WINTER PARK, Fla. and
BUFFALO, N.Y., Oct. 20, 2020 /PRNewswire/ -- Cytocom, Inc.
(Cytocom), a leading biopharmaceutical company in the area of
immune-modulation, and Cleveland BioLabs, Inc., (NASDAQ: CBLI), an
innovative biopharmaceutical company developing novel approaches to
activate the immune system, today 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, 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.
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.
Conference Call
Cytocom will host a conference call and live audio webcast at
8:00 a.m. EDT on October 28th to discuss the merger and
provide a strategic vision for the combined company. To access the
conference call supported with slides, please dial
646-558-8656 with the meeting ID: 841 7826 2704 and passcode:
281020. The conference call can also be accessed at
https://cleartrustonline.com/cytocom. Approximately two hours
following the live event, a webcast replay of the conference call
will be available on Cytocom's
website https://www.cytocom.com/investors/ for approximately
30 days.
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.
Contact
Cytocom Media:
Tiberend Strategic Advisors, Inc.
Johanna Bennett
212-375-2686
jbennett@tiberend.com
Cytocom Investors:
Maureen McEnroe, CFA / Miriam Weber Miller
212-375-2664 / 212-375-2694
mmcenroe@tiberend.com / mmiller@tiberend.com
Cleveland BioLabs:
Cleveland BioLabs, Inc.
(716) 849-6810 ext. 101
investor.relations@cbiolabs.com
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SOURCE Cytocom, Inc.