Q3 2022 Lantern Pharma Inc. Earnings Call
Good.
I'll open up the call for questions and answers after management's presentation.
A webcast replay of today's conference call will be available on our website at <unk> Dot com shortly after the call.
We issued a press release after market closed today summarizing our financial results and progress across the company for the third for the third quarter of 2022.
A copy of this release is available through our website at lantern pharma Dot Com, where you will also find a link to the slides that management will be referencing on today's call.
I would like to remind everyone that remarks about future expectations performance estimates and prospect and prospects constitute forward looking statements for purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1095.
Lantern pharma cautions that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated.
A number of factors could cause actual results to differ materially from those indicated by forward looking statements, including the impact of the COVID-19 pandemic 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 Monday November seven 2022, and Lantern pharma does not intend to update any of these forward looking statements to reflect events and circumstances that occur after today unless required by law.
A webcast replay of the conference call and webinar will be available on <unk> website.
On today's webcast, we have landrum CEO punished Sharma and CFO , David Margrave panel will start things off in a moment with an overview of <unk> operational highlights and business activity after which David will discuss our financial results. This will be followed by some concluding comments from prana and then we'll open up the call for Q&A.
Jim.
I'd now like to turn the call over to punish Sharma, President and CEO of Lantern Pharma Panna. Please go ahead.
Thank you Nicole good afternoon, everyone and welcome to our third quarter of 2022 earnings call. Thank you for joining US this afternoon to hear about our third quarter results and other corporate progress Atlanta.
Lantern pharma is at the leading edge of leveraging artificial intelligence machine learning algorithms biomarker clinical genomics and drug response data to transform the cost.
The timelines and Derisk oncology drug discovery as well as oncology drug development.
We are actively using this transformative approach, which leverages AI through our own radar AI platform.
We use this to uncover significant opportunities and cancer opportunities that are either underserved unmet, where often overlooked with advanced and rescued compounds and bring them to phase II clinical trials.
Also have develop entirely new drug candidates for first in human trials next year. We're doing this at a fraction of the cost and timeline of traditional drug development.
Our unique AI platforms powered today by more than 25 billion data points and over 200 algorithms.
These are the foundation of what helps us to understand predict and model questions that are fundamental to oncology drug development.
We are advancing two drug candidates that are in phase III clinical stage and expect to launch two additional drug candidates early next year.
This first in human trials will be with <unk> 84, and <unk> 84, both molecules can be synthetically lethal and certain cancers <unk> <unk> hundred 84, specifically in solid tumors, while LP acuity force directed at a range of blood cancers, specifically non Hodgkin's lymphomas.
We've also been focused on advancing our rescue drug candidate <unk> 103 hundred towards precise a meaningful treatment indications and unique patient populations.
We also have several therapeutic programs that we expect to introduce in the coming quarters with both our existing molecules and with new molecules and new combinations that we've been validating and developing through our AI guided process.
The compression of cost and timeline is a central and key issue.
And one that we are truly at the lead at the lead position of with our process. It's what's allowed us to growth our portfolio from three programs 15 months ago to 11 programs today.
We expect many of these programs to create high value opportunities for our investors and potentially life transforming therapies for cancer patients.
Core of our business is our IP not only on our drug products and also on the insights on how to best manufacturer utilized and direct them, but.
But also IP related to our AI platform and the methods and automation that drive the precision and power of radar.
We continue to expand the functionality of radar and will provide investors and analysts additional details during a tech and platform day, which we expect to have in early Q1 of 2023.
In addition, we recently published a paper in frontier and drug discovery, which highlighted our work with the National Cancer Institute in uncovering an entirely new DNA damage mechanism for LP 184, and also the development of a new indication in an ultra rare brain cancer Herc.
Lantern pharma has entered into a major period of transformation as we evolve and mature many of our initial AI driven insights and advance additional drug candidates into human clinical trials, we're continuing to make significant and meaningful progress in turning the observations and insights generated by our AI platform.
And then validated in the labs labs actually top tier academic and research partners eventually into advancements for cancer patients and hopefully to breakthrough clinical programs.
Our 11 programs span multiple indications that have been developed at a level of cash burn and resourcing that is largely unheard of but has been enabled by our.
AI and data driven approach, we expect many of these programs as we partner with larger Biopharma companies.
And it.
And as they further develop in the clinic.
We develop these programs again, not only a fraction of the cost but also in a very compressed timeline.
And we believe that traditionally can take upwards of 10 to up to $100 million to achieve a meaningful clinical program we've done that.
