Q1 2022 Syros Pharmaceuticals Inc Earnings Call
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Good morning, and welcome to the Cirrus Pharmaceuticals first quarter 2022 financial results Conference call.
Operator: Please continue to stand by.
At this time, all participants are in listen only mode.
This call is being webcast live on the investors and media section of <unk> website at Www Dot zeros Dot com.
Please be advised that today's call is being recorded.
At this time I would like to turn the call over to Courtney Solberg manager of corporate Communications and Investor Relations at Crs.
Operator: Thank you for your patience.
Operator: Good morning, and welcome to the Syros Pharmaceuticals first quarter 2022 financial results conference call.
Thank you. This morning, we issued a press release announcing our first quarter 2022 financial results and our broader business update.
It really it is available on the investors and media section of its website at Www Dot heroes dotcom.
I'll begin the call with prepared remarks by Doctor Nancy Simonian, our Chief Executive Officer, and Jason Haas, Our Chief Financial Officer.
Then open the call for questions Dr. David Roth, Our Chief Medical Officer Christian Stephens, Our Chief Development Officer, Dr. Eric Olson, our Chief Scientific Officer, and Connie 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 statements. We make on this 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 and.
Certainties and other factors, including those set forth in the risk factors section of our annual report on Form 10-K, and our quarterly report on Form 10-Q for the first quarter that we filed this morning and any other filings that we may make with as you see in the future.
Any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.
Specifically disclaim any obligation to update or revise any forward looking statements.
Operator: At this time, all participants are in listen-only mode.
I'd now like to turn the call over to Nancy.
Thank you Courtney and good morning, everyone and thank you for joining us.
Operator: This call is being webcast live on the investors and media section of Syros website at www.syros.com.
Operator: Please be advised that today's call is being recorded.
First quarter of 2022 was very productive for syros.
Our team continued to execute against our goal of discovering and developing small molecule medicines for patients with cancer and monogenic diseases.
We are very excited about the upcoming months as we expect to have important clinical data readouts.
Operator: At this time, I would like to turn the call over to Courtney Solberg, Manager of Corporate
To start off our select M. D. S. One phase III clinical trial of <unk> in higher risk Mds continues to be on track and we look forward to reporting our pivotal data in late 2023 or early 2020 for giving us the potential to file a new drug application with the FDA.
Courtney Solberg: Communications and Investor Relations at Syros.
In 2024.
Courtney Solberg: Thank you.
Tammy Barrington has the potential to set a new treatment paradigm for the approximately 30% of RARA positive higher risk Mds patients by offering them a convenient oral therapy that can deliver high complete response rates without sacrificing safety or tolerability.
Despite successful advancements in blood cancers, more broadly M. D. S has largely lagged behind in drug development.
Hypo methylene agents or Hma's remain the existing standard of care, while providing limited efficacy.
And aside from H M as no new therapies have been approved in over a decade.
We believe Tammy Barrett team has the potential to be the first therapy for a targeted population and high risk Mds and has the opportunity to change the standard of care.
We are also looking forward to providing safety and clinical activity data from the safety lead in portion of the select AML, one trial Etame Barrick team and the second half of this year.
Phase two trial will be evaluating Tami Barron team combined with fanatical acts and easiest cytidine compared to banana klaxon as a siding alone which is the standard of care.
We believe <unk> has the potential to deliver a significant benefit to be approximately 30% of newly diagnosed unfit AML patients who are RARA positive.
Our translational and clinical data support the potential for the RARA biomarker to enrich for patients more likely to respond to Tami Barron team and for whom the standard of care may be suboptimal.
So we are excited about tami barrick team's potential and expect the data from our select AML. One trial will provide key insights into the safety efficacy and combinability, Etame Barrington and ease of siding and been out of clocks.
Additionally, we expect to provide pharmacokinetic and safety data midyear from our dose confirmation study of 21 O. One in a P L.
As announced today given the current market conditions, we do not intend to advanced 21 to one into a phase III trial until we have secured additional capital.
However, we remain confident in the 'twenty one O. One program. We believe it has the potential to replace the standard of care for E. P. L patients by offering a significantly reduced treatment burden and increase access to therapy without sacrificing clinical benefit.
We also plan to announce safety and clinical activity data from the safety lead in portion of the $56 nine trial in relapsed pancreatic cancer in the second half of 2020 two.
The 50 609 pancreatic expansions are designed to establish proof of concept in combination with chemotherapy using a doublet regimen of <unk> 50, 609, and Gemcitabine and.
In a triplet regimen at $56 nine Gemcitabine and <unk>.
By exploring both the doublet and triplet regimens. We believe this will deepen our understanding of the combination tolerability profile as well as clinical activity, while maximizing the opportunity in an area of high unmet need.
Currently the only approved agent for second line pancreatic cancer is on a bead plus five that you Luca boring, which offers progression free survival of just three months.
We believe 50 609 in pancreatic cancer represents a large market opportunity and has the potential to make a big difference in these patients' lives.
As a reminder, in the phase one dose escalation 56 O nine showed promising clinical activity with good tolerability as a single agent in heavily pretreated patients most notably in patients with pancreatic cancer and with K, Ras mutations, including prolonged stable disease, along with <unk>.
Tumor shrinkage in tumor marker reductions.
We believe this single agent activity is clinically important and coupled with our preclinical data, which showed regression and K Ras mutant models and potentiation of Gemcitabine anti tumor activity sets. The stage for our current approach of evaluating 50 609 in combination with chemotherapy we look.
Forward to sharing safety data and the initial clinical activity data from the trial at the time of the data readout.
At the upcoming <unk> and EHR conferences, we are looking forward to sharing trial and progress abstract.
Detailing the designs of our $56 nine trial in pancreatic cancer, our select and the S. One trial and our select AML one trial.
As announced this morning, given the current market environment, we are deep prioritizing the development of 50 609 in hematologic malignancies at this time.
We continue to believe that 50 609 has the potential to make a transformative impact on patients with many difficult to treat tumors.
Beyond the work we are doing in pancreatic cancer. We are also pursuing the development of 50 609 in BRAF mutant colorectal cancer or CRC.
Based on the agreement we entered into with Roche in August of last year 50, 609 in combination with it has illicit ma'am is being explored in patients with BRAF mutant CRC.
Under the terms of the agreement we are supplying 50 6094, a combination dosing cohort in the Roche sponsored ongoing phase one one be intrinsic trial.
This arm of this study is expected to be open for enrollment in the first half of 2022.
The milestones expected this year and beyond will help inform next steps for each of our programs and we will provide insights on the potential of our investigational medicines to change the standard of care for patients.
Finally, turning to our gene control discovery engine in April at ACR, We presented a poster on our selected CDK 12 inhibitor program detailing the potency selectivity and anti tumor activity of one of our lead compounds.
This CDK 12 inhibitor impair DNA repair.
Cause cell cycle, Dysregulation, and genomic instability, leading to tumor growth inhibition and a pop ptosis as a single agent in preclinical models.
