Panna Sharma: Good morning. Howdy, everybody. Thanks for becoming a member of us to listen to about our first quarter 2025 outcomes and company progress. As a lot of you may have heard me say up to now, computational and AI-driven approaches are rising their presence and utilization at each giant and rising pharma firms for all aspects of drug discovery and improvement. Lantern’s management within the modern, environment friendly, and pragmatic use of AI and machine studying to rework the method of creating precision oncology therapies ought to yield vital returns for buyers and sufferers as our trade matures and adopts an AI centric, knowledge first method to drug improvement. The primary quarter of 2025 represents a pivotal inflection level for Lantern Pharma.
We have made vital developments throughout our medical stage portfolio, whereas concurrently increasing the capabilities of our proprietary radar AI platform to over 200 billion oncology centered knowledge factors. These achievements place us nicely for a number of worth creating catalysts within the coming quarters. Let me set up right this moment’s remarks round three strategic pillars. First, our medical pipeline progress. Second, our AI platform developments. And third, our initiatives to maximise shareholder worth. Beginning with our medical pipeline, we proceed to advance a number of applications which have the potential to handle vital unmet affected person wants for most cancers sufferers globally. Our Section 1a trial for LP-184 has progressed nicely with enrollment now by way of cohort 12.
We count on to finish enrollment with 62 to 65 sufferers throughout a variety of strong tumors by the June 2025. Importantly, we’re starting to see early indications of medical exercise at increased dose ranges, which aligns with our preliminary pharmacokinetic knowledge. This quarter, our Security Assessment Committee made the choice to backfill doses degree 10 and 11 to make sure readability on figuring out the utmost tolerated dose whereas sustaining affected person security. What distinguishes our artificial deadly method is its mechanistic precision. In contrast to typical chemotherapies and focused brokers that indiscriminately goal dividing cells, LP-184 and LP-284 exploit particular genomic vulnerabilities in most cancers cells, notably these deficiencies in DNA injury restore pathways.
The pharmacokinetic knowledge from these trials counsel we’re approaching focus ranges that correlate with the nanomolar efficiency noticed in preclinical fashions. This can be a important inflection level that would reveal definitive proof of mechanism in sufferers and pave the way in which for future trials and partnerships. With LP-184 now holding twin quick monitor designations for each glioblastoma and triple-negative breast most cancers, plus 4 uncommon pediatric illness designations. We have positioned this molecule for accelerated improvement throughout a number of excessive worth significant indications. The FDA has additionally not too long ago cleared two medical trial protocols that may present paths towards regulatory approvals, particularly, in triple0negative breast most cancers the place we even have a quick monitor designation.
The primary of those two protocols that has been cleared not too long ago is a Section 1b/2 research in TNBC evaluating LP-184, each as monotherapy and together with the PARP inhibitor, Olaparib. With an estimated annual market potential exceeding 4 billion in metastatic TNBC, this represents a significant vital alternative. The second, a Section 1b/2 research in a biomarker outlined subset of drug resistant, non-small cell lung most cancers with STK11 and/or KEAP1 mutations, a affected person inhabitants with notably poor prognosis, and a market alternative exceeding 2, billion yearly.
Moreover, an investigator led exploratory medical trial for LP-184 and recurrent bladder most cancers is deliberate to start in Denmark throughout Q3 2025, which might create a pathway towards business medical utilization within the third-line setting. Primarily based on work we now have finished with Dana-Farber and The Danish Most cancers Analysis Group and in different revealed analysis, about 25% to 30% of bladder cancers have DNA injury restore mutations at presentation and over 40% at recurrence. Now turning to our HARMONIC Section 2 trial for LP-300, we proceed to make robust progress with enrollment in Japan and Taiwan, the place by no means people who smoke symbolize about 33% to 40% of latest non-small cell lung most cancers instances in comparison with about 15% to 17% within the U.S.