Her program with a range of $2 million to $3 million.
Today, we had several notable advancements to share with you, including updates about the advancement of our harmonic clinical trial for <unk> 300, and never smokers with non small cell lung cancer updates on the IMD statuses of 184 to 84 and the clinical trial indications for those drugs.
We also will talk about some of the improvements on our radar platform.
Most notably this past quarter was marked the launch of the harmonic clinical trial a phase two.
Nickel trial for never aimed at never smokers that have non small cell lung cancer. We expect this trial to enroll 90 patients and we're looking at the effect of <unk> 300 in combination with standard of care chemotherapy, which is pemetrexed and carboplatin.
On overall response and also progression free survival overall survival and progression free survival. We've activated the first two clinical sites northwest oncology and Gabriele cancer Center in Ohio.
And I expect it to dose first patients and had several additional trial sites in the U S. In this quarter.
A novel and exciting aspect of the harmonic trial. It is also important for our future development is that we'll be collecting and analyzing liquid biopsies from these patients at four time points. During the trial. These biopsies liquid biopsies will then be analyzed for both genomic and transcript dobek data and we believe it could represent the largest.
Most comprehensive longitudinal biomarker studies done on never smokers, which is about 18% to 20% of new non small cell lung cancer cases.
Importantly, this data for the liquid biopsy will be used to generate insights for a potential pivotal phase III and also be used in the dossier to help partner.
The drug candidate out.
We're also continuing to engage in global Biopharma partner discussions for regions of the World, where there is a higher prevalence of non small cell lung cancer and never smokers, including parts of Asia, South America and Europe .
It's important to note that in our previous phase III multicenter clinical trials, a subset of never smoker patients with non small cell lung cancer, receiving <unk> 300 with chemotherapy showed increase overall in two year survival of 91% to 125% respectively.
Compared to patients suggest receive chemotherapy alone never.
Never smoker patients with non small cell lung cancer represent a potential market size of one five to $2 5 billion with nearly 200000 patients diagnosed with this cancer and about $20 to 30000 of.
Those are here in the U S alone again never smokers in non small cell lung cancer.
In Q3, we also announced the issuance of an exciting new patents relating to <unk> 300 that extends the commercial protection of LP 300 until late 2032 of its directed towards increasing the.
The survival time with patients receiving <unk> 300 that are marked by the overexpression of <unk> <unk> per diluted reduction.
This patent increases the potential for future partnering.
And <unk>.
<unk>.
Further growth in our patent state.
Moving on to our <unk> program. We are currently developing LP 184 for two major classes of cancers.
Solid tumors, including genetically defined pancreatic and bladder cancers, and central nervous system cancers, including GBM, Glioblastoma and brain Mets and also <unk>.
Across all programs <unk> 104 has the potential the value we think of this molecule.
Somewhere in the range of $5 billion to $8 billion.
L. P 184 has potential both as a potent monotherapy agent, but also to be used in combination with other therapies in the last year, we filed over 10 patents on this molecule and across multiple indications and have increased the size of the CNS indications that are in development significantly from one.
Last year to nearly five today.
The completion of the <unk> ready for IND, enabling studies and the submission of IND application to the FDA our anticipated for Q1 of 2023.
<unk> four is under development for two major classes of cancers solid tumors, including genetically defined pancreatic and bladder cancers and several central nervous system cancers.
Just on the difference in the clinical needs and standard of care for these cancer classes. We may have two separate phase one clinical trials.
Royalty 184, and we expect these to launch in the first half of 2023.
In the U S. The standalone market potential of these programs just in the CNS cancers alone we.
We expect it to be over $5 billion.
And then another $1 billion to $3 billion range for solid tumors.
In addition to <unk> 84, as adult cancer program LP 184 is also being developed for several rare pediatric cancers, including the ultra rare cancer <unk> at very aggressive and malignant CNS cancer with no existing standard of care therapy Landrum.
<unk> is in discussions with HCR to key opinion leaders about our pediatric trial design for a potential phase one clinical trial.
Also this is the same indication, which for which we have a rare pediatric voucher.
Boucher.
Landrieu presented new preclinical data at the ACR Special conference for pancreatic cancer in collaboration with our partners at Fox Chase Cancer Center. This presentation highlighted an important aspect of 184 and that it has potent anti tumor effects.
The mouse models that have DNA damage response.
Alterations or mutations and ATR and breath of one.
