CNTA Centessa Pharmaceuticals plc

8.99
+0.12  (+1%)
Previous Close 8.87
Open 8.8
52 Week Low 8.47
52 Week High 26.9
Market Cap $808,209,235
Shares 89,900,916
Float 88,178,513
Enterprise Value $757,735,234
Volume 357,100
Av. Daily Volume 194,388
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Upcoming Catalysts

Drug Stage Catalyst Date
SerpinPC (ApcinteX)
Hemophilia A
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
Lixivaptan - (ALERT)
Kidney Disease
Phase 3
Phase 3
Phase 3 data reported that ALT elevation peaked between 1.8x and 3.5x ULN and did not return to below ULN until 23 to 140 days after tolvaptan use was discontinued. Four patients were successfully titrated to a maintenance dose of lixivaptan of either 100 mg BID or 200 mg BID, noted December 14, 2021.
Lixivaptan - (ACTION)
Autosomal dominant polycystic kidney disease (ADPKD)
Phase 3
Phase 3
Phase 3 trial initiated December 14, 2021, first patient to be dosed in 1Q 2022. NDA planned.
ZF874 - (ZF-0101)
Alpha-1-antitrypsin deficiency (AATD)
Phase 1
Phase 1
Phase 1 update noted the first demonstration that a pharmacological chaperone can provide sufficient functional Z-A1AT increases to potentially achieve greater than 11 micromolar levels in individuals with PiZZ genotype. One subject with two-fold higher exposure experienced reversible ALT and AST elevations, reported November 1, 2021. Phase 2 trial to commence in 2Q 2022.
Imgatuzumab (I-PACE)
Cutaneous squamous cell carcinoma (CSCC)
Phase 2
Phase 2
Phase 2 trial has been initiated.

Latest News

  1. ~ Initiation of registrational Phase 3 ACTION clinical study with lixivaptan is an important milestone to bring this potential new treatment option to ADPKD patients ~

    ~ All four subjects in the ALERT Study who previously discontinued JYNARQUE® due to liver toxicity successfully titrated to maintenance dose of lixivaptan; no subjects met pre-specified stopping criteria; no cases of suspected drug-induced liver injury (DILI) ~

    ~ Issuance of new patent would cover use of lixivaptan in ADPKD through at least 2038 ~

    BOSTON and LONDON, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc ("Company") (NASDAQ:CNTA), together with subsidiary Palladio Biosciences, Inc. ("Palladio"), today announced the initiation of active recruitment…

    ~ Initiation of registrational Phase 3 ACTION clinical study with lixivaptan is an important milestone to bring this potential new treatment option to ADPKD patients ~

    ~ All four subjects in the ALERT Study who previously discontinued JYNARQUE® due to liver toxicity successfully titrated to maintenance dose of lixivaptan; no subjects met pre-specified stopping criteria; no cases of suspected drug-induced liver injury (DILI) ~

    ~ Issuance of new patent would cover use of lixivaptan in ADPKD through at least 2038 ~

    BOSTON and LONDON, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc ("Company") (NASDAQ:CNTA), together with subsidiary Palladio Biosciences, Inc. ("Palladio"), today announced the initiation of active recruitment of the global ACTION Study, a pivotal Phase 3 clinical trial evaluating lixivaptan as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Additionally, the Company reported initial safety data from four subjects who participated in the ongoing open-label ALERT Study of ADPKD subjects who previously discontinued JYNARQUE® (tolvaptan) due to liver toxicity and announced the Notice of Allowance for a U.S. Patent application covering use of lixivaptan in ADPKD.

    "Patients with ADPKD need alternative treatment options to the currently approved therapy, which is associated with a Risk Evaluation and Mitigation Strategies (REMS) program due to its side effect profile. I have been encouraged by the pharmacodynamic and tolerability data generated to date with lixivaptan and look forward to seeing the benefit and safety data from the upcoming pivotal ACTION Study," said Vicente Torres, MD, PhD, Professor of Medicine, Mayo Clinic and Chairman of the Steering Committee and Principal Investigator of the ACTION Study.

    "We are thrilled to begin the registrational ACTION Study so we can further evaluate lixivaptan's potential as a new treatment option in the broader ADPKD patient population," said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa. "Furthermore, the initial safety data from the ALERT Study in subjects who have stopped JYNARQUE due to liver toxicity continues to support the differentiated safety and tolerability profile of lixivaptan. In addition, the allowed claims addressed in the recently issued Notice of Allowance from the U.S. Patent & Trademark Office should provide patent protection for the covered use of lixivaptan in ADPKD treatment in the U.S. to at least 2038."

