BOSTON and LONDON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that its Board of Directors has appointed Mario Alberto Accardi PhD, President and founder of Centessa’s Orexin Program, as Chief Executive Officer (CEO) and member of the Board, effective January 1, 2026. Dr. Accardi will succeed Saurabh Saha MD PhD, who will step down from his position as CEO and a member of the Board, effective January 1, 2026. Dr. Sah ...

Centessa Pharmaceuticals (NasdaqGS:CNTA) FY Conference December 03, 2025 09:35 AM ET Company ParticipantsMario Accardi - CEOUmer Raffat - Senior Managing DirectorUmer RaffatExcited to have Centessa Management with us. I think this is a very exciting time for the company. I think you're also one of the most sought-after guys right now across buy-side as well as on the pharma side. So I'll let you kick things off, Mario.Mario AccardiThank you. Great to be here today. Thank you for the invitation. Super exciti ...

Summary of Centessa Pharmaceuticals FY Conference Call Company Overview - Centessa Pharmaceuticals is a clinical-stage biotech company focused on orexin biology and orexin agonism, particularly in the treatment of sleep disorders such as narcolepsy and idiopathic hypersomnia [2][3] Key Developments - The company recently updated its Phase 2 study results involving approximately 50-55 patients across Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) [2][3] - Centessa is the first company to present a robust dataset demonstrating statistically significant efficacy across all three indications [2][3] Pipeline and Future Studies - The lead asset, ORX750, is currently in Phase 2, with additional molecules ORX142 and ORX489 entering Phase 1 studies in Q1 2026 [3][4] - The company aims to expand beyond rare hypersomnias into neurodegenerative and psychiatric conditions [4] Efficacy Data - In NT1, a second dose of 1.5 mg showed a greater than 20-minute change from baseline in the Maintenance of Wakefulness Test (MWT), with half of the patients showing over 30 minutes improvement [6][7] - For NT2, a 4 mg dose resulted in a greater than 10-minute change from baseline, with the Epworth Sleepiness Scale (ESS) improving from 15-16 to 8 [7][8] - In IH, the initial 2 mg dose demonstrated clinically significant improvements in MWT and other efficacy measures [8] Safety and Tolerability - The drug has shown a favorable safety profile, with no significant adverse events reported, and only one dropout due to a pre-existing condition [31][32] Registration Program - The registration program is set to commence in Q1 2026, with flexibility to initiate across all three indications or staggered based on data from the next 50 patients [27][28] Competitive Landscape - The company believes it has a best-in-class profile based on the totality of evidence, including MWT, ESS, and tolerability metrics [34] - The orexin agonist class is viewed as having significant potential, akin to GLP-1 in the field of neurosciences [37] Intellectual Property - Centessa has developed a strong IP portfolio, with protections extending past 2040, based on unique structural biology technology [40] Conclusion - Centessa Pharmaceuticals is positioned to make significant advancements in the treatment of sleep disorders and potentially other neuropsychiatric conditions, with promising data from its lead asset and a robust pipeline [42]

Core Insights - 5AM Venture Management reduced its stake in Centessa Pharmaceuticals by 150,000 shares, now holding 680,945 shares, but the overall position value increased due to an 80% rise in stock price last quarter [2][6] - Centessa's stock price reached $29.03, reflecting a 65% increase over the past year, significantly outperforming the S&P 500's 14% gain in the same period [3][4] - The company has a market capitalization of $4.2 billion and reported a revenue of $15 million with a net loss of $242.7 million for the trailing twelve months [4] Company Overview - Centessa Pharmaceuticals is a UK-based biotechnology company focused on developing clinical-stage biopharmaceutical products for rare and serious diseases, including Lixivaptan for autosomal dominant polycystic kidney disease and SerpinPC for hemophilia [5] - The company is advancing a pipeline that targets conditions such as hemophilia, pulmonary arterial hypertension, and autoimmune diseases, serving a global patient base [5] Financial Performance - In the third quarter, Centessa reported a net loss of $54.9 million and ended the quarter with $349 million in cash and equivalents, sufficient to fund operations into mid-2027 [8] - The company announced a $250 million public offering at $21.50 per American Depositary Share (ADS) to strengthen its balance sheet [8] Market Position and Future Outlook - The decision by 5AM Venture Management to trim its position rather than exit indicates ongoing confidence in Centessa's potential, particularly in light of its promising clinical data and pipeline [6][9] - Centessa's orexin agonist platform is a key driver, with Phase 2a data showing significant improvements in wakefulness measures, and plans for a registrational program set to begin in Q1 2026 [8]

