• Revenue: No revenue recognized in Q2 2024, compared to $2.8 million in Q2 2023.
• R&D Expenses: $22 million in Q2 2024, down from $29.6 million in Q2 2023.
• G&A Expenses: $5.5 million in Q2 2024, compared to $7.2 million in Q2 2023.
• Net Loss: $23.3 million or $0.59 per share in Q2 2024, compared to $36.3 million or $1.30 per share in Q2 2023.
• Cash Position: $79 million as of June 30, 2024, down from $108.3 million as of March 31, 2024.

• Warning! GuruFocus has detected 5 Warning Signs with SYRS.

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 (NASDAQ:SYRS) 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 (NASDAQ: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 (NASDAQ: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.