Additionally, <unk> four was demonstrated to act very synergistically with other standard of care agents use in.
Pancreatic cancer, but also with spironolactone, which we've talked about before and also with radiation therapy. These combined results exemplify the potential for <unk> four as a therapeutic agent in some very aggressive cancers, both as monotherapy or in combination you can do the poster on our website.
<unk> 84, this is a totally new molecule.
This was first announced a little by little over a year ago introduced at Ash in 'twenty.
'twenty one.
It will be at Ash again here this year and we expect to finish the IND, enabling studies in Q1 of 2023 and file.
With the FDA, we expect the trial to launch again in the first half of 2023.
We're developing <unk> hundred 84 for non Hodgkin's B cell lymphomas.
Again, we've seen nano motor potency.
And there is also a very important clinical need and the NHL indications that we're particularly excited about our mantle cell and double hit lymphoma, a double hit lymphoma.
And globally natural selling double hit lymphoma is in fact, nearly 45000 patients a year would move virtually all patients relapsing two to five years after treatment and.
Typically they stop responding to existing standard of care agents. So there's a significant clinical need for late stage therapeutic options for these patients and represent we think another $1 billion opportunity at the society of Hematology and oncology. So host annual meeting <unk> Sciences presented new research on 284 for non Hodgkin's lymphoma.
And we presented also that <unk> had strong anti tumor effects.
<unk>.
Cell lines that are resistant to standard of care agents Ibrutinib and bortezomib. So.
<unk> hundred 84, the antitumor effect in those resistant cell lines support this potential for relapsed patients or patients who develop resistance that poster also it can be viewed on our website.
All the work that we do and validating our ideas about the molecules validating combinations in use is all done in collaboration with World class leaders at top cancer centers, including Johns Hopkins Fox Chase Cancer Center, Ut Health, San Antonio the Danish cancer Society and others.
Continuing to focus on providing insight and transparency about our research we continue to host Webinars.
Will be hosting a webinar and synthetic lethality to key mechanism of action for our $184 284 molecules and also for 100. The webinar will feature an internationally recognized expert in synthetic neutrality. Dr. Zsolt <unk> policy, who is the who has joined appointments both in cancer research and all.
<unk> is an assistant professor of Pediatrics at Boston Children's Hospital, and Harvard Medical School affiliate.
We will be announcing additional details about this webinar.
We are particularly excited about we think it creates.
Creates a lot of <unk>.
Additional excitement around that class of molecule for 184 to 84.
We're also happy to report that we surpassed our year end goal of 25 billion data points.
And we're several months ahead of schedule. This growth in data coincides with significant upgrades to our radars computational infrastructure automation and library of machine learning algorithms.
We think that this will continue to accelerate and more importantly continue to be used in our programs and programs of our collaborators.
The current collaboration with <unk> Therapeutics is advancing <unk> for their drug candidates <unk>, formerly <unk> 41, the radar generated insights has accelerated development initiatives for our regulus, including identification of candidate Biomarkers.
For patient selection and development of models to predict clinical response highlights. The ongoing successes collaboration are also planned to be shared at an upcoming webinar with actuaries team.
I'll now turn the call over to our CFO , David who will provide an overview of the quarter's financial results David.
Thank you Panna and good afternoon, everyone.
I will now share some of the financial highlights from the third quarter.
Our R&D expenses for the quarter ended September 30 22.
We're approximately zero point $7 million.
Compared to approximately $2 $96 million for the third quarter of 2021.
A substantial portion of this decrease in expenses relates to a $935000 payment. We received in July 22 from one of our service providers in connection with the resolution of a difference of views regarding the service provider agreement.
This payment we received contributed to an approximately $1 $6 million reduction in product candidate manufacturing related expenses. During the three months ended September 32022.
In addition, we made a $1 million upfront payment to <unk> therapeutics during the three months ended September 32021, which.
Which was non recurring so that expense did not occur again in the quarter ended September 32022.
General and administrative expenses were approximately $1 4 million for the third quarter of 2022.
Slightly from $1 $2 million in the prior year period.
We recorded a net loss of approximately $2 $3 million for the quarter ended September 32022, or 21 a share.
This compares to a net loss of approximately $4 1 million for the quarter ended September 32021.
Or <unk> 36 per share.
As of September 32022.
We had approximately $10 eight 6 million shares of common stock outstanding.
An outstanding warrants to purchase approximately 178000 shares.
An outstanding options to purchase 1 million 953 shares.
These warrants and options combined with our outstanding shares of common stock.
