-- Payment includes $9.75 million cash and
$3.25 million in Imugene Limited ordinary shares--
--The addition of this cash further reinforces
Precision’s expected cash runway into the second half of 2026--
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, gene insertion, and gene
excision, today announced maturity of a $13 million convertible
note from its previously announced strategic transaction with
Imugene Limited (ASX: IMU) for azercabtagene zapreleucel (azer-cel)
in oncology. The proceeds to Precision BioSciences include $9.75
million in cash and $3.25 million in Imugene ordinary shares.
“We are pleased that Imugene continues to advance azer-cel
toward a pivotal trial in LBCL for patients with significant unmet
need,” said Michael Amoroso, President and Chief Executive Officer
of Precision BioSciences. “This marks one year since our strategic
decision to focus our in-house programs exclusively on in vivo gene
editing and further bolsters our balance sheet, enabling us to
generate Phase 1 clinical data across multiple in vivo gene editing
programs starting in the first half of 2025. In the near term, we
are focused on progressing our pipeline towards the clinic and
remain on track to file applications with multiple global
regulatory bodies for PBGENE-HBV for chronic hepatitis B later this
year.”
In August 2023, Precision announced a strategic transaction with
Imugene. Under the agreement, Imugene assumed global rights to
azer-cel for cancer, the ongoing clinical execution for azer-cel in
large B-cell lymphoma (LBCL) patients who have relapsed following
autologous CAR T treatment as well as Precision BioSciences’ CAR T
capability, including manufacturing. In exchange, Precision
received upfront economics valued at $21 million (all figures in
USD) consisting of $8 million in cash and a $13 million convertible
note. The convertible note matured on August 30, 2024 and resulted
in payment to Precision of $9.75 million in cash and $3.25 million
in Imugene stock. Precision is also eligible for additional
payments based on azer-cel clinical milestones as well as
milestones for other future nominated cancer research programs.
As of June 30, 2024, Precision had approximately $123.6 million
in cash and cash equivalents, prior to receipt of the payment from
Imugene. Existing cash and cash equivalents, upfront and potential
near-term cash from CAR T transactions, along with expected
operational receipts, continued fiscal and operating discipline,
availability of Precision’s at-the-market (ATM) facility, and
marketable securities are expected to extend Precision’s cash
runway into the second half of 2026.
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.
The ARCUS® platform is being used to develop in vivo gene
editing therapies for sophisticated gene edits, including gene
insertion (inserting DNA into gene to cause expression/add
function), elimination (removing a genome e.g. viral DNA or mutant
mitochondrial DNA), and excision (removing a large portion of a
defective gene by delivering two ARCUS nucleases in a single
AAV).
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 and our partners’ and licensees’
product candidates and gene editing approaches including editing
efficiency, and the suitability of ARCUS nucleases for gene
insertion, gene elimination and gene excision and differentiation
from other gene editing approaches; the expected timing of
regulatory processes (including filings and studies for PBGENE-HBV
and PBGENE-PMM); expectations about our and our partners’
operational initiatives, strategies, and further development of our
programs; expectations and updates around our partnerships and
collaborations and our ability to enter into new collaborations,
license agreements or other arrangements; our expected cash runway
and available credit; the sufficiency of our cash runway extending
into the second half of 2026; 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 clinical data . In some cases,
you can identify forward-looking statements by terms such as “aim,”
“anticipate,” “approach,” “believe,” “contemplate,” “could,”
“designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,”
“mission,” “plan,” “possible,” “potential,” “predict,” “project,”
“pursue,” “should,” “strive,” “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 trials; potential
manufacturing problems associated with the development or
commercialization of any of our product candidates; 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 any pandemic, epidemic, or outbreak of an
infectious disease; the success of our existing collaboration and
other license 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 June 30, 2024,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240903924891/en/
Investor Contact: Naresh Tanna Vice President, Investor
Relations Naresh.Tanna@precisionbiosciences.com
Precision BioSciences (NASDAQ:DTIL)
過去 株価チャート
から 10 2024 まで 11 2024
Precision BioSciences (NASDAQ:DTIL)
過去 株価チャート
から 11 2023 まで 11 2024
