Earnings release
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MORPHIC THERAPEUTIC Morphic Announces Corporate Highlights and Third Quarter 2021 Financial Results November 4 , 2021 MORF - 057 phase 1 safety , receptor occupancy , PK and mechanistic measures exceeded objectives ; phase 2 program in ulcerative colitis expected to begin 1Q22 Announced appointment of Nisha Nanda , Ph.D. , to Morphic Board of Directors WALTHAM , Mass . , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- Morphic Therapeutic ( Nasdaq : MORF ) , a biotechnology company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases , today reported corporate highlights and financial results for the third quarter of 2021 . Recent Highlights and Outlook • Presented positive phase 1 data at the European Crohn's and Colitis Organisation ( ECCO ) Virtual Congress 2021 , fully supporting MORF - 057's target product profile as an oral inhibitor of the a4ẞ7 integrin • MORF - 057 was well tolerated in all dose cohorts with no safety signals identified • Pharmacodynamic data , including a4ẞ7 receptor saturation at 100 mg BID administered orally , strongly supported MORF - 057's ability to replicate the mechanism of approved therapeutic vedolizumab , administered via IV infusion • MORF - 057's dose - dependent and consistent pharmacokinetic data support twice daily dosing profile and enable plans to evaluate once - daily dosing in phase 2b • Lymphocyte subset changes strongly demonstrate early in - human evidence for MORF - 057's small molecule α4ẞ7 inhibition to replicate the published data on mechanism of action from approved biologic therapeutics in inflammatory bowel disease ( IBD ) • Planned initiation of MORF - 057 phase 2a remains on track for first quarter 2022 • All phase 2 readiness work , including chronic toxicology studies , on track and scheduled for completion in fourth quarter 2021 • Study to include 30-35 patients with moderate to severe ulcerative colitis treated with 100 mg BID ( twice daily ) with 12 - week induction phase and rollover to 40 additional weeks maintenance phase in patients • The primary endpoint is change in Robarts Histopathologic Index ( RHI ) at 12 weeks • Global phase 2b randomized controlled trial of MORF - 057 to commence after phase 2a initiation and then run in parallel • Welcomed Nisha Nanda , Ph.D. , to the Morphic Board of Directors , an experienced leader in preclinical and clinical - stage development strategy across multiple therapeutic areas • Received acceptance to present preclinical data from our avẞ8 inhibitor program at the upcoming Society for Immunotherapy of Cancer 36th Annual Meeting • Announced the planned resignation of Peter G. Linde , M.D. , Chief Medical Officer , effective December 31 , 2021. Dr. Linde has notified the Company that he is departing for personal reasons but will remain with the Company through year end to assist with an orderly transition of responsibilities " MORF - 057's performance in phase 1 studies exceeded our internal modelling across all key criteria and we are now finalizing preparations for the initiation of the MORF - 057 phase 2 program in patients with moderate - to - severe ulcerative colitis , " said Praveen Tipirneni , M.D. , President and Chief Executive Officer of Morphic Therapeutic . " Developing MORF - 057 with our MInT platform has generated an array of learnings that feed into our earlier proprietary pipeline , driving advances in Morphic's programs in immuno - oncology and other indications . In particular , we are looking forward to the presentation of new preclinical data from our avẞ8 program demonstrating the strong anti - tumor activity of a Morphic avẞ8 small molecule inhibitor dosed in combination with a checkpoint inhibitor and radioimmunotherapy in a tumor that is unresponsive to respective monotherapies or conventional radioimmunotherapy . " Financial Results for the Third Quarter 2021 • Net loss for the quarter ended September 30 , 2021 was $ 25.0 million or $ 0.69 per share , basic and diluted compared to