Q3 2023 Syros Pharmaceuticals Inc Earnings Call
Speaker 1: Good morning and welcome to Ciro's Pharmaceuticals Third Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. This call is being webcast live on the investors and media section of Ciro's website at www.Ciro's.com
Good morning, and welcome to Syros Pharmaceuticals third quarter 2020 financial results Conference call. At this time all participants are in a listen only mode. This call is being webcast live on the investors and media section Oxy Rosebel.
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Speaker 1: Please be advised that today's call is being recorded. At this time, I would like to turn the call over to Karen Hunade, Director of Investor Relations and Corporate Communications at Xerox. Please go ahead.
Please be advised that today's call is being recorded.
At this time I would like to turn the call over to Kevin Hern, it'd be director of Investor Relations and corporate communications at Zeros. Please go ahead.
Speaker 2: Thank you. This morning, we issued a press release announcing our third quarter 2023 financial results.
Thank you. This morning, we issued a press release announcing our third quarter 2023 financial results.
Speaker 2: The full release is available on the Investor & Media section of the CIROS website at www.ciros.com.
Full release is available on the Investor and media section of the Cro's Web site at Www Dot heroes dotcom.
Speaker 2: We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive Officer, Conley Chee, our Chief Commercial Officer, Chief Business Officer, and incoming Chief Executive Officer, Dr. David Roth, our Chief Medical Officer, and Jason Haas, our Chief Financial Officer. We will then open the call to the
We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive Officer, Connolly Qi, our Chief Commercial Officer, Chief business Officer, and incoming 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.
Speaker 2: Kristen Stevens, our Chief Development Officer, is also on the call and will be available for Q&A.
Kristen Stephens, our Chief Development Officer is also on the call and will be available for Q&A.
Speaker 2: Before we begin, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements.
Before we begin I would like to remind everyone that the statements. We make on this conference call will include forward looking statements.
Speaker 2: 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, including those set forth in the risk factors section of our quarterly report on Form 10Q that we filed this morning, our annual report on Form 10K that we filed earlier in the year, and any other filings that we may make with the SEC in the future.
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, including those 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 and any other filings that we may make with the ICC in the future.
Speaker 2: 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 statement.
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 with that I'd now like to turn the call over to Nancy Nancy.
Speaker 2: With that, I'd now like to turn the call over to Nancy. Nancy?
Speaker 3: Thank you, Karen. Good morning, everyone, and thank you for joining us.
Thank you Karen good morning, everyone and thank you for joining us.
Speaker 3: Today's call marks my last as the CEO of Sero.
Today's call marks my last as the CEO of zeros.
Speaker 3: In October , we announced my planned retirement as CEO and the appointment of Conley Chee as Ciro's next CEO .
In October we announced my planned retirement as CEO and.
And the appointment of Connolly Chi it's cirrhosis next CEO.
Speaker 3: I am incredibly proud of the company we built over the last 11 years.
I am incredibly proud of the company, we built over the last 11 years.
Speaker 3: We have made tremendous progress toward our mission of translating breakthrough science into new medicine that can make a profound difference for patients.
We have made tremendous progress toward our mission of translating breakthrough science into new medicines that can make a profound difference for patients.
Speaker 3: on the foundation of a strong experienced leadership team in a collaborative patient-focused culture.
On the foundation of a strong experienced leadership team and a collaborative patient focused culture.
Speaker 3: I look forward to supporting CEROS in partnering with Conley and the team as I continue my service on CEROS's board of directors.
I look forward to supporting zeros, and partnering with Connolly and the team as I continue My service Cirrhosis board of directors.
Speaker 3: Following our strategic prioritization earlier this fall, SIROS is a company with a singular focus.
Following our strategic prioritization earlier this fall.
<unk> is a company with a singular focus.
Speaker 3: We are devoting our resources to the advancement of Tammy Baratine, our oral, selective, and potent RAR alpha agonist for the frontline treatment of hematologic malignancy.
We are devoting our resources to the advancement of <unk>, our oral selective and potent <unk> alpha agonist for the frontline treatment of hematologic malignancies.
Speaker 3: As Conley and David will detail this morning, we believe Tammy Berateen has the opportunity to become the standard of care for higher risk MDS and unfit AML patients with Rara overexpression.
As Kelly and David will detail. This morning, we believe Tammy barricades has the opportunity to become the standard of care for.
For higher risk Mds.
Unfit AML patients with Aurora overexpression.
Speaker 3: Tamib Beretine has a differentiated profile. It is a biologically targeted agent that has demonstrated high complete response rates, a rapid time,
<unk> has a differentiated profile.
