Q4 2021 Lantern Pharma Inc. Earnings Call
Attendees are in a listen only mode.
We'll open the call for questions and answers after management's presentation.
Nicole lever with Investor Relations at Atlanta in pharma and I will be your host for today's call I will be joined by CEO and President Panna Sharma.
F O David Mark grades and CSO Kishore about yeah.
We issued a press release after the market closed today summarizing our financial results.
And progress across the company for the fourth quarter and fiscal year, 2020 one.
And a copy of this release is available through our website Atlanta and from a dotcom.
And where you can also find a link to the slides that management will be referencing for today.
Following the Safe Harbor statement will provide an overview of overview of lantern pharma is operational highlights after which David will discuss our financial results, which will be followed by Dr. <unk>, who will provide a.
An update on our development programs finally, panna will offer some concluding comments and then we'll open the call for Q&A I.
I would like to remind everyone that remarks about future expectations claims and prospectus constitute forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1995 Lantern pharma cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially.
<unk> from those anticipated.
Number of factors could cause actual results to differ materially from those indicated by forward looking statements versus the impact of the COVID-19 pandemic.
The results of clinical trials and the impact of competition.
Additional information concerning factors that could cause actual results to differ materially from those in the forward looking statements can be found in our annual report on Form 10-K for the year ended December 31, 2021 which is on file with the SEC and available on our website forward looking statements made on this conference call are as of today.
Thursday March 10, 2022, and lantern pharma does not intend to update any of these forward looking statements to reflect events from circumstances that occur after today unless required by law.
The webcast replay of the conference call and webinar will be available on <unk> website, and with that I would like to turn the call over to Panna, President and CEO of Atlantic in Farner Pan out. Please go ahead.
Thank you Nicole and thank you all for joining us.
Our June earnings call and webcast.
I'm really happy to be here with my colleagues and I'm sure in person.
We have a significant amount of opportunities progress and activity to share with you. All you all across virtually every measure of Barclays.
During 2021 and 2022, we've had a very productive and very fruitful.
14.
And I'm very proud of the effort.
Excuse me.
For the past 12 or 15 months.
Before I begin, though I'd like to take a moment.
More serious note.
Sure our concerns and voice of our support for the people with families and country a few points.
Violence and destruction.
<unk> has no question the economy, just decided to do it.
Personally.
Joining with many other biopharma Ceos.
And what you might be some aggression.
Quinn from Russia.
Coming back to life in Florida, I'm extremely proud as I mentioned with our teams' efforts.
Execution in the fourth quarter and throughout 2021, we've made many meaningful progress on multiple fronts clinically technically operationally and also on a regulatory front.
Brian Carey radar for that platform.
Also has no. It has now surpassed 18 billion data points and has grown by more than 1000% from last year significantly exceeding our growth expectations from earlier in the year and we've now.
Our target to $2 5 billion data points this year.
We've also grown the number of algorithms to power your analysis and run the classes of albums and our ability to manage the all of them.
And data are key.
Critical pieces in driving insights the power of our portfolio and help us develop new drugs faster and cheaper.
This increase in the power of our platform and data points provides us with several long term importance.
First we are accelerating our drug development by <unk>.
Given us ideas about the feasibility of different drug candidates or combination.
It allows us to uncover new therapeutic opportunities like we did with <unk>.
It allows us to look at potentially in licensing new contact lens with a certain level of de risked.
And it allows us to find new uses for existing drugs.
Thank you.
No one other as you look at additional tumor types.
It also allows us to develop insights in terms of how we will increase combination therapies group and <unk>.
Calling for sure talk a little bit about some of the.
First data readout switching combinations that where appropriate.
Finally, and very importantly, the one of the biggest advantages it expands our ability to collaborate with additional Biopharma partners.
Believe that the platform is now to say youre working to use not only for our existing portfolio, but for many other drug development portfolio in oncology.
This presents us with lots of new opportunities for value creation in the near term.
Obviously, the goal is to reduce the cost reduce the risk and accelerate the timeline to develop oncology medicines by uncovering insights on drugs from interactions and developing companion diagnostic type approaches potentially signatures that can be used that are central in understanding which patients are most lie.
I think to respond and which tumors are most likely to be sensitive to our drug programs.
They're monumental for combination therapy.
The likelihood of bringing a drug to market is on average five times or higher.
By those that are developed with a biomarker signatures than those that are not.
This was a study done by Dr. Jason Parker existing at University of Toronto.
Ultimately radar gives us the ability to potentially benefit and select patients that have the best option for our drug therapies, where the combination therapies that we understood that we are uncovering a fraction of the cost of traditional drug development.
