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.
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.
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.
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.
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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.
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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
Precision BioSciences Raises $110M to Advance ARCUS Genome Editing Programs
DURHAM, North Carolina, USA, June 26 2018 –Precision BioSciences today announced the closing of an oversubscribed $110M Series B financing to further product development efforts based on its ARCUS® genome editing platform. The financing was led by ArrowMark Partners and was joined by new investors Franklin Templeton Investments, Cowen Healthcare Investments, Brace Pharma Capital, Pontifax AgTech, OCV Partners, Adage Capital Management, Cormorant Asset Management, Gilead Sciences, Vivo Capital, Alexandria Venture Investments, Ridgeback Capital, Agent Capital, and entities affiliated with Leerink Partners. Existing investors venBio, F-Prime, RA Capital Management, Amgen Ventures, Osage University Partners, DUMAC, and the Longevity Fund also participated in the financing.
Precision intends to expand applications of its ARCUS genome editing platform in the areas of immuno-oncology, genetic disease, and food on its way to building a fully integrated biotechnology company. ARCUS is Precision’s proprietary, homing endonuclease-derived genome editing platform that leverages the small size and high specificity of a natural genome editing system. During 2018, Precision plans to utilize the proceeds from this financing to accelerate and expand its product portfolio. Specifically, Precision targets taking its lead, off-the-shelf CAR-T product into the clinic while advancing both its lead in vivo gene therapy program into IND-enabling studies and its flagship food program into field trials.
“We are thrilled to have such strong support from these leading healthcare investors who share in our vision for the future of human health through innovations in food and medicine,” said Matt Kane, CEO of Precision. “This financing provides us with a strong foundation from which we can advance our translational genome editing programs in multiple sectors.”
In conjunction with the Series B financing, Tony Yao of ArrowMark Partners has joined the Precision Board of Directors alongside existing directors Matt Kane, Derek Jantz, CSO of Precision, and Robert Adelman of venBio.
“We believe that Precision’s core gene editing technology represents a new way to alter the genome, and we are utilizing this technology to address several areas of great unmet need,” said Tony Yao, M.D., Ph.D. “I look forward to working with the team as we advance our programs.”
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
Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, LLP acted as outside counsel to Precision in connection with the financing.
Contact Precision BioSciences
Heather King
+1 919-314-5512
heather.king@precisionbiosciences.com
Precision BioSciences CSO to Join Gene Therapy Session at DIA 2018
DURHAM, North Carolina, USA, June 20 2018 – Precision BioSciences CSO Derek Jantz will present and join a panel discussion during the DIA (Drug Information Association) 2018 conference session #285, Gene Therapy: Advances in Translating Technology. Dr. Jantz will share Precision’s approach to advancing genome editing into the clinic and his perspectives from over 20 years of designing and developing gene editing tools for therapeutic applications. The panel will be chaired by Peter Marks, Director of CBER at FDA, and will also include Terence Flotte, Dean of the School of Medicine at University of Massachusetts; David Davidson, CMO at bluebird bio; and Michael Havert, CMC reviewer at the FDA. This session will address the existing regulatory framework as well as recent advances in the field of gene therapy.
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 DIA
DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities.
Contact Precision BioSciences
Heather King
+1 919-314-5512
heather.king@precisionbiosciences.com
Precision BioSciences to Present In Vivo Gene Therapy and Ex Vivo Cancer Immunotherapy Data at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting
DURHAM, North Carolina, USA, May 14 2018 – Precision BioSciences, the ARCUS genome editing company with novel product development programs in gene therapy, cancer immunotherapy and non-GMO food, will give three presentations at the upcoming ASGCT 21st Annual Meeting held in Chicago, Illinois, May 16-19, 2018.
Precision’s co-founder and CSO, Derek Jantz, will attend the conference along with a group of Precision scientists. He notes,
“The Precision team is looking forward to participating in the research dialogue at ASGCT this year. We are particularly eager to share our experiences towards developing an in vivo gene editing solution, including results of extensive NHP testing. We will also present new data from our gene-edited allogeneic T cell platform, including manufacturing results for our lead CAR T program.”
Precision BioSciences presentations at ASGCT include:
1. Development and Optimization of a PCSK9-Specific Meganuclease That Mediates Long-Term LDL Reduction in Non-Human Primates (#658; follows content of #657).
