CAR T Explainer

What do frozen samurai warriors and magic goggles have to do with treating cancer?

Join Precision BioSciences Chief Science Officer Derek Jantz on a journey into the future of cancer therapies and learn how ARCUS—Precision's genome editing technology—is used to make allogenic, donor-derived CAR T cell therapies with the potential to change the way the world battles cancer.



ASH Poster 2019

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


Precision BioSciences Welcomes Healthcare Industry Expert, Kevin J. Buehler, to its Board of Directors

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 pioneering, proprietary ARCUS® platform, announced today that Kevin J. Buehler, former CEO of Alcon Laboratories, has been appointed to its Board of Directors, which took effect following the company’s third quarter board meeting held on November 8, 2019.

“Kevin has worked in the healthcare industry for over thirty years, with extensive leadership and business experience in international operations, R&D and business development, and we are thrilled to have him join our Board,” said Matt Kane, CEO and co-founder of Precision BioSciences. “We have reached a transformative moment for Precision with the recent publication of our first clinical data from our off-the-shelf (allogeneic) CAR T portfolio, and our in vivo gene correction and food pipelines continue to advance, underscoring the great potential of our unique ARCUS platform. Our vision is to build a fully integrated, leading genome editing company that successfully addresses the core challenges of human health. Kevin’s wealth of experience in leading public healthcare companies through periods of exceptional growth will be a great asset to Precision as we navigate these challenges and opportunities. I would also like to take this opportunity to thank Dr. Robert Adelman, who is leaving our Board. Rob’s guidance and support has been invaluable to the success Precision has achieved so far.”

Mr. Buehler has over thirty years of experience in the healthcare industry. He spent the majority of his career with Alcon Laboratories, a publicly traded ophthalmology-focused healthcare company headquartered in Fort Worth, Texas. At Alcon, Mr. Buehler rose through the commercial organization, eventually becoming CEO, leading the company’s sale to Novartis and subsequently serving as Alcon division head within Novartis. He will assume the chairmanship of Precision’s Nominating and Corporate Governance Committee (replacing Mr. Kane), and will also join the company’s Audit Committee (replacing Dr. Adelman).

“As an advisor to healthcare companies, it is my goal to help shape growth strategies that ultimately bring differentiated treatments to patients in the U.S. and globally,” said Mr. Buehler. “Precision BioSciences is developing cutting-edge and potentially best-in-class off-the-shelf CAR T therapies and in vivo gene correction approaches that have the potential to transform treatment options for patients around the world. Precision’s food and agriculture subsidiary, Elo Life Systems, is developing solutions to improve and sustain the global food supply. I am very impressed by the quality of Precision’s science and team, and I am excited to work with the company to maximize the potential of their unique portfolio.”

Mr. Buehler holds a Bachelor of Arts degree from Carroll University in Waukesha, WI, with concentrations in Business Administration and Political Science. He graduated from the Harvard Program for Management Development in 1993. Mr. Buehler possesses public company board experience with prior service on the Alcon Laboratories Board of Directors. He also serves on the Carroll University Board of Trustees and previously served on the Boards of Directors of Acelity and AdvaMed.

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.


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 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 Appoints David Thomson, PhD, as Chief Operating Officer

DURHAM, North Carolina, USA, Sept. 23, 2019 – 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 David Thomson, PhD, has been appointed to the position of Chief Operating Officer. Dr. Thomson has served as Precision’s Chief Development Officer since 2017.

“David has made a dramatic impact since joining Precision over two years ago, and I am delighted that he is taking on these new responsibilities at a critical time when we believe our pace of growth is accelerating, and our CAR T cancer immunotherapy, in vivo gene correction and food portfolios are progressing at pace,” commented Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences.

