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Friday, 08/13/2021 4:38:21 AM

Friday, August 13, 2021 4:38:21 AM

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Cytocom, Inc. and La Jolla Institute for Immunology Announce

Five-Year Research Alliance Agreement

Cytocom to fund research in cancer, autoimmune and inflammatory conditions, and infectious diseases and applications to clinical-stage therapies

Research to accelerate immune-modulating drug development, leveraging world-class research infrastructure and Cytocom’s proprietary AIMS™ discovery platform

FORT COLLINS, Colo., August 12, 2021 /PRNewswire/ -- Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced a collaboration agreement to fund research and laboratory facilities at the La Jolla Institute for Immunology (LJI), a not-for-profit academic institution and a world leader in immunology research. The agreement is directed to research that will support the development of potential new immune-modulating agents targeting toll-like receptors for the treatment of cancer, infectious, autoimmune and chronic inflammatory diseases. The research will harness Cytocom’s proprietary drug discovery and development platform technology.

“An alliance with an academic institution the caliber of the La Jolla Institute marks a major achievement for Cytocom and our mission to advance best-of-class immune-modulating therapies that restore immune homeostasis,” stated Michael K. Handley, President and CEO of Cytocom. “With the completion of the merger between Cleveland BioLabs and Cytocom, we have built a robust pipeline of immune-modulating treatments targeting neutropenia and anemia, emergent viruses, cancer, and autoimmune diseases. Working with the La Jolla Institute, we will deeply explore the mechanisms that we believe will drive next-generation therapeutic development with our AIMS™ technology and bring hope to patients and their families battling serious medical conditions.”

Under the terms of the research agreement, the La Jolla Institute may select up to four laboratories to participate in research. Cytocom will provide research funding to these laboratories for projects of mutual interest or for research projects commissioned by Cytocom that explore immune modulation and the action of therapeutics on target toll-like receptors. Toll-like receptors are central to an immune response, connecting innate and adaptive immune compartments, and thus key to fighting disease as well as restoring immune homeostasis. In addition to the research funding for the selected projects, Cytocom will pay to the La Jolla Institute $350,000 per year for each selected laboratory, for a total annual discretionary funding contribution of up to $1.4 million, in addition to the research funding itself. Cytocom will also provide researchers at the La Jolla Institute with samples and materials. In return, Cytocom will have a first option to negotiate a license to new discoveries by the La Jolla Institute that arise from the research projects of common interest funded by Cytocom, however Cytocom will own any new discoveries that arise from research projects of interest to Cytocom that have been commissioned to the La Jolla Institute as “work for hire.”

“We are excited to work with Cytocom to interrogate the mechanisms of immune modulation and human immunity modulated through toll-like receptors,” stated La Jolla Institute President and Chief Scientific Officer Mitchell Kronenberg, Ph.D. “Collaborations between academic research organizations and the biopharmaceutical industry play a key role in advancing science and informing drug development to the benefit everyone involved, from discovery-oriented scientists to therapeutic-oriented companies. Such collaborations are an important element of our history and our mission looking to the future. Most importantly, the combined efforts provide hope to the millions of people worldwide who deserve immunotherapies that deliver a healthy life without disease.”

About the La Jolla Institute for Immunology

Founded in 1988, La Jolla Institute for Immunology is a nonprofit, independent biomedical research institute focused on improving human health through increased understanding of the immune system. Its scientists carry out research seeking new knowledge leading to the prevention of disease through vaccines and the treatment and cure of infectious diseases, cancer, inflammatory, and autoimmune diseases such as rheumatoid arthritis, type 1 (juvenile) diabetes, Crohn’s disease and asthma. To learn more about the Institute’s work, visit

About Cytocom

Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. The company also has one of the largest platforms of toll-like immune receptors (TLR4, TLR5 and TLR9) in the biopharmaceutical industry, addressing conditions such as radiation sickness and cancer treatment side effects. 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 several clinical-stage development programs for Crohn’s disease, hematology, pancreatic cancer, and COVID-19 in addition to expansion to fibromyalgia and multiple sclerosis. To learn more about Cytocom, Inc., please visit

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 expected clinical development timeline for our product candidates, our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objections of management for future operations, 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. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. The company’s actual future results may differ materially from those discussed here for various reasons. The company discusses many of these risks under the heading "Risk Factors" in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the company’s other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between legacy Cytocom and Cleveland BioLabs; unexpected costs, charges or expenses resulting from the merger; our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our historical reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; 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; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading “Risk Factors” in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.

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.


Cytocom, Inc.

Nichol Ochsner

Senior V.P. Investor Relations and Corporate Communications

(732) 754-2545

Tiberend Strategic Advisors, Inc.

Maureen McEnroe, CFA (Investors)

(212) 375-2664

Johanna Bennett (Media)

(212) 375-2686