Q1 2022 Lantern Pharma Inc. Earnings Call
<unk> clinical trials, we're continuing to make significant and meaningful progress in turning our ideas that have been generated by our AI platform radar into advancing our clinical programs and generating new preclinical compounds.
Atlanta, and our mission is to use AI machine learning and big data to understand the genomics biomarkers in biology of cancer, better faster and with greater precision.
We then leverage those understandings and insights to develop targeted oncology therapies at dramatically reduced cost with an improved risk profile for targeted patient populations in a compressed manner. We think that this approach of using AI and data can fundamentally change the lives of more cancer patients faster.
And with reduced risk.
When I joined the company, we had one active drug program. When we took the company public in June of 2020, we had three drug programs today, we have nine programs for targeted indications with three FDA granted orphan designations in one rare pediatric disease designation.
Im very proud of that accomplishment by our talented team and that would not have been possible in the traditional drug development process. The short amount of time.
In Atlanta, and we've done this because of data and more importantly, with AI and <unk>.
With growing our library of algorithms.
Right now we are living in the cost of the Golden age of medicine, and because of AI cloud computing and the growing availability of relevant biologic genomic and clinical data we're able to.
Generate insights into the development of new compounds the medicines at a much faster pace with.
With large scale technologies now at our disposal and also cost effective it's allowing lantern to bring drugs to market at a fraction of the time and cost of prototypical drug development models.
Today, we have two phase II clinical trials two phase one clinical trials that we'll be launching later this year and several very exciting preclinical programs in cancer indications, where there are often no therapies.
This first quarter was marked by several operational highlights across almost all of our programs, which I'd like to briefly touch on in the early part of this call.
First the launch of the harmonic clinical trial for our drug candidate <unk> 300.
As intended for never smokers with non small cell lung cancer is progressing we submitted an amendment to the IND application to the FDA in mid April and are anticipating the trial launch. This summer of 2022. We also made significant progress with <unk> hundred 84 into a phase one trial, where we're now completing the IND enabling study.
And anticipate that we will be able to submit them to the FDA in Q3 with the potential to launch trials first in human in Q4 at.
At the 2022 ACR conference, we presented a poster showing that our drug candidate <unk> hundred 84 was effective against brain metastases, especially those from lung skin breast and colon cancers.
In the U S brain Mets occurred about 10% to 30% of all cancers are diagnosed in over 100000 people per year globally that number may be closer to 300000. This is a significant opportunity to meet patient needs and at the same time leverage the unique nature of the insights regenerating from our radar.
<unk> platform to go after very specific indications.
Also now to accelerate the clinical development of <unk> hundred 84, and our other programs. While also being very cost efficient we establish a entrants subsidiary in Australia will be able to take advantage of their R&D tax incentive program, where we will earn $1 back for specific R&D spend.
That we do in Australia, our Australian subsidiary will allow us to remain capital efficient, while also accelerating clinical development and to open the Avenue for new collaborations as cancer centers in Australia.
Our radar AI platform also this past quarter surpassed 20 billion data points and its insights continued to accelerate objectives for our drug development programs, including those that have led to our newest syndication brain Mets and <unk>.
Additionally, we are also expanding the functionality of the platform and of the algorithms. So that we can better predict.
New concepts, such as synthetic reality and improve potential combination regiments again.
We also filed patents around these novel ideas. This past quarter, we filed an additional patent application for radar covering an ensemble approach towards automated algorithm creation for drug sensitivity prediction.
And our newest collaboration which is a fundamental part of our business model is a degree heat children's cancer Research Institute, which we announced in February and this research collaboration we are expanding our focus on rare pediatric cancers. This research has initially focus on advancing <unk> four into childhood cancer indications using models developed by Dr.
Peter Hutton at degree Kent.
Children's Cancer Institute at University of Texas Health Science Center in San Antonio So.
So far we've launched early studies and we will have a briefing on our findings later this quarter, but help you on 84 has demonstrated very promising efficacy and a number of pediatric cancer models.
