Q1 2021 Lantern Pharma Inc. Earnings Call
Yeah.
Good afternoon, and welcome to Lantern pharma was the first quarter of 2021 conference call on.
As a reminder of this call is being recorded and all of the participants are in a listen only mode. We will open the call for questions on the answers after the presentation I would now like to introduce your host for today's conference Mark the chassis with Investor Relations Atlanta on pharma Marc. Please go ahead Sir.
Thank you, Jim and welcome everyone to the Lantern pharma first quarter 2021 conference call.
On the call today are part of Sharma Lantern, President and CEO, David Maher, Great lengths for instance, CFO and Dr. Cary Barnhart claim trends Vice president of clinical development.
Our press release was issued today, what our first quarter financial results that we won't be discussing on our call today.
Following the Safe Harbor statement. The panel will provide an overview of business highlights after which David will overview of our quarterly financial results and Dr. Barnhart, who will provide an update on our L. P 300 programs.
Part of it will then offer concluding comments after which we will open this call to questions. Please also note that we have provided a link on the investor wants to.
Investor Relations website.
The slides that we may reference in today's call.
I would also like to remind everyone. The remarks about future expectations plans and prospects constitute forward looking statements for purposes of Safe Harbor provision under the private Securities Litigation Reform Act of 1995.
The lantern pharma cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated.
All of factors could cause our actual results to differ materially from those indicated by forward looking statements such as the impact of the COVID-19 pandemic results of our clinical trials and the impact of competition at the.
For information concerning factors that could cause actual results could differ materially from those in the forward looking statements can be found in the risk factors section in our annual report on form 10-K, which is dated March 10, 2021 on file with the SBC.
Forward looking statements made on this conference call speak only as of today Monday May 3rd 2021, and Lantern pharma does not intend to update any of these forward looking statements to reflect the events or circumstances that are current after today a webcast replay of the conference call will be available on the lantern pharma of websites.
And with that I'd like to turn the call over to President and CEO Panna Sharma for his opening comments panel. Please go ahead.
The American Thank you and good afternoon to everyone on the call today. Thank you for joining us for our first quarter 2021 and conference call. We got a number of very important.
<unk> points over the past quarter and over the past month.
Notably as many of you probably read this morning, we announced a collaboration with the Actuate therapeutics, where we will be leveraging our AI engine radar to help them advance their drug candidate.
As you know lantern pharma as an oncology Biopharma company that Leverages the power of our internally developed AI and machine learning platform called radar to develop oncology therapeutics. We believe that we are transforming the development of oncology drugs by changing the pace the cost of the risk of drug development and opening up new the.
For us to rescued repurpose drugs by using our data driven the machine learning enabled approach.
We are one of the few pure play AI based biopharma companies with multiple clinical stage programs as well as a rapidly growing proprietary platform for accelerating on understanding modeling and prediction of patient and tumor response to cancer therapies.
Nishi multiple key milestones in the first quarter I'm going to highlight a few of those that are critical.
Most notably our radar platform surpassed 4 billion data points from the last campaign by the end of March of the $4 6 billion as of the end of April.
We also submitted an updated clinical development plan to the FDA for a L. P 300.
For the phase two trial in non smokers non small cell lung cancer and Dr. Baumhauer I will provide an update on our L. P. 300 program later in today's call.
During the quarter, we also expanded potential indications for L. P. 184 to include atypical Teratoid Rab the tumors from ultra rare pediatric brain tumor and also for L. P 184, and drug resistant non small cell lung cancer.
The indication on lung cancer was published on good target this past quarter, while the a T. R. T work is being pursued in collaboration with Johns Hopkins.
We also initiated preclinical development L P to 80 for.
And entirely new molecule in certain hematologic cancers that have shown exceptional sensitivity to the SKU molecule in indications that are very different from our 184 more molecule.
We also strengthened our intellectual property portfolio with the filing of over 10 patent applications ranging from novel molecules the methods of use of manufacturing.
Identifying patient share.
Actually those that cover fundamental technology aspects of our radar platform.
Our research team published two peer reviewed studies in Orca target and BMC bioinformatics. The further validate our data driven machine learning enabled approach to drug development and also provide detail and transparency and how radars being used and implemented.
In our development of the L. P 184.
We think the drug development process for one of the four is actually of central hormone hallmark in a data driven approach.
Our scientists also presented a poster at the virtual a ACR this year.
Poster was initially conducted in collaboration with the Georgetown examining the efficacy and potency of L. P. One of you for in.
And prostate cancers, including and very importantly, those that had DNA damage repair mutations and we believe that the combination of P. T. G. R. One overexpression, along with DNA damage repair and first with the third potential path of synthetic lethality.
Very significantly we also completed of $69 million of follow on offering in January 20th that dramatically strengthened our balance sheet. It for.
<unk> the multiyear runway to execute our plan to harness the power of the radar to innovate precision oncology therapeutics that can bring hope and potentially increased personalization to cancer patients globally.