We plan on furthering our data expansion and the curation. This data moving forward, but very specific areas. Let me talk a little bit about those areas. One of them was in hematologic cancers, we started campaigns and growing demand for blood cancer data points. We'll continue that focus here for 2022, and Kishore will talk a little bit about some of.
Insights into blood cancer space will also enrich our platform in pediatric and rare cancers. As you know we announced a collaboration recently with University of Texas San Antonio.
Degree heat children's cancer Center.
We also plan on focusing on immuno oncology related to studies and trials and should we expect to uncover potential new combination opportunities for 184 to 84 and 100.
In addition to the data points and data sets to radar. We're also focused on the growth and evolution of our library of algorithms algorithms are critical because they are giving us new ways to correlate the data.
Finding new insights they allow us to automate the collection of the data automate the structuring of the data and it gives us ways to make decisions and a de risked and faster timeframe.
These algorithms also allow us to rapidly identify cancer subtypes that may have gone unnoticed or have been poorly understood and provide insight into the potential drug target interactions.
Algorithms can also help further our ability to uncover patient groups that can respond to specific drugs.
Not only.
Initially, but perhaps even over a course of treatment.
Now, but with such an incredible assortment of both data and algorithms as a growth. We've also embedded in our management of the algorithms.
Debit ops environment streamlining development operations environment. This is important because the management of algorithms becomes much more complex, especially when you use multiple algorithms.
With thousands of potential parameters and you're using what we're beginning to use increasingly which is an ensemble approach for algorithms are used together. So we multiplied our ability to get into greater precision or makeup for weaknesses of certain algorithms have by using other outlet.
All of this is critical because it helps us define and develop the strategy of bringing a drug to market and develop a potential combination approach of a companion diagnostic and this allows us to have a higher chance of approval.
And a faster route to getting to patients.
We think this will be a long term strategic advantage as we deepen our capabilities in two very important areas, both antibody drug conjugates and combination therapies. We believe that this will help with increasing number of patients and ultimately add significantly more value for investors.
Now turning to our biomarker signatures. We think this is an area of real importance. It was as I mentioned there was a recent study about a year ago that was conducted by published by Dr. Jason Parker University of Toronto. He had reviewed he and his team reviewed over 10000 clinical trials.
And cost about 745 drug programs. In this study showed that <unk> moniker based trials of success rates that were 4% to 12 times higher than those clinical trials, but did not use biomarkers. The study team also concluded that there is clear evidence of Biomarkers increased clinical trial success rates in multiple indications mainly of those.
<unk>, which we're going after.
And this is a hallmark of our development process. This further encourages us that utilizing our radar platform with our drug candidates and potentially with other drug candidates.
Can have a very meaningful way, reducing costs and accelerating our ability.
To get.
Our drug.
It's two patients.
As you know we began to witness firsthand growing industry interest in AI and machine learning solutions, especially ones that help innovate or de risk the development of precision therapies and combination therapies. We believe that there is a growing appetite for these kinds of solutions. Many of the solutions our data powered or powered by AI approaches.
In learning techniques, and we think these techniques will increasingly be adopted by bigger biopharma companies and ultimately yielded greater investor value for us.
Now before passing the call over to David to discuss our financial results I want to briefly talk about some of the highlights.
In 2021 and into this year of our drug development candidates.
During 2021, we have multiple areas, where we advanced our drug programs, we reported positive preclinical data for LP. One of these four patriotic cancer and Glioblastoma and also on our rare pediatric cancer Herc. We also advanced <unk> 300 for a phase II clinical trials of harmonic trial for never smokers non small cell lung cancer.
This will be at 90 patients randomized phase III clinical trial, two arms, where LP 300 will be co administered along with a chemo doublet to patients that have failed or stock prep stop responding to <unk> therapy, and we will be looking at the Cove endpoints of overall survival and progression free survival the unwanted clinical trial.
We are actually looking at sites today.
One arm will be 60 patients to two to one ratio when our own will be 30 the controller.
We began an assessment also of the next phase of our other phase II program <unk> 100 in metastatic castration resistant prostate cancer. We've actually also found that there are several other cancers will be that could be very sensitive to this drug and we'll talk about that little bit later and also share more of the data from that trial the trial.
Has dosed nine patients and a target of 27% and the median overall survival for that initial cohort has been 12, five months, which is higher than other.
Other fourth and fifth line trials have been done in metastatic castration resistant prostate cancer we've.
We also presented positive data.
Late last year at Ash for a new drug <unk> in hematologic cancers, including several rare blood cancers, such as mantle cell lymphoma and double hit lymphoma.
We plan on sharing additional data on this drug program later this year and also announced research collaborations in that program.