Now the volatility in the biotech markets continues, especially among micro cap and small cap companies and we continue to feel that our valuation is hyper attractive for investors with evaluation near our cash position our board announced in March that they had approved an extension of our existing share purchase program through the <unk>.
End of July 31 <unk>.
This authorizes us to purchase up to an additional $3 $6 million worth of the company's stock.
Colleague, David So next year, we'll give you more details on that into the financial section.
I'd like to spend some additional time, giving an update on some on our upcoming phase II trial, the harmonic trial.
But the harmonic clinical trial, which is intended for never smokers in advanced non small cell lung cancer.
And this disease, a molecularly very different from lung cancer and smokers. The genomic profile of patients is also significantly different.
The harmonic trial will be a 90 patient two arm randomized open label trial and will include 15 to 20 sites all in the U S. Several of which are already being set up.
In mid April we submitted an amendment to the IND application for the monarch trial to the FDA and our target of enrolling patients later this summer for the harmonic trial, our primary endpoints of progression free survival and overall patient survival.
My colleague to shore will tell you a bit more about the mechanisms behind <unk> 300 later in his section.
In regards to LP won 84 very excited to tell you that we're getting closer to human trials as we progress on our IND, enabling studies we.
We anticipate the first in human Phase one clinical trial in Q4 of this year. We've been we've completed several of the IND, enabling studies and we believe that will be completed by Q3, and then submit IND to the FDA at that point.
Sure I'll speak more towards this later in the call.
Our latest drug program <unk> hundred 84, which I mentioned in brain Mets, there's a very.
<unk> unique area that has high clinical need we announced at the ICR conference in March our findings in brain metastases initial findings have been it's very exciting since we've demonstrated anti tumor activity in multiple cell models of brain Mets from lung skin and breast with some very high sensitivity.
Currently there is a real need for a new approach because many of the existing therapies that are pointed at <unk>.
Really don't cross the blood brain barrier and most importantly.
I have not shown a significant improvement to overall survival.
Again, we believe that 10% to 30% of cancer cases, metastasized to the brain and are diagnosed and about 100000 plus patients just in the U S and globally. The number is closer to 300000.
Due to allocate 184 as favorable blood brain barrier permeability.
<unk> with its observed clinical efficacy in <unk>, we think we're very well positioned for rapid progress and potential success in the brain Mets market <unk>.
In January we also announced receiving rare pediatric disease designation and orphan designation for another form of CNS cancer, <unk>, which is aggressive and rapidly.
Rose.
Primarily in children in the central nervous system. We also got the rare pediatric disease designation, which underscores the critical value of our growing focus on rare pediatric oncology indications.
We think this is a significant opportunity for land turned and our investors, but most importantly for children, where there have only been four new approvals over the last 15 years.
In September .
As we've established.
Australia subsidiary.
Okay.
<unk> Pharma, Australia limited to take advantage of the research and development tax incentives. This will allow us to be more capital efficient and give us greater flexibility by generating cash from tax offsets for our eligible R&D expenditures.
This will give us more flexibility for our upcoming drug programs.
And many of our studies already are underway. So we think that will improve our capital efficiency going forward.
In addition to our clinical programs. We also reached a significant milestone for our radar AI platform, which earlier in the quarter reached over 20 billion data points.
Applying data machine learning algorithms and radar allows us to uncover new opportunities in cancer opportunities that are underserved unmet or overlooked radar.
And it allows us to do several very powerful things one finding new indications to revitalize drugs that have been overlooked a shelf or new indications for our existing drug candidates develop entirely new drug space on targets or are based on areas, where we believe there is going to be activity and then ultimately find page.
<unk> populations much.
Much faster at a fraction of the cost of traditional patient stratification approaches and we find those patients that will respond to our therapies or other therapies with potential collaborators. When we went public in December of 2020 radar had about $275 million and data points today, we're at more than $20 billion in before the end of this year.
We expect to be well above our target of 25 billion data points for the year and.
So why is that important the more data points, we have the more we can understand and model things that may or may not be occurring just like with any other large complicated system, whether traffic patterns evolution the market and we can explore opportunities where our compounds can potentially change the outcome in certain cancers as we grow our data.
