Q2 2021 Lantern Pharma Inc. Earnings Call
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Good afternoon, and welcome to Atlanta in Pharma second quarter, 2021 conference call.
This call is being recorded and all the participants are in a listen only mode. We will open the call for questions and answers. After the presentation I would now like to introduce your host for today's conference Goslin went to Investor Relations Atlantan Lantern pharma Jocelyn. Please go ahead.
Thank you Gretchen and welcome everyone.
1.2 engine pharma second quarter 2021 conference call on the call today are punished pharma managements, President and CEO, David Margaret Lantern, CFO and COO, Dr. Kishore, Bacci, Atlanta, and Chief Scientific Officer.
The press release was issued today with our second quarter financial.
They were much debt, we will be discussing on our call today.
Following the Safe Harbor statement on I will provide an overview of our business highlights after which David will review our quarterly financial results.
Doctor Bacci I will provide an update on our R&D efforts on.
Well then after concluding comments.
After which we will open this call for questions.
Please also note that we have provided a link on the Investor Relations website for additional sites that we may reference on today's call.
Okay.
I would also like to remind everyone that remarks about future expectations claims and prospects constitute.
On the cute forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
And from a cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated.
A number.
A number of factors could cause our actual results to differ materially from those indicated.
We're looking statements, especially as the interest of the COVID-19 pandemic results of our 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 the risk factors section in our annual report on form 10-K, which is dated March 10, 2021 on file with SEC.
Forward looking statements made on this conference call speak only as of today Thursday.
Day July 29th 'twenty, 'twenty, 1 and lantern pharma does not intend to update any of these forward looking statements to reflect events or circumstances that occur after today.
A webcast replay of the conference call will be available in lantern pharma website.
With that I'd like to turn the call over to Panna Sharma.
Sharma, President and CEO of <unk> pharma Panna. Please go ahead. Thank.
Thank you Jocelyn and.
Good afternoon to everyone on the call today. Thank you for joining us for our second quarter 2021conference call.
For those of you that are new to our story Lantern pharma is in oncology Biopharma company that leverages the power of.
Only develop artificial intelligence and machine learning platform called radar to both rescue and develop oncology focused therapies.
We believe that we are transforming the development of oncology drugs by changing the pace the cost and the risk of drug development.
We're 1 of the few pure play AI based biopharma companies.
With multiple clinical stage programs as well as a rapidly growing proprietary platform for accelerating our understanding modeling and prediction of tumor response to cancer therapies, namely the drug candidates in our portfolio and those in classes.
Sales synergy of their molecules and also those of our partners.
We reached several milestones in the second quarter in April we announced that our radar AI platform exceeded $4.6 billion data points.
And now we're enhancing our data lake with data from a wide range of blood cancers.
We're really excited about the rate of growth that we're that we're undergoing at this time period.
Additionally.
There's significant new functionality that we're building into our platform.
This is because of the massive growth rate of over Forex since the beginning of the year and now we're approaching 5 X.
As our growth rate has expanded we now expect to achieve over 8 billion data points. During the next campaign, which is scheduled to begin later this quarter.
In terms of our portfolio. We've made a major announcement this past week, we announced a major milestone in our existing phase II clinical program in metastatic castration resistant prostate cancer by requiring all global development and commercialization rights and an agreement with our former our licensing partner <unk>.
That program was previously licensed.
License to Liberty Therapeutics, a public Danish biotech company and this transaction ensures that the appropriate resources and focus on applied to the future of the iron ore L. P 100 program.
We reached other very important progress points during the second quarter.
Such as our progress in pancreatic cancer, which Dr.
Troy <unk>, our Chief Scientific officer will expand on later today.
And as you know pancreatic cancer is an orphan disease has a 5 year survival rate of 7.9% and with nearly 490000 cases globally and 62000 just here in North America.
Yes.
Because again, there's a significant need for improved therapies.
We believe that nearly 35% of these pancreatic cancer cases are ideal candidates for our L. P 184 drug candidates.
Is an area of high patient need.
Roughly over 1 billion on an annual therapy sales that this represents in North America alone.
Signet also very importantly for <unk> hundred 84, we made new advances in validating the application of this drug candidate to bladder cancers and potentially other cancers that have DNA damage repair mutations.
We will be sharing data in these indications as we prepare for conferences publications and manuscripts in the very.
Future.
We also made progress on initiating clinical trial site selection for L. P 300, and an upcoming phase II trial for non small cell lung cancer and never smokers.
