Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) and
SmartPharm Therapeutics, Inc. (“SmartPharm”) announced today the
signing of a merger agreement under which Sorrento will acquire
SmartPharm, a gene-encoded therapeutics company developing
non-viral DNA and RNA gene delivery platforms for COVID-19 and rare
diseases with broad potential for application in enhancing
antibody-centric therapeutics.
As previously announced on July 24, 2020,
Sorrento and SmartPharm entered into a letter of intent setting
forth the terms and conditions by which Sorrento would acquire
SmartPharm. In consideration for the acquisition, at closing,
SmartPharm equity holders will receive up to an aggregate of $19.4
million of shares of Sorrento common stock, subject to certain
adjustments, based on a price per share calculated in accordance
with the merger agreement.
Sorrento and SmartPharm also previously
announced a research and development collaboration to encode and
express in vivo Sorrento’s proprietary SARS-CoV-2 neutralizing
monoclonal antibodies utilizing SmartPharm’s Gene Mab plasmid
nanoparticle platform.
Using SmartPharm’s technology, Sorrento has
identified STI-2020dna (DNA plasmid injection), an antibody encoded
DNA plasmid candidate derived from Sorrento’s proprietary STI-1499
(COVI-GUARD™) and matured and optimized for DNA plasmid delivery to
generate antibodies in vivo directed against the SARS-CoV-2 virus
and its highly contagious D614G variant. STI-2020dna is currently
undergoing preclinical in vivo studies and has the potential to
generate long-lasting anti-viral protection with a single
intra-muscular administration.
“We are very encouraged by the preclinical data
generated thus far by our STI-2020dna plasmid candidate against
COVID-19,” said Henry Ji, Ph.D., CEO of Sorrento Therapeutics.
“STI-2020dna has the potential to produce potent antibodies in the
human body in vivo which may provide an attractive alternative to
vaccines that might not be effective against the emerging and
highly contagious variants of the virus.”
“The merger with Sorrento presents a tremendous opportunity to
advance our next-generation, non-viral gene therapy technology and
combine it with Sorrento’s significant R&D and manufacturing
capabilities,” said Jose Trevejo M.D., Ph.D., CEO of SmartPharm
Therapeutics. “From the first emergence of this deadly coronavirus,
Sorrento has dedicated their resources to the development of
multiple countermeasures to COVID-19, including potent antibody
candidates. This merger should help accelerate our gene-encoded
antibody platform technology (Gene Mab) with the ultimate goal of
helping patients affected by this global pandemic as well as other
diseases.”
The transaction is expected to close in early
September 2020, subject to customary closing conditions. If the
proposed merger is consummated, the issuance of the shares of
Sorrento common stock would be made in accordance with an exemption
from the registration requirements of the Securities Act of 1933,
as amended (the “Securities Act”), pursuant to Section 4(a)(2)
thereof and Regulation D thereunder. Such shares of Sorrento common
stock would not be registered under the Securities Act and could
not be offered or sold without registration unless an exemption
from such registration is available. This press release does not
constitute an offer to sell or the solicitation of an offer to buy,
any shares of Sorrento common stock.
About SmartPharm
Therapeutics
SmartPharm Therapeutics, Inc. is a privately
held, development stage biopharmaceutical company focused on
developing next-generation, non-viral gene therapies for the
treatment of serious or rare diseases with the vision of creating
“Biologics from Within.” SmartPharm is currently developing a novel
pipeline of non-viral, gene-encoded proteins for the treatment of
conditions that require biologic therapy such as enzyme replacement
and tissue restoration. SmartPharm commenced operations in 2018 and
is headquartered in Cambridge, MA, USA. For more information,
please visit www.smartpharmtx.com.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to turn
malignant cancers into manageable and possibly curable diseases.
Sorrento's multimodal, multipronged approach to fighting cancer is
made possible by its extensive immuno-oncology platforms, including
key assets such as fully human antibodies ("G-MAB™ library"),
clinical stage immuno-cellular therapies ("CAR-T", "DAR-T™"),
antibody-drug conjugates ("ADCs"), and clinical stage oncolytic
virus ("Seprehvir™"). Sorrento is also developing potential
coronavirus antiviral therapies and vaccines, including COVIDTRAP™,
ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™; and
diagnostic test solutions, including COVI-TRACK™ and COVI-TRACE™.