Oral Session Title: Cardiovascular and Pulmonary Diseases
Date and Time: Friday, May 18, 2018, 4:00 p.m. – 5:45 p.m. CDT
Location: International Ballroom South
2. Development of a Clinical-Grade Meganuclease for Allogeneic CAR T Cell Production (#784).
Poster Session Title: Cell Therapies III
Session Date and Time: Friday, May 18, 2018, 5:45 p.m. – 7:45 p.m. CDT
Location: Stevens Salon C & D
3. A P23H RHO-Specific Meganuclease Rescues Photoreceptor Morphology and Function in Mouse Models of Retinitis Pigmentosa (#565).
Poster Session Title: Neurologic Diseases II
Session Date and Time: Thursday, May 17, 2018, 5:15 p.m. – 7:15 p.m. CDT
Location: Stevens Salon C & D
About Precision BioSciences
Precision BioSciences is a biotechnology company dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet through innovative scientific solutions and with a focus on genome editing. ARCUS®, Precision’s unique, therapeutic-grade genome editing system combines the specificity and efficacy required to translate the promise of gene editing into life changing gene therapies, cell therapies, and agricultural products.
About The American Society of Gene & Cell Therapy
ASGCT is the primary membership organization for scientists, physicians, professionals, and patient advocates involved in gene and cell therapy. The Society’s mission is to advance knowledge, awareness and education leading to discovery and clinical application of gene and cell therapies to alleviate disease. ASGCT’s vision is to serve as a catalyst to transform medicine by advancing gene and cell therapies to benefit patients and society.
Contact Precision BioSciences
Heather King
+1 919-314-5512
heather.king@precisionbiosciences.com
Precision BioSciences Announces Appointment of Gene Liau, Ph.D. and Bruce McCreedy, Ph.D. to Management Team
RESEARCH TRIANGLE PARK, North Carolina, September 2nd, 2015 – Precision BioSciences, the genome editing company, today announced two key additions to the executive team – Gene Liau, Ph.D., as Senior Vice President, Gene Therapy and Bruce McCreedy, Ph.D., as Senior Vice President, Cell Therapy.
“We are excited to welcome Gene and Bruce to the Precision team,” said Matthew Kane, Chief Executive Officer of Precision BioSciences. “Their proven leadership and breadth of experience will undoubtedly prove critical to our gene and cell therapy product development programs. Together, we will work to transform our class-leading ARCUS editing platform into a highly disruptive product pipeline within oncology and genetic disease.”
Dr. Liau joins Precision from Pfizer where, as Executive Director, he led External R&D for the Rare Disease Unit and spearheaded the Pfizer Gene Therapy initiative. Prior to Pfizer, Dr. Liau led groups at Novartis and Shire working on cardiovascular/metabolic diseases, gene therapy, and rare diseases. Before entering industry, Dr. Liau was a Tenured Professor at the George Washington University Medical Center and Jerome H. Holland Laboratory at the American Red Cross. He received his Ph.D. in Biochemistry from Vanderbilt University and has authored over fifty peer-reviewed publications.
“Precision Biosciences has developed one of the most exciting and powerful genome modifying technologies I have come across in my years in the industry,” said Dr. Liau. “I am delighted to have the opportunity to help Matt and the team build a therapeutic pipeline that can utilize the full potential of this unique platform.”
Precision welcomes Dr. McCreedy from NexImmune, an immunotherapy-focused company, where he served as Chief Development Officer and Executive Vice President of Research and Development. Before joining NexImmune, Dr. McCreedy served in leadership functions at Roche, LabCorp, Triangle Pharmaceuticals (now Gilead), Metabolon, and Fulcrum Pharma. He received his Ph.D. in Microbiology and Immunology from Wake Forest University and has published his research extensively in the field of immunotherapy.
“I am thrilled to be joining the talented and experienced team at Precision BioSciences and to have the opportunity to utilize the proven capability of the ARCUS genome editing platform to create novel and powerful cellular immuno-therapies for the treatment of patients with cancer,” said Dr. McCreedy.
About Precision BioSciences
Precision BioSciences is a genome editing company dedicated to improving life. Our team seeks to solve significant problems in oncology, genetic disease, agriculture, and beyond via its ARCUS genome editing platform. ARCUS is Precision’s latest and wholly proprietary genome editing platform which now encompasses an industry leading combination of site specificity, ease of delivery, and breadth of editing capabilities.
Contact Precision Biosciences
Chelsea Lynam
+1 919-314-5512
chelsea.lynam@precisionbiosciences.com