PRECISION BIOSCIENCES INC

DTIL

Held by 1 specialist biotech fund

1 fund opened new positions. Next phase2 readout (pCAR-19B cells): Dec 2024. Short interest: 9.3% of float.

BiotechnologyCEO: Michael AmorosoIPO: 2019Website ↗

Precision BioSciences, Inc. is a clinical-stage biotechnology firm based in the United States, specializing in the creation of both in vivo gene editing solutions and ex vivo allogeneic CAR T-cell therapies. At its core is ARCUS, a proprietary genome editing platform designed to address and potentially cure genetic diseases. The company's portfolio also encompasses Ex vivo Allogeneic CAR T Immunotherapy, an innovative approach where specific immune cells, known as T-cells, are genetically modified outside the body to precisely identify and eliminate cancer cells. Among its prominent therapeutic candidates are: PBCAR0191, currently undergoing Phase 1/2a clinical trials for adult patients battling relapsed/refractory (R/R) non-Hodgkin lymphoma or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). PBCAR19B, an anti-CD19 CAR T candidate leveraging a "stealth cell" platform through a single-step gene edit, engineered to reduce the likelihood of chromosomal abnormalities. PBCAR269A, an investigational allogeneic CAR T immunotherapy formulated to target BCMA, intended for the treatment of R/R multiple myeloma. Precision BioSciences has strategically formed several collaborative alliances. These include an agreement with Les Laboratoires Servier for the development and commercialization of allogeneic chimeric antigen receptor T-cell therapies, aimed at various antigen targets, including hematological cancers beyond CD19, and solid tumors. The company is also partnering with Tiziana Life Sciences to assess foralumab, a fully human anti-CD3 monoclonal antibody, for its utility as a lymphodepleting agent in potential cancer treatments. Furthermore, a collaboration with iECURE, Inc. focuses on advancing ARCUS-based gene editing therapies. Established in 2006, Precision BioSciences, Inc. maintains its corporate headquarters in Durham, North Carolina.

Catalysts

Phase 2NegativeQ4 2013ICT-107Glioblastoma MultiformeNCT01280552

Primary: Overall Survival (OS) (2 -3 years)Enrollment:124/124Sites: 25RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q1 2022Part A: 20 and 40 mg PRAX-944Essential TremorNCT05021978

Phase 3Q2 2022PRAX-114Major Depressive DisorderNCT04832425

Phase 2Q3 202210 mg PRAX-114Major Depressive DisorderNCT04969510

Phase 2Q4 2023CEA CAR-T cellsSolid Tumor, Lung Cancer, Colorectal CancerNCT04348643

Phase 2Q4 2024pCAR-19B cellsAcute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic LeukemiaNCT05334823

Primary: Objective response rate after pCAR-19B infusion [Effectiveness] (3 months)Enrollment:Target 100Sites: 16NA, TREATMENT

Phase 2Q3 202530mg PRAX-628Focal Onset Seizure, Primary Generalized EpilepsyNCT06908356

Primary: To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs (8 weeks)Enrollment:Target 50Sites: 11NA, TREATMENT

Phase 2Q3 2025PRAX-222 - Initial DoseSCN2A-DEE, EpilepsyNCT05737784

Primary: Number of participants with treatment-emergent adverse events (Preliminary Safety, Dose Escalation) (Screening (-8 weeks) through up to 92 weeks)Enrollment:Target 60Sites: 3RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 202560 mg ulixacaltamideEssential TremorNCT06087276

Primary: Parallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score (8 weeks (56 days))Enrollment:Target 1,000Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q4 2025PRAX-562SCN2A Encephalopathy, SCN8A EncephalopathyNCT05818553

Primary: PART A (Cohorts 1 and 2) RDB: To evaluate the safety and tolerability of PRAX 562 in pediatric participants with SCN2A- and SCN8A- DEEs (16 weeks)Enrollment:Target 77Sites: 8RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q4 202520mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeksFocal SeizureNCT06999902

Phase 2Q4 2025CD123 targeted CAR-NK cellsAcute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Relapse LeukemiaNCT06006403

Phase 2Q4 2025CEA-targeted CAR-T cellsGastric Cancer, Colon Cancer, Rectal CancerNCT06006390

Phase 3Q4 2025ICT-107Glioblastoma MultiformeNCT02546102

Phase 2Q2 2026NEO-201 in combination with pembrolizumabNon Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical CancerNCT03476681

Primary: Determine the safety of the combination of NEO-201 with pembrolizumab the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. (1.5 years)Enrollment:Target 121Sites: 2NA, TREATMENT

Phase 3Q2 20261mg elsunersenEpileptic Encephalopathy, SCN2A EncephalopathyNCT07019922

Primary: To assess the efficacy of elsunersen on seizure frequency in participants with early-onset SCN2A DEE (24 weeks)Enrollment:Target 40Sites: 10NON_RANDOMIZED, TREATMENT

Phase 2Q4 2026BCMA targeted prime CAR-T cellsMultiple Myeloma, Neoplasm, Plasma Cell, Multiple Myeloma in RelapseNCT04776330

Primary: Adverse events that related to treatment (2 years)Enrollment:Target 80Sites: 1NA, TREATMENT

Phase 3Q4 20261.0mg/kg/day PRAX-562Developmental and Epileptic Encephalopathy 1NCT07010471

Primary: To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo (16 weeks)Enrollment:Target 160Sites: 11RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2026BCMA CAR-T cellsMultiple Myeloma, Neoplasm, Plasma Cell, Multiple Myeloma in RelapseNCT04271644

Primary: Adverse events that related to treatment (2 years)Enrollment:Target 80Sites: 1NA, TREATMENT

Phase 2Q4 2026CD19 and CD22 targeted prime CAR-T cellsB-ALLNCT04781634

Primary: Adverse events that related to treatment (2 years)Enrollment:Target 40Sites: 1NA, TREATMENT

Phase 3Q1 202740 mg/day vormatrogine for 12 weeksFocal EpilepsyNCT07505004

Primary: To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs (12 weeks)Enrollment:Target 300Sites: 7RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2027OPM-101Advanced MelanomaNCT07040436

Phase 2Q4 2027donor-derived NK cell infusionNon-small Cell Lung CancerNCT04616209

Phase 3Q2 2028vormatrogineEpilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized SeizureNCT07287163

Phase 2Q4 2029PBGENE-DMD (IV)Duchenne Muscular Dystrophy With Mutations Amenable to PBGENE-DMDNCT07429240

PRECISION BIOSCIENCES INC

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