WINTER PARK, Fla., Oct. 21, 2020 /PRNewswire/ -- Cytocom, Inc.,
a leading biopharmaceutical company in the area of
immune-modulation, today announced that its Chief Executive
Officer, Michael K. Handley, has
issued a Letter to the stockholders of Cytocom and Cleveland
BioLabs, Inc. (NASDAQ: CBLI) regarding the recently announced
merger between the companies. The full text of the letter, which
has also been posted to the Company's website, is as follows.
Dear Shareholder,
In July we announced that Cytocom had signed an agreement to
acquire ImQuest Life Sciences, Inc., a drug development company and
contract research organization. We followed that yesterday with our
announcement that Cytocom has signed a definitive merger agreement
with Cleveland BioLabs, Inc. (NASDAQ: CBLI). I write to welcome all
stockholders of both companies to the Cytocom family, and to
provide our vision for the combined entities. Once the
Cytocom/Cleveland BioLabs merger is completed, we will have a new
company operating under the name "Cytocom, Inc." that we expect to
have listed on the Nasdaq Capital Market if the combined company
meets all the Nasdaq listing requirements. We anticipate trading on
the Nasdaq Capital Market under the proposed ticker symbol "CYTO."
This merger represents the culmination of months of hard work and
the dedication of many talented people. We are proud to have
reached this milestone and are excited about what we can accomplish
in the future.
The all-stock transaction, which was unanimously approved by
both companies' Boards of Directors and received majority
shareholder approval, is expected to close in the first quarter of
2021. After close, the new Cytocom will include a shareholder base
comprised of the former shareholders of Cleveland BioLabs, ImQuest
Life Sciences, and Cytocom. The equity holders in Cytocom will
become majority holders of Cleveland BioLabs' outstanding common
stock upon close of the merger.
Cytocom is a late-stage clinical biopharmaceutical company
focused on developing immune-modulating agents for the treatment of
serious diseases. We boast a robust pipeline that includes, among
other programs, four Phase 3-ready clinical programs for Crohn's
disease, fibromyalgia, multiple sclerosis, and pancreatic
cancer.
The merger with Cleveland BioLabs and the potential subsequent
Nasdaq listing (contingent on meeting Nasdaq listing requirements)
fit firmly with our vision to become a recognized leader in
immune-modulating treatments targeting infectious diseases,
including COVID-19, cancer, inflammation and autoimmune diseases,
and further builds on our intended acquisition of ImQuest Life
Sciences. We believe this transaction will enhance our visibility
and exposure to the public markets, and by doing so will enable us
to showcase the power of our drug development platform and our
near-term clinical and commercial milestones to further generate
shareholder value.
Two lead investigative compounds developed using our proprietary
platform — CYTO-201 for the treatment of Crohn's disease and
CYTO-401 for the treatment of pancreatic cancer — are expected to
enter Phase 3 clinical trials by the first quarter of 2021. A Phase
2 clinical trial for COVID-19 is expected to begin this year. We
remain focused on advancing these drug candidates through the
clinical trial process.
Building on our growth strategy are the assets we will acquire
from Cleveland BioLabs, as well as the drug development tools and
services obtained with the acquisition of ImQuest Life Sciences.
These two transactions represent a transformative growth
opportunity, not only for Cytocom, but also for the shareholders of
both Cleveland BioLabs and ImQuest Life Sciences.
Founded in 2003, in partnership with Cleveland Clinic, Cleveland
BioLabs is pursuing the development of a proprietary platform of
toll-like immune receptor activators with applications in radiation
sickness, cancer radiation therapy and counteracting cancer
treatment side effects, as well as cancer immunotherapy and
vaccines. The company's lead drug candidate, entolimod, a specific
toll-like receptor 5 (TLR5) agonist is nearing its submission for
FDA approval for use in Acute Radiation Syndrome, has also shown
preclinical potential as a cancer immunotherapy. It has advanced
into early-stage clinical trials for advanced solid tumors and
colorectal cancer. We look forward to accelerating the development
of entolimod and other product candidates emerging from this unique
platform as part of our mission to introduce a new generation of
immunotherapies targeting serious medical needs.
ImQuest Life Sciences and its contract research organization,
which is under its ImQuest Biosciences subsidiary, expands our
reach in a different but complementary direction. This is a
self-sustaining revenue generating business that should expand our
relationships in the drug development arena, as well as expand our
own drug development capabilities. The ImQuestSUCCESS platform of
services and tools offered by ImQuest Biosciences help drug makers
evaluate preclinical drug candidates to identify compounds that are
likely to succeed in preclinical and clinical trials. The ability
to minimize time-consuming and expensive preclinical and clinical
failures is a potential gamechanger for drug makers, and ImQuest
has proven its unique capabilities. Cytocom is excited to utilize
and further develop these same tools to strengthen our internal
drug discovery and development efforts. We also plan to continue
offering these same tools to other drug makers.
In the months to come, Cytocom will be working to close its
merger with Cleveland BioLabs, formalize its acquisition of ImQuest
Life Sciences and its subsidiaries, and prepare for our potential
debut as a publicly-traded company. After the closing of the
acquisition, ImQuest BioSciences will continue to operate as a
wholly owned subsidiary of Cytocom under its existing management
team, led by Dr. Robert W. Buckheit,
Jr., President and Chief Scientific Officer. Dr. Buckheit is
also serving as the Chief Technical Officer of Cytocom.
Again, I would like to thank our employees for their dedication
and loyalty along with our stakeholders for their continued support
as we evolve and grow in an effort to become one of the top
recognized immune-focused companies.
Best Regards,
Michael K. Handley,
CEO
Cytocom, Inc.
About Cytocom, Inc.
Cytocom, Inc. is a leader in immune modulation for the treatment
of serious disease is a 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
Forward-Looking Statements:
This release contains forward-looking statements that involve
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties inherent in research and development; the
uncertainties inherent in business and financial planning,
including, without limitation, risks related to Cytocom's business
and prospects, adverse developments in Cytocom's markets, or
adverse developments in the U.S. or global capital markets, credit
markets, regulatory environment or economies generally; the impact
of COVID-19 on our business, operations and financial results; and
competitive developments. The Company assumes no obligation to
update forward-looking statements contained in this release as a
result of new information or 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
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SOURCE Cytocom, Inc.