As a result of the encouraging results in 100 before in regards to Glioblastoma and pancreatic cancer. We were granted orphan drug designation in both and also in <unk>, where we additionally got rare pediatric designation.
This not only allows us to have tax credits for the trials being done here in the U S waiver of marketing registration application fees, reducing product fees, but these are massively important because they reduce our burden as development to give us increased commercial protection and a potentially gives us a voucher that upon approval, we can actually sell for.
$100 million to $110 million.
Also these orphan drug designations give us validation of our AI driven approach. Both of these were all three of these orphan drug designations are achieved.
Quite rapidly based on the data and insight driven from our machine learning algorithms and our AI approach. We also submitted an abstract with Fox Chase cancer Center researcher Dr. Eager astra's drug even established NCI funded physician scientist who is also a co leader of the really big pancreatic cancer Institute of Fox Chase.
And there was also presented for virtual conference at ACR.
The data showed that <unk> hundred <unk>.
It was very attractive and potentially as a synthetic lethal agents in pancreatic cancers that have DNA damage repair deficiency. This is an area that we're particularly excited about and we believe gives us a roadmap for prioritizing additional cancers, where we can develop a first in class solutions and showed significant improvement over the existing standard of care outcomes.
Yes.
We also showed that.
GBM.
We also had a very good responses work was done in conjunction with Kennedy Krieger from Johns Hopkins University. This is a multibillion dollar indications in both pancreatic and for GBM. We're now in.
IND, enabling studies, which are.
Already quite long and these studies will allow us to file.
The IND for.
For this year and then get into phase one human trials hopefully later this year.
We also believe that another development that was important for us our technology collaborations we announced two very important technology collaborations last year. Your one with deep lens in order to accelerate our ability to find patients best suited for our treatment in our harmonic trial, a trial, but never smokers and we announced the collaboration.
<unk> with code Ocean that allows us to scale up more securely and Containerize, our AI platform. So both codell versus <unk>. We believe are best in class technology partners and they both offer us ways to scale up our ability to add more important as they align with our philosophy of using data and technology to axa.
<unk> for developing medicines.
More importantly, it allows us to do this in a cost efficient environment.
David will walk you through our financials has been financially very disciplined.
Not only internally, but also the types of studies that we launched in the types of collaborations as we generate and this collaboration will have quite a bit of data coming up this year.
So our current cash resources will give us a great runway for our development programs well into 2025, not only in part because of the good financial discipline that we show but also.
And the way that we're actually developing our programs in designing our trials to shed more light on that David our CFO will provide an overview of the fourth quarter and full year financial results David.
Thank you Panna and good afternoon, everyone.
I'll now share some financial highlights.
From our fourth quarter and the full year ended December 31.
<unk> 2021.
I'll start with the review of the fourth quarter.
Our R&D expenses were $2 2 million for the fourth quarter of 2021.
Up from $1 4 million in the fourth quarter of 2020.
As was the case throughout the year the increase in R&D expense was primarily attributable to <unk>.
Increases in manufacturing related expense for product candidates and.
And to re research studies and R&D payroll expenses.
General and administrative expenses were $1 4 million for the fourth quarter of 2021 down from $1 6 million in the <unk>.
Prior year period.
We recorded a net loss of $3 5 million for the fourth quarter of 2021, or <unk> 31 per share compared to a net loss of $2 $9 million.
<unk> 47 per share for the fourth quarter of 2020.
For the full year of 2021, our R&D expenses were $7 6 million.
Up from $2 2 million for 2020.
As mentioned a moment ago. This increase was primarily attributable to increases in manufacturing related expenses for product candidates.
Research studies and RMB payroll expense.
Specifically for the full year 2021, our product manufacturing related expenses increased by approximately $2 $7 million, while research studies increased approximately zero point $8 million.
R&D payroll expenses were up approximately zero point $7 million.
Additionally for the full year 2021, we recorded a nonrecurring expense of $1 million related to the upfront payment to <unk> therapeutics in July for the global rights to <unk> 100, our phase two asset for the treatment of metastatic castration resistant prostate cancer.
Okay.
Our general and administrative our general and administrative expenses for 2021.
$5 million.
Up from $3 7 million for 2020.
The annual increase was primarily attributable to increases in business and corporate development expense of approximately zero point $4 million.
<unk> and corporate insurance expense of approximately zero point $6 million and.
And increases in legal and patent related expenses of approximately zero point $4 million.
Our R&D expenses continued to exceed our G&A expense by a strong margin.
Reflecting our focus on advancing and expanding our product pipeline.
Net loss for the full year 2021 was $12 4 million.
Or $1 13 per share compared to $5 9 million or $1 37 per share for 2020.