“Under David’s leadership as Chief Development Officer, we have achieved numerous significant milestones, including successfully advancing our first off-the-shelf CAR T therapy candidate PBCAR0191 into the clinic and receiving FDA clearance to begin clinical trials with our second, PBCAR20A. He has been central to the ongoing momentum in our preclinical activities in both CAR T and in vivo gene correction and was instrumental to Precision opening the Manufacturing Center for Advanced Therapeutics (MCAT) earlier this year, believed to be the first in-house cGMP compliant manufacturing facility dedicated to genome edited, off-the-shelf CAR T cell therapy product candidates in the United States. We expect this pace of progress to only accelerate – as Chief Operating Officer, David will spearhead operational excellence across all of Precision’s activities and ensure that, even as our portfolio expands, we continue to deliver on the enormous potential of our unique programs to address the core challenges of human health.”As Chief Development Officer, I have had the privilege of leading a team that has translated the potential of our innovative ARCUS® editing platform into preclinical success, and delivered therapeutic candidates into the clinic that have truly life-changing potential for patients,” commented Dr. Thomson. “Precision is entering a new and tremendously exciting period of growth, and we expect to soon have multiple allogeneic CAR T therapy candidates in ongoing clinical trials, an accelerating portfolio of in vivo gene correction programs, and growing momentum at our Elo Life Systems food-focused subsidiary. I am honored to become Precision’s Chief Operating Officer and look forward to applying my operational leadership experience to advance Precision’s unique and innovative therapeutic and food product candidates through development and into commercialization.”

his role as Chief Development Officer, Dr. Thomson has been responsible for shaping and executing Precision’s preclinical, clinical and manufacturing strategy. He successfully led preclinical development, manufacturing process optimization and investigational new drug (IND) application approvals for Precision’s first two allogeneic CAR T therapy candidates, PCAR0191 and PBCAR20A, oversaw dosing of the first patient in the company’s first clinical trial, led the opening of MCAT, and advanced multiple preclinical programs. Prior to joining Precision, Dr. Thomson most recently served as Senior Vice President, Research and Nonclinical Development for Shire Plc (Shire), where he was responsible for the strategy and operational direction of the Global Research and Nonclinical Development Organization, including transitioning programs from research into clinical development and supporting programs through commercialization. Earlier in his career he served as Senior Vice President and Global Head, Research and Development Operations for Shire. He received a BSc in chemistry from the University of Strathclyde, a PhD in organic chemistry from the University of Toronto and completed post-doctoral work at Yale 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 growth pace and the progression of our prospective portfolios and product candidates, the timing of planned and clinical trials and likelihood of success, as well as plans and objectives of management for future operations, 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 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:      
Michael Lampe
Scient PR
Tel. (484) 575-5040
michael@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


Precision BioSciences Appoints Dario Scimeca as General Counsel

DURHAM, North Carolina, USA, June 12, 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 that Dario Scimeca has joined Precision BioSciences as General Counsel.

“Dario’s impressive resume and accomplishments over the last ten years at Genentech and Élan Pharmaceuticals, including navigating strategic partnerships, reflect his strong understanding of the legal needs facing companies like Precision BioSciences,” said Matt Kane, Chief Executive Officer and co-founder of Precision BioSciences. “He is a great fit, and I am excited to welcome him to our team.”

“As in-house counsel for companies that develop and commercialize innovative therapies, I view helping those with unmet medical needs as the ultimate goal of my work,” said Mr. Scimeca. “Precision BioSciences is not only developing cutting-edge therapies but also working to solve important agricultural problems, and I am excited to work with the team toward making a significant, positive impact on medicine, nutrition and the environment in my new role.”

Prior to joining Precision BioSciences, Mr. Scimeca served as associate general counsel for Genentech, a world leader in biotechnology and oncology therapeutics, where he supported the development and commercialization of multiple drug products including Rituxan®, Tecentriq®, Gazyva®, Venclexta® and Hemlibra®.  Before that, he was corporate counsel at Élan Pharmaceuticals, one of the world’s leading neuroscience-based biotechnology companies, where his primary functions included oversight of FDA and EMA regulatory matters, management of securities and intellectual property litigation, and responsibility for commercial contracts and compliance matters. Earlier in his career, Mr. Scimeca was a corporate associate at Cooley LLP and at Heller Ehrman LLP and a litigation associate at Farella Braun + Martel LLP. He attended law school at University of California, Berkeley and served as a law clerk for the Honorable James L. Dennis of the United States Court of Appeals for the Fifth Circuit.

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 Appoints Christopher R. Heery, M.D., as Chief Medical Officer

DURHAM, North Carolina, USA, May 14, 2019 – Precision BioSciences (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its proprietary ARCUS® genome editing platform, announced today that Christopher R. Heery, M.D. has joined Precision BioSciences as its Chief Medical Officer.

“We are thrilled to welcome Chris Heery as our Chief Medical Officer. Chris has exceptional experience in the rapidly evolving field of cell therapies and has led many first-in-human clinical trials during his time at the National Cancer Institute (NCI). We believe his skill set and experience are a perfect fit to guide our off-the-shelf immunotherapy and in vivo gene correction programs through human clinical trials,” said Matt Kane, Chief Executive Officer and co-founder of Precision BioSciences.

