Good evening, everybody. I am Nicole Leber with Investor Relations here at Lantern Pharma. And welcome to our First Quarter 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.

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 the market closed today, summarizing our financial results and progress across the company for the first quarter of 2022.

A copy of this release is available through our website where you can also find a link to the slides that management will be referencing on today's call.

I would like to remind everybody about 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 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, Tuesday, May 3, 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.

On today's webcast, we have CEO, Panna Sharma; CFO, David Margrave and joining us by audio is Chief Scientific Officer, Kishor Bhatia. Panna will begin with an overview of Lantern's operational highlights, after which Dr.

Bhatia will provide additional scientific and clinical updates on our portfolio and programs and then David will discuss our financial results and other corporate events. This will be followed by concluding comments from Panna and then we'll open up the call for questions and answers.

And I'd now like to turn the call over to Panna Sharma, CEO and President of Lantern Pharma. Panna, please go ahead..

one, finding new indications to revitalize drugs that have been overlooked for shelf or new indications for our existing drug candidates, develop entirely new drugs based on targets or based on areas where we believe there's going to be activity and then ultimately find patient populations much faster at a fraction of the cost of traditional patient stratification approaches.

And we find those patients that will respond to our therapies or to the therapies with potential collaborators. When we went public in December of 2020, RADR had about 275 million datapoints. Today, we're at more than 20 billion. And before the end of this year, we expect to be well above our target of 25 billion datapoints for the year.

And so why is that important? The more datapoints we have, the more we can understand and model things that may or may not be occurring, just like with any other large complicated system, whether traffic patterns, evolution in the market and we can explore opportunities where our compounds can potentially change the outcome in certain cancers.

As we grow our datapoints, we're able to discover new places where our drugs work such as the ones I outlined with ATRT and brain mets or we can find new indications or new uses of drug -- new drug targets such as LP-284 which again wasn't even in our portfolio less than two years ago, I said less than one year ago.

So this development at this kind of pace are things that just weren't being done as little as seven years ago in cancer drug development and certainly not at this cost. In addition to aggregating data for RADR, we're also expanding algorithms within the RADR to better utilize our data lake.

I'm going back to the history of the company, we had about three or four algorithms that's focused on very specific problems related to differential gene analysis which is the building blocks of looking at patient stratification and signature creation.

But as many of you know, algorithms can solve a variety of problems related to a workflow or to the creation of a solution. And as the algorithms become more powerful, more predictive, they can actually begin now training themselves on our massive data sets to create insights and correlations that will accelerate our drug development process.

These algorithms can look at very specific questions such as -- which networks are most likely to be involved in the mechanism. They can look at identifying genes or driver genes in a central biological problem that we're looking at.

They can potentially generate combinations that may have been overlooked for combinations with non-cytotoxic drugs that haven't been thought about before. Today, we're doing all of those things.

In terms of -- beyond that, we've also demonstrated this past quarter that LP-284 has growing efficacy and we'll be hosting an update on LP-284 in a number of hematologic cancer, specifically in mantle cell lymphoma and double-hit lymphomas.

I'll now turn over the call to Kishor initially to provide further details on our development programs and then to David to talk about our financials and update on other key matters of the company.

Kishor?.

Thank you, Panna. I'd first like to update everyone on the study's directly relevant to clinical trials of both LP-300 and LP-184. The HARMONIC trial which is investigating the efficacy of LP-300 when used in combination with the standard of care carboplatin and pemetrexed continues to move forward.

The retrospective analysis of a multicenter Phase III trial showed that LP-300, given in combination with chemotherapy, increased the two year and overall survival by 125% and 91% in a subset of patients who turned out to be never smokers. What an LP-300 mechanism action may help explain the survival benefits observed in lung cancer in never smokers.

Well, one of LP-300's mechanism of action is to covalently modify the systems of certain proteins potentially inactivating them. Previous and ongoing multi or mixed data clearly signify that lung cancer in never smokers has distinct gene and protein expression profile when compared to lung cancer in smokers.

For example, some recent data published in the International Journal of Cancer identify fewer somatic mutations and lesser chromosome instability but confirm higher frequency of mutations in EGFR and ErbB2.

