Centessa Pharmaceuticals(CNTA) - 2025 Q2 - Quarterly Results

Company Overview and Strategic Vision CEO's Message and Strategic Focus Centessa Pharmaceuticals is advancing its OX2R agonist franchise, aiming to redefine care for sleep-wake disorders and related comorbidities - Centessa is well-positioned with a novel, potential best-in-class OX2R agonist pipeline targeting sleep-wake disorders and comorbidities like excessive daytime sleepiness, impaired attention, cognitive deficits, and fatigue across neurological, neurodegenerative, and neuropsychiatric conditions[3] - ORX750 is progressing in an adaptive Phase 2a study, with data expected this year for NT1, NT2, and IH, aiming to be the first OX2R agonist for NT2 and IH[4] - ORX142, the second OX2R agonist candidate, recently initiated clinical development, with data in acutely sleep-deprived healthy volunteers also expected this year[4] Orexin Receptor 2 (OX2R) Agonist Pipeline Highlights The company's OX2R agonist pipeline includes ORX750 in Phase 2a, ORX142 in Phase 1, and ORX489 in IND-enabling studies, with key clinical data expected this year - ORX750 Phase 2a CRYSTAL-1 study for NT1, NT2, and IH is on track, with data expected this year and first-in-class potential in NT2 and IH[5] - ORX142 Phase 1 clinical trial for select neurological and neurodegenerative disorders is underway, with data in acutely sleep-deprived healthy volunteers expected this year[5] - ORX489 is in IND-enabling studies for the treatment of neuropsychiatric disorders[5] Recent Business Developments and Program Updates ORX142 Clinical Development Following FDA IND clearance in June 2025, Centessa initiated a Phase 1 clinical trial for ORX142, with initial data anticipated by the end of 2025 - Initiated Phase 1 first-in-human clinical trial for ORX142 in June 2025 after FDA IND clearance[9] - Data from ORX142 Phase 1 study in acutely sleep-deprived healthy volunteers expected in 2025[9] ORX750 Clinical Data and Presentations Additional Phase 1 data for ORX750 showed sustained wakefulness and improved sleepiness scores, and an abstract on the Phase 2a CRYSTAL-1 study was accepted for World Sleep 2025 Congress - Additional Phase 1 data for ORX750 presented at AAN Annual Meeting in April 2025, showing sustained effects (mean sleep latency >30 mins on MWT) and improved KSS scores at 5.0 mg dose over 8 hours[9] - An abstract detailing the adaptive design of the ORX750 Phase 2a CRYSTAL-1 study, including an open-label long-term extension, was accepted for poster presentation at World Sleep 2025 Congress (September 5-10, 2025)[9] - The Phase 2a CRYSTAL-1 study for ORX750 is ongoing, with data in NT1, NT2, and IH expected in 2025[9] ORX489 Preclinical Status ORX489, another OX2R agonist candidate, is currently undergoing IND-enabling studies, advancing towards potential clinical development - ORX489 is currently in IND-enabling studies[9] Second Quarter 2025 Financial Results Financial Performance Summary For Q2 2025, R&D expenses increased to $42.7 million, G&A expenses rose to $11.9 million, leading to a net loss of $50.3 million, with cash reserves of $404.1 million providing runway into mid-2027 Q2 2025 Financial Highlights (in millions USD) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------------- | :------ | :------ | :----------- | | Research & Development (R&D) Expenses | $42.7 | $32.8 | +$9.9 | | General & Administrative (G&A) Expenses | $11.9 | $11.2 | +$0.7 | | Net Loss | $(50.3) | $(43.8) | $(6.5) | | Cash, Cash Equivalents and Investments (as of June 30, 2025) | $404.1 | N/A | N/A | | Cash Runway | Into mid-2027 | N/A | N/A | - Cash, cash equivalents and investments totaled $404.1 million as of June 30, 2025, expected to fund operations into mid-2027[9] Consolidated Statements of Operations and Comprehensive Loss The consolidated statement of operations shows a net loss of $50.3 million for Q2 2025, an increase from $43.8 million in Q2 2024, primarily due to higher R&D expenses Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30, in thousands USD) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------ | :------------ | :------------ | | License and other revenue | $— | $— | | Research and development | 42,741 | 32,815 | | General and administrative | 11,912 | 11,165 | | Loss from operations | (54,653) | (43,980) | | Interest and investment income | 4,380 | 3,240 | | Interest expense | (2,884) | (2,525) | | Other non-operating income (expense), net | 3,592 | 154 | | Loss before income taxes | (49,565) | (43,111) | | Income tax expense | 778 | 705 | | Net loss | (50,343) | (43,816) | | Net loss per ordinary share - basic and diluted | $(0.38) | $(0.40) | | Weighted average ordinary shares outstanding | 133,677,405 | 109,489,184 | Condensed Consolidated Balance Sheets As of June 30, 2025, total assets decreased to $492.1 million from $576.8 million, primarily due to reduced cash and cash equivalents, while total shareholders' equity declined to $344.9 million Condensed Consolidated Balance Sheets (as of, in thousands USD) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $44,242 | $383,221 | | Investments in marketable securities | 359,888 | 98,956 | | Other assets | 87,997 | 94,621 | | Total assets | $492,127 | $576,798 | | Other liabilities | $37,663 | $66,313 | | Long term debt | 109,545 | 108,940 | | Total liabilities | $147,208 | $175,253 | | Total shareholders' equity | $344,919 | $401,545 | About Centessa Pharmaceuticals About Centessa's Orexin Receptor 2 (OX2R) Agonist Program The OX2R agonist program targets the orexin pathway to regulate the sleep-wake cycle and address symptoms like excessive daytime sleepiness, with a pipeline including ORX750, ORX142, and ORX489 - Orexin is a neuropeptide regulating the sleep-wake cycle, and targeting the OX2R pathway is a promising approach for excessive daytime sleepiness, impaired attention, cognitive deficits, and fatigue[11] - Centessa's OX2R agonist pipeline includes ORX750 (Phase 2a for NT1, NT2, IH), ORX142 (for neurological/neurodegenerative disorders), and ORX489 (for neuropsychiatric disorders)[11] About Centessa Pharmaceuticals Centessa Pharmaceuticals is a clinical-stage company dedicated to discovering, developing, and delivering transformational medicines, primarily focusing on its pioneering OX2R agonist program - Centessa Pharmaceuticals is a clinical-stage company focused on discovering, developing, and delivering transformational medicines[12] - The company is pioneering a new class of potential therapies within its OX2R agonist program for EDS, impaired attention, cognitive deficits, and fatigue across neurological, neurodegenerative, and neuropsychiatric disorders[12] Forward-Looking Statements This section outlines forward-looking statements regarding clinical trials, regulatory approvals, and financial projections, subject to various risks and uncertainties - Statements regarding future events, such as clinical trial timing, data readouts, regulatory approvals, and financial runway, are forward-looking and subject to risks and uncertainties[13][14] - Risks include safety/tolerability profiles, patient recruitment, clinical trial success, intellectual property, financing, industry trends, and geopolitical factors[14] Contact Information This section provides contact details for investor relations inquiries - Investor Relations contact: Kristen K. Sheppard, Esq., SVP of Investor Relations, investors@centessa.com[15]