Earnings Labs

Lantern Pharma Inc. (LTRN)

Q4 2024 Earnings Call· Thu, Mar 27, 2025

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Transcript

Operator

Operator

Good afternoon, and welcome to our Fourth Quarter and Year End 2024 Earnings Call. As a reminder, this call is being recorded, and all attendees are in a listen-only mode. We will open the call for questions-and-answers after our management's presentation. A webcast replay of today's conference call will be available on our website at lanternpharma.com shortly after the call. We [Audio Gap] quarter and year ended December 31, 2024. A copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slide’s management we will be referencing on today's call. We 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 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, 2023, which is on file with the SEC and available on our website. Forward-looking statements made on this conference call are as of today, March 27, 2025, 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. On today's webcast, we have Lantern Pharma’s CEO, Panna Sharma, and CFO David Margrave. Panna will start things off with introductions and an overview of Lantern's strategy and business model, and highlight recent achievements in our operations after which David will discuss our financial results. This will be followed by some concluding comments from Panna and then we’ll open 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

Management

Maddie, thank you. Hello everyone and thank you for joining us this afternoon to hear about our fourth quarter and fiscal year 2024 results and corporate progress. As many of you have heard me say in the past, computational and AI-driven approaches are increasing their presence and usage at both large and emerging pharma companies for all facets of drug discovery and development. Our leadership in the innovative use of AI and machine learning to transform the process of developing precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI centric data first approach to drug development. 2024 was a transformational year for Lantern Pharma across many measures; portfolio, the platform and patient impact. I would like to highlight Lantern Pharma and our team's extraordinary progress across our clinical pipeline and our AI platform. These developments aren't merely incremental advancements; they actually represent transformative approaches that are reshaping how we develop precision oncology therapies for patients that usually have very limited treatment options and hopefully enable a much more efficient future for drug developers. Our team today is about 23 people focused and comprised of leaders and high value contributors and they have made significant strides over the past quarter and actually throughout all of 2024 across all of our clinical programs and with our AI platform, RADR and also in our ongoing efforts in developing an entirely new company, Starlight Therapeutics, which was largely possible due to our AI and data driven model, which is used to understand how and where a molecule can work best against a particular cancer and actually identify the cancers that are going to be most sensitive to a molecule. In fact, this is one of the core features of our AI. RADR, our precision…

David Margrave

Management

Thank you, Panna and good afternoon everyone. I'll now share some financial highlights from our fourth quarter and full year ended December 31, 2024. I'll start with a review of the fourth quarter. Our general and administrative expenses were approximately $1.6 million for the fourth quarter of 2024, up from approximately $1.3 million in the prior year period. R&D expenses were approximately $4.3 million for the fourth quarter of 2024, up from approximately $3.6 million in the fourth quarter of 2023. We recorded a net loss of approximately $5.9 million for the fourth quarter of 2024 or $0.54 per share compared to a net loss of approximately $4.2 million or $0.39 per share for the fourth quarter of 2023. For the full year 2024 our R&D expenses were approximately $16.1 million up from approximately $11.9 million for 2023. This increase was primarily attributable to increases in research studies of approximately $2.95 million relating to the conduct and support of our clinical trials, as well as increases in research and development payroll expenses of approximately $897,000 and increases in consulting expenses of approximately $376,000. Our general and administrative expenses for 2024 were approximately $6.1 million, up slightly from approximately $6 million for 2023. The increase was primarily attributable to increases in other professional fees. Our R&D expenses continue to exceed our G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Net loss for the full year 2024 was approximately $20.8 million, or $1.93 per share, compared to approximately $16 million or $1.47 per share for 2023. Our loss from operations in the 2024 calendar year was partially offset by interest income and other income net totaling approximately $1.4 million. Our cash position, which includes cash equivalents and marketable securities, was approximately $24 million as of December 31, 2024. Based on our currently anticipated expenditures and capital commitments, we believe that our existing cash, cash equivalents, and marketable securities as of December 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from today's date. We expect that we will need substantial additional funding in the near future, and one of our key objectives for the remainder of 2025 will be to – be to pursue additional funding opportunities. As of December 31 2024, we had 10,784,725 shares of common stock outstanding, outstanding warrants to purchase 70,000 shares and outstanding options to purchase 1,245,694 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 12.1 million shares as of December 31, 2024. Our team continues to be very productive under a hybrid operating model. We currently have 24 employees focused primarily on leading and advancing our research and drug development efforts. And I'll now turn the call back over to Panna for an update on some of our development programs. Panna?