Summary of Centessa Pharmaceuticals Conference Call Company Overview - Centessa Pharmaceuticals is a clinical-stage biotech company focused on developing orexin agonists for treating excessive daytime sleepiness disorders, particularly narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) [3][4][5] Core Insights and Arguments - **Orexin Agonists**: The company is developing a novel class of drugs targeting the orexin system, which is crucial for regulating sleep and wakefulness. The loss of orexin leads to debilitating symptoms in narcolepsy patients [3][4] - **Clinical Data**: Recent phase two study results showed significant efficacy of their lead drug, ORX750, across all three indications. The data indicated a potential best-in-class profile, particularly in NT1 and NT2 [4][6][10] - **Efficacy Metrics**: In NT1, 50% of patients achieved a mean wakefulness time (MWT) of over 30 minutes at a low dose of 1.5 mg. The Epworth Sleepiness Scale (ESS) showed a reduction of 13 points, indicating substantial improvement in patient-reported outcomes [12][13] - **Safety Profile**: The drug demonstrated a clean safety profile with no serious adverse events reported. Visual disturbances were mild and transient, not affecting the therapeutic index [20][30] - **Pharmacokinetics**: ORX750 has a flat pharmacokinetic (PK) curve, allowing for once-daily (QD) dosing, which is advantageous for patient compliance and efficacy [21][22] Market Opportunity - The combined market for NT1, NT2, and IH is estimated at $18 billion, with a prevalence of approximately 620,000 patients. There is significant unmet clinical need, as current treatments do not adequately address the symptoms for many patients [34][38] Future Plans - Centessa plans to continue its phase two studies and initiate a registration program in Q1 2026. The company has raised $270 million to support these efforts [5][33] - The company is also developing additional candidates, ORX142 and ORX489, which are expected to enter patient studies in Q1 2026 [34][37] Additional Considerations - **Dosing Flexibility**: The potential for split dosing is being evaluated to enhance symptom control for patients with varying schedules [23][24] - **Competitive Landscape**: Centessa aims to differentiate itself from competitors by focusing on the unique efficacy and tolerability of its orexin agonists [27][28] - **Long-term Vision**: The company sees orexin agonists as having broader applications beyond narcolepsy, potentially impacting various neurodegenerative disorders and cognitive functions [35] Financial Position - Centessa's balance sheet shows a proforma cash position of $620 million, providing a solid runway for ongoing and future clinical programs [39]

Core Viewpoint - Nxera Pharma is undergoing a focused restructuring to concentrate investments on high-value programs and reduce operating expenses, aiming for net sales of ≥JPY50 billion and an operating profit margin of ≥30% by 2030 [1][5] Restructuring Objectives - The restructuring aims to prioritize high-probability, high-return programs and streamline operations to enhance efficiency and accelerate program progression [5][6] - A portfolio review has identified non-priority programs for potential partnership or termination, focusing on next-generation therapies for obesity and metabolic disorders [6][12] Financial Strategy - Nxera plans to reduce cash R&D expenditure by approximately JPY3.5 billion in FY2026 and expects a minimum of JPY1.0 billion in year-on-year savings [6][11] - The company maintains a strong cash position with current cash and liquid investments of JPY30.9 billion, allowing flexibility in executing its strategy [6][11] Leadership Changes - Dr. Patrick Foerch has been appointed as Chief Scientific Officer and President of Nxera Pharma UK, bringing significant experience to enhance R&D focus [5][9] - The executive team will be reduced from ten to seven members by March 2026, and a workforce reduction of approximately 15% will occur across Japan and UK operations [6][11] R&D Focus - Nxera will leverage its NxWave™ platform, utilizing AI technology to enhance drug discovery and development, particularly in GPCR-targeted programs [6][12] - The company has an extensive pipeline of over 30 active programs, with several partnered programs progressing through clinical development [12]