    "The initial safety data we shared today from the ALERT Study is similar to the case study we previously reported from the Mayo Clinic and provides additional evidence of lixivaptan's tolerability profile, especially in a group of ADPKD subjects who had previous liver chemistry abnormalities while taking tolvaptan," said Neil Shusterman, MD, Chief Medical Officer of Palladio. "We look forward to bringing this potential new treatment option to ADPKD patients."

    ACTION Study Initiation

    Recruitment has commenced in the global Phase 3 ACTION Study which consists of a two-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm, open-label phase (Part 2). The study will evaluate the benefit and safety of lixivaptan that has been titrated to a maximum tolerated dose between 100-200 mg BID in subjects with ADPKD and a Mayo Clinic MRI imaging classification of 1C, 1D or 1E and an estimated glomerular filtration rate (eGFR) ≥25 and ≤90 mL/min/1.73 m2.

    The primary analysis of the ACTION Study will be performed at the end of Part 1 of the trial, which will have a 2:1 randomization (lixivaptan:placebo) and is designed to assess lixivaptan in slowing the decline in renal function as measured at 52 weeks by the difference in eGFR between the lixivaptan-treated and placebo-treated subjects. Final efficacy measurements at the end of the double-blind period will be conducted while the subject is off study drug over three successive clinic visits. The sample size of the study will be up to 1,350 subjects to provide 90% power to the primary analysis, aiming to detect a 1.4 mL/min/1.73 m2 eGFR difference between lixivaptan-treated and placebo-treated subjects. Thirteen clinical sites have been initiated and the trial is ultimately expected to enroll subjects across more than 200 sites in more than 20 countries. As previously disclosed, the Company expects to dose the first subject in the ACTION Study by the first quarter of 2022.

    All subjects successfully completing Part 1 are expected to continue into Part 2 of the study and will be treated with lixivaptan for an additional 54-56 weeks to further assess the sustainability of the potential benefit on eGFR change over a two-year period. Consistent with Part 1, updated efficacy measurements will be conducted off study drug. Both parts of the study will contribute to further establishing the safety profile of lixivaptan. An independent data monitoring committee will periodically review all safety data including the liver chemistry data for all subjects throughout the study. The Company anticipates completing enrollment in 2H 2023 and, pending positive data, plans to submit a New Drug Application (NDA) after completion of the one-year double-blind portion of the study (Part 1).

    ALERT Study Update

    The Company also reported initial safety data from the ongoing open-label ALERT Study of ADPKD subjects who previously discontinued JYNARQUE® (tolvaptan) due to liver toxicity. The ALERT Study is designed to assess liver and non-liver safety in subjects who previously experienced liver chemistry test abnormalities that met the criteria for likely drug-induced liver injury (DILI) while being treated with tolvaptan and who permanently discontinued the drug. Subjects in the ALERT Study undergo up to 8 weeks of screening followed by a three-week baseline measurement period and then a three- to six-week titration phase with lixivaptan, with weekly liver chemistry test monitoring during the baseline and titration phases. During the maintenance phase, liver chemistry tests are obtained every four weeks. The primary outcome measure in the study is the proportion of subjects who develop alanine aminotransferase (ALT) levels >3x ULN adjudicated to be related to lixivaptan resulting in discontinuation of the study drug.

    To date, ten subjects have entered screening, five failed screening, and one failed the baseline measurement period. The four subjects who enrolled in the study had cases of DILI while being treated with tolvaptan for ADPKD and had ALT elevations that peaked between 1.8x and 3.5x ULN and did not return to below ULN until 23 to 140 days after tolvaptan use was discontinued. Each of these subjects was successfully titrated to a maintenance dose of lixivaptan of either 100 mg BID (one subject) or 200 mg BID (three subjects) and entered the maintenance phase of the study.

    As of the most recent data cutoff (December 3, 2021), three out of four subjects remain on lixivaptan with the longest treatment duration being 366 days, and the remaining subjects at 174 days and 172 days on treatment. One subject successfully titrated to 200 mg BID lixivaptan but withdrew consent after 93 days of dosing. No subjects have had clinically meaningful ALT elevations attributed to lixivaptan and no subjects met the pre-specified stopping criteria of an ALT level >3x ULN.

