Earnings Call Transcript - LTRN Q4 2021

Nicole Leber, Investor Relations

Good afternoon, everybody. And welcome to the Lantern Pharma Fourth Quarter and Fiscal Year 2021 Earnings Call. As a reminder, this call is being recorded and all the attendees are in a listen-only mode. We will open the call for questions-and-answers after management’s presentation. I am Nicole Leber with Investor Relations at Lantern Pharma and I will be your host for today’s call. I will be joined by CEO and President, Panna Sharma; CFO, David Margrave; and CSO, Kishor Bhatia. We issued a press release after the market closed today summarizing our financial results and progress across the company for the fourth quarter and 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, Panna 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, Panna will offer some concluding comments and then we will open the call for the Q&A. I would like to remind everyone that remarks about future expectations, claims and prospectus 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 10-K 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.

Panna Sharma, CEO

Thank you, Nicole. And thank you all for joining us on our Zoom earnings call and webinar today. I am really happy to be here with my colleagues David and Kishor 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 have had a very productive and fruitful time for our team, and I am very proud of the efforts and achievements the focus team has made over the past 12 months 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 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 our concern to the aggression in Ukraine from Russia. Coming back to Lantern Pharma, I am extremely proud as I mentioned of our team’s efforts and execution in the fourth quarter and throughout 2021. We made meaningful progress on multiple fronts: clinically, technically, operationally, and also on a regulatory front. Our proprietary RADR AI platform has also grown; it’s now surpassed 18 billion data points, and it’s grown by more than 1,000% from last year, significantly exceeding our growth expectations from earlier in the year, and we now increased our target to 25 billion data points this year. We have also grown the number of algorithms that are powering the analysis and enhanced our ability to manage these algorithms. Algorithms and data are critical to 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 insights into the feasibility of different drug candidates or combinations that allows us to uncover new therapeutic opportunities like we did with ATRT. It helps us to potentially in-license new compounds with a certain level of de-risk. Furthermore, it allows us to identify new applications for existing drugs in our portfolio, as we have done now with LP-100, as you look at additional tumor types. It also enables us to develop insights regarding how we can create combination therapy programs. My colleague Kishor will talk a little bit about some of the first data we have and some combinations that we are approaching. Finally, very importantly, one of the biggest advantages is that it expands our ability to collaborate with additional biopharma partners. We believe that the platform is now at 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 costs, decrease risk, and accelerate timelines to develop oncology medicines by uncovering insights on drugs from 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, whether they are mono or combination therapies. The likelihood of bringing a drug to market is on average five times higher for 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 the University of Toronto. Ultimately, RADR gives us the ability to potentially benefit and select patients that have the best option for our drug therapies or 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 discuss those areas. One of them was in hematologic cancers. We started campaigns to grow the number of blood cancer data points, and we will continue that focus here in 2022. Kishor will talk a little about some of our insights into the blood cancer space. We will also enrich our platform in pediatric and rare cancers. As you know, we recently announced a collaboration with the University of Texas, San Antonio, with The Greehey 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 LP-184, LP-284, and LP-100. In addition to the data points and datasets to RADR, we are also focused on the growth and evolution of our library of algorithms. Algorithms are critical because they provide us with new ways to correlate data and find new insights; they allow us to automate the collection of data, automate the structuring of the data, and provide us ways to make decisions in a de-risked and faster timeframe. These algorithms also enable us to rapidly identify cancer subtypes that may have gone unnoticed or poorly understood and provide insights 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 potentially over the course of treatment. With such an incredible assortment of both data and algorithms as it grows, we have embedded the management of the algorithms in a DevOps environment, specifically in a machine learning development operations environment. This management of algorithms becomes much more complex, especially when we are using multiple algorithms with thousands of potential parameters and what we are beginning to use increasingly, which is an ensemble approach where algorithms are used together. Thus, we can enhance our ability