Syros(US:SYRS)2023-11-14 11:47Revenue and Collaboration - For the three and nine months ended September 30, 2023, the company recognized revenue of $3.8 million and $9.6 million, respectively, related to its collaboration with GBT[178]. - The collaboration with GBT terminated effective October 16, 2023, and the company does not expect to recognize collaboration revenue from GBT following that date[179]. - Revenue for the three months ended September 30, 2023, was $3.8 million, a decrease of 3% from $3.9 million in the same period of 2022[194]. - Revenue for the nine months ended September 30, 2023, was $9.6 million, a decrease of 39% from $15.6 million in the same period of 2022[204]. Clinical Trials and Development - The company is advancing tamibarotene in combination with azacitidine in a Phase 3 clinical trial (SELECT-MDS-1) for higher-risk myelodysplastic syndrome (HR-MDS), with an expected total addressable market of approximately $3.3 billion by 2026[170]. - The SELECT-MDS-1 trial is designed to include approximately 550 patients to assess overall survival as a key secondary endpoint, with pivotal complete response data expected by mid-Q4 2024[170]. - The ongoing Phase 2 clinical trial (SELECT-AML-1) for tamibarotene in combination with venetoclax and azacitidine reported a composite complete response rate of 83% in a small cohort of newly diagnosed unfit AML patients[171]. - The company has stopped further investment in the clinical development of SY-2101 to prioritize the ongoing development of tamibarotene[167]. - The total addressable market opportunity for all AML patients is expected to grow to approximately $6.6 billion by 2025[169]. - The company is exploring out-licensing opportunities for SY-5609, a selective inhibitor of CDK7, after completing a Phase 1/1b clinical trial[174]. - The company is focused on the clinical trials of tamibarotene and associated companion diagnostic tests, with ongoing development efforts for future product candidates[230]. Financial Performance - Research and development expenses increased by approximately $2.5 million, or 10%, from $25.8 million in Q3 2022 to $28.3 million in Q3 2023[195]. - External research and development costs rose by approximately $3.9 million, or 31%, primarily due to increased costs associated with clinical trials of tamibarotene[199]. - General and administrative expenses decreased by approximately $0.3 million, or 4%, from $8.1 million in Q3 2022 to $7.8 million in Q3 2023[196]. - Interest income increased by approximately $1.2 million, or 317%, due to higher interest rates in Q3 2023 compared to Q3 2022[193]. - Interest expense increased due to higher interest rates on credit facilities and equipment financing arrangements[201]. - The net loss for the three months ended September 30, 2023, was $40.1 million, an increase of 33% from a net loss of $30.3 million in Q3 2022[193]. - Total operating expenses decreased by 11% from $43.3 million in Q3 2022 to $38.4 million in Q3 2023[193]. - Research and development expenses increased by approximately $2.6 million, from $84.0 million in 2022 to $86.7 million in 2023, representing a 3% increase[205][206]. - General and administrative expenses rose by approximately $0.4 million, or 2%, from $22.0 million in 2022 to $22.4 million in 2023[207]. - Interest income surged to $5.5 million in 2023, a 927% increase from $0.5 million in 2022, due to higher average cash balances and interest rates[210]. - Net loss for the nine months ended September 30, 2023, was $100.2 million, an 11% increase from a net loss of $89.9 million in 2022[221]. Cash Flow and Funding - Cash and cash equivalents as of September 30, 2023, were approximately $112.2 million, which is expected to fund operations into 2025[219][227]. - Net cash used in operating activities was $91.1 million in 2023, a slight decrease from $92.0 million in 2022[223]. - Net cash provided by investing activities was $35.8 million in 2023, compared to $29.5 million in 2022, primarily due to the maturity of marketable securities[224]. - The company expects to incur significant expenses related to advancing clinical trials and commercialization efforts for tamibarotene, necessitating additional funding[226][228]. - As of September 30, 2023, $250.0 million of securities remained available for future issuance under the 2023 Registration Statement[218]. - The company may need to relinquish valuable rights to technologies or future revenue streams if additional funds are raised through collaborations or licensing arrangements[229]. Market Risks and Economic Factors - The company is exposed to market risk related to changes in interest rates, but a 10% change in market interest rates is not expected to materially impact the investment portfolio[231]. - The company contracts with vendors in Asia and Europe, exposing it to foreign currency exchange rate fluctuations, but currently does not hedge this risk[232]. - Inflation has increased labor and clinical trial costs, but it did not have a material effect on the company's financial condition during the nine months ended September 30, 2023[233].