Lantern Pharma Inc. Q1 2023 Earnings Call

$7 billion in annual sales, where we can use it both as a single agent or as a combination therapy.

This phase one clinical trial for <unk> four in genomics defined solid tumors will be launching in mid 2023 for patients with recurrent solid tumors, including brain cancers.

We also plan on completing our IND, enabling studies for <unk> hundred 84.

And launching our first in first in human Phase one clinical trial in multiple non Hodgkin's lymphomas. This is about a $1 2 billion indication and this is targeted in the second half of this year.

We also received notice of allowance from the U S. PTO for composition of matter patent for <unk> hundred 84 as well.

Gives us exclusivity for this new molecule into 2039 2014.

We also developed an industry leading series of AI algorithms.

A series of algorithms that not only are now top ranking at the therapeutic data comments, which is an industry consortium, but it helps solve one of the most challenging problems in brain cancer drug discovery, which is predicting with some level of accuracy a compounds blood brain barrier permeability.

Our top four algorithms are not only.

Highly accurate, but also ultrafast and scalable we can run thousands of molecules at a level and scale that was not possible before on a daily basis.

We also established an additional radar collaboration the center with one of the leaders in breast cancer TTC oncology to help advance their phase II ready drug candidate TTC $3 52 in ER positive breast cancers. This continues to prove and validate that in fact, our AI platform radar.

Is valuable currency and dealmaking and in drug asset development.

We also continued to show fear.

Discipline and ended the quarter with $51 5 million in cash cash equivalents in marketable securities, giving us cash runway into 2025.

Now with those highlights.

Behind US, let me turn the call over to our CFO , David Margaret will provide an overview of our first quarter financial results David.

Thank you Panna and good afternoon, everyone.

I'll now share some financial highlights from our first quarter ended March 31 2023.

Our R&D expenses were $2 $6 million for the first quarter of 2023 down slightly from $2 $7 million in the first quarter of 2022.

We see R&D expenses, increasing in the second half of 2023, as we advance our L. P 300 phase II trial and commence our phase one trials for <unk> 184, and LPT years 84.

General and administrative expenses were $1 7 million for the first quarter of 2023 up slightly from $1 $4 million in the prior year period.

We recorded a net loss of $3 9 million for the first quarter of 2023 or <unk> 36 per share.

<unk> to a net loss of $4 $1 million or.

<unk> 38 per share for the first quarter of 2022.

Offsetting the loss from operations in the first quarter of 2023 was interest income and other income net in the aggregate amount of $419000.

Interest income was approximately $134000 for the first quarter of 2023.

Other income net was approximately $285000 for the first quarter of 2023 and.

And reflected increases in dividend income of approximately $80000 increases in unrealized gains on investments of approximately $207000.

And increases of approximately $136000 in research and development tax incentives related to our Australia subsidiary.

These were offset in part by increases in foreign currency losses of approximately $60000.

As of March 31, 2023, we had approximately 10 eight 6 million shares of common stock outstanding.

<unk> outstanding warrants to purchase approximately 177998 shares.

And outstanding options to purchase approximately 1 million 95046 shares.

These warrants and options.

And bind with our outstanding shares of common stock.

A total fully diluted shares outstanding of approximately $12 1 million shares as of March 31 2023.

Our cash position, which includes cash equivalents and marketable securities at March 31, 2023.

$51 $5 million.

This balance is expected to curious 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.

Our team continues to be very productive under our hybrid operating model. This.

This hybrid model also removes geographic restrictions to our hiring initiatives.

Which gives us the ability to recruit extremely high caliber team members that otherwise might not be available.

We currently have 23 employees, who are primarily focused on leading and advancing our research and development drug.

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 partner for an update on some of our development programs.

<unk>.

Thank you David.

As we mentioned earlier in the call. This week, we will be submitting our IND application to the FDA for <unk> first in human trial for advanced solid tumors and brain cancers.

On average we've been able to advance our newly developed drug programs from initial AI insights to first in human clinical trials in two plus years at a cost of around one to 2 million per program. Both metrics that are completely unheard of in oncology drug discovery.

This breakthrough pace of development was most recently highlighted in Starlight therapeutics as it intends to pursue human clinical trials for multiple CNS indications starting in late 2023.

Building on prior IND, enabling studies and the upcoming phase <unk> clinical testing that will be conducted by land turned in the coming months with.