For those of you that have listened to my prior talks and the earnings calls, namely the and I believe passionately about not only changing the pace at which drugs.
For oncology are brought to market, but also the cost.
And we believe the only way to do this is to use AI and machine learning which has.
Absolutely smashed the product development cycle and cost curve with every other industry.
The growth in radar to over $4 6 billion data points now represents a 16 fold increase since last may and of nearly fourfold growth since the beginning of the year.
Let me put this differently and very simply.
We are adding roughly a billion data points of curated biologically relevant.
Information the guide drug development in cancer each month during the first quarter.
This is the monthly pace of life of the volume of data acquired during the entirety of our 'twenty 'twenty campaigns on.
The campaigns are becoming larger.
Becoming more of the illuminate.
And we're on track now the smash of previous goal of reaching $3 to 4 billion data points by the end of this year, which we already reached and are expecting to achieve over 10 billion. During the next campaign.
We also expect the activity and functionality to keep increasing as our teams collaborate more effectively and soon more in person as we end the near of the pandemic in many locations.
Most importantly, the insights and knowledge that we are now able to acquire from radar is opening up the true tremendous opportunities to not only develop our own pipeline innovative oncology drug candidates, but also the collaborate with other biopharma companies to help accelerate the development of their cancer drug candidates this kind of on.
For the Kennedy will yield potential equity and milestone the arrangements for <unk>.
Lantern and for our investors.
Exemplifying this aspect of our business model is the collaboration with accurate therapeutics that we announced earlier today.
The collaboration focuses on leveraging the radar AI platform on machine learning methodologies and of large scale oncology datasets to accelerate key aspects of the accurate nine I N. G 41 drug candidate and best in class G. S. K III beta inhibitor in active development in multiple phase II clinical trials.
<unk> for pancreatic cancer.
The collaboration is expected to start immediately in fact that has already started and will potentially generate novel intellectual property that will be jointly owned by the companies under the terms of the collaboration lantern pharma will receive upfront equity and actually therapeutics subject to meeting certain conditions of the collaboration as well.
The development milestones in the form of additional equity if results from the collaboration of our utilized and future development efforts. We think this is a great way to leverage this growing assets.
Our mission remains the same to unleash the power of radar and our AI platform to transform the pace risks and costs of oncology drug discovery and development ultimately impacting the lives of cancer patients worldwide by bringing therapies to market faster and with the reduced cost radar has the potential to significantly accelerate our understanding of.
Of which compounds should be developed for which indications and this may ultimately improve and personalized patient outcomes with reduced risk decreased capital and the increase the ability to personalize therapy.
During previous calls Ive spoken about how we are all experiencing and living in the beginning of of Golden age of AI in medicine, an era, where the availability of relevant data of computing power cloud resources, along with on demand sequencing of global talent pool, and the acceleration of AI and large scale data analytics and algorithms.
Along with industrial and economic demands of a line to make highly responsive machine driven approaches to solving complex problems in medicine and health care of reality.
This is especially true in drug development, and especially in drug development that is earmarked by Biomarkers and genomics.
We are harnessing the trends in the capabilities of this golden age to accelerate our expanding pipeline of oncology drug candidates and now also those of our partners.
Since our 2020 June IPO, we've grown the number of programs in active development to seven from three.
Very very critical.
Both from a risk reward standpoint, but also from of shots on goal standpoint.
We are giving more opportunities to investors to generate upside even in the limited amount of time since we've been public plus.
Plus we are now also initiating development of an antibody drug conjugate program and just 10 months, we of more than doubled the shots on goals.
Increase the range of cancers that we can have an impact on <unk> and <unk>.
Significantly increased the number of opportunities for potentially accretive licensing in or partnering transactions were particularly excited by the fact that we're opening into areas, where there's massive clinical need for improved therapies.
Especially in certain rare and ultra rare cancers the.
This may enable us to bring certain assets such as L. P 184, and a T RTP or other ultra rare cancers directly to patients and to the market ourselves. This is an important point to note.
Let's discuss quickly our pipeline.
We remain firmly on track to begin in early in Q and three third quarter of 2021 the Fei.
<unk> two trial of L. P 300 of small molecule drug candidate targeting of growing but unaddressed type of non small cell lung cancer among never among non smokers.
L. P 300 is now likely the most clinically advanced drug candidate anywhere that has high medical high unmet medical need for this patient population Dr.
Dr. Cary Barnhart will provide a detailed update review of the clinical trial protocol later in the call L. P. 300 represents a potentially first in class combination therapy for non small cell lung cancer patients who are non smokers, a histologically define the dean of carcinoma that accounts for approximately 20% of new non.
Non small cell lung cancer cases globally, and actually even more in certain geographies.
We believe that each year about $2 $5 billion spent globally on therapies and drug treatments for this patient population.
Moving on to a more rapidly evolving L. P 184 program. That's now an active development across for disclosed tumor types.
Recall that the among the central features of our business model is to collaborate on the development of our drug candidates and the specific indications with leading researchers in that area. So that we can leverage their respective knowledge and experience in a given the therapeutic area and their experience with therapy for that patient population.
