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.

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…

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…

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…

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

[Operator Instructions]. First, I see John Vandermosten's hand up. John, you should be able to talk.

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?

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.

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?

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.

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?

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?

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.

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

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?

I'll take a first crack at that. In regards to the LP-300, we will not be doing any genomic based selection because that's kind of already been done in many ways because these patients will have relapsed or stopped responding to TKI therapies. So they're kind of self-selected already for that as never smokers. We will be taking liquid biopsy for these 90 patients. And those liquid biopsy results might give us some idea about potential surrogate markers of response or potentially some interesting signatures that correlate to improved response in certain types of patients. But we won't know until we collect that, but that data will be very useful in future studies, potentially Phase 3 or to license the drug out. But for the current trial, one of the beauties of the trial is that we already have patients that have been genomically stratified because these are going to be TK failures largely. In terms of the additional combinations, like with spironolactone, with PARP inhibitors, we definitely think the spironolactone seems to be a significant enhancement in the potency of 184 and perhaps 284, but definitely 184. And we can see ourselves using that as an additional arm in certain cancers where we may want to see a uptick in the potency, or maybe we may see in certain patient types a less than ideal therapeutic window or safety profile. So if you want to give less drug, but get a heightened response or the same response at the tolerated dose, then that's where we could use spironolactone. But we see that as being introduced as an additional arm in the trial. In terms of PARP, we're early on, but we think that we could actually mount some trials directly with PARP and compare it head to head against PARP alone. Because as you know, PARP has got a couple billion dollars in sales in certain indications. We think in many of those indications, we can significantly improve the outcome. And I think, Kishor, you had some data on PARP on the approval and you want to share some of that with Michael.

PARP inhibitors have been approved for, for example, for prostate cancer. Clearly, focused on those prostate cancers that have mutations in BRCA or ATM. But after some time, several of these patients do develop resistance. So one part that also is that – A, the combination might delay this resistance, but in addition, if they become refractory, then perhaps LP-184 will still work on those. And there are toxicities associated with, of course, both LP-184 and PARP. And using a combination in a more strategic way to diminish those toxicities is another path that we have.

If I can maybe summarize what I've heard, is it fair to say that you'll need to get single agent PK/PD for your maybe recommended Phase 2 dose before you start adding things like spironolactone or adding to PARP.

At this time, that's [indiscernible].

Okay. So, the question I have on spironolactone – I can understand PARP, you could probably refer to data that's in the public domain as far as what single agent activity should be from a PARP before you add 184 on top. Bu I'm just wondering, in the case of spironolactone, where it's not thought of as an anti-neoplastic, how does one it – because when you do combination studies, the FDA is always interested in what does the agent add as a single agent? Do you have to do some studies showing that spironolactone no effect on tumors?

Yeah. Spironolactone is an FDA approved drug. So the safety profile and other things are known about it, those are the pharmacokinetics. We have already gathered data in vivo in animal models that the combination works and is more effective in certain context of certain tumors more effective than LP-184. So we believe that the data we have is sufficient for us to go to the FDA and design a study to use this combination.

But also in those studies, we did spironolactone alone and it showed no effect on the tumor.

Yes. Spironolactone alone did not show any effect. That's right.

I just wonder if you have to show it in many of the small number of patients, but I'll leave that for now. And then just on Starlight, is there still gating items? Maybe just sort of the documentation for the Phase 1 trial that would have you somewhat behind the studies of LP-184. If I read your slide correctly, show that Starlight IND would be a little bit later this year behind the anticipated one for 184.

Starlight, we'd just pick up after the 1a. So, Starlight, that would pick up in Phase 1b or 2a. So, the 1a is going to be multi-tumor. And once we have the MTD and the MTD-1, then we'll probably in that Phase 1a have certain CNS cancer patients. And once we've established that MTD, then we can enrich…

Turning it over to Starlight. I got it.

One more question we have is, does the expected increased cash burn rate factor into our projections through 2025?

Yes, we're taking that into account when we're stating that our current financial position carries us into 2025.

Okay. And with that, that will conclude our webcast for today. Thank you all for joining and we'll hope to see you over at our KOL webinar tomorrow. Thank you, everyone.