Q2 2023 Syros Pharmaceuticals Inc Earnings Call
Yes.
[music].
Good morning, and welcome to Sirius Pharmaceuticals, second quarter 2023 financial results Conference call.
At this time, all participants are in listen only mode.
This call is being webcast live on the investors and media section of services website at Www Dot Souris dotcom.
Please be advised that today's call is being recorded.
At this time I would like to turn the call over to Karen <unk>.
Director of Investor Relations and corporate communications at Crs. Please go ahead.
Thank you.
We issued a press release announcing our second quarter 2023 financial results.
The full release is available on the investors and media section of cirrhosis website at Www Dot com.
We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive Officer.
Dr. David Roth, our Chief Medical Officer, and Jason Haas, Our Chief Financial Officer.
We will then open the call for questions Christian Stephens, Our Chief Development Officer, Dr. Eric Olson, our Chief Scientific Officer, and Connolly Qi, our Chief commercial officer are also on the call and will be available for Q&A.
Before we begin I would like to remind everyone that the statements. We make on this conference call will include forward looking statements.
Actual events or results could differ materially from those expressed or implied by any forward looking statements as a result of various risks uncertainties and other factors.
Please note set forth in the risk factors section of our quarterly report on Form 10-Q that we filed this morning, our annual report on Form 10-K that we filed earlier in the year.
Any other filings that we may make with the SEC in the future.
Any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, we specifically disclaim any obligation to update or revise any forward looking statements.
I would now like to turn the call over to Nancy.
Okay.
Thank you Karen good morning, everyone and thank you for joining us today.
The first half of the year has been very productive for Sierra and we are encouraged by ongoing momentum across our clinical trials and our pre commercial activities.
We remain laser focused on clinical trial execution and are well positioned to achieve each of our upcoming milestones.
With data Readouts from our phase II study evaluating <unk> in newly diagnosed unfit AML expected in the fourth quarter of 2023.
And from our pivotal phase III trial of <unk> in higher risk Mds expected in the third quarter of 2024.
And an update on PK data and registration plans for FY 'twenty 101 in APL expected in the second half of this year.
As we execute against our clinical development plans and approach data Readouts, we are engaging in pre commercial activities to ensure that we are well positioned to effectively deliver our novel treatments to patients.
We believe the potential of our biologically targeted programs in Mds.
Mel and APL Cups.
Coupled with their commercial synergies positioned us for substantial long term success.
With the opportunity to fulfill key unmet needs in the frontline treatment of hematologic malignancies.
And ultimately deliver new standards of care to thousands of patients in need.
I'd now like to turn the call over to David Our Chief Medical Officer to provide a more detailed update on our ongoing clinical programs.
David.
Thank you Nancy.
We're very pleased by the progress in our efforts to advance <unk> our.
Our novel oral selective and potent <unk> alpha agonist and genomic Lee defined subsets of patients with higher risk Mds and AML, whose disease is characterized by the overexpression of the railroad gene.
Enrollment in both the select AML, one phase II trial.
And the select Mds, one phase III trials are ongoing.
And we are on track to achieve the enrollment numbers necessary to support planned data readouts with initial data from the select AML one in the <unk>.
Fourth quarter, 2023, and pivotal CR data from the select MTS one in the third quarter of 2024.
As we continue to screen patients for both trials we've observed.
<unk>, 50% of patients with higher risk Mds.
30% of AML patients are positive Ferrara, overexpression consistent with our expectations.
As such we continue to believe that Tommy Barrett team has the potential to address a significant market opportunity by addressing sizable segments of the higher risk Mds and unfit AML patient populations, who are underserved by existing options.
We have compelling data to support our belief that the addition of Jeremy Barrett team could improve upon the outcomes of the standard of care.
Over the past several years, we've evaluated <unk> in multiple clinical trials, which have consistently demonstrated activity with potential for meaningful benefit most.
Most recently as we announced late last year in the safety lead in portion of our phase III AML study evaluating Jeremy Barrett teams.
<unk> with Azacitidine and vanilla Clark's our triplet regimen demonstrated high composite complete response rates with rapid time to response and favorable tolerability with no attitude Milo suppression.
Given the similarities between Mds and AML and the supportive data we've seen across these patient populations to date. These results give us confidence that xiaomi Barra teams' differentiated profile could benefit biologically targeted mds and AML patient populations that are readily identify.
<unk>.
Potentially establish a new standard of care for people with Robert <unk> Overexpression.
It's also worth emphasizing the sizeable unmet need in higher risk Mds and AML maybe.
May be addressed by Tami Barron teams.
Starting with higher risk Mds, there have been no new therapies beyond hypo mirth waiting agents or HMA.
Proved in well over a decade.
The existing standard of care provides limited efficacy with 17% CR rate and a median overall survival of just 18 six months.
This may be attributed to the use of a non targeted agent like an HMA in an unselected higher risk Mds patient population with clinical and genetic heterogeneity.