Additionally, this CDK 12 inhibitor induced tumor regressions in small cell lung and breast cancer in vivo models and demonstrated activity in combination with <unk> in a small cell lung model as well as elaborate showing antitumor activity in a PARP inhibitor resistant patient.
Xenograft model of ovarian cancer.
Taken together these data support our belief that CDK 12 inhibition could play a key role in the treatment of breast lung and ovarian cancer. We look forward to naming a development candidate from our CDK 12 program in the second half of the year.
We are confident that our clinical pipeline, which is focused on advancing our ongoing phase two and three trials etame barentine for AML and Mds, respectively.
Our dose confirmation trial of 21 to one and a P L as well as our $56 nine trial in pancreatic cancer will allow us to provide benefit to patients and maximize value for our company and our shareholders. We look forward to executing on our near term value drivers and continuing to work towards achieving our mission of making it.
Profound difference in patients' lives.
Courtney Solberg: This morning, we issued a press release announcing our first quarter 2022 financial results and
I will now turn the call over to Jason to review our financial results.
Courtney Solberg: a broader business update.
Thank you Nancy based on our current plans, we believe we have sufficient capital to fund our planned operating expenses and capital needs into the second quarter of 2023 now.
Courtney Solberg: The release is available on the investors and media section of Syros' website at www.syros.com.
Now I will turn to our financial results, we recognized $5 $5 million in revenue in the first quarter of 2022.
Consisting of $5 $1 million from our collaboration with GBT and $400000 from our collaboration with insight.
In the first quarter of 2021, we recognized a total of $4.8 million in revenues under our collaborations with GBT and the insight.
R&D expenses were $25 $2 million in the first quarter of 2022 as compared to $20 million for the first quarter 2021.
This increase was primarily due to the advancement of our clinical and preclinical programs and increases in employee related expenses due to head count growth.
G&A expenses were $6 $9 million in the first quarter of 2022 as compared to $5 7 million for the first quarter of 2021.
This increase was primarily due to increases in employee related expenses and an increase in patent prosecution costs and consulting fees.
Ali we reported a net loss for the first quarter of $25 $1 million or <unk> 40 per share compared to a net loss of $14.2 million or 23 per share for the same period in 2021.
Courtney Solberg: We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive
With that I will turn the call over to the operator for questions.
Courtney Solberg: Officer, and Jason Haas, our Chief Financial Officer.
If you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
Courtney Solberg: We will then open the call for questions.
To withdraw your question press the pound key.
Our first question comes from Ted turned off with Piper Sandler.
Sure.
Good morning, and thank you for the update I was wondering looking forward to multiple data readouts. This year I'm wondering when it comes to our six O nine.
<unk>.
Are there potential strategic alternatives.
Alternative.
Considering this a drug that you remain committed to.
Developing yourself space.
Courtney Solberg: Dr. David Roth, our Chief Medical Officer, Kristen Stephens, our Chief Development Officer,
Hey, Ted Thanks for the question.
Courtney Solberg: Dr. Eric Olson, our Chief Scientific Officer, and Conley Chee, our Chief Commercial Officer,
Courtney Solberg: are also on the call and will be available for Q&A.
We are incredibly excited about all of the programs that we have and we're gonna be making you know data.
Courtney Solberg: Before we begin, I would like to remind everyone that statements we make on this call will
Courtney Solberg: include forward-looking statements. Financial 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, including those set forth in the risk factors section of our annual report on Form 10-K and our quarterly report on Form 10-Q for the first quarter that we filed this morning and any other filings that we may make with the SEC in the future.
Courtney Solberg: Any forward-looking statements made on this call represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date.
Courtney Solberg: We specifically disclaim any obligation to update or revise any forward-looking statements.
Driven strategic decisions is we turnover some of these data cards.
And as always we're thinking about a variety of different opportunities to make sure that we are.
We have the necessary capital and approaches to moving these programs forward. So I would just say you know these are set of data driven started strategic decisions on how we'll progress everything.
Excellent well looking forward to lots of data this year.
Great. Thanks Ted.
Yeah.
Our next question comes from Eva per the tariff with Cowen.
Courtney Solberg: I would now like to turn the call over to Nancy.
Nancy Simonian: Thank you, Courtney.
Hi, good morning, Thanks for taking our questions. So.
Nancy Simonian: Good morning, everyone, and thank you for joining us.
So for the safety lead in data from the select AML trial.
Can you maybe.
Give a little bit more detail on.
What we can expect to see in terms of Quantico activity will there be a breakdown of CR here is here H M LFS.
Is that something we can expect to see.
Great I'm going to have David Roth answer that question sure.
Nancy Simonian: The first quarter of 2022 was very productive for CSIROS as our team continued to execute
So you have to select AML trial.
Remind everybody.
Who is listening in.
<unk> in newly diagnosed unfit AML patients.
Nancy Simonian: against our goal of discovering and developing small-molecule medicines for patients with
And we're evaluating the combination of Tami Barron team with.
Venetic Klaxon as excited Jim and the intent is to move this into a randomized trial to compare that triplet versus the ven as a doublet in those patients. So we're very excited about this opportunity in particular, because 30% of patients we know.
Who would get the standard base.
Don't respond or when they respond often will lose their response and we do think theres an opportunity to improve upon that by supplementing RARA positive patients with Xiaomi Barraging. So our trial will start with our safety lead in.
Nancy Simonian: cancer and monogenic diseases.
And then it will move into the randomized portion in the future.
And what we're looking for obviously is safety and Tolerability.
And then we will see responses.
In those patients who've enrolled so we'll have that and we will certainly you know the primary endpoint as you asked the question is the composite complete response rate and that consists of the CR plus the cri rate and the proportion of patients who have that but.
But of course, we'll be breaking that down into the sea ours and see arise. We will also be looking at other.
Measures of efficacy. So just to remind you. We know we've had a very high degree of transfusion independence in our prior studies. So we'll certainly be looking at at that time to response.
And all sorts of parameters molecular features of the patients and so on so we're very excited about this data and looking forward to sharing that with you in the second half of the year.
Nancy Simonian: We are very excited about the upcoming months, as we expect to have important clinical data readouts.
Nancy Simonian: To start off, our SelectMDS1 Phase 3 clinical trial of tamibaritine and higher-risk MDS continues to be on track,
Nancy Simonian: and we look forward to reporting our pivotal data in late 2023 or early 2024, giving us the potential to file a new drug application with the FDA in 2024.
Nancy Simonian: Tamibaritine has the potential to set a new treatment paradigm for the approximately 30% of RARA-positive, higher-risk MDS patients
Perfect. That's really helpful and just a follow up can you.
Nancy Simonian: by offering them a convenient oral therapy that can deliver high complete response rates without sacrificing safety or tolerability.
Nancy Simonian: Despite successful advancements in blood cancers more broadly, MDS has largely lagged behind in drug development.
Nancy Simonian: Hypomethylating agents, or HMAs, remain the existing standard of care while providing limited efficacy.
Nancy Simonian: And aside from HMAs, no new therapies have been approved in over a decade.
