Lantern Pharma Inc. (NASDAQ:LTRN) Q4 2022 Earnings Call Transcript

Lantern Pharma Inc. (NASDAQ:LTRN) Q4 2022 Earnings Call Transcript March 20, 2023

Nicole Leber: Welcome to our fourth quarter and full-year 2022 earnings call. I will be your host for today’s call. As a reminder, this call is being recorded and all attendees are in a listen-only mode. We will open up the call for questions and answers after management’s presentation. A webcast replay of today’s conference call will be available on our website at lanternpharma.com after the call. We issued a press release after market closed today, summarizing our financial results and progress across the company for the fourth quarter and full year of 2022. A copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slides that management will be referencing on today’s call.

I would like to remind everyone that remarks about future expectations, performance, estimates and prospects 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, including 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, 2022, which is on file with the SEC and available on our website.

Forward-looking statements made on this conference call are as of today, Monday, March 20, 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. A webcast replay of the conference call and webinar will be available on Lantern’s website. On today’s webcast, we have Lantern Pharma’s CEO, Panna Sharma, CFO, David Margrave; and CSO, Kishor Bhatia. Panna will start things off in a minute with an overview of Lantern’s strategy and business model and highlight recent achievements in our operations, after which David will discuss our financial results, which will be followed by Dr. Bhatia who will provide a brief update on our development programs and upcoming webinars.

This will be followed by some concluding comments from Panna, and then we’ll open up the call for Q&A. I’d now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.

Panna Sharma: Thank you, Nicole. Good afternoon, everyone. And welcome to our fourth quarter 2022 earnings call and company update. Thank you for joining us this afternoon to hear about our fourth quarter and year-end results and also our corporate progress of Lantern Pharma. Lantern Pharma is at the leading edge of leveraging artificial intelligence, machine learning algorithms, biomarker, clinical, genomic and drug response data to transform the costs, compress the timelines, and derisk oncology drug discovery and development. During 2022, our team was extremely focused on taking these insights and driving them to meaningful clinical programs that will be launched this year with our new first-in-human drug candidates, LP-184 an LP-284.

We’ve done this at a fraction of the time of traditional drug development approaches. This is really also the future of drug development, specifically in cancer where there’s so much data available, and that data can be used to accelerate programs, derisk the identification of patients who will respond to the drug, or diseases that will best benefit from the therapy and progress those potentially life changing medicines with reduced cost and reduced time. Our model both works for transforming early stage discovery and development, where we’ve been able to develop many new indications in a fraction of the time, literally less than two years for many indications, most of those in parallel. And it also helps with sharpening later stage clinical trials, where we believe by focusing on fewer and more select patients, those patients that are more likely to respond, we can significantly save time and money in later stage trials.

Our platform is focused on being able to accomplish both. At the same time, our team has been advancing the clinical foundation and infrastructure for our Phase 2 HARMONIC clinical trial for never smokers with non-small cell lung cancer. And this has been a very important endeavor. And we’ve strengthened our clinical operations team with some select and highly experienced colleagues that have joined us to help scale up the program. We now have over activated over five clinical trial sites across 12 different locations and centers in the US, including Ohio, Illinois, New York, Texas, and California. Across the five clinical trial sites, there’s already one consented patient that is anticipated to be dosed later this month, and also 14 additional potential patients that are being pre-screened and are being monitored for possible enrollment.

Multiple additional trials sites across the US are expected to be activated in the first half of 2023 and will bolster patient recruitment and enrollment. In the US, there are approximately 20,000 to 30,000 never smokers, with non-small cell lung cancer diagnosed annually, representing an estimated annual market potential just in the US of $1.5 billion to $2 billion. This opportunity has been developed by understanding why certain molecular profiles in non-small cell lung cancer those largely associated with never smokers and those with very low tumor mutation burden and targeted mutations, largely in the tyrosine kinase pathways are responsive to our drug LP-300 when used in combination with the current chemotherapy standard of care. This effort without the use of large scale data and modeling would have really continued to stay on the shelf.