L. P. One of the core is currently an active collaboration with Johns Hopkins and various CNS tumors, including Glioblastoma.
And a T R a T.
With Georgetown University, we're working in studies of L. P 184 in prostate cancer and with Fox Chase Cancer Center inactive studies of the L. P 184 and pancreatic cancer.
We continue to explore additional opportunities for collaboration development and we expect to announce additional collaborations with leading institutions in the coming months.
The scope of work being done at each of our collaboration is to prepare the drug help you want 80 for or other candidates for clinical development and targeted clinical trials, where we have a clear indication.
That the clear indication of the patient need and the mechanism of action and are driving the genomic and biomarker based signature.
We believe that we can gain relevant insights expertise and experience from these kols and we remain firmly on track to leverage this model to potentially begin phase one clinical trials in each of these collaborations and their respective indications in 2022.
We will continue to provide regular updates on each of these programs as appropriate.
Factory of data, we expect in this quarter next quarter for all of these programs.
Among the goals of the ongoing collaboration to help guide the development and validation of the signature of believes that can potentially serve as the companion diagnostic and thereby more clearly defined the commercial potential of each of our innovative cancer drug candidates. It's important also to note that in fact, there was a recent publication.
Done by University of Toronto, researchers that indicated that clinical trial in cancer that used the biomarker or use the biomarker based signature were five times more likely to receive regulatory approvals and certain cancers like breast cancer. It was the.
Increase was more notable such as 12, that's the other cancers like pancreatic and prostate and it was moving lower in like six to seven ex Forex and colorectal.
These collaborations will allow us to get there I believe in a very cost effective and very efficient manner.
For example, our collaboration with the Georgetown is currently focused on validating the role of P. T. G. R. One and the genetic mutations that drive the DNA damage repair pathways that make L. P 184, highly potent and price certain prostate cancers.
Intimately with the goal of the collaboration is to create a more biologically relevant and robust gene signature in preparation for clinical trials with the objective of the allowing the future prostate cancer patients to experience the benefit of a personalized of treatment approach.
We believe the lantern to AI driven approach can save millions of dollars in drug development costs, while significantly accelerating the path to personalization and commercialization of therapy.
We also have the similar research and collaboration agreement with Fox Chase Cancer Center for the further development of 184 L. P wanted you for it in pancreatic cancer. This collaboration advances the targeted use of L. P 184 in genetically defined subtypes of pancreatic cancer.
And also the government of Roomba the gene signature, we believe just kind of open up the pathway to more personalized therapy option that has the potential to improve survival. This program is being led by doctors eager asked gesture of at the molecular Therapeutics program at Fox Chase.
We also announced the new collaboration research agreement with Johns Hopkins too for the development of all people wanted for an atypical keratoid Rab Deutsch tumors or a T. R T and ultra rare and fast growing cancers tumor of the brain that presents primarily in children age.
T. R. T. Notably also is marked by smart b, one deletion either entirely or in part so smart b one mutated cancers represent another category for help you want to do for her.
Hopkins as many of you know is the leading research center for brain cancers, and one of the largest brain tumor treatment of research centers in the world, where the focus on treating patients detected by all types of brain tumors HR.
<unk> currently has no effective therapy on the urgency of directing this drug towards helping children Battle. This particularly aggressive cancer was soft evident as of the opportunity to collaborate with John Hopkins Pediatric oncologist, Dr. Eric Rab, who has devoted his career to studying these pediatric brain cancers pediatric brain cancers of the second.
The cause of.
Pediatric cancer deaths with the incidence rate growing unfortunately, the approximately 2.7 to two 9% per year.
We believe that the rarity of the incidents of ATR tea in the U S and it's actually globally and it's prevalent in children and supports the potential for L. P 184 to qualify in the future for a possible grant by the U S. F D. A for a rare pediatric disease designation.
We were successful in receiving the rare pediatric disease designation.
And if it receives the ultimate approval, we could qualify for getting a priority review voucher that review of the actual represented significant value enhancing milestones for lantern pharma.
These research programs such as the ones of highlighted with the Hopkins.
The Georgetown and Fox Chase are at the forefront of translation on cancer medicine, they'll be used patient derived cancer cells that are studied using physiologically relevant in vitro and even in vivo models. This innovative approach allows researchers to more precisely understand the biology of the tumor guided of course by early stage work.
That's done in a cycle with our radar AI platform. This allows us to more accurately establish the precise signature in a the cyclical manner. This data driven insight also gives us insight into additional mechanisms that can be leveraged in creating the combination programs.
And in creating potentially new targets for new molecules.
Our mission.
Is the transform and accelerate the cancer drug development process. If we can compress the time, the clinical trials and Derisked. Our drugs sections up you want 80 for we can save years of research and tens of millions of dollars of developing treatments for G. B M E T R T pancreatic and other potential.
Potential rare or ultra rare cancers, such as the ones. We're currently evaluating.
