Release Date: July 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Syros Pharmaceuticals Inc (SYRS, Financial) is preparing for upcoming data readouts for tamibarotene in AML and higher-risk MDS patients, with plans for NDA filing and launch readiness.
- The company is well-positioned to execute on the commercial opportunity for tamibarotene in the U.S., leveraging its team's successful track record.
- Tamibarotene has shown high complete response rates, rapid time to response, and a favorable tolerability profile in trials, indicating potential as a new standard of care.
- The SELECT-MDS-1 trial is powered to over 90% to show a difference in CR rates, with pivotal data expected by mid-Q4 2024.
- Syros Pharmaceuticals Inc (SYRS) has reduced R&D and G&A expenses, reflecting a focused approach on advancing tamibarotene, and has sufficient cash to fund operations into Q3 2025.
Negative Points
- Syros Pharmaceuticals Inc (SYRS) did not recognize revenue in Q2 2024, compared to $2.8 million in Q2 2023, due to the termination of a collaboration agreement with Pfizer.
- The company reported a net loss of $23.3 million for Q2 2024, although this is an improvement from the $36.3 million loss in Q2 2023.
- There is uncertainty regarding the go/no-go decision for advancing tamibarotene into a pivotal study in AML, pending further data analysis.
- The European commercialization strategy for tamibarotene is not yet fully defined, with plans to seek a partner for execution.
- Cash, cash equivalents, and marketable securities decreased from $108.3 million as of March 31, 2024, to $79 million as of June 30, 2024.
Q & A Highlights
Q: In AML, when will you decide on advancing tamibarotene into a pivotal study? Will the data from 40 patients in September be sufficient?
A: David Roth, Chief Medical Officer: We plan to provide an update on the SELECT-AML-1 trial at the SOHO Annual Meeting in September. The analysis will include at least 40 patients. We need to see the data before making a go/no-go decision. It's premature to specify the criteria for advancement without analyzing the comparative results across the two arms.
Q: What would you want to see in the data to decide on moving to a pivotal study in AML?
A: David Roth, Chief Medical Officer: We previously reported a 100% CR/CRi rate with a high CR rate in the triplet arm compared to the control. The difference between the arms and the quality of responses, such as duration, will be crucial in our decision-making process.
Q: What are your plans for commercialization in Europe for MDS?
A: Conley Chee, CEO: In the U.S., we plan to commercialize through our own efforts. In Europe, due to its fragmented nature, we aim to license or find a partner to execute commercialization.
Q: Are the current expenses a new run rate, or should we expect them to increase in future quarters?
A: Jason Haas, CFO: Expenses have decreased due to reprioritization, focusing on MDS and AML data and preparing for commercial launch. This is a new run rate, and we are being judicious with expenses.
Q: Can you remind us of the powering for the SELECT-MDS-1 Phase III trial?
A: David Roth, Chief Medical Officer: The trial is powered over 90% to show a difference in CR rates across the two arms, with approximately 190 patients needed. We anticipate having the pivotal primary readout by mid-Q4.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
