October 21, 2020 --
InvestorsHub NewsWire -- via Stock Investor Wire -- Cytocom,
Inc. , a leading biopharmaceutical company in the area of
immune-modulation, and Cleveland BioLabs, Inc., an
innovative biopharmaceutical company developing novel approaches to
activate the immune system, announced that they have entered into a
definitive merger agreement to combine their businesses in an
all-stock transaction. Cytocom shareholders will have a
majority position in the newly combined entity, which the parties
anticipate will continue to be listed on the Nasdaq under
the ticker symbol -
CBLI and the initial Board of Directors for the
combined company will consist of four members selected by Cytocom
and three members selected by Cleveland BioLabs. The Boards of
Directors of both companies have approved the
combination.
For Immune
Therapeutics, Inc. (Ticker:
IMUN) and it’s shareholders who hold a considerable
stake in Cytocom this means that the value for all of the years of
support and collaboration with Cytocom can be realized.
The Cytocom platform technologies and product pipeline, in
combination with Cleveland BioLabs, have the potential to drive
significant future growth in Immune’s shareholder
value.
Each party to the proposed
merger believes that the combined company will create near-term
commercial opportunities in numerous areas of significant unmet
medical needs including acute radiation injury, oncology,
infectious disease, inflammation and autoimmune-mediated
conditions, with multiple commercial, regulatory and clinical
milestones expected over the next 12 to 18 months. Operating as
“Cytocom, Inc.” and under the leadership of Cytocom’s experienced
management team, the combined company will be positioned for
consistent growth.
Overview
Michael K. Handley, President
and Chief Executive Officer of Cytocom, stated, “Our merger with
Cleveland BioLabs and its subsequent immune-focused platform will
be a transformative growth opportunity for Cytocom and Cleveland
BioLabs shareholders. We believe that the combination of these
highly complementary late-stage pipelines will strengthen our
position and advance our efforts to unlock the potential of
immune-modulating agents in the treatment of serious medical
conditions. Further, this merger will enhance our ability to become
a recognized leader in immune-modulating treatments and builds on
the momentum created by our recent acquisition of ImQuest Life
Sciences. We plan to utilize the combined platform to further drive
value with additional clinical and commercial products and continue
to seek strategic partnerships and acquisitions.”
Dr. Andrei Gudkov, Chief
Scientific Officer of Cleveland BioLabs, said: “This is an exciting
day for Cleveland BioLabs and a great opportunity for our
stockholders. The merger with Cytocom will allow us to add the
strength of our science and bright perspectives associated with
Entolimod development in cancer treatment and radiation defense
arenas with a string of immunomodulators developed by Cytocom to
form a powerful blend of conceptually and scientifically aligned
products. We believe that the merger with Cytocom is the ideal way
to unlock the value of our technology platform and our lead drug
candidate, Entolimod, and I look forward to seeing this exciting
new therapy advance through the clinic.”
Conditions
The proposed transaction is
subject to customary closing conditions, including approval by the
stockholders of Cleveland Biolabs, the shares of the combined
company being approved for listing on Nasdaq and a registration
statement under the Securities Act becoming effective. Cytocom and
Cleveland Biolabs expect the transaction to close during the first
quarter of 2021.
About
Cytocom
Cytocom, Inc. is a
clinical-stage biopharmaceutical company developing novel
immunotherapies targeting autoimmune, inflammatory, infectious
diseases and cancers based on a proprietary platform designed to
rebalance the body’s immune system and restore homeostasis. Cytocom
is developing therapies designed to elicit directly within patients
a robust and durable response of antigen-specific killer T cells
and antibodies, thereby activating essential immune defenses
against autoimmune, inflammatory, infectious diseases, and cancers.
