On August 10, 2022 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company with a Research & Development ("R&D") innovation engine that aims to discover, develop, and ultimately deliver impactful medicines to patients, reported financial results and business highlights for the second quarter ended June 30, 2022, and provided a program update for ZF874 for Alpha-1 Antitrypsin Deficiency (AATD) (Press release, Centessa Pharmaceuticals, AUG 10, 2022, View Source [SID1234618007]).
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"We continue to rapidly advance our robust rare diseases and immuno-oncology pipeline and set the stage for a number of important company milestones which we believe will help us address the needs of several patient populations," said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa. "We remain on track to initiate registrational studies for SerpinPC for the treatment of Hemophilia B in the second half of this year and look forward to initiating clinical trials with LB101 (PD-L1xCD47) for solid tumors, after our planned IND filing late this year. Beyond these, we are continuing to advance our earlier stage programs and expect multiple clinical proof of concept readouts across our pipeline over the next two years. Importantly, with a world-class R&D team and cash runway that extends into 2026, we are exceptionally well positioned to deliver on these goals."
ZF874 Program Update
The Company reported its decision to discontinue development of ZF874 following a recent report of an adverse event (AE) involving elevated liver enzymes (AST/ALT) in a PiMZ subject dosed with 5 mg/kg BID of ZF874 in the Phase 1 study. ZF874, a pharmacological chaperone designed to rescue the folding of the Z variant of alpha-1-antitrypsin (A1AT), was in a Phase 1 study for the treatment of AATD. As previously reported in November 2021, elevated liver enzymes were observed in a subject dosed with 15 mg/kg BID of ZF874 in the first cohort of patients within Part B of the Phase 1 study. Based on the results observed to date, the Company concluded that ZF874 was unlikely to achieve the desired target product profile.
Dr. Saha concluded, "While this is disappointing news for the A1AT patient community, we continue to believe that the pharmacological chaperone approach has the potential to address both the lung and liver manifestations of AATD. We are analyzing data from the Phase 1 study to help inform potential future development plans for our back-up compounds."
Recent Highlights
In July, the Company appointed Dr. Mathias Hukkelhoven, former Senior Vice President, Global Regulatory, Safety & Biometrics at Bristol Myers Squibb (BMS), to its Board of Directors. The Company also announced the addition of Dr. Harris L. Rotman as Senior Vice President of Regulatory Affairs.
In June, the Company presented the first preclinical data for LB101 (PD-L1xCD47) showing that single-agent LB101 delivered systemically led to meaningful tumor regressions and was well tolerated. The Company expects to initiate clinical trials with LB101 following its planned Investigational New Drug (IND) application submission late this year. Additional LockBody molecules, such as LB201 (PD-L1xCD3), are being progressed toward candidate selection expected early 2023.
Anticipated Upcoming Program Milestones
2H 2022: SerpinPC – Initiate registrational studies in Hemophilia B.
Q4 2022: SerpinPC – Two-year follow-up data from Phase2a open label extension study.
Q4 2022: LB101 – IND submission late this year.
The Company continues to progress its earlier stage programs and where applicable, expects to provide updates as they enter clinical studies.
Second Quarter 2022 Financial Results
Cash and Cash Equivalents: $484.2 million as of June 30, 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: $53.7 million for the quarter ended June 30, 2022, compared to $18.1 million for the quarter ended June 30, 2021.
General & Administrative Expenses: $14.8 million for the quarter ended June 30, 2022, compared to $11.8 million the quarter ended June 30, 2021.
Net Loss Attributable to Ordinary Shareholders: $64.7 million for the quarter ended June 30, 2022, compared to $41.5 million for the quarter ended June 30, 2021.