At the same time this provides a unique opportunity for differentiation with Tami Barron our biologically targeted approach designed specifically to address the approximately 50% of patients who present with Robert gene over expression and who can be readily identified using a simple blood test assay.
Tommy Barracuda also benefits from a generally well tolerated safety profile, which is particularly well suited to this generally elderly and frail population.
As a reminder, in our select MTS one phase III trial, we are evaluating the combination of Tami Barrow team plus <unk> in a double blind placebo controlled study in <unk>.
Julie diagnose higher risk Mds patients with <unk> overexpression.
Russia.
The primary endpoint of the study is complete response rate in the initial 190 patients with overall survival now included as a key secondary endpoint.
As we described last quarter recent FDA feedback continues to support our use of CR rate is an appropriate primary efficacy endpoint for either full or accelerated approval.
That said, if Tammy bear team received accelerated approval.
Addition of overall survival as a key secondary endpoint in the same study could allow select Mds one to also confirm clinical benefit to support full approval in the future potentially avoiding the need for a separate confirmatory study.
Under the current protocol to select Mds, one trial will enroll a total of 550 newly diagnosed higher risk Mds patients, including the initial 190 patients supporting the primary endpoint.
We're on track to complete enrollment of the initial patients necessary to support approval using a CR endpoint in the fourth quarter of this year.
And plan to report pivotal CR data in the third quarter of 2024.
Now moving on to AML, where we're evaluating Tammy Barrett team in the select AML, one phase II trial in newly diagnosed unfit AML patients with Robert Overexpression.
Despite recent advancements in AML roughly one third of newly diagnosed unfit AML patients do not respond to the current standard of care and virtually all patients eventually relapse.
And as for Mds, We continue to believe there is an important opportunity for Jeremy Barrett team to address existing unmet need and a sizeable AML patient segment approximately 30%.
Identifiable by RARA overexpression.
The randomized portion of the ongoing select AML one phase II study is designed to evaluate the safety and efficacy of Jeremy Barrett team in combination with then Asia compared to <unk> alone and approximately 80 newly diagnosed unfit AML patients.
Patients were randomized one to one into the two treatment arms with composite CR rate or the CR cri rate as the primary endpoint.
In the fourth quarter of this year, we expect to report initial data from this trial.
This will be the first direct comparison of patients with RARA overexpression treated with the triplet regimen of Tami <unk> plus within Asia.
Compared to <unk> alone.
And we believe may help inform our understanding of the performance of the triplet versus the doublet in AML in advance of sharing additional data in 2024.
Now turning to 2101, which is being evaluated in an ongoing dose confirmation study.
We remain encouraged by the potential of our novel form of Ato to alleviate a significant burden of the current standard of care for APL that includes the use of intravenous PTO.
While <unk> is highly effective offering a cure rate of over 80%. It is highly burdensome for patients requiring up to 140 treatment infusions over nearly a year.
Each of which lasts two to four hours.
By providing an oral form of Ato. We believe we can offer an oral regimen that is effective while also increasing access and we do see health care costs and utilization.
We continue to gather PK data from the dose confirmation study and we look forward to providing an update in the second half of this year, which will include the development path and timing for further evaluation of 'twenty 101 in a registration enabling study in APL.
Finally at the <unk> annual meeting in June we presented encouraging new data from the phase one phase <unk> clinical trial of $56 nine which supports further development of $56 nine and pancreatic and HR positive breast cancer and demonstrates the significant potential.
Up selected CDK <unk> inhibition.
Wide range of tumor types and combinations.
These data received a warm reception from clinicians and key opinion leaders, who are encouraged by the promising activity observed in heavily pretreated populations that are unlikely to respond to the standard of care as well as the predictable well managed tolerability profile.
We believe these data strongly support our ongoing exploration of out licensing opportunities to support further development of this program and look forward to providing an update at the appropriate time in the future.
I would now like to turn the call over to Jason Our Chief Financial Officer to review, our second quarter financial results.
Jason.
Thank you David now turning to our second quarter financial results, we recognized $2 $8 million in revenue in the second quarter of 2023, consisting entirely of revenue recognized under our collaboration with Pfizer.
<unk> recognized $6 $3 million of revenue in the second quarter of 2022, consisting of $5 $7 million in revenue recognized under our Pfizer collaboration and $6 million recognized under our collaboration with insight.
R&D expenses were $29 6 million in the second quarter of 2003 as compared to $33 1 million for the second quarter of 2002, our R&D expenditures are now principally focused on the advancement of the Companys late stage clinical programs.
G&A expenses were $7 2 million in the second quarter 'twenty, three as compared to $6 $9 million for the second quarter of 2022.
We reported a net loss for the second quarter of $36 3 million or $1 30 per share compared to a net loss of $34 $5 million or $5 40 per share for the same period in 2022.
Cash cash equivalents in marketable securities as of June 32023 were $144 million as compared to $166 million of March 31 2023.
We continue to believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into 2020, fives, which is beyond phase III data from the select Mds, one trial and data from the randomized portion of the select AML one trial.
With that I will turn the call over to the operator for questions.
