Lantern Pharma Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 9, 2023

There are 3 speakers on the call.

Operator

You have joined the meeting as an attendee and will be muted throughout the meeting. This concludes the 2023 earnings call. I will be your host for today's call. As a reminder, this call is being recorded and all attendees are in a listen only mode. We will open up the call for all questions and answers after our management's presentation.

Operator

A webcast replay of today's conference call will be available on our website atlanthernpharma.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 Q2 ended June 30, 2023. A copy of this release is available through our website atmanturnpharma.com, where you will also find a link to the slides that management will be referencing on today's call. I would like to remind everyone that remarks about future Cations, performance, estimates and prospects constitute forward looking statements for purposes of Safe Harbor provisions under the Private are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated. A number of factors could cause shows actual results to differ materially from those indicated by forward looking statements, including results of clinical trials and the impact of competition.

Operator

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 ks for the year ended December 31, 2022, which is on file with the SEC and available on our website. Forward looking statements made on this conference call are as of today, August 9, 2023, and Lincoln Pharma does not intend to The webcast replay of the conference call and webinar will be available on Lantern's website. On today's webcast, we have Lendron Pharma CEO, Pana Sharma and CFO, David Margrave. Pana 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 Prana, and then we'll open up the call for Q and A.

Operator

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

Speaker 1

To hear about our 2nd quarter results and corporate progress. As you know, this is truly a golden age for AI and medicine and it really is just beginning. It's been powered by large scale highly available computing power, massive data storage. Additionally, it's being fed by healthcare patient and cancer data, Which is more widely available and at increasing levels of quality than ever before. Companies that harness these capabilities in the biotech And Tech Bio Industry and make them core their business to be long term leaders that create massive value for patients, for investors and for our industry.

Speaker 1

Lanteridge Pharma is among the leaders in this transformation of the pace, Risk and cost of oncology drug discovery and development. This transformation has a promise to not only make medicines faster, Cheaper and with increased precision for patients, but also to help change the direction of R and D productivity and output in the pharma industry. I'll touch on this critical element later in our call. Our proprietary AI platform, Radar, continues to have a meaningful growth in its size, scope and capabilities and is at the center of this paradigm shift towards AI driven Drug Development. Just 3 years ago when we went public, we had only 3 drug programs addressing markets we had estimated to be about $5,000,000,000 to $6,000,000,000 in its potential Annual therapy sales.

Speaker 1

Today, we have over 14 drug programs, many with orphan drug designations and additional commercial protections. We're addressing markets today estimated to be approximately $14,000,000,000 plus in annual therapy sales. We also diligently Our assessing several additional promising programs and molecular candidates for future development. Our growing pipeline of oncology drug candidates is In science, where we can understand and accelerate the focus of specific molecules towards a more targeted and more effective oncology medicine. Importantly, Radar has empowered us to compress the timeline of early stage drug development so far by an impressive 70%, While concurrently achieving about 80% reduction in the costs when benchmarked with traditional drug development in the pharma industry, We think we can continue to improve upon this.

Speaker 1

With our cutting edge AI platform, radar, and also our adoption of leading technologies and innovative approach, We are eliminating the path for the next generation of oncology drug discovery. In the past 2 years, we have successfully developed and launched 11 additional programs, A testament to the agility, efficiency and groundbreaking nature of our approach. On average, these programs are advancing from initial AI insights The first in human clinical trial in just 2.5 years at an average cost of approximately $2,000,000 per program. Some have actually even been below that. These are metrics that are previously unheard of in oncology drug discovery.

Speaker 1

In fact, in a recent study published in drug discovery today and also In nature, it was reported that nearly half of the 16 largest pharma companies had negative R and D productivity for the last 20 years. And they had spent collectively an average of $6,200,000,000 per drug approval. The number was slightly less than smaller pharma companies. But these startling figures served as a stark reminder of the traditional model of big pharma R and D is not a sustainable or effective strategy And it is not the right approach to improve drug pricing or drug availability. With this escalating economic and political pressures over drug prices, it's clear that our industry, Such as cancer drug prices, it's clear that our industry needs to rethink its approach fundamentally and we believe that big pharma will increase adoption of AI And computationally driven approaches to elevate above this current issue.

