Earnings Labs

Lantern Pharma Inc. (LTRN)

Q2 2022 Earnings Call· Mon, Aug 8, 2022

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Transcript

Operator

Operator

Good afternoon, everyone. I’m Nicole Leber with Investor Relations here at Lantern Pharma. And welcome to our Second Quarter 2022 Earnings Call. I will be your host for today's call. As a reminder, this call is being recorded and all attendees are in a listen-only mode. We will open 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 lanternpharma.com shortly after the call. We issued a press release after market closed today, summarizing our financial results in progress across the company for the second quarter of 2022. A copy of this release is available through our website at lanternpharma.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 prospectus constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Lantern Pharma cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially 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 would 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, August 8, 2022 and Lantern Pharma does not intend to update any of these forward-looking statements to reflect events from circumstances that occur after today, unless required by law. The webcast replay of the conference call and webinar will be available on Lantern's website. On today's webcast, we have Lantern Pharma’s CEO, Panna Sharma; and CFO, David Margrave. Panna will start things off in a minute with an overview of Lantern's operational highlights and business activity, after which, David will discuss our financial results. This will be followed by some concluding comments from Panna, and then we'll open up the call for Q&A. I’d now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.

Panna Sharma

Management

Thank you, Nicole. Good afternoon, everyone. And welcome to our second quarter 2022 earnings call. Thank you for joining us this afternoon to hear about our second quarter results and corporate progress. For those of you that are new to Lantern, Lantern Pharma is at the leading edge of leveraging artificial intelligence, machine learning algorithms, biomarker, genomic and drug response data to better understand where drugs work and where they don't work, and also how to model how drugs can be effectively combined to create new therapeutic options specifically for cancer. This was something that was simply not possible at a commercial scale, even just a few years ago. We're actively using this transformative approach through our proprietary RADR AI platform. We're using this platform to uncover significant opportunities in cancer, opportunities that are either underserved, unmet or often overlooked. Unlike a lot of companies that are using AI to create diagnostics or provide data or matching services, we're focused on the ultimate goal of improving and potentially saving the lives of patients by creating more precision therapies. We're doing this while generating potential oncology drugs at a fraction of the cost of traditional drug development. This is of high value and a highly needed business. Our unique AI platform is powered today by more than 21 billion data points and nearly 200 algorithms and computational models that can help us understand predict and model questions that are fundamental to oncology drug development. Core to our business is our IP, not only on our drug products and the insights in how to best manufacture, utilize and direct them, but also relating to our AI platform and the methods and automation that drive the precision and growing power of RADR. Lantern Pharma has entered into a major period of transformation as…

David Margrave

Management

Thank you, Panna and good afternoon, everyone. I will now share some of the financial highlights from the second quarter. Our R&D expenses for the quarter ended June 30, 2022 were approximately $3 million up from approximately $1.2 million for the second quarter of 2021. This increase was primarily attributable to increases in product candidate manufacturing related expenses and increases in research studies. General and administrative expenses were approximately $1.4 million for the second quarter of 2022, up from $1.3 million in the prior year period. We recorded a net loss of approximately $4.5 million for the quarter ended June 30, 2022 or $0.41 a share. This compares to a net loss of approximately $2.3 million for the quarter ended June 30, 2021 or $0.21 per share. As of June 30, 2022, we had approximately 10.8 million shares of common stock outstanding and outstanding warrants to purchase 177,998 shares and outstanding options to purchase 939,940 shares. These warrants and options combined with our outstanding shares of common stock give us a total fully diluted shares outstanding of approximately 11.9 million shares as of June 30, 2022. Our cash position, which includes cash equivalence and marketable securities as of June 30, 2022 was approximately $62.2 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 RADR 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. As mentioned on prior calls, we have migrated 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 gives us the ability to recruit extremely high caliber team members that otherwise might not be available in a smaller local talent pool. We currently have 18 employees who are primarily focused on leading and advancing our research and drug development efforts. We see this number expanding slightly in coming quarters, as we add additional experienced and talented individuals to help advance our mission. I’ll now turn the call back over to Panna for some final comments. Panna?

