Precision BioSciences, Inc. - Common Stock (DTIL)

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PBGENE-HBV. PBGENE-HBV is Precision’s lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes. Precision is in final stages of U.S. site activation, enabling the ELIMINATE-B trial to begin enrolling patients in the U.S. where over one million people are infected with chronic hepatitis B. The ELIMINATE-B trial is actively enrolling patients in Moldova, Hong Kong, and New Zealand and will soon initiate Phase 1 clinical activities in the U.S at the Liver Center at Massachusetts General Hospital. The Company recently announced promising safety and efficacy data for PBGENE-HBV following first dose administration at the lowest dose level in the ELIMINATE-B clinical trial.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, today announced that the company will present preclinical data from the PBGENE-DMD program for the treatment of Duchenne muscular dystrophy (DMD) during an oral presentation at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 16-19, 2025.

Precision BioSciences reports early PBGENE-HBV trial data showing safety and antiviral activity in chronic Hepatitis B patients, with more results expected in 2025.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced initial results from the first administration of PBGENE-HBV in cohort 1, the lowest dose level of the ELIMINATE-B trial. The ELIMINATE-B trial is designed to investigate PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients afflicted with chronic Hepatitis B who are HBeAg-negative.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, today announced enhancements within the Company’s senior leadership team. Precision continues to progress its lead in vivo gene editing program, PBGENE-HBV, through Phase 1 clinical study, while preparing to advance additional in vivo programs into clinic.

Precision BioSciences gains momentum as iECURE reports positive ECUR-506 data, and analysts forecast significant HBV program-driven stock growth.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination, today announced that its partner iECURE has reported clinical efficacy and safety data in the first patient dosed with ECUR-506 in the Phase 1/2 OTC-HOPE study. ECUR-506 is iECURE’s in vivo gene insertion program designed to treat neonatal onset Ornithine Transcarbamylase (OTC) deficiency utilizing a PCSK9-specific ARCUS nuclease, licensed from Precision, that enables insertion of a functional copy of the OTC gene.

iECURE, Inc., a gene editing company focused on the development of mutation-agnostic in vivo gene insertion therapies for the treatment of liver disorders with significant unmet need, today reported preliminary findings from the first infant dosed in the ongoing OTC-HOPE Phase 1/2 study of ECUR-506, the company’s clinical candidate designed to treat neonatal onset ornithine transcarbamylase (OTC) deficiency. Treatment with ECUR-506 was generally well tolerated in this infant with no significant clinical safety concerns apart from asymptomatic transaminitis at four weeks. The asymptomatic transaminitis was managed with immunosuppressive therapy and resolved within four weeks. Twelve weeks after a single dose of ECUR-506, ammonia scavenger medication was discontinued and mean daily protein intake was increased to age-appropriate levels. Protein liberalization was well tolerated, and the subsequent mean ammonia level remained within normal limits and was reduced compared to the mean pretreatment level.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it has received Clinical Trial Application (CTA) approval in Hong Kong to study PBGENE-HBV in the ongoing ELIMINATE-B Phase I trial. PBGENE-HBV is Precision’s lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes. The company is actively recruiting patients for the ELIMINATE-B trial in Moldova and has begun activating a top infectious disease clinical site in Hong Kong as part of its global regulatory and clinical operations strategy.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it will participate in the following upcoming investor conferences.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today will present preclinical data supporting the advancement of PBGENE-HBV into clinical development. The Company will also outline the design of its first-in-human study, ELIMINATE-B, in patients with chronic hepatitis B. Company management will present these updates and host panel discussions on the unmet need in chronic hepatitis B and the approach to treatment with PBGENE-HBV during a virtual event being held today, November 15, 10:00 a.m. EST / 7:00 a.m. PST before commencement of the American Association for the Study of Liver Diseases (AASLD) Meeting.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it will publish financial results for the third quarter 2024 and provide a business update on November 4, 2024.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced it will host a Hepatitis B Investor Event on Friday, November 15, 2024, from 7:00 a.m. – 8:30 a.m. PST prior to the American Association for the Study of Liver Diseases (AASLD) Meeting.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced a poster presentation at the European Society of Gene & Cell Therapy (ESGCT) 31st Annual Congress being held October 22-25, 2024, in Rome, Italy. The poster highlighted preclinical data demonstrating the ability of ARCUS to achieve high-efficiency gene insertion, gene replacement and base correction via homology-directed repair (HDR).

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it has received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. PBGENE-HBV is Precision’s wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), while also inactivating integrated HBV DNA in hepatocytes. The company has opened the Phase 1 clinical program and is moving towards dosing patients.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it will participate in the following upcoming investor conferences.

Precision BioSciences, Inc. (Nasdaq: DTIL) is an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion which is necessary for diseases where a defective gene is remedied by expression of a new DNA sequence, today announced a poster presentation at the upcoming European Society of Gene & Cell Therapy (ESGCT) Congress being held October 22-25, 2024, in Rome, Italy.

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits including viral gene elimination, today announced that the Company will present during a fireside chat at the H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference taking place October 8, 2024.

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that the Company submitted Clinical Trial Applications (CTA) to initiate a Phase 1 study evaluating PBGENE-HBV. PBGENE-HBV is the Company’s wholly owned in vivo gene editing program designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, today announced that, on September 18, 2024, the Compensation Committee of Precision’s Board of Directors approved the grant of inducement awards to new employees under the Precision BioSciences, Inc. 2021 Employment Inducement Incentive Award Plan (“Inducement Award Plan”). The inducement awards consist of options to purchase (“stock options”) 66,523 shares of Precision’s common stock, par value $0.000005 (the “Common Stock”), and 1,841 restricted stock units (“RSUs”), granted to two employees in connection with their commencement of employment. Each award was granted under Nasdaq Listing Rule 5635(c)(4) as an inducement for the employee to commence service with Precision.

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, today announced changes within the Company’s clinical leadership team strengthening its infectious disease and hepatitis capabilities as it prepares to initiate development of its first in vivo gene editing candidate for hepatitis.