Q3 2020 Salarius Pharmaceuticals Inc Earnings Call

Ladies and gentlemen, please continue to hold your conference call will begin momentarily.

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So to speak a presentation that will be a question and answer session to ask a question during the session.

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I would now like to hand, the conference over to your speaker today to Mr., Jason Rando D. Brent strategic advisor. Thank you. Please go ahead Sir.

Good afternoon.

Everyone and thank you for joining todays 2023rd quarter financial and corporate results call.

Earlier this afternoon, Ancillaries Pharmaceuticals issued a press release detailing its financial results for the three months ended September Thirtyth, 2020, which we encourage listeners to read.

The press release can be found in the news section.

And that's the Larry's pharma dot com.

So with Harris will also file a 10-Q tomorrow morning before market open and the 10-Q will be available on Ancillaries farmer Dot com and S.U.C. Dot Gov.

Before beginning today's call I would like to make the following statement.

They will be making forward looking statements about future expect.

Asians clan events and circumstances, including statements about our strategy future operations and development of our lead investigational drug candidate SEKCO dense debt, including.

Including statements related to study results and our expectations regarding our capital allocation and cash resources.

These statements are based on current.

Current expectations and you should not place undue reliance on these statements.

Actual results may differ materially due to risks and uncertainties, including those detailed in the risk factor section of Solaris Pharmaceuticals, 10-Q filed with the SEC and other filings, we make with the SEC from time to time.

So Larry.

Pharmaceuticals disclaims any obligation to update information contained in these forward looking statements.

Whether as a result of new information future events or otherwise.

Joining me on today's call, David Arthur Director, and CEO oscillators Pharmaceuticals.

Provide an update ancillary sales corporate and clinical achievements during the third quarter.

Corridor and its vision for the future.

And Mark Rosenblum CFO, we've used to linger since third quarter 2020 financial results.

David go ahead.

Thank you, Jason and thank you to everyone joining our conference call. This afternoon, including all of you joining for the first time.

Two.

2020 continues to be an exciting year for Solaris and events during third quarter illustrate the significant progress hilarious has made affirming our growth strategy and highlighting the opportunity. The second attempt that offers as a potential treatment for pediatric cancers solid tumors and other cancers.

But.

Of you participating for the first time, let me take a moment to describe Solaris in.

In a nutshell, we are developing new medicines for patients who need them. The most soliris is a clinical stage biopharmaceutical company developing potential treatments for children and adults with pediatric cancers solid tumors and other cancer.

Those.

We're currently treating patients with our investigational new oral drugs sex with them stat into clinical trials to explore its potential as a treatment for multiple types of cancers.

Our lead clinical program as Ewing's sarcoma, a rare and devastating bone and soft tissue pediatric.

Cancer, which is the second most common tumor among children and adolescence.

Patients diagnosed with metastatic ewing's sarcoma or cancer that has already spread at the time of diagnosis have five year survival rates between only 18 and.

30%.

The prognosis for patients with recurrent ewing's sarcoma is particularly poor.

The five year survival after a recurrence of viewing is approximately 10% to 15%.

And Unfortunately, the median age of diagnosis of patients with viewing is on.

Only 15 years of age.

As a potential twice daily oral treatment that is not a cytotoxic agent.

Meaning secular them stat is not chemotherapy SEC, let them start represents a potential breakthrough a breakthrough in the treatment of select pediatric cancers.

With that.

As a backdrop, let's now talk about the third quarter.

There were several important events that provided bookends to what has been an active three plus months.

For Solaris in July we welcome Dr., Nadine Mirza as our senior Vice President of clinical development.

Since is higher Dr. Mirza has been instrumental in advancing our clinical programs in ewings sarcoma, and solid tumors as well as identifying potential opportunities to grow our SEC with them is that pipeline.

In this regard in July we announced plans to expand our ongoing human clinical trial to include pace.

It's with sarcoma is that share a similar biology to ewing's sarcoma.

As part of that announcement, we highlighted a refractory ewing's sarcoma patient who was treated with SEC, let them staff.

For six months and demonstrated a reduction of over 80%.

In their prospectively defined target lesions.

Target lesions generally represent a patient's largest measurable tumors.

We believe this is a remarkable result, given the extreme challenges of the disease and the fact that this patient was treated.

We should single agent secular them stat therapy, meaning this patient received no other anti cancer treatment, while taking several of them stat.

While we recognize this is only a single patient we believe it demonstrates drug activity in a patient with treatment resistant ewing's sarcoma in.

