trials, hopefully later this year. We also believe that another development that was important for us are our technology collaborations. We announced two very important technology collaborations last year, one with DeepLens in order to accelerate our ability to find patients best suited for our treatment in our harmonic trial. That's a trial for nervous smokers. And we announced a collaboration with Code Ocean that allows us to scale up more securely and containerize our AI platform. So both Code Ocean and DeepLens we believe are best-in-class technology partners, and they both offer us ways to scale up our ability and, more importantly, they align with our philosophy of using data and technology to accelerate the development of medicine. More importantly, it allows us to do this in a cost-efficient environment. As Dave will walk you through our financials, we've been financially very disciplined, not only internally, but also the types of studies that we launch and the types of collaborations we generate. And these collaborations will have quite a bit of data coming out this year. So our current cash resources would give us a great runway for our development programs well into 2025, not only in part because of the good financial discipline that we show, but also in the way that we're actually developing our programs and designing our trials. To shed more light on that, David, our CFO, will provide an overview of the fourth quarter and the full year financial results. David.

Thank you, Pana. And good afternoon, everyone. I'll now share some financial highlights from our fourth quarter and the full year ended December 31, 2021. I'll start with a review of the fourth quarter. Our R&D expenses were 2.2 million for the fourth quarter of 2021, up from 1.4 million in the fourth quarter of 2020. As was the case throughout the year, The increase in R&D expense was primarily attributable to increases in manufacturing related expense for product candidates and to research studies and R&D payroll expenses. General and administrative expenses were $1.4 million for the fourth quarter of 2021, down from $1.6 million in the prior year period. We recorded a net loss of 3.5 million for the fourth quarter of 2021 or 31 cents per share compared to a net loss of $2.9 million or 47 cents per share for the fourth quarter of 2020. For the full year 2021, our R&D expenses were $7.6 million up from $2.2 million for 2020. As mentioned a moment ago, this increase was primarily attributable to increases in manufacturing related expenses for product candidates, research studies, and R&D payrolls expense. Specifically, for the full year 2021, our product manufacturing related expenses increased by approximately $2.7 million, while research studies increased approximately $0.8 million, and R&D payroll expenses were up approximately $0.7 million. Additionally, for the full year 2021, we recorded a non-recurring expense of $1 million related to the upfront payment to Alarity Therapeutics in July for the global rights to LP100, our phase two asset for the treatment of metastatic castration-resistant prostate cancer. Our general and administrative expenses for 2021 were $5 million, up from $3.7 million for 2020. The annual increase was primarily attributable to increases in business and corporate development expense of approximately $0.4 million, increases in corporate insurance expense of approximately $0.6 million, and increases in legal and patent-related expenses of approximately $0.4 million. Our R&D expenses continue to exceed our G&A expense by a strong margin, reflecting our focus on advancing and expanding our product pipeline. Net loss for the full year 2021 was $12.4 million, or $1.13 per share, compared to $5.9 million, or $1.37 per share for 2020. As of December 31, 2021, we had approximately 11.1 million shares of common stock outstanding and outstanding warrants to purchase approximately 274,000 shares and outstanding options to purchase approximately 891,000 shares. These warrants and options, combined with our outstanding shares of common stock, gave us a total fully diluted shares outstanding of approximately 12.3 million shares as of December 31, 2021. Our cash position, which includes cash equivalents and marketable securities at December 31, 2021 was $70.7 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. Lantern Pharma implemented a share repurchase program in 2021 whereby the company is authorized to repurchase up to $7 million of common stock. Through March 1st, 2022, the company has repurchased approximately 430,000 shares for a total of approximately $3.1 million, including purchase fees. This includes approximately 122,000 shares purchased in 2021 for a total of approximately $940,000. We believe these purchases will be accretive to shareholder value. We are migrating to a hybrid work environment, and I'm proud to say that our team continues to be very productive under this operating model. The hybrid model also 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. We currently have 16 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 over to Kishore for an update on some of our development programs. Kishore. Thank you, David.