Speaker 1

As Vida demonstrated, our radar platform has an impressive predictive accuracy of 88% in identifying which patients are most likely to respond to our drugs To respond to drugs in clinical trials, we showcased this in a real world study presented at ASCO with our collaboration partner, ACTUATE for this Phase II trial. This is not only a good technical feat, but really a game changer for patient stratification and selection by reducing the cost of trials And enrolling those patients who can ultimately benefit most from these targeted therapies. By combining our unique cutting edge AI with robust Clinical, genomic and drug response data, which we do in our platform, we believe that we have increased our ability to de risk our programs And increase the odds of success by a significant factor. Multiple studies by academics, including work by Doctor. Jason Parker, who I've quoted before at University of Toronto and Industry Analysts have shown that the use of biomarker signatures can increase the success factor from 5x to 12x in oncology clinical development.

Speaker 1

This reduction in risk and cost comes also with the compression of the timeline, especially in later stage trials. So this underscores our technology's immense potential to produce insights that leads the development of targeted cancer therapies. Currently, our AI driven pipeline consists of 14 drug programs, including those underway are collaborations and our Phase 2 clinical trial called HARMONIC for lung cancer and nervous smokers. Our team's unwavering commitment to harness and empowered AI for drug discovery has also led to the formation of a partnership with Delafel University in Germany To develop the next generation of antibody drug conjugates. These are conjugates that are being designed and advanced with our Radar AI platform.

Speaker 1

This collaboration has the potential to pave the way the therapies with higher efficacy, a faster development timeline and significantly reduced cost of early stage development. ADTs are a rapidly growing excitement treating medallion that is still in the early stages of commercial growth. Globally, Agency Drug Programs are one of the fastest growing drug development segments and are projected to grow $4,000,000,000 as of last year to over $14,000,000,000 by 2027. There are many specific instances of value creation That we've talked about, but also we've also developed an entirely new company, Starlight Therapeutics, whose sole focus will be on CNS and brain cancers. This demonstrates that Lantern continues to be at the forefront of a transformative and aggressive approach to oncology drug discovery and development.

Speaker 1

As we continue to accelerate the pace at which we're developing and validating insights, these insights can lead to meaningful drug assets. We are well positioned to impart these drug assets out of larger companies. At this time sorry, at the same time, David will cover our CFO shortly. We have a strong cash position that's been carefully utilized to make more meaningful progress in a disciplined manner. We believe our approach is the future of developing cancer therapies, where data can be used to accelerate programs, derisk the identification Have issues and progress with potentially life changing medicines.

Speaker 1

Now let's turn to some of the more specific highlights of our progress during the Q2. During the Q2, we received FDA clearance of our IND application for LP-one hundred and eighty four, And we subsequently activated the initial point of the sites for the program. Now we're also identifying several potential patients for the Phase 1 Basket trial, this Basket trial will serve multiple solid tumors and brain cancers categories that have significant unmet clinical needs. We also completed the IND enabling studies for LP-two eighty four. LP-one hundred and eighty four and two eighty four are part of our franchise of synthetic release of agents.

Speaker 1

We anticipate submitting the IND to the FDA by the end of August and will set the stage for a first in human Phase 1 trial for LP284 In advanced non Hodgkin's lymphomas in the second half actually in Q4 of 2023. Data demonstrating 2 84 in vitro and in vivo anti tumor potency for mantle cell lymphoma, double hip lymphomas and other non Hodgkin's lymphomas will publish an Onco target in the quarter further supporting the advancement of this potentially powerful therapeutic option for a range of blood cancers. We also dosed additional patients in the Phase II HARMONIC clinical trial of LP300 in non small cell lung cancer for nervous smokers And expanded patient recruitment and enrollment to several additional trial sites. As I mentioned a moment ago also, we entered into a collaboration with Delafield Diversity in Germany, we had the 2nd quarter of the system developed breakthrough new antibody drug conjugates that we believe will set the stage for A new generation of novel ADCs that offer higher efficacy, faster development timelines and significantly reduce cost comes to market. Our intellectual property was also strengthened and further in the quarter with the receipt of notice of allowance for a new patent Covering the composition of matter totaling new drug LP284, extending commercial protection for this asset into early 2,039.