    The ALERT Study remains open for enrollment of subjects who have had a confirmed case of DILI while being treated with tolvaptan. Most subjects who stop treatment with tolvaptan due to liver toxicity are also eligible for enrollment in the ACTION Study, which is now the primary focus of the Company's recruitment efforts.     

    Notice of Allowance for Key Lixivaptan U.S. Patent Application

    On December 3, 2021, the U.S. Patent and Trademark Office issued a Notice of Allowance for Palladio's patent application entitled "Formulations of Lixivaptan for the Treatment of Polycystic Disease," which has claims drawn to using a divided dose regimen of lixivaptan in treating ADPKD. The anticipated patent term would expire June 8, 2038, before consideration of any applicable patent term extensions or adjustments.

    About Centessa Pharmaceuticals

    Centessa Pharmaceuticals plc ("Centessa") aims to bring impactful new medicines to patients by combining the strengths of an asset-centric model with the benefits of scale and diversification typical of larger R&D organizations. The asset-centric model refers to a highly specialized, singular-focused company that is led by a team of well-recognized subject matter experts. Centessa's asset-centric companies' programs range from discovery-stage to late-stage development and include diverse therapeutic areas such as oncology, hematology, immunology/inflammation, neuroscience, hepatology, pulmonology and nephrology. For more information, visit www.centessa.com.

    About Palladio Biosciences

    Palladio Biosciences, Inc. ("Palladio") was created with the goal of developing transformative medicines for rare diseases of the kidney. Palladio is actively investigating the potential of its lead product candidate, lixivaptan, in patients with autosomal dominant polycystic kidney disease (ADPKD).

    About Lixivaptan

    Lixivaptan is an investigational, oral, nonpeptide selective vasopressin V2 receptor antagonist in development for the potential treatment of ADPKD. The development program is designed to show that lixivaptan can slow the decline in renal function that is typically observed in ADPKD patients while avoiding the liver safety issues associated with JYNARQUE®, a form of branded tolvaptan indicated for ADPKD, which is the only drug currently approved for ADPKD. Lixivaptan has been granted Orphan Drug Designation from the FDA. 

    About the ACTION Study

    The ACTION Study is an ongoing two-arm Phase 3 pivotal trial consisting of a double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm open-label phase (Part 2) to assess the efficacy and safety of lixivaptan in subjects with ADPKD.

    In Part 1, all subjects will receive placebo and all subjects will receive lixivaptan to establish dosing. Up to 1,350 subjects will be randomized 2:1 to receive lixivaptan or placebo. After 52 weeks of randomized treatment, the administration of study drug will be paused, and final eGFR assessments for Part 1 will be obtained during three follow-up visits starting over a period of 28 days.

    All subjects completing Part 1 are expected to continue into Part 2 of the study and be treated with the active drug, lixivaptan, for an additional 54-56 weeks. At the end of that time, study drug will be discontinued, and final eGFR assessments for Part 2 will be obtained during three follow-up visits starting over a period of 28 days. Further information on the study can be found at clinicaltrials.gov at the following link:

    https://clinicaltrials.gov/ct2/show/NCT04064346

    About the ALERT Study

    The ALERT Study is an ongoing open-label, repeat-dose study designed to assess liver and non-liver safety in subjects who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Subjects will be enrolled and treated with lixivaptan for 52 weeks following titration to an optimal dose. Further information on the study can be found at clinicaltrials.gov at the following link: https://clinicaltrials.gov/ct2/show/NCT04152837

    About ADPKD

    ADPKD is a rare hereditary disorder characterized by the formation and enlargement of cysts in the kidney, liver, and other organs. It is the fourth leading cause of kidney failure in the U.S. and one of the most common inherited genetic diseases in humans, occurring equally in women and men, in all races, globally. There are an estimated 140,000 diagnosed ADPKD patients in the U.S.

    Forward Looking Statements 

    This press release contains forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company's ability to deliver impactful medicines to patients; the ability of our key executives to drive execution of the Company's portfolio of programs; our asset-centric business model and the intended advantages and benefits thereof; research and clinical development plans; the scope, progress, results and costs of developing our product candidates or any other future product candidates; the design, scope and purpose of our ongoing ALERT and ACTION studies; the development and therapeutic potential of our product candidates, including lixivaptan; strategy; regulatory matters, including the timing and likelihood of success of obtaining approvals to initiate or continue clinical trials or market any products; and market size and opportunity for our product candidates.

    Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to our ability to protect and maintain our intellectual property position; business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing products and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to our asset-centric corporate model; the risk that any one or more of our product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and risks related to the COVID-19 pandemic including the effects of the Delta, Omicron and any other variants. These and other risks concerning our programs and operations are described in additional detail in our most recent Form 10-Q, which is on file with the SEC. We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

    Contacts:

    Investors: 
    Jennifer Porcelli, Head of Investor Relations 
    Centessa Pharmaceuticals 
     
      
    Media: 
    Dan Budwick, 1AB 
      
      
      
      
      



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  2. BOSTON and LONDON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc ("Company") (NASDAQ:CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, today announced that it has been added to the NASDAQ Biotechnology Index (NASDAQ:NBI). The addition will become effective prior to market open on Monday, December 20, 2021.

    The NASDAQ Biotechnology Index contains securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted…

    BOSTON and LONDON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc ("Company") (NASDAQ:CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, today announced that it has been added to the NASDAQ Biotechnology Index (NASDAQ:NBI). The addition will become effective prior to market open on Monday, December 20, 2021.

    The NASDAQ Biotechnology Index contains securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology. More information about the Index can be found at https://indexes.nasdaqomx.com/index/overview/NBI.

    About Centessa Pharmaceuticals

    Centessa Pharmaceuticals plc aims to bring impactful new medicines to patients by combining the strengths of an asset-centric model with the benefits of scale and diversification typical of larger R&D organizations. The asset-centric model refers to a highly specialized, singular-focused company that is led by a team of well-recognized subject matter experts. Centessa's asset-centric companies' programs range from discovery-stage to late-stage development and include diverse therapeutic areas such as oncology, hematology, immunology/inflammation, neuroscience, hepatology, pulmonology and nephrology. For more information, visit www.centessa.com.

    Contacts:

      Investors:

      Jennifer Porcelli, Head of Investor Relations

      Centessa Pharmaceuticals

     

      Media:

      Dan Budwick, 1AB

     



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  3. Health Industry and Scientific Veterans to Support Company's Mission to Further Discovery and Development of Precision Medicines for Immune-Mediated Inflammatory Diseases

    IMIDomics Inc., a global biotechnology company focused on the discovery and development of new medicines for the treatment of patients with immune-mediated inflammatory diseases (IMIDs), announced today the formation and members of its Scientific Advisory Board and Business Advisory Board. The groups will work closely with IMIDomics as the company leverages its Precision Discovery Engine to identify new therapies for IMIDs, a group of seemingly unrelated conditions that share common inflammatory pathways including lupus, rheumatoid arthritis, Crohn's disease and ulcerative…

    Health Industry and Scientific Veterans to Support Company's Mission to Further Discovery and Development of Precision Medicines for Immune-Mediated Inflammatory Diseases

    IMIDomics Inc., a global biotechnology company focused on the discovery and development of new medicines for the treatment of patients with immune-mediated inflammatory diseases (IMIDs), announced today the formation and members of its Scientific Advisory Board and Business Advisory Board. The groups will work closely with IMIDomics as the company leverages its Precision Discovery Engine to identify new therapies for IMIDs, a group of seemingly unrelated conditions that share common inflammatory pathways including lupus, rheumatoid arthritis, Crohn's disease and ulcerative colitis.

    "IMIDs are enormously complex diseases that are chronically undertreated and difficult to diagnose," said Juan Harrison, president and CEO of IMIDomics. "Patients with IMIDs deserve medicines that offer better health outcomes and an improved quality of life. We are proud to welcome this diverse group of scientific, medical and business experts whose collective experience and insights will help fuel our precision discovery efforts and potentially uncover new approaches to treat IMIDs that could fundamentally change the way medicines are discovered for these complex diseases."

    With IMIDomics co-founder Dr. Richard M. Myers, who is also president, science director and a faculty investigator of the HudsonAlpha Institute, serving as chair of the Scientific Advisory Board, its members include:

    • Dan Littman, MD, PhD is the Helen L. and Martin S. Kimmel professor of Molecular Immunology at the Skirball Institute of Biomolecular Medicine of NYU Langone Medical Center and an investigator at the Howard Hughes Medical lnstitute. Previously, he served as professor of Microbiology and Immunology at the University of California San Francisco. Dr. Littman is a scientific founder and a member of the Scientific Advisory Boards of Vedanta Biosciences and Immunai and is a member of the Pfizer Board of Directors. He serves on a number of other advisory boards, including for ChemoCentryx, Inc., Vor Biopharma, the Broad Institute, the Ragon Institute of MGH, MIT and Harvard, and the Whitehead Institute.
    • Eric Perakslis, PhD is the chief science and digital officer at the Duke Clinical Research Institute and professor of Population Health Sciences at the Duke University School of Medicine who brings deep expertise in the use of data to better understand complex diseases. He previously served as chief information officer and chief scientist (Informatics) at the U.S. Food and Drug Administration, as senior vice president and head of the Takeda R&D Data Science Institute, and as senior vice president of R&D Information Technology at Johnson & Johnson Pharmaceuticals R&D.
    • Luisa Salter-Cid, PhD is the chief scientific officer (CSO) at Pioneering Medicines where she is responsible for spearheading a portfolio of groundbreaking treatments. She was previously the CSO at Gossamer Bio and spent more than a decade at Bristol Myers Squibb. At Bristol Myers Squibb, she served as vice president and head of Immunology, Small Molecule Immuno-Oncology, and Genomics Discovery overseeing the development of therapeutics for autoimmune diseases and cancer.
    • Séverine Vermeire, MD, PhD is a staff member at the Gastroenterology Department of the University Hospitals Leuven as well as professor of medicine and Research Director for the Biomedical Sciences Group at the Catholic University of Leuven. She has been actively involved in the development of therapeutics for inflammatory bowel disease and has authored more than 500 peer-reviewed articles. Dr. Vermeire previously served as president of the European Crohn's and Colitis Organization and of the Belgian IBD Research and Development Group.

    Sandy Zweifach, former Executive Chair of IMIDomics, now chairs the IMIDomics Business Advisory Board, which includes:

    • Dan Bradbury is a Life Sciences Executive with over 35 years of experience creating and implementing strategies that transform businesses, bring novel medicines to market and maximize shareholder value. He is the managing member of BioBrit LLC, a life sciences consulting and investment firm, as well as executive chairman and co-founder of Equillium, (NASDAQ:EQ), a publicly traded biopharmaceutical company focused on developing products to treat severe autoimmune and inflammatory disorders. Previously, he served as President, CEO and Director of Amylin Pharmaceuticals until their acquisition by the Bristol-Myers Squibb Company. He also continues to serve on the boards of a number of leading healthcare companies.
    • Jessica Owens is a founding partner at Initiate Ventures and Studios. She previously served as co-founder and executive at GRAIL, where she led product strategy, marketing, and commercial. Prior to that, she was the founder and CEO of Spark Diagnostics, a digital health platform for the management of chronic neurological disorders. Additionally, she has been a partner at Kleiner Perkins and managed business strategy for Genomic Health.
    • Jim Weiss is a healthcare, biopharma, and medical tech visionary who has been recognized as one of the health care industry's most influential people. He is the founder and chairman of Real Chemistry, a global health innovation company that uses real-world data, proprietary technologies and analytical insights to solve the healthcare industry's most significant engagement and commercialization challenges. He also serves as an executive advisor of New Mountain Capital, Real Chemistry's investment partner. Mr. Weiss is a Board member of Indapta Therapeutics, as well as a Board member and contributor to the LAGRANT Foundation, the Cancer Research Institute, the Commons Project, and the Healthcare Businesswomen's Association.
    • Sandy Zweifach is a senior executive with 30 years in the life sciences industry. Most recently he was Chair of Palladio Biosciences and Janpix, which were merged into Centessa Pharmaceuticals (NASDAQ:CNTA), created by Medicxi through the merger of 10 private biotech companies. Mr. Zweifach is currently the Chair of Carisma Therapeutics, the Executive Chair of Kaerus Biosciences, a Non-Executive Board Member of Compugen, Board Member of Essa Pharma, and advisor to several life science companies across several therapeutic areas. He has shepherded the growth of several significant life sciences companies, including serving as co-founder and CEO of Nuvelution Pharma, Inc, and as co-founder and CEO of Ascendancy Healthcare, Inc. He also was Managing Director and CFO of Bay City Capital.

    ABOUT THE PRECISION DISCOVERY ENGINE

    The IMIDomics Precision Discovery Engine is a proprietary, data-powered system that integrates 15 years of clinical, epidemiologic and biomolecular data, along with patient samples, to identify new therapies for immune-mediated inflammatory diseases (IMIDs) including lupus, Crohn's disease, rheumatoid arthritis and ulcerative colitis and others. The Precision Discovery Engine leverages state-of-the-art analytics, machine learning and bioinformatics expertise to analyze the data from the Vall d'Hebron IMID-Biobank and uncover new insights about IMIDs based on precisely defined patient populations. IMIDomics maintains an exclusive commercial license to leverage the Vall d'Hebron IMID-Biobank, a leading resource on IMIDs, for treatment discovery and development.