Give us a total fully diluted shares outstanding of approximately 12.04 million shares as of September 32022.
Our cash position, which includes cash equivalents and marketable securities as of September 32022 was approximately $57 8 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.
Our capital efficient manner.
<unk> currently has 17 employees.
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.
I'll now turn the call back over to Palmer for some final comments.
Thank you David as David mentioned, we're well positioned and are executing on our mission to leverage AI and data in a highly cost efficient manner to generate clinically needed programs in cancer therapy. We continue to have a strong fiscal discipline with our cash utilization most.
Most of which was spent on external research manufacturing and trials.
Our focus remains on leveraging our intellectual knowledge capabilities around scientific strategy and the AI platform and then working with World class partners <unk> to execute on those needs. This enables us to scale to work as needed and rapidly adjust as our data or the markets dictate.
This nimble model can be a hallmark of future drug development, that's both efficient and derisked.
Later, this quarter and this year in Rancho and presenting new preclinical data at several scientific conferences, including the society of Neuro oncology annual meeting in Tampa, that's coming up in 2016 to the 20th.
The San Antonio breast cancer Symposium in early December we were presenting.
Some exciting new data.
And the American Society of Hematology Ash in New Orleans in mid December where we'll be talking more about $2 84.
We'll also be attending to buy a future conference. This week in New York and the disruptive growth Conference in New York also in early December .
Currently we believe many of our programs as they further develop can be partnered out for several hundred million dollars or potentially even billions of dollars.
In addition to providing multiple shots on goal are maturing development pipeline with two phase two assets the upcoming launch of multiple phase one trials and additional assets under development should provide a steady flow of catalysts news and data moving forward to attract an increasing level of interest from both the investment communities and <unk>.
Pharma companies with extraordinary potential ahead of US we continue to believe our current market cap and prices on accurately reflect the true value of our development programs and our AI technology platform for oncology drug development. We are actively pursuing and continue to pursue activities to increase our visibility Atlanta in pharma with the Reits such as <unk>.
<unk> and also to engage with larger global Biopharma companies.
For partnering one or several of our programs I believe we've crossed an important inflection point in our business with our platform and now has repeatedly proven its capabilities are delivering important insights to expand our pipeline and to aid in the development of others pipeline with Russia, and a new era for our company.
Are now leveraging AI driven insights to.
To get to cancer patients in a more effective and efficient manner.
I want to thank everyone for their time today and interest in metrics on this call.
I will now open up the call to questions.
Thank you Panna.
If you would like to ask a question you can do so in one of two ways you can either take your question and using the Q&A tool or you can click on the raise hand tool to speak directly to management and I will allow you to speak.
Hum.
Few questions coming in here one from Jon Vander, most Kim you may need an entirely new IMD for each indication for <unk> hundred 84.
No we're not expecting that we think we can develop this under the same IMD.
We'll have different protocols potentially for the trials with the IMD would be one.
Yeah.
And I see here, Michael King raising his hand, Michael go ahead and ask your question.
Hi, guys can you hear me yes.
Yes, yes, Hello, Michael Thanks for taking the question congrats on the progress.
Several questions I'll try to keep it brief.
Just in general could you talk a bit about 184 since it's Scott so many potential indications how do you foresee making specific go no go decisions.
Decisions for the various indications in the CNS.
Including pediatric Hi, how are you going to.
Priority ties the different indications.
That's a great question and the first and we will probably have a multi tumor.
Trial and 184.
And from that phase, one or phase <unk> data will probably enriched for phase one beer to basin that tumors that are most responsive will also during that trial and gather information about.
Large scale information about.
The DNA damage response profile and also <unk> levels as well.
And so we will enrich from that initial phase one <unk> to a more targeted one beer to trial and so I expect we will we're going to probably enroll lots of solid tumors and that that solid tumor will give us some good dosing information as well.
Allow us to get the safety data that we won and from that will probably launch them to phase one and <unk>.
CNS cancers, and again very similar to safety one.
For solid tumors, we probably will enroll the majority of the recurrent CNS cancers, and then enrich in GBM and some of the more responsible malignant gliomas that we've seen are more responsive.
So we are going to allow patient data real clinical data to guide.
Downstream selection, but we have some good ideas already where we think the most responsive tumors will be we will pursue those first.
They're the most responsive.
Is there a clinical need that's clear and can we get through trials in a rapid way, but yes. There is a lot of that's why we think one of your for such an exciting molecule.
And remind me kind of youre not going to pre screen patients for their <unk>.