It is a biologically targeted agent that has demonstrated high complete response rates.
Rapid time to response.
Speaker 3: and a favorable tolerability profile across multiple clinical trials.
And a favorable tolerability profile across multiple clinical trials.
Speaker 3: I am incredibly proud to have taken CEROS from a scientific discovery in 2014 to late-stage development on the path to commercialization.
I am incredibly proud to have taken spyros.
From a scientific discovery in 2014.
Two late stage development on the path to commercialization.
Speaker 3: As a company, we are approaching this important transformation with data from our first pivotal study in higher risk MDS to be reported next year.
As a company we are approaching this important transformation with data from our first pivotal study in higher risk Mds to be reported next year.
Speaker 3: and initial data from the randomized portion of our phase 2 study and AML that we plan to present in early December .
And initial data from the randomized portion of our phase II study in AML that we plan to present in early December.
Speaker 1: As we prepare for our maturation into a commercial company, it is a natural time to transition leadership to Conley, our chief commercial and business officer, who is an expert at building effective commercial organizations and launching targeted oncology therapy.
As we prepare for our maturation into a commercial company. It is a natural time to transition leadership to Connolly, our chief commercial and business Officer, who is an expert at building effective commercial organization and launching targeted oncology therapies.
Speaker 3: Conley has been a valuable member of our leadership team for over two years informing all aspects of our business.
<unk> has been a valuable member of our leadership team for over two years informing all aspects of our business.
Speaker 3: Having worked with Conley during this time and during our transition over the last month, I am confident he will be an impactful and effective leader in this next stage for CIRA.
Having worked with Connolly during this time and during our transition over the last month I am confident he will be an impactful and effective leader in this next stage for cerus.
Speaker 3: With that, I would like to turn the call over to Connelly to provide some brief remarks.
With that I would like to turn the call over to Kelly to provide some brief remarks.
Finally.
Thank you Nancy.
Speaker 4: I'm incredibly honored to lead Seiros into its next exciting phase and to build on the foundation that faults our sway to Foods and our rock-paper- pact movement around our shutouts.
I am incredibly honored to lead <unk> into its next exciting phase.
And to build on the foundation that Nancy and the team have established.
Speaker 4: on behalf of all our colleagues, I would like to thank you Nancy.
Please go on behalf of all of our colleagues I would like to thank you Nancy for all your years of leadership.
Speaker 4: I'm here to work closely alongside my colleagues and partners in my new role as CEO to execute on our development plan.
I'm eager to work closely alongside my colleagues and partners.
New role as CEO.
Cute on our development plans for Tammy Barrick team.
Speaker 4: for our first NDA filing and launch, and ultimately deliver Tamibaratine to the thousands of MDS and AML patients in the United States.
Here for our first NDA filing and launch and ultimately deliver Tommy Barentine thousands of Mds and AML patients in need of better options.
Speaker 4: Since I joined CIROS two years ago, we've made great strides in building a roadmap to commercialize.
Since I joined <unk> two years ago we've.
We've made great strides in building a roadmap to commercialization.
Speaker 4: With the recent restructuring, we've also now streamlined our operations to focus on our...
With the recent restructuring we've also now streamlined our operations to focus on our <unk> program.
Speaker 4: We continue to execute on our clinical development to prepare for an NDA filing and are developing the plan for commercial infrastructure.
We continue to execute on our clinical development to prepare for an NDA filing and are developing the plan for commercial infrastructure.
Speaker 4: As we approach the initial data readout in the randomized portion of SelectAML1,
As we approach the initial data readout in the randomized portion of select AML one.
Speaker 4: in early December and the pivotal data from Select MDS 1 next year.
In early December and the pivotal data from select Mds, one next year.
Speaker 4: We're increasingly focused on building a robust commercial business that can submit Tamibiracine as a standard of care for patients with bra-bra overexpression.
We are increasingly focused on building a robust commercial business that can submit <unk> as the standard of care for patients with <unk> over expression.
We believe the market for <unk> is significant.
Speaker 4: With higher risk MDS and unfit AML are diseases that are notoriously difficult to treat.
With higher risk Mds and unfit AML are diseases that are notoriously difficult to treat.
Speaker 4: The number of frontline therapies and late-stage development have shrunk in recent months, and existing frontline options are insufficient.
The number of frontline therapies in late stage development have shrunk in recent months and existing frontline auctions are insufficient.
Speaker 4: Given that these patients are often elderly and frail, it is important to have new treatment regimens that are tolerable and manageable. With contrasts, we were dropped out of the hospital.
Given that these patients are often elderly and frail.
It's important to have new treatment regimens.
Our tolerable and manageable.
