0000950170-23-047585.txt : 20230912 0000950170-23-047585.hdr.sgml : 20230912 20230912070239 ACCESSION NUMBER: 0000950170-23-047585 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230912 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230912 DATE AS OF CHANGE: 20230912 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PRECISION BIOSCIENCES INC CENTRAL INDEX KEY: 0001357874 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38841 FILM NUMBER: 231248986 BUSINESS ADDRESS: STREET 1: 302 EAST PETTIGREW STREET STREET 2: SUITE A-100 CITY: DURHAM STATE: NC ZIP: 27701 BUSINESS PHONE: 919-314-5512 MAIL ADDRESS: STREET 1: 302 EAST PETTIGREW STREET STREET 2: SUITE A-100 CITY: DURHAM STATE: NC ZIP: 27701 8-K 1 dtil-20230912.htm 8-K 8-K
0001357874false00013578742023-09-122023-09-12

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 12, 2023

 

 

Precision BioSciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38841

20-4206017

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

302 East Pettigrew St.

Suite A-100

 

Durham, North Carolina

 

27701

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 919 314-5512

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.000005 per share

 

DTIL

 

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

Item 7.01 Regulation FD Disclosure.

On September 12, 2023, Precision BioSciences, Inc. (the “Company”) issued a press release regarding discussion topics for the Company’s virtual in vivo gene editing R&D Day (the “R&D Day”), including its current development programs, pipeline updates, and underlying ARCUS platform technology. A copy of the press releases is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated in this Item 7.01 by reference.

As previously announced, the R&D Day will take place today, September 12, 2023, beginning at 9:00 a.m., Eastern Time. The dial-in conference call number is 1 (888) 800-8518. The conference ID number for the call is 2795912, and the accompanying presentation will be available on the Events & Presentations in the Investors section of the Precision BioSciences website at https://investor.precisionbiosciences.com. An archived replay of the webcast will be available on the Company website for one year following the presentation. Registration for this virtual event and access to the live webcast is available at http://precision2023rdday.q4ir.com or under Events & Presentations in the Investors section of the Precision BioSciences website at https://investor.precisionbiosciences.com.

The information in this Item 7.01 (including Exhibit 99.1) of this Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On September 12, 2023, the Company provided updates with respect to its current development programs, its pipeline and the underlying ARCUS platform, its continued focus on its lead program PBGENE-HBV designed to target hepatitis B virus ("HBV") and the Company’s first development candidate designed to target mitochondrial DNA, PBGENE-PMM.

Pipeline Overview and Updates to Development Programs

•
PBGENE-HBV is being developed for the treatment of patients with chronic hepatitis B, with submission of a clinical trial application ("CTA") and/or investigational new drug ("IND") application targeted for 2024. Data showed the potential of PBGENE-HBV to eliminate covalently closed circular DNA and inactivate integrated HBV DNA to drive durable antigen loss, leading to a potential functional cure.
•
PBGENE-PMM is being developed as a potentially first-in-class opportunity for treatment of m.3243 associated primary mitochondrial myopathy ("PMM"). Mitochondrial diseases are the most common hereditary metabolic disorder, affecting 1 in 4,300 people. PMM currently lacks a curative treatment and impacts approximately 50% of patients with mitochondrial disease. The high specificity and single component nature of Precision’s mitoARCUS nucleases are designed to enable specific editing of mutant mitochondrial DNA while allowing the normal (wild-type) mitochondrial DNA to repopulate in the mitochondria and restore normal function. The Company expects to submit a CTA and/or IND application in 2025.
•
PBGENE-NVS is being developed in collaboration with Novartis for patients with hemoglobinopathies, such as sickle cell disease and beta thalassemia. The companies intend to insert a therapeutic transgene in vivo as a potential one-time transformative treatment that could overcome many of the hurdles present today with other therapeutic technologies, including those that are utilizing an ex vivo gene editing approach.
•
PBGENE-DMD is being developed with Prevail Therapeutics, a wholly-owned subsidiary of Lilly, and is designed to utilize a pair of ARCUS nucleases, delivered by a single adeno-associated virus, to excise an approximately 500,000 base pair mutation “hot spot” region from the dystrophin gene, resulting in a variant of the dystrophin protein that is functionally competent. Preclinical data has demonstrated the potential of ARCUS in vivo gene editing for large gene excisions and that the edited dystrophin variant was observed in multiple tissue types frequently involved in progression of Duchenne muscular dystrophy, including skeletal muscle, heart, and diaphragm, enabling significantly improved muscle function.
•
iECURE-OTC is being developed by iECURE as a potential treatment for neonatal onset ornithine transcarbamylase ("OTC") deficiency with a target CTA and/or IND submission in 2023. Data demonstrated that iECURE-OTC showed stable gene insertion at one year and that efficient targeted insertion was achieved in non-human primates up to three months of age. In addition, 12-month follow-up biopsies continued to demonstrate durability, with gene insertion efficiency exceeding 20%, well above the expected threshold for clinical benefit.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be