Following our compelling preclinical — following our compelling preliminary knowledge displaying an 86% medical profit charge and 43% goal response charge within the security lead in cohort, further affected person knowledge from the enlargement cohort continues to assist the same optimistic pattern. We sit up for sharing up to date outcomes, together with knowledge from sufferers in our Asian enlargement cohort throughout Q3 and knowledge from the continued advantages from our preliminary lead in cohort. By our wholly-owned subsidiary, Starlight Therapeutics, we’re advancing STAR-001 for indications in CNS and mind cancers. Just lately, our collaborators at Johns Hopkins have offered impartial affirmation of hypersensitivity in uncommon pediatric mind tumors to LP-184 supporting our deliberate medical trial with the pediatric consortium centered on CNS tumors.
A Section 1b/2 trial in recurrent GBM is anticipated to start in late 2025, topic to profitable further protocol clearance and funding. Additionally, keep in mind that LP-184 has a number of pediatric illness designations that, upon approval in that indication, can yield a precedence evaluation voucher, which might then be marketed and offered for $100 million to $150 million every. And Lantern and Starlight have the potential and pathway for 4 of these alternatives. Starlight, which is a 100% owned by Lantern, can have the potential to be one other very optimistic impression on our buyers as we monetize this distinctive asset, the patents, and the medical indications and perception.
The dosage and security knowledge obtained within the Section 1 trial for LP-184 will likely be used to advance the central nervous system indications as STAR-001 for future Section 1b and Section 2 trial sponsored by Lantern’s wholly-owned subsidiary, Starlight Therapeutics. Globally, the annual market potential for LP-184’s goal indications is estimated to be about 14 billion consisting of 4 billion to five billion for CNS cancers, each major and secondary, and about 10 billion for different strong tumors. Turning now to our second pillar, which is our AI platform. Let’s discuss in regards to the enlargement and commercialization now of our radar AI platform. This quarter, our proprietary radar platform grew to roughly 200 billion oncology centered knowledge factors.
The platform continues to ship worth throughout a number of dimensions from drug candidate optimization and creating mixture methods, to biomarker signature improvement and mechanism of motion clarification. We have made an vital and thrilling resolution to open up the radar AI platform on a module by module foundation to the broader scientific and analysis group. We count on to initially do that as a freemium kind method, which will likely be anticipated to drive collaborations and economics to Lantern.
The massive scale and extremely cheap evolution of RAG (ph) and agentic applied sciences has fully modified the power for small rising firms like Lantern to make use of cloud infrastructure to open up algorithms and distinctive processes to a broader group at a scale, value, and degree of complexity unimaginable up to now. A milestone this previous first quarter was a strengthening of our AI mental property portfolio with the PCT publication of our proprietary blood mind barrier penetration prediction patent utility. This expertise acquired a good PCT search report indicating no vital prior artwork, and our algorithms at present maintain 5 of the highest 10 positions on the Therapeutic Commons leaderboard, a exceptional achievement demonstrating our management in AI drug improvement.
This will likely be one of many first modules that we make publicly out there within the coming quarters. Our BBB permeability prediction instrument can course of as much as 100 thousand molecules per day with trade main accuracy, and the algorithm continues to evolve and enhance. This technological benefit has profound implications for accelerating CNS drug discovery and the power to foretell in a site that is been notoriously difficult. However 98% of small molecules traditionally have didn’t successfully penetrate the blood mind barrier, and our algorithm’s unprecedented accuracy allows us to determine promising CNS penetrant compounds and in addition optimize current compounds with extraordinary effectivity, probably decreasing conventional discovery timelines by months whereas dramatically rising success possibilities.
This computational functionality does not merely improve our current applications. It opens up fully new therapeutic improvement prospects throughout not solely most cancers however different neurological indications for a lot of different drug improvement groups. We’re notably enthusiastic about our plans to make this and different radar AI modules commercially out there to the scientific and analysis group this yr. This represents a brand new potential income stream and alternative to foster collaborative open supply innovation in most cancers drug improvement. We have additionally expanded radar with an modern AI powered module to enhance the precision, fixed timeline of antibody drug conjugate improvement.