Speaker 1

We also during the quarter filed 5 new patent applications for LP-one hundred and eighty four and LP-two eighty four that cover the use of these drug candidates And combination regimens and also specific tumor subtypes where we think the potential is highest for these drugs. Very importantly, our continued fiscal discipline with our cash, we have a balance of $48,000,000 in cash, cash equivalents and marketable securities as of the end of the Q2, which provides us a strong cash runway into 2025. I'll now turn the call over to our CFO, David Margrave, will provide an overview of the Q2 financial results and then I'll come back with additional comments on our programs. David? Our general and administrative expenses were approximately $1,600,000 for the Q2 of 2023, Up slightly from approximately $1,400,000 in the prior year period.

Speaker 1

R and D expenses Our increased R and D expenses were in line with expectations And primarily driven by increases in research studies and R and D related payroll and compensation expenses, This was partially offset by a decrease in product candidate manufacturing expenses. We recorded a net loss of approximately 4 point $7,000,000 for the Q2 of 2023 or $0.44 per share Compared to a net loss of approximately $4,500,000 or $0.41 per share for the Q2 of 2020, Our loss from operations in the Q2 of 2023 was partially offset by interest income and other income net Totaling approximately $444,000 our interest income and other income net increased by an aggregate of approximately $541,000 for the Q2 of 2023 $3,000 increases in dividend income of approximately $168,000 an increase in unrealized gains on investments of Approximately $150,000 and an increase of approximately $109,000 in research and development Tax incentives related to our Australia subsidiary. As of June 30, 2023, We had approximately 10,860,000 shares of common stock outstanding and outstanding warrants to purchase Approximately 177,998 shares and outstanding options to purchase approximately 1,100,000 shares. These warrants and options combined with our outstanding shares of common stock give us a total fully diluted shares outstanding of approximately 12,100,000 shares as of June 30, 2023.

Speaker 1

Our cash position, which includes cash equivalents and marketable securities, is approximately $48,000,000 as of June 30, 2023, And we expect this balance to carry us into 2025. Importantly, we believe our solid financial position will fuel continued growth and evolution of our radar AI platform, accelerate the development of our portfolio of targeted oncology drug candidates And allow us to introduce additional targeted products and collaboration opportunities in a capital efficient manner. Our team continues to be very productive under a hybrid operating model. This hybrid model also removes geographic restrictions our hiring initiatives, which has given us the ability to recruit extremely high caliber team members that otherwise might not have been available. We currently have 22 employees focused primarily on leading and advancing our research and drug development efforts.

Speaker 1

We see this number expanding slightly in coming quarters as we add additional experience and talent as individuals to help advance our mission. I'll now turn the call back to Fana for an update on some of our development programs. Fana? Thank you, David. As many of you know, we received FDA clearance for our IND application for LTL-one hundred and eighty four in June and have already activated The initial clinical trial sites for our Phase 1 basket trial.

Speaker 1

The clearance of the IND application was a significant milestone for our LP-one hundred and eighty four program, Validating our approach of leveraging AI and machine learning to advance our pipeline of novel drug candidates. Insights from our AI platform radar were instrumental in our development of LK194 and aided in discovering its mechanism of action, identifying and prioritizing The ideal cancer subtypes to pursue and generating biomarker signatures that we can use in future clinical trials to help us with patient stratification and selection. We developed these signatures literally sometimes in weeks or months, A process that normally would have taken half a year to 18 months. We believe that LP-one hundred and eighty four has blockbuster potential for patients With multiple types of advanced solid tumors and CNS cancers, many of which have no or limited effective therapeutic options. We're more excited today about the opportunity for this drug than even 2 3 years ago.