As of December 31, 2021.
We had approximately $11 1 million shares of common stock outstanding.
An outstanding warrants to purchase approximately 274000 shares.
And outstanding options to purchase approximately.
891000 shares.
These warrants and options combined with our outstanding shares of common stock.
It was a total fully diluted shares outstanding of approximately 12 3 million shares as of December 31, 2021.
Our cash position, which includes cash equivalents in marketable securities at December 31, 2021 was $77 million.
This balance is expected to curious into 2025.
Importantly, we believe our solid financial position, we will see you will fuel continued growth and evolution of our radar AI platform.
Accelerate the development of our portfolio of targeted oncology drug candidates.
It allow us to introduce additional targeted products and collaboration opportunities.
In a capital efficient manner.
Lantern pharma implemented a share repurchase program in 2021.
The company is authorized to repurchase up to $7 million of common stock.
Through March one 2022, the company has repurchased approximately 430000 shares for a total of approximately $3 1 million.
<unk> purchase fees.
This includes approximately 122000 shares purchased in 2021.
For a total of approximately $940000.
We believe these purchases will be accretive to shareholder value.
We are migrating to a hybrid work environment.
And I am proud to say that our team continues to be very productive under this operating model.
The hybrid model also removes geographic restrictions to our hiring initiatives, which gives us the ability to recruit extremely high caliber team members that otherwise might not be available.
We currently have 16 employees, who are primarily focused on leading and advancing our research and drug development efforts.
We see this number expanding slightly in coming quarters, as we add additional experienced and talented individuals to help advance our mission.
Now I'll turn the call over to <unk> for an update on some of our development programs for sure. Thank you David Good afternoon.
I'm going to start by just recapping.
Some information we discussed in our last call and as some of you may recall that last fall, we updated you about some exciting advances.
Our molecule <unk> 184.
To recap FDA granted LP, when maybe forward with orphan drug designations for three indications.
<unk> been glioblastoma pancreatic cancers and herc.
In addition, we received rare pediatric drug designation for the ERP.
<unk> hundred 80, <unk> moving steadily towards initial clinical studies.
Final data from <unk> and Pharmacology studies are due soon.
We have begun discussion with multiple sites.
<unk> its initiation of phase one studies and these discussions are ongoing to refine the details of the coordinated studies. So that they will inform the phase II clinical studies in cancers, which are either homologous recombination deficient.
Nucleotide excision repair deficiency.
In the preclinical space looking forward. We are also completing studies to identify synergies with standard of care drugs that might guide future applications of LP when it before.
<unk> seen excellent results.
Hi, good synergy of LP, One April the Ducks like Jim said, Jim side of it for example.
Among the clinical indications one important need that LTE 'twenty before potentially meet this therapy for cancers.
Thanks to the brain.
As many of you are aware.
Cancers of lung colon, kidney and skin often spread to the brain.
The activity of <unk> in tumor cells of these audits.
And with the ability of <unk>, 1% before the cross the blood brain barrier and does this molecule with the necessary properties for such then the desk epic cancers.
This week, we are present in a poster at ACR, providing evidence of <unk> efficacy in 50 models.
But that's going to take lung and breast cancers.
Good day I wanted to spend some more time to share with you.
Information on other molecules LP to a beautiful.
Both LP, we wanted before and B to April a faithful.
In our clinical wounds like many other small molecules or Tyler.
Unlike many other small molecules that target DNA.
<unk> of the derived tumor targeting <unk>.
LTE 184.
Generally also known as <unk> tightened as improvement.
Meekly demonstrate differential activities in two months from now so one iPhone monetize very specific.
Do marketing properties and the other is somewhat a different setup cumulative properties. These data. Therefore enables the independent development of the positive by some one off hydroxyapatite pooling, which we designate as <unk> 84, and these are particularly for the indications and immunological cancer.
Space.
Upgrading our data analysis.
The key difference in LP, one may be for negative Soma, and LPT 84 positive I somewhere.
And that one day before is obligatory dependent upon the activity of the enzyme <unk>.
<unk>.
<unk> does not.
Since <unk> is expressed at levels below the threshold required to activate 184 LP wondering before is not potently cytotoxic to blood cancer cells to 84 on the other hand is.
Further examination of LPTA before.
Wide range of blood tumors demonstrated strong support for efficacy.
Large b cell lymphoma.
Chronic myeloid leukemia, <unk> lymphoma, and metro cell lymphoma.
The latter stands out as an exceptional.
<unk> indications.
For several reasons.
The preclinical data.
Yes.
Yes.
Many excellent because of all the six month shifted showed potent lots of <unk> been exposed to minimal levels of 280 <unk> in vivo.
