Precision BioSciences Presents Updated Interim Clinical Data at the ASH Annual Meeting from Relapsed / Refractory NHL and B-ALL Patients Treated at Dose Levels 1 & 2 in the Ongoing Phase 1/2a Clinical Trial of PBCAR0191, a Novel CD19 Targeted Allogeneic CAR T Therapy Candidate

-Preliminary data from ongoing Phase 1/2a trial of PBCAR0191 for the treatment of relapsed/refractory non-Hodgkin lymphoma or relapsed/refractory B-cell precursor acute lymphoblastic leukemia-

-Abstract summarizes early results from first three patients with advanced NHL treated with PBCAR0191 at Dose Level 1 as of August 1, 2019-

-No serious adverse events or dose-limiting toxicities observed over median 60 days follow-up. Two of three patients experienced objective tumor responses by Lugano criteria, with the third patient having evidence of anti-tumor activity-

-Trial is ongoing and updated data, including from patients treated at Dose Level 2, will be presented during the ASH Annual Meeting-

-Precision BioSciences to host investigator update event during ASH to discuss these data, starting at 8:15 p.m. ET on December 9, with live webcast available online-

PBCAR0191 continues to be associated with no serious adverse events or dose limiting toxicities observed to date, and no cases of graft-versus-host disease-

-Seven of nine treated patients (78%) had objective evidence of tumor shrinkage at any timepoint-

-R/R non-Hodgkin lymphoma (NHL) cohort achieved day 28+ objective response rate (ORR) of 66% (4/6 patients across DL1 and DL2) including one complete response (CR) and three partial responses (PRs); two further patients achieved early responses that progressed. R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) cohort achieved day 28+ ORR of 33% (1/3 patients at DL2) comprising one CR – two patients who did not respond had poor prognosis at trial entry-

-Progression free survival up to 180 days in NHL cohort – most durable response so far seen is in one NHL patient who previously relapsed following treatment with Yescarta®

-Preliminary exploratory evidence of dose-dependent CAR T cell expansion and persistence. B-cell aplasia observed in all patients corresponding to timing of expected peak cell expansion and persistence-

-Trial is ongoing and updated data, including from patients treated at Dose Level 3, expected to be presented in Q1 2020-

-Precision BioSciences to host investigator update event today starting at 8:15 p.m. ET, with live webcast available online-

DURHAM, N.C., Dec. 09, 2019 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, today announced updated interim clinical data from the ongoing Phase 1 trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, which targets the well characterized cancer cell surface protein CD19. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. Data will be presented by Bijal Shah, MD, Moffitt Cancer Center, at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, during a poster session from 6:00-8:00 p.m. ET today (Poster #4107, Hall B).

“We are very encouraged by the evidence of cell-mediated anti-tumor activity and objective tumor responses that we have observed in both NHL and B-ALL patients treated with PBCAR0191, in the context of a manageable adverse event profile,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “These data give us incremental confidence in our unique approach to allogeneic CAR T cell therapy, and we look forward to the potential of this therapy positively impacting the lives of more patients as the trial continues. At these still low dose levels, and using only mild lymphodepletion, it is remarkable to see anti-tumor activity in the majority of patients treated with PBCAR0191, including a durable response that lasted six months in one patient, and two complete responses. We have also seen preliminary evidence of dose dependent CAR T cell expansion and persistence, supporting our belief that cell persistence and clinical response is likely to increase as we increase dose level.”

“New treatment options are desperately needed for patients with advanced NHL and B-ALL who often undergo multiple cycles of therapy with limited clinical benefit,” commented Bijal Shah, MD, Moffitt Cancer Center. “These first-in-human data for PBCAR0191 suggest a tolerable safety profile and encouraging early evidence of clinical activity. Further study is required to determine durability of response at the current dose levels, as well as to establish safety and activity at Dose Level 3.”

Patient baseline characteristics and trial overview
A total of nine patients are reported in these initial Phase 1 trial results, including six with NHL (three treated at Dose Level 1 and three treated at Dose Level 2), and three with B-ALL (all treated at Dose Level 2). Key baseline characteristics were as follows:

  • Dose Level 1 (3×105 cells/kg) – three NHL patients (two with diffuse large B cell lymphoma, one with mantle cell lymphoma) with a mean age of 54 years (min-max 34-64 years). Patients had received a median of four prior lines of therapy, with two patients being refractory to their last treatment, and one having previously relapsed following treatment with Yescarta®, an FDA-approved autologous CD19-targeted CAR T therapy.
  • Dose Level 2 (1×106 cells/kg) – three NHL patients (all with mantle cell lymphoma) with a mean age of 74 years (min-max 71-77 years) who had received a median of two prior lines of therapy, with one patient refractory to their last treatment and two who had relapsed. Three B-ALL patients were also treated at DL2, with a mean age of 56 years (min-max 48-72 years); these patients had received a median of four prior lines of therapy – all three patients were refractory to their last treatment, with two patients having poor prognostic indicators at trial entry.

Patients received a single infusion of PBCAR0191 on day 0, following three days of lymphodepletion using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day. The primary objective of this Phase 1 portion of the ongoing Phase 1/2a trial is to evaluate safety as measured by the occurrence of dose limiting toxicities (DLTs). Secondary objectives include assessment of objective tumor responses using standard criteria, and further evaluation of adverse events (AEs) and adverse events of special interest, including graft-versus-host disease (GvHD), cytokine release syndrome (CRS), and IEC-associated neurotoxicity syndrome (ICANS). Data are presented as of a November 4, 2019 cutoff date, with additional critical data collected through December 2, 2019, including occurrence of CRS, ICANS, GvHD and evaluation of objective responses.

Safety of PBCAR0191
No serious adverse events or evidence of GvHD was observed through December 2, 2019. Three of the nine patients (33%) treated with PBCAR0191 developed CRS, including two Grade 1 cases and one Grade 2 case. One of the nine patients (11%) developed Grade 2 neurotoxicity. All events of CRS and neurotoxicity resolved, and no deaths occurred on study. In addition, one patient experienced a Grade 3 AE that was deemed related to PBCAR0191 (pain at the site of their tumor mass for one day following infusion), and one patient experienced Grade 4 lymphopenia (seven days duration) deemed related to PBCAR0191.

Clinical activity of PBCAR0191
Of the nine patients treated with PBCAR0191, seven (78%) had objective evidence of tumor shrinkage at any timepoint. Results also provide preliminary evidence of dose-dependent CAR T cell expansion and persistence.

In the NHL cohort, four of six patients (66%) achieved an objective response by Lugano 2014 criteria at day 28+, including three partial responses (two patients treated at DL1 and one patient treated at DL2) and one complete response (patient treated at DL2). As of December 2, 2019, one patient (treated at DL2) remains in complete response. One patient (treated at DL1) achieved a partial response then progressed six months after treatment with PBCAR0191. This was the most durable response observed to date and was also notable given the patient had relapsed following treatment with Yescarta®. The remaining two NHL patients, one treated at DL1 and one at DL2, achieved early responses (one CR, one PR respectively) at day 14; both patients had evidence of disease progression at day 28.

In the B-ALL cohort treated at DL2, one of three patients (33%) achieved a complete response by NCCN 2017 criteria at day 28+ (with undetectable B-ALL in the bone marrow by flow cytometry, described as minimal residual disease (MRD) negative), and continues to be followed on study. The remaining two patients did not respond at day 28 – these patients had poor prognostic indicators on entry into the trial, one with prior CNS involvement and 95% blast infiltration into the bone marrow, and one with 77% blast infiltration into the bone marrow and disease refractory to two previous lines of treatment.