Thank you Sir.
Ladies and gentlemen, we will now begin the question and answer session.
If you would like to ask a question. Please press star followed by the number one on your telephone keypad.
If your question has been answered and you would like to withdraw from the queue. Please press star followed by the number too Andy.
And if you are using a speaker phone please lift your handset before pressing any keys.
One moment. Please for your first question.
Your first question will come from Ted Ted talks at Piper Sandler. Please go ahead.
Great. Thank you very much good morning, and thanks for taking my question et cetera for the update on the select program.
My question had to do a little bit more on the partnering side just with the discovery efforts over the past partnerships.
609, where are you guys currently internal to us evaluating are considering new partnerships. Thanks, so very much.
<unk>.
Hey, Chad Thanks for the question.
Currently.
Answer that question Colin.
Hi, Thanks for the question Ted Yeah, as you know we are.
Jason just mentioned, we're really focusing our resources on our late stage programs.
With regards to <unk> in 2101, so we've been in discussions and continue to be in discussions around our $56 nine program and all of our discovery efforts and.
As soon as we have any news for you, we'll certainly update you on that.
Okay.
Great excited for select data later this year and next year.
Yes, yes.
Okay.
Okay.
Yes.
Your next question will come from Phil Nadeau at TD Cowen. Please go ahead.
Good morning, and congrats on progress and thanks for taking our questions a few from us so in terms of timing.
AML when do you think you'd be in a position to make a go no go decision on further development. There is the data that we're going to get in queue for sufficient ore.
The extended results in 2024 more likely to inform that decision.
Yes, thanks, so I'm going to have David answer that question. Thanks, Phil.
So we are planning to present, our initial data coming from the randomized portion of the trial in the fourth quarter.
And we're looking to that data to have greater insights into the upcoming.
Data readouts that we have targeted for 2024.
So while we haven't specified what would be a go no go and when that would occur.
I think that you should view the anticipated data presentation of the fourth quarter as initial data.
And what's your updated thoughts on how many patients will see in Q4.
We haven't specified the numbers of patients obviously, we look forward to presenting.
Information so one can meaningfully to understand what's going on and help us to provide insights into how we are moving forward now keep in mind. This will be the very first.
Data readout of the triplet of <unk> versus <unk> in patients with Robert over expression. So we're really excited too.
Providing our initial insights into how.
The triplet will be performing in our targeted population and.
I think that.
You should look forward to hearing what we have to say at that point.
Great and then in terms of Slicked Mds one.
We recently saw a growing that fail and it's had a futility analysis.
Can you, let us know whether there are any futility analysis planned for select MTS one after the primary endpoint, but before the overall survival data are are produced and maybe more generally was there anything that you learned from <unk>.
Maps failure.
David sure those are all.
All good questions, obviously its disappointing for the.
The patients who were looking to that program for.
For future treatment option.
We.
We regret that.
<unk>.
In terms of of our program.
We're conducting a randomized placebo controlled trial, we do have.
An interim futility analysis.
And then our first efficacy analysis is the primary analysis for the CR rate based on those initial 190 patients. So we havent really specified additional analyses subsequent to that as you know we amended the trial to add additional patients up to $5 50 for a future confirmatory.
Laurie secondary endpoint of survival.
But we haven't really specified.
Additional analysis beyond our primary analysis.
For the initial approval.
In terms of.
Why they have the result, they had unfortunately, we can't really speak to it because we don't have insight into their data with the performance of their study.
And so for that reason, we really can shed light on whether there is any read through to our own program. However, certainly don't feel there is.
We have a unique mechanism of action, where our small molecule not an antibody and we have a targeted.
Population that we can readily identify so with our novel biology and are generally well tolerated safety profile. We think we have several features that differentiate us from Wattenberg roadmap was trying to do and how they were working.
That insulates us from from any read through.
And the fatality analysis, you mentioned is that before the primary endpoint.
Analysis, yes, there likely will be a futility before the primary efficacy analysis.
And.
Again, that's largely.
A futility analysis based on the safety and the risk benefit ratio and it's all blinded we won't really have insight into the details of the data at that point.
Great and then last question from Us on 21 <unk>.
In terms of the updates in the second half of the year is an FDA meeting scheduled and.
What new PK data will you be people to present once you do.
It is on the path forward.
So for that program.
No.
We're currently working on the dose confirmation trial.
Analysis of the PK data assets being generated we've said that we would provide an update in the second half of the year.
We will obviously share more information coming out of that study with more details around what our development plans and timelines will be.
For next steps.
At that point, we'll be able to provide you with more specific information.
Great. Thanks for taking all of our questions.
Thank you Tom.
There are no further questions on the phone lines. So I will turn the conference back to Nancy Simonian for any closing remarks.
Thank you operator, and thank you everyone for joining us today and for your continued support of Crs. Please reach out with any further questions have a great day.
Okay.
Ladies and gentlemen, this does conclude your conference call for this morning, we would like to thank everyone for participating and ask you to please disconnect your lines.
Yes.
[music].