Core Insights - Centessa Pharmaceuticals reported significant progress in its OX2R agonist program, particularly with ORX750, which shows potential as a best-in-class treatment for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) [2][5][9] - The company plans to initiate a registrational program for ORX750 in Q1 2026, supported by promising Phase 2a data demonstrating statistically significant improvements in key efficacy measures [2][5][14] OX2R Agonist Program Updates - ORX750 achieved statistically significant, clinically meaningful, and dose-dependent results in the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS), and Weekly Cataplexy Rate (WCR) across initial cohorts [2][6][9] - The Phase 2a study included 55 participants, with ORX750 showing a favorable safety profile and transient mild to moderate treatment-emergent adverse events [4][9] - ORX142, another candidate in the program, demonstrated a highly differentiated profile in Phase 1 studies, with plans for patient studies to begin in Q1 2026 [2][10][14] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $349.0 million, expected to fund operations into mid-2027 [19] - Research and development expenses for Q3 2025 were $41.6 million, an increase from $33.9 million in Q3 2024, while general and administrative expenses were relatively stable at $12.2 million [19][23] - The net loss for Q3 2025 was $54.9 million, compared to a net loss of $42.6 million in the same period of the previous year [19][23]

Group 1 - Centessa Pharmaceuticals (NASDAQ:CNTA) is recognized as a promising stock with significant upside potential, with a Buy rating and a price target of $39.00 set by LifeSci Capital analyst Francois Brisebois [1][3] - In Q2 2025, Centessa reported cash and investments totaling $404.1 million, which is expected to sustain operations until mid-2027. R&D expenses rose to $42.7 million from $32.8 million in Q2 2024, resulting in a net loss of $50.3 million compared to a net loss of $43.8 million in the previous year [2] - The company is advancing its orexin receptor 2 (OX2R) agonist pipeline, with its lead candidate ORX750 in a Phase 2a study for narcolepsy and idiopathic hypersomnia, and data from this study is expected within the year [3] Group 2 - Centessa Pharmaceuticals is a clinical-stage pharmaceutical company focused on discovering, developing, and delivering medicines [4]

Core Insights - Centessa Pharmaceuticals is advancing a potential best-in-class orexin receptor 2 (OX2R) agonist pipeline, with key data readouts expected in 2025 [2][3] - The company aims to redefine the standard of care for sleep-wake disorders and related comorbidities through its innovative drug candidates [2][3] Pipeline and Milestones - ORX750 is in an adaptive Phase 2a study for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH), with data expected this year [6][7] - ORX142 has initiated a Phase 1 clinical trial, with results from acutely sleep-deprived healthy volunteers anticipated in 2025 [6][7] - ORX489 is currently in IND-enabling studies targeting neuropsychiatric disorders [6][7] Financial Performance - As of June 30, 2025, the company reported cash, cash equivalents, and investments totaling $404.1 million, expected to fund operations into mid-2027 [12] - Research and Development (R&D) expenses for Q2 2025 were $42.7 million, up from $32.8 million in Q2 2024 [12] - The net loss for Q2 2025 was $50.3 million, compared to a net loss of $43.8 million in Q2 2024 [12][14]

Pipeline and Milestones - Centessa Pharmaceuticals 专注于发现和开发针对患者的变革性药物[7, 50]。 - 公司预计在 2025 年实现 OX2R 激动剂管线的多个临床里程碑[7, 50]。 - ORX750 的 2a 期临床数据预计在 2025 年公布，针对嗜睡症 I 型 (NT1)、嗜睡症 II 型 (NT2) 和特发性嗜睡症 (IH) 患者[10]。 - ORX142 在急性睡眠剥夺的健康志愿者中的临床数据预计在 2025 年公布[10]。 - ORX489 正在推进 IND (新药研究申请) 支持性研究[10, 49]。 ORX750 and Market Opportunity - ORX750 是一种高效、选择性的 OX2R 激动剂，有潜力重新定义睡眠-觉醒障碍患者的标准治疗方法[21]。 - NT1、NT2 和 IH 代表着庞大的潜在患者群体，美国约有 62 万名患者[23, 25]。 - 在美国，大约有 27 万名 NT1、NT2 和 IH 患者被诊断和治疗[23, 25]。 ORX750 Clinical Data - 在一项研究中，2.5 毫克、3.5 毫克和 5.0 毫克剂量的 ORX750 在急性睡眠剥夺的健康志愿者中均产生了超过 30 分钟的 MWT LS 平均睡眠潜伏期[29]。 - ORX750 在 KSS 评分中显示出剂量依赖性的显著改善，与安慰剂相比，剂量 ≥ 2.5 毫克时具有显著性[32]。 - ORX750 显示出良好的安全性和耐受性[38]。