Speaker 1

Globally, the aggregate annual market potential for LP-one hundred and eighty is estimated to be over $10,000,000,000 consisting of about $5,000,000,000 in solid tumors and another $5,000,000,000 to 6,000,000,000 for CNS cancers, both primary and those arising as a result of metastasis. LP-one hundred and eighty four is the first of our drug candidates We developed entirely internally and the significant use of our AI platform to uncover the subtypes where we believe we can meet Highly underserved needs or in areas where there's no therapeutic options. This molecule has been advanced now to a first immune Phase 1 VASPA trial And the trial is designed to evaluate 35 patients and will assess the safety and tolerability of escalating doses using a planned design. We also believe that we have seen exceptional results in cancer that have DNA damage response deficiencies And that will be also an additional target for later phases of the trial. The initial trial sites have been open and we are actively screening patients for dosing We anticipate completing the trial sometime in 2024.

Speaker 1

Another very promising new molecule is one that we developed from LightBoard to a first in human clinical trial in under 2.5 years And with an estimated cost of $1,000,000 to $3,000,000 This drug is not even on our pipeline when we went public. It's Very exciting molecule and the initial insights around the specific mechanism of synthetic lethality was derived from large scale comparative data using our radar based platform. We then leverage our GMP manufacturing process for its sister molecule, Lp-1e4, to efficiently ramp up and develop Q and A as well as continuing to refine the indications and mechanisms. Ultimately, we studied both selection and organ designation in mantle cell lymphoma. Today, we are preparing for our 1st clinical Phase 1 trial, which we expect to launch in the Q4 of this year.

Speaker 1

As I mentioned earlier, with IND enabling the study now complete, we anticipate submitting the IND to the FDA by the end of this month and we also have already received orphan drug designation in mantle cell lymphoma. The market we believe for this mantle cell in double digit lymphoma is a very aggressive non Hodgkin And then subtypes is currently about $1,200,000,000 in the U. S. And Europe and we think that the number globally is about 2 to 2.5 times that number. LP-one hundred and eighty four and two eighty four represent our synthetic lethality franchise, which has shown significant potency in a wide range of cancers, Both in monotherapy and also in combination with other patients, LP-one hundred and eighty four has selected preference for solid tumors that have high levels of PTG01 expression For deficiencies in DNA repair pathways, while ALP-two eighty four has shown potent efficacy in a wide range of immunological Mainly non Hodgkin's lymphoma.

Speaker 1

And we also have seen the LP-two eighty four share the ability to effectively will regress mantle cell lymphoma xenograft after they become refractory to both Ibrutinib or bitezolim. Both of our candidates have also shown promising activity in the range of pediatric tumors, which will be pursuing research centers focusing on children's cancers such as University of Texas Health and Greetings Children's. And we believe that those will be in 2 Phase 1 trials, one for dosing and safety have been established from LP-one hundred and eighty four-two eighty four early trials. We also know that LP-two eighty four has demonstrated a Significant impact on a wide range of sarcomas including Ehling Sarcoma and rhabdomyosarcoma, both pediatric cancers largely. Additionally, LP1804 was granted a rare pediatric disease designation in ATRT, atypical territory of lab coatumus, And ultrarare cancer, which has no approved standard of care agents and largely reflects children under the age of 5.

Speaker 1

We published with the National Cancer Institute It's pretty new publication where we uncovered the mechanism of pointing this drug toward these promising modeling deficient tumors, Mainly looking at SMARCB1, we plan on reporting out more details from these studies And the potential emerging indications later this year. Now moving on to our Phase 2 clinical trial LPD-three hundred. Initial patients in our Phase 2 HARMONIC trial of LTL-three hundred for never smokers and non small cell lung cancer have been dosed and we have 5 additional active Trial sites will be adding. We expect to add additional trial sites throughout this quarter and also multiple patients. We're also screening increasing We're also increasing the number of patients who are screened.

Speaker 1

This comes as a direct result of increased awareness among patient advocacy groups, Later investigator interactions and briefings. Additionally, Doctor. Joseph Treat of Fox Chase Cancer Center has been appointed as new principal investigator for the Harmonic study, Doctor. Treat brings them a stellar focus and background of serving not only the lung cancer community, But also background in clinical trials in the neva smoker population. He was recently leading a 100 plus patient Phase 2 interventional trial Focused on never smokers with Stage IV disease who have never smoked irrespective of their driver mutation status.