Discuss your expectations for the efficacy of the then he's a doublet in this population of Robert powers positive patients.
Who tend to have like as you've described previously the monothetic phenotype.
Sure how should we be thinking about the bar for efficacy here.
So yes, it's a very important question and the way, we're thinking about it and you're making reference to the data we presented at Ash 2020, where we showed.
That an emerging pattern of features in patients with AML, who don't respond to banana clacks.
Involves having what we refer to as Monostich features it doesn't necessarily mean, they're monocytes per se, but they have molecular characteristics of monocytes and we were able to show that patients who are RARA positive, but a high percentage of those patients. Indeed have these features which is what led us to speculate.
Speculate that RARA positive patients may not only.
Have increased sensitivity to response to Tammy, but possibly a lower.
Response to the standard of care, which in this case would include Burnet o'clock. So.
You know that the doublet, the etame as a doublet as well as but then he is a doublet.
Each has.
A composite CR rate in the low 60% range.
And so where we're anticipating.
If that holds up in our randomized portion of the trial that when we test RARA positive patients would've been Asia. They would have a response rate less.
And then go out and you know, we're looking hopefully for a response rate somewhere.
North of that low 60% range in our own triplet. So that's what sort of gives you a sense you know we haven't.
Specify that an actual number but we need to see the data to know.
That's very helpful. Thank you.
Our next question comes from Jason Butler with JMP Securities.
Hi, Thanks for taking the questions just a quick follow up on the 56 or nine Triple combo data can you just remind us what the average follow up of duration of follow up we would see from the safety lead in period or when we see this data cut later this year.
David.
You know, what we're going to be you know presenting data.
On the enrolled patients.
For the safety lead in of the combination with chemotherapy right and and you know.
We're obviously following all the patients.
Through their time on study, we haven't specifically said the exact number of patients or how long the follow up would be what we generally present all the data that's available to us to help you understand as we understand it how the how the combination is emerging now just to remind you again just to make sure everyone is familiar enough with the trial.
<unk>, we had presented at ESMO single agent data, which showed very sick clinically important activity in pancreatic cancer patients we had nearly a 40%.
Stable disease rate in the pancreatic patients who had enrolled and those were heavily pretreated patients so for a single agent.
You know a pretty significant observation and that was the general consensus of are clear.
Clinical investigators who are helping us interpret this data as well and not only did we have a relatively high stable disease rate, but we also saw a very objective evidence of clinical activity tumors were shrinking CA 19, nine tumor biomarkers. We're we're plummeting in many of those patients who had serial measures.
And so we really have confidence that this is a good place to pursue and it was really informed our thinking and that was in many ways also supported by preclinical data and you know you may remember some of our posters, where we showed a high degree of 56 to nine activity in tumor models with K <unk>.
<unk> mutations and I'll, just remind you that <unk> is a very common mutation in pancreatic cancer.
And we've also seen evidence of a chemotherapy combination synergy in particular with Gemcitabine, which is the backbone of our of our development strategy. In this case. So so we're advancing a doublet.
In combination with Gemcitabine at a triplet in combination with Gemcitabine and Abraxa and wishes Nab Paclitaxel.
And we're doing that in the doublet the patients will either be in first or second relapse, So where it will be second or third line patients provided they've had fullfare nox prior to study enrollment and the triplet will be purely in second line patients who have progressed following a fullfare nox treatment and that will really nicely.
We set the stage for us to understand the combination activity the contribution of each of the drugs to that activity.
So we'll be looking at things like obviously safety and Tolerability, but we'll also be looking at response rates duration of response and the amount of data. We have as you know certainly going to be dependent on how much we can collect and.
Pull together in time for the second half of the year. So we'll look forward to sharing all that with you.
Great I appreciate the details there and looking forward to the Readouts later this year. Thanks.
Thanks, Jason.
Our next question comes from Mark Breidenbach with Oppenheimer.
Hey, good morning, guys. Thanks for taking the questions probably.
Both of these are directed toward Nancy.
I guess I'm wondering as we get closer to 2023, and if we're still in a situation where there are financial limitations on clinical bandwidth I'm wondering how you would most likely prioritize the distribution of capital between the three main ongoing trials in Mds AML it in pancreatic cancer.
So that's one question.
And then the other one is just since we're getting pretty close to the dose confirmation readout for 'twenty one O one.
I just wanted confirmation that there was no data driven reason to hold off on the phase III study and that this decision is being purely driven as a result of financial considerations. Thanks for taking the questions.
Hey, great. Thanks, Mark.
We are very committed to Tami Barron team in our phase III trial in higher risk Mds.
Nancy Simonian: We believe tamibaritine has the potential to be the first therapy for a targeted population in high-risk MDS and has the opportunity to change the standard of care.
And we've reiterated our guidance of having data from that trial at the end of 'twenty 23 early 2024.
I think with so.
So I'll just state that with.
50, 609, and the AML study, we're going to be turning over some data cards. Later this year and as always we'll make set of data driven decisions around kind of how we want to allocate capital will be very thoughtful about that.
Nancy Simonian: We are also looking forward to providing safety and clinical activity data from the safety-leading portion of the SelectAML1 trial of tamibaritine in the second half of this year.
I will just relationship to 'twenty, one O. One our decision to seek additional capital is in no way due to a lack of confidence in the potential 21 O. One. We think this is a really great opportunity for patients. We believe it will change the standard of care and make a big difference.
Nancy Simonian: The Phase 2 trial will be evaluating tamibaritine combined with venetoclax and azacitidine compared to venetoclax and azacitidine alone, which is the standard of care.
Nancy Simonian: We believe tamibaritine has the potential to deliver a significant benefit to the approximately 30% of newly diagnosed unfit AML patients who are RARA-positive.
Nancy Simonian: Our translational and clinical data support the potential for the RARA biomarker to enrich for patients more likely to respond to tamibaritine and for whom the standard of care may be suboptimal.
And our decision is strictly due to the current market conditions, we want to make sure that we have the capital necessary to move it into phase III before we commit and we look forward to progressing the program. Once we have secured the appropriate resources.
Okay fair enough. Thanks, Thank you for the clarity on that and thanks for taking the questions.
Our next question comes from Zach <unk> with Roth Capital Partners.
Good morning, and thanks for taking my questions and thanks for that detail updates almost seems like he has three data readout to come in or out in the second half of the year I meant the second half of the year. You said you just had a couple of quick questions. The first one is Laura do you feel like you'll know study.
Nancy Simonian: So, we are excited about tamibaritine's potential, and expected data from our SelectAML1 trial will provide key insights into the safety, efficacy, and combinability of tamibaritine and azacitidine and venetoclax.
Nancy Simonian: Additionally, we expect to provide pharmacokinetic and safety data mid-year from our dose confirmation study of 2101 in APL.
Nancy Simonian: As announced today, given the current market conditions, we do not intend to advance 2101 into a Phase 3 trial until we have secured additional capital.
Nancy Simonian: However, we remain confident in the 2101 program.
