Q4 2022 Lantern Pharma Inc Earnings Call
Speaker 1: 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 Pana, and then we'll open up the call for Q&A.
Speaker 1: I'd now like to turn the call over to Pana Sharma, President and CEO of Lantern Pharma. Pana, please go ahead.
Speaker 2: 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 at Lantern Pharma.
Speaker 2: Lantern Pharma is at the leading edge of leveraging artificial intelligence, machine learning algorithms, biomarker, clinical, genomic, and drug response data to transform the cost, compress the timelines, and de-risk oncology drug discovery and development.
Speaker 2: 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 clinical, with our first in human drug candidates LP 184 and LP 284. We've done this at a fraction of the time of traditional drug development approaches.
Speaker 2: those potentially life-changing medicines with reduced cost and reduced time.
Speaker 2: 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.
Speaker 2: 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.
Speaker 2: Our platform is focused on being able to accomplish both.
Speaker 2: At the same time, our team has been advancing the clinical foundation and infrastructure for our phase two harmonic clinical trial for never smokers with non-small cell lung cancer. And this has been a very important endeavor. We strengthened our clinical operations team with some select and highly experienced colleagues that have joined us. Thank you for joining us today.
Speaker 2: to help scale up the program. We now have over activated over five clinical trial sites across 12 different locations and centers in the US including Ohio, Illinois, New York, Texas, and California. Across the five clinical trial sites there's already one consented patient.
Speaker 2: that is anticipated to be dosed later this month.
Speaker 2: and also 14 additional patients, potential patients, that are being pre-screened and are being monitored for possible enrollment.
Speaker 2: Multiple additional trial sites across the US are expected to be activated in the first half of 2023 and will bolster patient recruitment and enrollment. In the US there are approximately 20 to 30 thousand never smokers with non small cell lung cancer diagnosed annually.
Speaker 2: representing an estimated annual market potential just in the US of $1.5 to $2 billion.
Speaker 2: This opportunity has been developed by understanding why certain molecular profiles in non-small cell lung cancer, those largely associated with never smokers, and those with very low tumor mutation burden, and targeted mutations larger than the tyrosine kinase pathways are responsive to our drug LP300 when used in combination with the current chemotherapy standard of care.
Speaker 2: This effort, without the use of large-scale data and modeling, would have really continued to stay on the shelf.
Speaker 2: We're also using this transformative data-driven approach through our proprietary radar AI platform.
Speaker 2: Our platform uncovers significant opportunities in cancer, opportunities that are either underserved, unmet, or often overlooked. We do this with tremendous accuracy. Our prediction success is 80-90 percent. That's because not only the data points, but also because we're relying on over 200 advanced machine learning algorithms.
Speaker 2: We've used this to both advance and rescue compounds, bringing them into phase two clinical trials and also to develop entirely new drug candidates for first and human trials, many that will be launching in the coming months. And again, we're doing this at a fraction of the cost and timeline and David will discuss some of our financials later today.
Speaker 2: Also, Kishore will talk about the progress on our exciting new molecules and how they are entering the clinic in the next few months and quarters.
Speaker 2: Our unique AI platform, as I mentioned, is served by over 25 billion data points and nearly 200 algorithms that can help us understand, predict, and model questions that are fundamental to oncology drug development.
Speaker 2: Our goals for our platform this year, we expect that it will reach over 50 billion data points, and we expect it to enhance functionality in three major areas. One, better predict and model combination regimens of small molecules with certain antibody classes, anti-cancer antibodies at least.
Speaker 2: The ability to understand and develop ADCs, antibody drug conjugates, at a fraction of the current cost.
Speaker 2: and third, develop highly specific
Speaker 2: targeted predictions of key safety features of a compound and predict blood brain barrier permeability of those compounds.
Speaker 2: And we're already pretty far along the process of generating algorithms that we believe are not only best in class, but probably will be some of the best BBB algorithms out there.
Speaker 2: In talking about our new clinical trials, the first in human trials will be with drug candidates LP-184 and LP-284. We believe that both molecules can be synthetically lethal in certain cancers, LP-184 largely in solid tumors, while LP-284 is directed at a range of blood cancers.
Speaker 2: The compression of costs and timeline that we are creating with our drug development process have allowed us to grow our portfolio from three programs about 30 months ago to 12 programs today. We expect that many of these programs to create high value opportunities for our investors and potentially life transforming therapies for cancer patients.