The clinical development of Star <unk>, and CNS cancers beyond the phase <unk> trial will be conducted exclusively by Starlight.

But following that landfill, we will continue to advance the <unk> preclinical and clinical development for non CNS indications, including pancreatic bladder triple negative breast cancer and other solid tumors that have DNA damage repair deficiencies.

The formation of Sterlite.

As a wholly owned subsidiary allows lantern to sharpen the focus on advancing <unk> hundred one through targeted clinical trials and dedicate increased time resources and personnel to progress one of the most promising drug candidates for CNS cancer patients in decades.

We believe that by focusing our efforts by our Starlink, we can accelerate and deepen our commitment to the CNS cancer patient community, while also creating the potential for meaningful additional upside for our investors.

We'll always be looking for additional opportunities with a development needs and unique focus of certain programs our assets can be separated and developed in a more focused and perhaps.

More evolved manner.

As we've pointed out we are accelerating the pace at which we are developing.

Validating our insights and then leaning those into potentially meaningful and breakthrough drug assets.

We're very well positioned to then partner these dry gas assets out with larger companies and we will begin exploring some of those licensing and partnership opportunities with Biopharma companies. This year.

Other objectives for us. This year will continue will be to continue expanding radar to beyond 50 billion data points will be to establish additional radar based collaborations and also advance our ADC preclinical development ADC development.

<unk>.

Through advances in our platform, but also advances in exciting new preclinical compounds that will talk about later this year.

At the same time, David pointed out in his review of our strong cash position is being carefully utilize to make meaningful progress in a disciplined manner.

The most exciting which.

Coming up which is scaling to more patients for <unk> 300, and launching <unk> 184 in the clinical setting now with that I'd like to open up the call to any questions.

Thank you Panna.

Asked a question you can detail in one of two ways you can either take your question using the Q&A tool or you can click on the raise hand tool can speak directly to management and I will allow you to speak.

We have a question coming in here from an investor about our data in radar.

Where do we source our data and how do we validate and clean it.

That's a great question so we.

Get our data not only from public sources, like <unk> and <unk> and the NCI.

But also from private sources, such as collaborations that we have our own sequencing and biomarker studies that we do routinely with all of our drug programs and with our CRO partners. We also get it from.

Different studies that are posted at places like ACR <unk> et cetera, we also get them from historical drug programs that historical trials.

So there is a number of different places, including our own proprietary data that we're generating both preclinical and clinical data.

And.

Validating that data is interesting obviously, we run our studies in multiple duplicate.

To make sure the data we're getting is reliable. We also know that a lot of historical data is not terribly reliable or has its own challenges. So.

We embarked a few years back on a massive cleanup bolivar.

Of all of our NCI and.

<unk> and other historical key CGA related data sources.

And so we re normalize and re curated a lot of that data.

So through a lot of it away when the very first things I did when I joined land turn is about 30% of the data that we had at the time was tossed simply because it was not.

Reliable enough, where it came from cell lines that were.

Unknown or dubious in nature, and these are pretty well known in the industry. So most people who use the data either work around it cleanup or duplicated, which is pretty normal, but what we've done which is unusual as we've gone through tons of tagging and will give each of the data sets of data quality score.

So we know what machine it comes from what labs, where it was generated how was published was public publishing duplicate deeply transformed the data so.

So we have multiple ways that we not only <unk>, but then clean and normalize the data that we can use it.

You hear Michael King is raising his hand, Michael you should be able to speak.

Can you hear me.

Yes.

Guys.

Wanted just to ask you to speak about partnering strategies I'm, just wondering where you are a sweet spot where you think your sweet spot is in terms of.

Public private academic et cetera companies or not.

Institutions to.

To source further assets for the pipeline or are you better.

Or maybe simultaneously.

Do deals based around radar and other peoples.

Compounds.

That's a great question so imminent.

Give you a lengthy answer we can.

Talk more about it.

That Youre conference later this week Michael.

So in terms of ingest, new new molecules new ideas.

We have ideas of what things are a higher priority for us than others and so what we've tried to see if those things are out there and if they are available.

It had been manufactured they tested that they come in biological data.

Then puts us ahead of the game.

So.

So there are different definitely certain areas.

And we're always open to learning new things Youre only as.

Your question is only going to be as good as.