Nancy Simonian: We believe it has the potential to replace the standard of care for APL patients by offering a significantly reduced treatment burden and increased access to therapy without sacrificing clinical benefit.
Simply a follow up question posed earlier wanted to get a sense of how derisking.
This data set will be what kind of defining the next gold flash strategy.
Nancy Simonian: We also plan to announce safety and clinical activity data from the safety-leading portion of the 5609 trial in relapsed pancreatic cancer in the second half of 2022.
Nancy Simonian: The 5609 pancreatic expansions are designed to establish proof of concept in combination with chemotherapy using a doublet regimen of 5609 and gemcitabine and a triplet regimen of 5609, gemcitabine, and abraxas.
Nancy Simonian: By exploring both the doublet and triplet regimens, we believe this will deepen our understanding of the combination tolerability profile, as well as clinical activity, while maximizing the opportunity in an area of high unmet need.
Hey, Sam I think as David mentioned to you.
Nancy Simonian: Currently, the only approved agent for second-line pancreatic cancer is Onavid plus 5-SU-Lucaborin, which offers progression-free survival of just three months.
We're going to be looking not only at the safety, but the clinical activity from the safety lead in and you know as.
As David said, you know, we know kind of the general clinical activity rate for the two doublets Tammy Asia, and then Asia, and we're going to want to be seen.
Activity that sort of north of what we see with either double it as sort of part of our rationale to move forward into the next phase. So I think it is gonna be derisking in the sense of that activity will help drive a what's the next best steps and we'll you know gives the potential for data that would support this being an important.
Triplet combination and you know we know the patients in AML frontline unfit.
You need to have a very large unmet medical need and so we think theres room definitely room to move to demonstrate.
Higher activity with that triplet combination.
Yeah.
Nancy Simonian: We believe 5609 in pancreatic cancer represents a large market opportunity and has the potential to make a big difference in these patients' lives.
Does that help Doug Martin Yeah that was helpful and the next one is just about 50 609 looses lending if you do see some compelling data in pancreatic cancer patients are you likely to.
Nancy Simonian: As a reminder, in the phase one dose escalation, 5609 showed promising clinical activity with good tolerability as a single agent in heavily pre-treated patients, most notably in patients with pancreatic cancer and with KRAS mutations, including prolonged stable disease, along with tumor shrinkage and tumor marker reductions.
Nancy Simonian: We believe this single-agent activity is clinically important, and coupled with our preclinical data, which showed regressions in KRAS mutant models and potentiation of gemcitabine antitumor activity, sets the stage for our current approach of evaluating 5609 in combination with chemotherapy.
Move this into a much larger that isn't the only reason I'm asking is because of that the capital constraints that you kind of mentioned I am just wondering you know are you well capitalized enough to kind of limit on it.
Nancy Simonian: We look forward to sharing safety data and the initial clinical activity data from the trial at the time of the data readout.
Yeah. Thanks.
I think as similar to what I've said overall, we were going to have data from the safety lead in portion of that trial at the end of the year.
Nancy Simonian: At the upcoming ASCO and EHA conferences, we are looking forward to sharing trial-in-progress abstracts detailing the designs of our 5609 trial in pancreatic cancer, our SelectMDS1 trial, and our SelectAML1 trial.
Nancy Simonian: As announced this morning, given the current market environment, we are de-prioritizing the development of 5609 in hematologic malignancies at this time.
Nancy Simonian: We continue to believe that 5609 has the potential to make a transformative impact on patients with many difficult-to-treat tumors.
Nancy Simonian: Beyond the work we are doing in pancreatic cancer, we are also pursuing the development of 5609 in BRAF mutant colorectal cancer, or CRC.
And again based on what that data looked like we'll make decisions about moving into the the next phase, which is sort of the expansion phase.
Nancy Simonian: Based on the agreement we entered into with Roche in August of last year, 5609, in combination with etezolizumab, is being explored in patients with BRAF mutant CRC.
Nancy Simonian: Under the terms of the agreement, we are supplying 5609 for a combination dosing cohort in the Roche-sponsored ongoing Phase 1, 1b intrinsic trial.
Nancy Simonian: This arm of the study is expected to be open for enrollment in the first half of 2022.
Where we've enrolled I think practically 25 patients in each of the either doublet or triplet or what are the other or if the data don't support it we wouldn't move it forward.
And I think well you know us that the readouts of those studies to enable us to think about what's the best way to move them forward.
Thanks, and then the last one he again just about the capital position.
Position, just kind of getting them just kind of trying to get a sense. If you know what's driving that.
That stands right now does it largely on the.
These three M D as sharp as one looks at the cash balance relative to some of your peers, just because you've done a pretty decent position, but with that with the annuity new prioritization was just wondering is it because of that a large phase three Mds study and then also trying to get a sense of how you're thinking about your options for a reason.
Additional capital. So we can kind of perhaps think about how to model. Some of these changes for example, what might be the next 21 O. One study began based on you know how you think youre going to be able to secure additional capital. Thanks again.
Sure.
Yeah I'll take that.
Exactly.
We were clearly spending the majority of our capital on the phase III Mds trial.
It's the most advanced program is that what you said.
We're very focused on making sure that we've got the right resources and capitalization to support that data read out.
End of 'twenty three early 'twenty four.
And then in terms of capital I'm, not going to specifically comment on our financing strategy.
But like many other companies in our space, we're very proactive in exploring all the options available to Shiraz to make sure that we have the right amount of capital to continue to resource the company going forward.
As we said before we have capital into the second quarter of 'twenty, three and we like to try to have capital obviously beyond that so we are continuing to look at various options to raise incremental capital to make sure we're properly resource too to.
Manage all the clinical programs, we have going forward.
Thanks, Dave I was hoping to kind of tease out of the U plans for some BD with OLED.
Derisking data that's coming up.
Thanks again.
But what I will say implied in my answer is that we are looking at.
There is options and I think it's fair to say, where we're being very proactive about different opportunities to raise capital at the lowest cost possible to optimize our capital structure. So I think it's fair to say, where we're looking at a variety of things right now.
And although I asked me about that prioritization I mean, I think a lot of companies are going to have to go through this process.
The market conditions, and I think it isn't I think I don't you know far thinking I'm kind of doing that right now, especially as we have the pivotal study ongoing with that again, thanks again for the update.
Thanks.
As a reminder, if you'd like to ask a question at this time that is star then one.
Our next question comes from Matthew Cross with Alliance Global Partners.
Hi, all good morning, and thanks for taking a couple of questions from me.
Following up on some of the familiar themes here I guess as we're looking towards some of those data driven decisions and be in the second half.
Specific to AML.
Was curious just to get the kind of latest update on your assumptions based on interaction with the FDA for the regulatory path. There I guess once we have some the safety lead in data just wanted to know.
Kind of what your options might look like as far as proceeding into.
A full phase III, some kind of phase two b, along it sort of accelerated approval path given the focus under our productivity I.
Just wanted to get the latest thinking there in terms of whats next options could look like based on that data later in the year and then I have one follow up after that.