Points, we're able to discover new places, where our drugs work such as the ones I outlined with <unk> in brain Mets or we can find.
New indications.
We're new uses of drug.
New drug targets, such as <unk> hundred 84, which again wasn't even in our portfolio less than two years ago are sort of less than one year ago.
So this development at this kind of pace are things that just weren't being done.
As little as seven years ago, and cancer drug development and certainly not at this cost. In addition to aggregating data for radar. We're also expanding algorithms within the radar to better utilize our data Lake I'm going back to the history of the company, we had about three or four algorithms thats focused on very specific problems related to differentially gene analysis.
The building blocks of looking at patient stratification and signature creation, but as many of you know algorithms can solve a variety of problems related to a workflow to the creation of.
Our solution and as the algorithms become more powerful more predictive they can actually begin now training themselves on our massive datasets to create insights and correlations that will accelerate our drug development process. These algorithms can look at very specific questions such as <unk> networks are most likely to be involved in the mechanism. They can.
At identifying genes or driver genes in a central biological problem that we're looking at they can potentially generate combinations that may have been overlooked for combinations with non cytotoxic drugs that hasnt been even thought about before today, we're doing all of those things.
In terms of beyond that we've also demonstrated this past quarter that LP to 84 has growing efficacy will be hosting an update on <unk> hundred 84 in a number of hematologic cancer, specifically in mantle cell lymphoma and double hit lymphoma.
I'll now turn over the call to Chris sure initially.
<unk> further details on our development programs and then to David to talk about our financials and update on other key matters of the company for sure.
Thank you bye now.
I'd first like to update everyone on the studies directly relevant to clinical trials.
Both LP 300, and it will be what it is Paul.
The harmonics trial, which is investigating the efficacy of LP to 300.
Used in combination with the standard of care Carboplatin and Pemetrexed continues to move forward.
The retrospective analysis of a multi center phase III trial.
So that LP 300, given in combination with chemotherapy.
At least the two year and overall survival by 125% and 91%.
In the subset of patients who turned out to be never smokers.
What else dependence mechanical excellent may help explain that.
Survival benefit observed in lung cancer, and there were small groups.
Well one of LP three hundreds mechanism of action.
Is to covalently modified the sustains.
Certain proteins.
Essentially in activating them.
Bbs and.
An ongoing multi omics data.
Clearly signify.
That lung cancer and never smokers has distinct gene and protein expression profiles.
When compared to lung cancer and small parts.
For example, some recent data published in the International Journal of cancer identified fewer somatic mutations and lesser chromosomal instability, but confirm higher frequency of mutations in Egfr and <unk>.
We do.
These features that distinguish lung cancer and never smallpox.
Also the proteins that are potential targets LP 300 days.
And the studies that involved.
Settlement of the direct interaction.
LP transit and some of those.
Schedules are shown on this slide.
The index of LP tendered and drivers of lung cancer never small goods like the titles in kinase outlook at <unk>.
GFR LP tuned it modify it just seemed rescue deals supporting that LTE 200 can inactivate <unk> kinase proteins that are primarily involved with lung cancer and never smokers.
L. P 300 has been previously shown to act as a chemo sensitized by.
By decreasing the activity of redox proteins.
Reduction in Qatar at auction.
Which are often all expressed in lung cancer and never smokers.
Exposure to LP 300 has the potential to restore the tumor cell to the docs balance sensitizing the cancer cells to chemotherapy.
We have designed the harmonic trial to prospectively assess the direct survival impact of including LPTA on rates with standard of care chemotherapy in lung cancer never smokers.
And as stated earlier, we expect to initiate enrollment in the coming months. This summer.
Moving now to our molecule <unk> 184, which has shown promise in multiple cancer types.
<unk> has been focused on moving towards a fifth and phase.
One.
Human clinical trial later this year.
Yes.
In preparation for this the non <unk> portion of the required studies has been completed and the <unk> portion will be completed by the third quarter of 2022.
In parallel we will also have the CMC report to include in our IND application.
Based on our current understanding of these timelines.
We are well positioned to initiate the human clinical trial before.