Speaker 1

So it's an ideal backdrop and experience, and also the point of the network for the HARMONIC trial. And we welcome his active leadership in HARMONIC and LIVING LANTRAIN. We're also exploring the potential to expand the HARMONIC trial into Asia, specific countries that have a higher incidence The never smokers and lung cancer patients. Overall, we anticipate enrollment of this 2 long open label randomized trial, Which is targeting magnitude patients to last between 14 18 months. The Phase 2 trial is designed to investigate LP300 in combination with standard of care chemotherapy, with the key measured endpoints being overall survival and progression through survival.

Speaker 1

In the previous multicenter Phase 3 clinical trial, what we saw was that a subset of never smokers, non small cell lung cancer, that received LP300 with chemotherapy showed a significant increase in overall 2 year survival, Overall survival of 91% increase in the never smoker population that were given LP300 and 125% increase In progression free survival in that same group of neversplendis versus the standard of care of chemo to CHEMO W. I discussed also earlier, our exciting collaboration with Bellafield University to develop breakthrough antibody drug conjugates. This partnership signifies an exciting stride forward in the development of next generation ADT using our radar AI platform. The initial purpose of the collaboration is to synthesize and evaluate novel ADC linked toryptophylacids. This is a promising class of antitumor molecule Due to their potency of ultra low picomolar concentrations, we believe we can attach several of these molecules to the ADCs or to the antibody of interest using a fairly need maker strategy.

Speaker 1

The cryptophycin based ADCs will undergo rigorous testing across multiple Cancer cell lines, both inbutrin and EVOID models and we anticipate sharing initial results in the coming months. We also plan to leverage our ADC development module has been fully integrated now into radar to launch multiple ADC opportunities through Lanta and also through our partners And also through our crystallizing based collaboration with the Magic with University of Bellafield. We believe ADCs are a very promising treatment modality with significant opportunities for partnership and also to license the larger pharma companies. Our AI guided strategy holds immense potential to de risk the ADC development process while simultaneously Enhancing the creation of effective and targeted ADCs. Given the rapidly growing global ADC market currently valued at over 4,000,000,000 that is projected to reach $14,000,000,000 and of course, over the next several years by 2027, we're eager to expand our footprint in this important emerging space.

Speaker 1

Under the terms of our collaboration, the team at Bellafield University under the leadership of Doctor. Seebald will synthesize, optimize and provide initial testing has a crypto device in linked to ABCs and Lantern has the exclusive worldwide option to license intellectual property from its Collaboration from Bellafield University and this IP will be generally this includes IP generally directed from our joint efforts. We anticipate sharing the results of this work probably during the Q4. Leveraging more than 34,000,000,000 we're now to 34,000,000,000 data points, oncology focused data points, and we are on pace now to surpass 50,000,000 data points by year end. Our radar platform itself had automated large scale biological analysis and response network analysis, given correlations that can be leveraged both for target identification, Drug response prediction and tumor and patient selection.

Speaker 1

But it's not just about the quality of data, our radar platform also continues To evolve in terms of its capabilities, during the Q2, we launched some pretty unique groundbreaking predictive models That enable us to access blood brain barrier permeability of any compound. We can do this with tens of thousands of compounds a day now. The capability is crucial for developing therapies targeting neurological disorders, where processing the blood brain barrier is often challenging. By accurately predicting the permeability and availability of the compound, we can optimize the design and delivery of potential treatments And more importantly, save massive amounts of time and money that are involved in targeting and understanding blood brain barrier permeability in early stage development. Furthermore, our platform's predictive power now extends to patient response and Combination usage for immune checkpoint inhibitors, we'll talk about more about later this quarter, but the immune checkpoint module now harnesses the power of the AI and machine learning modules and now radar can analyze vast amounts of data to predict how patients may or may not respond to lead inhibitors and this data includes both antigen data, prophium data, mutation data and RNA data.

Speaker 1

And this allows us also to identify potential combinations The more personalized treatment strategy, but also very importantly for larger pharmas to actually manage the downstream Long term value of your investments into these immune checkpoint inhibitors. And as I already discussed, we also made significant drives for designing the templates for next generation ADCs, using our ADC module. We think this has the potential to revolutionize The latest ABCs are created and have better high potency therapeutic payloads while minimizing damage to healthy tissue and systems. So Radar continues to advance its capabilities both in size and scope and also in functionality. And we believe that this will secure continue to secure Lantern's position at the forefront of leading AI based drug discovery and personalized Cancer Therapy Development.

