Earnings Labs

Lantern Pharma Inc. (LTRN)

Q4 2023 Earnings Call· Mon, Mar 18, 2024

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Transcript

Operator

Operator

Good afternoon, and welcome to our Fourth Quarter and Year End 2023 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 issued a press release after market close today summarizing our financial results and progress across the company for the fourth quarter ended December 31, 2023. A copy of this release is available through our website @lanternpharma.com where you will also find a link to the slides management 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 18, 2024, 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 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

Hello, everyone, and thank you for joining us this afternoon to hear about our fourth quarter and fiscal year 2023 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. Lantern's leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric and data-first approach to drug development. 2023 was a transformational year for Lantern Pharma across many measures. We launched multiple clinical trials for our using our AI-guided drug candidates. We had multiple peer-reviewed publications and posters for our drug candidates and for our radar AI platform. Our AI platform advanced, reaching over 60 billion data points last year and now is on the road to reaching over 100 billion this year. With significant and efficient expansion of our clinical infrastructure and operations team, this allows us to efficiently move our trials forward and maintain control over the data and operations of our clinical assets. We are also advancing a very exciting new company, Starlight Therapeutics, which is entirely focused on CNS cancers and an area where there has been no single approved therapy as monotherapy in nearly 18 years. We filed 11 patent applications last year across our drug candidates and our AI platform and we continue to show very strong focused fiscal discipline. Our team has accomplished a lot and is about 24 people today, small but focused and comprised of leaders at every level, high value contributors. They've made significant strides over the past quarter and throughout 2023 across…

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, 2023. I'll start with a review of the fourth quarter. Our general and administrative expenses were approximately $1.3 million for the fourth quarter of 2023, down somewhat from approximately $1.6 million in the prior year period. R&D expenses were approximately $3.6 million for the fourth quarter of 2023, up from approximately $2.3 million in the fourth quarter of 2022. We recorded a net loss of approximately $4.2 million for the fourth quarter of 2023 or $0.39 per share compared to a net loss of approximately $3.4 million or $0.31 per share for the fourth quarter of 2022. For the full year 2023, our R&D expenses were approximately $11.9 million, up from approximately $8.6 million for 2022. This increase was primarily attributable to increases in research studies of approximately $2.98 million, increases in research and development payroll expenses of approximately $1.2 million and increases in consulting expenses of approximately $160,000. These increases were partially offset by decreases in product candidate manufacturing-related expenses of approximately $631,000 and decreases of approximately $459,000 in payments to Allarity Therapeutics. During the year ended December 31, '22, we released an escrow payment of approximately $459,000 to Allarity Therapeutics, and there was not a release of escrow payment amounts to Allarity during the year ended December 31, '23. Manufacturing-related expenses for the year ended December 31, '22 were also reduced by $935,000 as a result of a payment we received in July 2022 from one of our service providers in connection with the resolution of a difference of views regarding the service provider agreement. Our general and administrative expenses for 2023 were approximately $6.0 million, up slightly from $5.9 million for 2022. The increase…

Panna Sharma

Management

Thank you, David. As we mentioned earlier in the call, one of the areas that we're very excited about is Starlight Therapeutics. We hired Dr. Marc Chamberlain, during the fourth quarter, and he's made excellent progress on advancing our clinical trial design in both adult and pediatric CNS cancers, and we expect to launch the initial adult trial during the second half of this year. This is incumbent on getting the type of safety and early efficacy signal from our current ongoing LP-184 trial, which is in Phase I and it's, at this point, over halfway enrolled. We will share more on the progress of this clinical trial in the coming weeks. Now Starlight's focus on CNS cancers came from initial screens to look at cancers that exhibited exquisite preclinical and in silico-based evidence of sensitivity to LP-184. It was essentially born from billions of data points and we had not yet gone to in vitro and in vivo observations. We naturally moved quickly to in vitro and in vivo observations as it was clear that the data was suggesting that GBM and actually several other brain cancers should be very sensitive given the genomic profile, given the interactome design and given the levels of DNA damage repair or PTGR1 we saw in those brain cancers. Let me share some background about the Starlight, which is 100% owned by Lantern, putting, of course, our shareholders. And we believe we'll have the potential to be another very positive impact on our investors as we monetize this unique asset, the patents and, of course, the insights. Starlight Therapeutics is targeted on several cancers, both adult and pediatric. The 5-year survival rate in many of these cancers is super low despite advances in cancer therapies. We think globally, there are over 500,000 patients…

