- Abstract from 2023 American Society of Hematology (ASH)
Meeting
- Data demonstrates differentiated profile from DARZALEX®
(daratumumab) with best-in-class potential, supports initiation of
clinical trials in 2024
- NAYA expects to close its previously announced merger with INVO
Bioscience (NASDAQ: INVO) in the first quarter of 2024
AVENTURA, Fla. and SARASOTA, Fla., Dec. 11,
2023 /PRNewswire/ -- NAYA Biosciences Inc. ("NAYA"),
a company which has recently signed a definitive merger agreement
with INVO Bioscience to establish an expanded, publicly-traded
life science company dedicated to increasing patient access to
breakthrough treatments in fertility, oncology, and regenerative
medicine, today announced that new data for its
CD38-targeted Flex-NK™ Bispecific Antibody (NY-338, formerly
CYT-338) for the treatment of Multiple Myeloma (MM) was published
as an abstract in the 2023 American Society of Hematology's (ASH)
meeting supplement of Blood, in the "Multiple Myeloma:
Prospective Therapeutic Trials" section.
"NAYA is building a portfolio of differentiated clinical-stage
oncology therapeutics, starting with two FLEX-NK™ bispecific
antibodies acquired from Cytovia Therapeutics," commented NAYA CEO
Dr. Daniel Teper. "We are excited
about this new data for our CD38-targeted antibody, which aims to
address limitations with the current standard-of-care and offer new
options for multiple myeloma patients."
"The synergistic engagement of NK cells through NKp46 greatly
enhances the immunotherapeutic effects of FLEX-NK™ bispecific
antibodies, reducing NK cell fratricide, maintaining NK cell
levels, and enhancing potency including reversal of NK cell
dysfunction," added Ola Landgren,
MD, PhD, co-author of the abstract and Professor of Medicine, Chief
of the Myeloma Division, and Leader of the Experimental
Therapeutics Program at the University of
Miami's Sylvester Comprehensive Cancer Center. "The data
supports initiation of clinical trials to evaluate this promising
new therapy and makes it a potential best-in-class anti-CD38
therapeutic for multiple myeloma."
Despite the clinical success of the first anti-CD38 targeted
monoclonal antibody, daratumumab, approved for the treatment of
multiple myeloma (MM), significant challenges remain such as CD38
antigen loss/internalization and/or natural killer (NK) cell
fratricide resulting in resistance to treatment over time. The data
presented for NY-338 demonstrates a differentiated profile from
daratumumab, with best-in-class potential, and supports the
initiation of clinical trials in 2024. Specifically, the
conclusions show that the unique NKp46 activation mechanism
provided by NY-338 for reducing NK cell fratricide and maintaining
NK cell levels together with the enhanced potency including
reversal of NK cell dysfunction makes it an attractive
best-in-class anti-CD38 therapeutic against MM compared to
daratumumab. These results support the development of CYT-338 in
both monotherapy and combination with other complementary
immunotherapy agents being developed or approved for MM. A
first-in-human Phase 1 study targeting patients with
relapsed/refractory MM is in development in the U.S.
About NAYA Biosciences
NAYA Biosciences is building a group of agile, disruptive,
high-growth companies dedicated to increasing patient access to
life-transforming treatments in oncology, fertility, and
regenerative medicine. NAYA's capabilities in biology, cell
and gene therapy, and artificial intelligence (AI) provide a
synergistic platform for the accelerated clinical development and
commercialization of these breakthrough treatments.
NAYA Oncology aims to achieve clinical
proof-of-concept for its two bispecific antibodies acquired from
Cytovia Therapeutics, with the goal of advancing towards
breakthrough outcomes for Hepatocellular Carcinoma and Multiple
Myeloma patients. Clinical trials are expected to start in
2024.
NAYA Fertility aims to increase accessibility to
advanced fertility care through a growing network of INVO-owned and
affiliated clinics and the commercialization of INVO's unique
FDA-cleared INVOcell® device.
NAYA Regenerative Medicine is evaluating the
acquisition of clinic-stage assets aiming to restore biological
function in patients with damaged tissues and organs.
For more information, please
visit www.nayabiosciences.com.
About NAYA's Proposed
Merger with INVO Bioscience
NAYA Biosciences and INVO Bioscience have announced a definitive
merger agreement to establish an expanded publicly-traded life
science company. Under the terms of the October 23rd merger agreement, pending approval
of the transaction by INVO's, Cytovia Therapeutic, Inc. 's,
and NAYA's stockholders and subject to key closing conditions, INVO
will acquire 100% of the outstanding equity interests in NAYA by
means of a reverse triangular merger of a wholly owned subsidiary
of INVO with and into NAYA, with NAYA surviving as a wholly owned
subsidiary of INVO (the "Merger"). In connection with the
Merger, INVO will issue to the stockholders of NAYA newly issued
common stock, representing, following such issuance, more than
eighty percent (80%) of its issued and outstanding common stock,
effectively resulting in a change of control.