    ABOUT IMIDOMICS, INC.

    IMIDomics, Inc. is a privately held global biotechnology company focused on the discovery and development of new medicines for the treatment of immune-mediated inflammatory diseases (IMIDs). Headquartered in San Rafael, California, IMIDomics was founded in Barcelona, Spain in 2015 by Dr. Sara Marsal, Head of the Rheumatology Department at the Vall d'Hebron University Hospital, and Dr. Richard M. Myers, President and Scientific Director at the HudsonAlpha Institute for Biotechnology. To learn more about IMIDomics, please visit www.imidomics.com.

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  4. ~ 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

    ~ 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 SerpinPC 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 Company and Oberland Capital. The Company's pro forma cash position as of September 30, 2021, following receipt of the net proceeds from the first tranche of notes in October, was $653.4 million.



    • Centessa Subsidiary, Orexia Therapeutics, Initiated Collaboration with Schrödinger to Discover Novel Orexin Receptor Agonists: In October, Orexia entered into an exclusive collaboration with Schrödinger focused on the discovery of novel therapeutics targeting the orexin-2 receptor ("OX2R"), which is known to play a role in a broad spectrum of sleep disorders including narcolepsy. The collaboration provides Orexia with substantial access to Schrödinger's entire computational platform as well as Schrödinger's extensive expertise in ultra-large-scale deployment of its technology.



    • Leadership Team Strengthened by Appointment of Chief Innovation Officer: In October, the Company announced the appointment of David Grainger, PhD, as Chief Innovation Officer. Dr. Grainger will be a member of the Company's executive leadership team and will be responsible for the overall management of the scientific and research activities.

    Upcoming Milestones

    • ApcinteX's SerpinPC, an activated protein C inhibitor for Hemophilia: During 2022, the Company expects to launch a global full development plan aimed at one or more registrations to maximize the broad potential for SerpinPC in the hemophilia space. The Company also expects to provide an update in 2022 on the ongoing Phase 2a open-label extension study.



    • Palladio Biosciences' lixivaptan, a vasopressin V2 receptor antagonist for Autosomal Dominant Polycystic Kidney Disease ("ADPKD"): By the end of 2021, the Company expects to report initial safety data from the ongoing open-label ALERT Study of subjects who previously discontinued JYNARQUE® (tolvaptan) due to liver toxicity. The Company expects to dose the first subject in the registrational Phase 3 ACTION Study by 1Q 2022.



    • Z Factor's ZF874, a Z-A1AT folding corrector for AATD: During 2022, the Company expects to report on additional PiMZ as well as PiZZ subjects from the expanded Phase 1 Part B. The Company anticipates starting a global Phase 2 study in 2Q 2022, with 6-month dosing to commence in 2H 2022 once a dose and regimen are established and chronic animal toxicology is completed.



    • Pega-One's imgatuzumab, a non-fucosylated anti-epidermal growth factor receptor ("EGFR") monoclonal antibody ("mAb") for Advanced Cutaneous Squamous Cell Carcinoma ("CSCC"): The Company expects to initiate an open-label, single arm, Phase 2 trial of imgatuzumab in advanced CSCC by the end of 2021 and dose the first subject in 1Q 2022.



    • Capella Bioscience's CBS001, an anti-LIGHT mAb for Idiopathic Pulmonary Fibrosis ("IPF"): In 1H 2022, the Company expects to submit a Clinical Trial Authorisation ("CTA") application with the UK Medicines and Healthcare products Regulatory Agency ("MHRA") for CBS001 and commence a Phase 1 study shortly thereafter.



    • Capella Bioscience's CBS004, an anti-BDCA2 mAb for Systemic & Cutaneous Lupus Erythematosus ("SLE/CLE") and Systemic Sclerosis ("SSc"): In 2H 2022, the Company expects to submit an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for CBS004 and commence a Phase 1 study shortly thereafter.



    • Orexia Therapeutics' oral orexin receptor agonist for Narcolepsy Type 1 ("NT1"), and other neurological disorders characterized by excessive daytime sleepiness: The Company is on track to select a candidate for its oral program and commence IND enabling activities in 2022.



