Q3 2021 Salarius Pharmaceuticals Inc Earnings Call
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Yeah.
Please go ahead.
Good afternoon, and thank you for joining US later as Pharmaceuticals, 2021 third quarter financial results call.
Earlier this afternoon, Soliris Pharmaceuticals issued a press release detailing its financial results for the three months ended September 32021, which we encourage listeners to read the.
Press release can be found in the news section of Soliris pharma dotcom.
Before beginning todays call I would like to make the following statement.
Today, I'll be making certain forward looking statements about operating metrics future expectations plans events and circumstances.
Statements about our strategy future operations, and the development and effectiveness of our lead investigational drug candidate <unk> and our exited expectations regarding our capital allocation and cash resources.
These statements are based on current expectations and you should not place undue reliance on these statements.
Actual results may differ materially due to our risks and uncertainties.
Including those detailed in the risk factors section of Soliris Pharmaceuticals annual report on Form 10-K for the year ended 2020, and subsequent quarterly reports on Form 10-Q, which have been filed with the SEC as well as well as our other filings, which we make with the SEC from time to time.
Soliris pharmaceuticals disclaims any obligation to update information contained in these forward looking statements.
Whether as a result of new information future events or otherwise.
With us on today's call is David Arthur Director and CEO of Soliris Pharmaceuticals, who will provide an update on soliris as corporate and clinical achievements during this quarter and its vision for the future.
Mark Rosenblum CFO will review the Soliris its third quarter financial results.
With that David ill turn the call to you.
Thank you, Jason and thank you to everyone dialing into our conference call today, particularly all of you who are joining us for the first time.
The third quarter in recent weeks, we get another exciting period for Soliris as we continued to implement our strategy to build a multi pronged approach to investigating several of them that in cancers, where LSD one is known to be a factor.
In summary during the third quarter in recent weeks hilarious increase the number of sarcoma clinical trial sites completed enrollment in the initial Ewing sarcoma combination therapy safety lead in cohort enrolled additional patients and the Myxoid LIFO sarcoma in SVT rearrange sarcoma.
Cohort and established a research partnership with the cancer Epigenetics Institute at Fox Chase Cancer Center.
In addition nationwide children's hospital presented data at an important medical conference demonstrating <unk> staff differentiated mechanism of action, resulting in unique anti cancer activity.
And finally, we received $2 $7 million from the cancer Prevention Research Institute of Texas.
And Soliris was added to the FTSE Global Microcap index.
While it was a busy quarter and has been a busy past few weeks. So there's a lot to review today, but before we get into details I would like to take a moment to provide some background for those of you on today's call who are new to the Celerity story.
For those of you who are not new to solarium. Please indulge me, while I add some perspective to our newest listeners.
Our lead asset called <unk> is an oral drug a tablet actually that inhibits a widely validated cancer target LSD one.
Targeting the LSD one enzyme has been an area of interest in cancer research for over a decade as LSP. One plays a key role in the development and progression of numerous cancers.
Blood cancer program, and our continuing research into other large market opportunities.
With that as the backdrop, let's discuss the accomplishments in the third quarter and recent weeks secondary status currently in two clinical programs spanning five different patient groups and is being studied as a single agent therapy and in two different combination therapy.
Our lead clinical program, which we refer to as our sarcoma program is a phase <unk> clinical trial with three patient arms. The first arm is investigating <unk> in combination with chemo therapies, <unk> and cyclophosphamide for the treatment of Ewing sarcoma.
The second and third arms are exploring several of them start as single agent therapy for the treatment of Myxoid LIFO sarcoma and other <unk> rearrange sarcomas.
During the third quarter Soliris added five new clinical trial sites to our sarcoma trial, increasing the number of active sites that are now supporting sarcoma enrollment too.
<unk> total sites.
Damn staff to a commonly used second and third line therapy, where the addition of sexual them start to this therapy is shown to be synergistic, meaning one plus one equals more than two in any cancer activity in preclinical experiments.