With Tami Barron gene, we are advancing a first of its kind targeted therapy.
Speaker 4: which could become standard of care for approximately 50% of higher risk MDS and 30% of unfitting EML patients who are positive for rara overexpression.
Which could become standard of care for approximately 50% of higher risk Mds and 30% of unfit AML patients who are positive for Robert over expression.
Speaker 4: As we've noted before, approximately 21,000 people are diagnosed with higher risk MDS and nearly 25,000 people are diagnosed with higher risk MDS.
As we've noted before approximately 21000 people are diagnosed with higher risk Mds.
Nearly 25000 people are diagnosed with uncertain AML annually in the U S and Europe.
Speaker 4: are diagnosed with unfit AML annually in the U.S. and Europe .
Speaker 4: Altogether, this creates a substantial market opportunity for Tami Bird.
Altogether this creates a substantial market opportunity for <unk>.
Speaker 4: As we move closer to potentially delivering Tamibertine to this market, we're beginning to engage in critical pre-commercial.
As we move closer to potentially delivering Tommy break into this market.
We're beginning to engage in critical pre commercial activities.
If approved.
Speaker 4: We plan to deliver Tamibiracine to patients through our own commercial efforts in the United States and are well positioned to execute on this opportunity.
We plan to deliver Tammy Barrington to patients through our own commercial efforts in the United States and are well positioned to execute on this opportunity.
Speaker 4: I look forward to leading the team through these important efforts.
I look forward to leading the team through these important efforts.
Speaker 4: as we work to realize the potential for Tamibaricine to provide profound benefit to patients.
As we work to realize the potential for <unk> to provide profound benefit to patients.
Speaker 4: With that, I'll now turn it over to David to review our programs and upcoming milestones in more detail.
With that I will now turn it over to David to review, our programs and upcoming milestones in more detail.
David.
Thank you kindly.
Speaker 5: We are very pleased by the continued progress in advancing tamibaratine through clinical development in both AML and higher risk MDF.
We are very pleased by the continued progress in advancing <unk> through clinical development in both AML and higher risk Mds.
Speaker 5: We are on track to share initial randomized data from approximately 20 patients in Select AML1 in early December .
We are on track to share initial randomized data from approximately 20 patients and select AML one in early December.
Speaker 5: As a reminder, the randomized portion of the select AML1 study is designed to evaluate the safety and efficacy of tamibarotene in a combination with venetoclax and azacytidine compared to veneza alone in approximately 80 newly diagnosed unfit AML patients with VARA overexpression.
As a reminder, the randomized portion of the select AML. One study is designed to evaluate the safety and efficacy of <unk> in the combination with kinetic lax and asus hydrogen compared to <unk> alone and approximately 80 newly diagnosed unfit AML patients with Robert over expression.
<unk>.
Speaker 5: Patients are randomized one to one into the two treatment arms with the composite CR rate, or the CRCRI rate, as the primary.
Patients are randomized one to one into the two treatment arms with a composite CR rate or the CRC, our run rate as the primary endpoint.
Speaker 5: We expect this initial data will inform our understanding of the potential clinical benefit of adding tambiabaratine to venesia, the standard of care.
We expect this initial data will inform our understanding of the potential clinical benefit of adding Cherokee Cherokee, Japan Asia the standard of care.
Speaker 5: In this initial set of patients, we expect most will have completed at least two cycles of therapy.
In this initial set of patients. We expect most will have completed at least two cycles of therapy.
Speaker 5: Given that the randomized portion of the trial started enrollment in the first quarter of this year, the focus of this initial data will be on the composite complete response rates and of course tolerability.
Given that the randomized portion of the trial started enrollment in the first quarter of this year. The focus of this initial data will be RMB composite complete response rates and of course tolerability.
Speaker 5: We believe this first direct and randomized assessment of patients with larva overexpression treated with the triplet regimen of tamivarotene plus venasa compared to the doublet of venasa alone will meaningfully inform our understanding of the potential benefits of our novel approach.
We believe this first direct and randomized assessment of patients with Robert Overexpression treated with the triplet regimen of <unk>, plus <unk> compared to the doublet of <unk> alone will meaningfully inform our understanding of the potential benefits of our novel approach.
Speaker 5: We previously shared compelling data to support our TAMI Venaisa triplet strategy in AML late last year.
We previously shared compelling data to support our Tami vetting as a triplet strategy in AML late last year.
Speaker 5: Data from the safety lead in portion of our select AML1 study showed a composite complete response rate of 83% with patients experiencing a rapid time to response and favorable tolerability with a no additive myelosuppression compared to historical data with venesia alone.