The trial, primarily designed to demonstrate safety not efficacy.

The momentum from these advances provides hilarious an opportunity to initiate and then complete in August a $6.2 million public offering.

We're now applying these capital resources and the resources we continue.

True to receive from the cancer Prevention Research Institute of Texas to progressing our SEC, let them staff development program.

I'd like to now discuss the development program.

As well as the ongoing clinical trials and.

More detail later.

But at this time I'd like to turn the call over to Mark Rosenblum for a brief review of Solaris is third quarter Financial report Mark. Please go ahead. Thank you David for the three month period ended September Thirtyth 2020, Solaris reported a net loss of $1.7 million or 10 cents.

Earnings per basic and diluted share.

Compared to a net loss of $2.6 million or 73 cents per basic and diluted share for the same period in 2019.

The loss before other income for the three months ended September thirtyth decreased by 2 million.

And and others compared to the loss for the same period last year, which was primarily due to.

To a $2.2 million decrease in general and administrative expenses, which more than offset the increase of $8.7 million in research and development expenses.

Increased research and development costs resulted from increased overall clinical trial expenses and SEC, let them stat manufacturing costs.

The decrease in general and administrative expenses resulted from the absence of costs related to Solaris is onetime transformation into a public.

Company.

During 2019.

Which did not reoccur in the current period.

In early August this year, so areas completed a $6.2 million underwritten public offering of our common stock we intend to use the proceeds from the offering to fund ongoing operations and the expansion.

Of the Ewing's sarcoma clinical trials to include other viewing related circulars.

As of September Thirtyth this year.

Total cash cash cash equivalents or re and restricted cash was $9.6 million compared.

Compared with $3.7 million.

For the year end 2019.

This does not however accurately reflect the extent of the financial resources available to Solaris.

One of the genuinely interesting and we believe underappreciated aspects of the Solaris story is our ability to access non dilutive capital.

Sales in 2016, Solaris received an $18.7 million grant from the cancer Prevention and research Institute of Texas, which we call secret.

Of which we have 6.5 million available under this deferred contract.

Subject to meeting certain requirements or approvals.

On top of that we have received non dilutive funding from the national Pediatric cancer Foundation to help fund our ewing's sarcoma clinical trials.

With these various funding sources, we believe Solaris as the financial resources to advance our spark our ewing's sarcoma and advanced solid tumor clinical.

Programs into the second half of 2021.

With that I would like to return the call today.

Thank you Mark.

As we discussed our goal is to maximize the potential of several of them staffed by bringing hope to patients and their families.

Facing limited treatment options.

All the while creating and building shareholder value look.

Looking forward through the end of 2020 and into 2021 and beyond we expect to not only advance our current clinical programs in ewings sarcoma in solid tumors, but also explore opportunities where secular them stack could address.

Occult other underserved cancers.

As highlighted earlier in the call in July we announced plans to expand enrollment in the Ewing's sarcoma clinical trial to include several additional sarcoma that share a similar gene rearrangement to ewing's sarcoma. These.

These additional sarcoma as our.

Also known as Ewing related Sarcomas.

Viewing related sarcoma as of interest include mix OID LIFO sarcoma, desmoplastic small round cell tumors and other sarcoma is that share a similar biology ewing's sarcoma.

This expansion allows us.

Our often now treat up to 50 patients with viewing and viewing related sarcoma as with the phase two recommended dose of SEC will then staff.

We in our clinical investigators are excited about the potential to treat these additional patients who are seeking new treatment options.

Also during the third quarter Soliris completed much of the work necessary to begin additional clinical trials and we look forward to announcing these trials in the near future.

One area of interest we have previously discussed is the use of several of them that in combination with immuno oncology therapies specific.

Our fleet checkpoint inhibitors.

Checkpoint inhibitors are a class of immunotherapy treatment designed to unleash a patient's immune system attack on cancer cells. However.

These drugs. These checkpoint inhibitors do not work in all cancer patients or in all cancer types.

Shifting addition patients that do show an initial response can become resistant to checkpoint inhibitor treatment and experienced a return of the disease, commonly known as a disease relapse.

Interestingly data from preclinical studies conducted by the translational Genomics Research Institute.

In Phoenix, Arizona and published in the peer reviewed journal PLO S., one demonstrated the potential of using SEC, let them stat in combination with checkpoint inhibitors to overcome cancer's ability to hide from the patient's immune system.

Which prevents checkpoint inhibitors from attacking the cancer.