CAR T cell expansion and persistence in the peripheral blood was assessed at DL1 and DL2 by flow cytometry and qPCR. Evidence of a dose-dependent increase in cell expansion was observed between subjects treated at DL1 and DL2, as was a dose-dependent increase in CAR T cell persistence. B-cell aplasia and serum cytokine analysis also anecdotally correspond to observed clinical responses and CAR T cell expansion.

This trial is ongoing and treatment of patients at DL3 (3×106 cells/kg) recently commenced. Updated results, including from patients treated at DL3, are expected to be presented at a medical meeting in the first quarter of 2020.

Investigator Update & Webcast Information
Precision will host a live webcast of an investigator update event during the ASH Annual Meeting to discuss these data, beginning at 8:15 p.m. ET on Monday, December 9, 2019. To access the webcast, please visit the “Events & Presentations” page within the Investors & Media section of the Precision BioSciences website at http://investor.precisionbiosciences.com/. A replay of the webcast will be available on the Precision website for 30 days following the event.

Precision’s Off-The-Shelf CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy by improving access to care through a well-tolerated lymphodepletion regimen, high quality cell products derived from carefully selected healthy donors, and a consistent final cell product with attributes in line with those previously observed to result in optimal safety and activity profiles. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR in a single step, creating a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

About Precision BioSciences, Inc.
Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, ARCUS. Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

About Precision’s Collaboration with Servier
Under the February 2016 partnership with Baxalta, now with Servier, Precision is solely responsible for early-stage research activities and Phase 1 execution for PBCAR0191, as well as preparation of clinical supply for any Phase 2 clinical trials. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.

Forward-Looking Statements
Information contained in this press release contains forward-looking statements. All statements other than statements of present and historical facts contained in this press release, including without limitation, statements regarding the potential for the successful development of PBCAR0191 for patients living with NHL or B-ALL, may be forward looking statements. Without limiting the foregoing, the words “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “potential,” the negative thereof and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements reflect various assumptions of Precision’s management that may or may not prove to be correct. No forward-looking statement is a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our quarterly report on Form 10-Q filed for the quarterly period ended September 30, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Nick Riddle
Precision BioSciences
Tel. (919) 314-5512
IR@precisionbiosciences.com

Media Contact:
Cory Tromblee
Scient Public Relations
Tel. (617) 571-7220
cory@scientpr.com


Precision BioSciences Reports Third Quarter 2019 Financial Results and Highlights Ongoing Operational Progress Including Initial Data from PBCAR0191 Phase 1/2a Clinical Trial

DURHAM, North Carolina, USA, Nov 12, 2019 – Precision BioSciences, Inc. (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, today announced financial results for the third quarter ended September 30, 2019 and provided a corporate update.

Key Highlights

-After quarter end, announced publication of an abstract accepted for presentation at the upcoming 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, December 7-10, 2019, supporting the safety and clinical activity of Precision BioSciences’s lead CD19-targeted off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T product candidate, PBCAR0191. Abstract reports initial data from first three patients treated at Dose Level 1 as of August 1, 2019. Trial is ongoing and updated data, including from patients treated at Dose Level 2, will be presented during the ASH annual meeting on December 9, 2019 at 6:00 pm ET.
-Announced an investigator update event during ASH meeting to discuss the PBCAR0191 data presented, starting at 8:15pm ET on December 9, 2019, with accompanying live webcast.
-Received acceptance from US Food and Drug Administration (FDA) of investigational new drug (IND) application for second and wholly-owned allogeneic CAR T therapy candidate PBCAR20A, targeting CD20. Phase 1/2a clinical trial to begin in the fourth quarter of 2019.
-Further enhanced senior leadership team with appointment of David Thomson, PhD, as Chief Operating Officer, and Nicholas Riddle, MD, PhD, as Vice President, Financial Strategy and Investor Relations.
-Ended the quarter with $206.3 million in cash and cash equivalents, which is expected to fund operating expenses and capital expenditure requirements into 2021.

“We reached a transformative moment for Precision BioSciences this quarter; it is very exciting to report initial data from our first clinical trial with a product candidate that leverages our unique approach to allogeneic CAR T therapy,” commented Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. “These data bring the reality of a true off-the-shelf CAR T therapy a step closer for patients in need of new and improved treatment options. While preliminary and from a limited number of patients, the safety profile, in vivo cell expansion and early evidence of clinical activity we have demonstrated with PBCAR0191 in the absence of biologic lymphodepletion is very encouraging and gives us confidence in the approach we have taken to allogeneic CAR T. We are looking forward to sharing updated results from patients treated at both Dose Level 1 and Dose Level 2 at ASH. The team at Precision is committed to advancing our pipeline of differentiated CAR T product candidates as rapidly as possible to bring these potentially transformative therapies to patients.”

Recent Developments and Upcoming Milestones

Program updates

  • On November 6, 2019, Precision announced that initial results from the ongoing Phase 1/2a trial of its lead investigational allogeneic CAR T cell therapy candidate, PBCAR0191, will be presented during the 61st Annual Meeting of the American Society of Hematology in Orlando, Florida, December 7-10, 2019. PBCAR0191, which is being developed in collaboration with Servier, is Precision’s first allogeneic CAR T therapy candidate in clinical trials and targets the well characterized cancer cell surface protein CD19. The Phase 1/2a trial includes adult patients with relapsed or refractory (R/R) non-Hodgkin’s lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The abstract outlining initial data from patients treated with PBCAR0191 at Dose Level 1 can be accessed on the ASH conference website. Data in the abstract include results as of the cutoff date of August 1, 2019 for three patients with advanced NHL treated at Dose Level 1. No significant toxicities were observed, including no serious adverse events and no dose-limiting toxicities. All patients had a minimum follow-up of 28 days (median 60 days). Two of the three patients experienced an objective tumor response by Lugano criteria, at day 14 and day 28, respectively. The third patient, who had previously progressed following treatment with axicabtagene ciloleucel (Yescarta®), an approved anti-CD19 autologous CAR T therapy, had not met the definition of response, but demonstrated evidence of central necrosis, decreased tumor size, and decreased PET-avidity at day 28, in the context of post-infusion tumor site pain and mild CRS symptoms. Peripheral blood analysis for CAR T cell expansion has identified preliminary evidence of cell expansion.
  • 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. Precision will host a live webcast of an investigator update event during the ASH meeting to discuss the presented data, beginning at 8:15 p.m. ET on December 9, 2019. The webcast will be accessible from the “Events & Presentations” page within the Investors & Media section of the Precision website and a replay will be available for 30 days following the call.
  • On September 16, 2019, Precision announced that the FDA accepted its IND application for PBCAR20A. Wholly-owned by Precision, PBCAR20A is an allogeneic anti-CD20 CAR T therapy candidate in development for the treatment of patients with NHL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). Precision plans to initiate a Phase 1/2a clinical trial in the fourth quarter of 2019, with initial data expected in 2020.

Senior leadership appointments

  • On September 30, 2019, Precision announced that Nicholas Riddle, MD, PhD, joined as Vice President, Financial Strategy and Investor Relations. Dr. Riddle joined Precision from J.P. Morgan where he was an Executive Director in the global healthcare investment banking group.
  • On September 23, 2019, Precision appointed David Thomson, PhD, to the position of Chief Operating Officer. Dr. Thomson previously served as Precision’s Chief Development Officer since 2017.