Also in talks about what our team has the also published was also published manuscripts, describing the efficacy of our drug in a variety of different models such as.
The one republishing unco target just over two weeks ago.
We're the clear clinical need for L. P 184 for non small cell lung cancer patients that are ineligible for targeted therapy for have developed resistance to other forms of therapy for us. This is a very interesting target because of on.
Complementary approach for the L. P 300, where we're targeting non smokers that have been very different molecular profile.
Similarly L. P. One of the four goes again for a very unique subset of non small cell lung cancer patients that aren't responding to targeted therapy for are no longer eligible so meaning existing targeted therapies, such as Egfr of Alex inhibitors will only work on genetically defined patient sets.
It's about 30 to close to 40 per cent that don't have those target of alterations such as Egfr al seed net and of or have developed resistance to the current standard of care therapies.
That leaves us patients for the out additional therapeutic options and actually not a very good prognosis. We believe that L. P 184 could potentially be effective in that patient class. We're now working pre clinically to show how L. P 184 inhibits.
Two of growth we've shown that now in the mouse xenograft model of K, Ras and P. F. One mutant lung cancers, and co occurring K Ras and T. F. One mutation of current about 17% of lung adenocarcinoma.
And the carcinoma cases and are of very aggressive form of lung cancer that is believed to be usually undruggable. We've developed the genomic signature that is believed to rep. We predict response in tumors that will be responsive to 184 and guidance further development of the drug.
Using the data driven approach we've shown that we not only we can find unique biomarkers that linked drug response of mechanism, but we can also rapidly uncover a clinically meaningful patient subgroups that can benefit from our portfolio of therapies in the past 10 months of being publicly our team has accomplished a significant amount.
In terms of advancing our portfolio uncovering new indications and very importantly, advancing our radar.
For them, we believe that together this will provide the potential for multiple of shareholder value enhancing milestones over the net for <unk> 2021 and 'twenty 'twenty, two and we have sufficient capital to achieve those milestones.
Now I'll hand over the call for David Margaret.
Our CFO for a review of our first quarter financial results and the.
Yeah.
Thank you Paula and good afternoon everybody.
I'm now going to share some of the financial highlights from our first quarter of 2021.
Yeah.
For the quarter ended March 31 2021.
We had a net loss of approximately 2.4 of $5 million.
For 24 cents per share.
Compared to a net loss of approximately.
477000 or.
For 24 cents per share per quarter.
<unk> ended March 31 2020.
Research and development expenses were approximately $1 3 million in the first quarter of 2021.
Compared to 137000 for the first quarter of 2020.
The increase was primarily attributable to increases in research studies.
Expansion of our research team.
The noncash research and development related stock option compensation expense.
We expect we will continue to increase our R&D spend.
We further advance our portfolio and recently initiated a D C program and moving towards commencement of additional clinical trials and research studies.
General and administrative general and administrative expenses.
For approximately 1.2 million for.
The first quarter of 2021.
<unk> to approximately 340000 for the first quarter of 2020.
The increase was primarily attributable to an increase in expenses associated with operating as a public company.
Along with increases in noncash general and administrative related stock option compensation expense.
Our team has also continued to grow.
We currently have 16 employees.
12, full time and for part time.
Who are primarily focused on leading and advancing our drug development biology and data science efforts.
We expect to operate in a hybrid work environment.
Looking for both in the office and remotely for the near future.
We look forward to moving towards the post COVID-19 environment, and improving our productivity even more.
As of March 31, 2021.
We had 11 million on her name.
The 1447 shares of common stock outstanding.
This amount includes a million of 928000.
571 shares.
The order issued in our January 2021 follow on offering.
At March 31, 2021 we also had warrants.
Purchased 305290 for shares.
And options to purchase.
823000.
826 shares.
These outstanding shares of common stock.
The other with warrants and options combined.
Give us a total fully diluted shares outstanding of $12 million.
310567 shares.
Yes.
Our cash position at March 31, 2021 was $81 4 million.
As a result of our 2020 development in the operational progress as part of discussed.
We're able to significantly strengthen our balance sheet in the first quarter.
With the closing of of 69 million for follow on public offering of January.
This additional cash extends our untested anticipated cash runway through mid 2025.
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 product opportunities and the capital efficient manner.
Thank you and I'll now hand, the call back the Potter on.
No.
David Thank you very much.
And would now like to invite Dr. Cary Barnhart colleague and our vice President of clinical development to provide everyone an update on our L. P 300 program as.
As many of you know or for those of you that are new L. P. 300 is a small molecule I saw a disulfide bond disrupting agent, which we believe can play an important role in the treatment of non small cell lung cancer and never smokers.
Gary welcome for the call them. Please go ahead.
Thank you Panna and good afternoon, everyone on the last Tuesday April 27 Lantern pharma submitted to the F. D. A its plans for the further clinical development of L. P 300, it never smoker patients with lung adenocarcinoma building upon earlier clinical results from an international.