In simple terms SEC, let them stat may turn tumors concealed from a patient's immune system.

Called cold tumors.

Into hot tumors or tumors, the immune system is able to identify and infiltrate these.

These now.

In hot tumors could.

Good then respond to treatment with checkpoint inhibitors.

This approach provides a significant opportunity for SEC, let them staff because it could be used to treat patients with a wide variety of cancers that are currently unresponsive to checkpoint inhibitors.

As previously mentioned.

Thanks, our common solid tumors remain our most advanced development programs.

Both clinical trials are designed is open label dose finding trials with primary objectives to characterize the pharmacokinetics and safety profile of secular them stat and to establish the drugs maximum tolerated dose or MTD.

Even reaching MTD is an important milestone in both of these trials as it will allow us to establish the dosing regimen for the phase two dose expansion arms of the trials.

Which is where we will treat up to 50 patients with Ewing and Ewing related sarcomas.

Solaris is on track to staff.

Applus MTD and in the first quarter next year begin treating the phase two dose expansion.

Patients in the expansion portion of the Ewing and now Ewing related sarcoma trial.

So far early clinical results in clinical observations in our two clinical.

Nickel programs have been encouraging.

Data supports twice daily dosing and we have observed drug concentration levels in humans or in our patients at or above where we noted efficacy in preclinical cell and animal studies.

This dosing data is a significant achievement as it confirms our ability to.

To treat patients with a twice daily oral regimen and that the regimen.

Can achieve the drug levels in humans, where we observed efficacy in animal models.

Also as noted earlier, a patient with Ewing's sarcoma, who was treated with.

Secular them staffed for six months after failing standard of care therapy saw an 80% decrease in the size of their prospectively identified target lesions, which occurred as I mentioned are generally the patients largest measurable tumors.

We believe this patient data and other clinical.

Ops or rate observations from both.

Cynical trials demonstrate preliminary drug activity and when coupled with preclinical data support our decision to expand the phase two dose expansion phase of the Ewing's sarcoma trial to include these.

These patients with Ewing related sorry.

Our comments.

In addition, the ongoing solid tumor clinical trial is providing an opportunity to investigate the potential of SEC, let them stacked in treating larger market cancers, such as prostate breast or ovarian cancers, while also helping identify tumors, where several of them that may show increased likelihood.

Sort of activity.

In all the progress that we have made since the beginning of the year and sales certainly and specifically over the past three months is substantial these.

These accomplishments have in turn positions so areas for growth on several fronts over the next several quarters.

With that I will now open the call to.

Questions.

Thank you Sir as a reminder to ask a question you would need to press star one on your telephone to withdraw your question. Please press the pound key.

Please stand by while we compile the Q and a roster.

I sure first question comes from the line of aid in.

In Hughes Youd Love from benchmark. Please go ahead.

Hi, Thanks for taking my questions I had one question regarding chemotherapy combinational trial.

I I recently, so clinical trials clinical combination.

Well I think that condemns caught with Pembrolizumab for gynecological cancer could you comment on that thank you.

Aid and good to hear from you. Thank you for the question I am aware of that study listed on clinical trials Dot Gov, but unfortunately at this moment I cannot comment on.

Trials that Soliris has not publicly announced so I apologize, but I'm going to have to not answer that question, but I would encourage you to.

Monitor our press releases and public communications as we hope to announce further information in the near future.

Sure sure thanks for that.

And for.

For the art Hematological trials on could you.

Comment what indications you might pursue and.

Kind of the reasons why you would pursue them and whether youre youre planning to release any preclinical.

Data thank you.

I'd be happy to and what I'd like to do is introduce Dr. Daniel SRT Esteban.

Also with hilarious.

Daniela are you are you on the line.

Hi, David Yes, I'm here and could answer his question.

Please do thank you.

He then I'm going to talk to you again.

In regards to way team indications are interested in pursuing a we haven't announced specifically the indication that we'd like to pursue in a clinical trial, but we have shown preclinical data in a variety of my last April.

Corporate and diseases, including AML.

And Mds and some of this data is available on our overview deck on our website.

The idea behind these is that these heme malignancies have a differentiation block where else do you want is involved in several of them that can help release that good.

Differentiation block to treat a variety of heme malignancies, but we hope to announce more information on a clinical program in the next few months.

Thank you. Thank you I understand you and the last question I had is regarding the enrollment of phase one solid tumor study phase one.

One could you provide any updates on how enrollment is going with this trial.

Happy to Aden.

The solid tumor study.

