Syros(US:SYRS)2024-05-14 10:42Revenue 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 no revenue recognized in Q1 2024 and $3.0 million in Q1 2023 from a collaboration that has since terminated[132] - Revenue for the three months ended March 31, 2024, was $0, a decrease of 100% compared to $2.954 million in the same period of 2023[145][146] - Net loss for the three months ended March 31, 2024, was $3.708 million, a significant improvement of 84% compared to a net loss of $23.789 million in Q1 2023[145] - Interest income decreased by 13% from $1.775 million in Q1 2023 to $1.546 million in Q1 2024 due to a lower average cash balance[145][151] - Interest expense increased by 7% from $1.217 million in Q1 2023 to $1.307 million in Q1 2024 due to higher interest rates[145][152] - Change in fair value of warrant liabilities increased by 204% from $8.865 million in Q1 2023 to $26.974 million in Q1 2024[145][153] - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities of approximately $108.3 million[161] - Net cash used in operating activities for Q1 2024 was $31.098 million, compared to $36.901 million in Q1 2023[162] - Net cash used in operating activities decreased to $31.1 million for the three months ended March 31, 2024, from $36.9 million in the same period of 2023, primarily due to a $2.3 million decrease in net loss from operations[164] - Net cash used in investing activities was $24.6 million for the three months ended March 31, 2024, compared to $25.7 million in the same period of 2023, mainly due to the purchase of marketable securities totaling $24.7 million[165] - Net cash used in financing activities was $0.3 million for the three months ended March 31, 2024, compared to net cash provided of $0.1 million in the same period of 2023, primarily due to payments related to issuance costs[166] - The company raised approximately $45.0 million through an underwritten offering of common stock and pre-funded warrants in December 2023[131] - The company has $203.6 million of securities available for future issuance under the 2023 Registration Statement as of March 31, 2024[160] Research and Development - Research and development expenses for Q1 2024 totaled $24.7 million, a decrease from $28.8 million in Q1 2023, with external costs for the tamibarotene program increasing to $16.5 million from $13.4 million[135] - The SELECT-MDS-1 trial for tamibarotene in combination with azacitidine is designed to include approximately 550 patients, with a primary endpoint focused on complete response rates and a key secondary endpoint on overall survival[127] - The SELECT-AML-1 trial reported a 100% complete response/complete response with incomplete blood count recovery (CR/CRi) rate among evaluable patients treated with tamibarotene, venetoclax, and azacitidine, compared to 70% in the control arm[129] - The company completed enrollment of 190 patients for the SELECT-MDS-1 trial in Q1 2024 and expects to report pivotal complete response data by mid-Q4 2024[127] - The SELECT-AML-1 trial is expected to report clinical activity and tolerability data from over 40 patients in Q3 2024[130] - The company is focused on advancing clinical trials and developing companion diagnostic tests for tamibarotene, which are critical for future commercialization efforts[167] Market Outlook - The company expects the global market for acute myeloid leukemia (AML) patients to grow to approximately $7.5 billion by 2028, with around 25,000 patients diagnosed annually in the U.S. and Europe[125] - The global market for myelodysplastic syndrome (MDS) patients is projected to reach approximately $4.7 billion by 2028, with an estimated 18,500 HR-MDS patients diagnosed annually in the U.S. and Europe[126] - The FDA granted Fast Track Designation to tamibarotene in combination with azacitidine for newly diagnosed HR-MDS patients with RARA overexpression in January 2023[127] Financial Risks and Funding - The company expects to incur significant expenses for clinical trials and commercialization of tamibarotene, necessitating substantial additional funding[167] - As of March 31, 2024, the company believes its cash, cash equivalents, and marketable securities will fund operations into the third quarter of 2025[168] - The company may need to rely on equity offerings, debt financings, and collaborations to finance its cash needs until substantial product revenues are generated[170] - If additional funding is not secured, the company may have to delay or reduce its product development efforts[171] - The company is exposed to market risks related to interest rates and foreign currency exchange rates, but does not currently hedge against foreign currency risks[172][173] - Inflation has not materially affected the company's business or financial condition during the three months ended March 31, 2024[174]