This is an important program for never smokers, where there are currently no approved therapies.
During the quarter, we did experience delays in the program due to equip.
Any near from materials issues with our primary manufacturing partner, but we now expect the final have final drug product. Later this quarter. This product will then be ready for subsequent shipment to sites that are selected for our clinical trial.
Electing patients on sites that are aligned with the inclusion criteria for L. P 300 will be a critical.
Quick minute of this phase II clinical trial.
Meaning we need to select patients that are not only never smokers, whether a chemo naive have no prior history of chemo treatment and have become nonresponsive or have relapsed from prior PKI therapies.
We will be working closely with leading sites to provide awareness.
Completion of LP 300, and identifying potential patients that may benefit from this therapy.
The current phase 2 trial is focused on having 2 arms for totaled 80 patients 1 arm with the current standard of care, which is a chemo doublet and 1 on with L. P 300, plus the standard of care in a combination regimen.
And as you turned the quarter. We also advanced our ADC program by further testing and refining our conjugation processes and testing various approaches to developing a highly targeted and potent new molecule for certain solid cancers.
Just on the initial work that we're doing we believe that the same approach can also be applied to certain hematologic cancers.
This is again, an early development, but will require additional validation, which we expect to accomplish during this quarter and Q4.
We also do you expect to finalize our conjugation process with this molecule and also its design this quarter and we'll plan on announcing details of the program and as well as its design and targets later this year.
Also during the second quarter, we announced a collaboration with accurate therapeutics, where we will be leveraging our AI engine.
And our AI engine will help them advance key aspects of their drug candidate <unk> <unk> 41, we discussed this briefly during the first quarter conference call, but as a quick reminder, benign ing's 41 drug candidate.
It is the best in class GSK, 3 beta inhibitor, which is in active development in multiple phase III clinical trials, including for pancreatic cancer.
This type of collaboration can potentially yield meaningful equity based milestones for lantern and our shareholders. We are actively in discussions with select other biopharma companies for similar collateral.
Patients, where our platform can help derisk development decisions and advanced meaningful therapeutic options for cancer patients.
Patents and intellectual property is a major component of developing significant moats around our business our drug candidates, how we apply our drug candidates our AI platform.
Form and our methods are all areas that we are focused on patenting.
During the second quarter, we filed 11 patents 2 of which are focused on our radar platform and the remainder around our drug candidates and their application in specific cancers or in combination with other drugs and drug classes.
We expect to continue.
Collateral, our aggressive development and filing of intellectual property.
Especially since our data driven approach is actually accelerating the creation of unique insights and also generating precision correlations of response or potential response and also other findings. We then take these findings and validate and refine them in the lab.
GAAP. This iterative rapid approach is generating patents that we feel will be quite valuable in the future.
We are particularly excited by the fact that we're entering into areas, where theres, a large clinical need for improved therapies, especially in certain rare and ultra rare cancers. This may enable faster development and the potential for priority review.
Review vouchers with certain assets in indications such as <unk> 184.
On a typical keratoid, Rob Doyle tumors, an ultra rare brain cancer.
From a L. P 284, and certain ultra again ultra rare blood cancers, where we're finding potential for meaningful response.
It's an important point to note.
More very important will help us develop transformative value not just for our shareholders, but more importantly for cancer patients that need improved and personalized cancer therapy options, especially in many cancers, where there are very few or no therapy options.
Atlanta, and we believe passionately about changing the pace.
Pace at which oncology drugs are brought to market and reducing the cost of cancer therapy. We believe the best way to do this is to use AI and machine learning, which is already dramatically altered the product development cycle on cost curve of other industries and now we can now witness how it will transform if not smash the product development cycles.
Note cancer drug development.
I'll now ask David migrate our CFO to provide an update on our financials, our transaction regarding <unk> 100, or IRA foreman and other financial details David.
Thank you Panna and good afternoon everybody.
I will share some of the financial highlight.
Highlights from our second quarter of 2021 ended June 30.
And also discuss some of the details around the transaction to reacquire, the global development and commercial rights to <unk> 100 that we have.
Announced earlier this week.
Yes.
We had a net loss of approximately 2.
And so $3 million from.
21, <unk> per share for the quarter ended June 32021.
Care to a net loss of approximately 833000 or <unk> 31 per share for the quarter ended June 32020.
Research and development expenses were approximately $1.2 million in the second quarter of 2021.
Compared to 167000 for the second quarter of 2020.
The increase was primarily attributable to.
Increases in research studies.