We believe these factors are all positively influencing enrollment across the sarcoma trial.
We are also pleased to report that the initial combination therapy safety lead in cohort for the Ewing's sarcoma trial.
Arm has completed enrollment.
And we expect the second of them staff recommended phase two dose and TC combination to be underway by early 2022.
We look forward to providing potential clinical data Readouts later this year and throughout next year.
All in all we are very pleased with our clinical process and.
In our clinical progress.
During the quarter. We we're also pleased to report the establishment of a research partnership with the cancer Epigenetics Institute at Fox Chase Cancer Center.
The research is to be conducted in the laboratory of Doctor Jonathan Wettstein, The Institute's director and will help identify additional indications and potential biomarkers for several events that.
Other ongoing prestigious research partnerships include nationwide Children's hospital, which recently presented research showcasing cycle dense that's unique ability to inhibit LSD, one non enzymatic function, leading to anti cancer activity and FTE rearrange sarcomas.
And the.
The MD Anderson cancer Center, which activated in investigator initiated clinical trial to study sechler them stat and hematologic blood.
Blood cancers, Milo Dysplastic syndrome, Mds and chronic.
Milo Monothetic leukemia or CML.
We believe this widespread interest in circle of them staff is due to the drugs unique and potentially have been pages properties.
The 20.
The loss from operations before other income for the three months ended September 30th.
2021 increased by $2 million compared to the loss from operations of $1.8 million for the same timespan last year, which was primarily due to the absence of grant income and increased overall spending.
Secret.
Secret Grant revenue was zero for the three month period ended September 30th 2021, compared to $1.4 million for the year ago period, resulting from the completion of the secret available funding under the grant during the second quarter of this year.
Hence we have reached the maximum amount of eligible spending that can be reimbursed from cheaper.
Physician or.
Our primary goal as a company is to maximize the potential effect with them that by expanding it's Houston into new and larger indications you've heard me describe a two pronged development strategy speed to market and expand the market represented by hematologic cancer program and are continuing research into how sick with them stat can address other <unk>.
Answers.
Let's take a moment to talk about the future, which is all about clinical data across our numerous patient populations and our pipeline.
Before I comment on our pipeline, let's review potential upcoming events.
As mentioned, we are actively enrolling in our sarcoma trial and expect potential data readouts as early as this year and throughout 2022.
The state of utilizing sexual them stat in combination with the checkpoint inhibitor keytruda.
Also known as symbolism map as we just mentioned Keytruda is a type of cancer drug that harnesses the immune system to kill cancer cells.
We are anxiously awaiting word from the honor Health Research Institute they are activated their trial and enrolling patients.
It is also important to note that in addition to combining secular them start with <unk> and Premo Lytham App. So Larry's is also conducting research to identify other promising combinations to address additional larger markets with unmet needs.
Finally, and something we have not typically included in our discussion is our pipelines for those of you who have attended one of our recent financial conferences or have visited this hilarious website and reviewed our corporate presentation. You will have noticed or discovery stage second generation LSD, one inhibitor program targeting both solid.
Tumors and hematologic cancers.
Given our experience in the LST one field. We believe this makes a lot of sense and you can see this activity in our increased non clinical research.
Prominent across the country with.
Work that we're doing with all of the major search engines and other institutes that specialize in advertising clinical trials for rare sarcoma cancers. So the short, but I just gave you the long answer the short answer to your question is the faster we can enroll patients the sooner we're going to be able to release.
Meaningful clinical data and that's what we're working on day in and day out right now.
Thanks for your answers David I have another question focusing on FCT reiterate critical months, considering you had some compelling data readouts from three patients that you enrolled.
Could you please remind us in terms of the addressable market, particularly comparing it to the evening sarcoma and I think the second part of my question is regarding next steps for <unk> range sarcoma patients. What is it thought process are you planning to access the dumbest Todd as a single agent.