Upcoming Corporate Presentations

Precision’s senior management team will be presenting and meeting with investors at the following upcoming conferences:

  • Barclays Gene Editing and Gene Therapy Summit, New York, NY, November 13, 2019
  • Stifel Healthcare Conference, New York, NY, November 20, 2019
  • Jefferies London Healthcare Conference, London, UK, November 20, 2019
  • Piper Jaffray Annual Health Care Conference, New York, NY, December 3–5, 2019
  • J.P. Morgan Healthcare Conference, San Francisco, CA, January 13-16, 2020

Third Quarter 2019 Financial Results

Cash and Cash Equivalents: As of September 30, 2019, Precision had approximately $206.3 million in cash and cash equivalents. We expect that existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2021.

Revenues: Total revenues for the quarter ended September 30, 2019 were $4.9 million, compared to $2.5 million for the quarter ended September 30, 2018. This increase was primarily due to research funding from a collaboration partner, offset by a decrease in license fees.

Research and Development Expenses: Research and development expenses were $19.8 million for the quarter ended September 30, 2019, as compared to $9.7 million for the same period in 2018. This increase of $10.1 million was primarily due to platform development and early-stage research expenses.

General and Administrative Expenses: General and administrative expenses were $7.1 million for the quarter ended September 30, 2019, as compared to $3.3 million for the same period in 2018. The increase of $3.8 million was primarily due to increased employee-related costs for additional personnel and facility costs associated with our growing infrastructure needs.

Net Loss: Net loss was $20.7 million, or $(0.41) per share, for the quarter ended September 30, 2019, compared to a net loss of $9.8 million, or $(0.62) per share, for the same period in 2018.

About Precision BioSciences, Inc.
Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, ARCUS. Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

Forward-Looking Statements

Information contained in or accessible through this press release contains forward-looking statements. All statements other than statements of present and historical facts contained in this prospectus, including without limitation, statements regarding the success of our allogeneic CAR T therapy product candidate PBCAR0191 and the timing of the Phase 1/2a clinical trial for our allogeneic CAR T therapy candidate PBCAR20A, may be forward-looking statements. Without limiting the foregoing, the words “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “potential,” the negative thereof and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements reflect various assumptions of Precision’s management that may or may not prove to be correct. No forward-looking statement is a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our quarterly report on Form 10-Q for the quarterly period ended June 30, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Investor Contact:
Nick Riddle
Precision BioSciences
Tel. (919) 314 5512
IR@precisionbiosciences.com

Media Contact:
Cory Tromblee
Scient Public Relations
Tel. (617) 571-7220
cory@scientpr.com 


Precision BioSciences Announces the Presentation of Initial Clinical Data Supporting the Safety and Clinical Activity of PBCAR0191, a Novel CD19 Targeted Allogeneic CAR T Therapy Candidate, at the American Society of Hematology Annual Meeting

Preliminary data from ongoing Phase 1/2a trial of PBCAR0191 for the treatment of relapsed/refractory non-Hodgkin lymphoma or relapsed/refractory B-cell precursor acute lymphoblastic leukemia-

-Abstract summarizes early results from first three patients with advanced NHL treated with PBCAR0191 at Dose Level 1 as of August 1, 2019-

-No serious adverse events or dose-limiting toxicities observed over median 60 days follow-up. Two of three patients experienced objective tumor responses by Lugano criteria, with the third patient having evidence of anti-tumor activity-

-Trial is ongoing and updated data, including from patients treated at Dose Level 2, will be presented during the ASH Annual Meeting-

-Precision BioSciences to host investigator update event during ASH to discuss these data, starting at 8:15 p.m. ET on December 9, with live webcast available online-

DURHAM, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, announced today that initial results from the ongoing Phase 1/2a trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, will be presented during the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, December 7-10, 2019.

PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials and targets the well characterized cancer cell surface protein CD19. It is being developed in collaboration with Servier, an international pharmaceutical company. The Phase 1/2a trial includes adult patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The abstract outlining initial data from patients treated with PBCAR0191 at Dose Level 1 is available on the ASH conference website (https://www.hematology.org/Annual-Meeting/Abstracts). This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be presented at the ASH Annual Meeting on December 9, 2019 starting at 6:00 p.m. ET.

“We are excited to share initial clinical data from Precision’s PBCAR0191 program at ASH, which we believe demonstrate the potential of our differentiated approach to the development of allogeneic CAR T therapies,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “These data bring the reality of a true off-the-shelf CAR T therapy a step closer for patients in need of new and improved treatment options. We remain committed to the wider goal of improving access to cellular therapies for patients with advanced NHL and ALL, and we are optimistic, based on these initial findings, that we may be able to help meet this need. While preliminary and from a limited number of patients, the safety profile, in vivo cell expansion and early evidence of clinical activity we have demonstrated at our lowest dose level with PBCAR0191 in the absence of biologic lymphodepletion is very encouraging. We look forward to sharing updated results from patients treated at Dose Levels 1 and 2 at ASH.”

Investigator Update & Webcast Information
Precision will host a live webcast of an investigator update event during the ASH Annual Meeting to discuss the presented data, beginning at 8:15 p.m. ET on Monday, December 9, 2019. To access the webcast, please visit the “Events & Presentations” page within the Investors & Media section of the Precision BioSciences website at http://investor.precisionbiosciences.com. A replay of the webcast will be available on the Precision website for 30 days following the call.

First Clinical Data from Precision’s PBCAR0191 Program
Title: Initial findings of the Phase 1 trial of PBCAR0191
Presenter: Bijal Shah, MD, Moffitt Cancer Center
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Retrospective/Observational Studies
Poster/Presentation Number: Poster III
Date and Time: December 9, 2019, 6:00-8:00 p.m. ET
Location: Orange County Convention Center, Hall B

PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials. This presentation will include initial data from the Phase 1 portion of the ongoing Phase 1/2a trial of PBCAR0191, which is designed to assess safety, identify an optimal dose of PBCAR0191 and evaluate preliminary clinical activity in patients with R/R NHL and B-ALL. The trial is a 3+3 dose escalation study (at dose levels of 3×105, 1×106, and 3×106 CAR T+ cells/kg); in each of the three dose levels up to six patients may be enrolled in each of the two cohorts (NHL and B-ALL). Lymphodepletion is achieved using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day.

Data in the abstract include results as of the data cutoff date of August 1, 2019 for three patients with advanced NHL treated at Dose Level 1, one with mantle cell lymphoma (MCL) and two with diffuse large B cell lymphoma (DLBCL). No significant toxicity was observed, including no serious adverse events and no dose-limiting toxicities. All patients had a minimum follow-up of 28 days (median 60 days).

Findings indicate preliminary evidence of cell-mediated anti-tumor activity, which will be evaluated more fully at subsequent dose levels. Two of the three patients experienced an objective tumor response by Lugano criteria, at day 14 and day 28, respectively. Both patients progressed due to new lesions (on day 28 and day 60, respectively). The third patient, who had previously progressed following treatment with axicabtagene ciloleucel (Yescarta®), an approved anti-CD19 autologous CAR T therapy, had not met the definition of response, but had shown evidence of central necrosis, decreased tumor size, and decreased PET-avidity at day 28, in the context of post-infusion tumor site pain and mild CRS symptoms.