Operator

Operator

Panna Sharma

Management

First question from John. A great question. He asked ADCs have been an important area of acquisition over the last year. And I have heard broadly that in general M&A conversations have picked up for life sciences, have you observed continued interest in ADCs from larger biopharmas?

Panna Sharma

Management

I want to answer that question. Yes, John, we've seen interest from actually small -- midsize and larger biopharmas in ADCs, specifically in our cryptophycin ADC. Again, it's early, a lot of the M&A deals that we saw earlier this year and some in last year, we're in later stage ADC companies, many of them actually were already clinical. So it is exciting. There is, I think, not a lot of really unique assets in the ADCs. I mean I think most of the payloads, almost 70-plus percent of payloads are all the same. The designs tend to be very clumped together in terms of the category. So I think the novel target and plus perhaps a novel payload, with superior potency, especially in areas that are overlooked, could be of a lot of interest. So I think if you follow the data as opposed to a me-too approach, I think you're going to create something valuable. Great question. And as we get more data, we will explore licensing or partnering the asset out as early as possible.

Panna Sharma

Management

Sure. We've another question from John. We hinted about our RADR platform moving now from five billion, I guess, a couple of years ago to 60 billion?

Panna Sharma

Management

Yes. So the -- we're going to have a more detailed platform kind of view day, but the platform now has begun evolving to the point, where it can begin curating -- ingesting and curating data on its own. So we've gone through the process of what we call campaigns. So we've data ingestion campaigns, where we initially were doing this manually. And as we created kind of road maps or templates for how to ingest the data, and what the data structures are like, what the issues are like, we, of course, now train the AI to begin doing this for us. The AI now has learned a lot of the common data sets and common data conventions and common meta tagging. And so the AI is beginning to do the data ingestion. That's a big platform evolution. The AI is also beginning to parametrize all the algorithms and generate new algorithms. So our team can now take a step back as the platform basically starts growing in and on itself. And so we've also now started a process to do what we called engineered data that we're extracting from other data that people don't have access to. And so this kind of level-2 data actually is going to be making a lot of the insight creation, even more efficient and even more proprietary. And we'll talk about that when we talk about our platform. But yes, the platform has grown. It's kind of a different beast now than it was even a year and a half ago, and it will continue to evolve.

Panna Sharma

Management

We've another question, this is about our buyback and plans for that. So David, do you want to talk a little bit about what we did last year?

David Margrave

Management

Sure. Sure. Yes. This was not a -- it was not a buyback program. It was purchased from two holders, but we felt this was in the best interest of the company, accretive to shareholders and made sense. We purchased 145,348 shares at $3.44 a share for an aggregate of right around $500,000. And as we described earlier in the call, it's reduced our shares outstanding, which we believe is also beneficial to our holders.

Panna Sharma

Management

Great. Thanks, David. Another question. The -- how are you -- about the timing for selecting a narrower Phase II indication?

Panna Sharma

Management

I think, again, we allow data to guide the decision process. So as we get the data from the first set of patients, which is about 35 patients in the Phase Ia may go slightly over that. We'll see what the data suggests. We certainly have ideas based on our in silico findings, in our in vivo work, in our animal model work. And so hopefully, it will support or validate or nullify. But data is everything. So we'll see what the data suggests about the narrow indications. We think, clearly, we see that tumors with DNA damage repair deficiency seem to be very sensitive. So we think that will probably be one of the indications that it may be a Pan-tumor indication. We've also seen that tumors with high levels of PTGR1 above a certain threshold, roughly around 4.2 times, what's in a normal cell, also tend to be very sensitive. So if this continues to hold up throughout the trial, those are two very good kind of hallmarks of a characteristic for the indication. We may go after some targeted indications. If we see that things like pancreatic and triple-negative breast cancer are even more sensitive and we see that there's a clear need, and we think we can do a focused trial, they'll obviously bubble up to the top. So we'll see what the data suggests. And then we'll take a look at it commercially what is the most efficient way to bring the drug to market.