Are there any combination studies strategies you are considering if so what would make the most sense combining exactly with other agents what is the thought processes in terms of strategy.
Subtype anywhere from 20, 30% to 50, 60%.
So as a as a whole it does relatively triple or quadruple.
They solely off Ewing's sarcoma numbers.
Okay. Thank you this is helpful. Daniel.
Josh.
Yeah.
Yep, Thank you Daniela hi.
Hi.
Thank you for the question.
What I heard from you was that you wanted to find out what our strategy is moving forward.
And as you mentioned, we saw some compelling signal in one of our advanced solid tumors and that data was presented at <unk> and will be presented as an update at the upcoming meeting.
Based on that we have.
We have two cohorts as David mentioned in the <unk>.
Patient population, we have a mix of our LIFO sarcoma cohort and we have also <unk> sarcoma cohort. Currently we are investigating single agent activity, but we are also looking into potential combination.
And we have already started working towards that.
Both in terms of generating some preclinical data, but more importantly, working towards.
With clinical program.
The plan moving forward would be to potentially combine secular dempster with most commonly used standard therapies for these mixed or LIFO sarcoma <unk> translocated sarcoma patients. So the short answer is yes, we will have both data for single agent.
And the next phase would be with the combination with commonly used.
Thanks.
Great. Thank you so I mentioned that in Danielle, let David good to hear from everyone.
You.
And Nadeem, if we were to think mis avoid LIFO sarcoma in combination with.
<unk>.
Other therapies wouldn't that move it up in the treatment paradigm and make it easier perhaps more convenient for physicians to treat patients absolutely. We're currently.
If you combine with the standard treatment. So we'll be looking at either first relapsed or second relapse and most likely we will move towards first relapsed switches.
Very early line of treatment.
We will follow the line of treatments approved for the other combination therapeutic so similar to what we have done in our Ewing sarcoma rearview.
Combining with <unk> and cyclophosphamide moving at an earlier phase of Ewing sarcoma.
Followed the same strategy for <unk>.
<unk> Dot com and also equity Sarcomas.
And then irreversible different binding pockets the scaffolding versus enzymatic activity. We thought we were in a we believe we are in a fantastic position to focus on the next generation when I focus but work on the next generation of LSD one inhibitors.
So we did not in license.
Any products for.
For this particular program we started at ground zero.
And we have a target product profile as you can imagine that incorporates all of our learnings to date and we are building. This from the ground up internally now as far as developing it we would follow the same process that we did with <unk> with them that which is.
Identify hit.
Focus on lead optimization select delete move into IMD, enabling studies and then move into the clinic, so very traditional development path forward.
And when would you expect this trial this this acid to reach clinical trials.
It's too early to even make predictions like that this is a very early stage research project and the fact that we're starting early gives us the opportunity to make sure that we can develop exactly what we think we need to truly represent.
What a what a second generation LST, one inhibitor needs to do so it's too early to predict any timing on clinical trials, but now.
Now that we've introduced the topic, we can continue to talk about it as we as we look forward to future earnings calls.
Okay.
There is also a newer company to the party.
Jubilant therapeutic so they have an L. S D. One H Doc dwell inhibitor. They have recently reported that they're gonna be.
Filing for their I D. Hopefully by your and so I anticipate seeing their trials start next year.
But we continue to be differentiated in terms of what indications, we <unk> tempers too.
And other than In-state, formerly going after Ewing sarcoma with their L. S. Do you Wanna inhibitor. We're we're the only ones in the space targeting both you and sarcoma in these F E. T rearranged Sarcomas of course will have competition as we.
Of disease, which will translate into longer.
<unk> fee survival.
That's the strategy, we're following using the phase one data to inform us on which patient population to further explore in the phase III.
And so based on that we have.
Currently have this.
Expansion phase, which has two different.
