Precision BioSciences Announces Closing of In Vivo Gene Editing Collaboration and License Agreement with Eli Lilly and Company

Rhea-AI Summary

DURHAM, N.C., Jan. 07, 2021 – Precision BioSciences, Inc. (Nasdaq: DTIL) announced the closure of its in vivo gene editing collaboration and exclusive license agreement with Eli Lilly, following regulatory clearance. The collaboration focuses on using Precision's ARCUS genome editing platform for up to six gene targets, including Duchenne muscular dystrophy. Precision receives $100 million upfront and has already received $35 million from share purchases. They are eligible for $420 million in milestones and royalties on product sales. Precision will lead pre-clinical research while Lilly handles clinical development.

Positive

• Upfront cash payment of $100 million received from Eli Lilly.
• $35 million from share purchases by Lilly.
• Eligibility for up to $420 million in potential milestone payments.
• Tiered royalties from mid-single digits to low-teens on commercialized products.
• Precision leads pre-clinical research, enhancing its pipeline.

Negative

• None.

DURHAM, N.C., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS^® genome editing platform, today announced the closing of its in vivo gene editing research collaboration and exclusive license agreement with Eli Lilly and Company following clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

As previously announced on November 20, 2020, Precision and Lilly entered into a research collaboration agreement to use Precision’s proprietary ARCUS genome editing platform for pre-clinical and IND-enabling activities for up to six gene targets, with an initial focus on Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets.

Under the terms of the agreement, Precision will receive an upfront cash payment of $100 million, and has received $35 million from Lilly’s purchase of newly issued shares of Precision’s common stock. Precision is also eligible to receive up to $420 million in potential development and commercialization milestones per product, as well as tiered royalties ranging from the mid-single digits to low-teens on product sales should Lilly successfully commercialize a therapy from the collaboration. Precision will lead pre-clinical research and IND-enabling activities, with Lilly then assuming responsibility for clinical development and commercialization. Lilly will have the right to select up to three additional gene targets for this collaboration. Precision can co-fund clinical development of one product in exchange for an increased royalty rate on co-funded product sales.

About ARCUS
ARCUS^® is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock-in), remove (knock-out), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision's platform and products are protected by a comprehensive portfolio including more than 65 patents to date.

About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS^® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, 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 that the collaboration may yield commercially successful products and statements regarding the potential milestone, royalty and other payments that we may earn under the collaboration. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “goal,” “may,” “will,” “would,” “should,” “could,” “target,” “potential,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as any 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 and the Investors & Media page of our website at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to 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:
Alex Kelly
Interim Chief Financial Officer
Alex.Kelly@precisionbiosciences.com

Media Contact:
Maurissa Messier
Senior Director, Corporate Communications
Maurissa.Messier@precisionbiosciences.com

FAQ

What is the recent agreement between Precision BioSciences and Eli Lilly?

Precision BioSciences has closed an in vivo gene editing research collaboration and exclusive license agreement with Eli Lilly, focusing on multiple gene targets.

What financial benefits is Precision BioSciences receiving from the agreement with Lilly?

Precision BioSciences receives $100 million upfront and has already received $35 million from Lilly's stock purchases, along with potential milestone payments totaling up to $420 million.

What is the primary focus of the gene editing collaboration with Eli Lilly?

The collaboration focuses on using Precision's ARCUS genome editing platform for gene targets, specifically targeting Duchenne muscular dystrophy among others.

What role will Precision BioSciences play in the collaboration with Eli Lilly?

Precision will lead the pre-clinical research and IND-enabling activities, while Eli Lilly will handle clinical development and commercialization.