Earnings release
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PRECIGEN Precigen Reports Second Quarter and First Half 2021 Financial Results August 9 , 2021 - Company to provide comprehensive clinical pipeline and data updates at R & D call on November 4th GERMANTOWN , Md . , Aug. 9 , 2021 / PRNewswire / -- Precigen , Inc. ( Nasdaq : PGEN ) , a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients , today announced second quarter and first half 2021 financial results . PRECIGEN ADVANCING MEDICINE WITH PRECISION ™ . " We have made significant progress in the first half of 2021 and are well on our way to meet or exceed the goals we set at the beginning of the year . We are excited about the advancement of our portfolio and look forward to providing further clinical updates and data readouts at a planned R & D call on November 4th as well as at medical congresses in the fourth quarter of the year , " said Helen Sabzevari , PhD , President and CEO of Precigen . " We see 2021 as a pivotal year for the UltraCAR - T , ActoBiotics and AdenoVerse platforms with significant new clinical data on our most advanced therapeutic candidates from these core therapeutic platforms . " Business Highlights : R & D Update Call • Precigen will host an R & D call on November 4th that will be dedicated to reviewing progress made in advancing the Company's clinical pipeline , including the latest data for several of our key programs . PRGN - 3005 UltraCAR - TⓇ • PRGN - 3005 UltraCAR - T is a first - in - class investigational therapy under evaluation in a Phase 1 / 1b clinical trial for the treatment of patients with advanced , recurrent platinum resistant ovarian cancer . Study subjects receive the PRGN - 3005 infusion either via intraperitoneal ( IP ) ( Arm A ) or intravenous ( IV ) ( Arm B ) infusion . ● Preliminary Phase 1 data previously reported from the two lowest dose levels of the IP arm showed a favorable safety profile with no dose - limiting toxicities ( DLTs ) , neurotoxicity or cytokine release syndromes ( CRS ) ; encouraging expansion and persistence without lymphodepletion ; and clinical activity as evidenced by regression in total target tumor burden . • The dose escalation phase of both the IP and IV arms of the trial is ongoing concurrently . Enrollment in dose level 4 of the IP arm and dose level 3 of the IV arm is ongoing . • The Company anticipates the presentation of interim data from the Phase 1 trial in the fourth quarter of 2021 . PRGN - 3006 UltraCAR - TⓇ • PRGN - 3006 UltraCAR - T is a first - in - class investigational therapy under evaluation in a Phase 1 / 1b clinical trial for the treatment of patients with relapsed or refractory ( r / r ) acute myeloid leukemia ( AML ) or higher - risk myelodysplastic syndromes ( MDS ) . Study subjects receive the PRGN - 3006 infusion either without prior lymphodepletion ( Cohort 1 ) or following lymphodepleting chemotherapy ( Cohort 2 ) . PRGN - 3006 UltraCAR - T has been granted Orphan Drug Designation in patients with AML by the US FDA . • Preliminary Phase 1 data previously reported for the two lowest dose levels in Cohort 1 and the lowest dose level in Cohort 2 showed a favorable safety profile with no DLTS or neurotoxicity ; encouraging expansion and persistence of