On November 13, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported financial results and business highlights for the third quarter ended September 30, 2023 (Press release, Centessa Pharmaceuticals, NOV 13, 2023, View Source [SID1234637531]).
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"We continue to execute and achieve key milestones across our pipeline of potential transformative medicines for patients with unmet needs," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We’re making good progress enrolling our registrational studies for SerpinPC in hemophilia B, with or without inhibitors, and are excited to share new data from the ongoing Phase 2a study of SerpinPC during a poster presentation at ASH (Free ASH Whitepaper) in December. We also continue to advance our novel LockBody technology platform with LB101, a PD-L1xCD47 LockBody, which is in an ongoing Phase 1/2a clinical trial for the treatment of solid tumors."
Dr. Saha continued, "Momentum continues to build with our orexin agonist development program. The preclinical data we recently shared at the World Sleep Congress show that ORX750 is a highly potent and selective novel orexin receptor 2 (OX2R) agonist that closely mimics the function of the endogenous peptide. We believe these data support a potential best-in-class profile for ORX750 for the treatment of narcolepsy and other sleep-wake disorders. We are focused on rapidly moving ORX750 through IND-enabling studies, obtaining IND clearance and initiating clinical development with the goal of sharing clinical proof of concept data in sleep-deprived healthy volunteers in 2024. In addition, we are exploring follow-up molecules for potential expansion opportunities into a range of sleep-wake disorders and broader neurological indications."Recent Highlights
•In October, the Company announced a set of new preclinical data from in vivo and in vitro studies of its investigational, novel OX2R agonist, ORX750, that support a potential best-in-class profile for the treatment of narcolepsy and other sleep-wake disorders. The preclinical data were presented recently at the World Sleep Congress and are also available within a recorded webcast at View Source
•In November, the Company announced that new data from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC, an investigational subcutaneously administered novel inhibitor of activated protein C (APC), for the treatment of hemophilia, has been accepted for a poster presentation at ASH (Free ASH Whitepaper) on December 10, 2023. The presentation will include efficacy and safety data from an additional 52-weeks of continuous treatment with a subcutaneous injection of SerpinPC in subjects with hemophilia.
•In October, the Company announced the dosing of the first subject in its registrational PRESent-3 clinical study of SerpinPC for the treatment of hemophilia B with inhibitors. The Company initiated dosing in its registrational PRESent-2 clinical study of SerpinPC for the treatment of hemophilia B without inhibitors in July.
•In August, the Company announced LB206, a PD-L1xCD3 LockBody, as a development candidate and shared preclinical data which demonstrated single agent regressions of large tumors in a difficult-to-treat mouse xenograft model.
Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC) – The registrational PRESent-2 and PRESent-3 studies are ongoing. Data from Part 5 of the ongoing Phase 2a study accepted for poster presentation at ASH (Free ASH Whitepaper) on December 10, 2023.
•Solid Tumors (LockBody Technology Platform)
◦PD-L1xCD47 LockBody LB101 – Phase 1/2a first-in-human clinical study is ongoing.
◦PD-L1xCD3 LockBody LB206 – LB206 is a development candidate.
•Narcolepsy and Other Sleep-Wake Disorders (ORX750) – The Company is focused on rapidly advancing ORX750 through IND-enabling studies, obtaining IND clearance and initiating clinical development with the goal of sharing clinical proof of concept data in sleep-deprived healthy volunteers in 2024.
Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.
Third Quarter 2023 Financial Results
•Cash, Cash Equivalents and Short-term Investments: $281.3 million as of September 30, 2023, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $28.2 million for the third quarter ended September 30, 2023, compared to $36.7 million for the third quarter ended September 30, 2022.
•General & Administrative Expenses: $12.0 million for the third quarter ended September 30, 2023, compared to $12.3 million for the third quarter ended September 30, 2022.
•Net Loss Attributable to Ordinary Shareholders: $38.6 million for the third quarter ended September 30, 2023, compared to $53.9 million for the third quarter ended September 30, 2022.