Including manufacturing expenses expansion of our research team and non cash research and development related stock option compensation expense.
We expect we will continue to increase our R&D spend.
As we advance and grow our pipeline.
We further advanced our portfolio and recently initiated the ADC program, which is now moving towards additional validation and research studies.
Additionally, we have begun site selection for <unk> 300, <unk>, our planned phase II clinical trial and never smokers with non small cell.
Cancer.
As the trial sites are selected and opened an enrollment advances we expect R&D expenses to increase for the third and fourth quarters of 2021.
General and administrative expenses.
Were $1.3 million for the second quarter.
<unk> 2021.
<unk> to approximately 676000 for the second quarter of 2020.
The increase was primarily attributable to an increase in expenses associated with operating as a public company.
Along with increases in non cash general.
Administrative related stock option compensation expense.
Many of you are excited about the <unk> hundred program being reacquired by lantern. So that we can move forward with the drug candidate and provide clarity to the market as to the future of this program.
This program.
As part of described earlier is in a phase III trial.
Where we will now assess future enrollment and other improvement opportunities.
So reacquire the global rights to the compound and the existing phase II trial in existing stock of drug supply.
Along with an exclusive license.
The DRP technology aimed at LP 100 use as a companion diagnostic.
In MCR PC.
We invested an upfront amount of $1 million U S dollars.
An additional 1 million U S dollars was placed in escrow, which.
To date over the next 24 months as milestones are met for drug development and advancing clinical trials.
Additionally, we may pay up to an additional $16 million.
Based on regulatory filings and eventual future marketing approval for the drug.
Which would be U S and the EU.
Our team continues to be very productive, especially as we migrate to a hybrid work policy.
Currently have 15 full time employees, who are primarily focused on leading and advancing our drug development biology and data science efforts.
As of June 32021.
We had 11 million 194039 shares of common stock outstanding.
This includes $4 million 928571 shares.
That were issued in our January 2000.
'twenty 1 follow on offering.
At June 32021.
We also have warrants outstanding to purchased 302000.
And 36 shares and outstanding options to purchase 823826 shares.
These warrants and options.
Combined with outstanding shares of common stock.
Give us a total fully diluted shares outstanding.
A $12 million.
309901 shares as of June 32021.
<unk> cash position.
Pellucid on cash equivalents and marketable securities at June 32021 was $79.6 million.
This balance is expected to carry us into 2025.
We believe our solid financial position will fuel continued.
On <unk> growth and evolution of our radar AI platform.
Accelerate the development of our portfolio of targeted oncology drug candidates and.
And allow us to introduce additional targeted product opportunities in a capital efficient manner.
I'll now hand, the call back to Paul.
On it.
David Thank you very much thank you for that overview I.
I would like now to invite Dr. Chris <unk>, our Chief Scientific officer and on 1 of our esteemed colleagues to provide some detail on the growing data and excitement on our early stage drug development programs.
Please go ahead.
Thank you Panna.
And in the next 5 minutes or so I will take you through some more details so that'll be 184 in pancreatic cancers as well as LP money depot in Glioblastoma and ERP.
And an additional interest.
<unk> is our newest molecule LPTA depot.
As you all May know pancreatic cancer is the current standard of care regimen is what is often known as culturally Nox.
Consists of Florida Euro zone.
He didn't know taken on.
I'll turn the platen.
Hollywood less debt.
25% of patients with pancreatic cancer survive the first year of diagnosis.
And <unk>.
<unk> percentage will survive beyond 5 years, so obviously, there's a great need to input their IP.
The activity of our drug L. P 184, and pancreatic cancers is therefore very encouraging.
Before this but for additional reasons I will elaborate upon.
1, particularly aggressive form of pancreatic cancers.
Sometimes called the unstable subtype frequently hardboard mutations in DNA damage response genes.
And the proportion is quite significant.
On our 20% of pancreatic cancers show mutations in sub genes.
Amongst them ATM is mutated in up to 5% of sporadic.
<unk> debt cancers.
Using pdx models, we validated L. P 184 efficacy in pancreatic cancers with mutation.
Not only the same ATM BRCA, 2 and other DNA damage response seen such as cloud 2 <unk>.
You did the ATM is particularly interesting because in Edison it in parts.
Homologous recombination deficiency character.
But also.
Even when it is heterozygous it can cause but that's terrific aggressive cancers.
<unk>, what is often known as epithelial mesenchymal.
On transition, which negatively impacts prognosis.