Panna Sharma

Management

Next question is, do we intend to create further value by creating other companies?

Panna Sharma

Management

Yes, that's a great question. We think Starlight is very unique because there's really no company that has focused 100% on a breakthrough new molecule for CNS indications. It's the reason we're able to get a lot of interest around it. We've had pharmas reach out about it. We've had biotechs reach out about it. The drug has some very good history in terms of its ability to be a proven mechanistic manner in which you can kill GBM cells, which is an alkylating agent. In fact, the only drug that seems to really work to kill off, our alkylators like nitro series and TMZ. I mean, everything else has had a middling to no effect. So we're in a good drug class. We're in a class that has a history of working. We're in a drug that seems to prefer cancer cells over any other type of cell. It seems to be much more bioavailable. And it seems to be -- have better blood-brain barrier penetrability than TMZ. It seems to be agnostic to MGMT, and it seems to work in several other brain cancers. So I think it was a very unique opportunity. We had the AI insights with a unique molecule. We're able to find not just one indication, but a family of kind of indications. And so it was really paramount that we launched this effort on its own and get it done further and deeper. If we see opportunities like that, we'll pursue them. We've to pursue them. I mean, I think ADCs could be like that. What we're seeing in terms of the early efforts, both on our antibody drug conjugate, but also another very exciting space we're looking at are fragments -- fragment bodies. And we can actually get even more precision against the antigen or the target of interest with what we call FDCs, fragment drug conjugates. And we've begun some very early exploratory work in that area with the cryptophycin and other picomolar agents. So again, we're trying to use the ADC module that we created to find targets and then to find something unique in those targets and then further classify both late-stage existing antibodies, but also some early stage where perhaps we can make the process compressed and cheaper and that fragment -- FDCs can hold that future. And then we're also trying to find the right agents that give us the right kind of DAR and improvement in kill rates. Like we said, the cryptophycin versus the MMAEs and others that just have a -- it's just -- it's a log better kill rate on the cancer cells. So it's -- if we think we can hold it up in a small portfolio of indications, again, it could be -- again, a very great spin-out idea or a partnering idea very early on.

Panna Sharma

Management

Another question is around business development opportunities.

Panna Sharma

Management

Yes. So we're exploring business development opportunities in three categories. Again, I don't like to really talk about deals until deals are really done. I don't think there's any point in getting people excited about pharma industry, everyone talks to everyone. So yes, we're in discussions with a lot of different companies. It doesn't mean that there may or may not be a deal. But let me walk through our deal ideas that we've that we're working on. Number one, we do expect to announce deals with other biotech companies where they use our platform, and we get certain rights to their drugs or development efforts. So we're using our platform as a currency to help those companies compress the time line or decrease the risk or increase the ideas around for their portfolio, and we get something in exchange for that. And that can be done with our platform. The second type of deal that we're beginning to explore and it's in fits and starts, but is with big tech companies. Big tech companies want to have unique platforms that they can offer in the cloud as a service to all their biopharma and academic and research groups. So now RADR can be taken into one of the big tech companies as a platform, and you can basically have RADR as a service. You can have any of these eight modules as a service, drug combination, blood-brain barrier penetrability, drug mechanism of action, hunting, ADC design. So any of these modules, and that's where we're trying to really create these unique modules. So again, that's very early. And the third one is traditional partnership, licensing, selling of an asset or program to big pharma. And I think the best way to excite big pharmas is data. So we'll power…

David Margrave

Management

Thanks a lot.

Panna Sharma

Management

Thank you, David.