Specifically, Cytocom has four programs in late-stage clinical
development in Crohn’s disease, Fibromyalgia, Multiple Sclerosis
and Pancreatic Cancer. Cytocom believes that its technologies
can meaningfully leverage the human immune system for prophylactic
and therapeutic purposes by eliciting killer T cell response levels
not achieved by other published immunotherapy approaches. Cytocom’s
immunomodulatory technology restores the balance between the
cellular (Th1) and the humoral (Th2) immune systems. Immune balance
is regulated through T-helper cells that produce cytokines. The Th1
lymphocytes help fight pathogens within cells like cancer and
viruses through interferon-gamma and macrophages. The Th2
lymphocytes target external pathogens like cytotoxic parasites,
allergens, toxins through the activation of B-cells and antibody
production to effect to dendritic cells, which are natural
activators of killer T cells, also known as cytotoxic T cells, or
CD8+ T cells. Furthermore, the Cytocom technology antagonizes the
Toll-like Receptors to inhibit pro-inflammatory cytokines. To
learn more about Cytocom, Inc., please visit
www.cytocom.com
About Cleveland
BioLabs
Cleveland BioLabs, Inc. is an
innovative biopharmaceutical company developing novel approaches to
activate the immune system and address serious medical needs.
Cleveland BioLabs’ proprietary platform of Toll-like immune
receptor activators addresses conditions such as radiation sickness
and cancer treatment side effects. Cleveland Biolabs’ most advanced
product candidate, Entolimod is being developed as a medical
radiation countermeasure for preventing death from acute radiation
syndrome and, through its joint venture with Everon Biosciences,
LLC – Genome Protection, Inc. – for other anticancer and antiaging
indications. Additionally, Cleveland BioLabs also conducts business
in the Russian Federation through a joint venture with Joint Stock
Company RUSNANO, Panacela Labs, Inc. Cleveland BioLabs maintains
strategic relationships with the Cleveland Clinic and Roswell Park
Cancer Institute. To learn more about Cleveland BioLabs, please
visit http://www.cbiolabs.com
Additional Information
and Where to Find It
Cleveland BioLabs plans to file
a Registration Statement on Form S-4 containing a proxy
statement/prospectus of Cleveland BioLabs and other documents
concerning the proposed merger with the SEC. Before making any
voting decision, Cleveland BioLabs stockholders are urged to read
the proxy statement/prospectus in its entirety when it becomes
available and any other documents filed by Cleveland BioLabs with
the SEC in connection with the proposed merger or incorporated by
reference therein because they will contain important information
about the proposed transaction and the parties to the proposed
transaction. Investors and stockholders will be able to obtain a
free copy of the proxy statement/prospectus (when it becomes
available) and other documents containing important
information about Cleveland BioLabs and Cytocom, once such
documents are filed with the SEC, through the website maintained by
the SEC at www.sec.gov. Cleveland BioLabs also makes available free
of charge at www.cbiolabs.com (in the “Investors” section), copies
of materials that Cleveland BioLabs files with, or furnishes to,
the SEC.
Participants in the
Solicitation
This document does not
constitute a solicitation of proxy, an offer to purchase or a
solicitation of an offer to sell any securities. Cleveland BioLabs
and Cytocom, and each of their respective directors, executive
officers and certain employees may be deemed to be participants in
the solicitation of proxies from the stockholders of Cleveland
BioLabs in connection with the proposed merger. Security holders
may obtain information regarding the names, affiliations and
interests of Cleveland BioLabs’ directors and officers in Cleveland
BioLabs’ Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, which was filed with the SEC on April 15, 2020,
and Amendment No. 1 to its Annual Report on Form 10-K, which was
filed with the SEC on April 29, 2020. To the extent the holdings of
Cleveland BioLabs’ securities by the directors and executive
officers of Cleveland BioLabs have changed from the amounts set
forth in Cleveland BioLabs’ amended Annual Report, such
changes have been or will be reflected on Statements of Change in
Ownership on Form 4 filed with the SEC. Additional information
regarding the interests of such individuals in the proposed merger
will be included in the proxy statement/prospectus relating to the
proposed merger when it is filed with the SEC. These documents
(when available) may be obtained free of charge from the SEC’s
website at www.sec.gov and Cleveland BioLabs’ website at
www.cbiolabs.com.
Forward Looking
Statements:
This press release contains
forward-looking statements that involve risks and uncertainties.