We’re also using this transformative data driven approach through our proprietary RADR AI platform. Our platform uncovers significant opportunities in cancer, opportunities that are either underserved, unmet or often overlooked. We do this with tremendous accuracy. Our prediction success is 80% to 90%. And that’s because not only the data points, but also because we’re relying on over 200 advanced machine learning algorithms. We’ve used this to both advance and rescue compounds, bringing them into Phase 2 clinical trials and also to develop entirely new drug candidates for first-in-human trials, many of them we’ll be launching in the coming months. And again, we’re doing this at a fraction of the cost and timeline and Dave will discuss some of our financials later today.

Also, Kishor will talk about the progress on our exciting new molecules, and how they are entering the clinic in the next few months and quarters. Our unique AI platform, as I mentioned, is served by over 25 billion data points and nearly 200 algorithms that can help us understand, predict and model questions that are fundamental to oncology drug development. Our goals for our platform this year, we expect that it will reach over 50 billion data points. And we expect to enhance functionality in three major areas. One, better predictive model combination regimens of small molecules with certain antibody classes, anti-cancer antibodies, at least; the ability to understand and develop ADCs, antibody drug conjugates, at a fraction of the current cost; and third, develop highly specific targeted predictions of key safety features of a compound and predict blood brain barrier permeability of those compounds.

And we’re already pretty far along the process of generating algorithms that we believe are not only best-in-class, but probably will be some of the best BBB algorithms out there. And talking about our new clinical trials, the first-in-human trials will be with drug candidates LP-184 and LP-284. We believe that both molecules can be synthetically lethal in certain cancers, LP-184 largely in solid tumors, while LP-284 is directed at a range of blood cancers. The compression of costs and timeline that we’re creating with our drug development process have allowed us to grow our portfolio from three programs about 30 months ago to 12 programs today. We expect in many of these programs to create high value opportunities for our investors and potentially life transforming therapies for cancer patients.

Several of these programs we have brought together in a very exciting, new, wholly owned subsidiary called Starlight Therapeutics. The program is being developed by Starlight were borne from the analysis of billions of oncology focused data points and by using Lantern Pharma’s AI platform RADR. STAR-001’s powerful anti-tumor mechanism, synthetic lethality, coupled with the collaborations that we’ve done with internationally recognized institutions including Hopkins and the Greehey Children’s Cancer Center at UT Health San Antonio, make it well positioned to rapidly advanced these CNS focused therapies in a targeted and efficient clinical development pathway. Starlight intends to pursue human clinical trials for multiple CNS indications. Again, we’ve gone from one to now seven indications, quite rapidly starting in late 2023.

It’ll build upon the prior IND enabling studies and the upcoming Phase 1a clinical testing that will be conducted by Lantern Pharma. The clinical development of STAR-001 in CNS cancers beyond the Phase 1a trial will be conducted exclusively by Starlight. Following the launch of Starlight, Lantern Pharma will continue to advance LP-184 in clinical development for non-CNS indications, indications such as pancreatic where we’ve partnered with Fox Chase Cancer Center, bladder cancer, triple negative breast cancer and other solid tumors that have DDR deficiencies. We’ll also continue to provide AI bioinformatics and computational biology support to Starlight. The formation of Starlight as a wholly owned subsidiary allows Lantern to sharpen the focus on advancing STAR-001 through targeted clinical trials and dedicate increased time, resources and personnel to progress what we think is one of the most promising drug candidates for CNS cancer patients in decades.

We believe that by focusing our efforts by Starlight Therapeutics, we can accelerate and deepen our commitment to the CNS cancer patient community while also creating the potential for meaningful additional upside for our investors. We’ll always be looking for additional opportunities where the development, needs and unique focus of certain programs or assets can be separated and developed in a focused manner. Our collaborative portfolio also continues to grow. In addition to our work with Actuate, we started a collaboration earlier this year with TTC Oncology, an emerging biotech focused on breast cancer. They have the best-in-class management team and they have a really exciting drug called TTC-352 that’s focused on certain unmet needs in ER positive breast cancer patients.

Photo by Raimond Klavins on Unsplash

And as we develop our collaboration, we may have the ability to get an exclusive right to license the drug and any collaborative intellectual property to then develop it. This is a real case of where the platform is the currency. And you’ll hear more about this program and this collaboration in the coming quarters as it develops. Lantern Pharma has entered now in a major period of transformation itself as we evolve and mature many of our initial AI driven insights and advance them to drug candidates into human clinical trials. We’re continuing to make significant meaningful progress and turning the observations and insights generated by our platform, validated in the labs into advancements for cancer patients and potentially breakthrough high value clinical programs.