Speaker 1

So 2023 is shaping the pivotal year for Lantern, where our insights are now entering into patients And the start of the journey to becoming meaningful therapies in cancer and at the same time increasing the functionality of our AI platform. Our collective efforts and dedication have fostered a transformational shift for our company, setting us on an exciting trajectory towards the future where we're Touching and improving the lives potentially of cancer patients with effective and hopefully more precise therapies. One of our primary focus in the second half of this year will be to further advance enrollment in our hematics. It will be also to advance the enrollment for our Phase 1 trial We've opened up the initial sites and we're actively screening patients today. We also expect our Phase 1 trial for LP284 to launch in the coming months, most likely in Q4, 2023.

Speaker 1

These trials marked significant milestones In the pursuit of the of Seachmark's significant milestone and our pursuit of advancing AI powered drug discovery into the clinic. Additionally, we plan on progressing LP-one hundred and eighty four known as STARW-one towards Phase III clinical trials and CNS in brain cancers under STARLIGHT Therapeutics And we think this underscores our commitment to addressing unmet needs in a focused manner and we think this is massive upside For our investors and our patients through Starlight. So in our portfolio side, we believe that our AI platform will reach over 50,000,000,000 data points and will further progress the key modules for new checkpoint inhibitors and for ADT development. These milestones have set a new standard for data driven drug discovery, but also established new radar based collaborations with companies and We also intend to actively explore licensing and partnership opportunities with biopharma companies to Celebrate the path to patients for our therapies and to showcase how our AI driven approach can generate results for investors and drive the future of our franchise. While we initially drive forward our R and D efforts, we will continue to uphold Discipline, fiscal management to create further value for our shareholders.

Speaker 1

As we have pointed out, we are accelerating the pace at which we are developing and validating insights, But we're also at the same time managing our cash and managing how we position these assets. We're partnering with larger companies. As we continue to advance our diverse portfolio, we'll be presenting new data and findings of very important several notable scientific conferences over the coming months. We have one coming up on August 10th at the Society of Neuro Oncology and the American Society of Clinical Oncology, the CNS Cancer Conference in San Francisco, Where we will share findings related to LP-one hundred and eighty four's ability to inhibit adult and pediatric CNS tumor cell growth, Especially in new data related to ATRT. We also will be at the International Conference on Drug Conjugates for Directed Therapy In Darmstadt, Germany on August 24, where our Chief Scientific Officer, Kishore Dhatia, will be presenting new details about our innovative AI driven approach to identifying ADT targets with improved tumor selectivity.

Speaker 1

And in fact, we'll be showcasing kind of our whole tumor select We'll also be presenting at the Society of Hematological Oncology's Annual Meeting In Houston, Texas on September 6, where we'll be sharing new research related to LP284 And its ability to target genetic deficiencies in non Hodgkin's lymphoma. So we have a lot of exciting scientific and clinical data that will be presented over the coming months, Which will set the groundwork for even more improved opportunities for Lantern Farming. In closing, I want to really express my gratitude to our team, our partners, our collaborators and also our investors and stakeholders for unwavering support and dedication to helping us transform the oncology development process. I think together we're driving the way towards a brighter future In oncology drug development, solving real world problems with unique proprietary AI solutions that allow us to develop these Precision oncology therapies have significantly reduced costs and timelines that have been unheard of. We think this place is not at the forefront of a new era of, as I said, a golden age of medicine in due to AI.

Speaker 1

With that, now I'd like to open up the call to any questions or clarifications. But also I'd like to take a moment to firstly thank our colleague, Doctor. Drew Sturtevant, who has been focused on our communication efforts, Thank you for the Preston Scientific community for helping in our last five earnings calls. I know the team enmeshed his involvement And his upbeat dedication to Lantra, but we wish him well in his new scientific endeavors. So again, let's take questions from our audience.

Operator

Thank you, Pana. If you would like to ask a question, you can do so in 1 of 2 ways. You can either type your question in using the Q and A tool already have a couple of questions coming in here. The first one is, Has the first stage of the UHIMONIC trial been enrolled yet and will land to report on the first stage of the trial before completion of the full study?