Speaker 2: Several of these programs we have brought together in a very exciting new wholly owned subsidiary called Starlight Therapeutics.
Speaker 2: The programs being developed by Starlight were born from the analysis of billions of oncology-focused data points and by using Lantern's AI platform, Radar.
Speaker 2: Start 001, powerful anti-tumor mechanism, synthetic lethality.
Speaker 2: coupled with the collaborations that we've done with internationally recognized institutions including Hopkins and the Greer Children's Cancer Center at UT Health San Antonio, make it well-positioned to rapidly advance these CNS-focused therapies in a targeted and efficient clinical development pathway. Starlight intends to pursue human clinical trials.
Speaker 2: for multiple CNS indications. Again, we've gone from one to now seven indications quite rapidly starting in late 2023. It'll build upon the prior IND enabling studies and the upcoming phase 1A clinical testing that will be conducted by Lantern. The clinical development of STAR-001 in CNS cancers will continue early March.
Speaker 2: beyond the Phase 1A trial will be conducted exclusively by Starlight.
Speaker 2: Following the launch of Starlight, Lantern will continue to advance LP184 in clinical development for non-CNS indications, indications such as pancreatic, where we've partnered with Fox Chase Cancer Center, bladder cancer, triple negative breast cancer, and other solid tumors that have DDR deficiencies.
Speaker 2: We'll also continue to provide AI, bioinformatic, and computational biology support to Starlight.
Speaker 2: The formation of Starlight as a wholly owned subsidiary allows Lantern to sharpen the focus on advancing STAR-001 through targeted clinical trials and dedicate increased time, resources, and personnel to progress what we think is one of the most promising drug candidates for CNS cancer patients in decades.
Speaker 2: We believe that by focusing our efforts by Starlight Therapeutics, we can accelerate and deepen our commitment.
Speaker 2: to the CNS cancer patient community, while also creating the potential for meaningful additional upside for our investors.
Speaker 2: We'll always be looking for additional opportunities where the development needs and unique focus of certain programs or assets can be separated and developed in a focused manner.
Speaker 2: Our collaborative portfolio also continues to grow. In addition to our work with Actuate, we started a collaboration earlier this year with TTC Oncology. They're an emerging biotech focused on breast cancer. They have a best in class management team and they have a really exciting drug called TTC 352.
Speaker 2: that's focused on certain unmet needs in ER-positive breast cancer patients. And as we develop our collaboration, we may have the ability to get an exclusive right to license the drug and any collaborative intellectual property to then develop it. This is a real case of where the platform is the currency.
Speaker 2: And you'll hear more about this program, this collaboration, in the coming quarters as it develops.
Speaker 2: Lancerin Pharma has entered now in a major period of transformation itself as we evolve and mature many of our initial AI driven insights and advance them to drug candidates into human clinical trials. We're continuing to make significant meaningful progress in turning the observations and insights generated by our platform.
Speaker 2: validated in the labs, into advancements for cancer patients, and potentially break through high-value clinical programs.
Speaker 2: Our programs both at Lantern and Starlight.
Speaker 2: spanned multiple highly attractive indications, and have been developed at a level of cash burn and resourcing that is almost unheard of in this space, but it has been driven by our growing AI platform.
Speaker 2: We expect many of these programs will be partnered with larger biopharma companies as they develop.
Speaker 2: In continuing our focus in providing insight, transparency, and also educating the market through webinars, we'll be hosting a KOL webinar on synthetic lethality, key mechanism of Lantern's drug candidates LP-100, 184, and 284. That webinar will be tomorrow, Tuesday.
Speaker 2: The webinar will feature an internationally recognized expert in synthetic lethality, results on Selasi's MD, serves joint appointments, both as a principal investigator at the Danish Cancer Research Center, which is one of our collaborative sites, and as an assistant professor of pediatrics at Boston Children's Hospital, a Harvard Medical School affiliate.
Speaker 2: Additional details of the KOL webinar can be found on our website and a link has also been provided in our earnings release and slides. We expect a follow up on this webinar with another additional webinar on synthetic lethality specifically in terms of what the programs are for 184 and the implications for both mono and combination therapy.
Speaker 2: This will be led by our own Dr. Kishore Bhatia, our Chief Scientific Officer, in late April .
Speaker 2: With that overview, I'll now turn the call over to our CFO , David Margrave, to provide an overview of our fourth quarter and year-end results.
Speaker 2: and also walk you through some basic housekeeping items. David.