Although such as schools along side with.
And then.
Hence with the non deficiency of DNA repair.
It will inevitably deposits can be further explored and exploited by L. P..1 day before because our in silica correlations using the NCSL miner.
These are just debt L. P on edible molecule has enhanced efficacy in.
2 months that have such Emt pathways.
Of course, more recently inhibitors of parts have shown clinical efficacy in a.
Homologous recombination defect of pancreatic cancers.
But it's important to note that such treatment often results in resistance to park within the first year.
And those treatment.
Along with the Pdx models.
Deficiency in homologous recombination.
Barclays. We have also conducted additional experiments that.
That included downregulation of ARCC poor on nucleotide excision repair gene using CRISPR based knock.
Both strategies.
The result was increased sensitivity of such tumors that on any of our deficient.
By a factor of 2 fold.
This strongly supports the notion that L. P..1 day before Houston, particularly lethal.
And not only.
Iraq recombination deficient, but also in nucleotide excision repair deficient tumors.
We are particularly excited by this observation of synthetic lethality.
As it opens the applicability of L. P on 84 in other any other deficient tumors.
Important example would.
B bladder cancers.
Over 30% of tumors have mutations that disrupt any other debt.
It also opens other doors the possibilities of using L. P..1 day before in combination with molecules that disrupt DNA damage repair.
As highlighted earlier, we have filed IP.
In areas, where we have seen the potential for combination approaches with our drug candidates.
So in terms of on future directions, we are focusing them on developing combination approaches with PARP inhibitors and other DNA damage repair proteins inhibitors.
<unk> those that would inhibit the ERC proteins.
This combination approach will increase the vulnerability of pancreatic cancers to L. P on India.
And broaden the genomics subtypes of pancreatic cancers that will respond to LP money before but in addition, it also provides an avenue to overcome or retard the resistance to existing therapies.
Now since the key enzyme that drives the sensitivity of tumors to LP wanted before because BTG on 1.
Regulated why stress Mccann exams.
On exploring the hypothesis that other modality of treatments such as radiation.
Increased BTG on 1 expression and therefore renders.
Tumors following radiation.
Stimulus simple activity of LP on a report.
Such a possibility we'll provide another dimension to help you on a report for treatment of local lesions in combination with radiation.
This is particularly of interest since over half of solid.
Vendors on initially treated with radiation.
And the localized upregulation of PD, Dr..1 provide a vulnerability window for the tumors that were hypothetically further protect against toxicities to non human cells.
Yeah.
I'm going to now shift the.
Did you must do a research studies and CNS tumors.
We have convincing data for efficiency and efficacy of L. P on default in Glioblastoma and another there are CNS tumor called a TRT.
We have obtained this efficacy data in in vivo models using.
Both subcutaneous and par glioblastoma subcutaneous as well as arthroscopic models.
Interestingly both of these indications what initially suggested by in Silicon gene correlations using the NCSL mine and our radar platform.
Low or absent expression.
Of smart be 1 which is an obligate genomic lesion on E T. R. A T.
Weighted with a significant correlation of negative zero point for.
Efficacy of L. P on it before.
We believe based upon other published data.
Debt loss of this chromatin modifying protein.
In parts of DNA repair deficiency phenotype to cells.
And thus makes tumors such as a T. R. A T..1 notable 2 L. P on 84.
Somebody is therefore, the selectivity is similar to what we are seeing in pancreatic cancers.
Similarly in Glioblastoma.
<unk> our radar data predicts.
Specific subsets of Glioblastoma.
Such as those with active NGL are pathways.
To be highly sensitive to help you on 84.
Another very exciting observation for us from a silicon analysis is the prediction.
<unk> expression of MGMT.
Correlates with increased cytotoxicity of L. P..1 day before.
The reason this is particularly relevant.
Is because.
Expression of MGMT in parts of resistance to the standard of care Amazon Walmart.
Over 50% of Glioblastoma.
Debt, therefore, do not respond to cameras on the money.
We believe therefore L. P. On 84 has the potential to be an alternative both as monotherapy and in combination with demos and on like for Glioblastoma.
Our future a preclinical collaboration with Johns Hopkins.
Tomorrow, particularly directed to provide additional evidence for.
For such applications in Glioblastoma.
And particularly in those glioblastoma debt have reversed their silence of expression of MGMT.
We expect to have more news on this in the coming weeks.
Early preclinical screening of LTM on 84 in a wide variety of tumors.