Additional novartis also suggest that like 184 to 84 efficacy is enhanced by the business of deficiencies in DNA repair and this brings the second one did I wanted to talk about why mantle cell lymphoma might be a good indication.
Memphis and for most frequently cabin mutation of the <unk> gene are deemed critical to DNA damage repair.
Other lithium also intrinsically getting mutations in DNA debated the genes are depicted phenotype of such deficiency. This phenotype often described as back on this.
Good.
The pound regulation of the function of genes like that Gabon.
Cause of the lesions gathered by Hematological cancers, such as the Bcl enable translocation.
I believe your LP to 84, two damaged DNA and the need of transcription coupled repair.
There is damage also indicates that <unk> is able to block nonfiction.
This property of 284 is likely to render Kansas, which Gaby oncogenic translocation.
Since many of these trans locations are driven by a deregulated transduction of the oncogene.
The starting of these oncogene, which has the necessary for the survival of these blood gases.
And half the ability of <unk> via 284 blocking of the transcription to sustain the Cumulus.
At this time, we are focused on that we're looking to fulfill mentoring diploma.
<unk> ongoing studies.
Extend the efficacy studies to individual models.
Complete the toxicology and fundamental pharmacological studies of the molecule and begin to design a phase one trial for <unk>.
At the macro cell lymphomas.
Just following targeted godaddy.
I'll hand, it over to bundle.
Sure. Thank you.
Before I open it up to questions I'd like to provide a brief recap and also discuss some of the upcoming milestones as you know we're very confident in the launch of multiple human clinical trials. This year for our drug candidates LP 300, 100 at 184. We're also looking at the ongoing growth of our radar platform and we remain committed to <unk>.
Our ADC program into IND, enabling studies, we also believe that with our network of strategic collaborators.
We'll also be at adding additional collaborators that we'll be able to generate exciting new data that will help us launch new programs that we can license, although we can develop and then license out.
We believe radar are central to this in terms of building our existing drug portfolio, but also generating new opportunities. We remain committed to achieving our goal of building the world's largest AI platform to purpose.
<unk> in oncology drug development, and we believe we're significantly on our way there already our goal. This year is to surpassed 25 billion data points move our.
Our late stage candidates into trials and continue to add valuable data in targeted areas such as immuno oncology rare cancers in pediatric cancers, where really significant need for improved therapies, we believe that our AI platform and our collaborative business model will be pivotal in uncovering new opportunities.
Cancer patients, but also for investors, we believe that we're well positioned to take advantage of the wide scale availability of data and the ability now to do large scale genomic and machine monthly analysis in the cloud.
<unk> built a great team internally that has multiple interdisciplinary capabilities and we have collaborators that are helping guide the development towards patients faster and faster.
So with that I'd like to now open the call up some questions.
Okay, Great. We have a couple of questions coming in here one is from pad you.
The COVID-19 related issues in sourcing equipment needed for our clinical progress and address.
Thank you Ted for that question.
Yes.
You pointed out we've had delays in manufacturing, mostly due to COVID-19 with.
With our <unk> 300 molecule those have been addressed in fact.
Just recently, we finalized the batch of drug products now.
Now.
Being tested for final stability.
So yes, we crossed a definitely delayed our timeline of manufacturing by three to four months. We also had delays due to omnicom due to staffing capabilities and our manufacturing partners and those are now also passed so.
We believe that clinical trial sites.
Are beginning to open back up probably not at the same level of.
Openness is pre pandemic, but we are beginning to see sites.
Open back up and take on new cancer trials.
Yes.
It did impact us impact us by at least three or four months in manufacturing and definitely slowed down clinical trial site selection and enrollment.
Yeah.
The next question can you please detail the biomarker the biomarker screening Youre planning for LP. One of these four do you plan combination therapy for wondering before and will the combination be guided by Biomarkers as well.
Yes.
Unpack that question, it's a great question.
We do plan on having a biomarker strategy and we've already talked a little bit about it <unk>.
<unk>, one is essential and.
Basically mechanize and 184 into an active cancer, killing agent.
So we are looking at cancers that over express <unk> mentioned essential biomarker.
Additionally, as Kishore pointed out that there are certain DNA damage repair deficiencies that make the <unk> hundred 84, synthetically lethal to many tumors and so we may have that presence such as efficiencies in BRCA ARCC potentially other DNA repair genes typically either in two paths, there's the nucleotide excision repair.
<unk> pathway and then the mortgage repair pathway.
When we find efficiencies in either what we've seen is that the tumors tend to be fixed.
Extraordinarily more sensitive to the drug by a factor of anywhere from two to eight X we've seen depending on the tumor type.
So, yes, we will definitely use biomarkers to help select.