Speaker 3: Thank you, Pana, and good afternoon, everyone.
Speaker 3: I will now share some financial highlights from our fourth quarter and the full year ended December 31, 2022.
Speaker 3: I'll start with a review of the fourth quarter.
Speaker 3: Our R&D expenses were $2.3 million for the fourth quarter of 2022.
Speaker 3: up slightly from $2.2 million in the fourth quarter of 2021.
Speaker 3: 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.
Speaker 3: We recorded a net loss.
Speaker 3: of $3.4 million for the fourth quarter of 2022, or $0.31 per share.
Speaker 3: compared to a net loss of $3.5 million, or 31 cents per share, for the fourth quarter of 2021.
Speaker 3: For the full year of 2022, our R&D expenses were $8.6 million, up from $7.6 million for 2021.
Speaker 3: This increase was primarily attributable to increases in research studies, increases in consulting expenses, and increases in R&D payroll expenses.
Speaker 3: Specifically, for the full year 2022, our spend on research studies increased by approximately 1.5 million dollars.
Speaker 3: Consulting expenses increased approximately $0.2 million, and R&D payroll expenses were up approximately $0.1 million.
Speaker 3: These increases were partially offset by decreases in product candidate manufacturing related expenses.
Speaker 3: of approximately $0.2 million, decreases in licensing fees of approximately $0.1 million.
Speaker 3: and a net decline in payments to Alarity Therapeutics of approximately $0.5 million.
Speaker 3: During the year ended December 31, 2021, we made a one-time, $1 million upfront payment to Alarity Therapeutics to take the rights to LP 100 back into our control, which we are now looking at combining with TARP inhibitors.
Speaker 3: in a combination program aimed at cancers with homologous repair deficiency, or HRD, cancers.
Speaker 3: During the year ended December 31, 2022, we released an escrow payment of approximately $459,000 to Alarity Therapeutics.
Speaker 3: Manufacturing related expenses for the year ended December 31, 2022 were also reduced by $935,000 as a result of a payment we received in July 2022 from one of our service providers.
Speaker 3: in connection with the resolution of a difference of views regarding the agreement with the service provider. Our general and administrative expenses for 2022 were $5.8 million, up slightly from $5 million for 2021.
Speaker 3: The increase was primarily attributable to increases in payroll and compensation expenses of $0.5 million, increases in other professional fees of $0.4 million, increases in legal and patent related expenses of $0.1 million.
Speaker 3: increases in travel expenses of 0.1 million dollars.
Speaker 3: Our R&D expenses continue to exceed our G&A expenses by a strong margin, reflecting our focus on advancing and expanding our product pipeline.
Speaker 3: The net loss for full year 2022 was $14.3 million.
Speaker 3: or $1.31 per share compared to a net loss of $12.4 million.
Speaker 3: for $1.13 per share for the full year 2021. As of December 31, 2022, we had approximately 10.86 million shares of common stock outstanding, and outstanding warrants to purchase approximately 177.
Speaker 3: per share for the full year 2021. As of December 31, 2022, we had approximately 10.86 million shares of common stock outstanding and outstanding warrants to purchase approximately 177,998 shares.
Speaker 3: and outstanding options to purchase approximately 1,037,591 shares.
Speaker 3: These warrants and options combined with our outstanding shares of common stock
Speaker 3: Give us a total fully diluted shares outstanding.
Speaker 3: of 12,072,629 shares as of December 31, 2022.
Speaker 3: Our cash position, which includes cash equivalents and marketable securities,
Speaker 3: at December 31, 2022 was $55.2 million.
Speaker 3: This balance is expected to carry us into 2025.
Speaker 3: Importantly, we believe our solid financial position will feel continued growth and evolution of our radar AI platform.
Speaker 3: accelerate the development of our portfolio of targeted oncology drug candidates.
Speaker 3: and allow us to introduce additional targeted products and collaboration opportunities.
Speaker 3: in a capital-efficient manner. Our team continues to be very productive under a hybrid operating model.
Speaker 3: This hybrid model also removes geographic restrictions to our hiring initiatives, which gives us the ability to recruit extremely high caliber team members that otherwise might not be available.
Speaker 3: We currently have 23 employees who are primarily focused on leading and advancing our research and drug development efforts.
Speaker 3: We see this number expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission.
Speaker 3: I'll now turn the call over to our Chief Scientific Officer, Kashore.
Speaker 3: or an update on some of our development programs. Kishore? Thank you, David.