Conclusively highlighted selectivity of 184 in solid tumors, but also lack of activity of 184 inhibitor logical cancers.
Interestingly the positive and then tumor.
Most of this compound is what we have now built on our newest drug candidate.
Which is named L. P 184.
Which appears to be.
Quite active in several hematologic cancers.
Our working hypothesis is that the molecule to 80.
Because of.
It's chirality is independent of BTG on 1.
But dependent upon other oxidoreductase is 2.
<unk>, which is.
The new molecule for Hematological cancers like 1 April is simple.
Severely damages tumor DNA.
And the damage inflict shutdown of RNA synthesis.
This shutdown versus longer, particularly in blood cancers with flow DNA repair deficiency.
Many hematologic cancers, including those with trans locations, which are quite common inhibitor logic malignancies.
Involving semic enable.
Evidence of low expression of DNA repair genes.
Prolonged shutdown of transcription stars such tumors of short lived proteins.
I detect and cannot live without.
We have also obtained evidence that the efficacy.
E. R. L. P 284 can be broadened to hematologic cancers.
Combinations with drugs that degrade the payer proteins, such as E RCC threep.
We are now actively engaged in developing collaborations to further our development of LPTA reported in the fundamentals.
And on seats, including dose with key unmet needs such as double hit lymphoma, and relapsed and resistant mantle cell lymphoma.
Well at CMO.
Because shown resistance 2 kinase inhibitors.
We expect to announce additional details on these findings.
And the indications later this year.
With that on.
I turn the call back to you.
Sure. Thank you before we open up the call to questions and a few closing comments on both of our business model and our focus from the new near future.
As you can tell.
<unk> Mellon data is helping us move forward rapidly, we'll continue advancing our pipeline of drug candidates using as genomics make targeted data driven methodology. We believe this is the future of <unk>.
Not only drug development, specifically oncology drug development, where there's an avalanche of data available to help guide discovery.
Development and patient stratification.
We expect to strategically grow radar to become among the world's largest AI platforms for oncology drug discovery and development. Additionally, we will begin actively exploring additional collaborations and partnerships with larger biotech and pharma companies.
We are confident that the growth of radar.
And the growth of the algorithms will continue to present additional opportunities for drug development R&D collaboration and partnering relationships are data driven and genomic we targeted and biomarker driven approach allows us to pursue a transformational drug development strategy that identifies rescues or developed potential drug candidates and what we believe is a fraction.
At the time and cost associated with traditional cancer drug development.
Just to note the last year, we've grown our programs from 3 at the time of our IPO to over 8 to day.
Maintaining what we believe is a very capital efficient and modest burn rate on.
Our dual approach to oncology drug discovery.
Developing de Novo biomarker.
<unk> guided drug candidates and rescue historical drug candidates is we believe and then black and emblem of this new era in drug discovery and 1 that we believe lantern as a leader in.
There is potentially every decade.
Hundreds if not thousands of discarded or otherwise day prioritized therapeutic candidates.
Across industry and academia, we aimed to bring many of them at least 1 of these drug candidates into our pipeline every 12 months to 18 months in the past 12 months, we've actually beaten this.
Benchmark significantly.
We are laser focused on the quality of the.
Drug candidates, but more importantly on our ability.
Fully understand and characterize that we'd go into clinical development and a very de risked manner.
In this context, we're focused on building a portfolio of high quality high impact oncology drug candidates, which can be potentially partnered.
<unk> brought to market rapidly and rare ultra rare indications.
We believe this provides a clear and defined path for potential high value creation for our shareholders, but also very importantly for improving the ability of personalized cancer treatment for patients. Our mission is to unleash the power of radar and our AI platform to transform the pace the risk and the cost of oncology drug discovery.
<unk> on it.
We believe this is the only way to impact the lives of patients globally.
Radar has the potential to significantly accelerate our understanding which compounds should be developed and for which indications.
We believe we're uniquely positioned to be able to continue this pursuit and to that end we've grown the number of programs in our active development.
From 3 to 8 and regain control of our molecule L. P 184, which is in a phase 2 clinical trial.
This is important as it provides more opportunities to generate near term upside and is highly synergistic with our portfolio and it improves the risk reward equation for investors.
So with that I'd love.
<unk> developed the call to any questions.
Okay.
At this time, if you'd like to ask a question. Please press the star and 1 on your Touchtone phone you may remove yourself from the queue at any time by pressing the pound Keith once again that is star and wanted to ask a question, we'll pause for a moment to allow questions.
