TG Therapeutics Announces Global License Agreement with Precision BioSciences for the Development and Commercialization of Precision’s Allogeneic CD19 CAR T Cell Therapy Program for the Treatment of Autoimmune Diseases
2024年1月9日 - 9:00PM
TG Therapeutics, Inc. (NASDAQ: TGTX), “the Company,” today
announced that it has entered into an agreement with Precision
BioSciences, Inc. (NASDAQ GS: DTIL) to acquire a worldwide license
to Precision’s Azercabtagene Zapreleucel (azer-cel), an allogeneic
CD19 CAR T cell therapy program for autoimmune diseases and all
other non-oncology indications. Azer-cel is an allogeneic (off the
shelf) CAR T program and the Company has near-term plans to
evaluate the program in multiple autoimmune indications, with an
investigational new drug (IND) filing targeted for mid-2024.
Michael S. Weiss, Chairman and Chief Executive Officer of TG
Therapeutics stated, “We are excited to expand our autoimmune
portfolio and leverage our robust drug development and
commercialization expertise in partnering with Precision on this
CAR T program. We look forward to exploring azer-cel’s potential to
be a meaningful therapy for patients with various autoimmune
disorders with a target IND filing mid-2024.”
“We are excited to partner with TG Therapeutics to extend the
therapeutic opportunity for our allogeneic CAR T product azer-cel
to address unmet medical needs in autoimmune conditions and other
diseases beyond oncology. TG Therapeutics has a strong track record
of development, regulatory and commercial success in the multiple
sclerosis space, and we believe they will bring their expertise to
the development of azer-cel for autoimmune diseases,” said Michael
Amoroso, President and Chief Executive Officer of Precision
BioSciences.
Under the terms of the agreement, TG Therapeutics will receive
exclusive worldwide rights to develop and commercialize azer-cel in
non-oncology indications, and in exchange, 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 Precision common stock by TG Therapeutics at a 100%
premium to the 30-day VWAP prior to purchase. Precision will also
receive $2.5 million in deferred consideration due within 12 months
as an equity investment in Precision’s common stock at a 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, consisting of cash
and the purchase of Precision common stock by TG at a 100% premium
to the then current 30-day VWAP. Precision is also eligible to
receive up to $288 million in additional 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.
ABOUT TG THERAPEUTICSTG Therapeutics is a
fully integrated, commercial stage, biopharmaceutical company
focused on the acquisition, development and commercialization of
novel treatments for B-cell diseases. In addition to a research
pipeline including several investigational medicines, TG has
received U.S. Food and Drug Administration (FDA) approval for
BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients
with relapsing forms of multiple sclerosis (RMS), to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, as well as approval by the
European Commission (EC) and the Medicines and Healthcare Products
Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with
RMS who have active disease defined by clinical or imaging features
in Europe and the United Kingdom, respectively. For more
information, visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and on LinkedIn.
Cautionary StatementThis press release contains
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release. In addition to the risk factors identified from
time to time in our reports filed with the U.S. Securities and
Exchange Commission (SEC), factors that could cause our actual
results to differ materially include the below.
Such forward looking statements include, but are not limited to,
statements regarding the azer-cel allogeneic CD19 CAR T cell
therapy program for all non-oncology indications. Factors that
could cause our actual results to differ materially include the
following: our ability to successfully and cost-effectively
complete preclinical and clinical trials related to the CD19 CAR T
cell therapy program; the risk that early clinical trial results
that may have influenced our decision to undertake the development
of the azer-cel allogeneic CD19 CAR T cell therapy program will not
be reproduced in future studies; the risk that the company will not
move forward with the development or commercialization of the
azer-cel allogeneic CD19 CAR T cell therapy program for any
non-oncology indications; the risk the IND is not filed or accepted
by regulatory authorities in the timeline provided or at all; the
risk that the azer-cel allogeneic CD19 CAR T cell therapy does not
exhibit a clinical profile that is suitable for autoimmune disease;
the risk that the equity investments in Precision may not
appreciate in value, hold value, or have any value in the future.
Further discussion about risks and uncertainties can be found in
our Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 and in our other filings with
the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
This press release and prior releases are available
at www.tgtherapeutics.com. The information found on our
website is not incorporated by reference into this press release
and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option
6
TG Therapeutics (NASDAQ:TGTX)
過去 株価チャート
から 8 2024 まで 9 2024
TG Therapeutics (NASDAQ:TGTX)
過去 株価チャート
から 9 2023 まで 9 2024