End of the year.
For the phase one clinical trial of LTE <unk>.
Sure.
<unk> identified four sites and.
And discuss the trial designed with clinical investigators.
But I'd love to activity is that data to.
Enable our clinical trials. We also continued to obtain very exciting and encouraging data on L. P 184 that identify additional properties of the molecule.
Making it relevant in the treatment of tumors with clinical needs.
An example of this was mentioned earlier.
Earlier.
Where do we recently presented results at the ACR annual meeting.
Describing the preclinical efficacy of <unk> in cancers that.
The size of the brain.
This is important because brain metastasis occurred in approximately 10% to 30% of all cancer cases.
And represent a much larger proportion of pain related cancers than primary brain cancers.
These brain Mets are difficult to treat due to the lack of standard of care treatments.
That can cross the blood brain barrier.
Given the excellent blood brain barrier penetration of LP, what 84, coupled.
Coupled with the broad preclinical activity in diverse tumor types.
It was obvious that would be 184 be assessed for activity in brain Mets.
Our results presented at ACR provide the foundational evidence that LP 184 is equally effective in brain Mets, a few months from lung breast and melanoma as it is in the prime results of these tumor types.
Our next steps towards developing LP 100 people.
For treating patients with brain Mets includes assessment of LP, what 84 in animal models of brain Mets.
CNS pharmacokinetics, clearly supports the availability and exposure of the drug in brain tissues.
This therefore, it gives us ample confidence in advancing L. P 100 default in this important indication.
It impacts or 100000 patients in the U S annually.
I'm not going to now touch upon some exciting observations of LP, we're ready for that.
Debt related.
Two.
New concept.
The concept of synthetic lethality.
Synthetic lethality is gaining greater recognition as a mechanism to specifically target tumor cells.
In multiple studies L. P 184 has demonstrated a novel synthetic lethal relationship.
In tumors deficient in nucleotide excision repair do much we call notes and also in <unk> deficient in homologous recombination pathway due mostly called hoods.
Northern Hertz.
Cause of mutations in genes in these spot space.
And these are the genes that play a role in DNA repair.
As many as 10% to 20% of tumors are nodes on Hertz.
Our preclinical data using the response of various tumor cell lines as well as ex vivo patient derived pdx is confirmed this synthetic lethal relationship.
Between <unk> 84, and two months of it such mutations.
In fact robust responses in vivo.
Also evident in tumors that are resistant to either PARP inhibitors and other synthetic lethal agent at again DNA damaging agents such as cisplatin.
We continue to use radar and other data driven approaches to identify mutations in various genes that enhance the sensitivity of LP 184.
The information on specific genetic mutations that cooperate to elicit the spin typically tally of LP when it is important to.
Allow the preferential killing of SKU months, but not normal cells.
We are in the process of developing a mutational response signature of tumors that will allow us to best select highly sensitive tumors for our drug candidates.
So I would say importantly mentioned in this context that LP 100 also has a synthetic relationship and nodes and we have initiated in Silicle and targeted wet lab studies assessing the potential of LP 100 in combination with PARP inhibitors in a clinical setting.
We believe that the results from this study can help further derisk and pinpoint the use of LP 100 cancer patients.
I will now turn the call over to David Margrave, our CFO , who will provide an overview of our first quarter financial results David.
Yeah.
Thank you Kishore and good afternoon, everyone.
I will now share some of the financial highlights from the first quarter.
Our R&D expenses were $2 $7 million for the first quarter of 2022.
Up from $1 3 million in the first quarter of 2021.
The increase in R&D expense was primarily attributable to increases in manufacturing related expenses for product candidates research studies.
And an escrow payment released two hilarity under the hilarity asset purchase agreement.
Which payment was a nonrecurring expense.
General and administrative expenses were $1 4 million in the first quarter of 2022.
Up from $1 2 million for the prior year period.
We recorded a net loss of approximately $4 1 million for the first quarter of 2022 or <unk> 38 per share.
As of March 31, 2022, we had approximately $10 8 million shares of common stock outstanding.
An outstanding warrants to purchase approximately 891000 shares.