Among key closing conditions, INVO must obtain shareholder
approval along with certain approvals from existing warrant
holders, an estimated $5 million or more (at NAYA's
discretion) in interim private financing in INVO at a premium to
INVO's market price at time of financing ("Interim PIPE"), and a
private offering by the combined company at a target price
of $5.00, representing a premium to INVO's last offering
of $2.85 per share. The merger target valuation
is $12,373,780 for INVO and $90,750,000 for
NAYA, based on a target stock price of $5.00 per share.
Subject to the Interim PIPE, immediately following the closing of
the Merger (but prior to the private offering), the equity holders
of NAYA are expected to own approximately 88% of the issued and
outstanding common stock of the combined company while the equity
holders of INVO are expected to own approximately 12% of the issued
and outstanding common stock of the combined company.
The Merger has been unanimously approved by the board of
directors of each company and is expected to close in the first
quarter (Q1) of 2024.
Glaser Weil Fink Howard Jordan & Shapiro LLP is serving
as legal counsel to INVO. Pearl Cohen Zedek Latzer Baratz
LLP is serving as legal counsel to NAYA.
Additional Information about the Proposed Merger and Where to
Find It
INVO will furnish to the U.S. Securities and Exchange Commission
(the "SEC") a Current Report on Form 8-K regarding the Merger,
which will include the Merger Agreement as an exhibit thereto.
Shareholders and others wishing to obtain additional information
regarding the Merger Agreement and the Merger are urged to review
these documents, which will be available at the SEC's website
(https://www.sec.gov).
In connection with the Merger, INVO and NAYA will file relevant
materials with the SEC, including a registration statement on Form
S-4 filed by INVO that will include a proxy statement of INVO that
also constitutes a prospectus of INVO. A definitive proxy
statement/prospectus will be distributed to stockholders of
NAYA. This communication is not a substitute for the
registration statement, proxy statement, or prospectus or any other
document that INVO or NAYA (as applicable) may file with the SEC in
connection with the proposed Merger. Before making any
voting or investment decision, investors and security holders of
INVO and NAYA are urged to read carefully and in their entirety the
registration statement, the proxy statement/prospectus, and any
other materials filed with or furnished to the SEC when they become
available, as well as any amendments or supplements to these
documents, as they contain or will contain important information
about INVO, NAYA, the Merger Agreement, the Merger, and related
matters. In addition to receiving the proxy
statement/prospectus by mail, shareholders also will be able to
obtain the full registration statement and the proxy
statement/prospectus and the exhibits thereto, as well as other
filings containing information about INVO, the Merger Agreement,
the Merger, and related matters, without charge, from the SEC's
website (http://www.sec.gov), or at the SEC's public reference room
at 100 F Street, NE, Room 1580, Washington,
D.C. 20549. The information included on, or accessible
through, INVO's or NAYA's website is not incorporated by reference
to this communication.
INVO, NAYA and certain of their directors, executive officers,
and other members of management and employees may, under SEC rules,
be deemed to be "participants" in the solicitation of proxies from
INVO's shareholders with respect to the Merger. Information
about the directors and executive officers of INVO will be set
forth in the proxy statement/prospectus and in its Form 10-K for
the year ended December 31, 2022, which was filed with the SEC
on April 17, 2023. Information about the directors and
executive officers of NAYA will be set forth in the joint proxy
statement/prospectus.
This announcement is not a solicitation of a proxy, an offer to
purchase, or a solicitation of an offer to sell any securities and
it is not a substitute for the Schedule 14A, the registration
statement on S-4, the proxy statement/prospectus, or other filings
that may be made with the SEC in connection with the Merger
Agreement and the Merger.
No Offer or Solicitation
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor a solicitation
of any vote or approval with respect to the proposed transaction or
otherwise. No offer of securities shall be made except by means of
a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended, and otherwise in accordance
with applicable law.
Safe Harbor Statement
This release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
The Company invokes the protections of the Private Securities
Litigation Reform Act of 1995. All statements regarding our
expected future financial position, results of operations, cash
flows, financing plans, business strategies, products and services,
competitive positions, growth opportunities, plans and objectives
of management for future operations, as well as statements that
include words such as "anticipate," "if," "believe," "plan,"
"estimate," "expect," "intend," "may," "could," "should," "will,"
and other similar expressions are forward-looking statements. All
forward-looking statements involve risks, uncertainties, and
contingencies, many of which are beyond our control, which may
cause actual results, performance, or achievements to differ
materially from anticipated results, performance, or achievements.
Factors that may cause actual results to differ materially from
those in the forward-looking statements include those set forth in
our filings at www.sec.gov. We are under no obligation
to (and expressly disclaim any such obligation to) update or alter
our forward-looking statements, whether as a result of new
information, future events or otherwise.
CONTACT
NAYA Biosciences:
Anna Baran-Djokovic
305-615-9162
anna@nayabiosciences.com
INVO Bioscience:
Steve Shum
978-878-9505
sshum@invobio.com;
INVO Investor Contact:
Robert
Blum (Lytham Partners, LLC)
602-889-9700
INVO@lythampartners.com
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SOURCE INVO Bioscience, Inc.