From the safety lead in portion of our select AML. One study showed a composite of complete response rate of 83% with patients experiencing a rapid time to response and favorable tolerability with no additive Milo suppression compared to historical data with <unk> alone.
Speaker 5: in early December will provide data on an additional set of patients, all with RARA overexpression treated with the triplet, as well as a direct randomized comparison to patients with RARA overexpression treated with the venesia doublet.
In early December will provide data on an additional set of patients all with Huawei overexpression treated with the triplet as well as the direct randomized comparison to patients with Wawa overexpression treated with the venues are doubled.
Speaker 5: Today, the standard of care for unfit AML patients is venetoclax with azacytidine, which has shown a 66% composite CR rate and a median overall survival of less than 15 months.
Today, the standard of care for unfit AML patients is <unk> with ACO strategy.
As shown a 66% composite CR rate and a median overall survival of less than 15 months.
Speaker 5: Unfortunately, approximately one third of AML patients do not respond to the current standard of care with Veniza, and nearly all who initially respond will relax.
Unfortunately, approximately one third of AML patients do not respond to the current standard of care within Asia, and nearly all who initially respond will relapse.
Speaker 5: Post relapse, patients have a very poor prognosis with a median survival of only a few months.
Post relapse patients have a very poor prognosis with a median survival of only a few months.
Speaker 5: based on data that informed the Select AML-1 study, we believe Tami Baratine is uniquely positioned to improve upon the standard of care in unfit AML. And we look forward to sharing initial randomized data next.
Based on data that informs the select amyloidosis study, we believe <unk> is uniquely positioned to improve upon the standard of care and unfit AML and we look forward to sharing initial randomized data next month.
Speaker 5: In parallel, we continue to evaluate tamibaritine for the treatment of higher-risk MDS, which, like AML, represents an area of high unmet need.
In parallel we continue to evaluate <unk> for the treatment of higher risk Mds, which like AML represents an area of high unmet need.
Speaker 5: The existing standard of care provides limited efficacy with a 17% complete response rate and a median overall survival of just 18.6 months.
The existing standard of care provides limited efficacy with a 17% complete response rate and a median overall survival of just $18 six months.
Speaker 5: No new therapies beyond hypomethylating agents or HMAs have been approved in well over a decade.
No new therapies beyond high Bloom escalating agency <unk> have been approved in well over a decade. This.
Speaker 5: This too provides a unique opportunity for our biologically targeted approach to improve the care and treatment of patients with Rara overexpression, who can be readily identified using a simple blood test.
<unk> provides a unique opportunity for our biologically targeted approach to improve the care and treatment of patients with Robert over expression, who can be readily identified using a simple blood test assay.
Speaker 5: Temi-Barotene also benefits from a generally well tolerated safety profile, which is particularly well suited to this generally elderly and frail population.
<unk> also benefits from a generally well tolerated safety profile, which is particularly well suited to this generally elderly and frail population.
Speaker 5: We continue to enroll patients in the ongoing select MDS one phase three trial evaluating Tammy Baratee plus a decided
We continue to enroll patients in the ongoing select Mds, one phase III trial evaluating <unk> plus he has decided to.
Speaker 5: As a reminder, the primary endpoint of the trial is complete response rate in the initial 190 patients, with overall survival now included as a key secondary endpoint based on continued enrollment to approximately 550 patients.
As a reminder.
Primary endpoint of the trial is complete response rate in the initial 190 patients with overall survival now included as a key secondary endpoint based on continued enrollment to approximately 550 patients.
Speaker 5: We're very excited as we approach the completion of enrollment for the primary endpoint. We can now project the enrollment trends more precisely and expect to complete enrollment of the initial 190 patients necessary to support approval using a CR endpoint in the first quarter of 2024 and plan to report pivotal CR data by mid Q4 of 2024.
We're very excited as we approach the completion of enrollment for the primary endpoint. We can now projected enrollment trends more precisely and expect to complete enrollment of the initial 190 patients necessary to support approval using a CRM point in the first quarter of 2024 and.
And plan to report pivotal CR data by mid Q4 of 2024.
Speaker 5: Given the biologic and clinical similarities that establish the well understood relationship between higher risk MDS and AML and the supportive data we've seen across these patient populations to date, we believe that Tammy Baratine can provide significant benefit to readily identifiable, genomically defined subsets of the MDS and AML patient populations and potentially establishes a new standard of care for people with rara overexposed.
Given the biologic and clinical similarities that establish the well understood relationship between higher risk Mds and AML and the supportive data we've seen across these patient populations to date, we believe etame verity can provide significant benefit to readily identifiable genomic leader.
Subsets of the Mds and AML patient populations and potentially establishes a new standard of care for people with Robert Overexpression.