Great Man I'm Gonna have David answer that sure so.
We are embarking on a fairly robust randomized phase II study.
That we would believe would give us very good quality data to compare the triplet versus the doublet.
And so the nature of that data will really be what informs the best strategy.
To move forward.
We know the.
The food and drug administration has.
Awarded approvals two drugs in the ammo space based on single arm data.
Using.
The complete response rate and durability of response, but.
The opportunity to have randomized data.
<unk> may also be an option and then of course, there are considerations for what it what's required to get global approvals both in the United States and Europe were randomized data may be the preferred development strategy. So, let's just say, we're looking forward to generating the data in the second half related to the safety lead in and moving forward.
And we will keep you informed about next steps as our data evolve.
Fair enough I appreciate the insight as I know right. That's kind of an ongoing question the heme space about the F. D. A tightening some of the rins around these accelerated approvals based on randomized data or are there other parameters.
Second one was just kind of a capital question related to was curious if there was anything you could say.
Any additional context, you could give us maybe the scale generally of capital required for the 'twenty one O. One phase III that led to the assumption to pause on that for a bit maybe compared to the mds trial or framing against any potential cost savings from choosing not to pursue 56 or nine firm.
They're in heme malignancies, just wanted to get kind of a sense of the offset from that against what that phase III could look like.
Sure, Matt It's Jason again.
I don't want to comment on the specific clinical trial costs, but I think it's fair to say you know our phase III in APL is significant relative to some of our other potential expenditures on trials.
So we would you want to make sure as Nancy said that we have the right capital allocated to start the trials. So we don't have any capital constraints going forward. Once we do start the trial and we're confident that we'll be able to find that capital at the right time.
So.
So in terms of the APL, where we're gonna.
Continue to explore the different alternatives.
And hopefully you have the right capital to start that trial, because we're very excited about the program.
In terms of some of the re prioritization, we announced this morning. It allows us to have capital into kind of the second quarter of 'twenty, three and we're going to continue to evaluate the market backdrop and our potential sources of capital to continue to make sure. We always have capital available to us, particularly.
As we head into the end of 'twenty three early 'twenty four trial results for Ngls.
Understood. Okay. Thanks, looking forward to the data in the second half of the year and that means more answers on some of these questions I appreciate it.
Thanks, Matt.
That concludes today's question and answer session I'd like to turn the call back to Nancy Simonian for closing remarks.
Nancy Simonian: The milestones expected this year and beyond will help inform next steps for each of our programs and will provide insights on the potential of our investigational medicines to change the standard of care for patients.
Thank you operator, thank you everyone for joining us today and for your continued support of Cerus we.
Nancy Simonian: Finally, turning to our gene control discovery engine.
Nancy Simonian: In April at AACR, we presented a poster on our Selective CDK12 Inhibitor Program, detailing the potency, selectivity, and antitumor activity of one of our lead compounds.
Nancy Simonian: This CDK12 inhibitor impaired DNA repair, caused cell cycle dysregulation, and genomic instability, leading to tumor growth inhibition and apoptosis as a single agent in preclinical models.
Nancy Simonian: Additionally, this CDK-12 inhibitor induced tumor regressions in small-cell lung and breast
Nancy Simonian: cancer in vivo models and demonstrated activity in combination with lorbanuctinin in a small-cell
Nancy Simonian: lung model, as well as olaparib, showing antitumor activity in a PARP-inhibitor-resistant patient-derived
We look forward to updating you again soon as we advance our portfolio and work to build <unk> into a leading biopharma pharmaceutical company.
Nancy Simonian: xenograft model of ovarian cancer.
Nancy Simonian: Combined together, these data support our belief that CDK-12 inhibition could play a key role in the treatment of breast, lung, and
Nancy Simonian: ovarian cancer.
Nancy Simonian: We look forward to naming a development candidate from our CDK-12 program in the second half of the year.
Nancy Simonian: We are confident that our clinical pipeline, which is focused on advancing our ongoing Phase 2 and 3 trials of tamibarotene for
Nancy Simonian: AML and MDS, respectively, our dose confirmation trial of 2101 in APL, as well as our 5609 trial in pancreatic cancer, will allow us to
Nancy Simonian: provide benefit to patients and maximize value for our company and our shareholders.
Nancy Simonian: We look forward to executing on our near-term
Nancy Simonian: value drivers and continuing to work towards achieving our mission of making a profound difference in patients' lives.
Please reach out to us if you have any questions and have a great day.
Nancy Simonian: I will now turn the call over to Jason to review our financial results.
Jason Haas: Thank you, Nancy.
Jason Haas: Based on our current plans, we believe we have sufficient capital to fund our planned operating expenses and capital needs
Jason Haas: into the second quarter of 2023.
Jason Haas: Now I'll turn to our financial results.
Jason Haas: We recognized $5.5 million in revenue in the first quarter of 2022,
Operator: This concludes today's conference call.
This concludes today's conference call.
Jason Haas: consisting of $5.1 million from the collaboration with GBT and $400,000 from our collaboration with Insight.
Jason Haas: In the first quarter of 2021, we
Jason Haas: recognized a total of $4.8 million in revenues under our collaborations with GBT and Insight. R&D expenses were $25.2 million in the first
Thank you for participating.
Jason Haas: quarter of 2022, as compared to $20 million for the first quarter of 2021. This increase was primarily due to the advancement of our
Jason Haas: clinical and preclinical programs and increases in employee-related expenses due to headcount growth.
May now disconnect.
Jason Haas: G&A expenses were $6.9 million in the
Jason Haas: first quarter of 2022, as compared to $5.7 million for the first quarter of 2021. This increase was primarily due to increases in
[music].
Jason Haas: employee-related expenses and an increase in patent prosecution costs and consulting fees.
Jason Haas: Finally, we reported a net loss for the first
Jason Haas: quarter of $25.1 million, or $0.40 per share, compared to a net loss of $14.2 million, or $0.23 per share, for the same period in 2021.
Jason Haas: With that, I will turn the
Operator: call over to the operator for questions.
Operator: If you'd like to ask a question at this time, please press the star and the number one key on your touchtone telephone.
Operator: To withdraw your
Operator: question, press the pound key.
Ted Tentoff: Our first question comes from Ted Tentoff with Piper Sandler.
Ted Tentoff: Great.
Ted Tentoff: Good morning, and thank you for the update.
Ted Tentoff: I was wondering, I'm looking forward to multiple data readouts this year.
Ted Tentoff: I'm wondering when it comes to
Ted Tentoff: Are there potential strategic alternatives that you guys are considering, or is this
Ted Tentoff: a drug that you remain committed to developing yourself?
Ted Tentoff: Thanks.
Nancy Simonian: Hey, Ted.
Nancy Simonian: Thanks for the question.
Nancy Simonian: We are, you know, incredibly excited about, you know, all of the programs that we have,
Nancy Simonian: and you know, we're going to be making, you know, data-driven strategic decisions as we
Nancy Simonian: turn over some of these data cards.
