Item 2.02. Results of Operations and Financial Condition.
Although it has not finalized its full financial results for the fourth quarter
and fiscal year ended December 31, 2020, Precision BioSciences, Inc. (the
"Company") expects to report that it had $90 million in cash and cash
equivalents as of December 31, 2020.
The information contained in this Item 2.02 of this Current Report on Form 8-K
(the "Form 8-K") is unaudited and preliminary, and does not present all
information necessary for an understanding of the Company's financial condition
as of December 31, 2020 and its results of operations for the three months and
year ended December 31, 2020. The audit of the Company's financial statements
for the year ended December 31, 2020 is ongoing and could result in changes to
the information set forth above.
The information contained in this Item 2.02 of the Form 8-K 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 (the "Securities
Act"), or the Exchange Act, except as expressly set forth by specific reference
in such filing.
Item 7.01.Regulation FD Disclosure.
On January 25, 2021, the Company announced that it has received a Notice of
Allowance from the U.S. Patent and Trademark Office for a patent application
covering PBCAR19B, a next-generation, stealth cell, CD19 allogeneic chimeric
antigen receptor T cell ("CAR T") product candidate for patients with
relapsed/refractory ("R/R") Non-Hodgkin Lymphoma ("NHL"). A copy of this press
release is furnished as Exhibit 99.1 to this Form 8-K and incorporated into this
Item 7.01 by reference.
The information contained in this Item 7.01 (including Exhibit 99.1) of the Form
8-K shall not be deemed "filed" for purposes of Section 18 of 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, or the Exchange Act, except as expressly set forth by specific
reference in such filing.
Item 8.01. Other Events.
On January 19, 2021, the Company announced that the U.S. Federal Drug
Administration accepted the Company's Investigational New Drug application for
PBCAR19B. This Phase 1 study will be a non-randomized, open-label, single-dose,
dose-escalation and dose-expansion study deigned to evaluate the safety and
clinical activity of PBCAR19B at increasing flat dose levels (2.7 x 108 - 8.1 x
108 CAR T cells) in patients with R/R NHL. The primary objective of the study is
to identify the maximum tolerated dose and any dose-limiting toxicities.
Additionally, on January 21, 2021, the Company received from Eli Lilly and
Company ("Lilly") the upfront cash payment of $100 million pursuant to the
previously announced collaboration and exclusive license agreement entered into
between Lilly and the Company. The Company believes that its expected cash and
cash equivalents as of December 31, 2020, its expected operational receipts, the
upfront payment from Lilly and its available credit will enable it to fund its
operating expenses and capital expenditure requirements into 2023.
On January 25, 2021, the Company announced that it has received a Notice of
Allowance from the U.S. Patent and Trademark Office for a patent application
covering PBCAR19B. The allowed composition claims of U.S. Patent Application No.
16/908,030 encompass genetically-modified human T cells comprising the Company's
PBCAR19B construct, which is inserted within the T cell receptor alpha constant
locus. Once issued, patents arising from this patent family will have standard
expiration dates in April 2040.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements contained in
this Form 8-K that do not relate to matters of historical fact should be
considered forward-looking statements, including statements regarding the
Company's expected financial results and
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cash runway. Forward-looking statements may be identified 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 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 Precision BioSciences, Inc. Press Release, dated January 25, 2021
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