This multiomic method leverages proprietary algorithms to design and optimize goal choice, payload effectivity, and tumor selectivity, addressing a quickly rising phase of the oncology market that has been notoriously troublesome and really time consuming. Our AI powered antibody drug conjugate improvement module represents a basic reinvention of a historically useful resource intensive excessive danger improvement course of. By figuring out promising targets and goal indication mixtures, we have established a strong pipeline of alternatives in one in every of oncology’s most quickly rising therapeutic modalities. The technical implications for this are substantial. Iterative testing of antibodies, linkers, and payloads, which might take years and eat tens of hundreds of thousands of {dollars} might be narrowed down, streamlined, and derisked.
Our computational method, we consider can cut back these timelines by 30% to 50% and preclinical value by as much as two-thirds whereas concurrently enhancing goal choice and understanding of actual world goal availability in an concerned most cancers setting. This effectivity benefit positions us to quickly advance our personal candidates with distinctive selectivity profiles, but in addition to allow different firms to make the most of this. This module can even be one of many many modules we place into an agentic interface and framework to be used by our collaborators and companions. We’ll discuss this extra later this quarter and doubtless host a particular name speaking in regards to the evolution of our AI platform to a extra public dealing with business alternative.
AI and platform pushed insights proceed to information our medical improvement technique. For LP-184, we have additionally developed a qPCR assay for PTGR1, which as we all know is the bioactivation agent for LP-184. And by measuring PTGR1 ranges, we can assist information affected person stratification and in addition on the similar time determine indications which may be very promising. For LP-284, we have additionally used our platform to determine promising mixture methods. For instance, the rituximab, which have proven compelling preclinical synergy. Transferring on to our third strategic pillar. To maximise shareholder worth by way of — we have finished this now by way of disciplined capital administration and numerous strategic initiatives.
We have maintained our disciplined method to capital deployment, ending the quarter with roughly $19.7 million in money, money equivalents and marketable securities, offering an anticipated working runway by way of a minimum of center of Could subsequent yr. Our quarterly web loss decreased to roughly $4.5 million in comparison with $5.4 million in the identical interval final yr, reflecting our continued give attention to operational effectivity. Need to remember that the corporate’s final capital elevate was in January of 2021. So we have maintained large fiscal self-discipline in getting our molecules into medical trials, into significant inflection factors, and executing on our twin technique of advancing medical applications whereas increasing vastly our AI platform capabilities.
And now we’ll enter into — we consider productive discussions with potential biopharma companions, whether or not by way of licensing agreements, expertise partnerships, or co-development. Now I am going to flip the decision over to our CFO, David Margrave, who will present extra particulars on the monetary outcomes for the quarter.
David Margrave: Thanks, Panna, and good morning, everybody. I am going to now share some monetary highlights from our first quarter 2025 ended March 31, 2025. Our basic and administrative bills had been roughly $1.51 million for the primary quarter of 2025 in comparison with roughly $1.48 million within the prior yr interval. R&D bills had been roughly $3.3 million for the primary quarter of 2025, down from roughly $4.3 million within the first quarter of 2024. The lower was primarily attributable to reductions in CRO and medical web site prices for LP-184, which additionally mirrored our goal to perform extra with our inner medical operations workforce.
We recorded a web lack of roughly $4.5 million for the primary quarter of 2025 or $0.42 per share in comparison with a web lack of roughly $5.4 million or $0.51 per share for the primary quarter of 2024. Our money place, which incorporates money equivalents and marketable securities was roughly $19.7 million as of March 31, 2025. Primarily based on our at present anticipated expenditures and capital commitments, we consider that our current money, money equivalents, and marketable securities as of March 31, 2025 will allow us to fund our working bills and capital expenditure necessities for a minimum of 12 months from right this moment’s date, Could 15, so till a minimum of mid-Could 2026.
