PBCAR 20A / Precision BioSci - LARVOL DELTA

Precision BioSciences Reports First Quarter 2023 Financial Results and Provides Business Update (Businesswire) - "Research and development expenses were $22.2 million for the quarter ended March 31, 2023, as compared to $20.0 million for the same period in 2022. The increase of $2.2 million was primarily due to an increase in direct research and development expenses related to our azer-cel and PBCAR19B product candidates as well as consulting fees related to our increased focus on quality management, partially offset by a decrease in expenses related to manufacture of materials for use in preclinical studies, PBCAR20A external development costs, and share-based compensation expense from recent forfeitures."

Commercial • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL (clinicaltrials.gov) - P1/2 | N=17 | Completed | Sponsor: Precision BioSciences, Inc. | Recruiting ➔ Completed | N=90 ➔ 17

Enrollment change • Trial completion • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD20

Precision BioSciences Reports Third Quarter 2021 Financial Results and Provides Business Update (Businesswire) - "PBCAR19B: PBCAR19B is being administered at flat dose levels starting at 2.7 × 108 CAR T cells per patient, the same as Dose Level 3 for PBCAR0191. Precision expects to provide an initial study update in 2022...PBCAR269A: Precision expects to provide an interim update on the monotherapy arm of the study during its conference webcast on December 11, 2021....PBCAR20A: Treatment with PBCAR20A did not result in compelling response rates in a Phase 1/2a clinical study. Precision will not continue development of PBCAR20A. All subjects enrolled in the study and evaluated for treatment with PBCAR20A..."

Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Precision BioSciences Reports Second Quarter 2021 Financial Results and Provides Business Update (Businesswire) - "Precision has completed Dose Level 3 (4.8 × 108 cells per patient given as a fixed dose) of its Phase 1/2a anti-CD20 study of PBCAR20A and has paused the study until PBCAR0191 and PBCAR19B durability is demonstrated. Precision expects to provide an interim update for PBCAR20A in 2021; Precision continues to enroll patients in its Phase 1/2a study of PBCAR269A targeting B-cell maturation antigen (BCMA) for patients with R/R multiple myeloma...Precision expects to provide an interim update on the monotherapy arm of the study in 2021."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Precision BioSciences Reports First Quarter and 2021 Financial Results and Provides Business Update (Businesswire) - “PBCAR0191…Precision will continue to monitor the results for durability from this eLD regimen and expects to report updated interim results in June at ASCO 2021. PBCAR20A…Precision expects to provide an interim update for the PBCAR20A study in 2021. PBCAR269A…Precision expects to provide an interim update in 2021. Precision also expects to initiate the combination arm of its ongoing Phase 1/2a clinical study with PBCAR269A and nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor, in the first half of 2021. PBCAR269B…Precision is conducting IND-enabling studies for PBCAR269B and expects to file an IND application in early 2022."

IND • New P1/2 trial • P1/2 data • Preclinical • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor

Precision BioSciences Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides Business Update (GlobeNewswire) - “PBCAR0191: Precision expects to provide updated interim data for PBCAR0191 by mid-2021; PBCAR19B: The Phase 1 study is expected to begin by mid-year 2021 and will be a non-randomized, open-label, single-dose, dose-escalation and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in patients with R/R NHL; PBCAR20A: Precision also continues to enroll patients in its Phase 1/2a clinical trial of PBCAR20A, a wholly-owned investigational allogeneic anti-CD20 CAR T therapy for patients with R/R NHL including patients with R/R chronic lymphocytic leukemia or R/R small lymphocytic lymphoma…The Company expects to report interim data for the PBCAR20A study in 2021.”

P1/2 data • Trial status • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: Precision BioSciences, Inc.; Trial primary completion date: Jul 2021 ➔ Mar 2022

Clinical • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: Precision BioSciences, Inc.; Trial completion date: Feb 2021 ➔ Feb 2023; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Precision BioSciences reports first quarter 2020 financial results and provides business update (GlobeNewswire, Precision Biosciences) - "PBCAR0191 Phase 1/2a Trial is Progressing with Updated Interim Data Expected in 2020; Phase 1/2a Trial of PBCAR269A in Patients with Multiple Myeloma Expected to Begin in 2020."

New P1/2 trial • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Multiple Myeloma • Oncology

Precision BioSciences announces dosing of first patient in phase 1/2a clinical trial of PBCAR20A for relapsed/refractory NHL, CLL, and SLL (GlobeNewswire) - “Precision BioSciences, Inc…announced the initiation of patient dosing in a Phase 1/2a clinical trial of its second off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR20A…The first cohort will enroll patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), and the second will include patients with R/R chronic lymphocytic leukemia (CLL) or R/R small lymphocytic lymphoma (SLL). The NHL cohort will include patients with mantle cell lymphoma (MCL)…”

Enrollment open

Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: Precision BioSciences, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Oct 2019 ➔ Mar 2020

Clinical • Enrollment open • Trial initiation date

Precision BioSciences reports fourth quarter and fiscal year 2019 financial results and provides business update (GlobeNewswire) - “Precision expects to announce additional clinical data from the PBCAR0191 trial for both the NHL and B-ALL cohorts during 2020…In September 2019, the FDA cleared the Investigational New Drug (IND) application for PBCAR20A, Precision’s second and wholly-owned CAR T therapy candidate, which is expected to enter the clinic in Q1 2020…In January 2020, the FDA also cleared Precision’s IND application for its third CAR T therapy candidate, PBCAR269A…dosing of patients in a Phase 1/2a clinical trial is expected to begin in 2020.”

Enrollment status • New trial • P1/2 data

Precision BioSciences reports third quarter 2019 financial results and highlights ongoing operational progress including initial data from PBCAR0191 phase 1/2a clinical trial (GlobeNewswire) - “The PBCAR0191 Phase 1/2a trial is ongoing and updated results from patients treated at Dose Level 1 and Dose Level 2 will be presented at the ASH annual meeting on December 9, 2019 starting at 6:00 p.m. ET; On September 16, 2019, Precision announced that the FDA accepted its IND application for PBCAR20A….Precision plans to initiate a Phase 1/2a clinical trial in the fourth quarter of 2019, with initial data expected in 2020.”

New P1/2 trial • P1/2 data

"#PrecisionBioSciences Announces #FDA Clearance of the InvestigationalNewDrug for #PBCAR20A, a #CD20 Targeting Genome Edited #Allogeneic #CARTTherapy $DTIL https://t.co/0cYTJJp1k2" (@1stOncology)

IND

Precision BioSciences announces FDA clearance of the IND for PBCAR20A, a CD20 targeting genome edited allogeneic CAR T therapy (GlobeNewswire) - “Precision BioSciences, Inc….announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PBCAR20A, the Company’s second off-the-shelf chimeric antigen receptor (CAR) T cell therapy program. Wholly owned by Precision, PBCAR20A is an allogeneic anti-CD20 CAR T therapy candidate in development for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). The company plans to initiate a Phase 1/2a clinical trial in the fourth quarter of 2019, with initial data expected in 2020….Precision BioSciences has received Orphan Drug Designation for MCL and plans to pursue this indication.”

IND • New P1/2 trial • Orphan drug • P1/2 data