Speaker 4: During the last quarter, we provided you with updates to our drug programs, other people need to follow and then be ready for it.
Speaker 4: These programs included developing LT184 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 mess.
Speaker 4: The second program was developing LP-284 for lymphomas that focus on mantle cell and diffuse large B-cell lymphomas and among the later particularly double-headed and triple-headed lymphomas. At that time, we had a great view of our plans to launch phase 1 clinical trials.
Speaker 4: for LP 184 in early 2023.
Speaker 4: I am pleased now to provide you with updates on these plans along with insights from our completed IED and editing studies.
Speaker 4: Following a recent filing of pre-IND application with the FDA and completion of essentially all the pharmacology, toxicology studies required to find the IND, we are pleased to report that the necessary documents and results for the IND submission are nearly complete.
Speaker 4: And we are anticipating the ID submission to occur in early April 2023.
Speaker 4: with a steady startup in later quarter 2.
Speaker 4: We expect the first patient to be dosed in summer of 2023.
Speaker 4: We anticipate to have all currently targeted clinical sites activated in the third and fourth quarter of 2023.
Speaker 4: The sites where this clinical trial will be conducted will include top-tier comprehensive cancer centers such as the Fox Chase Cancer Center and Johns Hopkins.
Speaker 4: These and other similarly planned sites routinely assess tumor genome sequencing and characterization, a resource that is critical to our approach for identifying the most sensitive tumors.
Speaker 4: Additionally, the protocol for phase one trial has been finalized.
Speaker 4: after discussions without needing KOLs.
Speaker 4: The phase one design is depicted in the slide that you see.
Speaker 4: The trial design is a Bayesian optimal interval design.
Speaker 4: And this was chosen because it allows us to balance the risk of inadvertent pain arriving at a lower dose while maintaining safety to reach at an effective dose.
Speaker 4: following the escalation phase and as recommended by FDA, we'll have two cohorts.
Speaker 4: of 10 patients each at two dose levels.
Speaker 4: which will provide us with a relative dose response, or RDR, for the phase 2 products.
Speaker 4: Based upon the dose range finding studies in dogs from the completed IND enabling studies,
Speaker 4: We will begin the first in human studies with a starting dose of 0.015 milligrams per kg.
Speaker 4: Now LP184 of course has the potential as a potent motor therapy agent but also
Speaker 4: as a potential to be used in combination with other FDA.
Speaker 4: These combination choices to us are dictated and guided by clues based upon the mechanism of action of LP monitoring core as well as the interrogation of the interactive pathways using our in-syndical assessment on the radar platform.
Speaker 4: The transcription coupled megalotype excision repair or TCNER pathway which is critical in the repair of DNA damage caused by LP184, provides the synthetic lethal properties in tumours that are deficient in this pathway.
Speaker 4: The mechanism of action of LP184 can be leveraged further, therefore, by combination of molecules that would diminish the activity of the TCNER pathway.
Speaker 4: Such molecules as you can envisage will also help broaden the tumor indications.
Speaker 4: that become hypersensitive to LP184, as well as provide the potential for widening the sclerotic index of LP184. In this regard, one molecule that we have been investigating and for which we now have substantial
Speaker 4: Positive in silico, in vitro, as well as in vivo data is spironolactone.
Speaker 4: This is an FDA approved drug for hypertension and other non-oncological indications.
Speaker 4: In continuing our focus on providing insight and transparency about our research through webinars, we are hosting a KOL webinar on synthetic lethality as Panda mentioned, tomorrow March 21st at noon Eastern.
Speaker 4: This webinar will feature an internationally recognized expert in synthetic lethality, Dr. Sotam Shrivasti.
Speaker 4: who serves joint appointments as principal investigator at the Danish Cancer Center, with whom we collaborate, and as Assistant Professor of Pediatrics at Boston Children's Hospital, a Harvard Medical School at Yale.
Speaker 4: Later on, in the second quarter, we had an in-depth, second webinar.
Speaker 4: on how Lantan is leveraging the synthetic research properties of LP184 and LP284 for multiple solid tumors.
Speaker 4: Now in addition to updating you on LP184 clinical trial plans, we also have updates for our LP184 clinical development plans.
Speaker 4: As I had mentioned before, line 10 is developing LPQ84 for multiple B-cell
Speaker 4: non-hard-sense performers where LP284 has shown nanomolar potency across multiple in vitro and in vivo studies.
Speaker 4: And the formal weather is demonstrated where you can meet.