Not only the tumor types that we would go after but also potentially the patients that are most likely to respond.
Yes.
The second part of that question I believe was in combination.
We have some slides in the combination with <unk> do you want to talk about some of the combinations of Laguardia uncover yes, so our strategy to look at combinations.
Begins again.
<unk> platform using depth map and Jim formulation studies to identify which box space together would see no days.
Our next step then is to answer questions after the tubs and that possibly.
Once that are being used for indications that we are pointing people need.
<unk>.
Once we arrive at that.
So then we conduct wet lab studies could actually get evidence.
Real life evidence of synergistic activity. So based upon these kind of.
Teddy designs, we have identified several drugs that have shown very good synergy.
<unk> hundred 84, and so we believe that we will have the potential to use <unk> 184 in a thoughtful and rational way in combinations.
You have some more clarity we have seen significant synergy with gemcitabine in pancreatic cancer as they've had some exceptional list synergy scores. That's one of those scores. It's usually look at synergy of drugs. So bliss score above 10, typically shows that theres very promising synergy.
We use different synergy algorithms that's one.
We also saw synergy with.
Spironolactone is which is very promising spironolactone is already a drug that's used widely today, we've seen that spironolactone certain tumors <unk> <unk>.
<unk> a.
A mutation a deficiency in the RCC III.
That's a really exciting story and.
It's an amazing story because.
Despite lepton combination could allow us to do would be to basically convert almost any tumor into a node tumor making it exclusively sensitive <unk>.
<unk> hundred 84, but we have we have.
Focusing on this area quite actively and we do find that.
Once we get that make us more and more confident.
That.
This combination is going to be.
We are winning combination play with people maybe for now.
And again, we also many of our patents that we filed last year were for combination approaches that we think are very promising.
We will continue to look at those and we think spinal outcome and potentially even other protest will be very useful.
Combination with 184 good.
Good question.
The next question comes from Michael Kim any update on whether bladder cancer remains on the radar for 184.
Yes in summer as some others.
That's definitely on the radar for 1% to four in multiple ways and potentially all season 100.
So bladder cancer as a target others several subtypes of bladder cancer as you know.
And maybe we can talk a little bit abstract.
The next phase of work that we're doing looking at bladder cancer. This year. So we have designed studies to.
Position LP 100, and also the strategic studies with <unk> 184 and different.
Types of bladder cancer.
Blue.
<unk> says that a localized non muscle invasive bladder cancers.
That has become refractory to things like <unk> for instance.
So looking at like aesthetic Deblock answers about 10% to 12%.
<unk> have deficiencies in DNA repair genes.
Lending those genes that.
Our essential.
Our survival following damage with MTN 80 foot obviously.
Set bladder cancers.
Good.
It would be good indications for <unk>.
284, and some of our.
In vitro data already shows us that if we create.
In the laboratory and knockdown of those teams.
The efficacy of <unk> hundred 84, an increase spend to 30 fold.
So yes, we are.
Focus on Datacom.
In discussions with several meeting.
Our party's embedded cancer too.
Sure.
To develop.
Steady the collaborations.
Great question, so you'll definitely see us in bladder cancer this year from us.
Next question comes from Michael Samuels, how do you see yourself compared to other small cap <unk> in terms of pipeline and talent and Melinda among other thing.
Well, that's a great per loaded question I mean, I think the <unk>.
Biotech, obviously has been a challenging sector.
Underperforming loss included but.
I think unlike.
Many biotechs I believe we have the ability to generate new potential wins for investors on a continual basis Thats why we believe in our platform I think we have a very good cash position, but also a good financial discipline in terms of where we're investing and how we're investing in our programs and so forth.
Our relative burn rate, which has been.
Last quarter was $3.5 million.
We do expect it to increase slightly this year closer to four to $4 $5 million or quarter, especially as we.
Finalize manufacturing launch sites. So the burn rate will increase but we have cash that allow us to get into 2025, and we have programs that can be with <unk>.
Several billion dollars and we have a platform that continues to churn out new ideas.
<unk>, an AI platform that actually can do collaborations on its own so I think relative to other small cap biotech I think once biotech is.
I think it would be in favor again, but the need for innovative new medicines in understanding disease is not going to go away. So.
As things shift I think it will be.
More.
The cream rises to the top and I think we're part of that kind of company because we have a pipeline that can be continually growing and we have a platform that also is continually growing and we have drug programs that are de risked in very targeted so I think we'll be one of the long term winners in the biotech space.
Next question also comes from Michael King question about radar, what can you do with 25 billion data points that can be done with $18 billion. When do you hit diminishing rate of return can you discuss can you discuss how you are leveraging deep land and kudos to increase efficiencies and data analysis.