to achieve greater precision or make up for weaknesses that certain algorithms have by using complementary algorithms. All of this is critical because it helps us define and develop the strategy of bringing a drug to market and developing a potential combination approach or a companion diagnostic, giving us a higher chance of approval and a faster route to getting to patients. We believe 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 this will help an increasing number of patients and ultimately add significantly more value to investors. Now turning to our biomarker signatures, we think this is an area of real importance. It was recently published that biomarker-based trials had success rates that were four to twelve times higher than those clinical trials that did not use biomarkers. This further encourages us that utilizing our RADR platform with our drug candidates and potentially other drug candidates can significantly reduce costs and accelerate our ability to get our drug candidates to patients. We have begun to witness firsthand the growing industry interest in AI and machine learning solutions, especially those that help innovate or de-risk the development of precision therapies and combination therapies, and we believe there’s a growing appetite for these solutions. Many of the solutions are data-powered or driven by AI approaches or machine learning techniques, which we think 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 made multiple advancements in our drug programs. We reported positive preclinical data for LP-184 in pancreatic cancer, glioblastoma, and also in the rare pediatric cancer ATRT. We also advanced LP-300 to the Phase 2 clinical trial, the Harmonic trial for never-smokers and non-small cell lung cancer. This will be a 90 patient randomized Phase 2 clinical trial with two arms, where LP-300 will be co-administered along with chemotherapy to patients that have failed or stopped responding to TKI therapy. We will be looking at the co-endpoints of overall survival and progression-free survival. The Harmonic clinical trial is actually looking at sites today, with one arm consisting of 60 patients in a 2 to 1 ratio, and the other arm consisting of 30 in the control arm. We began an assessment of the next phase of our other Phase 2 program, LP-100, in metastatic castration-resistant prostate cancer. We found several other cancers that could be very sensitive to this drug and we will talk about that later, sharing more 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 completed in metastatic castration-resistant prostate cancer. We also presented positive data late last year at ASH for our new drug, LP-284, 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 announced research collaborations in that program. As a result of the encouraging results in LP-184 for glioblastoma and pancreatic cancer, we received orphan drug designation for both, as well as ATRT, where we also obtained rare pediatric designation. This not only allows us to benefit from tax credits for the trials being conducted here in the U.S., waiver of marketing registration application fees, and reduced standing product fees but these are all massively important because they reduce our burden of development. They provide increased commercial protection and the potential to receive a voucher that, upon approval, we can actually sell for $100 to $110 million. Additionally, these orphan drug designations validate our AI-driven approach. All three of these orphan drug designations were achieved quite rapidly based on the data and insights driven from our machine learning algorithms and AI approach. We also submitted an abstract with Fox Chase Cancer Center researcher Dr. Igor Astrosoft, an established NCI funded physician scientist who’s also co-leader of the Greenberg Pancreatic Cancer Institute at Fox Chase. The data demonstrated that LP-100 was very effective as a synthetically lethal agent in pancreatic cancers that had DNA damage repair deficiency. This is an area that we are particularly excited about and we believe gives us a roadmap for prioritizing additional cancers where we can develop first-in-class solutions that show significant improvement over the existing standard of care outcomes. We also showed that in GBM we had very good responses, where work was done in conjunction with Kennedy Krieger and Johns Hopkins University. This is a multi-billion dollar indication and in both pancreatic and GBM, we are now at IND-enabling studies, which are already quite lengthy, and these IND studies will allow us to file the IND for this year and get into Phase 1 human trials hopefully later this year. Additionally, an important development for us was our technology collaboration. We announced two significant technology collaborations last year, one with Deep Lens to accelerate our ability to find patients best-suited for treatment in our Harmonic trial and another with Code Ocean, which allows us to scale up more securely and containerize our AI platform. We believe both Code Ocean and Deep Lens are best-in-class technology partners, offering us scaling capabilities and, more importantly, aligning with our philosophy of using data and technology to accelerate the development of medicine. Our current cash resources provide us with a great runway for development programs well into 2025, partly due to the good financial discipline that we exhibit, and the way that we are 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?