All statements other than statements of current or historical fact
contained in this press release, including statements regarding the
future financial position, business strategy, new products,
budgets, liquidity, cash flows, projected costs, regulatory
approvals, the impact of any laws or regulations applicable to
Cleveland BioLabs or Cytocom, plans and objectives of management
for future operations, the expected ownership in the combined
company by the former Cytocom securityholders and securityholders
of Cleveland BioLabs as of immediately prior to the merger and
governance of the combined company are forward-looking statements.
The words “anticipate,” “believe,” “continue,” “should,”
“estimate,” “expect,” “intend,” “may,” “plan,” “project,” “will,”
and similar expressions, as they relate to us, are intended to
identify forward-looking statements. We have based these
forward-looking statements on the current expectations about future
events held by management of both companies. While we believe these
expectations are reasonable, such forward-looking statements are
inherently subject to risks and uncertainties, many of which are
beyond the control of either company. The actual future results of
Cleveland BioLabs or Cytocom may differ materially from those
discussed here for various reasons. Cleveland BioLabs discusses
many of these risks in Item 1A under the heading “Risk Factors” in
its Annual Report on Form 10-K for the year ended December 31,
2019, as updated by its other filings with the SEC. Factors that
may cause such differences include, but are not limited to, the
risk that the proposed merger may not be completed in a timely
manner or at all, which may adversely affect Cleveland BioLabs’
business and the price of Cleveland BioLabs’ common stock; the
failure of either party to satisfy any of the conditions to the
consummation of the proposed merger, including the approval of
Cleveland BioLabs’ stockholders; uncertainties as to the timing of
the consummation of the proposed merger; the occurrence of any
event, change or other circumstance that could give rise to the
termination of the merger agreement; the effect of the announcement
or pendency of the proposed merger on Cleveland BioLabs’ business
relationships, operating results and business generally; risks that
the proposed merger disrupts current plans and operations and the
potential difficulties in employee retention as a result of the
proposed merger; risks related to diverting management’s attention
from each company’s ongoing business operations; the outcome of any
legal proceedings that may be instituted against Cleveland BioLabs
or Cytocom related to the merger agreement or the proposed merger;
unexpected costs, charges or expenses resulting from the proposed
merger; each company’s need for additional financing to meet
its business objectives; the history of operating losses
experienced by both companies; the substantial doubt expressed by
each company’s independent auditors about its respective ability to
continue as a going concern; each company’s ability to successfully
develop, obtain regulatory approval for, and commercialize its
products in a timely manner; each company’s plans to research,
develop and commercialize its product candidates; each company’s
ability to attract collaborators with development, regulatory and
commercialization expertise; each company’s plans and expectations
with respect to future clinical trials and commercial scale-up
activities; each company’s reliance on third-party manufacturers of
its product candidates; the size and growth potential of the
markets for each company’s product candidates, and each company’s
ability to serve those markets; the rate and degree of market
acceptance of each company’s product candidates; regulatory
requirements and developments in the United States, the European
Union and foreign countries; the performance of each company’s
third-party suppliers and manufacturers; the success of competing
therapies that are or may become available; each company’s ability
to attract and retain key scientific or management personnel;
Cleveland BioLabs’ historic reliance on government funding for a
significant portion of its operating costs and expenses; government
contracting processes and requirements; the exercise of control
over Cleveland BioLabs by its majority stockholder; the
geopolitical relationship between the United States and the Russian
Federation as well as general business, legal, financial and other
conditions within the Russian Federation; each company’s ability to
obtain and maintain intellectual property protection for its
product candidates; each company’s potential vulnerability to
cybersecurity breaches; and other factors discussed in other SEC
filings of Cleveland BioLabs, including its Annual Report on Form
10-K for the year ended December 31, 2019.
Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. The forward-looking statements included in this press
release are made only as of the date hereof. We do not undertake
any obligation to update any such statements or to publicly
announce the results of any revisions to any of such statements to
reflect future events or developments.
Tickers:
IMUN,
CBLI,
HALB,
ARSN
SOURCE: Stock Investor
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