Outstanding options to purchase approximately 178000 shares.
These warrants and options combined with our outstanding shares of common stock gave us a total fully diluted shares outstanding of approximately one 9 million shares as of March 31 2022.
PON I mentioned, our share repurchase program and through March 31, 2020 to.
The company has repurchased a total of 475157 shares.
Of those 353667 shares were purchased in the first quarter of 2022.
Our cash position.
<unk> cash equivalents in marketable securities at March 31, 'twenty two.
It was 65 $2 million.
This balance is expected to carry us into 2025.
Importantly, we believe our solid financial position will fuel continued growth and evolution of our radar AI platform.
Accelerate the development of our portfolio of targeted oncology drug candidates.
And allow us to introduce additional targeted products and collaboration opportunities.
In a capital efficient manner.
Consistent with our focus on capital efficiency.
In September 'twenty, one as Kannan mentioned, we created as an Australian subsidiary with the objective of enabling lantern to take advantage of Australia's R&D tax incentive program.
Which provides tax offsets for eligible R&D expenditures.
We see this program is providing us with the opportunity.
To conduct selected upcoming preclinical and clinical studies and trials with increased financial flexibility and capital efficiency.
As <unk> previously discussed we have already initiated preclinical and IND, enabling studies through our subsidiary in Australia.
As mentioned on prior calls.
We're migrating to a hybrid work environment and I'm proud to say our team continues to be very productive under this operating model.
This hybrid model removes geographic restrictions to our hiring initiatives.
Which also gives us the ability to recruit extremely high caliber team members that otherwise might not be available.
We've maintained discipline in managing our head count and we currently have 60 employees, who are primarily focused on leading and advancing our research and development efforts.
We see our number of employees expanding slightly in coming quarters, as we add additional experienced and talented individuals to help advance our mission.
At the end of April we announced that Dr. Maria <unk> was nominated for election to our board of directors.
He is the current CEO , president and a director of <unk> Bio Inc.
Pharma company focused on developing therapies.
Zero degenerative diseases.
If elected she will bring decades of experience and progressing drug candidates through late stage clinical trials.
Dr. <unk> will be presented alongside alongside a slate of five existing directors at <unk> upcoming annual meeting to be held on June .
2022.
I'll now turn the call back to ponder for some final comments. Thank you David.
I believe we're very well positioned today, we would continue to have very strong fiscal discipline strong balance sheet and great oversight of our programs. Our focus is on leveraging our intellectual knowledge and our unique capabilities around scientific strategy and clinical trial design and on.
AI platform development, while we work with zeros and leading cancer centers.
To accelerate our trials and our studies this model enables us to keep our company lean and mission focused while allowing us the flexibility to increase or decrease the studies the trials the wet lab work as they are needed and also as results dictate.
During the year, we expect to bring multiple assets and to focus clinical trials in 2022, where theres demonstrated patient need or where there's really no proven therapy for example, brain Mets or a TRT, while remaining focus on capital efficiency.
We will continue to take initiatives this year to make our dollars go further such as of the Australia subsidiary potentially looking at additional partnerships focusing on non dilutive funding through grants and other mechanisms. Additionally, our AI platform radar will continue to grow significantly across all measures data analytical rigor generation of new publisher <unk>.
Sites and new functionality.
As data and AI continue to drive changes in cost speed and efficiency of drug discovery to development our team in Atlanta and will remain at the forefront of transforming oncology therapeutic development.
So with that now I'd like to open up the call to any questions.
Yes.
Thank you Panna.
If you would like to ask a question you can do that in one of two ways you can either use the raise hand tool.
If you wish to speak directly to management and I will enable you to speak or you can take your question directly into the Q&A tool.
Yes.
Okay.
Yes.
Couple of questions coming in already one from Keith Thompson Lands' end as the only company I know of that mentioned the size of its AI data Bank. Why is that is 20 billion plus the largest small number related to AI and Iot.
I think it is.
Good to report how the progress of the data Lake is because.
It gives you a sense of.
What are the types of things our team is focused on what is the velocity of.