Phase three trial conducted by bio on American its partners, which showed a clinically and statistically significant survival benefit from adding L. P 300 to standard chemotherapy in this unique patient population lands from plans to conduct a new trial, we're never smoker patients who have really.
Laughs disease after being treated with either tyrosine kinase or immune checkpoint inhibitors, but having not been previously treated with standard chemotherapy will now be treated with either standard of care of chemotherapy or standard of care chemotherapy plus L. P 300.
Of this trial, which we believe can best further confirm the attitudes of survival benefit of the L. P 300 will enroll approximately 40 patients in each of the two treatment arms.
In addition to providing the F D a.
A full description of our clinical development plans. We also submitted supportive preclinical data from a bridging study that we conducted during the first quarter of this year. The shows the Tolerability of L. P 300 added the standard of care of chemotherapy.
We entered the also requested a meeting with the FDA to discuss these plans and the FDA has granted that meeting request that meeting has been scheduled now for the third week of June.
And finally, I'll just comment that new L. P 300 drug manufacturing is ongoing currently and we anticipate having final drug product available for use in the clinical trial in the second half of this year.
And I'll be happy during the Q&A session to answer anybody's questions about our clinical development plans for this molecule and with that going on I'm trying to get back to you.
Kerry Thank you.
Before we open up the call to questions a few closing comments.
Moving forward, we will continue to strategically grow radar to become among the world's largest AI platforms for oncology drug discovery and development.
We're confident that not only are we entering a new era.
Of drug discovery, what I called the Golden age of medicine, but at the gross of radar and the growth of the algorithms will continue to present additional opportunities for R&D collaborations such as the agreement we announced this morning with accurate therapeutics for.
We're excited we're excited to soon begin our L. P 300 trial in non small cell lung cancer. Among never smokers are very unique of needed patient population.
We also anticipate updates on our various collaboration and development plans of the L. P 184, and L. P 284 <unk>.
Likewise, our antibody drug conjugate program continues to advance and we're working on refining the conjugation and chemistry with that molecule and we plan on Britain getting into clinical trials in 2022.
Our data driven genomic with targeted and biomarker driven approach allows us to pursue a transformational drug development strategy that identifies rescues or develops.
Potential drug candidates at what we believe it's a fraction of the time and cost associated with traditional cancer drug development.
Our dual approach to both developed and Novo biomarker guided drug candidates such as L. P 184, and $2 84, and also rescue of historical drug candidates such as L. P 300 by leveraging the datasets in our radar AI platform, along with the continuous advances in genomics and computational biology.
We believe this is emblematic of a new era in drug discovery and development and one that Atlanta is the leader.
In this context for where our focus on building a portfolio of quality potentially high value oncology drug candidates each of which can be potentially partnered for pivotal registration directed trials for potentially out license and we believe this provides a clear and defined path for potential high value creation for our shareholders for.
Perhaps even brought to market directly and certain rare and ultra rare indications.
Were focused on establishing lantern, a day, leading AI driven oncology drug discovery and development brand and franchise. We're building a company that can deliver enduring and significant value for our shareholders.
There are potentially every decade.
Our many thousands of discarded or otherwise the prioritized therapeutic candidates across the industry and academia, we aim to bring at least one of these into our pipeline every 12 to 18 months. We are laser focused on the quality of rescue on the quality of the new drug candidates and our aim is to build the franchise.
<unk> with significant long term value.
It's also worth mentioning that the board and management collectively own well over 25% of Lantern pharma.
I'll leave the Golden age of AI in drug discovery and development is here in Atlanta and of the lead the one of the leaders in this paradigm shift in this paradigm shift will bring a change in the pace risks and costs of oncology drug discovery and development.
We believe that we're proving that the significant efficiencies in the time and cost of oncology drug discovery and development of possible such as time, the new indication time, degenerating signature time to uncover and combinations and most importantly, bringing those insights into an actual.
Number of product in your pipeline.
As our history or history of share them with more than doubled.
The number of candidates that we're pursuing and programs through the rapid identification and validation, where we're understanding the molecular drivers of cancer and perhaps the molecular drivers of response to specific compounds in a much more targeted way and one that we believe can be more effective for oncology drug patient oncology patients.
Crucially as our radar AI platform grows over the coming year to perhaps exceed 10 billion data points, we anticipate the discovery of additional high value targets and indications of monotherapy and combination therapies for as part of our antibody drug conjugate platform. We look forward to sharing our ongoing progress with you in future update.
And we would like to answer any question that investors or analysts have on this call. So with that I'd like to open up the call to questions.
Gentlemen, thank you and to our listening audience at this time, if you would like to ask the question. Please press the star and one on your Touchtone phone you may remove yourself from the queue at any time by pressing the pound cash once again that is star and one to ask the question and we'll pause for a moment to a lot of questions too.
Q.
Our first questions.
Our first question the day, ladies and gentlemen, it's kind of come from Jon Vander most of them at Saks SCR of please go ahead.
All right good afternoon.