These features that distinguish lung cancer in never smokers are also the proteins that are potential targets of LP-300 in studies that involve the assessment of the direct interaction of LP-300 and some of those sketches are shown on this slide of the interaction of LP-300 and drivers of lung cancer in never smokers like the tyrosine kinase ALK or EGFR, LP-300 modified cysteine residues supporting that LP-300 can inactivate tyrosine kinase proteins that are primarily involved with lung cancer in never smokers.

LP-300 has been previously shown to act as a chemosensitizer by decreasing the activity of redox protein, thioredoxin and glutaredoxin which are often overexpressed in lung cancer in never smokers. Exposure to LP-300 thus has the potential to restore the tumor cells' redox balance sensitizing the cancer cells to chemotherapy.

We have designed the HARMONIC trial to prospectively assess the direct survival impact of including LP-300 with standard of care chemotherapy in lung cancer and never smokers. And as Panna stated earlier, we expect to initiate enrollment in the coming months this summer.

Moving now to our molecule, LP-184 which has shown promise in multiple cancer types. Our progress has been focused on moving towards a first in Phase I human clinical trial later this year. In preparation for this, the non-GLP portion of the required studies have been completed and the GLP portion will be completed by the third quarter of 2022.

In parallel, we'll also have the CMC report to include in our IND application. Based on our current understanding of these time lines, we are well positioned to initiate the human clinical trial before the end of the year.

For the Phase I clinical trial of LP-184, we have identified four sites and discuss the trial designed with clinical investigators.

Parallel to activities that directly enable our clinical trials, we also continue to obtain very exciting and encouraging data on LP-184 that identify additional properties of the molecule, making it relevant in the treatment of tumors with clinical needs.

An example of this was mentioned by Panna earlier, where we recently presented results at the AACR Annual Meeting, describing the preclinical efficacy of LP-184 in cancers that metastasize to the brain.

This is important because brain metastasis occur in approximately 10% to 30% of all cancer cases and represent a much larger proportion of pain-related cancers than primary brain cancers. These brain mets are difficult to treat due to the lack of standard of care treatments that can cross the blood-brain barrier.

Given the excellent blood-brain barrier penetration of LP-184, coupled with the broad preclinical activity in diverse tumor types, it was obvious that LP-184 be assessed for activity in brain mets.

Our results presented at AACR provide the foundational evidence that LP-184 is equally effective in brain mets of tumors from lung, breast and melanoma as it is in the primary cells of these tumor types. Our next steps towards developing LP-184 for treating patients with pain meds includes assessment of LP-184 in animal models of brain mets.

The CNS pharmacokinetic clearly supports the availability and exposure of the drug in brain tissues. This, therefore, gives us ample confidence in advancing LP-184 in this important indication that impacts over 100,000 patients in the U.S. annually.

I'm now going to now touch upon some exciting observations of LP-184 that relate to a new concept, the concept of synthetic lethality. Synthetic lethality is gaining greater recognition as a mechanism to specifically target tumor cells.

In multiple studies, LP-184 has demonstrated a novel synthetically lethal relationship in tumors deficient in nucleotide excision repair, tumors we call NERDs and also in tumors deficient in homologous recombination of pathway, tumors we call HERDs. NERDs and HERDs occur because of mutations in genes in these pathways.

And these are the genes that play a role in DNA repair. As many as 10% to 20% of tumors are NERDs or HERDs. Our preclinical data using the response of various tumor cell lines as well as ex vivo patient-derived PDXs confirm the synthetic lethal relationship between LP-184 and tumor such mutations.

In fact, robust responses in vivo are also evident in tumors that are resistant to either PARP inhibitors and other synthetic lethal agent or to DNA damaging agents such as a platin. We continue to use RADR and other data-driven approaches to identify mutations in various genes that enhance the sensitivity of LP-184.

The information on specific genetic mutations that cooperate to elicit the synthetic vitality of LP-184 is important to allow the preferential killing of tumors but not normal cells. We are in the process of developing a mutational response signature of tumors that will allow us to best select highly sensitive tumors for our drug candidates.