Our programs both at Lantern and Starlight span multiple highly attractive indications and have been developed at a level of cash burn and resourcing that is almost unheard of in this space. But it has been driven by our growing AI platform. We expect many of these programs would partner with larger biopharma companies as they develop. And continuing our focus and providing insight transparency and also educating the market through webinars, we’ll be hosting a KOL webinar on synthetic lethality, key mechanism of Lantern’s drug candidates, LP-100, LP-184 and 284. That webinar will be tomorrow, Tuesday. The webinar will feature an internationally recognized expert in synthetic lethality, Zoltan Szallasi. He’s an MD, who serves joint appointments both as a principal investigator at the Danish Cancer Research Center, which is one of our collaborative sites, and as an Assistant Professor of Pediatrics at Boston Children’s Hospital, a Harvard Medical School affiliate.

Additional details of the KOL webinar can be found on our website and the link has also been provided in our earnings release and slides. We expect to follow up on this webinar with another additional webinar on synthetic lethality, specifically in terms of what the programs are for 184 and the implications for both mono and combination therapy. This will be led by our own Dr. Kishor Bhatia, our Chief Scientific Officer, in late April. With that overview, I’ll now turn the call over to our CFO, David Margrave, to provide an overview of our fourth quarter and year-end results and also walk you through some basic housekeeping items. David?

David Margrave: 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, 2022. I’ll start with a review of the fourth quarter. Our R&D expenses were $2.3 million for the fourth quarter of 2022, up slightly from $2.2 million in the fourth quarter of 2021. General and administrative expenses were $1.6 million for the fourth quarter of 2022. up slightly from $1.4 million in the prior-year period. We recorded a net loss of $3.4 million for the fourth quarter of 2022 or $0.31 per share compared to a net loss of $3.5 million or $0.31 per share for the fourth quarter of 2021. For the full year of 2022, our R&D expenses were $8.6 million, up from $7.6 million for 2021.

This increase was primarily attributable to increases in research studies, increases in consulting expenses, and increases in R&D payroll expenses. Specifically, for the full year 2022, our spend on research studies increased by approximately $1.5 million, consulting expenses increased approximately $0.2 million and R&D payroll expenses were up approximately $0.1 million. These increases were partially offset by decreases in product candidate manufacturing related expenses of approximately $0.2 million, decreases in licensing fees of approximately $0.1 million and a net decline in payments to Allarity Therapeutics of approximately $0.5 million. During the year ended December 31, 2021, we made a one-time, $1 million upfront payment to Allarity Therapeutics to take the rights to LP-100 back into our control, which we are now looking at combining with PARP inhibitors in a combination program aimed at cancers with homologous repair deficiency, or HRD cancers.

During the year ended December 31, 2022, we released an escrow payment of approximately $459,000 to Allarity Therapeutics. Manufacturing related expenses for the year ended December 31, 2022 were also reduced by $935,000 as a result of the payment we received in July 2022 from one of our service providers in connection with the resolution of a difference of views regarding the agreement with a service provider. Our general and administrative expenses for 2022 were $5.8 million, up slightly from $5 million for 2021. The increase was primarily attributable to increases in payroll and compensation expenses of $0.5 million, increases in other professional fees of $0.4 million, increases in legal and patent related expenses of $0.1 million, and increases in travel expenses of $0.1 million.

Our R&D expenses continued to exceed our G&A expenses by a strong margin, reflecting our focus on advancing and expanding our product pipeline. The net loss for full year 2022 was $14.3 million or $1.31 per share compared to a net loss of $12.4 million or $1.13 per share for the full-year 2021. As of December 31, 2022, we had approximately 10.86 million shares of common stock outstanding and outstanding warrants to purchase approximately 177,998 shares and outstanding options to purchase approximately 1,037,591 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of 12,072,629 shares as of December 31, 2022. Our cash position, which includes cash equivalents and marketable securities, at December 31, 2022 was $55.2 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 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. Our team continues to be very productive under a hybrid operating model. This 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 23 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 our Chief Scientific Officer, Kishor, for an update on some of our development programs. Kishor?