Speaker 4: NHS implications for LP284 are targeted at this time to include microcell lymphomas and double head lymphomas and a few other NHS cancer suffices. There is a significant clinical need for additional late stage therapeutic options for these patients.
Speaker 4: as nearly all patients relapse from the current standard of care therapies such as Bertheosomate and Iglutinib.
Speaker 4: We are therefore equally excited about beginning the clinical trials with LPQ84.
Speaker 4: The I&T enabling studies and the I&T submissions are slated to be completed the second quarter of 2023.
Speaker 4: We have already received interest from multiple major cancer centers.
Speaker 4: to serve as LP284 trial sites when launched.
Speaker 4: Our confidence in the molecules is
Speaker 4: Our confidence in the molecules is grounded.
Speaker 4: molecule is rounded on
Speaker 4: several exciting results such as those that we presented.
Speaker 4: at the 2020 Ash Annual Meeting.
Speaker 4: There we show that mantle cell lymphomas are highly sensitive to LP-284. And as you can see in this slide, the tumors that actually become non-responsive to standard of care agents, ibrutinib and botoxanib, which is shown on panel B in this slide.
Speaker 4: Continue to retain responsiveness to LP24. This is critically important from a patient perspective as nearly all patients relax from these agents.
Speaker 4: Later this year, we will also look forward to sharing with you additional data from our Druitt league medical ADC solutions development programApplause
Speaker 4: and also from a rapidly progressing pediatric studies for both LP184 and LP284. Most importantly,
Speaker 4: We'll also share with you critical data from our upcoming and ongoing clinical trials.
Speaker 2: I'll now turn the call back to Bhangra. Thank you, Kishore. As Kishore pointed out, we are accelerating the pace at which we're developing and validating insights and these insights are meaningful and ready to be deployed now into the clinic.
Speaker 2: We're also very well positioned to efficiently develop our assets and partner them out with larger biopharma companies.
Speaker 2: 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 so our strong cash position is being carefully utilized to make meaningful progress in a disciplined manner.
Speaker 1: With that, I'd like to now open the call up to any questions. Thank you, Pana. If you would like to ask a question, you can do so in one of two ways. You can either type your question in using the Q&A tool, or you can click on the Raise Hand tool to speak directly to management, and I will allow you to speak. We already have some questions coming in here.
Speaker 1: First, I see John VanderMosen's hand up.
Speaker 1: First, I see John VanderMosen's hand up. John , you should be able to talk.
Speaker 5: All right, thank you, Nicole. I'd start out with kind of a bigger picture question. We saw a recent bid for CGN. 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? Yes, I think so.
Speaker 2: John that's a great question. Thank you for asking that. We're very excited about the Kaiser's buying out the cGen or Seattle genetics to their ADC program. As you know I started looking at ADC and developing that inter-pipeline a year ago, but we've been I would say more focused on launching into the clinic because that's kind of a...
Speaker 2: cash preservation and so the ADCs were kind of on the a little bit more of a back burner. But we've got some really good progress now in our ADCs. We'll have some data out later this year probably very shortly about what we're doing in the ADCs. It's a very exciting category. We've also fine-tuned radar now.
Speaker 2: to do more work in being able to predict and help us model both ADCs and antibody drugs, antibody, small molecule, regimens. So I think ADCs will be a big focus going forward, but I think everyone wants to see patients dosed to 184 and 284 and 300.
Speaker 2: that continues to be the primary focus. But ADC is definitely the next chapter for us. Great.
Speaker 5: Another question on, you know, 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 those other programs as we move along?
Speaker 2: Yeah, we are looking at grants and also collaborations and so yes that's a I would say that's a valid question. A lot of these are very ultra rare cancers.
Speaker 5: There definitely are ways to look at grant dollars to help accelerate those. Okay, great. And let's see, I guess kind of a modeling question, now that Harmonic's in full swing, what should we think about in terms of R&D for 2023?
Speaker 2: as we start adding the adding the patients and you know seeing that that kind of take off. Sure, we'll let David kind of give you some guidance for the year, but you know we're pretty disciplined and have modeled kind of a scale-up of harmonic over the next four to six quarters.
Speaker 3: Sure. Hi, John . 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.
Speaker 3: LP 300 as well, we'll see our cash increase some of that, but fairly controlled from where we are now.
Speaker 1: Great. Thank you, David. Appreciate it. Okay, I see that Michael King's hand is also raised.