It's also important to mention in this context that LP-100 also has a scientific relationship in NERDs and we have initiated in silico and targeted vet lab studies, assessing the potential of LP-100 in combination with PARP inhibitors in a clinical setting.

We believe that the results from this study can help further derisk and pinpoint the use of LP-100 in cancer patients. I will now turn the call over to David Margrave, our CFO, who will provide an overview of our first quarter financial results.

David?.

Thank you, Kishor and good afternoon, everyone. I will now share some of the financial highlights from the first quarter. Our R&D expenses were $2.7 million for the first quarter of 2022, up from $1.3 million in the first quarter of 2021.

The increase in R&D expense was primarily attributable to increases in manufacturing-related expenses for product candidates, research studies and an escrow payment released to Allarity under the Allarity asset purchase agreement which payment was a non-recurring expense.

General and administrative expenses were $1.4 million in the first quarter of 2022, up from $1.2 million for the prior year period. We recorded a net loss of approximately $4.1 million for the first quarter of 2022 or $0.38 per share.

As of March 31, 2022, we had approximately 10.8 million shares of common stock outstanding and outstanding warrants to purchase approximately 891,000 shares and outstanding options to purchase approximately 178,000 shares.

These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 1.9 million shares as of March 31, 2022. Panna mentioned our share repurchase program and, through March 31, 2022, the company has repurchased a total of 475,157 shares.

Of those, 353,667 shares were purchased in the first quarter of 2022. Our cash position, including cash equivalents and marketable securities at March 31, '22, was $65.2 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.

Consistent with our focus on capital efficiency, in September 21, as Panna mentioned, we created an Australian subsidiary with the objective of enabling Lantern to take advantage of Australia's R&D Tax Incentive program which provides tax offsets for eligible R&D expenditures.

We see this program as providing us with the opportunity to conduct selected upcoming preclinical and clinical studies and trials with increased financial flexibility and capital efficiency. As Kishor previously discussed, we've already initiated preclinical and IND-enabling studies through our subsidiary in Australia.

As mentioned on prior calls, we're migrating to a hybrid work environment and I'm proud to say our team continues to be very productive under this operating model.

This hybrid model removes geographic restrictions to our hiring initiative which also gives us the ability to recruit extremely high-caliber team members that otherwise might not be available.

We've maintained discipline in managing our headcount and we currently have 60 employees who are primarily focused on leading and advancing our research and development efforts. We see our number of employees expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission.

At the end of April, we announced that Dr. Maria Maccecchini was nominated for election to our Board of Directors. He is the current CEO, President and a Director of Annovis Bio Inc., a biopharma company focused on developing therapies for neurodegenerative diseases.

And if elected, she will bring decades of experience in progressing drug candidates through late-stage clinical trials. Dr. Maccecchini will be presented alongside a slate of five existing directors at Lantern's upcoming annual meeting to be held on June 2022. I'll now turn the call back to Panna for some final comments.

Panna?.

Thank you, David. I believe we're very well positioned today. We will continue to have a very strong fiscal discipline, strong balance sheet and great oversight of our programs. Our focus is on leveraging our intellectual knowledge and our unique capabilities around scientific strategy and clinical trial design and on AI platform development.

While we work with CROs and leading cancer centers to accelerate our trials and our studies. This model enables us to keep our company lean and mission-focused while allowing us the flexibility to increase or decrease the studies, the trials, the wet lab work as they're needed and also as results dictate.

During the year, we expect to bring multiple assets into focused clinical trials in 2022, where there's demonstrated patient need or where there's really no proven therapy, for example, brain mets or ATRT, while remaining focused on capital efficiency.

We'll continue to take initiatives this year to make our dollars go further such as the Australia subsidiary, potentially looking at additional partnerships, focusing on nondilutive funding through grants and other mechanisms.

Additionally, our AI platform RADR will continue to grow significantly across all measures, data, analytical rigor, generation of new publishable insights and new functionality.

As data and I continue to drive changes in cost, speed and efficiency of drug discovery development, out team at Lantern will remain at the forefront of transforming oncology therapeutic development. So with that, now I'd like to open up the call to any questions..