Yes, those are great questions Michael.
So we're at 18 now I think we will get to 25 this year, but in that $18 billion.
We don't have I believe enough data on certain rare cancers or pediatric cancers. So we want a second all of that data. So that we can better understand what pediatric cancers can be responsive to the kinds of compounds that were interested in developing.
That allows us to have another shot or two or three on goal.
Also one of the things as we mentioned earlier is that we are very interested in exploring combinations with approved therapies. Many of those combinations can be io therapies. So again.
On a roadmap to getting to beyond 25 billion as we go for 50 and 100 billion.
Second a lot of immune data, new non with data antigen data and Theres a lot of algorithms that predict immune response combination mean response plus other cytotoxic agents and so we will be able to model that we're at a very early phase of that I think will be better at it by the end of the year and so the platform's ability to do things that are relevant in cancer, but will only grow.
And so.
I don't think we'll hit the law of diminishing returns.
Because there's so much new data, that's being generated new classes of drugs, new medicines, new tumor subtypes.
We will have a lot of return on the roadmap to 100 billion.
After that I think.
Take a deep breath after 100 billion and see what's what's next but also don't forget that new generations of machines are coming out of sequencing machines that arent transcriptome machines and ways to look at the genome that we didn't do before the way to collect biomarker data and that's now specialty organize it gives you different types of ideas about how.
The cancer is evolving or not and so we haven't even scratched the surface of that so I think.
As we get more advanced ideas about drugs and drug classes, we're going to start throwing away or adding to that data. So I think I.
I don't think there is a law of diminishing returns right now.
In general if you know what kind of data to suck in for what problems now if I wanted to just go out and get a $1 billion more data points for some chemotherapy that was launched 30 years ago that maybe that may not give us any more value than we already have we already have enough data on most of the chemotherapy regimen. So I don't mean more cisplatin data. So we don't.
So after that <unk> need more systems patent data in breast and ovarian lung so SD prioritize baidu need it in certain rare pediatric cancers that hasn't been well studied so that I'll accept.
Yes.
All of them not all data is equal the value of that data and data types. All different. So we have to think about those datasets as we curated and make our list to think about what the campaigns are so hopefully that answers. Your question in terms of the collaborations depo.
Sorry to replenish the important for deep lens is our.
Our ability to find patients faster and thats going to be evident in the 300 trial that we're launching now so we have sites and potential patients and so if we can reach patients in need.
How theyre going to potentially come off a PKI therapy and their chemo nave and we know a little bit about the history. We can be more aggressive about trying to bring inventory trial is being proactive I think its a central part of the clinical trial design going forward in terms of code Ocean freight will accompany that allows us to scale up radar and a way to allow us to do collaborations.
<unk> external partners.
We're now using that with some of our partners that we announced the collaboration with Dana Farber identify ever in the Danish cancer Research Society. So they can plug into our containers that coda Ocean user algorithm showed the data our data in a scalable and highly secure way.
And there is no passing around files and Dev ops environment and so it just makes mixed.
Essential ingredient of doing collaboration and in AIA to one each year and allows us to have a lower.
Burden of managing infrastructure in managing the environment, because we can't hire one.
Tech stack manager for every three or four programs. We hire that's just not scalable solution. So the great thing about technology today's.
There are some really great cloud based.
Container solutions that are scalable and secure and code Ocean is one of those so both.
Companies allow us to do things faster cheaper and more scalable and that's part of I think adopting these tech forward solutions.
Great. The next question is about 284 could you expand on how you plan to leverage <unk> gradation mechanism of <unk> 84, and ways that may be independent, it's Brian on Lockdown or do you envision that sparano lockdown treatment would be a requirement to 84.
Okay. Good question, who asked that question.
When you have Peru.
So it was a question on here.
Yes so.
Spend on Elektron is not required for efficacy of 284.
So for the Charterer is a chart that we have we see nano more potency across a wide range of him and in that chart I saw $1 spironolactone.
Two.
Answered the question about VLCC three spironolactone.
The background behind this is that.
Yes.
When we looked at $2 84 in different.
Tumor types.
And so in cell lines with.
The ability for us.
That's a big teams such as CSP.
<unk> three <unk>.
And so forth.
The phone.
Not surprisingly since two way because the president of <unk> 84, we found at 284.
Efficiency increases dramatically.
Tumor cell.
<unk> does not have the ability to repair the damage caused by the way before.
In tableau.
Don South that spironolactone.
Has the ability to very specifically degrade <unk> III.
CCP is an essential component of the repopulation of the required.
If the seller needs to repair damaged by 'twenty four.
