- Precision to Receive $17.5 Million in Upfront
and Near-Term Payments with Potential for up to $288 Million in
Other Development Milestone Payments
- Upfront Cash and Near-Term Payments Expected
to Extend Precision’s Cash Runway into the First Half of 2026 and
Fund Precision’s Wholly-Owned In Vivo Gene Editing Programs Through
PBGENE-HBV and PBGENE-PMM Phase I Clinical Data
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
announced completion of a strategic transaction with TG
Therapeutics, Inc. (Nasdaq: TGTX) for an exclusive license to
develop Azercabtagene Zapreleucel (azer-cel) for autoimmune
diseases, and other indications outside of cancer.
“We are excited to extend the utility of our allogeneic CAR T
assets into immunology by collaborating with TG Therapeutics as
they advance novel treatments for B-cell diseases. Key factors in
our decision to partner with the TG team include their recent
development, regulatory and commercial successes in the multiple
sclerosis space, which we believe are strong indicators of the
commitment and expertise they will bring to the development of
azer-cel in autoimmune diseases,” said Michael Amoroso, President
and Chief Executive Officer at Precision BioSciences. “As TG
Therapeutics assumes development of azer-cel for immunology,
Precision will remain focused on capitalizing on the utility of
ARCUS for gene elimination and gene insertion, beginning with our
wholly owned PBGENE-HBV program for chronic hepatitis B and
PBGENE-PMM for primary mitochondrial myopathy.”
“After an extensive review of the CAR T products available for
development in immunology, we are excited to bring azer-cel into
our portfolio as we look to expand our offerings for patients
suffering from autoimmune diseases,” said Michael S. Weiss,
Chairman and Chief Executive Officer of TG Therapeutics. “We are
pleased to partner with Precision BioSciences for azer-cel, and the
equity investment we are making is indicative of our optimism in
the near- and long-term opportunities for ARCUS for in vivo gene
editing.”
In exchange for global rights to azer-cel for autoimmune
diseases and indications outside of cancer, Precision will receive
upfront and potential near-term economics valued at $17.5 million.
The upfront payment of $7.5 million will consist 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 $2.5 million within 12 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 receive an
additional $7.5 million payment in cash and the purchase of
Precision common stock by TG Therapeutics at a 100% premium to the
then current 30-day VWAP. Precision is eligible to receive up to
$288 million in additional milestone payments based on the
achievement of certain clinical, regulatory, and commercial
milestones, in addition to high-single-digit to low-double-digit
royalties on net sales.
“With this deal and the Imugene oncology collaboration for
azer-cel announced in August 2023, Precision has now completed two
cell therapy collaborations to realize value from our allogeneic
CAR T platform while enabling development of azer-cel for patients
in diseases with high unmet need. These transactions are expected
to extend our runway and will fund continued development of our
wholly owned in vivo gene editing programs. As a result of these
two accretive partnerships, Precision has received or is eligible
to receive $47 million in upfront and potential near-term payments
and has the potential to receive more than $900 million in
development, regulatory and commercial milestone payments,” added
Mr. Amoroso.
Although it has not finalized its full financial results for the
year ended December 31, 2023, Precision expects to report that it
had approximately $116 million in cash and cash equivalents as of
December 31, 2023. Upfront and potential near-term cash from
azer-cel transactions, along with existing cash and cash
equivalents, expected operational receipts, continued fiscal and
operating discipline, availability of Precision’s at-the-market
(ATM) facility, and available credit are expected to extend
Precision’s cash runway into the first half of 2026 and through
clinical phase 1 readouts for its wholly owned HBV and PMM
programs.
Precision will continue to evaluate potential partners for other
assets from its allogeneic CAR T platform that are no longer being
developed internally, including PBCAR19B stealth cell and BCMA
targeting CAR T assets for multiple myeloma.
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; the suitability of ARCUS nucleases for gene insertion,
large gene deletion, and other gene editing approaches; the
expected timing of regulatory processes; expectations about our
operational initiatives and business strategy; expectations around
partnership opportunities; 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/20240109377137/en/
Investor and Media Contact: Mei Burris Senior Director of
Finance and Controller Mei.Burris@precisionbiosciences.com
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