The data you have so of course, we're always looking at new assets as well, but they all do go through radar. So if you look at the unique relationship we have with TTC.

Although we are helping them with the definition of that.

Patients that are most likely to respond to the drug and also how their drug can be used in other indications. We also do have a clause in there that allows us to.

Potentially license and co develop the asset.

So as we develop it into.

Some meaningful radar driven insights, we do try to always have that.

That clause.

Basically.

Executable to try to get that asset through radar in terms of licensing out our goal is either phase two or phase III to license it out to bigger Biopharma companies that will then take the asset whatever molecular signatures that we have et cetera that make it meaningful and then put it into later stage trials.

Hopefully that answers your question.

Yes, thanks, very much for taking it.

A few other questions coming in here one from John Daniel Chen.

Are some of the characteristics that radar has identified and compounds that are able to cross the BBB.

That's great and detailed questions. So John will be able to send your white paper and we look at.

Probably somewhere in the range of between four and 5000 different characteristics everything simple characteristics like weight and size and number of carbon rings.

Surface area of the carbon rings.

Whether it's in a NAND tomorrow, and Theres like somewhere between four and 5000 different characteristics and we try to boil those down to the most important ones.

But we use multiple algorithms. So it's not just the characteristics different algorithms with preferred different characteristics.

And then we also run an ensemble approach if.

If you look at therapeutic data Commons, which I urge you to look at the top performing algorithm right now is the ensemble algorithm.

Which means it's a it's a mash up of the three or four other algorithms that all come right underneath it.

And so that.

<unk>.

So these molecular fingerprints in these unique things about each.

Chemical come from its structure from its <unk>.

Smiles characteristics and then.

<unk> basically ingest all that and decide which of the few thousand are most important.

Hopefully that answers your question.

Another one here from John regarding the ACR abstract on <unk> 184 does the related studies suggest about using combination approaches with PARP inhibitors or other agents that can disrupt damage of care pathways.

Yes.

So if you put the question back there. Thanks again regarding the ACR abstract as the related studies suggest that.

About <unk>.

Using accommodate with PARP inhibitors or other agents.

Yes, I think <unk> because there are a number of <unk> that are approved there.

That's where we're actually actively exploring 184 and potentially 100, both with power bi.

Drugs.

There is a big opportunity because number one they're already approved or selling in the billions and we know that theres dosage issues with PARP inhibitors people become.

Sensitive and there is some toxicity issues.

So we are in discussions with some of the part by investigators to look at combination with 184 now one of the unique things that came out in the ACR abstract maybe not as clear as we'd like but definitely has hinted at it will come out in the next set is that the PARP.

<unk> inhibitors.

They.

Keep the.

Molecules this or that cancer cells from repairing themselves are great blockers of repair.

And so that's what gives it the cancer cell kind of capability.

Now interestingly enough.

<unk> four is a great breaker of DNA.

<unk>.

And so as it breaks the double strands.

And then part buys our dose and the <unk> keep the double strands from repairing it is like a really perfect one to hit.

That's why we like the 184 plus power bi.

Combination.

Could other double strand, breaking agents be used gas, perhaps like some <unk> some races.

Maybe some M&A, but those have tremendous amounts of toxicity and so youre going to get toxicity side effects from both of those drugs that are just not good that's what makes it went 84 more unique.

Especially when using carbide, because it's complementary mechanisms.

And we're also able to we believe change the dosage level significantly so that's it.

This is an area we're very excited about.

Another question coming in here, our cash runway hasnt changed through our last few quarters can you expand on that Amit.

Well I wish I wish that was the 100% true.

We had been frugal with our cash, but I'll, let David kind of walk you through been burning between three and $4 million roughly of quarters, but David go ahead.

<unk> as we described on the call we have about.

$51 5 million in cash cash equivalents in marketable securities at the end of the quarter.

And we have been consistent.

And I think pretty solid and are forecasting in terms of where our cash would would carry us.

We manage that very carefully.

I think the reality is compared to a large portion of our sector. We are in a very strong cash position.

We're always looking for.

We're watching this cash position very carefully we're looking for opportunities and we'll continue to.

Operate in a very fiscally disciplined manner.

Hey, thanks.

Yes.

Thank you think that might be other questions.

Sure.

And today. Thank you everyone that joined US today, and we hope to see.

Thank you.

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