Peripheral blood analysis for CAR T cell expansion has identified preliminary evidence of cell expansion.

This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be shared at the ASH conference.

Precision’s Off-The-Shelf CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy by improving access to care through a well-tolerated lymphodepletion regimen. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

About Precision BioSciences, Inc.
Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, ARCUS. Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

About Precision’s Collaboration with Servier
Under the February 2016 partnership with Baxalta, now with Servier, Precision is solely responsible for early-stage research activities and Phase 1 execution for PBCAR0191, as well as preparation of clinical supply for any Phase 2 clinical trials. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.

Forward-Looking Statements
Information contained in or accessible through this press release contains forward-looking statements. All statements other than statements of present and historical facts contained in or through this press release, including without limitation, statements regarding the potential for PBCAR0191 to provide a therapy option for patients living with NHL or B-ALL. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our quarterly report on Form 10-Q for the quarterly period ended June 30, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Nick Riddle
Precision BioSciences
Tel. (919) 314-5512
IR@precisionbiosciences.com

Media Contact:
Cory Tromblee
Scient Public Relations
Tel. (617) 571-7220
cory@scientpr.com 


Precision BioSciences Appoints Nicholas Riddle, MB, BChir, PhD, as Vice President, Financial Strategy and Investor Relations

DURHAM, N.C., Sept. 30, 2019 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, announced today the appointment of Nicholas Riddle, MB, BChir (MD), PhD, as Vice President, Financial Strategy and Investor Relations. Dr. Riddle joins Precision from J.P. Morgan where he was an Executive Director in the global healthcare investment banking group.

“We are delighted to welcome Nick to Precision to help lead our financial strategy, capital markets and investor engagement activities,” commented Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. “Nick played an important role in our successful IPO earlier this year as a financial advisor to Precision, and we expect his combination of extensive capital markets and corporate finance experience together with his medical scientific background will be a significant asset as we continue to grow as a public company.”

“Having worked closely with Precision in an advisory capacity, I am thrilled to now be part of the team,” commented Dr. Riddle. “Precision’s unique ARCUS technology platform, extensive and rapidly advancing portfolio of therapeutic and food product candidates, and dedicated, pioneering team are special and unique. I am looking forward to helping Precision continue its impressive pace of growth and bring innovative and life-changing therapeutics and food products to patients and consumers.”

Prior to joining Precision, Dr. Riddle spent over a decade working in corporate finance and strategy, investment banking and the capital markets. He was most recently an Executive Director in J.P. Morgan’s healthcare investment banking group where he had broad coverage responsibilities across the global biotechnology and pharmaceutical industries. In this capacity, he helped raise over $10 billion of equity and debt capital for his clients and advised on more than $40 billion of M&A transactions. Earlier in his career Dr. Riddle gained experience as a public market equity analyst at York Capital Management in London. He holds a medical degree and PhD in neurophysiology from Cambridge University.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

Forward-Looking Statements

Information contained in or accessible through this press release contains forward-looking statements. All statements other than statements of present and historical facts contained in this prospectus, including without limitation, statements regarding our future results of operations and financial position, business strategy, prospective products, and timing and likelihood of success may be forward-looking statements. Without limiting the foregoing, the words “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “potential,” the negative thereof and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements reflect various assumptions of Precision’s management that may or may not prove to be correct. No forward-looking statement is a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our quarterly report on Form 10-Q filed with the SEC on August 14, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this presentation, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

This presentation may also contain estimates, projections, and/or other information regarding our industry, our business and the markets for certain of our product candidates, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, clinical trials, studies and similar data prepared by market research firms and other third parties, from industry, medical and general publications, and from government data and similar sources. Information that is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information.

Investor Contact:
Jason Wong
Blueprint Life Science Group
Tel. (415) 375-3340 Ext. 4
jwong@bplifescience.com

Media Contact:
Michael Lampe
Scient PR
Tel. (484) 575-5040
michael@scientpr.com 


Precision BioSciences Reports Second Quarter 2019 Financial Results and Highlights Ongoing Operational Progress

DURHAM, N.C., Aug. 14, 2019 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, today announced financial results for the second quarter ended June 30, 2019, and provided a corporate update.

Key Highlights and Recent Developments

  • Initiated a Phase 1/2a clinical trial of Precision’s first off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191. PBCAR0191 will be evaluated in adult patients with relapsed or refractory (“R/R”) non-Hodgkin lymphoma (“NHL”) or R/R B-cell precursor acute lymphoblastic leukemia (“B-ALL”).
  • Enrolled and dosed patients in the Phase 1/2a clinical trial of PBCAR0191 consistent with expected timelines at three leading US sites with expertise in CAR T cell therapies: Moffitt Cancer Center, Dana Farber Cancer Institute, and City of Hope National Medical Center.
  • Enhanced senior leadership team with key appointments including Chief Medical Officer Christopher R. Heery, MD, and General Counsel, Dario Scimeca.
  • Presented pre-clinical updates for multiple in vivo gene editing programs at the American Society for Gene and Cell Therapy (ASGCT) Annual Meeting.
  • Opened an in-house Current Good Manufacturing Practice (cGMP) compliant manufacturing facility, believed to be the first in the United States dedicated to genome-edited, off-the-shelf CAR T cell therapy product candidates.
  • Celebrated Mario Pennisi, Resident Director of wholly-owned subsidiary Elo Life Systems Inc. (Elo Life Systems), being awarded the BIO Leadership and Legacy Award in Industrial Biotech and Agriculture.
  • Ended the quarter with $226 million in cash and cash equivalents, expected to fund operating expenses and capital expenditure requirements into 2021.

“Following the closing of our successful IPO at the beginning of April, we have continued to leverage the unique capabilities of our proprietary ARCUS genome editing platform for therapeutic and human health applications. We achieved a significant milestone in our mission to deliver transformative, off-the-shelf CAR T cell therapies to cancer patients by dosing the first subjects with our lead allogeneic product candidate, PBCAR0191. Our portfolio of in vivo gene correction candidates continues to progress towards the clinic, and we are excited by the ongoing momentum at Elo Life Systems,” commented Matt Kane, Chief Executive Officer and Co-Founder of Precision. “In the second quarter of 2019, we also successfully expanded our senior leadership team and are pleased to welcome Christopher Heery, MD, as Precision’s first Chief Medical Officer, and Dario Scimeca as General Counsel. In addition, we expect that our newly opened, in-house CAR T cell manufacturing facility, which we believe to be the first of its kind in the United States, will be able to support multiple simultaneous clinical trials and, in time, the commercialization of our product candidates, if approved. Our focus on manufacturing continues to demonstrate our commitment to rapidly deliver our advanced therapeutic candidates to patients in need.”