considered forward-looking statements, including, without limitation,statements regarding the clinical development and expected safety, efficacy and benefit of our product candidates and gene editing approaches including ARCUS’s potential editing efficiency and differentiating aspects and the ability for the ARCUS genome editing platform to develop differentiated programs; the suitability of ARCUS nucleases for gene or viral elimination, large excision, gene insertion, and other complex gene editing approaches to drive defined outcomes; the expected timing of regulatory processes; expectations about our operational initiatives and business strategy; expectations around the Company’s partnerships; and expectations about achievement of key milestones. The words “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “designed”, “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “promise,” “pursue,” “should,” “target,” “will,” “would,” and other similar words or expressions, or the negative of these words or similar words or expressions, are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, but involve 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 to advance our programs; risks associated with raising additional capital and requirements under our current debt instruments and effects of restrictions thereunder; 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; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential product 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 advance product candidates into, and successfully design, implement and complete, clinical or field trials; 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; our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; 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; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; 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; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price, 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, 2023, as any such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (“SEC”), which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this Current Report on Form 8-K 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.

Item 9.01 Financial Statements and Exhibits.

 

(d)

Exhibits

 

Exhibit
No.

Description

99.1

Press release of Precision BioSciences, Inc. dated September 12, 2023.

104


Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Precision BioSciences, Inc.

 

 

 

 

Date:

September 12, 2023

By:

/s/ John Alexander Kelly

 

 

 

John Alexander Kelly
Chief Financial Officer

 

 EX-99.1 2 dtil-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

Precision BioSciences Hosts Virtual R&D Day Highlighting its Proprietary ARCUS Technology and Recent In Vivo Gene Editing Program Developments

-
Company highlights new preclinical data for wholly-owned and partnered programs following prioritization of in vivo gene editing portfolio
-
Expands portfolio with PBGENE-PMM as a potentially curative treatment for primary mitochondrial myopathy
-
Virtual R&D Day featuring key opinion leaders and members of Precision’s leadership and scientific teams to be held today at 9:00 AM ET

DURHAM, N.C., September 12, 2023 -- Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, today announced that the Company plans to highlight its current development programs, pipeline updates, and underlying ARCUS platform technology during a virtual R&D Day to be held today at 9:00 AM ET.

“At Precision, we are moving forward with a renewed identity and focus on our core foundational strength as a gene editing company. During today’s R&D Day, we are excited to highlight the potential of our ARCUS genome editing platform to develop differentiated programs enabled by the nature of ARCUS’ unique cut, size, and simplicity,” said Michael Amoroso, Chief Executive Officer at Precision BioSciences. “In addition to illustrating where we see a clear advantage for ARCUS, we will drill down on the novel attributes of ARCUS that inform our development program strategy. We look forward to highlighting the progress we are making across our robust wholly-owned and partnered in vivo gene editing portfolio.”

“As we continue advancing our lead program PBGENE-HBV targeting hepatitis B virus (HBV) toward a 2024 clinical trial application (CTA) and/or investigational new drug (IND) application, we are pleased to introduce PBGENE-PMM, our first development candidate targeting mitochondrial DNA. PBGENE-PMM holds the potential to deliver a one-time, transformative treatment for patients with primary mitochondrial myopathy (PMM),” said Jeff Smith, Co-Founder and Chief Research Officer. “Together with PBGENE-HBV, we believe that both of these programs are emblematic of the unique advantages of our ARCUS technology. As we look ahead, we plan to drive organic development of programs focusing on more sophisticated edits such as viral or mutant mitochondrial genome elimination, defective gene excision, and gene insertion with ARCUS, while also establishing partnerships to rapidly advance programs.”

Guest speakers will include:

•
Mark Sulkowski, M.D. - Chief, Division of Infectious Disease, John Hopkins University School of Medicine
•
Carlos T. Moraes, Ph.D. - Lichtenstein Professor for Neurology, University of Miami Miller School of Medicine
•
Michio Hirano, M.D. - Chief, Division of Neuromuscular Disorders, New York Presbyterian/Columbia University Irving Medical Center

 

 

Highlighted R&D Day Topics

ARCUS Platform Overview

Precision will highlight key capabilities and differentiating characteristics of its proprietary ARCUS genome editing platform, which may enable ARCUS nucleases to drive more intended, defined outcomes.