Speaker 1

Great question. I think it's from John. But yes, we're in the middle of the first stage of the trial. We will report out Results as they get reviewed and we'd expect to report out the information. Yes.

Speaker 1

Thank you.

Operator

Another one here from an analyst. How will the genomic and transcriptomic data collected in the Harmonic will help guide the 2nd stage and potentially the registrational trial.

Speaker 1

Yes, I think Yes, for that question and Hitt and John also, we can pivot into a registrational trial from those trial design. So We expect to get both mutational and transcriptomic data from lipid biopsies that we're taking and we'll be able to see I think we'll see some differences in response Based on the prior TKI or the prior therapy of these patients. And so we can probably tune in to some specifics based on The data that we get from the liquid biopsy data. And that could actually pave the way for a number of really new things that we Already at SuneSilicon, we've seen that PD L1 high does not respond well potentially to these types of therapies. So we could actually go after something that's Maybe PDL-one low, we could go after signatures that showcase certain types of signatures that correlate to another smoker signature Plus high response to resetting the rego cycle plus response to chemotherapy reset.

Speaker 1

So yes, there's a couple of ideas, but again, once we have the patient data from LVLX, we can design a signature that we can use potentially for registration event. And Big Pharma like signatures, right? They don't pay for signatures, the machine learning derived signatures that makes the asset always more attractive. Thank you. I think Tony has a question.

Speaker 1

Is that right?

Operator

Yes. Tony, I see your hand raised. You should now be able to speak.

Speaker 2

A couple of questions. One is related to Harmonic and you alluded to it just a minute ago. But First, let me ask, in the previous data, the previous Phase 3 trial, At least I'm not going to

Speaker 1

put a percentage on it,

Speaker 2

but certainly a good bit of the data responding to LP300 is really driven by females. And so the question is, what's novel and Clearly less driven substantially less driven by males. What do you think biologically is going on between genders In the study, that's question 1. Question 2 is, this is really related to Checkpoints, but in particular pembro. And do you have any preclinical data that actually tells you regardless of PDL-one PD L1 high or low that the combination actually could work better in These particular types of patients.

Speaker 2

So that's really related to Harmonic. I'll come back and ask my second question And again, because it's very, very different than the first. Thanks.

Speaker 1

Thanks, Ted. So in regards to the ratio, I think The trial really represents the ratio of the female to male in the real world. It's about 2 thirds to 1 third of the never smoker population That comes down in non small cell lung cancer, adenocarcinoma is 2 thirds of them, roughly 60% to 66% are female. So There's no magic or reason why it's over indexed. It's just that's the actual disease epidemiology.

Speaker 1

And that's pretty consistent across races and continents. It tends to skew more females Get some of these TCI driver mutations in some cases or more females, it's supposed some research has shown That females also can have lung cancer arise as a result of Metabolism of estrogen that collects in the lining of the lungs and that's cancer. So Obviously, that's also something that's been observed. But I expect our trial to be the same. It will be more females than males.

Speaker 1

Right now, it's not enough patient to show, but I do expect that to be I look at the screening data that's there is more females than males. I don't know the biology of that. I don't know if that's something that you need to I'm worried about it, but if you look at the response, the response both the males and females It's similar. It's slightly better than females, but either if you take out male or female, you saw nearly 90% 91% increase in overall survival in the mother smoker population and a doubling in the Progression free survival regardless of the gender.

Speaker 2

And the pembro combo thoughts as it relates to regardless of Whether or not it's PD L1 high, we're in for clinical data that you're aware of that can support that that actually may be A good place to have a cohort of patients.

Speaker 1

And you could have one more.

Speaker 2

Yes, it doesn't matter. And what I'm suggesting is What the data are telling you would be that may be different, but the combination may actually it could be irrelevant So whether it's PD L1 low or high, that's what I'm alluding to. Do you have any information that says that's the case?

Speaker 1

No, we do not have any information. We just know that Neversmiths tend to have PD L1 low in most oral instances. So PD L1 high tends to be really in-depth for people who have what's called Heavy tumor mutation burden, which is what drives the PD-one expression. So people with high tumor mutation burden 10 to 3 smokers, 90 plus percent of them. And so we know that when tier indication burden is high, It's less likely to respond to 300 and to chemogevibilates.

