Syros(US:SYRS)2024-07-31 10:55Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future, with no revenue recognized during the three and six months ended June 30, 2024 [124]. - For the three and six months ended June 30, 2023, the company recognized revenue of $2.8 million and $5.8 million, respectively, from a collaboration with Global Blood Therapeutics, which was terminated in October 2023 [124]. - Total revenue for the three months ended June 30, 2024 was $0, a decrease of $2.8 million or 100% compared to $2.8 million in the same period of 2023 [138]. - The company did not recognize any revenue during the six months ended June 30, 2024, compared to $5.8 million in revenue for the same period in 2023 [147]. Clinical Trials and Research - The SELECT-MDS-1 trial is evaluating tamibarotene in combination with azacitidine in newly diagnosed HR-MDS patients with RARA overexpression, with a total of approximately 550 patients enrolled to assess overall survival as a key secondary endpoint [118]. - In the SELECT-AML-1 trial, the CR/CRi rate was 100% among response evaluable patients treated with tamibarotene, venetoclax, and azacitidine, compared to 70% in the control arm [120]. - The median time to CR/CRi response was 21 days for the triplet arm, compared to 25 days for the control arm [120]. - The FDA granted Fast Track Designation to tamibarotene in combination with azacitidine for the treatment of adults with newly diagnosed HR-MDS who are positive for RARA overexpression [118]. - The company completed enrollment of 190 patients necessary to support the primary endpoint analysis for the SELECT-MDS-1 trial in the first quarter of 2024 [118]. - The company anticipates reporting pivotal CR data from the SELECT-MDS-1 trial by the middle of the fourth quarter of 2024 [118]. Financial Performance - Research and development expenses decreased by approximately $7.7 million, or 26%, from $29.6 million in Q2 2023 to $21.9 million in Q2 2024 [139]. - General and administrative expenses decreased by approximately $1.7 million, or 24%, from $7.2 million in Q2 2023 to $5.5 million in Q2 2024 [142]. - Net loss for the three months ended June 30, 2024 was $23.3 million, a decrease of $12.9 million or 36% compared to a net loss of $36.3 million in Q2 2023 [137]. - Total operating expenses for the six months ended June 30, 2024 were $58.3 million, a decrease of $14.7 million or 20% compared to $73.0 million in the same period of 2023 [146]. - Interest income for the three months ended June 30, 2024 was $1.1 million, a decrease of $1.0 million or 49% compared to $2.1 million in Q2 2023 [137]. - Change in fair value of warrant liabilities resulted in a gain of $4.4 million for the three months ended June 30, 2024, compared to a loss of $3.1 million in Q2 2023, representing a change of $7.5 million or 241% [137]. - Research and development expenses for the six months ended June 30, 2024 totaled $46.6 million, down $11.8 million or 20% from $58.4 million in the same period of 2023 [146]. - General and administrative expenses decreased by approximately $2.9 million, or 20%, from $14.6 million for the six months ended June 30, 2023, to $11.7 million for the six months ended June 30, 2024 [149]. - Interest income decreased by approximately $2.0 million, or 6%, due to a lower average cash balance during the six months ended June 30, 2024, compared to the same period in 2023 [150]. Cash Flow and Liquidity - Net cash used in operating activities was $60.8 million during the six months ended June 30, 2024, compared to $59.3 million for the same period in 2023, reflecting an increase in net operating assets and liabilities [162]. - As of June 30, 2024, cash and cash equivalents were approximately $79.0 million [159]. - The company expects to incur significant expenses related to ongoing clinical trials and commercialization efforts for tamibarotene, necessitating substantial additional funding [166]. - As of June 30, 2024, $203.6 million of securities remained available for future issuance under the 2023 Registration Statement [158]. - The company issued shares resulting in gross proceeds of $45.0 million in December 2023, before deducting transaction costs [157]. - Interest expense increased due to a higher interest rate during the six months ended June 30, 2024, compared to the same period in 2023 [151]. - The company anticipates that its cash and cash equivalents will fund planned operating expenses into the third quarter of 2025 [167]. - As of June 30, 2024, the company had cash and cash equivalents of $79.0 million and an accumulated deficit of $749.8 million [171]. - The company has incurred significant net operating losses every year since inception and expects to continue incurring significant losses for at least the next several years [171]. - The company anticipates that its current cash and cash equivalents will meet liquidity requirements into the third quarter of 2025, but there is substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance date of the financial statements [173]. - The company has plans to mitigate liquidity risks, including raising additional capital through equity or debt financings and reducing cash expenditures [173]. Market Risks - The company is exposed to market risk related to changes in interest rates, but an immediate 10% change in market interest rates is not expected to materially impact its financial condition [174]. - The company is also exposed to foreign currency exchange rate fluctuations due to contracts with vendors in Asia and Europe, but it does not currently hedge this risk [175]. - Inflation has increased the company's cost of labor and clinical trial costs, but it did not have a material effect on its business during the six months ended June 30, 2024 [176].