It looks like our first question is from Kyle Boser. Your line is open. Please go ahead.
Hey on Python on thanks for all the updates today.
On maybe a couple of questions on the collaboration with actuate.
To the extent you can share what sort of development milestones are attached to this end.
Have other company.
Companies are approached Atlanta on as a result of your agreement with accurate.
I thought that's a good very good question.
That actually support a number of companies to reach out to us.
We're in discussions with several of them.
All of them make.
Some molecules are great candidates for approach others can be more challenging.
<unk>.
We want to take on the projects that make the most sense.
So we want to make sure that we get what we believe is fair consideration. So there are a lot of really unique opportunities, but for us we wanted to take a meaningful participation in the molecule upsides, So if theres milestones.
<unk>.
<unk> development.
That's important for our shareholders and for us to get upside and of course, if the molecule interest into certain targeted areas that were unknown or uncovered as a result of our platform. Those are also on milestones or trigger points for upside. These are the kind of triggers that we did have with the actuate deal the detailed terms.
Disclosed.
Closed there in the press release, but the.
We basically.
Get some upset some stock in the company some equity in the company for.
On delivering insights about which indications and insights about.
On a companion diagnostic type signature on a stratification approach.
Those approaches then go.
Go into the commercial market are pursued then we get additional equity based on that.
Got it that's helpful and.
And can you talk talk a little bit about how the agreements kind of play out for example that there's actually kind of work with your team to answer questions or.
Is there a dashboard that you can give them access to is probably not that simple.
But just trying to understand how automated radar is and what the goal is here. Thank you.
As I mentioned before Kyle the goal is twofold, 1 to find additional indications where there are drug which is a GSK 3 beta inhibitor may be applied either.
Sorry bureaus in combination therapy.
Those indications is partly.
Bob and silicone and real world on enrichment from looking at different classes of molecules.
There is not a dashboard weird routine interactions chief scientific and medical officer.
<unk>.
I don't think this approaches.
Cash work like I mean, we do share our findings and data. We've just finished a big data enrichment campaign.
We just finalized curated and cleaning some of their existing data from clinical trials.
And its interactive I think there could be a day, though.
In probably in the next few quarters, where there is more of a dashboard.
Cash gored like <unk>.
Delivery system for radar, but again, let's remember this is not our primary business model, our business model and the way we're going to create value is by advancing our drugs to patients.
This is a wonderful way to increase the value of our platform and give it more experience in terms of making it more robust but.
But it is not the primary driver of value.
No that makes sense I appreciate it thanks for all the updates on them.
Our next question comes from John Kim Your.
Your line is open. Please go ahead.
Hi, Manav.
Yeah.
To start off John how are you on.
Doing pretty good pretty good here on.
On the L. T 100, you bring that back in house, that's great how much of that data, we'd be able to use as you move forward with it and are you able to pick up where you left off in the phase II trial or do you have to start over or are you evaluating that.
We are a valued and that that's a great question as I mentioned in the first 9 patients that were enrolled had a median overall survival of 12.5 months.
We think that's a success.
Major improvement over other fourth line or later metastatic castration resistant prostate cancer trials, which are typically had.
Median overall survival.
Well as low as 5.6 and up to 9 or 10.
Depending on the patient population, but against kind of all the analysis that we've looked at this as a it's a major improvement.
Obviously, it's a small number of patients and we believe we can increase it by going to the target enrollment.
Survival 27, but there are new insights as we've talked about regarding <unk> regarding DNA repair genes and they might enable us to have a better enrich trial. We're in discussions with the investigators now on that.
Okay.
We are going to get all the data.
From the trial that.
Enrollment is a part of.
The transaction was.
It'd be very compliant with G P. Dr which is very stringent in Europe.
And there are some patient level details, we may not get but we will load that data into our analysis in terms of how we go forward.
And also take some of our other findings.
It was obvious from 184 and other molecules and guide the development.
So yeah, there's a it's a big need for.
Fourth line and later, which have all in most all cases have less than 1 year on typically about 9 months of survival. So there's a great need for this especially for people who are nonrecurring.
On soup to both chemo and androgen therapies.
So we think this has a great place 9 patients with a small number but the response the overall survival is a very.
Very meaningful Mark and I think we can actually improve upon that potentially so that's a good indication indication about $200 million.
And U S spend alone and probably close to 700 million globally. So there's a significant commercial room for this drug.
Alright, and then in terms of R&D spend for El Pen 100, how much should we layer on for that.
While providing additional financial details as we.