Panna Sharma

Management

Thank you, David. We’re well positioned today, and we are executing on our mission to leverage AI and data, and also in a highly cost effective manner to generate clinically needed programs in cancer therapy. We continue to have very strong fiscal discipline with our cash utilization rate, mostly focused externally on research, manufacturing and clinical trials and not on internal infrastructure development. Our focus remains on leveraging our intellectual knowledge capabilities around our scientific and AI strategy, and then working with world class partners in research and in clinical trials, and also with experienced CROs to execute on our needs. This is important because it enables us to dial up or dial down the work and cash burn as needed and rapidly adjusted as our or the markets dictate. Later this quarter and this year Lantern will be presenting new preclinical data at several scientific conferences that are coming up, including at the American Association for Cancer Research. They’re having a special conference in pancreatic cancer in September. We’re presenting data that we’ve done in conjunction with our collaborators there, which as you know, is one of our cornerstone indications for 184. We’ll also be presenting at the Society for Hematologic Oncology, the 10th annual meeting in Houston that will be focused on LP-284. We have several others also that are developing. We will announce more conference details in the coming weeks. We’ll also be attending the MicroCap Rodeo investor conference in Chicago on October 12 and 13 and at the ThinkEquity Conference in New York on October 26. I will also be hosting a panel on how established emerging biopharma companies are using AI specifically in drug discovery and development at the ThinkEquity Conference on the morning of October 26. Ultimately, we believe many of our programs as…

A - Nicole Leber

Operator

Great. Thank you, Panna. [Operator Instructions] So we have one coming in here from John Vandermosten. What is your sense of the capacity of CROs and trial sites to take on clinical trials?

Panna Sharma

Management

That’s a great question, John. Kind of sounds like you’re doing some additional homework for your CRO coverage. So as you know, I ran a pretty large CRO in the past, but I think – an investor calling me directly now, it’s crazy. Okay. All right. The capacity, I think the capacity is fairly limited. I think CROs are taking on a lot of work and projects and really delaying the launch part of that is driven because the lack of available healthcare workers and staff at the sites to take on new trials. So it really, it becomes a lot of pushing and a lot of, unfortunately personality that will drive trial sites to engage. But I think CROs are hungry for revenue. So they – I think are overestimating their capacity. I think there are a lot of under – sorry, overutilized teams across too many projects in CROs. And I think that’s going to be quite challenging for certain trials, especially later stage trials, unless what’s also beginning to happen is that you’re seeing increasing usage of other geographies. So that’s also positive. But I do think that CROs have kind of over promised and are slow to deliver. Not delivering, but slow to deliver. And so that focuses on pharmas like us and sponsors like us becoming more involved in what I call greater patient awareness. And we’re doing that with the Harmonic trial. So if we can drive greater patient engagement and patient awareness, especially in these unique populations that allows us to then drive the clinical sites that want to participate more actively. Well, that’s definitely an issue.

Nicole Leber

Analyst

We have a couple of other questions coming in here, one from Michael King. With the increase in data points, does your processing power not have to increase commensurately, so it’s to not create a knowledge bottleneck?

Panna Sharma

Management

It’s a great question, Michael, wonderful question. This is what we – so if you notice we got to 20 billion data points in Q1 – late Q1 which is a big increase. But we only got to a little over 21 billion in Q2 and that’s because our attention quickly focused to this very issue. So we’ve done things to increase the speed of our pipeline, increase parallelization. So right now we solve some of those challenges by going massively parallel with simultaneous pipeline management and also tweaking the algorithms to perform faster using certain languages switching them from R to Python or switching them even from Python to parallel Python and other things. So yes, that’s something we’re acutely aware of. So we’ve been able to address that head on. We continue to address that through greater automation so that our focus is on the actual run time. The run times are going highly parallel and they’re going through more nodes. So we haven’t – we’ve seen the bottleneck. We’ve addressed the bottleneck and actually in some cases we’ve improved the output by 70-plus-percent. So I think we’re ahead of the curve again. And we’re going to go back to sucking in more data.

Nicole Leber

Analyst

Another question coming in here from John Vandermosten. I noticed that you highlighted combination therapy using PARP inhibitors with LP-100. Do you have any additional detail here?

Panna Sharma

Management

Yes, John, we do have additional detail and we’ll be sharing that I think in the coming weeks and months. But we have a great synergy data with PARP inhibitors and LP-100. The key thing that it allows us to do is two things, we think it allows us to go from later stage kind of fourth line where LP-100 was using – being used in metastatic castration resistant prostate cancer to earlier where PARPs are currently used, which is second line gives us a much larger available market size. And second, the synergy with PARP, because PARP is given in fairly high doses and eventually there’s some response issues over time and toxicity issues, more adverse reaction than toxicity. And so we can give a smaller dose of PARP with 100 sets our thesis, and that’s what we’re most likely going to reengage with for that drug. But we’ll be sharing additional details on our studies and the impact as a result of that. But we’re pretty excited by that.

Nicole Leber

Analyst

Okay. I have another question here. Can you tell us when you expect the clinical trial for LP-300 to increase the burn rate?

Panna Sharma

Management

Yes, I expected this quarter. So yes, as you know, we just made some major payments to manufacturers and to clinical trial sites to get them up and running. And so the logistics definitely took – will take a big chunk out this quarter and next quarter, but anything you want to add to that, David?

David Margrave

Management

No, I think it's consistent with the progress we're making towards advancing the clinical trials and we will see it increase not dramatically, but we will see it increase as we move into clinical trials and ramp those up.

