Syros(US:SYRS)2023-08-08 15:12Financial Data and Key Metrics Changes - The company recognized $2.8 million in revenue for Q2 2023, entirely from its collaboration with Pfizer, compared to $6.3 million in Q2 2022 [38][44] - R&D expenses decreased to $29.6 million in Q2 2023 from $33.1 million in Q2 2022, focusing on late-stage clinical programs [39] - General and administrative expenses increased to $7.2 million in Q2 2023 from $6.9 million in Q2 2022 [45] - The net loss for Q2 2023 was $36.3 million, or $1.30 per share, compared to a net loss of $34.5 million, or $5.40 per share, in the same period of 2022 [45] - Cash, cash equivalents, and marketable securities as of June 30, 2023, were $144 million, down from $166 million on March 31, 2023, with sufficient funds projected to last into 2025 [46] Business Line Data and Key Metrics Changes - The SELECT-MDS-1 Phase III trial is evaluating tamibarotene plus azacitidine in newly diagnosed high-risk MDS patients, with a primary endpoint of complete response rate [29] - Enrollment in SELECT-AML-1 and SELECT-MDS-1 trials is ongoing, with initial data from SELECT-AML-1 expected in Q4 2023 and pivotal CR data from SELECT-MDS-1 anticipated in Q3 2024 [23][14] Market Data and Key Metrics Changes - Approximately 50% of patients with higher-risk MDS and 30% of AML patients are positive for RARA overexpression, aligning with expectations [24] - The existing standard-of-care for high-risk MDS has a complete response rate of 17% and a median overall survival of 18.6 months, indicating a significant unmet need [18][27] Company Strategy and Development Direction - The company remains focused on clinical trial execution and aims to achieve upcoming milestones, including data readouts from its Phase II study of tamibarotene [14] - The strategy includes addressing unmet needs in hematologic malignancies and establishing new standards of care for patients with RARA gene overexpression [15][28] - The company is exploring out-licensing opportunities for its 5609 program to support further development [37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing momentum in clinical trials and precommercial activities, indicating a productive first half of the year [6][7] - The management team highlighted the potential of tamibarotene to improve outcomes for high-risk MDS and unfit AML patients, emphasizing the differentiated profile of their biologically targeted programs [9][26] Other Important Information - The company plans to report initial data from the SELECT-AML-1 trial in Q4 2023, which will be the first direct comparison of the triplet regimen versus the doublet in AML [20] - The SELECT-MDS-1 trial is designed to enroll a total of 550 patients, with the initial 190 patients supporting the primary endpoint [31] Q&A Session Summary Question: Update on SELECT program and potential partnerships - The company is in discussions regarding partnerships for the 5609 program and will provide updates as they arise [41][42] Question: Go/no-go decision timeline for tamibarotene in AML - Initial data from the randomized portion of the trial in Q4 2023 will inform the go/no-go decision, with further insights expected in 2024 [51][55] Question: Futility analysis timing - A futility analysis is planned before the primary efficacy analysis, focusing on safety and risk/benefit ratios [58] Question: Updates on 2101 and FDA meetings - The company is analyzing PK data from the dose confirmation trial and will provide updates in the second half of the year regarding development plans and timelines [59]