We are moving away that EBITDA from the tumor cell you can give it no other choice except to done and therefore, the combination of money before either in Blackstone.
Several things it allows us to focus on those two one styles.
That up a little bit more resistant to 284 and required might be quite higher levels of <unk> 84.
Using spironolactone, we could reduce the.
The amount of 284 required it gives us a few months ago.
So you enhance.
The function and indications where it might already have strong ability, but you also open additional indications beyond what you have another one.
And of course, if we can keep the at some point you want to make sure you want to give a little of a drug to get the maximum et cetera, and so when we look at dose finding and dose plus range, but it might say hey, we're getting to a point, where we have some concern where we can back off of it if the person will be centered in spite peso. So those studies.
Something.
But also one other things if it opens up also.
People that have taken smart electric now.
Different bill so.
No.
A function of ARCC III.
Is important when BN is damaged.
Of course, all of us consistently have some being at average or the other.
But.
The synthetic lethality of L.
<unk> hundred 84 is more like a culmination pumps and there's so much tremendous damage.
Because of the insult to the DNA by 184 in absence of that.
A few a few molecules up for <unk>.
Not going to Mexico, rather than spironolactone is has been used by pension and so many of them.
Stillwater attention again et cetera.
Very good question are there any other questions today nickel.
We have time for one more this one comes from power Boulger as you prepare for the phase III trials for L. P. 300 evaluate site. How are you finding in connecting with sites. How many have signed up and how many more would you like to have before commencing in melanoma.
So what was that.
Our new site I haven't I don't think.
We're in the process of talking to the sites getting NDA is in place et cetera. So.
We would like to get for the first launch about five sites cone, but pretty close to that now.
However, we're finding it.
I think it is.
<unk>.
So in part through deep lens in part through our CRM our CRM.
But we have is kind of described earlier, we've seen improvement, but there have definitely been impacts from COVID-19 in terms of.
Shortages staff staffing shortages at clinical trial sites.
And delays getting the phone calls and delays in getting.
The physician teams.
Briefed. So there have been delays, but I think we're just beginning to I would say in the last few weeks, we began to see some changes certainly isn't as bad as it was a month or two ago.
But because of that because of the unique focus on never smokers and the fact that the.
Control arm get standard of care drugs anyway, it's very attractive.
From a clinical trial design perspective and.
And because of our ratio of two to one. That's also good that means 60 patients youre going to get the <unk> 300 in combination with standard of care agents. So we have.
A higher chance that patient getting.
Potentially new great therapies. So the design is as I think.
Very appealing and the fact that the history of the drug is very safe and historical trials is also very appealing.
Now that we're hopefully at the end of the pandemic, we can get people to stop.
Clearing out.
The hospitals and centers and making room for more of the oncology trials, but there definitely have been delays and I'd like to get five of them going upfront to then start initiating patient.
And dosing.
Okay.
We can maybe squeeze in one more question here also from Cal Bowser I know you definitely do not want to sacrifice the quality of the curated data points, yet significantly accelerated pace.
You are adding two radar can you talk about how you've been able to streamline this process without sacrificing quality.
We've actually I think in many ways is actually increased quality.
We're doing things much more automated or scripting is getting better we are going after bigger chunks of data.
We've been more disciplined in which chunks were going after.
But a lot of that it really just comes down to automated automating the scripts and automating the analysis and putting it into the data Lake and so as we go after more of them, we have more experienced and so we can deal with all the different datasets.
The bigger and bigger bites each time.
I think as I mentioned, we'd like this 25 billion, but we do have a roadmap for $100 billion. So that that is going to be some that will.
Push our limits for May.
Our current generation of automation.
Look at some new things too so.
We will continue.
Okay and with that I believe that is all the time, we have for questions. Today I will now turn it back over to upon us for some closing remarks. Thanks, Nicole So we believe <unk> 2022 will be a transformed transformational year for us we laid the foundation last year in 2021 in terms of advancing our drugs for.
Trial, getting orphan designation advancing the platform maintaining financial discipline.
<unk> the share purchase program a show that we have a lot of confidence in our programs and in our stock.
<unk> ended the year with over $70.
$7 million in cash and cash equivalents in marketable securities. We've also increased our intellectual property with over 12, new patent applications and actually have some great ideas for combination approaches. So I think that this year will continue growing our platform will advance our portfolio and also our team is very committed to bringing these <unk>.
<unk> patients not only doing it faster and cheaper, but with better insight and so our strong cash position along with our history of accomplishment I think bodes well for our pipeline and also for potentially for investors. So thank you for joining our call today and we hope to continue to follow and track our.
<unk> and what our team is doing thank you. Thank you. Thank.
Thank you.
Yes.