Expression right, but you'll you'll do some kind of a post hoc analysis or how is that actually going to work. That's the current thought they would.
<unk> select based on <unk> levels initially, but we're still looking at we're still in discussions with Kols and looking at feedback, but we made pre select based on DNA damage response mutation profile, though so.
So if someone has a.
Whether it be homologous repair deficient or nucleotide excision repair deficient that might be the criteria across all solid tumors and later stage trials, we very well could use the <unk> as a selection.
Eligibility criteria as well.
Got it and then just one more quick question.
As far as.
Strategic imperatives are concerned.
You said in the formal remarks and in the press release that.
You're going to start introducing perhaps some more.
Novel compounds of new compounds into the pipeline in novel combinations I just wonder.
You know how much.
Can you keep filling up the front of the funnel so to speak.
Because are you going to get limited on bandwidth you could potentially have five different trials on 184 alone.
And then you've got 284 300 100 so.
It's filling up the front end of the funnel at this point in time really the priority or would you rather see some flow through into <unk>.
Clinical advancement.
Pipeline compounds.
The clinical advancement is clearly a priority so.
But there are a lot of new.
Ideas and advancements that are being made.
Very likely announce with partners. So youre right Theres only so many trials that we can handle alone, but we do have some interesting things that.
We are like to develop a probably will develop with a partner faster, but our current priority is the clinical advancement of <unk>.
That we've talked when we've talked about that first but I don't want investors or other so forget. This is also a platform the amount of new content that's coming out.
Right, that's only getting more precise in larger and so.
That was our hope as we grew the platform and I think that's beginning to.
A big opportunity for us to partner and so that's why we raised the clinical advancement of the existing compounds as the number one priority.
Thanks for taking the questions.
Thank you Michael.
You have another question coming in here what are the first observations on screening success for the harmonic trial.
Yeah.
We're in the process of screening probably half a dozen two dozen.
Patient so we will we won't know until.
We've started the process start with dosing process, but yeah, we've got.
Probably six to 12 patients.
Hunter being bidder and the likely stage.
No observations yet.
Okay anybody else have any last minute questions feel free to raise your hand or type in using the Q&A tool.
I see John Daniel mentioned is raising his hand.
John you should be able to ask your questions.
Hello, guys can you hear me.
Yes Hello.
I thought it was really interesting that you had noted about taking the liquid biopsies over the course of the trial and wonder if there was any precedent for that and if so any observations and then Mike that also be useful for conducting some kind of adaptive trial design in the future.
Yeah like I said in the comments the liquid biopsy, probably been one of the largest longitudinal studies on the same patients.
And never smokers. So what happens now is never spoken population is there typically if they have an actionable mutation, they're given a range of Teekay is some stop responding in a few months take two to three years, if they're egfr they might mutate to $2 970 M, which you can be on that drug also for it.
Year or two so my expectation is that the.
The.
Cancer genome will be pretty different across these never smokers will probably be some subtle variations based on the drug history.
Treatment history that they've had and so.
Things that we may expect different levels of response to the L. P 300, plus chemo doublet based on the clinical treatment history, and so that will allow us to really pinpoint it.
Who is going to be the most responsive and if theres a signature that comes out of it we can use that signature regardless of never smoking status and we made then have a pivotal phase III based on that signature.
It will advance our understanding of ever smoking cancer biology in general, but I think it will be very helpful into creating a more focused and even narrow trial and it will also help us with pharma partners as pharma partners of course asked the same question why do we have a range of very variability in response to you can you tell us what you see.
It may or may not correlate with their prior clinical treatment, but I think we will find a lot of.
Good insightful data and in the liquid biopsy.
Is that we collect.
And I think very exciting aspect of this.
The de identified data will then be included and incorporated in radar, which will make that even more powerful.
And just to add on to that we will be doing in liquid biopsy.
Enrollment in multiple time points wherever possible and all of our trials, so it'll be pretty standard.
So what we're doing on the GBM trial, we'll be doing in the solid tumor trial for wide before we'll be doing that with 204 trial because it just there's a wealth of data the cost for liquid biopsy done.
Much more reasonable.
If patients are amenable to it and which in many cases they are.
It gives us a lot of very clear ideas on how to advance the molecule.
Great. Thank you for taking the question.
Thank you John .
That is all the questions I see that we have for today and thank you everyone for joining and have a great rest of your day.
Nicole Thank you David Thanks, Thanks, a lot appreciate it.
Goodbye.