Business Strategy and Development - The company approved a revised operating plan in March 2024 to focus on high potential value programs, specifically targeting the CAR-Monocyte candidate CT-0525 for solid tumors, while ceasing development of CT-0508[110] - In December 2024, the company decided to cease development of the HER2 directed autologous cell therapy platform, including CT-0525, due to competitive landscape assessments[111] - A cash preservation plan was approved in March 2025, reducing operations to those necessary for exploring strategic alternatives and preparing to wind down the business[115] - The company entered into a Merger Agreement with OrthoCellix, with the intention of completing a tax-free reorganization[118] - Future operations are highly dependent on the success of the OrthoCellix Merger, with potential bankruptcy proceedings if the merger does not close[136] - The company plans to complete the OrthoCellix Merger, which is critical for future operations, although there is no assurance of timely completion[172] Financial Performance - The company reported net losses of $19.0 million for the six months ended June 30, 2025, compared to $30.1 million for the same period in 2024[133] - Collaboration revenues were zero for the three months ended June 30, 2025, compared to $9.2 million for the same period in 2024, related to the Moderna collaboration[148] - For the six months ended June 30, 2025, collaboration revenues decreased to $3.7 million from $12.6 million in 2024, a decline of approximately 70.5%[160] - Total operating expenses for the three months ended June 30, 2025, were $5.8 million, a decrease from $20.9 million in 2024[147] - Total operating expenses for the six months ended June 30, 2025, were $18.8 million, down from $43.8 million in 2024, representing a reduction of about 57.0%[159] - Cash used in operating activities for the six months ended June 30, 2025, was $16.0 million, compared to $38.5 million in 2024, indicating a reduction of 58.5%[179] Expenses and Cost Management - The company implemented workforce reductions resulting in the termination of 62 full-time employees, approximately 58.0% of the total workforce, incurring $4.1 million in severance costs[113] - The company incurred $4.2 million in expenses during the six months ended June 30, 2025, primarily related to one-time employee termination benefits due to workforce reduction[200] - Research and development expenses decreased to $2.4 million for the three months ended June 30, 2025, from $15.3 million in 2024, primarily due to a cash preservation plan[151] - Research and development expenses for the six months ended June 30, 2025, were $11.6 million, a significant decrease of 64.7% compared to $32.8 million in 2024[163] - General and administrative expenses were $3.4 million for the three months ended June 30, 2025, down from $5.6 million in 2024[147] - General and administrative expenses for the six months ended June 30, 2025, totaled $7.3 million, down 34.0% from $11.0 million in 2024[166] Compliance and Regulatory Issues - The company is not in compliance with Nasdaq listing criteria and has been granted an extension until October 7, 2025, to demonstrate compliance[116] - A reverse stock split was approved to increase the per-share closing bid price to comply with Nasdaq listing requirements[117] Cash Position and Future Outlook - As of June 30, 2025, the company had $2.0 million in cash and cash equivalents and an accumulated deficit of $324.6 million[133] - There is substantial doubt about the company's ability to continue as a going concern, as current cash and cash equivalents are only expected to sustain operations into the fall of 2025[188] - If the OrthoCellix Merger does not close, the company may need to consider bankruptcy or liquidation, which could result in stockholders losing a significant portion of their investment[190] - The company has no intention of resuming historical research and development activities unless a strategic transaction is completed or significant additional funding is obtained[192] Shareholder and Investment Information - Post-merger, OrthoCellix's stockholders are expected to own approximately 90.0% of the combined company, while the company's stockholders are expected to own about 10.0%[120] - Ocugen has agreed to purchase $5.0 million of shares as part of a Concurrent Investment related to the merger[128] - The company has sold 1,362,917 shares of common stock for net proceeds of $3.0 million as of June 30, 2025[177] - The company may face dilution of ownership interest if additional capital is raised through equity or convertible debt securities[193] Other Financial Considerations - The company recognized $3.5 million in losses on the sale of held-for-sale assets during the six months ended June 30, 2025, with no such losses reported in 2024[168] - Interest income from cash and cash equivalents was $0.1 million for the six months ended June 30, 2025, compared to $1.0 million for the same period in 2024, indicating sensitivity to interest rate changes[204] - Inflation has not had a material effect on the company's business or financial condition during the six months ended June 30, 2025[205] - The company may need to reserve a portion of its assets for contingent obligations if liquidation and dissolution are pursued[190]
SESEN BIO(SESN) - 2025 Q2 - Quarterly Report