David Margrave, CFO

Thank you, Panna, and good afternoon, everyone. I will now share some financial highlights from our fourth quarter and the full year ended December 31, 2021. I will 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 expenses 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 $0.31 per share, compared to a net loss of $2.9 million or $0.47 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 earlier, this increase was primarily attributable to increases in manufacturing-related expenses for product candidates, research studies, and R&D payroll expenses. Specifically, for the full year 2021, our product manufacturing-related expenses increased by approximately $2.7 million, while research studies increased by 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 Allarity Therapeutics in July for the global rights to LP-100, our Phase 2 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 expenses of approximately $0.4 million, increases in corporate insurance expenses 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 expenses by a strong margin, reflecting our focus on advancing and expanding our product pipelines. 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, outstanding warrants for approximately 274,000 shares, and outstanding options to purchase approximately 891,000 shares. These combined with our outstanding common stock gave us a total fully diluted shares outstanding of approximately 12.3 million 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, our solid financial position will fuel continued growth and evolution of our RADR 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 1, 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 am 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 may 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 will now turn the call over to Kishor for an update on some of our development programs.

Kishor Bhatia, CSO

Thank you, David. Good afternoon. I am going to start by just recapping some information we discussed in our last call and as some of you may recall, in the last call, we updated you about some exciting advances of our molecule LP-184. Just to recap, the FDA granted LP-184 orphan drug designations for three indications, including glioblastoma, pancreatic cancers, and ATRT. In addition, we received rare pediatric drug designation for ATRT. LP-184 is moving steadily towards initial clinical studies. The final data from toxicology and pharmacology studies are due soon. We have begun discussions with multiple sites for the initiation of Phase 1 studies, and these discussions are ongoing to refine the details of the correlative studies so that they will best inform the Phase 2 clinical studies in cancers that are either homologous recombination deficient or nucleotide excision repair deficient. In the preclinical space, looking ahead, we are also completing studies to identify synergies with standard-of-care drugs that might guide future applications of LP-184. We have seen excellent results that provide good synergy of LP-184 with drugs like gemcitabine, for example. Among the clinical indications, one important need that LP-184 could potentially meet is therapy for cancers metastasizing to the brain. As many of you are aware, cancers of the lung, colon, kidney, and skin often spread to the brain. The activity of LP-184 in tumor cells of these organs, coupled with its ability to cross the blood-brain barrier, endows this molecule with the necessary properties for treating such brain metastatic cancers. This week, we are presenting a poster at AACR, providing evidence of LP-184 efficacy in 3D models of brain metastatic lung and breast cancers. Today, I wanted to spend some more time sharing information on our other molecules, LP-284. Both LP-184 and LP-284 are acylfulvenes. And acylfulvenes, like many other small molecules, are chiral. Unlike many other small molecules that target DNA, the different chirality of the derived tumor-targeting agent, LP-184, generically also known as hydroxyurea methyl acylfulvene, uniquely demonstrates differential activities in tumor cell lines. Thus, one isomer has very specific tumor-killing properties while the other has a different set of tumor-killing properties. These data, therefore, enable the independent development of the positive isomer of hydroxy methyl acylfulvene, which we designate as LP-284, specifically for indications in the hematological cancer space. Our RADR data analysis highlighted a key difference in LP-184, the negative isomer, and LP-284, the positive isomer. LP-184 is obligately dependent upon the activity of the enzyme PTGR1, while LP-284, on the other hand, is not. Since PTGR1 is expressed at levels below the threshold required to activate LP-184, LP-184 is not potently cytotoxic to blood cancer cells; however, LP-284 is. Further examination of LP-284 across a wide range of blood tumors demonstrated strong support for efficacy in diffuse large B-cell lymphomas, chronic myeloid leukemia, Burkitt’s lymphoma, and mantle cell lymphoma. The latter stands out as an exceptional indication for several reasons. First, the preclinical data was excellent, as all six lines tested showed potent loss of viability when exposed to nanomolar levels of LP-284 in vivo. Additional laboratory results suggest that, like LP-184, LP-284 efficacy is enhanced by the presence of deficiencies in DNA repair pathways. This brings me to the second point as to why mantle cell lymphomas might be a great indication. Mantle cell lymphomas frequently carry a mutation of the ATM gene, which is critical to DNA damage repair. Other blood tumors either intrinsically carry mutations in DNA repair genes or depict a phenotype of such deficiency. This phenotype, often described as BRCA-related, could arise from the downregulation of functions of genes like BRCA1 due to lesions carried by hematological cancers, such as the BCR-ABL translocation. The ability of LP-284 to damage DNA and the need for transcription-coupled repair to address such damage indicates that LP-284 could block transcription. This property of LP-284 is likely to render blood cancers, which carried oncogenic translocations, vulnerable. We are currently focused on developing LP-284 for mantle cell lymphomas. Our ongoing studies aim to extend efficacy assessments to in vivo models, complete the toxicology and pharmacology studies of the molecule, and design a Phase 1 trial for treating mantle cell lymphomas that have relapsed following targeted therapy. I will hand it over to Panna.

