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About Centessa Pharmaceuticals Plc
Centessa Pharmaceuticals Plc (Nasdaq: CNTA) is a clinical-stage biopharmaceutical company dedicated to discovering and developing transformational medicines for patients with significant unmet medical needs. Headquartered in Cambridge, Massachusetts, the company employs an innovative asset-centric research and development (R&D) model, supported by a centralized infrastructure and expert management team. This approach enables Centessa to advance a diverse portfolio of highly validated programs efficiently and effectively.
Core Business Areas
Centessa focuses on three primary therapeutic areas:
- Sleep-Wake Disorders: The company is pioneering the development of orexin receptor 2 (OX2R) agonists, including its lead candidate, ORX750, for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and excessive daytime sleepiness (EDS) in neurological, neurodegenerative, and psychiatric conditions. These investigational therapies aim to address the underlying pathophysiology of orexin neuron loss, offering potential first-in-class and best-in-class solutions.
- Immuno-Oncology: Centessa's proprietary LockBody® technology platform is designed to redefine cancer treatment by selectively targeting the tumor microenvironment (TME) while minimizing systemic toxicity. The platform's lead candidate, LB101, is a conditionally tetravalent bispecific monoclonal antibody currently in Phase 1/2a clinical trials.
- Hemophilia: Although the company recently discontinued its SerpinPC program for hemophilia B to prioritize its orexin agonist franchise, this decision underscores Centessa's commitment to focusing resources on high-impact areas.
Innovative R&D Model
Centessa's asset-centric R&D model is a cornerstone of its strategy. Each program operates as a subsidiary, led by specialized teams with deep expertise in their respective fields. This structure allows the company to advance multiple programs simultaneously while leveraging centralized resources for operational efficiency. By focusing on highly validated targets, Centessa aims to de-risk its pipeline and accelerate the development of breakthrough therapies.
Competitive Landscape
Centessa operates in a competitive pharmaceutical landscape, where innovation and differentiation are critical. Its orexin agonist program competes with other emerging therapies targeting sleep-wake disorders, while the LockBody platform positions the company uniquely in the immuno-oncology space. By addressing significant unmet needs and leveraging cutting-edge technologies, Centessa aims to carve out a distinct market position.
Commitment to Patients and Shareholders
Centessa's mission is to deliver medicines that transform patient outcomes and establish new standards of care. The company is also committed to creating long-term value for shareholders by focusing on high-potential assets and maintaining a robust financial position. With a cash runway extending into mid-2027, Centessa is well-positioned to execute its clinical development plans and achieve multiple value-creating milestones.
Key Differentiators
- Orexin Agonist Program: A pipeline of highly potent and selective OX2R agonists, including ORX750 and ORX142, targeting a broad spectrum of sleep-wake and neurological disorders.
- LockBody Technology Platform: A novel approach to immuno-oncology that aims to enhance efficacy while reducing systemic toxicity.
- Asset-Centric R&D Model: A unique structure that combines the agility of focused subsidiaries with the scalability of centralized operations.
Conclusion
Centessa Pharmaceuticals Plc represents a next-generation approach to biopharmaceutical innovation. By combining an asset-centric R&D model with cutting-edge technologies, the company is well-positioned to address some of the most challenging medical conditions. Its focus on transformational medicines underscores its commitment to improving patient outcomes and redefining treatment paradigms.
Centessa Pharmaceuticals (Nasdaq: CNTA) reported its Q4 and full-year 2024 financial results, highlighting progress in its orexin receptor 2 (OX2R) agonist pipeline. The company's lead candidate, ORX750, showed positive Phase 1 results with significant wakefulness increases in sleep-deprived volunteers and is advancing in Phase 2a CRYSTAL-1 study for narcolepsy and idiopathic hypersomnia.
Financial highlights include:
- Cash position of $482.2M as of December 31, 2024, expected to fund operations into mid-2027
- Q4 2024 R&D expenses increased to $60.9M (vs $29.7M in Q4 2023)
- Full-year 2024 net loss of $235.8M (vs $151.1M in 2023)
The company is advancing two additional compounds: ORX142 in IND-enabling studies with clinical data expected in 2025, and ORX489, their most potent OX2R agonist to date, also in IND-enabling studies.
Centessa Pharmaceuticals (Nasdaq: CNTA) announced that data from their Phase 1 clinical trial of ORX750, a novel orexin receptor 2 (OX2R) agonist, will be presented at the American Academy of Neurology (AAN) 2025 Annual Meeting in San Diego.
The presentation will focus on Phase 1 clinical data of ORX750 in acutely sleep-deprived healthy participants. ORX750 is being developed for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH). The drug is currently being evaluated in an ongoing Phase 2a clinical trial called CRYSTAL-1.
The poster presentation will be delivered by Dr. Deborah Hartman, Global Scientific Head of the Orexin Program, on April 5, 2025, at 11:45 AM PT.
