On May 12, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported its financial results and business highlights for the first quarter ended March 31, 2023 (Press release, Centessa Pharmaceuticals, MAY 12, 2023, View Source [SID1234631591]).
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"Centessa continued strong clinical momentum in the first quarter with multiple clinical milestones planned for the year," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We are advancing the registration program for SerpinPC for the treatment of hemophilia B; dosing subjects in the ongoing Phase 1/2a clinical trial for LB101, our first LockBody molecule for the treatment of solid tumors; and, conducting IND enabling activities for our newest product candidate, ORX750, for the treatment of narcolepsy with potential expansion into other sleep disorders."
Dr. Saha continued, "We expect to rapidly drive our pipeline forward and anticipate a lower cash burn rate for the remainder of the year. We believe we are well positioned with a cash runway into 2026 to support multiple clinical readouts across our programs."
Recent Highlights
•In March, the first subject was dosed in the Phase 1/2a first-in-human clinical trial of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody from the Company’s LockBody technology platform for the treatment of solid tumors. LB101 is the Company’s first
LockBody candidate to enter the clinic. The Company announced clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate the Phase 1/2a trial in January.
•In March, the Company announced ORX750, an orally administered, selective orexin receptor 2 (OX2R) agonist, as a product candidate for the treatment of narcolepsy with potential expansion into other sleep disorders.
•In February, the Company presented additional data from the open-label extension (OLE) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia during an oral presentation at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD). With total exposure of over 40 patient-years across multiple dosing regimens, the Phase 2a data showed a continued favorable safety and tolerability profile for SerpinPC, as well as evidence of sustained efficacy, as measured by a reduction in the all-bleeds annualized bleeding rates (ABR). To date, no thromboembolic events and no treatment-related sustained elevations of D-dimer have been observed across the Phase 2a study.
Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC)- The registrational program for hemophilia B is ongoing. PRESent-5, an observational feeder study, is enrolling subjects and the Company expects to begin dosing in the PRESent-2 and PRESent-3 studies later this year. In addition, the Company plans to share data from Part 5 of the OLE of the Phase 2a study of SerpinPC, subject to completion, at a scientific meeting this year.
•Solid Tumors (PD-L1xCD47 LockBody LB101)- The Phase 1/2a first-in-human clinical study is ongoing.
•Narcolepsy and Other Sleep Disorders (ORX750)- ORX750 is in preclinical development and undergoing IND-enabling activities. The Company plans to share preclinical data at a scientific meeting later this year.
The Company has multiple earlier-stage programs, including MGX292 and other LockBody molecules such as PD-L1xCD3, and discovery-stage programs. Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.
First Quarter 2023 Financial Results
•Cash, Cash Equivalents and Short-term Investments: $346.2 million as of March 31, 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: $32.8 million for the first quarter ended March 31, 2023, compared to $36.9 million for the first quarter ended March 31, 2022.
•General & Administrative Expenses: $16.1 million for the first quarter ended March 31, 2023, compared to $14.4 million the first quarter ended March 31, 2022.
•Net Loss Attributable to Ordinary Shareholders: $50.7 million for the first quarter ended March 31, 2023, compared to $54.5 million for the first quarter ended March 31, 2022.