Panna Sharma, CEO

Sure. Thank you. Before I open it up to questions, I’d like to provide a brief recap and also discuss some of the upcoming milestones. As you know, we are very confident in the launch of multiple human clinical trials this year for our drug candidates LP-300, LP-100, and LP-184. We are also looking at the ongoing growth of our RADR platform and we remain committed to advancing our ADC program into IND-enabling studies. Additionally, we’re collaborating with various strategic partners and we will be adding more collaborators that will generate exciting new data that will help us launch new programs for development and licensing. We believe RADR is essential for building our drug portfolio and generating new opportunities. We remain committed to achieving our goal of building the world’s largest AI platform for precision oncology drug development, which we believe we are progressing towards. Our aim this year is to surpass 25 billion data points, advance our late-stage candidates into trials, and continue to add valuable data in targeted areas, such as neuro-oncology, rare cancers, and pediatric cancers, where there is a significant need for improved therapies. We believe that our AI platform and collaborative business model will be pivotal in uncovering new opportunities for cancer patients and investors alike. We are well positioned to take advantage of the widespread availability of data and the ability now to conduct large-scale genomic and machine learning analysis in the cloud. We have built a great internal team with multiple interdisciplinary capabilities, alongside partners that help expedite development towards patient access. With that, I’d now like to open the call up to some questions.

Nicole Leber, Investor Relations

Okay. Great. We have a couple of questions coming in here. One is from Ted Yu. Have the COVID-related issues in sourcing equipment needed for clinical progress been addressed?

Panna Sharma, CEO

Thank you, Ted, for that question. As you pointed out, we have had delays in manufacturing, mostly due to COVID with our LP-300 molecule. Those have been addressed. In fact, we recently finalized the batch of drug products, and it is now being tested for final stability. So, yes, we overcame those delays in our timeline for manufacturing, which were at least three to four months. We also faced delays due to omicron, and those issues have now passed. We believe clinical trial sites are beginning to open back up, though not at the same level as pre-pandemic; however, we are starting to see sites reopening for new cancer trials. COVID did impact us but we're getting back on track.

Nicole Leber, Investor Relations

The next question, can you please detail the biomarker screening you were planning for LP-184? Do you plan combination therapy for LP-184, and will the combination be guided by biomarkers as well?

Panna Sharma, CEO

We will have to unpack that question; it’s a great question. We do plan on having a biomarker strategy, and we have already talked a little bit about it. PTGR1 is essential for mechanizing LP-184 into an active cancer-killing agent. So we are looking at cancers that overexpress PTGR-1, which is an essential biomarker. Additionally, as Kishor pointed out, there are certain DNA damage repair deficiencies that make LP-184 synthetically lethal to various tumors. When we observe that presence, such as deficiencies in BRCA, ERCC, and potentially other DNA repair genes, we find these tumors are extraordinarily more sensitive to the drug, by a factor of anywhere from two to eight times, depending on the tumor type. Therefore, we will definitely use biomarkers to select the tumor types we target and to identify patients most likely to respond. The second part of that question relates to combination; we have several promising combinations in the works. Kishor, would you like to elaborate on this?

Kishor Bhatia, CSO

Yes. Our approach to investigate combinations involves using our RADR platform and performing gene correlation studies to identify synergies. Our next step is to ascertain whether there are drugs within the identified pathways that have been approved for indications where we are targeting LP-184. Once we determine this, we will conduct wet-lab studies to collect real-world evidence on synergistic activity.

