Q2 2022 Rain Therapeutics Inc Earnings Call

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Good day and welcome to the rain Therapeutics second quarter 2022 earnings Conference call. Today's conference is being recorded at this time I'd like to turn the conference over to Bobby Eddie. Please go ahead.

Thank you operator, and good afternoon, everyone.

With me today on the call are obligations, Milwaukee, Chief Executive Officer of brain Therapeutics, Nelson Botswana SVP of finance.

During today's call <unk> will provide an overall business update including a range of clinical programs and research efforts and Nelson will review the financials.

Before we begin I'd like to remind you that statements made during this conference call.

Non historical facts are forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

These forward looking statements are based upon <unk> current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Actual results may differ materially from those anticipated in such forward looking statements.

As a result of various risks and uncertainties.

Ascribed in the rains annual report on Form 10-K for the year ended December 31, 2021, and subsequent filings with the Securities and Exchange Commission.

All forward looking statements made during this conference call are based on management's assumptions and estimates as of today August four 2022.

<unk> undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after today, except as required by law.

With that said, it's my pleasure to turn the call over to avenues Milwaukee.

<unk> of rain therapeutics ABA niche.

Thank you Bob and thanks to everyone for joining us for our second quarter earnings call. We are pleased to share updates today on our two ongoing clinical trials and our mantra phase III Registrational trial in patients with LIFO sarcoma, and the mantra to tumor agnostic basket trial in advanced solid tumor patients exhibiting.

<unk> gene amplification.

We're going to have a different format on this call with prepared remarks from myself and Nelson combats, one <unk> senior Vice President of Finance and then move more quickly to Q&A, we'll be joined by our President and Chief Scientific Officer, Dr. Bob <unk>, and our Chief Medical Officer, Dr. Richard Bryce.

First and foremost we announced earlier this morning, we had completed enrollment in the phase III mantra trial in patients with well differentiated Dedifferentiated lipo sarcoma.

At the end of July we completed enrollment with 175 patients exceeding our 160 patient target in five months ahead of our prior year end guidance, we saw a clear acceleration of enrollment since your update call at the end of the first quarter of this year at which point, we announced we were approximately half enrolled.

We believe this speaks to the tremendous unmet need in patients with Dedifferentiated lipo sarcoma, which lowered <unk> offers a targeted therapeutic strategy relative to standard cytotoxic options.

<unk> enrolled across 70 international sites in the U S Europe and Asia.

As a reminder, this pivotal trial compares <unk> monotherapy to the approved agent Jan Dallas or <unk>.

<unk> was dosed at 260 milligrams daily for three days, followed by 11 days of therapy, we refer to this as the three out of 2014 day schedule.

We anticipate top line data from this trial in the first half of 2023.

We also anticipate that if the mantra data are supportive we would submit an NDA for mill demonstrated lampo sarcoma in the U S with similar submissions in Europe , and possibly other regions as well.

Second our phase II tumor agnostic mantra to trial is progressing as planned with 11 sites activated in the U S to date and additional just in time sites opening as necessary from referrals from the 10% tariffs genomic testing services to recap. This trial is evaluating <unk> in multiple solid tumors.

Hypes in patients with P 53, wild type tumors exhibit high MDM to gene amplification.

Copy number of 12 or greater we anticipate enrolling approximately 65 patients across a range of solid tumors and using the same dosing regimen as in the Registrational mantra trial and continue to anticipate interim data on the first 10 evaluable patients in the fourth quarter of this year.

We continue to anticipate commencing two additional trials before year end, both democracy three trial in Merkel cell carcinoma, and the mantra for trial evaluating the combination of <unk> with a checkpoint inhibitor <unk> in patients with P 53, Wild type advanced solid tumors exhibit loss of the gene.

CDK and two way.

Also at the recent annual Astro meeting, we presented preclinical data detailing the rationale for the mantra for trial.

New preclinical data across multiple in vivo tumor models with CDK into a loss and Walter P. 53 supported potential synergy of <unk> and immune checkpoint inhibitor in this genetic subset we remain very excited about.