Speaker 1: Michael, you should now be able to speak as well.
Speaker 6: You may have to unmute yourself.
Speaker 6: You may have to unmute yourself.
Speaker 6: Bing him.
Speaker 2: Sorry, it took me a second to hand-eye coordination to unmute the line. Can you guys hear me all right now?
Speaker 2: Yes, Michael, I can hear you. Great. A couple of questions. I just would love to get a little more clarity on how you guys are thinking about.
Speaker 2: the algorithm of both combination therapy as well as patient enrichment. For example, in case of LP300, are you doing
Speaker 2: Any genetic selection up front or is that going to weigh, you know, recommended phase two dose?
Speaker 2: And then when you think about combining things like PARP inhibitors, spironolactone, etc., as the studies mature, how should we think about...
Speaker 7: the way you guys are going to layer those things in as well.
Speaker 2: Sure, I'll take a first crack at that. So in regards to the
Speaker 2: LP300, 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.
Speaker 2: So they're kind of self-selected already for that as never smokers. We will be taking liquid biopsy for these 90 patients and the liquid biopsy results might give us some idea about potential surrogate markers of response or potentially some interesting signatures that correlate to improved response.
Speaker 2: 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 three 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.
Speaker 2: these are going to be TKI failures largely. In terms of the additional combinations like the spironolactone with PARP inhibitors, we definitely think the spironolactone seems to be a significant failure if
Speaker 2: enhancement in the potency of 184 and perhaps 284 but definitely 184 and we could 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
Speaker 2: and certain patient types, a less than ideal therapeutic window or safety profile. So if we 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 spironolactam. But we see that as being introduced as an additional arm in the trial.
Speaker 2: 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 and in certain indications, we think in many of those indications we can significantly improve the outcome.
Speaker 2: I think for sure you had some data on PARP on the approval and you want to share some of that?
Speaker 4: with Michael? Yes, so and this 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
Speaker 4: After some time, several of these patients do develop resistance. So one part also is that, A, the combination might delay this resistance, but in addition, if they become refractory, then perhaps LP-194 will still work on those.
Speaker 4: And there are toxicities associated with, of course, both MP1D4 and PAR. And using a combination in a more strategic way to diminish those toxicities is another part that we have. Okay, but if I can maybe.
Speaker 7: Okay, so the question I have on spirinolactone, I can understand part, you could probably refer to data that's in the public domain as far as what single agent activity should be from a part before you add in 184 on top, but I'm just wondering in the case of spirinolactone where it's not thought of as.
Speaker 7: you know, antineoplastic, how does one, you know, because when you do combination studies, the FDA is always interested in what does the, all of the, you know, the agent add as a single agent. Do you have to do some studies showing that spiroelectron has no effect on tumors? Yeah, so I mean, spiroelectron is an FDA-approved drug.
Speaker 4: So the safety profile and other things are known about it. So the other fundamental kinetics. We have already gathered data in vivo in animal models that the combination works and is more effective in certain contexts of certain tumors.
Speaker 4: more effective than LB184. So we believe that the data we have is sufficient for us to go to the FDA and
Speaker 2: and design a study to use this combination. But also in those studies, we did spinal ectome alone and it showed the other factor on the tumor. Yes, spinal ectome alone did not show any effect. That's right. So.
Speaker 7: Okay, I just wanted to be able to show it and maybe even a small number of patients, but I'll leave that for now. And then just on Starlight, what is, are there some gating items?
Speaker 7: 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, it would show that Starlight IND would be a little bit later this year behind the anticipated one for 184.
Speaker 2: I know that the starlight would just pick up after the 1A. So starlight, you know, we would, that would pick up in phase 1B or 2A. So the 1A is going to be multi-tumor and once we have an MTD and the MTD minus 1...
Speaker 8: then we'll probably in that phase 1A have certain CNS cancer patients. Okay. And once we've established that MPD then we can enrich. And you're pulling it over to starlight. I got it. Okay. All right. Thanks guys. No problem.
Speaker 8: we'll probably in that phase 1A have certain CNS cancer patients. Okay. And once we've established that MPD, then we can enrich. And you're pulling it over to starlight. I got it. Okay. All right. Thanks, guys. No problem. We have one more question.
Speaker 9: Yes, thank you Michael. One more question we have is does the expected increased cash burn rate factor into our projections through 2025?
Speaker 8: 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 all over at our KOL webinar tomorrow.
Speaker 9: Thank you, everyone.