Earnings release
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CENTESSA TM PHARMACEUTICALS Centessa Pharmaceuticals Announces Third Quarter 2021 Financial Results and Business Updates November 15 , 2021 ~ Announced positive topline data from proof - of - concept study of SerpinPC in severe hemophilia A and B subjects not on prophylaxis , demonstrating 88 % reduction in median Annualized Bleeding Rate ( " ABR " ) for all bleeds and 94 % reduction in median ABR for spontaneous joint bleeds in highest dose tested - ~ Announced proof - of - mechanism data from first three PiMZ subjects dosed in Phase 1 Part B study evaluating ZF874 for the treatment of Alpha - 1 Antitrypsin Deficiency ( " AATD " ) ~ - Announced collaboration between Orexia Therapeutics and Schrödinger to discover novel orexin receptor agonists - - ~ Successful entry into a $ 300 million financing facility with Oberland Capital to enable further scale - up of development activities and pursuit of strategic business development opportunities ~ ~ Centessa leadership team strengthened through appointment of David Grainger , PhD , a leading biotech entrepreneur , as Chief Innovation Officer ~ Programs across Centessa portfolio continue to progress , with multiple INDS / CTAs expected in 2022 ~ - BOSTON and LONDON , Nov. 15 , 2021 ( GLOBE NEWSWIRE ) -- Centessa Pharmaceuticals plc ( Nasdaq : CNTA ) , a clinical - stage company ( " Centessa " or " Company " ) leveraging its innovative asset - centric business model to discover , develop and ultimately deliver impactful medicines to patients , today reported financial results for the quarter ended September 30 , 2021 , and provided a review of recent accomplishments and anticipated upcoming milestones . " This has been a very productive quarter , as we continued to build our team and shared the first two data updates since the formation of Centessa earlier this year . We announced positive topline data from our proof - of - concept study evaluating SerpinPC in severe hemophilia subjects and seek to move this program into registrational studies in 2022. More recently , in our Phase 1 Part B study evaluating ZF874 for the treatment of AATD , we reported encouraging proof - of - mechanism data from three initial PiMZ subjects and plan to provide an update in 2022 once we have data on PIZZ subjects at multiple doses . In addition to these exciting early results , we are continuing to progress programs across our entire portfolio , " said Saurabh Saha , MD , PhD , Chief Executive Officer of Centessa . Dr. Saha continued , “ Our recent $ 300 million financing facility with Oberland Capital will provide additional financial flexibility to help further advance our portfolio and better enable the Company to pursue strategic business development opportunities . " Recent Business Highlights • Announced Positive Topline Data from Proof - of - Concept Study of SerpinPC in Severe Hemophilia A and B Subjects Not on Prophylaxis : In September , the Company , together with subsidiary ApcinteX Limited ( " ApcinteX " ) , announced positive topline results from the Phase 2a part of AP - 0101 , the six - month repeat dose portion of the ongoing first - in - human proof - of - concept study evaluating Serpin PC in severe hemophilia A and B subjects . In the highest dose cohort , SerpinPC reduced the self - reported all bleeds Annualized Bleeding Rate ( " ABR " ) by 88 % during the last 12 weeks of treatment ( pre - specified primary assessment period ) as compared to the all bleeds ABR prospectively measured during the pre - exposure observation period . In this cohort , five out of eight subjects had zero or one bleed during the 12 - week pre - specified primary assessment period and self - reported spontaneous joint bleeds ABR was reduced by 94 % . SerpinPC was well - tolerated with no sustained elevations in D - dimer . • Demonstrated Proof - of - Mechanism in First Three PiMZ Subjects Dosed in Part B of Phase 1 Study Evaluating ZF874 : In November , the Company , together with subsidiary Z Factor Limited ( " Z Factor " ) , announced proof - of - mechanism data from the first three PiMZ subjects dosed in the ongoing repeat dose Phase 1 Part B study of ZF874 in subjects carrying at least one Z - mutated alpha - 1 - antitrypsin allele ( PiXZ ) . These are the first clinical data that suggest a pharmacological chaperone may be able to sufficiently increase functional Z - A1AT to levels greater than 11 micromolar in individuals with the PiZZ genotype , levels that have been the basis for approval of the existing A1AT augmentation therapies . Because one subject showed a delayed , reversible increase in ALT and AST , the Company will be exploring lower doses and different dosing regimens . The Company is taking steps to increase enrollment by adding sites in the United Kingdom and intends to expand the study to the European Union . • Secured $ 300 Million Financing Facility with Oberland Capital Management LLC : In October , the Company entered into a $ 300 million financing facility ( " Oberland Agreement " ) . Under the terms of the agreement , Oberland Capital Management LLC ( " Oberland Capital " ) will purchase up to $ 300 million of 6 - year , interest - only , senior secured notes from the Company , including $ 75 million funded in October , a total of $ 125 million available within 24 months at the option of the Company , and $ 100 million available to fund M & A , in - licensing , or other strategic transactions , at the option of the