Financial Data and Key Metrics Changes - The company recognized $3.8 million in revenue for Q3 2023, a decrease from $3.9 million in Q3 2022, primarily due to the conclusion of a collaboration with Pfizer [6] - The net loss for Q3 2023 was $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 [46] - Cash, cash equivalents, and marketable securities as of September 30, 2023, were $112 million, down from $144 million on June 30, 2023 [7] Business Line Data and Key Metrics Changes - R&D expenses increased to $28.3 million in Q3 2023 from $25.8 million in Q3 2022, focusing primarily on the advancement of tamibarotene [31] - G&A expenses slightly decreased to $7.8 million in Q3 2023 from $8.1 million in Q3 2022 [31] Market Data and Key Metrics Changes - The market opportunity for tamibarotene is significant, with approximately 21,000 people diagnosed with higher-risk MDS and nearly 25,000 diagnosed with unfit AML annually in the U.S. and Europe [41] - The existing standard of care for unfit AML patients has a composite CR rate of 66% and a median overall survival of less than 15 months [4][59] Company Strategy and Development Direction - The company is focused on advancing tamibarotene as a potential standard of care for higher-risk MDS and unfit AML patients with RARA overexpression [22][26] - The company plans to report pivotal data from the SELECT-MDS-1 trial next year and initial data from the SELECT-AML-1 trial in early December [23][42] - The leadership transition to Conley Chee is aimed at building a robust commercial business for tamibarotene [24][40] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet medical need in the treatment of higher-risk MDS and unfit AML, emphasizing the importance of developing well-tolerated therapies [65][66] - The company remains optimistic about the potential of tamibarotene to improve patient outcomes, particularly in the context of evolving treatment landscapes [11][59] Other Important Information - Restructuring costs for Q3 2023 amounted to $2.4 million, including severance and asset impairment charges [63] - The company believes its current cash position will be sufficient to fund operations into 2025, covering anticipated expenses related to ongoing trials [32] Q&A Session Summary Question: Changes in the AML and MDS landscape since designing the SELECT studies - Management acknowledged the evolution of treatment standards and the ongoing unmet needs in these areas, expressing hope for tamibarotene's distinct mechanism to address these challenges [50][66] Question: Efficacy of adding tamibarotene to the combination therapy - Management indicated that the expected composite CR rate for the ven/aza control arm is 66%, and they are looking for a response rate above that in the triplet regimen [67] Question: Enrollment completion timeline for SELECT-MDS - Management updated the expected completion of enrollment for SELECT-MDS to Q1 2024, citing improved accuracy in projections as enrollment nears completion [69]
Syros(SYRS) - 2023 Q3 - Earnings Call Transcript