Centessa Pharmaceuticals (Nasdaq: CNTA) has announced its management team's participation in four upcoming investor conferences in early 2025. The schedule includes:
- Guggenheim SMID Cap Biotech Conference on February 6, 2025 (Fireside Chat at 1:00 PM ET)
- Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025 (Fireside Chat at 10:40 AM ET)
- TD Cowen 45th Annual Health Care Conference on March 4, 2025 (Fireside Chat at 1:50 PM ET)
- Leerink Partners Global Healthcare Conference on March 11, 2025 (Fireside Chat at 10:00 AM ET)
Live webcasts and archived recordings of these events will be accessible through the "Events and Publications" tab on Centessa's investor relations website.
Centessa Pharmaceuticals (Nasdaq: CNTA) has appointed Stephen Kanes, MD PhD, as Chief Medical Officer. Dr. Kanes, a neuropsychiatrist with over 30 years of experience in neuroscience, clinical psychiatry, and drug development, joins the company as it advances its orexin receptor 2 (OX2R) agonist portfolio.
Dr. Kanes previously served as CMO at Sage Therapeutics (2013-2021), where he led the development of ZULRESSO®, the first approved treatment for Postpartum Depression. He was most recently CEO of EmbarkNeuro and previously held positions at AstraZeneca and the University of Pennsylvania. The appointment comes as Centessa progresses Phase 2a clinical studies of ORX750, targeting sleep-wake, neurological, neurodegenerative and psychiatric disorders.
Centessa Pharmaceuticals (CNTA) reported Q3 2024 financial results and announced positive interim data from its Phase 1 study of ORX750, showing significant increased wakefulness in sleep-deprived volunteers. The company initiated a Phase 2a study for narcolepsy and hypersomnia treatments, with data expected in 2025. Financial highlights include $518.4M in cash and equivalents, R&D expenses of $33.9M, and a net loss of $42.6M. Centessa discontinued SerpinPC development, reallocating approximately $200M savings to expand their OX2R agonist franchise. The company's cash runway extends into mid-2027.
Centessa Pharmaceuticals (Nasdaq: CNTA) has announced its management team's participation in three upcoming investor conferences. The company will attend the Guggenheim Healthcare Innovation Conference in Boston on November 13, 2024, with a fireside chat at 9:00 AM ET, the Jefferies London Healthcare Conference on November 19, 2024, at 1:30 PM GMT, and the 7th Annual Evercore HealthCONx Conference in Miami on December 5, 2024, at 10:00 AM ET. Live webcasts and recordings will be accessible through the company's investor relations website.
Centessa Pharmaceuticals (Nasdaq: CNTA) presented preclinical data for ORX142, a novel orexin receptor 2 (OX2R) agonist, at the 27th Congress of the European Sleep Research Society. The data from non-human primate (NHP) studies support ORX142 as a potential treatment for excessive daytime sleepiness (EDS) in select neurological, neurodegenerative, and psychiatric disorders.
Key findings include:
- ORX142 showed significant activity in promoting wakefulness at very low doses (0.03 mg/kg)
- It potently activated human OX2R with an EC50 of 0.069 nM and >13,000-fold selectivity over human OX1R
- Induced sustained increases in wakefulness, suppressing NREM and REM sleep
- Associated with normal physiological arousal and EEG power spectra signatures of enhanced alertness
ORX142 is currently in IND-enabling studies as Centessa's second OX2R agonist drug candidate.
Centessa Pharmaceuticals (Nasdaq: CNTA) has announced the pricing of an upsized public offering of 15,254,237 American Depositary Shares (ADSs) at $14.75 per ADS. The offering is expected to raise approximately $225 million in gross proceeds. Centessa has also granted underwriters a 30-day option to purchase up to an additional 2,288,135 ADSs. The offering is anticipated to close around September 16, 2024, subject to customary conditions. Goldman Sachs & Co. , Leerink Partners, Evercore ISI, Guggenheim Securities, and BMO Capital Markets are acting as joint book-running managers for the offering. The ADSs are being offered pursuant to a registration statement on Form S-3 filed with the SEC on September 11, 2024.
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, has announced a proposed public offering of $150 million of American Depositary Shares (ADSs). The company plans to grant underwriters a 30-day option to purchase up to an additional $22.5 million of ADSs. Goldman Sachs & Co. , Leerink Partners, Evercore ISI, Guggenheim Securities, and BMO Capital Markets are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there is no guarantee of its completion or final terms. A registration statement on Form S-3 has been filed with the SEC, and a preliminary prospectus supplement will be available.
Centessa Pharmaceuticals (Nasdaq: CNTA) has announced positive interim data from its Phase 1 trial of ORX750, a highly potent and selective orexin receptor 2 (OX2R) agonist, in acutely sleep-deprived healthy volunteers. The 2.5 mg dose of ORX750 restored normative wakefulness with a mean sleep latency of 32 minutes, showing significant improvements compared to placebo. The drug demonstrated a favorable safety and tolerability profile with no observations of common adverse events associated with other OX2R agonists.
Based on these promising results, Centessa plans to rapidly advance ORX750 into Phase 2 studies for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) starting in Q4 2024. The company believes ORX750 has the potential to be a best-in-class treatment for sleep-wake disorders, supporting once-daily oral dosing.
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