Wanted to start off for the question on the on the data points and what's behind the exponential growth of them.
It seems like if you look on the chart. It just keeps on accelerating how is that how is that debt.
Very good question you know partly.
When we went publication of the team was much smaller so we've added some great great team, we'd give them good resources, but we've also invested the time on the infrastructure side.
Largely driven by our chief architect of principal architect it to focus on automation. So on any test that we tried to do we try to automate it.
And so.
We can get a lot of done more importantly, we're able now to scour of data sources internally and externally.
With a lot more precision.
And then of the prioritized the pipeline and as we've gotten more experience with sucking in data and understanding what problems. We had with the quality of data issues are wherein theres duplicate data again, we put all of that insight back into the automation procedures and so as the second more data we understand what were the exceptions are where the excess.
<unk> or not.
And that's allowed us to a second more and more data faster.
So that's kind of been the process and as I mentioned, we're planning our next campaign and we believe our next campaign should get us very close to 10 billion.
Whether it takes three months for six months or you know, we're not sure but for the process of trying to obviously beat our last campaign, where we sucked in all of the 3 billion data points. So yeah. It's a lot of it of automation a lot of US learning what goes why what goes wrong on.
Understanding how to handle and manage the exceptions and then building that into pipelines that are more self aware.
Okay and.
And next question is on L. P to 80 for it I wanted to make sure I understand I understand that molecule.
It's the mirror image of of $2 80 for is that right.
Oh, it's a mirror image or the serial isomer of what's called the 184.
Okay, So theyre not.
I mean, I guess, the orientation of 184 and an annuity for us distinct.
Correct Yep, yeah, Okay. It depends on the mixed together than a non summers of mixed so I guess the there they are distinct and I guess has there been a lot of preclinical work done that youre using in your and your AI work to look at the effectiveness and side effects of both of these and <unk>.
There has been some not of significance since 284 as it is the new molecule. There really is no of historical work that we can rely on where we're doing the work.
But we can learn from kind of other precedents, we can learn from similar chiral situations, but it's the new molecule. So there's really not much work done at all on this kind of molecule since it's new we patented it.
So this is like we said it has some surprising distinct properties and.
Hematologic for blood cancers, where 184 does not.
So we're actually quite excited by it because.
Our initial low speed.
Be honest on initial thought.
This is kind of rewinding, but it's a little more of the labor when we first did 180 for it.
As a molecule it was created semi synthetically, which led us to this mixed negative and positive enantiomer of mix.
Because of the semi synthetic because of the occurs naturally that way when.
When we found the results of the semi synthetic molecule there was an underlying.
Thesis or beliefs that the muted effects that we saw in many of the cancers was because there was different binding between the positive and negative in antitumor and this actually had been observed in other anti cancer drugs.
And so many drugs are separated based on the NAND to more of like Bendamustine in.
I believe that's one of them the case studies and so there was the thought from our chemists that perhaps we need to purify and really get to the negative of NAND tomorrow or the positive enantiomer and that's actually the one that has the stronger potency as predicted by the AI engines.
And we said, okay that makes sense and this is one of the actually the free for things when we were a private company that we looked at and started working on and.
And there were a lot of debates about whether this molecule was in fact different and unique or whether we're not seeing the potency that we should've seen and so the enantiomer thesis made some sense and we chase that down.
We made then we invested significantly in creating a fully synthetic route of 184, not starting from alluded the fungal cultures, so starting purely from a pure synthetic chemistry.
And we found that in fact 184 was super potent as we know it minimal of potency and many of the solid tumor is actually better than what was expected and of course, what we saw as the neither the effect was because of the positive of NAND tomorrow, not having the same kind of binding strength in property and actually.
Kind of muting the effects of the negative enantiomer.
So in part the positive enantiomer for awhile.
And we said, okay, we have to really characterize its negative enantiomer and so as you've seen we had more money in capability. After we went public we characterized 184 to depth, which which Joe the sequences for some types of cancer with the CRISPR editing to figure out if PT jar of what it was the driver.
We really characterize the molecule.
And there was a thought from some of our team members that perhaps we should benchmark.
284 versus 184.
And some more.
Studies and as part of the studies we found.
Found that in fact acuity for was very potent in certain hematologic cancers, and it's still very early and we still have to take this to the right more relevant physiological models and small animals et cetera on the pdx, but what we're finding is that in fact the blood.
Cancer is and which 184 really doesn't have much of the sac because P. T. G. R. One is not present as the driver and many of the other genes that are required for one or two for the habits potency that those are not hallmarks of many of these cancers.
And so we believe QAD for does work in a very different way and so what was seen as potentially a weakness in solid tumors has turned out to actually be of strength.
In certain hematologic cancers, and so as we grew the team we had the bandwidth from the time to really pursue that indication in fact now we have some ideas as to why we have more data we filed IP and so you know it's it's really the.
It's very really very very interesting you know.
But it's still early we hope they will get more data as we pursue to 80 for it in blood cancers.