Kishor Bhatia: Thank you, David. During the last quarter, we provided you with updates to our drug programs, LP-184 and LP-284. These programs included developing LP-184 for two main classes of cancers, solid tumors, such as genetically defined pancreatic and bladder cancers, and also the central nervous system cancers, including glioblastoma and brain mets. The second program was developing LP-284 for lymphomas with a focus on mantle cell and diffuse large B cell lymphomas. And among the latter, particularly double hit and triple hit lymphomas. At that time, we had appraised you of our plans to launch Phase 1 clinical trials for LP-184 in early 2023. I’m pleased now to provide you with updates on these plans, along with insights from our completed IND-enabling studies.

Following a recent filing of pre-IND application with the FDA and completion of essentially all the pharmacology/toxicology studies required to file the IND, we are pleased to report that the necessary documents and results for the IND submission are nearly complete and we are anticipating the IND submission to occur in early April 2023, with a steady startup in later quarter two. We expect the first patient to be dosed in summer of 2023. We anticipate to have all currently targeted clinical sites activated in the third and fourth quarter of 2023. The sites where this clinical trial will be conducted will include top tier of cancer centers such as the Fox Chase Cancer Center and Johns Hopkins. These and other similarly planned sides routinely assess tumor genome sequencing and characterization, a resource that is critical to our approach for identifying the most sensitive tumors.

Additionally, the protocol for Phase 1 trial has been finalized after discussions with our leading KOLs. The Phase 1 design is depicted in this slide that you see. The trial design is a Bayesian optimal interval design. And this was chosen because it allows us to balance the risk of inadvertently arriving at a lower dose while maintaining safety to reach at an effective dose. Following the escalation phase, and as recommended by FDA, we will have two cohorts of 10 patients each at two dose levels, which will provide us with a relative dose response, or RDR, for the Phase 2 trials. Based upon the dose range finding studies in dogs from the completed IND-enabling studies, we will begin the first-in-human studies with a starting dose of 0.015 milligrams per kg.

Now, LP-184, of course, has the potential as a potent monotherapy agent, but also has a potential to be used in combination with other FDA approved therapies. These combination choices to us are dictated and guided by clues based upon the mechanism of action of LP-184 as well as the interrogation of the interactive pathways using our in silico assessment on the RADR platform. This transcription coupled nucleotide excision repair or TC-NER pathway, which is critical in the repair of DNA damage caused by LP-184, provides it with synthetic lethal properties in tumors that are deficient in this pathway. The mechanism of action of LP-184 can be leveraged further, therefore, by combination of molecules that would diminish the activity of the TC-NER pathway.

Such molecules, as you can envisage, will also help broaden the tumor indications that become hypersensitive to LP-184 as well as provide the potential for widening the therapeutic index of LP-184. In this regard, one molecule that we have been investigating and for which we now have substantial positive in silico, in vitro as well as in vivo data is spironolactone. This is an FDA approved drug for hypertension and other non-oncological indications. In continuing our focus on providing insight and transparency about our research through webinars, we are posting KOL webinars on synthetic lethality, as Panna mentioned, tomorrow, March 31, at noon Eastern. This webinar will feature an internationally recognized expert in sympathetic lethality, Dr. Zoltan Szallasi, who serves joint appointments as principal investigator at the Danish Cancer Center with whom we collaborate, and as Assistant Professor of Pediatrics at Boston Children’s Hospital, a Harvard Medical School affiliate.

Later, in the second quarter, we have an in-depth second webinar on how Lantern is leveraging the synthetic lethal properties of LP-184 and LP-284 for multiple solid tumors. Now in addition to updating you on LP-184’s clinical trial plans, we also have updates for our LP-284 clinical development plans. As I had mentioned before, Lantern is developing LP-284 for multiple B cell, non-Hodgkin’s lymphomas, where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies and lymphomas where there is demonstrated clinical need. Additional indications for LP-284 are targeted at this time to include micro cell lymphomas and double hit lymphomas and a few other NHL cancer subtypes. There is a significant clinical need for additional late stage therapeutic options for these patients, as nearly all patients relapse from the current standard of care therapies such as bortezomib or ibrutinib.

