Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene
editing company utilizing its novel proprietary ARCUS® platform to
develop in vivo gene editing therapies for sophisticated gene
edits, including gene elimination, insertion, and excision, today
received an upfront cash payment and equity investment from TG
Therapeutics, Inc. (Nasdaq: TGTX) for an exclusive license to
develop Azercabtagene Zapreleucel (azer-cel) for autoimmune
diseases, and other indications outside of cancer. This is the
first in a series of payments, with Precision to receive a total of
$17.5 million in upfront and potential near-term payments as part
of the consideration for this license.
In exchange for global rights to azer-cel for autoimmune
diseases and indications outside of cancer, Precision has received
an upfront payment totaling $7.5 million, consisting of cash and
the purchase of 2,920,816 shares of Precision common stock by TG
Therapeutics at a price of $0.77 per share, a 100% premium to the
30-day volume-weighted average price (VWAP) prior to purchase.
Precision will also receive an additional $2.5 million within 11
months, as an equity investment in Precision’s common stock at 100%
premium to the then 30-day VWAP prior to purchase. Upon the
achievement of certain near-term clinical milestones, Precision
will also receive an additional $7.5 million payment. Precision is
eligible to receive up to $288 million in milestone payments in
addition to high-single-digit to low-double-digit royalties on net
sales.
Precision expects that these recent payments from its azer-cel
transactions, along with existing cash and cash equivalents,
expected operational receipts, continued fiscal and operating
discipline, and availability of Precision’s at-the-market (ATM)
facility will extend Precision’s cash runway into the first half of
2026, through phase 1 clinical readouts for its wholly owned
programs.
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.
Key capabilities and differentiating characteristics may enable
ARCUS nucleases to drive more intended, defined therapeutic
outcomes. 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. 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 (including azer-cel)
and gene editing approaches including editing efficiency and
differentiating aspects; the suitability of azer-cel for oncology
indications and non-oncology indications including immunological
diseases; expectations about our operational initiatives and
business strategy; our expected cash runway; expectations about
achievement of key milestones and receipt of any milestone,
royalty, or other payments; expectations regarding our liquidity
and capital resources; and anticipated timing of initial clinical
data. In some cases, you can identify forward-looking statements by
terms such as “aim,” “anticipate,” “approach,” “believe,”
“contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,”
“look,” “may,” “mission,” “plan,” “possible,” “potential,”
“predict,” “project,” “pursue,” “should,” “target,” “will,”
“would,” 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. These statements are neither promises nor
guarantees, and involve 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 to advance our programs; risks
associated with our capital requirements, anticipated cash runway,
requirements under our current debt instruments and effects of
restrictions thereunder, including our ability to raise additional
capital due to market conditions and/or our market capitalization;
our operating expenses and our ability to predict what those
expenses will be; our limited operating history; the progression
and 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, including clinical trial and
investigational new drug applications; public perception about
genome editing technology and its applications; competition in the
genome editing, biopharmaceutical, and biotechnology fields; our or
our collaborators’ or other licensees’ ability to identify, develop
and commercialize product candidates; pending and potential product
liability lawsuits and penalties against us or our collaborators or
other licensees related to our technology and our product
candidates; the U.S. and foreign regulatory landscape applicable to
our and our collaborators’ or other licensees’ development of
product candidates; our or our collaborators’ or other licensees’
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; delays
or difficulties in our and our collaborators’ and other licensees’
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 or our
licensees’ 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’ or other
licensees’ 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 the COVID-19 pandemic and variants
thereof, or 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; our
ability to meet the requirements of and maintain listing of our
common stock on Nasdaq or other public stock exchanges; 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, 2023, 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240212039949/en/
Investor and Media Contact: Naresh Tanna Vice President
of Investor Relations Naresh.Tanna@Precisionbiosciences.com
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