About the potential for the mantra for trial and its strategy with that I'd like to turn it over to Nelson to review our financial results Nelson.

Thank you Evan ish and good afternoon, everyone. I am pleased to provide an update to our financial results for the second quarter ended June 32022.

I'd also like to invite you to review our Form 10-Q filed today for more details.

For the second quarter of 2022, we reported a net loss of $17 6 million compared to a net loss of $8 2 million in the second quarter of 2021.

Research and development expenses were $14 3 million in the second quarter of 2022 as compared to $5 5 million in the second quarter of 2021.

The increase was primarily driven by R&D costs, mainly for our lead candidate Mila Demeton from the ongoing phase III <unk> clinical trial, our ongoing phase III mantra to trial as well as personnel costs.

As of June 32022 brand continues to have a strong balance sheet with $106 million in cash cash equivalents and short term investments.

We anticipate that our second quarter cash position, who will provide runway into mid 2024, and we believe that the mill identified program is well funded.

With that I'll now turn the call back over to Avnet.

Thanks, Nelson rain continues to focus on the clinical execution of our <unk> program and we're thrilled with the rate of progress, thus far, particularly with enrollment now completed in our Registrational phase III mantra trial five months earlier than previously guided.

And anticipates, a broad clinical data set from <unk> with a steady cadence of updates over the next two plus years, we look forward to phase III mantra data in the first half of 2023.

With that we will have Dr. Bob Doable and Dr. Richard Bryce join us and available to answer your questions operator.

Thank you if you'd like to ask a question. Please signal by pressing star one on your telephone keypad, if you're using a speaker phone. Please make sure. Your mute function is turned off to allow your military equipment.

Again, Thats press Star one to ask a question, we'll pause for a moment to allow everyone an opportunity to signal.

We will take our first question from the line of Michael Schmidt with Guggenheim.

Hey, good afternoon. This is ebay on for Michael Thanks.

Thanks for taking our questions and congrats on the earlier than expected.

Enrollment for the manpack.

I guess.

We'll start with the.

A question on Lps. So one competitor has presented some early data at <unk>.

MDM two inhibitor.

So what do you think of the potential read through.

From the from the presented data to mill at <unk> competitive position and to the ongoing management study and I have a follow up thank you.

Hi, This is <unk>. Thanks for the question, let me turn the question over to Bob Thanks for the question.

We're not going to comment.

I went on there.

However, we get rid of it.

<unk> entry into the MGMT space validates our approach it rain using MDM too.

Validated cancer target in terms of like the patient population.

Got it and then I guess as a follow up can you elaborate your current thinking in consideration around our first line strategy.

Lps either.

With Miller monotherapy or maybe perhaps even in combination with other agents.

Yes, I'm happy to take that one you gave so so obviously, we want to wait on mantra results before starting to articulate such good plans.

So I think Thats first and foremost, but I think we will comment that if successful with mantra. There is does have a successful outcome, our expectation would be to expand the opportunity across a multitude of indications inclusive of frontline LIBOR sarcoma, but we don't want to get into the details of what that looks like at this moment in time.

Okay, great. Thank you very much.

Absolutely.

We will take our next question from the line of Joe <unk> with Piper Sandler. Please go ahead. Your line is now open.

Hi, This is Dan on for Joe Thanks for taking my question.

Could you just provide a little more detail on what you think drove this acceleration in enrollment.

Now with that.

Rapid acceleration do you think that the topline data can now come maybe in the early part of first half would be great.

Hi, Sam Thanks for the question, let me turn it over to Richard.

Sure happy to answer that.

So I think that speaks to two things first of all I do want to take this opportunity to call out the excellence of our clinical team and collaborative.

Two with this achievement.

Incredible.

Enrollment into the study in the in the last six months.

I think that surpassed expectations both at our level.

At the physician level.

What does it mean.

Beyond that I think it's important to just underlines our underscores the tremendous enthusiasm amongst physicians and patients for a new <unk>.

Treatment option, particularly at targeted treatment option for patients with.