Nancy Simonian: And you know, as always, we're thinking about a variety of different opportunities to make
No.
Nancy Simonian: sure that we have the necessary capital and approaches to moving these programs forward.
Hum.
Nancy Simonian: So I would just say, you know, these are sort of data-driven sort of strategic decisions
Nancy Simonian: on how we'll progress everything.
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Ted Tentoff: Excellent.
Ted Tentoff: Well, looking forward to lots of data this year.
Ted Tentoff: Great.
Ted Tentoff: Thanks, Ted.
Eva Priveterov: Our next question comes from Eva Priveterov with Cowen.
Eva Priveterov: Hi.
Okay.
Eva Priveterov: Good morning, and thanks for taking our questions.
Eva Priveterov: So for the safety lead-in data from the SelectAML trial, can you maybe give a little bit more
Okay.
Eva Priveterov: detail on what we can expect to see in terms of clinical activity?
Eva Priveterov: Will there be a breakdown of CR, CRI, CRH, MLFS?
Yeah.
Eva Priveterov: Is that something we can expect to see?
Hey.
Nancy Simonian: Great.
Yeah.
David Roth: I'm going to have David Roth answer that question.
David Roth: Sure.
David Roth: So, yeah, the SelectAML trial, just to remind everybody who's listening in, is in newly
David Roth: diagnosed unfit AML patients, and we're evaluating the combination of tamibaritine with panetoclaxonazacitidine.
Yeah.
David Roth: And the intent is to move this into a randomized trial to compare that triplet versus the venasa
David Roth: doublet in those patients.
Yes.
David Roth: So we're very excited about this opportunity, in particular because 30% of patients we know
Uh huh.
David Roth: who would get the standard venasa don't respond, or when they respond often will lose their
David Roth: response.
David Roth: And we do think there's an opportunity to improve upon that by supplementing RARA-positive
Sure.
David Roth: patients with tamibaritine.
Okay.
David Roth: So our trial will start with a safety lead-in, and then it will move into that randomized
Yes.
David Roth: portion in the future.
Yes.
David Roth: And what we're looking for, obviously, is safety and tolerability, and then we'll see
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David Roth: responses in those patients who've enrolled.
David Roth: So we'll have that.
David Roth: And we'll certainly, you know, the primary endpoint, as you asked the question, is the
David Roth: composite complete response rate, and that consists of the CR plus the CRI rate and the
David Roth: proportion of patients who have that.
David Roth: But of course, we'll be breaking that down into the CRs and the CRIs, and we'll also
David Roth: be looking at other measures of efficacy.
David Roth: So just to remind you, you know, we've had a very high degree of transfusion independence
Okay.
David Roth: in our prior studies, so we'll certainly be looking at that, the time to response, and
David Roth: all sorts of parameters, molecular features of the patients, and so on.
Yes.
David Roth: So we're very excited about this data, and looking forward to sharing that with you in
David Roth: the second half of the year.
Eva Priveterov: Perfect.
Okay.
Eva Priveterov: That's really helpful.
Eva Priveterov: And just to follow up, can you discuss your...
Yeah.
Eva Priveterov: What are your expectations for the efficacy of the venasa doublet in this population of
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David Roth: raripar's positive patients who tend to have, as you've described previously, the monocytic
David Roth: phenotype?
David Roth: Sure.
David Roth: How should we be thinking about the bar for efficacy here?
David Roth: So yeah, it's a very important question.
David Roth: And the way we're thinking about it, and you're making reference to the data we presented
David Roth: at ASH 2020, where we showed that an emerging pattern of features in patients with AML who
David Roth: don't respond to venetoclax involves having what we refer to as monocytic features.
David Roth: That doesn't necessarily mean they're monocytes per se, but they have molecular characteristics
David Roth: of monocytes.
David Roth: And we were able to show that patients who are raripositive, a high percentage of those
David Roth: patients indeed have these features, which is what led us to speculate that raripositive
David Roth: patients may not only have increased sensitivity to response to TAMI, but possibly a lower
David Roth: response to the standard of care, which in this case would include venetoclax.
David Roth: So you know that the doublet, the TAMI-AZ doublet, as well as the venasa doublet, each
David Roth: has a composite CR rate in the low 60% range.
David Roth: And so we're anticipating if that holds up in our randomized portion of the trial, that
David Roth: when we test raripositive patients with venasa, they would have a response rate less than
Sure.
David Roth: that.
David Roth: And we're looking, hopefully, for a response rate that's somewhere north of that low 60%
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David Roth: range in our own triplet.
David Roth: So that just sort of gives you a sense.
David Roth: We haven't specified an actual number, but we need to see the data to know.
David Roth: That's very helpful.
Eva Priveterov: Thank you.
Jason Butler: Our next question comes from Jason Butler with JMP Securities.
Jason Butler: Hi.
Yes.
Jason Butler: Thanks for taking the questions.
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Jason Butler: Just a quick follow-up on the 5609 triple combo data.
Jason Butler: Can you just remind us what the average follow-up or duration of follow-up we would see from
David Roth: the safety lead-in period or when we see this data cut later this year?
David Roth: David?
David Roth: Yeah.
David Roth: So we're going to be presenting data on the enrolled patients for the safety lead-in of
David Roth: the combination with chemotherapy, right?
David Roth: And we're obviously following all the patients through their time on study.
David Roth: We haven't specifically said the exact number of patients or how long the follow-up would
David Roth: be, but we generally present all the data that's available to us to help you understand,
David Roth: as we understand it, how the combination is emerging.
David Roth: Now, just to remind you, again, just to make sure everyone is familiar enough with the
David Roth: trial design, we had presented at ESMO single-agent data, which showed very clinically important
David Roth: activity in pancreatic cancer patients.
David Roth: We had nearly a 40% stable disease rate in the pancreatic patients who had enrolled,
David Roth: and those were heavily pretreated patients.
David Roth: So for a single agent, that's a pretty significant observation, and that was the general consensus
David Roth: of our clinical investigators who were helping us interpret this data as well.
David Roth: And not only did we have a relatively high stable disease rate, but we also saw very
David Roth: objective evidence of clinical activity.
Okay.
David Roth: Tumors were shrinking, CA-99 tumor biomarkers were plummeting in many of those patients
David Roth: who had serial measures.
David Roth: And so we really have confidence that this is a good place to pursue and really informed
David Roth: our thinking, and that was in many ways also supported by preclinical data.
David Roth: And you may remember some of our posters where we showed a high degree of 5609 activity in
Okay.
David Roth: tumor models with KRAS mutations, and I'll just remind you that KRAS is a very common
David Roth: mutation in pancreatic cancer.
Yes.
David Roth: And we've also seen evidence of chemotherapy combination synergy, in particular with gemcitabine,
David Roth: which is the backbone of our development strategy in this case.
Yeah.
David Roth: So we're advancing a doublet in combination with gemcitabine, and a triplet in combination
Sure.
David Roth: with gemcitabine and abraxane, which is NAVPAC or TAXA.