Nicole Leber

Analyst

Another question here is what is the next outcome if the Harmonic trial is successful?

Panna Sharma

Management

A conference call with analysts probably, if the Harmonic trial is successful, it's very likely that we would use the data to then refine the pivotal trial or partner it out in a pivotal trial with a big pharma. It's very interesting to note that pharma companies have wonderful programs in PD-L1 where tumor mutation burden is high. We talked about that earlier and never smokers tumor mutation burden is low. And so if Harmonic trial is successful, I think it would be a great compliment to many of the non-small cell lung cancer programs that big biopharma companies have today. So that's most likely the outcome is that we'd use the data, refine and design if pivotal Phase 3 in collaboration with a much larger partner. And again, it's a $1.5 billion to $2 billion plus opportunity. So I think it would attract a lot of attention from the better commercially equipped by our pharma companies. It's a very interesting indication.

Nicole Leber

Analyst

Another question coming in here from John, will there applied to a drug candidate after every phase trial to further refine patients in trial protocol?

Panna Sharma

Management

Yes, RADR will be applied. The key will be to make sure that we have the anonymized data and that we've gathered the data, but we will probably – in fact, one of the initiatives that we have internally is to make liquid biopsies a central part of all of our trials, because you can potentially get access in a noninvasive way to both genomic and transcriptomic data and do it in parallel. Sorry, do it in over the time of the trial. So you can actually see some of the evolution of the therapy. So yes, that's something that we'll be a center of kind of excellence at Lantern will be the use of liquid biopsies to monitor and to design further refinement approaches, because it'll tell us how to refine the future trial, but also it might give us new insights into where the drug can be used. So I think we'll have two areas of value and liquid biopsies are becoming cheaper and cheaper and cheaper and also much more sensitive. So at the same time, the state-of-the-art is increasing. And I think that's going to inure to the benefits of companies that are using how to powerfully utilize liquid biopsy.

Nicole Leber

Analyst

Another question coming in here, I've been noticing that the FDA is requiring more development companies to form dose finding studies. Have you observed this and will it impact your program design?

Panna Sharma

Management

Yes, so most of our Phase 1 is for dose finding, finding that maximum tolerated dose. So that's definitely true with some of these more potent agents and we're reviewing those kind of considerations as part of our trial design.

Nicole Leber

Analyst

Some others coming in here, you have several CNS indications now, can you give us highlights of why you're excited in that area?

Panna Sharma

Management

Sure. I mean, CNS indications have, they're historically have been – there's a huge unmet clinical need. There's some of the most aggressive cancers, both in children as well as in adults. As a percentage, they cause massive amounts of heartache and grief. And there's a lot of spend in that area. The last drug was approved 17 years ago, TMZ, there was a more recent drug, but it was only approved in Japan by Daiichi Sankyo. And it was an oncolytic virus and it's only – it's not used very much. Tumor treating fields have somewhat mixed results, although, positive for patients. So it's an area where there's huge need, no drugs have been approved. We have two great drugs, one both 184 and we believe 284 that has similar dynamics and bioavailability across the CNS and a whole number of indications that we can go after. So yes, I think we're really excited. It's a huge clinical need, the data supports going after it. And the early data, preclinical data has been unlike that I've seen in any other CNS small molecule. So for those reasons I'm particularly excited about it.

Nicole Leber

Analyst

And sort of on that topic, what's the next pediatric milestone?

Panna Sharma

Management

We plan on having a KOL webinar with Dr. Peter Houghton later this quarter, I believe in September. And then we'll have some additional data to talk about from our pediatric program and also some of the other work that we've done in RADR, but we expect that we'll open up some new pediatric indications potentially as a result of that work. That's why we're engaged in it.

Nicole Leber

Analyst

The next one is, sorry, Panna. The next question is, have you started to speak with larger pharma companies and where are we with that?

Panna Sharma

Management

That's a great question. We hired someone specifically to help us with corporate development activities with larger biopharma companies. We've started having active discussions with a few of them. We've had debriefings, we've signed NDAs. And so, yes, I think that's a big part of our strategy over the next six and 12 months is to get in front of the pharma, let them know better programs, let them know which ones we'd like to partner, share all the details of the initial data under CDA or NDAs as needed. And then have them probably watch and wait and look at our great data and partner. I mean, it takes a while to do these deals and they want to see progress. So I think Phase 1, get the attention, get our programs into their mindset, show them how uniquely positioned versus all the other programs that are out there, demonstrate those results in ongoing studies, publications, and clinical trials, and then partner those assets out. Great question.

Nicole Leber

Analyst

That is all the questions I see coming in here today. And with that, we'll end the call. So thank you everyone for attending and have a great rest of your day.

Panna Sharma

Management

Thanks everybody.

David Margrave

Management

Thank you.