Panna Sharma, CEO

To provide some clarity, we have observed significant synergy with gemcitabine in pancreatic cancer, boasting exceptional Bliss synergy scores, a score of about 10 typically signifies promising synergy. Additionally, we also noticed synergy with spironolactone, which is notable, as spironolactone is already a commonly used drug today. We found that spironolactone in certain tumors induces deficiencies in ERCC3, enhancing its potential therapeutic applications. Kishor, could you elaborate further on the promise of this combination?

Kishor Bhatia, CSO

Absolutely. The possibility that spironolactone can convert nearly any tumor into a sensitive one to LP-184 is compelling, and we are rigorously pursuing this area due to the encouraging results.

Panna Sharma, CEO

Moreover, many of our patents filed last year include promising combination approaches, which we will continue to explore. Spironomactone indeed shows promise along with other prototypes we are examining closely. Excellent question.

Nicole Leber, Investor Relations

The next question comes from Michael King. Any updates on whether bladder cancer remains a priority for LP-184?

Panna Sharma, CEO

Yes, bladder cancer is indeed on our radar for LP-184 in various capacities and also potentially for LP-100. Several subtypes of bladder cancer are being considered, and we can discuss further in subsequent phases of our research.

Kishor Bhatia, CSO

Yes, we are designing studies to evaluate LP-100 and LP-184 for various types of bladder cancer, including localized and refractory cases. We are also examining metastatic bladder cancers where around 10-12% show deficiencies in DNA repair genes. Our in-vitro data indicates that if we create a knockdown of those genes, the efficacy of LP-184 increases by 10% to 34%. So, yes, we are focused on bladder cancers, and discussions with leading experts are ongoing for further studies.

Panna Sharma, CEO

Great question. You can expect news regarding bladder cancer from us this year.

Nicole Leber, Investor Relations

The next question comes from Michael Samuels. How do you perceive yourself compared to other small-cap biotechs in terms of pipeline and talent among other factors?

Panna Sharma, CEO

That’s a great yet loaded question. The biotech sector has certainly been challenging recently. However, I believe we possess the capacity to generate new potential wins for investors consistently. Our platform is robust, and we have a strong cash position along with sound financial discipline regarding our investments in programs. Our burn rate was $3.5 million last quarter; however, we expect it will slightly increase this year, peaking around $4 million to $4.5 million per quarter due to manufacturing finalizations and site launches. Nevertheless, our financial resources are sufficient to sustain us through 2025 while our pipeline has the potential value worth billions. We remain committed to providing innovative solutions and a constantly evolving platform which keeps us well-positioned for long-term success when biotechs eventually gain favor again.

Nicole Leber, Investor Relations

Next question, also from Michael King regarding RADR. What insights can you provide concerning the data point increase to 25 billion versus 18 billion? At what point do you expect to hit diminishing returns? Also, could you discuss the roles of Deep Lens and Code Ocean in improving efficiencies and data analysis?

Panna Sharma, CEO

Those are fantastic questions, Michael! We currently have 18 billion data points, and I believe we can reach 25 billion this year. However, within the current 18 billion, we lack sufficient data concerning certain rare and pediatric cancers. Thus, we will continue to gather this data to better understand the responsiveness of pediatric cancers to the compounds we aim to develop, thereby optimizing our chances. We are also interested in exploring combinations with approved therapies, which can encompass immuno-oncology options. On our roadmap to surpassing 25 billion data points, we are targeting 50 billion and subsequently 100 billion, particularly focusing on immune data, antigen data, and algorithms predicting immune responses. We remain in the early stages of this process, but we anticipate that our capabilities will improve substantially by year-end. I do not anticipate reaching diminishing returns for a while since ample new data is constantly emerging in novel drug classes and tumor subtypes. Once we obtain more advanced drugs for analysis, we can discard outdated data. However, not all data is of equal value, so we must remain judicious regarding our data sets as we curate them. Regarding collaborations, Deep Lens enhances our patient recruitment in the ongoing trials we are setting into motion now. Patient identification is becoming more proactive, and we expect their contributions will be evident in recruiting for the LP-300 trial. Code Ocean allows us to scale RADR affordably and securely while collaborating with external partners. That enables us to use our algorithms while sharing data without cumbersome file transfers; it's an efficient, scalable, and secure approach. So these partnerships help us conduct research faster and in a cost-effective manner.