Chief Development Officer, David Thomson, commented, “Chris brings a highly unique and sought-after skill set to Precision BioSciences. He has been a translational clinical trialist at one of the world’s preeminent research institutions, NCI, where his first-in-human immunotherapy clinical trials included a Phase 1 study of an anti-PD-L1 treatment (avelumab) that is now approved for use in the United States. Chris’s most recent experience as Chief Medical Officer at Bavarian Nordic has given him a strong understanding of regulatory requirements, clinical trial oversight, and leadership that will allow him to play a key role in helping Precision BioSciences build a successful clinical organization. We look forward to advancing our clinical pipeline under Chris’s leadership.”

Prior to joining Precision BioSciences, Dr. Heery most recently served as Chief Medical Officer of Bavarian Nordic, where he oversaw clinical development programs for its immune-oncology and infectious diseases portfolios. Prior to this, he was Head of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at NCI. He joined the NCI Medical Oncology Branch as a Medical Oncology Fellow in 2009 and also served as an Adjunct Appointment in the Genitourinary Malignancies Branch. He was part of the larger effort of the Laboratory of Tumor Immunology and Biology to create new immunotherapies for the treatment of cancer. Dr. Heery is board certified in Medical Oncology and Internal Medicine and received his M.D. from East Carolina University Brody School of Medicine. He completed his internal medicine residency at the University of Illinois at Chicago. Dr. Heery completed his undergraduate studies at Duke University, where he received a BA in English Literature.

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.

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 success as a clinical organization and our advancement of our product candidates.  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:      
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 Reports First Quarter 2019 Financial Results

DURHAM, North Carolina, USA, April 29, 2019 – Precision BioSciences, a genome editing company dedicated to improving life (Nasdaq: DTIL) (“Precision”) through the application of its proprietary ARCUS genome editing platform, announced today financial and corporate results for the first quarter 2019 and provided an overview of recent accomplishments and upcoming events.

Key Highlights and Recent Developments
• Executed private financing and initial public offering (IPO) on Nasdaq for combined net proceeds to Precision of over $170 million
• Bolstered Board of Directors with addition of Raymond Schinazi, PhD
• Initiated patient dosing for Phase 1/2a clinical trial of off-the-shelf CAR T cell therapy

“The first quarter was truly transformative for Precision BioSciences, as we completed our successful initial public offering, further strengthening our ability to deliver on the promise of ARCUS genome editing,” said Matt Kane, Chief Executive Officer and co-founder. “Since the completion of our IPO, we have transitioned to a clinical stage company with the dosing of the first patient in a Phase 1/2a clinical trial of our lead allogeneic CAR T therapy, targeting CD19 for the treatment of non-Hodgkin lymphoma and acute lymphoblastic leukemia. We believe our team and technology have the potential to bring meaningful benefits to the lives of many.”

On March 27th, the Company priced the initial public offering of its common stock, which was underwritten by J.P Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays who served as joint book-running managers for the offering. The IPO closed on April 1, 2019 with gross proceeds to Precision of $145.3 million before underwriting discounts, commissions and offering costs. Precision issued 9,085,000 shares of common stock, inclusive of the underwriters’ overallotment option, at an offering price of $16.00 per share. The IPO was preceded by a private convertible financing of approximately $40 million. Following the closing of the IPO, Precision had approximately 50.4 million shares of common stock outstanding, including shares of preferred stock and convertible promissory notes that converted into common stock.

Earlier in the quarter, on March 14th, the Company appointed Raymond Schinazi, PhD, Hon DSc to its board of directors. Dr. Schinazi is the Frances Winship Walters Professor of Pediatrics and director of the Laboratory of Biochemical Pharmacology at Emory University. A world leader in nucleoside chemistry, he is best known for his pioneering work on HIV, HBV, and HCV drugs d4T (stavudine, Zerit), 3TC (lamivudine, Epivir), FTC (emtricitabine, Emtriva), LdT (telbivudine, Tyzeka), and sofosbuvir (Sovaldi), which are all approved by the US FDA and EMEA. More than 94% of HIV-infected individuals in the US on combination therapy take at least one of the drugs he invented, and he has founded or co-founded several pharmaceutical companies, including Triangle Pharmaceuticals, Idenix Pharmaceuticals, and Pharmasset, Inc.