I would now like to turn the call over to Jason Our Chief Financial Officer.
<unk>, our third quarter financial results.
Jason.
Speaker 6: Thank you, David. Now turning to our third quarter financial results.
Thank you David now turning to our third quarter financial results we.
Speaker 6: We recognize 3.8M dollars in revenue in the third quarter of 2023, consisting entirely of revenue recognized under our sickle cell disease collaboration with Pfizer that ended in October .
We recognized $3 $8 million in revenue in the third quarter of 2023, consisting entirely of revenue recognized under our sickle cell disease collaboration with Pfizer that ended in October <unk>.
Speaker 6: Cirrus recognized $3.9 million in revenue in the third quarter of 2022, consisting of $3.7 million in revenue recognized under our collaboration with Pfizer and $200,000 recognized under our former collaboration with In bland October 2016 these Helena
<unk> recognized $3 $9 million in revenue in the third quarter of 2022, consisting of $3 $7 million in revenue recognized under our collaboration with Pfizer and $200000 recognized under our former collaboration with insight.
Speaker 6: R&D expenses were $28.3 million in the third quarter of 2023, as compared to $25.8 million for the third quarter of 2022. Our R&D expenditures are now principally focused on the advancement of temer Marc been covered.
R&D expenses were $28 3 million in the third quarter of 2023 as compared to $25 8 million for the third quarter of 2022.
Our R&D expenditures are now principally focused on the advancement of <unk>.
Speaker 6: G&A expenses were $7.8 million in the third quarter of 2023, as compared to $8.1 million for the third quarter of 2022.
G&A expenses were $7 8 million in the third quarter of 2023 as compared to $8 1 million for the third quarter of 2022.
Speaker 6: Restructuring costs were $2.4 million for the third quarter of 2023. And these restructuring costs were comprised of $2 million of severance, post-employment benefits, stock-based compensation, and outplacement services, as well as $400,000 of asset impairment charges related to the laboratory equipment as classified as assets held for sale.
Restructuring costs were $2 4 million for the third quarter of 2023.
And these restructuring costs were comprised of $2 million of severance post employment benefits stock based compensation and outplacement services as well as $400000 of asset impairment charges related to the laboratory equipment as classified as assets held for sale.
Speaker 6: We reported a net loss for the third quarter of $40.1 million or $1.43 per share compared to a net loss of $30.3 million or $3.21 per share for the same period in 2022.
We reported a net loss for the third quarter of $40 $1 million or $1 43 per share compared to a net loss of $30 3 million or $3 21 per share for the same period in 2022.
Speaker 6: Cash, cash equivalents and marketable securities as of September 30th, 2023 were $112 million as compared with $144 million on June 30th, 2023.
Cash cash equivalents in marketable securities as of September 32023 were $112 million as compared with $144 million on June 32023.
Speaker 6: We continue to believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into 2025, which is beyond phase 3 data from the select MDS 1 trial and additional data from the randomized portion of the select AML 1 trial. With that, I will turn the call.
We continue to believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into 2025, which is beyond phase III data from the select Mds, one trial and additional data from the randomized portion of the select AML one trial.
With that I will turn the call over to the operator for questions.
Speaker 1: Thank you and ladies and gentlemen should you have a question simply press star followed by the number one on your telephone keypad. You will hear a three tone prompt acknowledging your request and your questions will be pulled in the order we are received. Should you wish to decline from the polling process simply press star followed by the number two and if you're using a speakerphone please leave the handset before pressing any keys. One moment please for your first question.
Thank you and ladies and gentlemen should you have a question simply press star followed by the number one on your telephone keypad you will hear it from lodging Eric question and your question will be pulled into order received should you wish to decline from the polymer processing. Please press the star followed by the number too.
And if you're using a speaker phone please lift the handset before pressing <unk> one moment. Please for your first question.
Speaker 1: Your first question comes from the line of Ted Dantoff from Piper Sandler. Your line is open. Great, thank you very much.
Your first question comes from the line of Ben Danfoss from Piper Sandler Your line is open.
Oh, great. Thank you very much and good morning.
Speaker 7: So I just want to start by...
So I just wanted to start by.
Yes.
Asking about.
Speaker 7: sort of how the landscape is changing both in the AML and MDS.
Sort of how the landscape is changing both AML and Mds.
Speaker 7: and whether or not you think there's any major changes that have occurred since you designed the select studies. And I also just want to thank Nancy for all of our hard work. I really can't say how much I've enjoyed working with you. And Conley, I know you're going to do a great job with the company, but Nancy, thanks so much, and I wish you all the best.