Despite the sarcoma, which as we know as MTN two upsides.

By definition and so.

That's really reflected in the <unk>.

The enormous enthusiasm to enroll into the study and we would expect to see that play itself out.

In future trials.

Future circumstances, hopefully at the study is positive in the commercial setting as well.

Great. Thank you.

We will take our next question from the line of Jeff Jones with Oppenheimer. Please go ahead. Your line is now open.

Thank you and good afternoon guys.

Two questions for me.

On Monster two basket trial.

Any idea what kind of duration of response data you will happen hand, when that reads out top line ended the year and then the second question.

Any update on the Rad 52 program.

Hi, Jeff. Thanks for the question, let me turn that question over to Bob.

Yes, so to answer the first part of the question regarding <unk>.

We've.

Messaged in the past that we expect to have 10 patients with a meaningful duration of follow up.

This would be at least four months approximately to scale for.

For those patients.

Duration and that expectation has not changed.

Regarding your second question on the Rad 52 program.

We are continuing to.

Progressive project.

And we've signaled in the past however that we have mitigated spend on that to focus on a milligram of town.

And based on that.

Yes.

Progress in the Rad 52 program.

Great. Thanks.

As John said again, if you'd like to ask a question press star one.

And we'll take our next question is from Sumit Roy with Jones Research. Please go ahead. Your line is now open.

Hi, everyone.

Possibly this is a question for Bob.

I was wondering as we are seeing in multiple phase III trials, the standard of care or the control of the army is outperforming the historical data anything that.

Possibly due to better chemo monitoring or better supportive care. So.

I'm curious to get your thoughts on if you think.

The control arm could outperform the seven year or eight year old.

Historic data or water if there is any concern for that.

Great. Thank you for your question Bob Yes.

Yes.

This is.

So we're looking at that obviously from a registrational trial conducted in which is the arm.

Trial.

That is a modern clinical trial with robots subset analysis, and we see no indication to expect that the trabecular metal outperform.

And the mantra study compared to.

It's registration.

Yes, let me address some of that of course.

Predict but.

But as a reminder, in terms of the clinical trial design for mantra, we actually did assume.

The control arm.

Modestly improved.

Its.

The efficacy from the Registrational study.

So we didn't actually anticipate potential improvement.

It's still it's still anticipate.

An opportunity to succeed.

Great I have a quick second question.

Are you, allowing crossover.

From the control arm.

And the trial months of trial.

No we're not there's.

There is no crossover mantra.

Alright.

Thank you so much for taking the questions and congratulations on the fashion.

Fast enrollment.

Joey.

We will take our last question from the line of Tony Butler with Roth Capital. Please go ahead. Your line is now open.

Yes.

Thanks very much.

I just wanted to ask about mantra for since it's one of the things we haven't discussed this evening detailed given the population size.

The opportunity for.

The compound.

At CDK.

Okay.

Population and as you're looking forward to that trial I would think that the number of sites that could or would like to participate which would be quite a few could you just provide a brief discussion.

If I may on <unk>.

Are you thinking about a small number or would this would this would you would you get in with both feet and perhaps expanded including internationally. Thank you.

Even if it is a phase one I understand.

Let me know.

For the question Toni Let me turn that question over to Bob Yes.

Yes.

Thanks for the question.

Obviously, the mantra for study is very similar to the mantra to study which is ongoing.

The fact that it is a basket design all commercial of tumors genetically selected patients.

I hope that the learnings from the market to trial in another month before you could expect probably some overlap in terms of the site.

Obviously as you mentioned the population as far water for the CDK into a loss.

Population.

And therefore, we would expect enrollment.

Kind of a per site basis to be much much faster.

Ms patient population.

Those.

Hopefully that answers your question.

Thank you Bob I appreciate it.

That concludes today's question and answer session I would like to turn the conference back over to Mr. Cohen for any additional closing remarks.

Thank you operator, and we want to thank everyone for joining us on this quarter's earnings call and we look forward to updating everyone on our progress over the next quarter. Thank you.

This concludes today's call. Thank you for your participation you may now disconnect.

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