    • Janpix Limited's dual degrader of Signal Transducer and Activator of Transcription proteins 3 and 5 ("STAT3" and "STAT5") for Acute Myeloid Leukemia: By the end of 2021, the Company expects to select a candidate for the STAT3/5 program.



    • PearlRiver Bio's small molecule kinase inhibitors for EGFR mutations in Non-Small Cell Lung Cancer ("NSCLC"):  The Company is progressing an EGFR-C797S mutation inhibitor for the treatment of NSCLC and expects to report on ongoing candidate selection in 2022. The Company will not select a candidate for its exon20 mutation program in 2021 and is presently reviewing this program.

    Third Quarter 2021 Financial Results

    Cash Position: Cash and cash equivalents were $578.8 million as of September 30, 2021, compared to $613.8 million as of June 30, 2021, a reduction of $35 million. On a pro forma basis as of September 30, 2021, cash and cash equivalents were $653.4 million, inclusive of the net proceeds of $74.6 million from the first tranche received under the Oberland Agreement on October 4, 2021. Based on the current, non-risk-adjusted operating plan, the Company expects the cash and cash equivalents as of September 30, 2021, plus the net proceeds of the first tranche, supplemented by the additional funds available under the Oberland Agreement, if drawn, to fund its operations into mid-2024.

    Research & Development ("R&D") Expenses: R&D expenses for the Company for the three months ended September 30, 2021, were $25.9 million, compared to $1.9 million for the Centessa Predecessor Group (comprised of Z Factor Limited, LockBody Therapeutics Ltd, and Morphogen-IX Limited, three of the Centessa Subsidiaries acquired in January 2021) for the three months ended September 30, 2020. The $23.9 million increase is primarily attributable to the growth in the portfolio of product candidates under development following the acquisition of the Centessa Subsidiaries in January 2021, as well as increased spending in the Centessa Predecessor Group.

    General & Administrative ("G&A") Expenses: G&A expenses for the Company for the three months ended September 30, 2021, were $12.5 million, compared to $0.2 million for the Centessa Predecessor Group during the three months ended September 30, 2020. The $12.2 million increase is primarily attributable to public company costs, the operating costs of Centessa Pharmaceuticals plc and Centessa Pharmaceutical Inc., including professional fees and personnel costs, and the increase in operating costs resulting from the acquired Centessa subsidiaries. In addition, the increase in personnel related expenses includes an increase in headcount and an increase in share-based compensation expense of $2.6 million which is primarily attributable to the equity awards issued at the time of the acquisition and the subsequent issuances of awards through September 30, 2021.

    Net Loss: Net Loss attributable to common stockholders for the quarter ended September 30, 2021, was $40.2 million, or $0.45 per share, compared to a net loss of $2.1 million for the Centessa Predecessor Group for the quarter ended September 30, 2020.

    About Centessa Pharmaceuticals

    Centessa Pharmaceuticals plc aims to bring impactful new medicines to patients by combining the strengths of an asset-centric model with the benefits of scale and diversification typical of larger R&D organizations. The asset-centric model refers to a highly specialized, singular-focused company that is led by a team of well-recognized subject matter experts. Centessa's asset-centric companies' programs range from discovery-stage to late-stage development and include diverse therapeutic areas such as oncology, hematology, immunology/inflammation, neuroscience, hepatology, pulmonology and nephrology. For more information, visit www.centessa.com.

    Forward Looking Statements

    This press release contains forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements including statements related to the Company's ability to deliver impactful medicines to patients; the ability of our key executives to drive execution of the Company's portfolio of programs; our asset-centric business model and the intended advantages and benefits thereof; research and clinical development plans; the scope, progress, results and costs of developing our product candidates or any other future product candidates; our collaborations and the intended benefits thereof; strategy; regulatory matters, including the timing and likelihood of success of obtaining approvals to initiate or continue clinical trials or market any products; market size and opportunity; our ability to complete certain milestones; the availability of funding to operate our business and pursue our objectives; and our cash position and runway.

    Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to our ability to protect and maintain our intellectual property position; business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing products and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to our asset-centric corporate model; the risk that any one or more of our product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and risks related to the COVID-19 pandemic including the effects of the Delta and any other variants. These and other risks concerning our programs and operations are described in additional detail in our reports that we file with the SEC. We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

    Contacts:



    Investors:

    Jennifer Porcelli, Head of Investor Relations

    Centessa Pharmaceuticals

    Media:

    Dan Budwick, 1AB

    Centessa Pharmaceuticals plc (Successor) and Centessa Predecessor Group (Predecessor)

    Consolidated and Combined Statements of Operations and Comprehensive Loss

    (unaudited)

    (amounts in thousands except share and per share data)

     Successor Predecessor
     Three months

    ended September

    30,


    2021
     Period from

    January 30, 2021

    through

    September 30,


    2021
     Period from

    January 1, 2021

    through

    January 29,

    2021
     Three months

    ended September

    30,


    2020
     Nine months

    ended


    September 30,

    2020
    Operating expenses:         
    Research and development25,850  54,126  600  1,923  6,604 
    General and administrative12,464  29,900  121  193  831 
    Change in fair value of contingent value rights  11,312       
    Acquired in-process research and development  220,454       
    Loss from operations(38,314) (315,792) (721) (2,116) (7,435)
    Interest income (expense), net65  100  (9) (22) (56)
    Amortization of debt discount    (37) (78) (220)
    Other income (expense), net(1,906) (4,605)   6  (5)
    Gain on extinguishment of debt      72  339 
    Net loss(40,155) (320,297) (767) (2,138) (7,377)
    Other comprehensive loss:         
    Foreign currency translation adjustment(487) 2,828  45  372  (359)
    Total comprehensive loss$(40,642) $(317,469) $(722) $(1,766) $(7,736)
              
    Net loss per ordinary share - basic and diluted$(0.45) $(4.60)      
    Weighted average ordinary shares outstanding - basic and diluted89,899,454  69,597,648       

    Centessa Pharmaceuticals plc (Successor) and Centessa Predecessor Group (Predecessor)

    Condensed Consolidated and Combined Balance Sheets

    (unaudited)

    (amounts in thousands except share and per share data)

     Successor Predecessor
     September 30, 2021 December 31, 2020
    Total Assets   
    Cash and cash equivalents$578,815  $7,227 
    Other assets33,392  4,490 
    Total assets$612,207  $11,717 
        
    Total Liabilities   
    Liabilities$29,144  $8,619 
    Contingent value rights33,930   
    Total liabilities63,074  8,619 
        
    Total combined deficit and shareholders' equity549,133  3,098 
    Total liabilities, combined deficit and shareholders' equity$612,207  $11,717 

     



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  5. BOSTON and LONDON, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc ("Company") (NASDAQ:CNTA) today announced that Saurabh Saha, MD, PhD, Chief Executive Officer, will present at the following investor conferences:

    Event: Jefferies London Healthcare Conference
    Date: Thursday, November 18, 2021
    Presentation Details: Recording available on-demand on Thursday, November 18, 2021, starting at 3:00 AM ET (8:00 GMT)

    Event: Evercore ISI HealthCONx Conference
    Date: Thursday, December 2, 2021
    Fireside Chat Details: 4:20 PM ET (21:20 GMT)

    Access to the live webcasts of these events, as well as archived recordings, will be available under the "Events" tab on the investor relations section of the Centessa Pharmaceuticals website at https://investors.centessa.com/events-presentations

    BOSTON and LONDON, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc ("Company") (NASDAQ:CNTA) today announced that Saurabh Saha, MD, PhD, Chief Executive Officer, will present at the following investor conferences:

    Event: Jefferies London Healthcare Conference

    Date: Thursday, November 18, 2021

    Presentation Details: Recording available on-demand on Thursday, November 18, 2021, starting at 3:00 AM ET (8:00 GMT)

    Event: Evercore ISI HealthCONx Conference

    Date: Thursday, December 2, 2021

    Fireside Chat Details: 4:20 PM ET (21:20 GMT)

    Access to the live webcasts of these events, as well as archived recordings, will be available under the "Events" tab on the investor relations section of the Centessa Pharmaceuticals website at https://investors.centessa.com/events-presentations.

    About Centessa Pharmaceuticals

    Centessa Pharmaceuticals plc aims to bring impactful new medicines to patients by combining the strengths of an asset-centric model with the benefits of scale and diversification typical of larger R&D organizations. The asset-centric model refers to a highly specialized, singular-focused company that is led by a team of well-recognized subject matter experts. Centessa's asset-centric companies' programs range from discovery-stage to late-stage development and include diverse therapeutic areas such as oncology, hematology, immunology/inflammation, neuroscience, hepatology, pulmonology and nephrology. For more information, visit www.centessa.com.

    Contacts:

    Investors:

    Jennifer Porcelli, Head of Investor Relations

    Centessa Pharmaceuticals

    Media:

    1AB

    Dan Budwick

     



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