And whether or not you think there is any major changes that occurred occurred since designed the select studies.
That said this one up so I think Nancy.
Nancy for all of our hard work are really key.
Can't say, how much I've enjoyed working with you and currently I know you are going to do a great job with the company, but Nancy thanks, So much and I wish you all the best.
Yeah.
Speaker 5: Thank you, Ted. It's been a real honor and pleasure in also working with you and your team. I'm going to turn the question over to David to talk a little bit about how the MDS and AML landscape has changed since we designed the select studies. So thanks for that question, Ted. So I think, let me just start by saying some things have not changed. What hasn't changed is the fact that there remains a very significant unmet need for patients with higher risk MDS.
Thank you Ted.
It's been a real honor and pleasure and often working with you and your team.
Im going to turn that question over to David to talk a little bit about Mds.
Mds or AML landscape has changed since we design that select sites.
Thanks for that question Chad. So I think let me just start by saying some things have not changed.
What hasnt changed is the fact that there remains a very significant unmet needs for patients with higher risk Mds.
Speaker 5: It's really a challenging disease to treat so the majority of patients are elderly or frail and the need for a well tolerated
It's really a challenging disease to treat the majority of patients are elderly or frail and the need for a well tolerated.
Speaker 5: Preferably, I think, a morally available therapy that's easy to administer and helps maintain quality of life continues to this day. And that's really what motivates us to continue our development of chamomile barotene. What has changed, however, is that there have been many drugs put into development.
Preferably actually can orally available therapy.
Easily to administer and helps maintain quality of life continues to this day and Thats really what motivates us to continue our development of Xiaomi parity.
What has changed however is that there'll be many drugs put into development.
Speaker 5: over several years, over even the time that we've had TAMI in development, which have not been successful.
Over several years.
Even the time that we've had xiaomi in development, which have not been successful.
Speaker 5: And we've watched this evolution of various trials that are advanced to phase three that haven't made it. And of course, we reflect on that. We have a sort of a concern that patients need more and we sort of do wish others have success. But we look at our mechanisms, it's distinct. And we think that
And we've watched this.
Pollution.
Various trials that have advanced to phase III Hasnt made it.
And of course it reflect on.
That.
Sort of.
A concern that patients need more sort of to wish others.
Have success, but we look at our mechanism is distinct.
And we think that these issues.
Speaker 5: issues separate us from the rest of the pack. So we have reason to remain hopeful that our program will deliver ultimately and that's why we're so excited today.
Issues separate us from the rest of the pack. So we have reason to remain hopeful of that.
Our program will deliver ultimately and that's why we're so excited today.
Speaker 5: Do you want to talk about AML? Yeah, so just in AML, I'm sorry I didn't answer specifically, but for AML, I think the same sort of holds true. We have, I think, seen an evolution of a standard of care that now includes fanatic clack.
Yes.
I'm, sorry, I didn't answer specifically, but for AML I think the same sort of holds true.
We have I think seen an evolution of the standard of care that now includes <unk>.
Speaker 5: and Aza cytogene in AML. It has been developed primarily for patients who are unfit. And we all do appreciate the.
In Asia <unk> in AML.
Has been developed primarily for patients who are unfit and.
We do appreciate the.
Speaker 5: properties of venetoclax, which, while highly effective,
Properties is another clock switch while highly effective.
Speaker 5: can be associated with myelosuppression that makes it a bit more challenging for use in the patient population for which it was targeted.
Can be associated with myeloid suppression that makes it a bit more challenging for us in the patient population for which it was targeted and so even in that context, we still feel there is opportunity to improve.
Speaker 5: And so, even in that context, we still feel there's opportunity to improve on that standard. You know, obviously, we have a program where we're adding tamibeptine into the backdrop of MediClinic's Venasa with a hope to improve upon the performance there. You know, and I think there still remains significant unmet need with a third of patients not responding to Venasa or
On that standard.
Obviously, we have a program, where we're adding Tommy beverage incident backdrop with medical Arts in Asia with a hope to improve upon the performance there.
I think theres still remains significant unmet need with a third of patients not responding to than Asia or.
Speaker 5: patients who initially respond will ultimately relapse. So we think there's still much that can be addressed there. There's a range of new drugs in development that are being entered into the clinic. There's a large focus on immuno-oncology drugs.
Patients, who initially respond will ultimately be lapse. So we think there is still much that can be addressed there. There is a range of new drugs in development that are being entered into the clinic. There is a large focus on immuno oncology drugs, but.
Speaker 5: But it's still early days, and I think it's really a great place to be focused on our efforts for.
Still early days and I think it's it's really a great place to be focused on our efforts for helping patients.
