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| Statement |
|---|
| If approved, we plan to deliver tamibarotene to patients through our own commercial efforts in the United States and are well positioned to execute on this opportunity |
| I am incredibly proud of the company we've built over the last 11 years |
| We have made tremendous progress toward our mission of translating breakthrough science into new medicines that can make a profound difference for patients on the foundation of a strong experienced leadership team and a collaborative patient-focused culture |
| I am proud of the achievements we made together and I'm excited about the potential for tamibarotene to transform the lives of patients |
| So now that there's light at the end of the tunnel, I think we're feeling very, very confident that we can project completing the enrolment for the primary endpoint that 198 patient should be delivered in the first quarter of the year |
| It is a biologically targeted agent that has demonstrated high complete response rates, a rapid time to response and a favorable tolerability profile across multiple clinical trials |
| I am incredibly proud to have taken Syros from a scientific discovery in 2014 to late-stage development on the path to commercialization |
| That said, from our prior data last year, the safety lead-in smaller number of patients had 83% CR/CRI rate which we're very excited about |
| And as David said, that's why we're continuing to be so excited about the opportunity with tamibarotene |
| Tamibarotene also benefits from a generally well-tolerated safety profile which is particularly well suited to this generally elderly and frail population |
| 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 assay |
| Since I joined Syros 2 years ago, we've made great strides in building a road map to commercialization |
| We are very pleased by the continued progress in advancing tamibarotene through clinical development in both AML and higher-risk MDS |
| We're very excited as we approach the completion of enrolment for the primary end point |
| I'm incredibly honored to lead Syros into its next exciting phase and to build on the foundation that Nancy and the team have established |
| Based on data that informed the SELECT-AML-1 study, we believe tamibarotene is uniquely positioned to improve upon the standard of care in unfit AML and we look forward to sharing initial randomized data next month |
| 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 tamibarotene 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 overexpression |
| I am deeply grateful for the opportunity to start up and lead Syros over the past 11 years |
| 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 Syros |
| So we have reasons to remain hopeful that our program will deliver ultimately and that's why we're so excited today |
| Tamibarotene has a differentiated profile |
| So majority of patients are elderly or frail and the need for a well-tolerated preferably, I think, an orally available therapy that's easy to administer and helps maintain quality of life continues to this day |
| And currently, I know you're going to do a great job with the company |
| And so even in that context, we still feel there is opportunity to improve on that standard |
| Data from the safety lead-in portion of our SELECT-AML-1 study showed a composite complete response rate of 83% with patients experiencing a rapid time to response and favorable tolerability with no additive myelosuppression compared to historical data with ven/aza alone |
| Obviously, we have a program where we're adding tamibarotene into the backdrop of venetoclax ven/aza with a hope to improve upon the performance there |
| Nancy Simonian Maybe to just add one thing, Ted, it's pretty remarkable to think about the frontline treatment of these hematologic malignancies where the median overall survival in AML based on the standard of care, ven/aza, is just a little over a year |
| And I think it's really a great place to be focused on our efforts for helping patients |
| Altogether, this creates a substantial market opportunity for tamibarotene |
| It's been a real honor and pleasure also working with you and your team |
| Statement |
|---|
| Post relapse, patients have a very poor prognosis with a median survival of only a few months |
| We have sort of a concern that patients need more and we sort of do wish others have success |
| 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 |
| The number of frontline therapies in late-stage development have shrunk in recent months and existing frontline options are insufficient |
| It's really a challenging disease to treat |
| What has changed, however, is that there have been many drugs put into development over several years or even the time that we've had tami in development which have not been successful and we've watched this evolution of various trials that advance to Phase III that haven't made it and of course, we reflect on that |
| A couple of questions from us |
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