Thank you. Our next question today will come from the line of Cai of Bowser at Colliers Securities. Please go ahead.
Yeah.
Hi, This is Kim of Hostettler on for Kyle Thanks for taking the question on.
We just cannot be Kerala.
Yeah. We are just wondering about cash position and potential outside of acquisitions. I think you mentioned that cash would be especially on the thrill of 2025, but does not consider potential outside of investment on that.
The current pipeline and how should we think about your appetite for acquiring additional assets to the balance.
That's a wonderful question.
I'll, let David talk little bit about our <unk>.
Cash position the cash usage and then we'll talk about where we are on the BD pipeline.
Ex on them.
So we had $81 4 million.
At March 31, and.
We see our.
The expenses growing as we move through this year.
The net loss of $2 four of 5 million for.
For Q1.
We expect that will grow from current levels.
During the remainder of 2021.
We see R&D growing at a higher rate the G&A.
As we look to 23 for will.
Multiple trials in progress.
Our expenses will grow grow even further than that.
Our operating plan has the potential for.
Bringing in new candidates.
As part of our plans. So that's that's built into our estimates.
With respect to our runway.
We always want to.
On the lookout for those sorts of opportunities and I'll turn it back to part of to drill down a little bit more on that.
Thanks, So we've been fairly disciplined way to look at.
Assets in fact, one of our programs that we have internally.
Debt isn't quite really radar, but somewhat you know eventually I think it'll feed into radars also of data driven approach to look at all of oncology drug assets, we have an internal on.
Database called T for it's called transforming trash the treasurer that looks at every single oncology trial over the last 12 to 15 plus years by drug class by failure by category by drug type by and then characterizes those drugs on the trials on the reasons of failure of the <unk>.
<unk> weighed on the.
Indications.
And also on new new new combinations of new ideas and the drug classes. So we've looked at thousands of thousands of oncology.
Oncology drugs and prioritize the ones that we think are of interest.
And we go after some of those.
Proactively.
And we get the many many many opportunistically literally every Tvs.
But again, we have a disciplined process and we'll deploy capital disciplined way, but I don't think there'll be anything that'll take a meaningful or significant portion out of our cash position, but yeah. We have a good appetite we were very good but very well informed appetite for new drug assets.
And our next question from our phone audience today will come from Keith or excuse me from Daniel Carlson at Tw Research Group. Please go ahead. Your line is open Sir.
Thanks.
Thanks pound of.
Question for you on thank you for them.
Yeah.
A question on the L. P 300 trials.
If you can provide some more details on that trial and also.
Seems like it might be right for a partnership on the ones I'm wondering if you are looking to further monetize that or accelerate that trial of somehow.
Sure.
I'll, let Carey talk about some of the details on the.
The trial of the process to the extent that we can and then I will answer your questions about.
Kind of further monetizing that asset and some of the ideas around that.
Terry.
Sure.
As I described this is going to be a phase two randomized two arm trial in which we will be looking at never smoker lung adenocarcinoma patients who have failed. The initial therapies designed to target their tumors, whether they're tyrosine kinase inhibitor therapy.
<unk> or immune checkpoint inhibitor therapy.
And for those of those therapies actually do a fairly good job in many patients of showing initial responses, but unfortunately virtually all of those patients will eventually relapse and those therapies will not work for them and the standard of care to treat those patients is now commonly a platinum based chemotherapy.
Doublet, which is similar to what.
Historically L. P 300 showed statistically significant.
Survival benefits for us so we will be treating these patients after they fail their initial therapy.
With either standard of care of chemotherapy.
Standard of care of chemotherapy with the addition of L. P 300, and we are in the process right now of talking to sites, we have a small handful of sites.
The indicated initial interest in participating in the trial.
We're interviewing see our OS to bring on board a trial management and operations team.
And I think we'll be releasing more details in the coming months about all of that but part of the I'll turn it back to you. If you wanted to comment on partnership.
Yeah. So one of the things we want to do is get through and scale up the trial.
The that'll open up opportunities to potentially partner of the asset as I mentioned eight per cent.
For approximately 20% of.
The.
Non small cell lung cancer cases seem to be occurring and.
Never smokers and the never smokers tend to be predominantly female 66% of leased in the U S and the U K in fact of the 70% in some parts of Asia, it's closer to 80.
And there's not a lot of good options, but many of the big pharma companies Astrazeneca Merck Roche have wonderful I O programs that have blossomed over the last few years and those Io drugs work really well in smokers that have high tumor mutation burden.
Interestingly enough non smokers are never smokers actually have a very low tumor mutation burden on.
Very quiet very subtle mutations very different profile, so they don't respond well to Io therapy.
Or even the Io plus chemo.
And so we believe that there's a great way to monetize this by partnering with some of the larger players for us good storied franchises and non small cell lung cancer and so we'll be we'll have to do plan on having some of those discussions as the phase II trial watches and goes underway.
The way we're currently planning for it is as Carey mentioned in the multi arm trial is we have seen historically that there becomes kind of a separation of the survival curves in the healthy 300 treated arm versus the standard of care arm at around <unk>.