We are going to want further funding within the close to future, and one in every of our key goals is to pursue further funding alternatives. As of March 31, 2025, we had 10,784,725 shares of frequent inventory excellent, excellent warrants to buy 70,000 shares, and excellent choices to buy 1,242,378 shares. These warrants and choices mixed with our excellent shares of frequent inventory give us a complete absolutely diluted shares excellent of roughly 12.1 million shares as of March 31, 2025. Our workforce continues to be very productive below our hybrid working mannequin. We at present have 23 workers centered totally on main and advancing our analysis and drug improvement efforts.
I am going to now flip the decision again over to Panna for added updates and shutting remarks. Panna?
Panna Sharma: Thanks. Thanks, David. Our management within the modern use of AI and machine studying to rework prices and timelines within the improvement of precision oncology therapies has allowed us to carry three vital molecules to market with groups, prices, and effectivity that’s solely starting to make huge year-over-year enhancements. In the course of the first a part of 2025, we achieved our purpose of reaching almost 200 billion knowledge factors, rising that most cancers centered knowledge extra in six months than we had within the prior three years.
And extra of this knowledge progress and knowledge ingestion campaigns will likely be automated, liberating up our workforce to give attention to clever curation, evaluation of the info, and creating upstream engineered options, and frameworks to resolve particular issues that may then be remodeled into autonomous brokers. Now we’re coming into a transformative part the place radar will likely be — will leverage agentic AI capabilities, autonomous programs, able to making complicated selections, automating intricate organic datasets, and executing refined workflows with out fixed tremendous human — tremendous human supervision. This subsequent era platform represents a basic shift in drug improvement methodology, shifting from reactive, human restricted analytics to proactive, repeatedly studying programs, able to figuring out non-obvious patterns and alternatives throughout a number of therapeutic dimensions concurrently.
We’re strategically positioning our agentic radar platform not solely to drive inner pipeline progress, but in addition as a invaluable collaborative asset for biopharma companions, searching for to beat drug improvement bottlenecks. The golden age of AI in drugs, as a lot of you may have heard me say up to now, is not simply starting. It is accelerating exponentially. By integrating agentic capabilities, radar will remodel from an analytical platform to a real improvement accomplice, one able to working repeatedly throughout a number of dimensions, connecting insights throughout beforehand siloed areas, and in the end delivering — serving to to ship life altering therapies to sufferers quicker than ever thought potential. The velocity can even drive lowered prices. We aren’t simply constructing higher instruments.
We’re essentially reimagining what’s potential in precision oncology. As we proceed this journey, our agentic radar platform positions us on the forefront of a completely new paradigm in drug improvement, one the place AI does not actually help human researchers however actively drives discovery ahead by way of autonomous steady studying and insights that may be examined in laboratories after which deployed safely into the clinic for sufferers. As we advance by way of 2025, we at Lantern are laser centered on the next key worth creating milestones. First, finishing our LP-184 Section 1a trial enrollment in June with complete knowledge charge readouts after that, together with biomarker correlations, probably establishing proof of mechanism for our artificial deadly method, and organising pivotal future trials.
This is a chance that we consider represents over $10 billion in annual spend that LP-184 is nicely poised to take an important share of. Second, delivering expanded Harmonic Trial outcomes that embody our Asian enlargement cohort, additional validating our by no means smoker non-small cell lung most cancers thesis for LP-300. We count on this to happen additionally in Q3 in July. Third, initiating our FDA cleared Section 1b/2 trials for LP-184 in each TNBC and a biomarker outlined subset of non-small cell lung most cancers, which is drug resistant, and we consider we are able to leverage our quick monitor standing to speed up improvement and probably accomplice in these trials and people indications with giant pharma firms.