Nicole Leber, Investor Relations

Thanks. The next question is about LP-284. Could you expand on how you plan to leverage the ERCC3 degradation mechanism for LP-284 in ways that may be independent of spironolactone, or do you envision that spironolactone treatment would be a requirement for LP-284?

Panna Sharma, CEO

That's a good question. Who asked that question?

Kishor Bhatia, CSO

Spironolactone is not required for the efficacy of LP-284. When we evaluated LP-284 in various tumor cell types and cell lines deficient in specific genes such as CSD and ERCC3, we observed that LP-284’s efficiency dramatically increases when a tumor cell lacks the capacity to repair the damage it incurs from LP-284. Spironomactone aids in potentiating this effect by specifically degrading ERCC3, which is a crucial component of the repair mechanism. So, with spironolactone's application, we can reduce the amount of LP-284 needed to kill these tumor cells, enhancing its efficacy.

Panna Sharma, CEO

By selectively targeting these tumor cells resistant to LP-284, spironolactone can open avenues for treating other indications that may otherwise be untargeted.

Kishor Bhatia, CSO

The pivotal role of ERCC3 is crucial in conducting DNA repair. Given that all cells frequently encounter DNA damage—while synthetically lethal responses are elicited by LP-284 and spironolactone combinations—this provides a unique therapeutic window because of the substantial damage caused by LP-284. Should even a minimal quantity of ERCC3 persist within the cell, we may still achieve the desired effect.

Nicole Leber, Investor Relations

We have time for one more. This one comes from Kyle Bauser. As you prepare for the Phase 2 trial for LP-300 and evaluate sites, how are you finding and connecting with sites? How many have signed up, and how many more would you like to have before commencing enrollment?

Kishor Bhatia, CSO

We are currently in the process of discussing with sites, establishing NDAs, etc., and we'd like to start with about five sites for the launch. We are close to achieving that now. The site selection is partly facilitated by Deep Lens and our CRO. Although there have been delays caused by COVID in staffing at clinical trial sites, we have observed recent improvements over the past few weeks in site availability. Our trial design is appealing since it includes a control arm with standard-of-care drugs, thus offering potentially beneficial therapies under a favorable risk-to-benefit ratio. We're optimistic that as we move forward, we can resume patient recruitment.

Nicole Leber, Investor Relations

Okay. We can maybe squeeze in one more question here also from Kyle Bauser. I know you definitely do not want to sacrifice the quality of the curated data points, yet you have significantly accelerated the pace at which you are adding to RADR. Can you talk about how you have been able to streamline this process without sacrificing quality?

Kishor Bhatia, CSO

In many ways, we have actually enhanced the quality of our data collection. Our automation is getting better, allowing us to handle larger chunks of data while maintaining discipline regarding the data we pursue. A significant part of this improvement stems from automating our scripts and improving the efficiency of our data analysis. As we advance, we're confident we can handle increasingly larger datasets more efficiently, flexibly, and effectively.

Nicole Leber, Investor Relations

Okay. And with that, I believe that is all the time we have for questions today. I will now turn it back over to Panna for some closing remarks.

Panna Sharma, CEO

Thanks, Nicole. We believe 2022 will be a transformational year for us. We laid the foundation last year in 2021 in terms of advancing our drugs for trial, obtaining more designations, and enhancing our platform while maintaining financial discipline and announcing a share purchase program that reflects our confidence in our programs and stock. We ended the year with over $70 million in cash and cash equivalents and marketable securities. We have also expanded our intellectual property with over 12 new patent applications and have some great ideas for combination approaches. I believe this year, we will continue growing our platform and advancing our portfolio, with our team committed to delivering these drugs to patients faster and with enhanced insights. Our strong cash position, along with our history of accomplishments, bodes well for our pipeline and undoubtedly for investors. Thank you for joining our call today, and we hope you will continue to track our accomplishments and what our team is doing. Thank you.

Kishor Bhatia, CSO

Thank you.

Nicole Leber, Investor Relations

Goodbye.