Panna Sharma

Management

Thank you, David. So our leadership and the use, innovative use of AI and machine learning in many ways, AI for good to transform cost and timelines in the development of precision oncology therapies has allowed us to have a pretty exciting pipeline. It's allowed us to bring three molecules to market with teams cost and efficiency that continues to make massive year-over-year improvements. And we have LP-300 in Phase 2 again we plan on having another readout during the second quarter. We've accelerated enrollment because of our expansion into Japan and Taiwan. Specifically there the disease occurs in smokers at about a 2x to 3x higher rate. So this is particularly important because we'll also use that to leverage the Phase 2 data to look at partnerships, perhaps geographic partnerships as well, which have already begun having conversations with our Phase 1 trials for LP-184 and LP-284, both really potent synthetic lethal agents, one for solid tumors, has advanced to over 50 patients. We expect to enroll. We expect to enroll about 60 patients. So we're getting very close to what we believe will be the completion of the trial. LP-284, slightly different dosing schedule but similar cohort structure is a few months behind. And we think we'll be able to have that 30 patients enrolled later this year. So all three trials will have data. But very importantly, we also expect to have great ideas on how to pinpoint the use of these molecules in specific therapeutic areas. This is why we have over 11 orphan, rare pediatric and Fast Track designations. It's very important to note. So for a small company, we have 12 designations across 11 different programs ATRT having both orphan and rare pediatric. So that's really almost we have for every headcount we almost…

A - Panna Sharma

Management

So we've got the first question. I'll repeat the question before I answer it. Thank you, John, for your question. The question is from John is how is the pace and quality of enrollment in Asia compared to the U.S.? It is about 2x to 4x faster. They got ramped up faster. Some sites are slower than others, but in terms of output, just in this past few months we saw an equal amount of output from Asia as we saw in the U.S. but of course their timeline from onboarding to first patient was phenomenally faster and it's just accelerating. So I think it'll be 3x to 4x faster ultimately this year because of Asia. Great question. Next question is from John also, in the ADC realm and with help from radar, what are the opportunities for ADCs that substitute the toxic payload with another immunotherapy? So with an immuno. Well, it depends on what kind of immunotherapy, whether it's a modulating agent or binding. I think doing an antibody conjugate is potentially challenging. But if you do it with a small molecule that's an immunomodulating agent, like an IL agent or others, I think yes, it's possible you're going to start seeing many of those. You're going to see. One of the things that we're actually looking at, it's a great question John, is actually things that have multiple payloads. So more than one payload. So that's actually very exciting. It's a space that probably, it's not on our plate right now. But I do think that design of multi payload. Multi payload and bispecifics with multi payloads is definitely going to be in the future you may have payloads that are both immunomodulating and also toxic. So, I think you're going to see a lot of innovation. Now the challenge is of course always then testing those because right now one of the most expensive points in testing ADCs is testing them in the non-human primates. So how you test in non-human primates for some of these more complex architectures that are being imagined will be something that we got to sort out. But yes, theoretically that's definitely doable. It requires a level of precision biology and data collection that is just beginning to happen. So that's perfect area for AI. It's a wonderful question. I'm going to turn it over to Chad.

Unidentified Analyst

Management

Yes, hi Panna, thank you. Just wondering for the HARMONIC update in the later this year that we expect to get. If you could just set the stage for, where you guys think you're going to be, how much data you think you're going to have, what, what would you look, what we should look for in that update.

Panna Sharma

Management

So your question was on HARMONIC data, correct?

Unidentified Analyst

Management

Correct.