Fourth, commercialize our preliminary modules from radar to the scientific group, starting with our trade main BBB permeability prediction instrument after which shifting on to different modules on a choose foundation. Fifth, strategically advancing partnership discussions that would speed up our pipeline, whether or not they’d be by way of geographic rights for sure belongings or co-development rights in sure indications or spinning out belongings resembling our CNS and Starlight focus functionality or monetizing our AI platform capabilities. This quarter’s progress, whereas sustaining fiscal self-discipline and a give attention to bringing our belongings nearer to sufferers and approval reinforces what makes Lantern distinctive within the oncology panorama. We’re not simply creating medicine.
We’re pioneering a basic transformation in how most cancers therapies are found, developed, and delivered to sufferers utilizing AI for an method that’s each environment friendly and centered. Our twin engine method, medical belongings plus an AI platform, gives shareholders with a number of worth creation paths. Every medical advance demonstrates our AI platform’s energy, whereas each platform enhancement accelerates our pipeline and creates new partnership alternatives. As agentic AI capabilities emerge in our radar platform, we’re not merely collaborating on this AI revolution in drug discovery. We’re serving to to construct it. I wish to specific my honest gratitude to our distinctive workforce, companions, and shareholders.
Collectively, we’re lighting a path in a method towards precision oncology options that we consider can essentially enhance outcomes for sufferers whereas reworking the economics and timeline of most cancers drug improvement. With that, I might prefer to now open the decision to any questions or clarifications.
A – Panna Sharma: If you would like to ask a query, you are able to do so in one in every of two methods. You may kind your query utilizing the QA instrument, or you’ll be able to click on on the elevate hand instrument to talk instantly, and we’ll unmute your line. Okay. I feel Chad has his hand raised. Okay. I feel we have got two arms raised.
Unidentified Participant: Are you able to hear me now?
Panna Sharma: Yeah. No. Sorry for the delay there.
Unidentified Participant: All proper. Good. I am going to begin up. I had a few questions. The primary on making AI modules, commercially out there. It sounds just like the blood mind barrier penetration module may be one of many lead candidates there. It is a very fascinating, sounding module. What are the type of broader plans to roll this out? Are we going to cost a price for entry to those? Are we going to make some free and hope that, individuals form of get hooked and actually like these modules and it results in broader collaborations?
After which I assume additionally in addition to simply cash when different individuals begin utilizing these modules, after all, they may have knowledge they wish to put in there, and that, after all, may gain advantage the platform total. So simply, do you plan to mixture further knowledge and strengthen the platform that method? What are the plans there?
Panna Sharma: Sure. Nice questions. I do suppose we’ll begin with a freemium kind method to get individuals used to getting questions answered this — utilizing this methodology. The problem that we have seen with a whole lot of the present AI instruments on the market answering a few of these questions is simply, they’re sluggish. They are not scalable. You may’t depend on the standard of the info. So I feel that we’ll take an method initially the place the instrument is form of a freemium mannequin with a drive in direction of collaboration in order that we are able to proceed to watch intently the kind of knowledge and use that the analysis group has.
We’ve a street map that we’ll be discussing, most likely towards the tip of this quarter or early subsequent quarter on what that street map is and in addition a few of the enterprise fashions underlying, bringing radar into form of an agentic life type module by module. After all, we’ll decide the better modules that we expect might be readily scaled after which go into the extra complicated, workflow enabling modules over time. However keep in mind, we’re primarily centered on advancing our pipeline presently, and our purpose is to introduce these modules to drive a bigger tech partnership.
Unidentified Participant: Yeah. That makes a whole lot of sense. That is simply type of folds into your small business mannequin and method nicely. After which simply on the HARMONIC trial, very excited to be getting one other knowledge replace there. You referred to the Asian sufferers as a cohort a minimum of as soon as. I simply I wish to be certain that I perceive the design right here. Is that cohort, like, are we nonetheless enrolling extra sufferers within the U.S.? I assume, is one query.
Panna Sharma: So, yeah, perhaps not technically a cohort. So what we did is once we began the LP-300 trial, we clearly knew the numbers in East Asia. However as you already know, for a small U.S. biopharma firm, it is costly and expensive and introduces administration danger to do trials, in Japan and which can be very costly. So our purpose was to verify we acquired a top quality sign in a inhabitants that we might have prepared entry to. So the lead in cohort was the seven sufferers within the U.S., and 6 out of seven of them responded, which to us was implausible. And the preliminary goal response charge was very optimistic.