We are therefore equally excited about beginning the clinical trials for LP-284. The IND enabling studies and the IND submission are slated to be completed in the second quarter of 2023. We have already received interest from multiple major cancer centers to serve as LP-284 trials sites when launched. Our confidence in the molecule is grounded on several exciting results such as those that we presented at the 2020 ASH Annual Meeting where we showed that mantle cell lymphomas are highly sensitive to LP-284. And as you can see in this slide, the tumors that actually become non-responsive to standard of care agents, ibrutinib and bortezomib, shown on Panel B in this slide, continue to retain responsiveness to LP-184. This is critically important from a patient perspective, as nearly all patients relapse from these agents.

Later this year, we will also look forward to sharing with you additional data from our preclinical ADC development program and also from our rapidly progressing pediatric studies for both LP-184 and LP-284. Most importantly, we’ll also share with you clinical data from our upcoming and ongoing clinical trials. I’ll now turn the call back to Panna.

Panna Sharma : Thank you, Kishor. As Kishor pointed out, we’re accelerating the pace at which we’re developing and validating insights, and these insights are meaningful and ready to be deployed down to the clinics. We’re also very well positioned to efficiently develop our assets and partner them out with larger biopharma companies. At the same time, David pointed out in his review, our very efficient use of capital in developing multiple programs and multiple indications and also launching clinical trials completing our manufacturing campaigns, and our cash position is being carefully utilized to make meaningful progress in a disciplined manner. With that, I’d like to now open the call up any questions

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Q&A Session

A – Nicole Leber: . First, I see John Vandermosten’s hand up. John, you should be able to talk.

John Vandermosten: I’d start out with kind of a bigger picture question. We saw a recent bid for Seagen. Does that indicate in your mind a shift in interest to ADCs? And does that affect how you might develop your own portfolio given that positive indication?

Panna Sharma: We’re very excited about the Pfizer’s buying up of Seagen or Seattle Genetics for their ADC program. As you know, I started looking at ADC and developing that in the pipeline a year ago. But we’ve been, I would say, more focused on launching it into the clinic because that’s kind of what we heard from analysts/investors that they really wanted to see the clinical progress for 184 and 284. So we really shifted to that majority of last year, as opposed to balancing both ADC and 184. And with the long term, kind of, I would say, challenges in the biotech market, we’re really focused also on cash preservation. And so, the ADCs were kind of on the €“ really more of a backburner. But we’ve got some really good progress now in our ADCs. We’ll have some data out later this year, probably very shortly what we’re doing in the ADC.

It’s a very exciting category. We’ve also fine-tuned RADR now to do more work in being able to predict to help us model both ADCs and antibody small molecule regimens. So I think, yeah, I think ADCs will be a big focus going forward. But I think everyone wants to see patients dosed with 184 and 284 and 300. So that continues to be the primary focus, but ADC is definitely the next chapter for us.

John Vandermosten: And another question on €“ you’ve got about a dozen indications, dozen programs going on. And some of them are some smaller niche areas. Should we expect to see grant subsidies or some other support to help some of these other programs as we move along?

Panna Sharma: Yeah, we are looking at grants and also collaborations. And so, I would say that’s a valid question. A lot of these are very ultra rare cancers. And there definitely are ways to look at grant dollars to help accelerate those.

John Vandermosten: I guess a kind of a modeling question. Now that HARMONIC is in full swing, what should we think about in terms of R&D for 2023 as we start adding the patients and seeing that kind of take off?

Panna Sharma: Sure, we’ll let David kind of give you some guidance for the year, but we’re pretty disciplined and have modeled kind of a scale up of HARMONIC over the next four to six quarters. David?

David Margrave: We see our cash burn rate and our expenses increasing modestly, as we move into clinical trials with LP-184 and LP-284, but in a disciplined way, and then as the enrollment increases for LP-300 as well, we’ll see our cash increase some of that, but fairly controlled from where we are now.

Nicole Leber: I see Michael King’s hand is also raised. Michael, you should now be able to speak as well.

Michael King: A couple of questions. I just would love to get a little more clarity on how you guys are thinking about the algorithm of both combination therapy as well as patient enrichment? So, for example, in the case of LP-300, are you doing any genetic selection upfront? Or is that going to wait recommended Phase 2 dose? And then when you think about combining things like PARP inhibitors, spironolactone, et cetera, as the studies mature, how should we think about the way you guys are going to layer those things in as well?