Is continuing to enroll patients we are one of the things we've been pleased about is the fact.

That.

While co bid has affected all aspects of our personal and business lives.

Our clinical trials of Ewing's sarcoma and advanced solid tumors have remained open at our clinical trial sites.

Do you know.

A large part to the fact that both of these studies are prioritized very highly by our investigators as they are enrolling patients who have failed all existing.

Our standard of care treatments. So we're incredibly fortunate and I feel very fortunate that we've been.

Able to continue to enroll.

The so patients are continuing to enroll in advanced solid tumor study, we are continuing to escalate the dose and as we have reported in many of our communications we hope to.

Achieve maximum.

Tolerated dose in the advanced solid tumor study in the in the near future.

Alright, thanks for the question.

Thank you.

Our next question comes from the line of Hunter Diamond from Diamond Equity Research. Please go ahead.

Hi, everyone congratulations on the quarter.

So just I have two quick questions. So one was on the timeline that related to some of the trials I know we have the Ewing.

That obviously and then in the latest stack they talked about in Q4, the human logic trial and the immunotherapy trials are those still.

Still looking to be Q4 events or is it could those sort of move into Q1 2021.

So hunter. Thanks for the question good to hear from you.

The.

One as I mentioned in the earnings discussion.

In the third.

Quarter, we completed.

A tremendous amount of the work necessary to initiate additional clinical studies.

And as we've discussed and disclosed in our previous information and is available on our corporate deck. We're.

We're targeting immuno oncology and.

Hematologic cancer trials.

I will share with you that I believe as I said, we completed.

Much if not all of the necessary work to make this happen and I believe that the.

Outlets from Solaris are going to occur in the near future and as.

HM.

Brought up.

Honor health and TJ and have actually placed on clinical trials Dot Gov.

A study that involves several of them stat I'm, just not yet in a position to be able to comment on it. So I think you can.

You can.

No.

And with that we're moving forward now.

Pretty quickly on all these fronts and we're very very excited to get into the clinic in these these new indications so.

Stay tuned and we hope to get some additional information out to you in the very near future.

Okay perfect I appreciate that.

Note in on that.

My second question is obviously epigenetics is as you're well aware is a super hot area.

And there may be are some opportunities I would think at a universities or other assets that may be you could acquire giving you a non dilutive funding and potentially could raise additional capital. If there was a good asset.

But to acquire is that something that sort of on the company's radar or is that that.

Has been thought about or.

Are you more focused sort of on the existing trials.

So the I think you're asking a great question and we we are weaker.

So we feel very good about our secular done stack program.

We are advancing in solid tumors, we are advancing in sarcoma. We've expanded to include viewing related sarcoma.

Both you and Aten have asked about the additional clinical studies that we hope to be.

Well to formalize and announce in the very near future.

So we I say this because I always want to make sure that any comments I make about possible business development interest is not taken negatively I mean, we could not be happier with how were moving forward with several of them stat.

Having said that as a biotechnology company with an infrastructure.

Capable of advancing clinical.

Clinical candidates through R&D, enabling studies and submitting.

Our investigational new drug application to the FDA and getting drugs into the clinic and implement and clinical trials.

Our ability to identify.

Additional drugs and bring them into Solaris and advance them and create additional shareholder value is something we're always considering.

And if you if you come across good candidates. Please don't hesitate to send them our way.

Sure, absolutely and I will do that.

Okay perfect Thats, all I have in terms of questions.

And congratulations on the quarter.

Thank you.

Thank you.

I show, we have a question from the line of waxy Lee from Ladenburg.

Please go ahead.

Yes.

Yes.

Wamsi Your line is open.

Sure.

I will.

Okay.

Ladies and gentlemen, if you have a question at this time please press.

Star in one.

I show no further questions in the queue at this time.

Sorry, I actually I, just so no further questions in the queue. At this time I would like to turn the call over to Mr., David Our third director CEO for closing remarks.

Thank you.

As we've discussed today Solaris is on I believe Solaris is on strong footing operationally developmentally and financially and we are working extremely hard to maintain our momentum and I feel very good about the momentum we currently have.

I'd like to thank our employees for their dedication.

Patient and loyalty and as always I want to thank our stakeholders for their continued support as we work.

To bring hope.

To patients and their families battling these devastating cancers.

That we believe are well suited for treatment of the secular them staff.

I appreciate your time and attention.

Okay. Appreciate all of you who are new to Soliris and called in today and I'd like to extend my sincerest wishes of good health to all take care and be safe. Thank you.

Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.

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