Thank you, Panna. [Operator Instructions] We have couple of questions coming in already. One from Keith Thompson [ph]. Lantern is the only company I know of that mentions the size of its AI data bank.

Why is that? Is $20 billion-plus a large or small number related to AI in the bio space?.

I think it's good to report how the progress of the DLAK [ph] is because it gives you a sense of what are the types of things our team is focused on? What is the velocity of the increase but cancers, what data types gives you a sense of what are the questions that we're going to be exploring and what is the road map for development.

I'm sure there are other companies that talk about the numbers. I don't think many have the some kind of discipline in terms of reporting them or so might be afraid to report it. But I do see other companies in drug development. I think broadly in bio, I do see as many of the synthetic bio companies reporting similar types of metrics.

So, yes, it's growing. It's definitely growing thing to report the number of kind of the data elements or data types or unique sets of data..

Sure. The next question here and I see Michael Samuels [ph] is asking to raise his hand. And so, Michael, I will allow you to speak.

Any worries related to your cash runway?.

I can speak to that. I think, the answer is no. I think we all recognize that focus on cash availability and your cash runway is very important for companies in our space. That's something we do constantly. As Panna recognized, this is a challenging environment. We're well aware of that.

We're quite focused on maintaining capital efficiency and keeping the lean disciplined environment that we've been able to maintain at this point. We see if we do those things, we don't see cash runway as an issue for us.

Anything you would add to that, Panna?.

No. I think we've given guidance, we've got cash into 2025 which I think there will be a lot of developments between now and then. So, we should be cognizant but we're not worried..

Okay. And I see John Newman [ph] is asking to speak..

I just had a question about the Phase II HARMONIC study for LP-300 in never smokers. Just curious if that study will be including patients with brain mets? And I'm wondering if brain mets are any more or less common in never-smoker lung cancer patients than smokers..

I think, brain mets should be excluding people from the trial. Unfortunately, we won't confound the results of the study. And since brain mets is not the indication for LP-300, it probably makes sense for them to have a different care path that was the nature of your question.

In terms of the -- I think there is a second part to that question, LP-300 besides the brain mets.

John, what was the second part of that?.

Just curious if it's known whether brain mets are any more or less common in the never smoker patients, so perhaps never smoker patients wouldn't have as many brain mets. So there really wouldn't be any restrictions on them receiving the drug in the real world if it were approved..

I can take that. No, I mean, even non-smokers -- in lung cancer in non-smokers, there are brain mets. There's not sufficient data that I can point to but I think there is equal risk, whether the lung cancer occurs in smokers or non-smokers.

Yes, that's probably -- that's accurate from the anecdotal data but there's no comprehensive data I've seen in terms of percentage of bringing that from various smoking types..

And can you maybe talk about any type of genetic or biomarker data that you'll be collecting from the never smoker patients?.

Yes, I'd love to. Kishor, do you want to give the [indiscernible]..

Yes, sure. So, we have an exploratory end point where we are looking at circulating DNA to see if we can get early indications of responses.

But in addition to that, we are also going to collect already available genomic data from the archival tissues to be able to do more direct correlations in terms of the response, the patterns of response, so on and so forth. But all these are exploratory studies at this point..

Yes. We'll be taking liquid biopsy at enrollment after three cycles, six cycles and at end of study. And so, we might find some unique sort of biomarkers correlated to some of the observations. But again, those are exploratory at this point but we may use in later stage phases. Very good questions from John..

Okay. And I'm not seeing that we have any additional questions. So I'll give everyone a few moments if you would either like to type in your questions in the Q&A tool or if you would like to speak directly to management, feel free to use the raise hand tool. Okay. I'm not seeing any other questions coming in here.

Panna, would you like to make any final remarks?.

No, we look forward to talking more with our investors and shareholders as the quarter continues. We plan on having several updates on not only our existing clinical trials but some of the other programs and partnerships that we'll be creating. So, thank you all for attending and we hope we found this as informative as well. Thank you..

Thanks very much..

Thank you, everyone..

Thank you..