Panna Sharma

Management

Yes. So we've enrolled a nice chunk of patients in Asia and also in the U.S. in the last few months. So we are continuing to seeing the same kind of trend in terms of the clinical benefit. I think we hope to have a nice chunk of patients that will have multiple scans in terms of, resist criteria. So I think sometime in mid to late Q2, we'll have the next readout, but the key one will come at 30 events. So if we have 30 events, that will probably be closer to the end of the year and that'll be an important time because then we'll be able to decide do we take this into a larger, larger trial. And also will give confidence that we'll have data, enough data to partner out the asset. But we'll probably do something more near-term to kind of showcase that the trends that we saw in the early cohort are continuing in the existing cohort, which has included a lot of patients from Japan and Taiwan.

Unidentified Analyst

Management

Okay. And then if I may, just a follow up in a different direction on your ADC programs. What should we be looking for next? Obviously…

Panna Sharma

Management

Yes, there'll be two things. We’ve talked about that we made a conscious effort on this call not to focus on it, because we wanted to focus more on the clinical assets and some of the other AI features. But we've got some exciting preclinical data that we're validating. We put out some data last year in terms of HER2-low and HER2-medium, but definitely HER2-low expressing cancers where we saw tremendous potency several fold higher than existing FDA approved agents. With our crypto size and length ADC that we've designed. We also have another one that's in the elude and nasal folding family that we're working on some very exciting new payloads that are super, super potent, 100 times to 500 times more potent than LP-184. And we have some targets in mind. So we'll have more preclinical data as the year progresses. And we also will announce a couple of partnerships with groups that are using our ADC AI platform as an analytical tool. So those are the two things to expect.

Unidentified Analyst

Management

Thank you.

Panna Sharma

Management

Got a great question from Clay Heighten. So Clay asked a question about providing results in LP-184 in Q4 and then it was pushed. When will you provide results? That's a great question on the LP-184 data, Clay. So the 184 data originally was expected in Q4 because we expected to see MTD around dose level 9 or dose level 10. What's mostly changed is that the enrollment has gone to higher dose levels and so that's basically added to the time. So the calculations for PK and availability of the drug seem to end up more like rats than dogs. So our thought was, we'll probably end up somewhere in between, but we're definitely much more like rats in terms of the amount of drug that humans can take. That's actually a good thing because we're seeing higher therapeutic, sorry, higher likelihood of having therapeutic doses at these higher cohorts, these double digit cohorts. We're now in cohort 11, cohort 12. And so each cohort takes about a month and so that's exactly why we see that. So nothing other than the dose levels have gone higher and we haven't seen any significant serious adverse events and we're now just beginning to see therapeutic levels of efficacy. So that's added to the time. Hopefully that answers your question. Next question is on the dose in cohorts 11 and 12. I believe the dose is 0.61 right mg? I believe it's 0.61 mg, Clay. I will have to – I'll get back to them. Let me write that down. I'm going to have to look that up on my board, but I believe it's 0.61 mgs/kg. But let's find that out right now. While we look that up. I'm going to take another question from anonymous attendee. When will likely…

David Margrave

Management

So that was from just responding to Clay.

Panna Sharma

Management

Yes. So you want to go back?

David Margrave

Management

Yes. Clay, I think you'd ask a question about the dose levels for 184 and the current dose level 12 is 0.61 milligrams per kilogram, so that's where we are now.

Panna Sharma

Management

Hopefully that answers your question. You can raise your hand. Right. And we're at what percentage dose level we're increasing from dose level. Is it 25%? Yes, I think we're at a 25% level. So I think it was 100%, then 50% and 33% or 25%. I think we're at 25% increase. Okay, well, I would love to answer any other questions as they come in. Again, we think we're well positioned for the year. We've got multiple readouts. We believe we're getting very close to some of the final cohorts for both LP-184 and approaching LP-284 later this year. We'll have data at least once, maybe twice for 300, we think, once, as we get the next big chunk of data from the current subjects that have been enrolled. And we'll also have in that update, we'll also have updates from the initial lead in cohort. So we'll have some exciting data to report on those initial patients where we saw the 86% clinical benefit rate as well. So that'll be coming more near term and then the larger report on 300 probably later in the year as we get 30 events. So thank you, everyone, and I look forward to talking with many of you in upcoming meetings or one on ones. And thank you for your time today, and thank you to the lantern team as well. Bye-bye.

David Margrave

Management

Thanks very much.