Non response get all the data and have conversations with investigators.
I expect very modest amount in the third quarter, but more on the fourth quarter.
Okay, and then in 2022, I assume as well or is there any claim on a wrap up.
It will 2022 will be the bulk of the work.
Okay.
But since we're already in the third quarter into August as you know August in Europe isn't the most busy time.
<unk>.
We'll be analyzing the data getting the sites get them to site.
Irb's transferred working on from the regulatory backdrop getting control of the drug product and drug substance so kind.
Ticking and tying to basically take everything over so I expect a modest spend in Q3, but much more so in Q4 and Q1 of next year.
Okay, Great Great and then I'll tell you 184, that's a busy candidate for you guys isn't enough.
1 area is never a number of our programs ADC pancreatic bladder G. B M E T. R T.
Maybe I missed 1 on how do you prioritize or rank those internally in terms of their importance.
Right now the the pancreatic is the furthest along so there's a clear need there's a significant market as I mentioned close to 1.
$1 billion U S and spend.
So hi.
Need high commercial value for this long in development. So that clearly is a priority.
We're beginning on bladder because of the findings in bladder we're working now with Kols that are very interested.
But pancreatic and G. B M. Our 2 priorities of 184, right now and bringing those to patients.
Great. Thanks for taking my questions are on them.
Okay.
Yeah.
Our next question comes from Catherine Novack. Your line is open. Please go ahead.
Hi, Thanks for taking my question I, just wanted to ask on PC.
Wanted to ask on the L. P..3.
To you've mentioned earlier on the call that you plan to enroll never smokers, who are keen on I. Even have failed prior to me I just wanted to clarify about the status of patients with prior checkpoint inhibitors and are there other inclusion and exclusion criteria of note that might give us a better sense of the patient population.
Okay.
That's a great question Catherine typically.
The checkpoint if someone who's getting the checkpoint inhibitor a lot of checkpoint inhibitors are given where the chemo so that would make that make them not available for the trial. If they are going to have a very.
Already this is if their outcome is.
100, less in certain number of months that also would exclude them from the trial and other comorbidities typically exclude people from the trial, but.
The patient wanted to Q1, just chemo naive. So typically these patients will be not eligible for immunotherapy.
So then they'll do hotspot or DNA sequencing and if they have 1.
1 of the Hallmark mutations like Egfr hour plus 1.2 net wells.
Go on 1 of these targeted Teekay eyes.
And eventually people get Teekay <unk>, whether it be in round, 1 or round 2 or now with the third generation <unk> eventually.
Stop responding the great.
Yeah.
Tegra So of course, there's the 1 major exception to that which has been phenomenal.
That's where people that have exon 20.
But for almost everywhere else, particularly on the T begins to set in and.
And oftentimes or there are other potential side effects.
And so the clinicians at that point have a choice of whether to.
Take them off of PKI, and do Teekay holiday, which is always challenging because then the cancer then it's going to be coming back. So they prefer to go to a cable.
Chemo doublet.
At that point, the clinicians will have a choice to do the chemo doublet or chemo doublet plus 300.
And so that's those are the patients that are perfect for this trial.
And as you know there's 2.
Quite a few tpa is used in non small cell lung cancer.
We believe.
On driving the awareness of the clinical trial site selection about what.
Roll in places plays its part of the patient selection will allow us to enroll faster, but we're getting a lot of excitement from patient advocacy.
Patient groups that do harbor some of these.
On targeting mutations, but eventually stop responding or are never smokers and come down with the disease. So there's a lot of interest, but if you've done came up before or the checkpoint inhibitors or have other comorbidities that it would be those would all be disqualifying factors.
You can see growth.
Got it makes sense.
And then I just kind of wanted to confirm the timing of the trial initiation I think Pat mentioned that was planned for I think 3 key <unk>. Our second half and you had also mentioned that you plan to meet with FDA in June So I Wonder if you had any feedback.
Jack if the agency had any feedback on the trial design in your approach to selecting patients.
Okay.
We did he was a he was a non event so there's no issues there.
So we're going to submit the final CMC and as I mentioned earlier in the call we've had delays.
Ladies and manufacturing related to equipment and.
Some of the analytical equipment and supplies at the manufacturer level, so independent of any other issues, but those have now been resolved.
And we expect to have final.
Drug product.
Later this quarter. So we are parallel tracking to try to save as much time as we can.
But theres no issues the trial design, so that's moving forward.
And once we have the final CMC that'll be submitted and we expect.
