• Revenue: No revenue recognized in Q3 2024, compared to $3.8 million in Q3 2023.
• R&D Expenses: $20.5 million in Q3 2024, down from $28.3 million in Q3 2023.
• G&A Expenses: $5.7 million in Q3 2024, down from $7.8 million in Q3 2023.
• Net Loss: $6.4 million or $0.16 per share in Q3 2024, compared to $40.1 million or $1.43 per share in Q3 2023.
• Cash and Cash Equivalents: $58.3 million as of September 30, 2024, compared to $79 million as of June 30, 2024.

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

Release Date: October 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 advancing tamibarotene as a potential new standard of care for higher-risk MDS patients with RARA overexpression, targeting a significant unmet medical need.
• The SELECT-MDS-1 Phase III trial is nearing a pivotal data readout, which could be transformative for the company.
• The market opportunity for tamibarotene in the U.S. is projected to be over $800 million by 2029, indicating significant commercial potential.
• The company has reduced R&D and G&A expenses, reflecting a focused approach on tamibarotene and improved financial management.
• Syros Pharmaceuticals Inc (NASDAQ:SYRS) has a strong cash position, sufficient to fund operations into the third quarter of 2025, providing financial stability for ongoing projects.

Negative Points

• Syros Pharmaceuticals Inc (NASDAQ:SYRS) did not recognize any revenue in the third quarter of 2024, compared to $3.8 million in the same period of 2023, due to the termination of a collaboration agreement with Pfizer.
• The company reported a net loss of $6.4 million for the third quarter of 2024, although this is an improvement from the previous year's loss.
• There is uncertainty surrounding the outcome of the SELECT-MDS-1 trial, which is crucial for the company's future prospects.
• The company is heavily reliant on the success of tamibarotene, which poses a risk if the trial results are not favorable.
• Syros Pharmaceuticals Inc (NASDAQ:SYRS) has not yet secured a partner for its CDK7 inhibitor, 5609, which could limit its potential development and commercialization.

Q & A Highlights

Q: Can you walk us through the historical aza controls and how should we interpret the AML results in terms of their relevance to higher-risk MDS? A: The aza-label has a complete remission rate of 17%, which is a regulatory benchmark. Recent trials show variations, with some reporting CR rates in the low 20% range. The AML experiment aimed to leverage the apoptotic mechanism of tamibarotene and aza with venetoclax. The MDS trial is different, testing tamibarotene and aza without venetoclax. The AML results don't predict MDS outcomes, but they show high responses and good safety, important for elderly MDS patients.

Q: What will you be able to disclose in the upcoming data release? A: We will report the primary endpoint outcome of the CR rate in mid-November, evaluated in the first 190 enrolled patients. We will also provide data on the duration and time to complete response, overall response rate, and safety data. However, overall survival data will not be available at that time.

Q: What steps are needed post-data release for the FDA filing, and will a pre-NDA meeting be required? A: We will ensure all data is thoroughly corroborated and validated. Routine regulatory interactions will follow, but nothing unusual is required. We aim to submit the NDA efficiently and straightforwardly.

Q: Can you discuss the commercial preparations for tamibarotene's potential launch in MDS? A: We have been preparing for the launch for over a year, focusing on market awareness, field force sizing, infrastructure, brand planning, manufacturing, and diagnostics to ensure broad access and availability.

Q: Are there plans for a detailed presentation of the recent AML results, and any future plans for 5609? A: The complete AML data was presented at the SOHO meeting. Regarding 5609, it has high potential as a best-in-class CDK7, and we are seeking business development opportunities with larger pharma companies to fully exploit its potential.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.