10 to 12 months, you'll start seeing this kind of separation began.
And as we have further discussions we're thinking about kind of of a peaking of review at around that time.
Based on how many people we've got enrolled so I think you know in terms of monetizing of can we monetize the interaction of that event.
At around 12 months after the peaking period after the launch maybe it really depends on enrollment, but I definitely think of the heels of the end of the of the the first 12 to 18 months of enrollment I think there'll be a lot of big pharma that have franchises in lung cancer that actually have tried to go after non smokers in the past.
That would have a lot of interest in this asset.
So for the answers your question Dan.
Certainly thank you gentlemen, our next question comes from Keith skilled at counter Cherry and company.
Hey, Anthony.
How are you.
Okay. Thank you Keith.
Congratulations on all your.
Okay.
Yeah.
Kim Crawford.
Are you still there I believe we may of last year. Sir. Please go ahead and press the star one once more for Sir.
Yeah.
Hello, Mr. Gil can you hear us can you hear me okay.
Yes, Sir please continue.
Right.
Hello can you hear me. Please go ahead.
Oh Im sorry, okay. So again congratulations on the accurate.
RFP agreement now is this the model for future deals could there be possibly cash milestone, but we're on.
All the payments and how many or how often.
Lantern.
Of these type of deals thank you.
Great. Thank you Keith.
You know, we're not a service company or a services company of where we're going to continue focusing on developing.
Innovative are extremely high value oncology therapies, we will do it with partners, where we believe we can get a interest and the therapy or on the company.
And with actuate it happens to be very like minded groups, where they think that AI and biomarker driven approaches can accelerate their process and help them get to an exit and more importantly helped them define the right responder group, which is very valuable.
So I think those kind of of efforts we plan on taking the.
Collectively knowing that we're gonna be taking potentially.
Potentially equity or deferred cash or equity plus milestones based on success.
So.
I think the cash will come down the line I don't think we're going to try to build the of franchise. We're just doing is just purely for cash of services I think the bigger upside is and in doing this and drugs, where we have a higher likelihood of succeeding in getting it through the pipeline and then taking the.
Percentage of that company are taking a percentage of that drug assets I think we will see many of those types of deals hopefully over the coming quarters.
The next we'll take a follow up gentlemen from Daniel Carlson of Tw Research group.
Hey, sorry, guys I had the same question said no need thank you.
Yeah.
Oh very good. Thank you, ladies and gentlemen, once again that is star and one of if you would like to ask a question, we'll hear from Steve of POS Stitch at Builders, Inc.
Hello, Firstly on the I'd like to congratulate you and your team on the tremendous progress you've made over this last year.
So really satisfying for me to be an investor in your company.
Hi, Thanks.
The sure I thought you said the I heard you say that the the trial on the L. P 300, it was going to start on the second half of the sheer and.
And there was going to be approximately 40 patients involved in that.
Well, they all be women and will there be an age limit of on that on them.
Wonderful question, Steve I'll, let him actually carry of clarify I think there'll be two all of our.
For sure do you want to go ahead of me clarify that absolutely. So there are there will be two arms with 40 patients in each arm.
And they will not be exclusively women they will be exclusively never smokers.
We may in fact have a higher percentage of women just because there are a greater percentage of the I've never smokers that are women.
Lung adenocarcinoma.
But we will be stratified in each.
Individual clinical site for both age and gender so that in each individual clinical site there won't be an over balance of.
Age or gender and there is not at this point in time, a specific age limit there will be typical inclusion criteria for ex U know.
Life expectancy and performance status, but we do not have an upper limit of age there is a lower limit 18 or older.
But there is not an upper limit of it.
But the upper limit of age, mostly sort of where you probably know will be covered by many of the comorbidities or other conditions so but.
But yes.
Does that answer your question.
And gentlemen on his life income returned to the audience. We have no further questions coming from our audience today I'd like to turn the floor over to Mr. Sharma for any closing or additional remarks.
Thank you Jim and thank you for all of you for your great questions and we hope that in the future that we'll be able to meet with many of you in person to share some of our progress.
Of our team, we expect to be even more productive in the coming quarters and continue to have the discipline both on our.
The investments and on our balance sheet, but focus on developing and innovating on the drug development process and oncology. We believe our AI platform is unparalleled in terms of the size and scale and will continue to grow through the year, even more and more rapidly and as our drug programs continue to progress.
Yes.
Through clinical trials and in clinical development, we believe that any one of these opportunities can represent.
Exit and value points that are several times, our existing market cap so with that I'd like to thank you for your questions and we look forward to talking with many of you face to face in the future.
Ladies and gentlemen, this does conclude today's program. Thank you for your participation and you may disconnect at any time.
[music].
Yeah.
Okay.
Okay.
[music].
Okay.
[music].
Okay.
[music].
Yeah.
Hum.
Yeah.
Yeah.
Hum.
[music].
Yeah.
[music].