Speaker 1: Let me just add one thing, Ted. It's pretty remarkable to think about.
Okay.
But it's pretty remarkable to think about.
Speaker 1: the frontline treatment of these hematologic malignancies, where the median overall survival in AML based on the standard of care in Veneza is just a little over a year.
Hotline treatment of the hematologic malignancy.
Where the median overall survival in AML.
Thanks, Amit.
It's just a little over a year.
Speaker 1: And in MDS, it's a year and a half. I mean, there is just such a continued high unmet medical need in these spaces. And despite a lot of attempts to change that, I really do think that we are beginning to see sort of a potential inflection point, but that part has not changed over the years. And as David said, that's why we're continuing to be so excited about the opportunity with Tani Baratine. That's a great perspective.
And in Mds in a year and a half.
It's just such a continued high unmet medical need in these spaces and despite a lot of accounts.
I really do think that we are beginning to see solid.
So the inflection point.
That part of the Blackstone stuff.
As David said, that's why we're continuing to be so excited about the opportunity.
Yeah.
That's a great perspective, thank you all.
Thanks, gentlemen.
Speaker 8: Thank you. And ladies and gentlemen, once again, if you would like to ask a question, simply press star followed by the number one on your telephone keypad.
Thank you and ladies and gentlemen, once again, if you would like to ask a question simply press star followed by the number one on your telephone keypad.
Speaker 8: Your next question comes from the line of Phil Nadeau from TD Cowan. Your line is open.
Your next question comes from the line of ceiling that due from TD Cowen Your line is open.
Speaker 9: Good morning. Thanks for taking our questions. First, Nancy, let us add our congratulations on your tenure and coming retirement.
Good morning, Thanks for taking our questions first and ask you about is that our congratulations on your tenure and coming retirement.
Very well deserved a.
Speaker 9: a couple questions from us first unselect and now i think uh... in the prepared remarks he said that this initial data will give us some idea of the efficacy uh... of adding kennedy to the to the combination he took a bit more about that what what delta between the arms would give you confidence that you are seeing
A couple of questions from US first select AML I think in the prepared remarks, you said that this initial data will give us some idea of the efficacy.
Adding <unk> to the combination can you talk a bit more about that.
Delta between the arms would give you confidence that you are seeing additive efficacy in light of the relatively small patient numbers and.
Speaker 9: additive efficacy, it might have had a relatively small patient numbers. And in terms of the control arm, and specifically, I think you said a 66% CRCRI rate would be expected in the general population, what's the most recent data on what a rah-rah positive population would generate for CRCRI for prevention?
In terms of the control arm and specifically I think you said, 66% CR Cri rate would be expected in the general population.
What's the most recent data on wood, a RARA positive population.
Generate foresee our cri for preventive.
Speaker 5: Okay. Thanks, Bill. I'll take that one. So just to again remind for everyone who's listening, we're undergoing a randomized trial. All the patients are positive for viral overexpression. They all have unfit AML. And this represents the very first prospective clinical evaluation of TEN.
Okay. Thanks, Bill I'll take that one so just to again remind everyone who is listening.
Sure.
Undergoing a randomized trial all of the patients are positive for RARA over expression. They all have understood AML and this represents the very first prospective clinical evaluation.
Tommy Barra team.
Speaker 5: being used in RARA positive patients in combination with Veniza compared to Veniza. So your question about what we know about the performance of Veniza in RARA positive patients is unknown. And this will be our first data update that gives us initial insights into that. We are very excited that we have a new data update that will be coming out in the next 7 days for these Remedies and we are so excited that we will get to hear more about it and share it with you. Thank you. define it from time to time. Okay, lets turn to our next question.
Being used in RARA positive patients in combination with <unk> compared to <unk>. So your question about what we know about the performance of venues.
Positive patients.
And this will be our first.
Data update that gives us additional insights into that.
We are very excited that we can look forward to reporting on approximately 20 patients reminding you. It's randomized one to one so you can expect a relatively equal split across that population and we're specifically focused on those patients who have enrolled into the randomized portion.
Speaker 5: Can look forward to reporting on approximately 20 patients reminding you it's randomized one to one. So you can expect a relatively equal split across that population and we're specifically focused on those patients who have been rolled into the randomized portion. So reminding
No.
Speaker 5: a group who started enrollment in the first quarter and here we are in fourth quarter giving you this update. So we're large.
And are you. This is a group who started enrollment in the first quarter and here. We are fourth quarter give you this update.
We're largely focused on the response rates.
Speaker 5: on the response rates. We focus on our primary input, which is the composite CR rate, the CR-CRI rate. And of course, you know, we'll report on the tolerability.