Other Highlights and Upcoming Milestones

Program updates

  • On April 15, 2019, Precision initiated dosing of its first allogeneic CAR T cell therapy candidate, PBCAR0191, in a Phase 1/2a clinical trial. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. Made from donor-derived T cells modified using Precision’s ARCUS genome editing technology, PBCAR0191 recognizes the tumor cell surface protein CD19, an important and validated target in several B-cell cancers, and is designed to avoid graft-versus-host disease, a significant complication associated with donor-derived, cell-based therapies. Precision believes this to be the first US-based clinical trial to evaluate an allogeneic CAR T therapy for R/R NHL. The trial is designed to assess safety and tolerability of PBCAR0191 at increasing dose levels, with secondary objectives including evaluation of anti-tumor activity. Dosing of subjects continues to progress as planned. Precision expects to present interim data from this trial at a scientific conference no later than the first quarter of 2020.
  • Precision’s second allogeneic CAR T cell therapy product candidate, PBCAR20A, is expected to enter a Phase 1/2a clinical trial in the fourth quarter of 2019. PBCAR20A is wholly owned by Precision and targets the validated tumor cell surface target CD20. It will be investigated in subjects with two subtypes of NHL, chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
  • At the ASGCT Annual Meeting held in Washington, DC from April 29 to May 2, 2019, Precision presented several updates on its in vivo gene editing programs. During the meeting, Precision’s scientists and collaborators shared updates on four pre-clinical programs: hepatitis B (HBV, being developed in partnership with Gilead), autosomal dominant retinitis pigmentosa (adRP), primary hyperoxaluria (PH1), and familial amyloid polyneuropathy (FAP). Discussions with the US Food and Drug Administration (FDA) for the HBV program are planned for the second half of 2019.

Senior management additions

  • On May 14, 2019, Precision announced the first of two significant hires in the second quarter with Christopher R. Heery, MD, joining as the Company’s first Chief Medical Officer (CMO). Dr. Heery has strong experience managing translational clinical programs, having served as head of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute where he was the lead associate investigator of the Phase 1 study of the anti-PD1 immunotherapy avelumab. He also served as CMO at Bavarian Nordic and is board certified in both medical oncology and internal medicine.
  • On June 12, 2019, Precision announced the appointment of Dario Scimeca as General Counsel. Mr. Scimeca joined Precision from Genentech where he supported the development and commercialization of multiple drug products including Rituxan®, Tecentriq®, Gazyva®, Venclexta® and Hemlibra® as associate general counsel. A graduate of UC Berkeley Law School, in his previous roles Mr. Scimeca has overseen US FDA and European Medicines Agency regulatory matters, managed securities and intellectual property litigation, and been responsible for commercial contracts and compliance matters.

Manufacturing Center for Advanced Therapeutics

  • On July 18, 2019, Precision announced the opening of its in-house cGMP compliant manufacturing facility, located in Research Triangle Park, North Carolina, which the Company believes to be the first in the United States dedicated to genome-edited, off-the-shelf CAR T cell therapy product candidates. The Manufacturing Center for Advanced Therapeutics (MCAT) is designed to enable in-house production of three different drug substances: allogeneic CAR T cells, messenger RNA (including formulations development) and adeno-associated viral vectors. Precision intends to use this new manufacturing center to create clinical trial material for its planned Phase 1/2 clinical trials starting in 2020. In the longer term, Precision believes MCAT has the potential to be a commercial launch facility with the capacity to generate up to 10,000 allogeneic doses of CAR T cell therapies and 4,000 doses of gene therapies per year.

Elo Life Systems

  • Also in July 2019, the Company’s wholly owned subsidiary, Elo Life Systems, which is dedicated to creating novel products that enhance the nutrition and diversity of the global food supply, announced that Mario Pennisi, Resident Director of Elo Life Systems – Australia was awarded the prestigious BIO Leadership and Legacy Award in Industrial Biotech and Agriculture. The award is presented to individuals who have shown exemplary leadership and dedicated a significant portion of their career to advancing industrial biotechnology and growing the bio-based economy. This award further demonstrates the depth of talent at Precision, and the pioneering work ongoing at Elo Life Systems.

Upcoming Corporate Presentations

Precision’s senior management team will be presenting and meeting with investors at the following upcoming conferences:

  • Baird Global Healthcare Conference, New York, NY, Sept. 4 – 5, 2019
  • Presentation and panel discussion at The Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa, Carlsbad, CA, Oct. 2 – 4, 2019
  • Chardan Genetic Medicines Conference, New York, NY, Oct. 7 – 8, 2019
  • Jefferies Gene Therapy Summit Presentation, New York, NY, Oct. 9, 2019
  • Stifel 2019 Healthcare Conference, New York, NY, Nov. 19 – 20, 2019
  • Jefferies London Healthcare Conference, London, UK, Nov. 20 – 21, 2019
  • Piper Jaffray Annual Health Care Conference, New York, NY, Dec. 3 – 5, 2019

Second Quarter 2019 Financial Results

Cash and Cash Equivalents: As of June 30, 2019, Precision had approximately $226.1 million in cash and cash equivalents. We expect that existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2021.

Revenues: Total revenues for the quarter ended June 30, 2019 were $5.4 million, compared to $1.9 million for the quarter ended June 30, 2018. This increase was primarily due to research funding from our joint development collaboration partners.

Research and Development Expenses: Research and development expenses were $22.8 million for the quarter ended June 30, 2019, as compared to $10.9 million for the same period in 2018. This increase of $11.9 million was primarily due to increases in platform development and early-stage research expenses due to contract manufacturing costs and an increase in personnel costs and expenses to support our technology platform development and manufacturing capabilities, partially offset by a decrease in direct research and development expenses related to our CD19 program.

General and Administrative Expenses: General and administrative expenses were $6.5 million for the quarter ended June 30, 2019, as compared to $3.1 million for the same period in 2018. The increase of $3.4 million was primarily due to employee-related costs for our additional personnel and facility costs associated with our growing infrastructure needs.

Net Loss: Net loss was $19.4 million, or $(0.39) per share, for the quarter ended June 30, 2019, compared to a net loss of $11.8 million, or $(0.75) per share, for the same period in 2018.

About Precision BioSciences, Inc.

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the promise and potential impact of our ARCUS genome editing technology, expectations for our in vivo gene therapy candidates, timing of our discussions with the FDA, the performance of Elo Life Systems, the timing, objectives, status and the results of clinical studies of our CAR T product candidates and the capabilities of our manufacturing facility. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates; and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Investor Contact:
Jason Wong
Blueprint Life Science Group
Tel. (415) 375-3340 Ext. 4
jwong@bplifescience.com

Media Contact:
Cory Tromblee
Scient Public Relations
Tel. (617) 571-7220
cory@scientpr.com

 


Precision BioSciences Opens First In-House cGMP Manufacturing Facility Dedicated to Genome-Edited Allogeneic CAR T Cell Therapy in the United States

DURHAM, North Carolina, USA, July 18, 2019 – – Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its proprietary ARCUS® genome editing platform, announced today the opening of its Manufacturing Center for Advanced Therapeutics (MCAT), the first in-house current Good Manufacturing Process (cGMP) compliant manufacturing facility in the United States dedicated to genome-edited, off-the-shelf chimeric antigen receptor (CAR) T cell therapy products. This is part of a larger investment by the company in its cancer immunotherapy platform and facilities expansions in North Carolina in 2019. This new facility expands Precision BioSciences’ footprint, adding to a thriving North Carolina life sciences industry and providing opportunities for new high-skill jobs with a focus on manufacturing.

“As part of our mission to overcome cancer and provide valuable new treatment options for patients, we are rapidly advancing a pipeline of next-generation, off-the-shelf CAR T product candidates and we anticipate, once optimized, this platform will be able to support two new clinical programs per year,” said Matt Kane, Chief Executive Officer and co-founder of Precision BioSciences. “Given the potential output of our platform, we’ve known from the beginning that it was critical for us to address the need for scalable manufacturing of cell-therapy products in order to be able to effectively deliver them to patients. In addition to our clinical work, it also has the potential to be a commercial launch facility with the capacity to generate up to 10,000 doses of CAR T cell therapies and 4,000 doses of gene therapies per year.”