And we had one affected person over a yr on the drug with, 57% tumor quantity discount. So by virtually all measures, it was optimistic and in addition, the underlying inhabitants was additionally fairly combined. We had Hispanic. We had white. We had some Asian. It was extra male than feminine. So — and we additionally had a number of TKIs, proper, not simply EGFR. So we checked out that. We mentioned we had a great heterogeneous inhabitants. We had a 86% medical profit charge, 43% goal response charge, a pleasant set of tumors that had about 50% discount.
It gave us confidence that now we are able to go forward and spend money and time and power on increasing to the place there was a better — an even bigger quantity of sufferers. Now that — after that seven, it goes into what known as the enlargement cohort. The enlargement cohort will likely be each U.S. and Asian, however the enlargement cohort is randomized. So it is two to 1 randomization. So it is not the Asian cohort. It is simply the Asian sufferers as a part of the enlargement cohort, if that is sensible.
Unidentified Participant: Sure. Okay. Recognize that. Recognize that clarification. Thanks.
Panna Sharma: And for us, it is vital as a result of I do not suppose it will have made a whole lot of sense to spend all that cash getting arrange and working and getting all of the issues finished in Asia except we had been sure that, hey, that is going to go in the proper route.
Unidentified Participant: All proper. Thanks.
Panna Sharma: Thanks, Chad. I feel John has a query. John, do you wish to? John? I feel, John, for some motive, we can’t hear you. Okay. We’ve yet another query coming in on LP-184. Yeah. So LP-184, we count on the trial to be absolutely enrolled subsequent month. That is now a 60 to 65 affected person trial. I consider we’ll be — we’re virtually concluded with now — we’re over mid-50s, high-50s, and we consider that enrollment will likely be accomplished subsequent month. And, we’ll have preliminary knowledge after we begin getting the medical knowledge, the biomarker correlations, and so forth., shortly after that. Subsequent query is on FDA and utilizing AI. I — that is an important query.
I wish to consider that the FDA, will certainly have to make use of AI in its analysis of scientific literature, knowledge, and maybe higher come by way of mechanistic inputs from firms on the analysis of the protection and route of their new molecules. So I feel, sure, I feel they may do it. I feel they will do it in fairly fast scale over the following 12 months. I feel it will assist to carry down a few of the prices of the FDA and hopefully velocity issues up. However because the — as John identified, it does introduce some dangers.
I am unable to say, I am an knowledgeable on all these dangers, however I feel it will in the end, I feel the trade-off goes to be enhancements in value and enhancements in velocity. When it comes to the chance, I do suppose that, there’ll most likely be a interval by which they consider these strategies in parallel to the present strategies, and I do not suppose they are going to roll out something throughout the board till they’re have concluded, like, six months to 1 yr of those efforts. So I feel I’d give this a minimum of two years. By that point, the dangers will likely be well-known and identified, clearly, by the trade and doubtless simply addressed.
Subsequent query is about new funds in AI. That is precisely one of many the reason why we even have determined to go on to market on opening up these modules. I’ve seen a whole lot of the AI work that is being supplied by many AI first firms in drug improvement, and so they lack a few of the precision or focus or they’ve a whole lot of noise. However AI funds are very aggressively taking a look at AI, which I feel will assist our long run profile and in addition appeal to new buyers into the corporate or into our efforts. Thanks for that query.
Panna Sharma: Effectively, no additional questions presently. We’re at all times open to having discussions with buyers and shareholders. I might prefer to thank members of our workforce for serving to us put together for this name, and I sit up for speaking with all of you within the close to future. Thanks.
David Margrave: Thanks quite a bit.
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Lantern Pharma (LTRN) Q1 2025 Earnings Transcript was initially revealed by The Motley Idiot