David Roth: And we're doing that in the doublet.
David Roth: The patients will either be in first or second relapse, so that would be second or third
Okay.
David Roth: line patients, provided they've had Fulfernox prior to study enrollment.
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David Roth: And the triplet will be purely in second line patients who have progressed following a Fulfernox
David Roth: treatment.
David Roth: And that will really nicely set the stage for us to understand the combination activity,
David Roth: the contribution of each of the drugs to that activity.
David Roth: So we'll be looking at things like, you know, obviously safety and tolerability, but we'll
Yeah.
David Roth: also be looking at response rates, duration of response.
David Roth: And the amount of data we have is, you know, certainly going to be dependent on, you know,
Yes.
David Roth: how much we can collect and, you know, pull together in time for the, you know, second
David Roth: half of the year.
David Roth: So we'll look forward to sharing all that with you.
Jason Butler: Great.
Jason Butler: I appreciate the details there, and I'm looking forward to the readouts later this year.
Jason Butler: Thanks.
Jason Butler: Thanks, Jason.
Mark Bradenbach: Our next question comes from Mark Bradenbach with Oppenheimer.
Mark Bradenbach: Hey, good morning, guys.
Mark Bradenbach: Thanks for taking the questions.
Mark Bradenbach: Probably both of these are directed toward Nancy.
Mark Bradenbach: I guess I'm wondering, as we get closer to 2023, and if we're still in a situation where
Mark Bradenbach: there are financial limitations on clinical bandwidth, I'm wondering how you would most
Mark Bradenbach: likely prioritize the distribution of capital between the three main ongoing trials in MDS,
Mark Bradenbach: AML, and pancreatic cancer.
Mark Bradenbach: So that's one question.
Mark Bradenbach: And then the other one is just, since we're getting pretty close to the dose confirmation
Mark Bradenbach: readout for 2101, I just wanted confirmation that there was no data-driven reason to hold
Mark Bradenbach: off on the Phase III study and that this decision is being purely driven as a result of financial
Mark Bradenbach: considerations.
Mark Bradenbach: Thanks for taking the questions.
Mark Bradenbach: Thanks.
Nancy Simonian: Great.
Nancy Simonian: Thanks, Mark.
Nancy Simonian: We are very committed to tamibaritine in our Phase III trial and higher-risk MDS, and we've
Nancy Simonian: reiterated our guidance of having data from that trial the end of 2023, early 2024.
Nancy Simonian: I think with, so I'll just state that, with 5609 in the AML study, we're going to be turning
Nancy Simonian: over some data cards later this year.
Nancy Simonian: And as always, we'll make sort of data-driven decisions around kind of how we want to allocate
Nancy Simonian: capital and be very thoughtful about that.
Nancy Simonian: I will just, in relationship to 2101, our decision to seek additional capital is in
Nancy Simonian: no way due to lack of confidence in the potential 2101.
Nancy Simonian: We think this is a really great opportunity for patients.
Nancy Simonian: We believe it will change the standard of care and make a big difference.
Nancy Simonian: And our decision is strictly due to the current market conditions.
Nancy Simonian: We want to make sure that we have the capital necessary to move it into Phase III before
Nancy Simonian: we commit.
Nancy Simonian: And we look forward to progressing the program once we have secured the appropriate resources.
Nancy Simonian: Okay.
Mark Bradenbach: Fair enough.
Mark Bradenbach: Thanks for the clarity on that, and thanks for taking the questions.
Zegbe Jala: Our next question comes from Zegbe Jala with Roth Capital Partners.
Zegbe Jala: Good morning.
Zegbe Jala: Thanks for taking my questions, and thanks for the detailed updates.
Zegbe Jala: So it seems like you have three data readouts coming out in the second half of the year,
Zegbe Jala: or mid to second half of the year.
Zegbe Jala: And so I just had a couple of quick questions.
Zegbe Jala: The first one is for the Select AML study.
Zegbe Jala: Simply a follow-up to a question posed earlier.
Zegbe Jala: I just wanted to get a sense of how de-risking you think this data set will be for kind of,
Nancy Simonian: you know, defining the next go-forward strategy.
David Roth: Hey Zekva, I think as David mentioned to you, we're going to be looking not only at the
David Roth: safety but the clinical activity from the safety lead-in and, you know, as David said,
David Roth: you know, we know kind of the general clinical activity rate for the two doublets, TAMI-AZA
David Roth: and VEN-AZA, and we're going to, you know, want to be seeing activity that's sort of
David Roth: north of what we see with either doublet as sort of part of our rationale to move
David Roth: forward into the next phase.
David Roth: So, I think it is going to be de-risking in the sense of that activity will help drive
David Roth: what's the next best steps and will, you know, give the potential for data that would support
David Roth: this being an important, you know, triplet combination, and, you know, we know the patients
David Roth: in AML, frontline unfit, continue to have a very large unmet medical need, and so we
David Roth: think there's room, definitely room to move to demonstrate a higher activity with that
David Roth: triplet combination.
Zegbe Jala: Does that help, Zekva?
Zegbe Jala: Yeah, that was helpful.
Zegbe Jala: And the next one here is just about 5609, which is wondering if you do see some compelling
Zegbe Jala: data in pancreatic cancer patients, are you likely to move this into a much larger study?
Zegbe Jala: And the only reason I'm asking is because of the capital constraints that you kind of
Zegbe Jala: mentioned.
Zegbe Jala: So, I'm just wondering, you know, are you all capitalized enough to kind of move this
Nancy Simonian: forward?
Nancy Simonian: Yeah, thanks, Zekva.
Nancy Simonian: You know, I think similar to kind of what I've said overall, we're going to have data
Nancy Simonian: from the safety lead-in portion of that trial at the end of the year.
Nancy Simonian: And again, based on what that data look like, we'll make decisions about moving into the
Nancy Simonian: next phase, which is sort of the expansion phase, where we've enrolled, I think, approximately
Nancy Simonian: 25 patients in each of the either doublet or triplet, or one or the other, or if the
Nancy Simonian: data don't support it, we wouldn't move it forward.
Nancy Simonian: And I think we'll, you know, use the readouts of those studies to, you know, enable us to
Zegbe Jala: think about what's the best way to move them forward.
Zegbe Jala: Thanks.
Zegbe Jala: And then the last one here, again, just about the capital position, just kind of trying
Zegbe Jala: to get a sense of, you know, what's driving the spend right now?
Zegbe Jala: Is it largely the Phase 3 MDS trial?
Zegbe Jala: Because one looks at your cash balance relative to some of your peers, you're just like, oh,
Zegbe Jala: you're in a pretty decent position.
Zegbe Jala: But with the noted reprioritization, we're just wondering, is it because of the large
Zegbe Jala: Phase 3 MDS study?
Zegbe Jala: And then also trying to get a sense of how you're thinking about your options for raising
Zegbe Jala: additional capital, so we can kind of perhaps think about how to model some of these changes.
Zegbe Jala: For example, what might be the next 2101 study begin based on, you know, how you think you're
Zegbe Jala: going to be able to secure additional capital?