Site selection and activity that happened this quarter enrollments hopefully begin.
Q4.
Yeah.
Got it thanks very much.
Thank you.
And our next question comes from Ron.
Silver onshore your line is open. Please go ahead.
Hi, This is mobile on dialing in for Ron Suraj.
Thanks for taking my question, so with respect to that would be 100, I know you released the median overall survival data, but I'm. Just curious can you comment on the other parameters, including duration of response on all that and also will the drug be evaluated and the remaining 18 patients that allowed a day initially expected to enroll.
We will be evaluating that with the with investigators on.
There is no remaining 18 patients. So we haven't enrolled the other 8 tenths, so they'd have to be identified.
They'd have to be prioritized.
Enabled for the trial, so theres not a 18 patients remaining there.
We have to go through the process.
The trial was delayed due to Covid and then delay due to the resources of the partner and so now were picking back up this active trial and moving forward with it so.
Good released additional data on.
On the duration of response and the overall.
Sales just kind of on them at a later date once we've gone through everything.
With the investigators.
Understood. So now that you've regained that'd be 100, right. So what are your thoughts on initiating clinical trial activities in the U S line with respect to timing and are you planning to do.
For phase 2 b prior to launching a pivotal trial and approximately how many U S patients must demonstrate drug efficacy to gain FDA approval.
That's a great question, we do not have plans to do anything in the U S with the drug at this time.
So at this time, where we have a lot of investor.
Broad theatres, who are interested in the drug since we've been in discussions with it for some other indications we may pursue some of those that are with investigator led initiatives, but right now the priority would be to properly wrap up the existing trial to evaluate.
How to best move forward in that indication.
But that's already active in dollars have been spent.
Best again in Europe. So our goal is of course to maximize.
The amount of already spent investment and this drug and so I think once we evaluate that then we can consider perhaps.
U S focused efforts, but right now our focus is on the.
On the existing efforts as well as the investigators that have reached out.
Spend from real unique applications of the drug.
Alright, 1 final from me. This is just like a clarification so are those.
Terms and conditions associated with using a lot of these companion diagnostic tool or is it already embedded in the roughly $80 million total deal.
The total deal value is.
$1 million upfront 1 million over the next 24 months based on milestones and then up to $16 million based on commercialization and marketing approvals.
This is standard with a substantial portion of that letter amount based on.
For some actual marketing approval so it would be in the future at the time the drug would receive marketing approval in the U S or Europe.
So, but we do have the right to use their DRP companion diagnostic for this L. P 100 drug in this indication.
Again, I think they put some interesting work into it.
And but we also have additional insights about the molecule.
And the intended use but we do have new opportunities already that.
We think are very interesting, namely in bladder cancer, which we've talked about so that will be 1 of the 1 of the indication.
Acacia is that we think are a high priority for this molecule.
Alright, that's it from me congrats on your progress.
Thank you.
And once again that is star and wanted to ask a question next question comes from Art Bolander. Your line is open. Please go ahead.
And most of them on.
How are you.
Hey, good afternoon, how are you on your.
Good.
Yeah, I can see you on your team for the progress you've been making.
I was asking similar questions from me I'll pay you 100, there'll be consideration at all for a partner.
GAAP somewhere along the way with that drug.
Yeah.
Oh, absolutely I think.
We have to be cognizant of is the history of the drug and cognizant that it's in the middle of a trial that was delayed that we're revising now so I.
Partners elements need to be.
Taken off near term before that there are real partnering opportunities.
That's our goal now this is a.
And asset that hasn't been paid significant.
It hasnt been resource to adequately.
So I think we are going on or about to change that.
And we will now.
Now focus on.
Putting the right foot forward on the molecule and the right trial with the right datasets and then partnering will happen naturally as a result, but youre absolutely right. This is a great asset on partnering given given the indications.
On late stage metastatic castration resistant prostate cancer.
I think that's where high need indication.
And we believe the data is is we'll be it will be interesting, but what we're really where we will we do plan on releasing additional details on the data after without adequate time to discuss it with investigators.
Great great.
Okay.
Thank you and all the best going forward.
Yeah.
And it appears we have no further questions at this time.
Alright, Thank you for everyone's questions I'd like to thank everyone for their participation in today's call and I look forward to giving.
So it says we advanced the molecules and as also as we develop new ideas for the platform and announced new details about our existing trials <unk> new developments.
Thank you.
Yeah.
This does conclude today's program. Thank you for your participation you may disconnect at any time.
You update.
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