Sorrento's commitment to life-enhancing therapies for patients is
also demonstrated by our effort to advance a first-in-class (TRPV1
agonist) non-opioid pain management small molecule, resiniferatoxin
("RTX"), and ZTlido® (lidocaine topical system) 1.8% for the
treatment of post-herpetic neuralgia. RTX is completing a phase IB
trial for intractable pain associated with cancer and a phase 1B
trial in osteoarthritis patients. ZTlido® was approved by the FDA
on February 28, 2018.
For more information, visit
www.sorrentotherapeutics.com
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting contain forward-looking
statements related to Sorrento Therapeutics, Inc., under the
safe harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding the proposed acquisition of SmartPharm; the completion of
the proposed acquisition of SmartPharm; the potential effects that
the acquisition of SmartPharm may have on Sorrento’s business and
product candidate pipeline; the expected timing for the closing of
the transaction; the data read-outs related to ongoing studies for
COVID-19 using antibodies and gene-encoded antibodies; the potency
and potential blocking capabilities of STI-1499 and STI-2020dna and
their respective impact on SARS-CoV-2 and the D614G variant; the
expected length of any antiviral protection provided by STI-1499
and STI-2020dna; the potential administration and applications of
STI-1499 and STI-2020dna, alone or in combination; the timeline and
status of preclinical testing for STI-1499 and STI-2020dna; the
potential safety and efficacy of STI-1499 and STI-2020dna; the
therapeutic potential of STI-1499 and STI-2020dna for SARS-CoV-2
and COVID-19; the potential costs associated with manufacturing
STI-2020dna and other DNA plasmids; Sorrento’s ability to produce
antibody candidates against pathogens and cancer cells; Sorrento’s
ability to transition from product development to full scale
manufacturing and commercialization; Sorrento’s ability to advance
SmartPharm’s intellectual property, including its non-viral gene
therapy technology and its gene-encoded platform technology;
Sorrento’s ability to combine SmartPharm’s intellectual property,
including its non-viral gene therapy technology, with Sorrento’s
research and development and manufacturing capabilities; and
Sorrento’s potential position in the anti-viral immunity industry.
Risks and uncertainties that could cause our actual results to
differ materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risk
that the proposed acquisition of SmartPharm will not occur; risks
related to Sorrento's technologies and prospects with newly
acquired technologies, including the proposed acquisition of
SmartPharm and the utilization of SmartPharm’s Gene-Encoded
Therapeutics (GET) platforms for the treatment and prevention of
coronavirus infections and other pathogens and cancer cells; risks
related to seeking regulatory approvals and conducting clinical
trials; the clinical and commercial success of the treatment and
prevention of coronavirus infections using monoclonal antibodies
and gene-encoded antibodies; the viability and success of using
monoclonal antibodies and gene-encoded antibodies for treatments in
anti-viral therapeutic areas, including coronavirus; clinical
development risks, including risks in the progress, timing, cost
and results of clinical trials and product development programs;
risk of difficulties or delays in obtaining regulatory approvals;
risks that prior study and trial results may not be replicated in
future studies and trials; risks that clinical study results may
not meet any or all endpoints of a clinical study and that any data
generated from such studies may not support a regulatory submission
or approval; risks related to seeking regulatory approvals and
conducting clinical trials; risks of manufacturing drug product;
risks related to leveraging the expertise of its employees,
subsidiaries, affiliates and partners to assist the company in the
execution of its strategies; risks related to the global impact of
COVID-19 and other risks that are described in Sorrento's most
recent periodic reports filed with the Securities and Exchange
Commission, including Sorrento's Annual Report on Form 10-K for the
year ended December 31, 2019, and subsequent Quarterly Reports
on Form 10-Q filed with the Securities and Exchange
Commission, including the risk factors set forth in those filings.
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release and we undertake no obligation to update any
forward-looking statement in this press release except as required
by law.
Media and Investor
Relations
Contact: Alexis Nahama, DVM (SVP Corporate
Development)Telephone: 1.858.203.4120Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, COVI-GUARDTM, COVI-SHIELD™, COVIDTRAP™,
T-VIVA-19™, COVI-MAB™, ACE-MABTM, COVI-TRACK™, COVI-TRACE™,
Saving-Life™ and Improving-Life™ are trademarks of Sorrento
Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex
Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
© 2020 Sorrento Therapeutics, Inc. All Rights
Reserved.
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