Zegbe Jala: Thanks again.
Nancy Simonian: Sure.
Jason Haas: Jeremy, Jason answered that.
Jason Haas: Yeah, I'll take that.
Jason Haas: Zegber, you know, we're clearly spending the majority of our capital on the Phase 3 MDS
Jason Haas: trial.
Jason Haas: That's the most advanced program.
Jason Haas: And as Nancy said, we're very focused on making sure that we've got the right resources and
Jason Haas: capitalization to support that data readout, you know, kind of end of 23, early 24.
Jason Haas: And then in terms of capital, I'm not going to, you know, specifically comment on our
Jason Haas: financing strategy, but like, you know, many other companies in our space, we're very proactive
Jason Haas: in exploring all the options available to CIROS to make sure that we have the right
Jason Haas: amount of capital to continue to resource the company going forward.
Jason Haas: And, you know, as we said before, we have capital into the second quarter of 23.
Jason Haas: And we like to try to have capital, obviously, beyond that.
Jason Haas: So we are continuing to look at various options to raise incremental capital and make sure
Jason Haas: we're properly resourced to, you know, manage all the clinical programs we have going forward.
Jason Haas: Thanks, Jason.
Zegbe Jala: I was hoping to kind of tease out of you plans for some BD with all of these
Zegbe Jala: new risk and data sets coming up.
Zegbe Jala: But yeah, thanks again for the update.
Zegbe Jala: But what I will say, implied in my answer, Zegba, is that we are looking at various options
Jason Haas: and I think it's fair to say we're being very proactive about different opportunities to
Jason Haas: raise capital at the lowest cost possible to optimize our capital structure.
Jason Haas: So I think
Jason Haas: it's fair to say we're looking at a variety of things right now.
Jason Haas: Understood.
Zegbe Jala: And although I asked you about the reprioritizations, I mean, I think a lot
Zegbe Jala: of companies are going to have to go through this process, you know, given market conditions.
Zegbe Jala: And I think it's nice that you guys are, you know, far-thinking and kind of doing that
Zegbe Jala: right now, especially as you have the pivotal study ongoing.
Zegbe Jala: So again, thanks again for
Zegbe Jala: the update.
Zegbe Jala: Thanks, Zegba.
Operator: As a reminder, if you'd like to ask a question at this time, that is star, then one.
Operator: Our
Matthew Cross: next question comes from Matthew Cross with Alliance Global Partners.
Matthew Cross: Hi, all.
Matthew Cross: Good morning and thanks for taking a couple of questions from me.
Matthew Cross: Following up
Matthew Cross: on some of the familiar themes here, I guess, as we're looking towards some of those data-driven
Matthew Cross: decisions in the second half, specific to AML, was curious just to get the kind of latest
Matthew Cross: update on your assumptions based on interaction with the FDA.
Matthew Cross: For the regulatory path there,
Matthew Cross: I guess once we have some, the safety lead-in data, just wanted to know kind of what your
Matthew Cross: options might look like as far as proceeding into, you know, a full Phase 3, some kind
Matthew Cross: of Phase 2B, along a sort of accelerated approval path, given the focus on RRR positivity.
Matthew Cross: Just
Matthew Cross: wanted to get the latest thinking there in terms of what next options could look like
Matthew Cross: based on that set of data later in the year.
Matthew Cross: And then I have one follow-up after that.
Matthew Cross: Great, Matt.
Nancy Simonian: I'm going to have David answer that.
David Roth: Sure.
David Roth: So, you know, we are embarking on a fairly robust randomized Phase 2 study that
David Roth: we would believe would give us very, you know, good quality data to compare the triplet versus
David Roth: the doublet.
David Roth: And so, you know, the nature of that data will really be what informs the best
David Roth: strategy to move forward.
David Roth: We know the Food and Drug Administration has awarded approvals to
David Roth: drugs in the AML space based on single-arm data using the complete response rate and durability
David Roth: of response, but, you know, the opportunity to have randomized data, you know, may also be an
David Roth: option.
David Roth: And then, of course, there are considerations for what's required to get global
David Roth: approvals, both in the United States and Europe, where randomized data may be, you know, the
David Roth: preferred development strategy.
David Roth: So let's just say we're looking forward to generating the data in
David Roth: the second half related to the safety lead-in and moving forward, and we'll keep you informed
David Roth: about next steps as our data evolve.
Matthew Cross: Fair enough.
Matthew Cross: No, I appreciate the insight,
Matthew Cross: as I know, right, that's kind of an ongoing question in the HIEM space about the FDA
Matthew Cross: tightening some of the reins around these appropriate approvals based on randomized data
Matthew Cross: or other parameters.
Matthew Cross: The second one was just kind of a capital question related to, was curious if
Matthew Cross: there was anything you could say, any additional context you could give us for maybe the scale,
Matthew Cross: generally, of capital required for the 2101 Phase III that had led to the assumption to
Matthew Cross: pause on that for a bit, maybe compared to the MDS trial or framing against any potential
Matthew Cross: cost savings from choosing not to pursue 5609 further in HIEM malignancies.
Matthew Cross: Just wanted to get
Matthew Cross: kind of a sense of the offset from that against what that Phase III could have looked like.
Matthew Cross: Thanks.
Jason Haas: Sure, Matt.
Jason Haas: It's Jason again.
Jason Haas: I don't want to comment on the specific clinical trial
Jason Haas: costs, but I think it's fair to say, you know, a Phase III in APL is, you know, is significant
Jason Haas: relative to some of our other potential expenditures on trials.
Jason Haas: So we do want to make
Jason Haas: sure, as Nancy said, that we have the right capital allocated to start the trial so we don't
Jason Haas: have any capital constraints going forward once we do start the trial, and we're confident that
Jason Haas: we'll be able to find that capital at the right time.
Jason Haas: So in terms of APL, we're going to continue to explore the different alternatives and hopefully have the right capital to start that trial because we're very excited about the program.
Jason Haas: In terms of some of the reprioritizations we announced this morning, it allows us to have capital into kind of the second quarter of 23, and we're going to continue to evaluate the market backdrop and our potential sources of capital to continue to make sure we always have capital available to us, particularly as we head into the end of 23, early 24 trial results for MGS.
Matthew Cross: Understood.
Matthew Cross: Okay.
Matthew Cross: Thanks.
Matthew Cross: Looking forward to the data in the second half of the year and getting some more answers on some of these questions.
Matthew Cross: Appreciate it.
Matthew Cross: Thanks, Matt.
Operator: That concludes today's question and answer session.
Nancy Simonian: I'd like to turn the call back to Nancy Simonian for closing remarks.
Nancy Simonian: Thank you, Operator.
Nancy Simonian: Thank you, everyone, for joining us today and for your continued support of Syros.
Nancy Simonian: We look forward to updating you again soon as we advance our portfolio and work to build Syros into a leading biopharmaceutical company.
Nancy Simonian: Please reach out to us if you have any questions, and have a great day.