On March 30, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported recent business progress and financial results for the fourth quarter and full-year ended December 31, 2022 (Press release, Centessa Pharmaceuticals, MAR 30, 2023, View Source [SID1234629584]).

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"Centessa made substantial progress in 2022, highlighted by the achievement of important milestones toward our goal of bringing transformational medicines to patients," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We advanced key clinical and development objectives, prioritized our pipeline, and continued to manage our resources with timely data and science-driven decisions, consistent with our asset-centric model. As a result, we entered 2023 with solid momentum on our pipeline programs that we believe have the greatest potential to transform the lives of patients with unmet medical needs."

Dr. Saha continued, "Our most advanced product candidate is SerpinPC, a subcutaneously administered novel inhibitor of activated protein C (APC), which is in a registrational program for the treatment of hemophilia B. In December 2022, we presented data from a Phase 2a study showing SerpinPC to have a favorable safety and tolerability profile, as well as evidence of sustained efficacy in patients with hemophilia as measured by a reduction in the all-bleeds annualized bleeding rates (ABR). We believe these data support the potential for SerpinPC to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for individuals with hemophilia, subject to regulatory review and approval. We are excited to be enrolling subjects in PRESent-5, an observational feeder study, and are preparing to begin dosing in the PRESent-2 and PRESent-3 interventional studies this year."

"We are also very pleased to announce the dosing of the first subject in the Phase 1/2a clinical trial of LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody from our LockBody technology platform for the treatment of solid tumors. LB101 is the first LockBody candidate we have brought to the clinic, and we look to this study to provide valuable insights regarding the safety and tolerability profile of LB101, as well as the performance of our LockBody platform in a clinical setting. Following LB101 is our second LockBody program targeting PD-L1xCD3, for which we expect to name a product candidate this year," said Dr. Saha.

"Lastly, our team is excited to be advancing ORX750, an orally administered, selective orexin receptor-2 (OX2R) agonist, as our product candidate for the treatment of narcolepsy with potential expansion into other sleep disorders. We believe ORX750 has the potential to be a best-in-class therapy for the treatment of narcolepsy and look forward to sharing the candidate profile at a scientific meeting later this year," said Dr. Saha.

Dr. Saha concluded, "We are thrilled with the momentum at Centessa and believe we are well positioned with a cash runway into 2026 to support the potential for multiple clinical readouts across our pipeline."

Recent Highlights
•In January 2023, the Company announced clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human clinical trial of LB101 for the treatment of solid tumors. The first subject was dosed in March 2023.
•In December 2022 and February 2023, the Company presented data from the open-label extension (OLE) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia during oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), respectively. 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 ABRs. There were no thromboembolic events and no treatment-related sustained elevations of D-dimer observed across the Phase 2a study, to date. D-dimer is a sensitive measure of excessive thrombin generation.
•In December 2022, the Company began enrolling subjects into PRESent-5, an observational study in the SerpinPC registrational program for the treatment of hemophilia B.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC)- The registrational program for hemophilia B is ongoing. PRESent-5, an observational study, is enrolling subjects and the Company expects to begin dosing in PRESent-2 and PRESent-3 later this year. In addition, the Company expects 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.
–PD-L1xCD3 LockBody (Undisclosed)- The Company expects to name a product candidate and share preclinical data this year.
•Narcolepsy and Other Sleep Disorders (ORX750)- ORX750 was named as a product candidate and is currently in preclinical development and undergoing IND-enabling activities. The Company expects to share preclinical data at a scientific meeting later this year.

The Company expects to provide further updates on preclinical programs, including MGX292, as they advance towards clinical studies.
Fourth Quarter and Full-Year 2022 Financial Results
•Cash and Cash Equivalents: $393.6 million as of December 31, 2022, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $27.8 million for the fourth quarter ended December 31, 2022, compared to $41.5 million for the fourth quarter ended December 31, 2021, and $155.1 million for the full-year 2022 compared to $95.7 million for the period from January 30, 2021 through December 31, 2021.
•General & Administrative Expenses: $13.8 million for the fourth quarter ended December 31, 2022, compared to $13.0 million the fourth quarter ended December 31, 2021, and $55.2 million for the full-year 2022 compared to $42.9 million for the period from January 30, 2021 through December 31, 2021.
•Net Loss Attributable to Ordinary Shareholders: $43.2 million for the fourth quarter ended December 31, 2022, compared to $60.8 million for the fourth quarter ended December 31, 2021, and $216.2 million for the full-year 2022 compared to $381.1 million for the period from January 30, 2021 through December 31, 2021.