Speaker 1

And so we know that this population of never smokers tends to have in general PD L1 low and that's been seen in a lot of studies where They looked at every smokers, they looked at characteristics of PD-one way, or low tumor mutation burden. I can send you some of those Test study that was done. The most interesting one was like a meta study done at a time on it was just published, I believe, last year. I circulated that internally. And I looked at 6 different cohorts, looked at both proteomic and genomic analysis of PD L1 high low, TMB high low, Smoking status, etcetera, and I can send that to you.

Speaker 1

But we don't have It's a conjecture. We think PL-one low is probably going to be shared in most of these nervous smokers. We have seen an anecdotally that PL-one Lowe keeps these patients oftentimes from getting pembroke such chemo in the first line setting And sometimes they'll adjust the chemo and sometimes they do harbor a TKI, but they'll let you

Speaker 2

Thanks. So there's no thought around perhaps using a cohort of patients to actually test the combination. Which combination? The Pembro Plus 300.

Speaker 1

We do not have an ARM program design for Pembro Plus 300, I think right now, we're thinking of the best potential design that we have been thinking about is a TKI Plus $300,000,000 We think it could enhance the PTI's long term impact because we're Denaturing some of those PKIs that could be an added bonus for a TKI like an EGFR and ALK based TKI. We have extra crystallography data To showcase that we are dematuring the receptors and so that can give an added boost potentially. We've seen some synergistic effect Increased clinical studies of PKI plus 300, but again a lot of these people will stop responding to PKIs. So our feedback from KOLs and clinicians was that they were not that excited to put them on TKI plus 300, but that would obviously Chemo plus 300 because that's standard of care, a little bit of chemo double after failing to respond to 2KIs.

Speaker 2

Thank you. Appreciate that. The second question really is around the larger picture here from AI Discovery And the radar platform, not so much the radar platform, but just higher level. When you look across the landscape at other companies that have AI as a premise to their discovery engine, Be it Kelco or say insitro or even BioAge,

Speaker 1

just randomly naming 3.

Speaker 2

I'm just not aware that they've been able to move any program forward. And I don't think it's not for the computing power, maybe Or directionally where they may wish to go. But do you have any view about that?

Speaker 1

Yes, from a subsidiary, Rob, there are examples like you said, a lot of companies that are more, I would say, AI only or AI first and they haven't seen the same movement. So It's not easy, right? You need to have an AI answer. You still have to manufacture the molecule as under GMP. You still have to have some really excluded preclinical study to really isolate that mechanism or insight that you've garnered on the computer.

Speaker 1

The KOL decided you have to write the IND and do the AML studies. There's a lot of work. It's not a fact that we did this with 284, which is a molecule that didn't exist and went public 2 years ago to now, we're about to launch into a trial. I mean, that's like a and again, the total cost of less than $2,500,000 So It's a challenge. I think there are companies that are in trials building, so not just Lantern, but other companies like the Cursion that are in trials, Companies like Xcient that are in trial.

Speaker 1

There are larger companies, significant even ours by a factor of like 20, Burning $50,000,000 $60,000,000 $70,000,000 But the benefit of AI is really to reduce the time and cost, but there's still unique biology and Manufacturing knowledge and CMHC to then really advance it into humans. And so we've kind of really built that in terms of being a really fit for purpose in oncology. That's why we have a focused team. We work with a lot of KOLs and outside experts. Everyone at Lantern believes in a multidisciplinary approach.

Speaker 1

So whether it be a CSO or even our data scientists, They're not just data people, they also understand cancer. And even the cancer biologists really try to understand the data science. And so It's we're kind of fit for purpose, specifically in oncology. One of the larger companies are going after lots of disease states. I think that kind of Focus or lack of focus can keep things from advancing into human trials as quickly as we have.

Operator

Thank you, Tieni. And that's all the time we have for questions today. Thank you so much for tuning in and we hope you have a great rest of your day.

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Earnings Conference Call
Lantern Pharma Q2 2023
00:00 / 00:00