Recently, on April 17th, Precision initiated patient dosing in the Phase 1/2a clinical trial of an allogeneic CAR T cell therapy program, PBCAR0191, which 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 CAR T cell therapy. Precision believes this is the first US-based clinical trial to evaluate an allogeneic CAR T cell therapy for NHL. 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.

Upcoming Events

  • 22nd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), April 29 – May 2, 2019
  • Jefferies U.S. Healthcare Conference, June 4 – 7, 2019
  • Goldman Sachs 40th Annual Global Healthcare Conference, June 11 – 13, 2019
  • Raymond James Life Sciences & MedTech Conference, Jun 18 – 19, 2019

First Quarter 2019 Financial Results

Revenues: Total revenues for the quarter ended March 31, 2019 were $5.5 million, compared to $1.5 million for the quarter ended March 31, 2018. This increase was primarily related to research funding from our joint development collaboration partners.

Research and Development Expenses: Research and development expenses were $19.9 million for the first quarter of 2019, as compared to $8.1 million for the same period in 2018. This increase of $11.8 million was primarily due to increases in direct research and development expenses including contract manufacturing costs, as well as an increase in personnel costs and expenses to support our technology platform development and manufacturing capabilities.

General and Administrative Expenses: General and administrative expenses were $5.0 million for the first quarter of 2019, as compared to $2.6 million for the same period in 2018. The increase of $2.4 million was primarily due to additional personnel and facility costs associated with our growing infrastructure needs.

Net Loss: Net loss was $31.8 million, or $1.99 per share, for the first quarter of 2019, compared to a net loss of $9.0 million, or $0.57 per share, for the same period in 2018.

Cash and Cash Equivalents: As of March 31, 2019, Precision had approximately $116.5 million in cash and cash equivalents, including proceeds of approximately $40 million from a private convertible financing and excluding the net proceeds of $130.9 million from Precision’s IPO. Precision expects that existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operating expenses and capital expenditure requirements through 2020.

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

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 and the timing and the results of any clinical studies of our CAR T product candidates. 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” 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.


Contacts

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

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


Precision BioSciences Announces Pricing of Initial Public Offering

DURHAM, North Carolina, USA, March 28, 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 pricing of its initial public offering of 7,900,000 shares of common stock at a public offering price of $16.00 per share, for total gross proceeds of $126.4 million, before deducting underwriting discounts and commissions and expenses payable by Precision. In addition, Precision has granted the underwriters a 30-day option to purchase up to 1,185,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Precision. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “DTIL” on Thursday, March 28, 2019. The offering is expected to close on April 1, 2019, subject to customary closing conditions.

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

A registration statement relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 27, 2019. This offering is being made only by means of a prospectus. When available, 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, by 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
susanheins1@gmail.com

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Raymond Schinazi Joins Precision BioSciences Board of Directors

DURHAM, North Carolina, USA, March 14, 2019 –Precision BioSciences (“Precision”), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, has appointed Raymond Schinazi, PhD, Hon DSc to its board of directors. Dr. Schinazi is the Frances  Winship Walters Professor of Pediatrics and director of the Laboratory of Biochemical Pharmacology at Emory University.

“The cutting-edge technology developed by the Precision BioSciences team provides new opportunities to combat viral diseases like hepatitis B virus (HBV),” said Dr. Schinazi. “Their proprietary genome editing platform, ‘ARCUS,’ has the potential to enable alternative innovative therapies to safely and efficiently silence genes essential for viruses that cause significant human morbidity and mortality.”

“Dr. Schinazi’s expertise in virology and preclinical and clinical drug development will be invaluable as our company continues the development of our platform to tackle the problem of HBV and other viruses,” said Precision CEO Matt Kane. “His dedication to addressing unmet need in viral disease and his understanding of ARCUS at the mechanistic level make him an ideal board member as we work to build an innovative antiviral genome editing program.”

Dr. Schinazi’s distinguished career in drug discovery includes co-founding several biotechnology companies, including Triangle Pharmaceuticals and Pharmasset, Inc. He is also a Charter Fellow of the National Academy of Inventors and a Fellow of the American Society of Microbiology. He received a BSc and PhD in chemistry and DSc in biotechnology from the University of Bath. Dr. Schinazi also serves on the board of directors of Brace Pharma Capital and the board of trustees of amfAR.  

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

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Contact

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