<unk> sarcoma is run from excited and the other one for <unk> specifically.
Okay.
Okay, Alright, thank you very much I appreciate all the answers and again.
<unk> for the quarter.
Yes.
Thank you.
Your next question from Mike King with H C. Wainwright. Your line is now open.
Hey, good afternoon, guys. Thanks for the thorough update just a lot of my questions have been asked and answered. We just wanted to get a clearer understanding excuse me about the role that secondly them stat would play in conjunction with embolism, Matt. Thank.
Nadeem can you.
Elaborate a little bit on what the target patient population might look like and the reason I'm asking is.
Because there have been other studies as ware.
Reported active molecule, whether it's Idaho or.
Arginase Glutaminyl inhibitors combined with a checkpoint in a single arm study and then when those studies go to randomize randomized stage.
The effect size fade. So are you going to try to do anything in terms of study design in order to ensure that.
The real benefit above checkpoint.
Alone is due December instead of maybe you can elaborate.
Right, a little bit on that or is that still a work in progress.
Yes. So this particular study that I mentioned earlier, it's an investigator sponsored study. So this is the sponsor is on on how we are providing support.
Financial and some obviously our product support.
You are asking about strategy of where to explore.
So I understand if.
If you have.
The best way to approach this would be in my mind, if you wanted to.
To explore this theoretically.
We could look into patient populations that have have had prior checkpoint inhibitors and have stopped responding to see if you could.
<unk>.
The.
We haven't really talked about pipeline activities on call <unk>.
Previously.
But given that we are beginning to talk about it at the investor conferences, we thought we'd be teared up for today's discussion.
First of all we're not limiting ourselves to just considering epigenetic.
Programs, we do happen to have I think some expertise in the LST one inefficient space.
And that's why we launched our.
Discovery Phase program in a second generation LSD one inhibitor.
Now the other interesting thing that has happened to us over the past three to four or five months.
As we've been communicating set for them said advancing in the clinic and more importantly, the strength of our financial position. We've had a number of companies reach out to us proactively to talk about their assets that for whatever reason, they're unable or unwilling.
<unk> or they just don't want to advance and develop on their own and they've been talking to us about possibly getting involved in helping them or bringing the product.
Outright onboard and just hilarious.
Your questions about building pipeline.
Yes, there is an epigenetic component.
We've certainly learned a lot about epigenetics I would consider us.
Experts are pretty close to experts on the LST, one space, but given our financial strength, we've had the opportunity to take a look at a number of opportunities that are not necessarily in the epigenetics space. So I think the best way to answer your question in a short phrase is.
<unk>, one where all over that we.
We have a lot of people coming and talking to US right now and we'll just need to keep you informed at a later date to see whether or not something bubbles to the top and we decided to take action on it.
Great Great I appreciate the update.
That's all I have on my end, so again congratulations on the results.
Alright, thanks for calling in B C.
There are no further questions I would like to kind of look back to David Orange Christian.
Christian is a cough.
As you heard from today's discussion silly.
Hilarious continuing to fire on all cylinders.
I'm really proud of the team and I'm really proud of what we've been able to accomplish are clinical trials are actively enrolling patients across.
Five different segments.
We've added to our list of clinical trial sites that is only going to enhance our ability to enroll patients and get the clinical data that everybody's looking for.
Into your hands as soon as possible we've reached new research agreements.
An additional preclinical research is actively underway to explore.
Our scaffolding properties and how that can identify new cancer indications, where we can further improve and add to the treatment options that are available.
An underlying all of this and supporting this activity is our strong financial Foundation. So you couple that with the hard work and dedication of our employees and the support we received from our shareholders.
And we are really confident about where we're sitting right now without all these people have just mentioned hilarious would not be where it is today.
So I would just like to close by thanking everyone for your time and attention today and I extend my sincerest wishes of good health to all be safe and thank you.
And this concludes today's conference constantly everyone for participating you may now disconnect.
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