Currently, the new facility is undergoing CQV (commissioning, qualification, and validation) in preparation for cGMP manufacturing to begin in the fourth quarter of 2019. It is a multi-product facility designed to produce three different drug substances: allogeneic CAR T cells, messenger RNA (including formulations development) and adeno-associated viral vectors. Precision intends to initially use this new manufacturing center to create clinical trial material for its Phase I/II clinical trials in 2020. Precision BioSciences’ MCAT facility is designed to meet regulatory requirements in the United States, Europe and Japan.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about our manufacturing facility and the output and timing of production processes related thereto. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions. Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates; and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. All forward-looking statements speak only as of the date of this press release, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision BioSciences leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision BioSciences, please visit www.precisionbiosciences.com.


Investor Contact:
Jason Wong
Blueprint Life Science Group
Tel. (415) 375-3340 Ext. 4
jwong@bplifescience.com

Media Contact:      
Michael Lampe
Scient PR
Tel. (484) 575-5040
michael@scientpr.com


Elo Life Systems’ Mario G. Pennisi Awarded BIO Leadership and Legacy Award in Industrial Biotechnology and Agriculture at BIO World Congress

DURHAM, N.C. and BRISBANE, Australia, July 10, 2019 – Elo Life Systems Inc. (“Elo”), a wholly owned subsidiary of Precision BioSciences, Inc. (Nasdaq: DTIL) announced today that Mario G. Pennisi, Resident Director of Elo’s Australian subsidiary located in Brisbane, Australia, received the BIO Leadership and Legacy Award in Industrial Biotech and Agriculture. Mr. Pennisi was honored with this award during the BIO World Congress, which is taking place from July 8-11, 2019 in Iowa. This award is presented to individuals who have shown exemplary leadership and dedicated a significant portion of their career to advancing industrial biotechnology and growing the bio-based economy.

Mario Pennisi has more than 30 years of experience in managing and growing commercial operations in the life sciences industry. He is a member of several committees and advisory groups, including the University of Queensland Medicine and Biomedical Sciences Faculty Board and Schools of Chemistry and Molecular Biosciences Industry Advisory Board. He is a government-appointed member of the QUT Council, the Chairman of Griffith University’s Clinical Trials Advisory Committee and a member of the Queensland Government Biofutures Industry Advisory Group.

“We are incredibly proud of Mario, and this prestigious honor is a testament to his contributions to biotechnology and an unwavering commitment to improving the health and wellness of the planet and its people,” said Fayaz Khazi, Ph.D., Chief Executive Officer of Elo Life Systems. “Mario is a rare talent in this field and we look forward to continuing to advance our company under his leadership.”

“I’m both humbled and honored to receive the BIO Leadership and Legacy Award in Biotechnology and Agriculture,” said Pennisi. “I’ve dedicated my career to helping improve human health through agriculture, but great challenges remain. I look forward to our continued work toward meeting the demand for new, efficient food production systems.”

About Elo Life Systems

Elo Life Systems is a wholly owned subsidiary of Precision BioSciences Inc. Elo’s mission is to create novel products that enhance the nutrition and diversity of global food supply. To address agricultural needs, Elo partners with stakeholders in the food systems value chain, to bridge gaps and meet needs across agricultural productivity, nutritional demand, food security and human wellness. To learn more about Elo and Precision Biosciences please visit www.elolife.ag and www.precisionbiosciences.com.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision BioSciences leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision BioSciences, please visit www.precisionbiosciences.com.


Investor Contact:
Jason Wong
Blueprint Life Science Group
Tel. (415) 375-3340 Ext. 4
jwong@bplifescience.com

Media Contact:      
Michael Lampe
Scient PR
Tel. (484) 575-5040
michael@scientpr.com


Precision BioSciences Announces Presentations at the 14th Annual Terrapinn World Advanced Therapies & Regenerative Medicine Congress & Expo 2019

DURHAM, North Carolina, May 09, 2019 – Precision BioSciences (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS® genome editing platform, announced today that its Chief Scientific Officer, Derek Jantz, Ph.D., and Senior Vice President of Corporate Development, Michael Dombeck will participate in several panel discussions and presentations at the 14th Annual Terrapinn World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 to be held in London, U.K., on May 15-17, 2019.

Title: Translating in vivo genome editing capabilities into therapeutics (Chief Scientific Officer, Derek Jantz, Ph.D.)

Date/Time: May 16, 2:15 PM BST

Title: Panel discussion: Delivering on the Promise of Gene Therapy - Making genetic therapies a reality for patients (Chief Scientific Officer, Derek Jantz, Ph.D.)

Date/Time: May 16, 2:35 PM BST

Title: Company Presentation (Senior Vice President of Corporate Development, Michael Dombeck)

Date/Time: May 16, 4:45 PM BST

Title: Panel discussion: Development strategies for CAR-T and TCR therapies with the late stage in mind (Senior Vice President of Corporate Development, Michael Dombeck)

Date/Time: May 16, 5:05 PM BST

Title: Keynote panel discussion: Exploring advances in gene editing technology, therapeutics and research (Chief Scientific Officer, Derek Jantz, Ph.D.)

Date/Time: May 17, 9:00 AM BST

Additional information can be found on the conference website.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

Forward-Looking Statements

Information contained in or accessible through this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including without limitation, statements related to our product pipeline and clinical development and manufacturing plans.  In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates; and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the SEC under Form 424(b) on March 28, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.


Investor Contact:

Jason Wong

Blueprint Life Science Group

Tel. (415) 375-3340 Ext. 4

jwong@bplifescience.com

 

Media Contact:

Cory Tromblee

Tel. (617) 571-7220

cory@scientpr.com.com


Precision BioSciences Announces Presentations at the 22nd Annual Meeting of the American Society of Gene & Cell Therapy

DURHAM, North Carolina, April 24, 2019 – Precision BioSciences (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS® genome editing platform, announced today its participation in several preclinical presentations and a Genome Editing Workshop presentation at the 22nd Annual Meeting of the American Society of Gene & Cell Therapy (“ASGCT”) to be held in Washington, DC, April 29 – May 2, 2019.

Precision BioSciences Presentations:

Title: Genome Editing Workshop Presentation; Precision BioSciences Chief Scientific Officer Derek Jantz, Ph.D., will speak during the Corporate Review I session.

Session: 1:00-2:00 PM ET, Sunday, April 28 – Jefferson East

Title: A Gene Editing Approach to Eliminate Hepatitis B Virus In Vivo with an ARCUS Meganuclease Evolved to Prevent Off Target Cutting

Session: 5:00-6:00 PM ET, Tuesday, April 30 – Board no. 75

Title: Therapeutic Efficacy of ARCUS Meganuclease Gene Editing for Autosomal Dominant Retinitis Pigmentosa

Session: 10:15-10:30 AM ET, Thursday, May 2 – Jefferson

Presentations from Precision Collaborators:

Title: Gene Editing Approach to Disrupt Hydroxyacid Oxidase 1 for the Treatment of Primary Hyperoxaluria Type 1

Session: 10:30-10:45 AM, ET, Thursday, May 2 – Heights Courtyard 3

Title: Reduction of Transthyretin Expression by AAV Gene Delivery of a Novel Endonuclease in Mice

Session: 11:00-11:15 AM, ET, Thursday, May 2 – Heights Courtyard 3

Abstracts are available on the ASGCT meeting website.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

Forward-Looking Statements

Information contained in or accessible through this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including without limitation, statements related to our product pipeline and clinical development and manufacturing plans.  In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates; and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the SEC under Form 424(b) on March 28, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.