The increase what cancers, where data types gives you a sense of what are the questions that we're going to be exploring and what is the roadmap for development.
I'm sure there are other companies that talk about the.
The number is I don't think many have the same kind of discipline in terms of recording them or some might be afraid to report it but I do see other companies in drug development I think broadly in bio.
I do see many of the synthetic biochem Tony's reporting similar types of metrics.
So yes, it's growing it's definitely growing thing to report the number of them kind of a data elements or data types or unique sets of data.
Thank you for that.
Sure. The next question here and I see them, Michael Daniels is asking Tim Lee Hanse and.
So Michael I will allow you to speak.
Thank you cannot be yourself.
Michael I believe you're still on mute.
Okay.
Excellent.
<unk>.
Any worries related to your cash runway.
Okay.
Dave.
I can speak to that I think the answer is no.
I think we all recognize that focus on cash availability and your cash runway is very important for companies in our space, that's something we do constantly.
Recognize this is a challenging environment, we are well aware of that.
Quite focused on maintaining capital efficiency and keeping the lean disciplined environment that we've been able to maintain to this point.
We see if we do those things we don't see cash runway.
An issue for us.
Anything you would add to that.
I think we've given guidance that we've got cash and the 2025, which I think will have a lot of development between now and then so.
We should be cognizant of that we're not worried.
Okay, and I see a John Newman is asking to speak John .
John I will allow you to go ahead and ask your question.
Other things and thanks for taking my question gentlemen.
Just had a question about the phase two harmonics study for <unk> 300.
Never smokers, just curious if that study will be including patients with brain Mets.
And I'm wondering if.
Brain Mets are any more or less common and never smoker lung cancer patient then smokers. Thanks.
Okay.
Okay.
I think brain Mets would be.
Would exclude people from the trial, yes, yes, that's correct, yes. Unfortunately, it would confound the results of this study and since <unk> is not the indication for <unk> 300.
It probably makes sense for them to have a different care path.
That was the nature of your question in terms of the.
I think it was the second part to that question LP 300.
Signs of brain Mets journal as the second part of that.
Just curious if if it's known weather brain Mets are any more or less common in the never spoke of patients. So perhaps never smoker patients wouldn't have as many brain Mets. So.
There really wouldn't be many restrictions on them receiving the drug in the real world. If it were approved.
I can take that no I mean, even non smokers.
In lung cancer, and non small of course that our brain Mets, there's not sufficient data that I can point to but.
I think the.
There was equal risk.
Whether the lung cancer accordance and smokers are non smokers.
Yeah.
Yes, that's part of that's accurate from the anecdotal data, but theres no comprehensive data I've seen in terms of percentage of brain Mets from various.
Smoking types.
And can you maybe talk about any type of genetic or biomarker data that youll be collecting from the never smoker patients.
Yes.
Yes, I'd love to.
For sure you want to give them.
Sure, Yes, so we have an exploratory endpoint.
Where we are.
Where we are looking at circulating DNA.
To see if we can get only.
Indications of responses, but in addition to that we're also going to collect.
Eddie available genomic data from the archival tissues.
To be able to do.
All that is correlations and dumps have the response the patterns of response, so on and so forth.
But all of these are exploratory studies at this point.
Yes, we will be taking on liquid biopsy at enrollment.
After three cycles six cycles and at end of study and so we may find some unique set of biomarkers correlated to some of the observations.
But again those are exploratory at this point, but we may use in later stage phases.
Okay, great. Thank you. Thank you.
Very good questions from John .
Okay, and I'm not seeing that we have any additional questions I'll give everyone. A key amendments acuity there and like to type in your questions in the Q&A tool or if you would like to speak directly to management, you'll see that the.
The right hand tool.
Okay.
Okay.
Okay, I'm not seeing any other questions coming in here and panel or would you like to make any final remarks, we look forward to talking more with investors and shareholders as the quarter continues we plan on having several updates.
<unk> not only our existing clinical trials with some of the other programs and partnerships that will be trading. So thank you all for attending and we hope you found this is informative.
As well. Thank you. Thanks very much. Thank you everyone. Thank you.
Yeah.