Syros(US:SYRS)2024-10-31 10:49Revenue and Financial Performance - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future, with collaboration revenue of $3.8 million and $9.6 million recognized for the three and nine months ended September 30, 2023, respectively [126]. - Revenue for the three months ended September 30, 2024 was $0, a decrease of 100% compared to $3.8 million for the same period in 2023 [141]. - For the nine months ended September 30, 2024, revenue was $0, a decrease of 100% compared to $9.6 million for the same period in 2023 [150]. - Interest income for the nine months ended September 30, 2024 was $3.4 million, a decrease of 38% compared to $5.5 million in 2023 [149]. - The change in fair value of warrant liabilities resulted in a gain of $51.7 million for the nine months ended September 30, 2024, compared to a loss of $77,000 in the same period in 2023 [149]. - The company reported a net cash used in operating activities of $81.5 million for the nine months ended September 30, 2024, a decrease from $91.1 million in the same period of 2023, primarily due to a reduction in losses from operations [167]. Research and Development - Research and development expenses for the three months ended September 30, 2024, totaled $20.5 million, a decrease from $28.3 million for the same period in 2023 [131]. - The company expects significant research and development expenses as it advances the clinical development of tamibarotene [131]. - Research and development expenses for the nine months ended September 30, 2024 decreased by approximately $19.5 million, or 23%, from $86.7 million in 2023 to $67.1 million [151]. - The SELECT-MDS-1 Phase 3 clinical trial for tamibarotene in HR-MDS patients with RARA overexpression is expected to report pivotal complete response data in mid-November 2024 [122]. - The company completed enrollment of 190 patients necessary for the primary endpoint analysis in the SELECT-MDS-1 trial in Q1 2024 [122]. - The SELECT-AML-1 Phase 2 clinical trial was discontinued based on interim analysis results [123]. - The FDA granted Fast Track Designation to tamibarotene in combination with azacitidine for newly diagnosed HR-MDS patients with RARA overexpression in January 2023 [122]. Market Opportunity - Approximately 9,000 HR-MDS patients are diagnosed in the United States each year, with a total market opportunity for HR-MDS therapeutics projected to be $1.6 billion by 2029 [121]. - The total United States market opportunity for tamibarotene in HR-MDS patients with RARA overexpression is projected to exceed $800 million by 2029 [121]. Expenses and Losses - General and administrative expenses decreased by approximately $2.1 million, or 27%, from $7.8 million in Q3 2023 to $5.7 million in Q3 2024 [144]. - Total operating expenses decreased by approximately $12.2 million, or 32%, from $38.4 million in Q3 2023 to $26.2 million in Q3 2024 [141]. - Net loss for the three months ended September 30, 2024 was $6.4 million, a significant improvement of 84% compared to a net loss of $40.1 million in Q3 2023 [141]. - General and administrative expenses for the nine months ended September 30, 2024 decreased by approximately $5.0 million, or 22%, from $22.4 million in 2023 to $17.4 million [153]. Cash and Funding - As of September 30, 2024, the company had cash and cash equivalents of approximately $58.3 million and an accumulated deficit of $756.2 million [175]. - The company expects to incur significant expenses related to the clinical development of tamibarotene and may require additional funding to support ongoing operations [170]. - The company has a total of $203.6 million of securities available for future issuance under the 2023 Registration Statement as of September 30, 2024 [164]. - The company issued and sold 350,000 shares of common stock for gross proceeds of $1.4 million during the year ended December 31, 2023, under the 2023 sales agreement [161]. - The company anticipates that its cash and cash equivalents will fund its expenses into the third quarter of 2025 [170]. - The company incurred a net cash used in financing activities of $0.2 million during the nine months ended September 30, 2024, compared to a net cash provided of $0.1 million in the same period of 2023 [169]. Risks and Concerns - The company has significant losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern for at least 12 months [178]. - Plans to mitigate liquidity risk include raising additional capital through equity or debt financings and potentially selling SY-2101-related assets [178]. - The company is exposed to market risk related to interest rate sensitivity, but a 10% change in market interest rates is not expected to materially impact its financial condition [179]. - The company contracts with vendors in Asia and Europe, exposing it to foreign currency exchange rate fluctuations, but does not currently hedge this risk [180]. - As of September 30, 2024, the company did not have significant liabilities denominated in foreign currencies [180]. - Inflation has increased costs related to labor and clinical trials, but it did not have a material effect on the company's financial condition during the nine months ended September 30, 2024 and 2023 [181].