Pipeline Overview and Updates to Development Programs

•
PBGENE-HBV is being developed for the treatment of patients with chronic hepatitis B, with submission of a CTA and/or IND application targeted for 2024. The Company will show data highlighting the potential of PBGENE-HBV to eliminate covalently closed circular DNA and inactivate integrated HBV DNA to drive durable antigen loss, leading to a potential functional cure. In addition, Dr. Alan List, Chief Medical officer at Precision, will be joined by Dr. Mark Sulkowski for a fireside chat on the HBV landscape.
•
Precision will announce PBGENE-PMM as a potentially first-in-class opportunity for treatment of m.3243 associated primary mitochondrial myopathy. Mitochondrial diseases are the most common hereditary metabolic disorder, affecting 1 in 4,300 people. PMM currently lacks a curative treatment and impacts approximately 50% of patients with mitochondrial disease. The high specificity and single component nature of Precision’s mitoARCUS nucleases are designed to enable specific editing of mutant mitochondrial DNA while allowing the normal (wild-type) mitochondrial DNA to repopulate in the mitochondria and restore normal function. Precision expects to submit a CTA and/or IND in 2025. The Company will host a fireside chat between Dr. List, Dr. Carlos T. Moraes and Dr. Michio Hirano to discuss the mitochondrial disease space.
•
PBGENE-NVS is being developed in collaboration with Novartis for patients with hemoglobinopathies, such as sickle cell disease and beta thalassemia. The companies intend to insert a therapeutic transgene in vivo as a potential one-time transformative treatment that could overcome many of the hurdles present today with other therapeutic technologies, including those that are utilizing an ex vivo gene editing approach.
•
PBGENE-DMD is being developed with Prevail Therapeutics, a wholly-owned subsidiary of Lilly, and is designed to utilize a pair of ARCUS nucleases, delivered by a single AAV, to excise an approximately 500,000 base pair mutation “hot spot” region from the dystrophin gene, resulting in a variant of the dystrophin protein that is functionally competent. The Company will highlight preclinical data demonstrating the potential of ARCUS in vivo gene editing for large gene excisions and that the edited dystrophin variant was observed in multiple tissue types frequently involved in progression of DMD, including skeletal muscle, heart, and diaphragm, enabling significantly improved muscle function.
•
iECURE-OTC is being developed by iECURE as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency with a target CTA and/or IND submission in 2023. The Company will highlight data demonstrating that iECURE-OTC showed stable gene insertion at one year and that efficient targeted insertion was achieved in non-human primates (NHPs) up to three months of age. In addition, 12-month follow-up biopsies continued to demonstrate

 

 

durability, with gene insertion efficiency exceeding 20%, well above the expected threshold for clinical benefit.

Webcast Information

Registration for this virtual event and access to the live webcast is available at http://precision2023rdday.q4ir.com or under Events & Presentations in the Investors section of the Precision BioSciences website at https://investor.precisionbiosciences.com. The accompanying presentation will also be available on the Events & Presentations in the Investors section of the Precision BioSciences website at https://investor.precisionbiosciences.com. The dial-in conference call number is 1 (888) 800-8518. The conference ID number for the call is 2795912. An archived replay of the webcast will be available on the Company website for one year following the presentation.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is an advanced gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size and its simpler structure. ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of 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. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected safety, efficacy and benefit of our product candidates and gene editing approaches including ARCUS’s potential editing efficiency and differentiating aspects and the ability for the ARCUS genome editing platform to develop differentiated programs; the suitability of ARCUS nucleases for gene or viral elimination, large excision, gene insertion, and other complex gene editing approaches to drive defined outcomes; the expected timing of regulatory processes; expectations about our operational initiatives and business strategy; expectations around the Company’s partnerships; and expectations about achievement of key milestones. The words “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “designed”, “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “promise,” “pursue,” “should,” “target,” “will,” “would,” and other similar words or expressions, or the negative of these words or similar words or expressions, are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, but involve 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 to advance our programs; risks associated with raising additional capital and requirements under our current debt instruments and effects of restrictions thereunder; 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; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential product 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 advance product candidates into, and successfully design, implement and complete, clinical or field trials; 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; our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; 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; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; 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; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price, 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, 2023, as any such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (“SEC”), which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings 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 and Media Contact:

 

 

Mei Burris

Director, Investor Relations and Finance

Mei.Burris@precisionbiosciences.com

 

 

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