Investor Contact:

Jason Wong

Blueprint Life Science Group

Tel. (415) 375-3340 Ext. 4

jwong@bplifescience.com

 

Media Contact:

Cory Tromblee

Tel. (617) 571-7220

media@precisionbiosciences.com


Precision BioSciences Announces Dosing of First Patient in Off-The-Shelf CAR T Cell Therapy Phase 1/2a Clinical Trial

First NHL patient treated with allogeneic CAR T in US-based trial

DURHAM, North Carolina, April 17, 2019 – Precision BioSciences (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS® genome editing platform, announced today it has dosed the first patient in the Phase 1/2a clinical trial of PBCAR0191, its first gene-edited allogeneic anti-CD19 chimeric antigen receptor (CAR) T cell product candidate. Precision is developing PBCAR0191 in collaboration with Servier, an international pharmaceutical company. PBCAR0191 is made from donor-derived T cells that are modified using Precision’s ARCUS genome editing technology. These edits are designed to generate CAR T cells that specifically recognize CD19, an important target in several B-cell cancers, and to prevent graft-versus-host disease, a significant complication associated with existing donor-derived cell-based therapies. This CAR T cell product candidate is being evaluated in adult patients with relapsed or refractory (“R/R”) non-Hodgkin lymphoma (“NHL”) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) as an off-the-shelf cell therapy. The first patient dosed in this trial is being treated for R/R NHL, and Precision believes this is the first U.S.-based clinical trial to evaluate an allogeneic CAR T therapy for NHL.

This multi-center, open label study of PBCAR0191 is expected to enroll up to 80 patients and several dose levels of PBCAR0191 will be investigated. Clinical sites include City of Hope, Moffit Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. The primary objective of the trial is to evaluate the safety of PBCAR0191 and determine the maximum tolerated dose. Secondary objectives include evaluating the anti-tumor activity of PBCAR0191. Precision will also evaluate the expansion, trafficking and persistence of PBCAR0191 in treated patients. Lymphodepletion will be conducted several days prior to PBCAR0191 infusion. Patient outcomes will be collected for up to one year.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For additional information, please visit www.precisionbiosciences.com

About the Collaboration with Servier

Under their February 2016 partnership with Baxalta, now with Servier, Precision is solely responsible for early-stage research activities and Phase 1 execution for PBCAR0191, as well as preparation of clinical supply for any Phase 2 clinical trials. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including without limitation, the promise and potential impact of our genome editing platform and product candidate PBCAR0191.  In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding; our limited operating history; our ability to identify, develop and commercialize our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; our or our collaborators’ ability to identify, develop and commercialize product candidates; our or our collaborators’ ability to advance product candidates into, and successfully complete, clinical or field trials; our or our collaborators’ ability to obtain and maintain regulatory approval of future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the regulatory landscape that will apply to our and our collaborators’ development of product candidates; our ability to achieve our anticipated operating efficiencies as we commence manufacturing operations at our new facility; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; the potential for off-target editing or other adverse events, undesirable side effects or unexpected characteristics associated with any of our product candidates; the success of our existing collaboration agreements; our ability to enter into new collaboration arrangements; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; potential manufacturing problems associated with any of our product candidates; potential liability lawsuits and penalties related to our technology, our product candidates; and our current and future relationships with third parties; and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the SEC under Form 424(b) on March 28, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.

All forward-looking statements speak only as of the date of this press release, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.


Investor Contact:
Jason Wong
Blueprint Life Science Group
Tel. (415) 375-3340 Ext. 4
jwong@bplifescience.com

Media Contact:
Heather King
Tel. (919) 973-9431
media@precisionbiosciences.com


Precision BioSciences Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

DURHAM, North Carolina, April 1, 2019 – Precision BioSciences (Nasdaq: DTIL) (“Precision”), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, today announced the closing of its initial public offering of 9,085,000 shares of common stock, which includes the full exercise of the underwriters’ option to purchase 1,185,000 additional shares of common stock, at a public offering price of $16.00 per share. The total gross proceeds to Precision were approximately $145.4 million, before deducting underwriting discounts and commissions and expenses payable by Precision. All of the shares were sold by Precision. The shares commenced trading on the Nasdaq Global Select Market under the ticker symbol “DTIL” on Thursday, March 28, 2019.

J.P. Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays acted as joint book-running managers for the offering.

A registration statement relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission on March 27, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained by contacting: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204 or email: prospectus-eq_fi@jpmchase.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone: (866) 471-2526, facsimile: (212) 902-9316, or email: prospectus-ny@ny.email.gs.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone:  (877) 547-6340 or email: Prospectus_Department@jefferies.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone: (800) 603-5847.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Precision BioSciences

Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For additional information, please visit www.precisionbiosciences.com


Investor Contact:
Jason Wong
Blueprint Life Science Group
Tel. (415) 375-3340 Ext. 4
jwong@bplifescience.com

Media Contact:
Susan Heins
Tel. (864) 346-8336
media@precisionbiosciences.com


Elo Life Systems Announces a Collaboration With Ashland Subsidiary Avoca to Scale a Sustainable, Key Input for Fragrances

DURHAM, NORTH CAROLINA – February 25, 2019 – Elo Life Systems Inc. announced today a collaboration with Avoca LLC, a subsidiary of the specialty chemicals company Ashland, that is focused on improving the production of Clary Sage plants and a related compound called Sclareol.

Sclareol is a key component used by the fragrance industry to manufacture a sustainable substitute for a waxy substance secreted by a small percentage of sperm whales called ambergris. Avoca is one of the world’s primary manufacturers and suppliers of Sclareol extracted from Clary Sage.

“Elo’s business model is designed to enable the seamless integration of our innovative agricultural technologies with Avoca’s ability to rapidly translate them into a product,” said Elo Life Systems CEO Fayaz Khazi, PhD. “With such collaborative approaches, our technologies are positioned to deliver improved and sustainable products to the customer through our partners.”

“Avoca is pleased to utilize Elo’s technology to improve the production of Sclareol in Clary Sage plants,” said Avoca LLC President David Peele, PhD. “The future of our industry depends on utilizing new technologies to increase yields and improve operating efficiencies. This collaboration further strengthens Ashland’s bounty of sustainability solutions.”

About Elo Life Systems 

Elo Life Systems is a wholly owned subsidiary of Precision BioSciences Inc. Our mission is to create novel products that enhance the nutrition and diversity of global food supply. To address agricultural needs, Elo partners with stakeholders in the food systems value chain, to bridge gaps and meet needs across agricultural productivity, nutritional demand, food security and human wellness. To learn more about Elo and Precision Biosciences please visit  www.elolife.ag and www.precisionbiosciences.com

About Ashland

Ashland Global Holdings Inc. (NYSE: ASH) is a premier global specialty chemicals company serving customers in a wide range of consumer and industrial markets, including adhesives, architectural coatings, automotive, construction, energy, food and beverage, nutraceuticals, personal care and pharmaceutical. At Ashland, we are approximately 6,000 passionate, tenacious solvers – from renowned scientists and research chemists to talented engineers and plant operators – who thrive on developing practical, innovative and elegant solutions to complex problems for customers in more than 100 countries. Visit www.ashland.com to learn more.