Focus on our primary endpoint, which is the composite CR rate the CR cri rate.
And of course, we will report on the Tolerability.
Speaker 5: As you mentioned, the Benazir response is about 66%, but Tamiazir response in this population is about 61% from our prior phase two trial. So we're looking for a response to the triplet that is north of that.
As you mentioned the <unk>.
Responses about 66% that Tommy Asia response in this population is about 61% from our prior phase two trial. So we're looking for.
Sponsorship triplets avenues north of that.
Speaker 5: We haven't specifically stated exactly how far north we need to be of that. That said, from our prior data last year, the safety lead in a smaller number of patients had an 83% CRCR rate, which we were very excited about. And in that case, the tolerability supported advanced use of the randomized portion. So that just sort of gives you a sense of what we're doing.
Haven't specifically stated exactly how far.
North we need to be of that that said from our prior data last year. The safety lead in a smaller number of patients had an 83% CR Cri, which we're very excited about.
That case, the tolerability of supported and fasteners. The randomized portion. So let's just sort of gives you a sense as to what it is where we're hopeful for.
Speaker 5: as to what it is we're hopeful for as we move into the early December date of the disclosure.
As we move into the early December data this disclosure.
Speaker 9: That's very helpful. And then just one question on SelectMDS. It sounds like enrollment completion's now Q1 24. I think in the past guidance had been year end 23. Is there any reason for that? Were there any unforeseen challenges or is it simply now that enrollment is nearing completion you can give a more definitive and accurate guidance as to when?
That's very helpful. And then just one question on select Mds it sounds like enrollment.
Completion is now Q1 'twenty four I think in the past guidance had been year end 'twenty three.
Is there any reason for that or are there any unforeseen challenges or is it simply now that enrollment is nearing completion, you can give them more.
Definitive inaccurate.
Guidance as to when it's going to complete.
Speaker 5: Yeah, I think that the latter is the case. You know, we do our very best over time when a trial initiates.
Yes, I think that the latter is the case, we do our very best over time, when a trial initiate.
Speaker 5: It's all kinds of ways to project enrollment rates based on the numbers of sites that are activated and the delivery of the active sites to the trial. And as you get closer and closer to the finish line, the data are more robust in terms of the accuracy of how they lead us to come to our predictions. So now that there's light at the end of the tunnel, I think we're feeling very, very confident.
It has all kinds of ways to projected enrollment rates based on the numbers of sites that are activated in the delivery of active sites to the trial and as you get closer and closer to the finish line the data are.
More robust in terms of the accuracy of poverty lead us to come through our predictions. So now that Theres light at the end of the tunnel I think we're feeling very very confident.
Speaker 5: that we can project completing the enrollment for the primary endpoint that 190th patient should be delivered in the first quarter of the year. Since it's just a little different than what we previously said, we just thought it was appropriate to update that at this point.
That we can project completing the enrollment of the primary endpoint that 198 patient should should be delivered.
In the first quarter earnings since it's just a little different than what we previously said, we just thought it was appropriate to update that at this point.
Speaker 9: Fair enough. Thanks again for taking our questions, and Nancy, congrats again on a great tenure.
Fair enough. Thanks, again for taking our questions and answer.
Congrats again on a great tenure.
Yeah.
Thank you Phil.
Speaker 8: Thank you and there are no further questions at this time. I would like to turn it back to Dr. Nancy Simonian for closing remarks.
Thank you and there are no further questions at this time I would like to turn it back to Dr. Nancy Simonian for closing remarks.
Speaker 1: Thank you, operator, and thank you everyone for joining us today.
Thank you operator, and thank you everyone for joining us today.
Speaker 3: I am deeply grateful for the opportunity to start up and lead SIROS over the past 11 years.
I am deeply grateful for the opportunity to start up in late zero over the past 11 years.
Speaker 1: I am proud of the achievements we made together, and I'm excited about the potential for Temi-Barracene to transform the lives of patients.
I am proud of the achievements, we've made together and I'm excited about the potential for <unk> to transform the lives of patients.
Speaker 1: I look forward to CEROS's next chapter on the path to commercialization and continuing my service as a member of the board.
I look forward to cirrhosis next chapter on the path to commercialization.
And continuing my service as a member of the board.
Speaker 1: Finally, and importantly, I want to express my thanks to you, our investors and analysts, and the entire CIRAS team for your support over the years. It truly makes a difference for patients. Thank you.
Finally, and importantly, I want to express my Thanks to you our investors and analysts and the entire cerus team for your support over the years.
Truly makes a difference for patients. Thank you.
Okay.
Speaker 8: Thank you, presenters, and ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Thank you presenters and ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.