Centessa Pharmaceuticals(CNTA) - 2025 Q3 - Quarterly Report

Financial Position - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $349.0 million, expected to fund operations into mid-2027[120] - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $349.0 million, with $50.8 million in cash and cash equivalents, $195.4 million in short-term investments, and $102.8 million in long-term investments[146] - The company raised $8.1 million from financing activities during the nine months ended September 30, 2025, mainly from the ATM program and employee stock option exercises[157] - The company has access to up to $200.0 million in term loans, with $110.0 million already received and additional tranches available upon achieving specific milestones[147][149] - The term loans are set to mature on December 1, 2029, with an option to extend to December 1, 2030, depending on certain conditions[150] Research and Development - The company is developing ORX750, an OX2R agonist, currently in Phase 2a clinical trials, with 55 participants completing dosing as of September 23, 2025[109] - ORX750 demonstrated statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) with a p-value of 0.0213 compared to placebo[111] - ORX142, another OX2R agonist, is in Phase 1 clinical trials, with 89 healthy adult participants dosed as of October 3, 2025, showing rapid onset of action and well-tolerated at all doses[117] - The Phase 2a study of ORX750 is expected to enable dose selection for a registrational program planned for the first quarter of 2026[112] - The company is advancing ORX489, its most potent OX2R agonist, into IND-enabling studies with clinical studies planned for the first quarter of 2026[118] - Research and development expenses are expected to increase significantly due to costs associated with clinical trials and regulatory filings for current and future product candidates[122] Financial Performance - The company recorded a net loss of $54.9 million for the three months ended September 30, 2025, compared to a net loss of $42.6 million for the same period in 2024, reflecting a 28.8% increase in losses[133] - For the nine months ended September 30, 2025, research and development expenses totaled $117.7 million, up 31.7% from $89.4 million for the same period in 2024[141] - Research and development expenses for the three months ended September 30, 2025, were $41.6 million, an increase of 22.5% from $33.9 million for the same period in 2024[134] - The OX2R agonist program accounted for $35.6 million in research and development expenses for the three months ended September 30, 2025, compared to $11.7 million in the same period of 2024[134] - The company recognized $15.0 million in license and other revenue during the nine months ended September 30, 2025, related to an upfront payment from Genmab A/S[140] - Interest and investment income for the nine months ended September 30, 2025, was $16.0 million, an increase of 75.2% from $9.2 million for the same period in 2024[143] - General and administrative expenses for the nine months ended September 30, 2025, were $36.5 million, a slight decrease from $37.1 million for the same period in 2024[142] - Interest expense for the nine months ended September 30, 2025, was $8.7 million, up 13.1% from $7.6 million for the same period in 2024[144] - Other non-operating income for the nine months ended September 30, 2025, was $2.8 million, compared to $2.3 million for the same period in 2024, primarily due to foreign currency transaction gains[145] Operational Challenges - The company has incurred recurring losses and negative cash flows since inception, primarily funded through equity securities and debt financing[120] - The company expects to continue incurring significant development costs as it progresses through clinical trials and regulatory approvals[127] - During the nine months ended September 30, 2025, the company used $138.0 million in operating activities, reflecting a net loss of $131.4 million, adjusted by non-cash charges of $22.3 million[154] - The company incurred net cash used in investing activities of $200.4 million during the nine months ended September 30, 2025, primarily due to investments in marketable securities[156] - The company anticipates significant increases in expenses as it continues the development of product candidates and seeks marketing approvals, necessitating substantial additional funding[158] Licensing and Partnerships - The company has out-licensed its LockBody technology platform to Genmab for up to three targets, indicating potential revenue generation opportunities[121] Company Classification - The company is classified as an emerging growth company and a smaller reporting company, allowing it to benefit from reduced reporting requirements[164][166]