View Document


Contact Elo Life Systems

Media Relations Elo:
Adam Fisher
+1 919 314 5512
afisher@elolife.ag


Science Article About the Quest to Cure HBV Brings Context to Precision BioSciences Collaboration With Gilead

Precision BioSciences is pleased to be part of this important feature story from Science Magazine:

Forgotten No More – A long-overlooked scourge of millions, hepatitis B is in the crosshairs at last

You can read more about the collaboration between Gilead and Precision to develop therapies against hepatitis B virus using ARCUS genome editing here.


View Document

Heather King
+1 919-314-5512
heather.king@precisionbiosciences.com


Gilead Sciences and Precision BioSciences Announce Collaboration to Develop Therapies Against Hepatitis B Virus Using ARCUS Genome Editing

FOSTER CITY, Calif. and DURHAM, NC, Sept 12, 2018 – Gilead Sciences (Nasdaq: GILD) and Precision BioSciences announced today that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS.

An estimated 257 million people are living with HBV infection around the world. Current HBV treatments suppress HBV viral replication but do not completely clear the virus. The presence of covalently closed circular DNA (cccDNA) enables HBV replication if treatment is stopped. Preliminary studies at Gilead using ARCUS nucleases to target HBV cccDNA in vitro have demonstrated significant activity against cccDNA and integrated HBV DNA in human hepatocytes.

“Gilead is committed to developing innovative therapies to achieve functional cure for patients with chronic hepatitis B virus infection,” said John McHutchison, MD, Chief Scientific Officer and Head of Research and Development at Gilead. “We are excited about the potential of genome editing and Precision’s ARCUS technology, which has demonstrated promising in vitro activity. We look forward to exploring this technology as an important component of our HBV cure research efforts.”

Under the terms of the collaboration agreement, Precision will be primarily responsible for the development, formulation, and preclinical evaluation of the investigational nucleases, and Gilead will be responsible for the clinical development and commercialization of potential therapies. Gilead will fully fund the research and development. Precision is eligible to receive milestone payments of up to an aggregate of $445 million and tiered royalties that go up to the mid-teens for commercial products developed through the collaboration.

Precision Chief Scientific Officer Derek Jantz commented, “Gilead’s cure-based approach to hepatitis B is comprehensive and exciting. Precision is pleased that initial studies with our ARCUS platform have established an important role for genome editing in their HBV program. This is an excellent application for our technology, which has made notable progress toward therapeutic in vivo editing in relevant models over the last year.”

About Precision BioSciences

Precision BioSciences is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are striving to achieve this goal with ARCUS, our therapeutic-grade, naturally-derived genome editing system that combines both specificity and efficacy to help overcome life’s greatest genetic challenges. For additional information, please visit www.precisionbiosciences.com

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the parties may not realize the potential benefits of this collaboration. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.


View Document

Contact

Sung Lee, Gilead Investors
650-524-7792

Amy Flood, Gilead Media
650-522-5643

Heather King, Precision Media
919-314-5512 x1332


Penn Announces Publication of Clinically Relevant Genome Editing in Primates Using Precision's ARCUS Platform

Durham, NC July 09, 2018 – The University of Pennsylvania’s Perelman School of Medicine announced today that researchers from Jim Wilson’s Gene Therapy Program have found that using Precision’s ARCUS genome editing platform to inactivate PCSK9 in the liver effectively and sustainably reduces LDL cholesterol levels in non-human primates. This work was published today in Nature Biotechnology (Meganuclease targeting of PCSK9 in macaque liver leads to stable reduction in serum cholesterol).

The University of Pennsylvania’s press release is copied below and also available here.

Genome Editing Reduces Cholesterol in Large Animal Model, Laying the Groundwork for In-Human Trials 
Penn study finds genome editing in non-human primates highlights opportunities and challenges for future clinical trials

(Phildelphia) – Using genome editing to inactivate a protein called PCSK9 effectively reduces cholesterol levels in rhesus macaques, a species of monkey, according to researchers from the Perelman School of Medicine at the University of Pennsylvania. This is the first demonstration of a clinically relevant reduction of gene expression in a large animal model using genome editing. The team published their study this week in Nature Biotechnology, in whichthey describe a possible new approach for treating heart disease patients who do not tolerate PCSK9 inhibitors—drugs that are commonly used to combat high cholesterol.

Normally, the PCSK9 protein prevents receptors from removing excess LDL (“bad” cholesterol) in the liver. In the clinic, it has also been shown that inhibiting PCSK9 can lower LDL in humans. However, some patients with hypercholesterolemia—an extreme form of cardiovascular disease—do not tolerate these drugs. This study suggests that genome editing shows promise as a therapeutic approach for these patients.

“Most often these patients are treated with repeated injections of an antibody to PCSK9,” said first author Lili Wang, PhD, a research associate professor in Medicine. “But, our study shows that with successful genome editing, patients who cannot tolerate inhibitor drugs might no longer need this type of repeat treatment.”

Coauthors at Precision BioSciences, a biotech firm in Durham, NC, engineered an enzyme called a meganuclease to specifically recognize and inactivate the PCSK9 gene. In this study, the scientists employed an adeno-associated virus (AAV) vector carrying the meganuclease to disrupt the PCSK9 gene in the primates’ liver.

In animals treated with middle- and high-dose AAV vectors, PCSK9 levels reduced by 45 to 84 percent and LDL levels reduced by 30 to 60 percent, both clinically relevant and stable reductions. Molecular analyses of biopsied liver tissue also demonstrated that genome editing induced mutations in 40 to 65 percent of the PCSK9 genes. Importantly, the AAV vector doses used in this study have been safely and effectively used in clinical trials of AAV gene replacement therapy for patients with hemophilia.

“Our initial work with several delivery and editing approaches produced the most impressive data in non-human primates when we paired AAV for delivery with the engineered meganuclease for editing,” said senior author James M. Wilson, MD, PhD, a professor of Medicine and Pediatrics and director of the Gene Therapy Program at Penn. “We leveraged our 30-plus years of experience in gene therapy to progress the translational science of in vivo genome editing, and in doing so, reinforced the importance of early studies in nonhuman primates to assess safety and efficacy.”

Future studies will focus on ways to mitigate immune toxicity and the occurrence of editing in targets outside of the desired site within the PCSK9 gene. In addition to patients with hypercholesterolemia, these data should also inform potential use of this approach for a broad spectrum of liver metabolic diseases caused by mutations in other genes.

Other Penn authors include Jeff Smith, Janel Lape, Victor V. Bartsevich, along with Derek Jantz from Precision Biosciences. Camilo Breton, Peter Clark, Jia Zhang, Lei Ying, Yan Che, Peter Bell, Roberto Calcedo, Elizabeth L. Buza, Alexei Saveliev, Zhenning He, John White, and Mingyao Li are also coauthors.

The study was supported by Penn Medicine and Precision Biosciences.

About Precision BioSciences
Precision BioSciences is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are striving to achieve this goal with ARCUS, our therapeutic-grade, naturally-derived genome editing system that combines both specificity and efficacy to help overcome life’s greatest genetic challenges.


Contact Precision BioSciences

Heather King
+1 919-314-5512
heather.king@precisionbiosciences.com