UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): October 21, 2020
Cleveland BioLabs, Inc.
(Exact Name of Registrant as Specified in Charter)
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DELAWARE |
001-32954 |
20-0077155 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
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73 High Street Buffalo, NY 14203 |
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(Address of Principal Executive Offices and zip code) |
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(716) 849-6810 |
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(Registrant's Telephone Number, Including Area Code) |
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Securities registered or to be registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common stock, par value $0.005 |
CBLI |
NASDAQ Capital Market |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☒ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
As previously disclosed, on October 16, 2020, Cleveland BioLabs, Inc. (the “Company”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Cytocom, Inc. (“Cytocom”) and High Street Acquisition Corp., a direct, wholly owned subsidiary of the Company. On October 21, 2020, Cytocom released a letter to the stockholders of each of the Company and Cytocom regarding the Merger Agreement. A copy of the letter is attached as Exhibit 99.1 to this report and incorporated herein by reference.
Additional Information and Where to Find It
The Company plans to file a Registration Statement on Form S-4 containing a proxy statement/prospectus of the Company and other documents concerning the proposed merger with the SEC. Before making any voting decision, the Company’s stockholders are urged to read the proxy statement/prospectus in its entirety when it becomes available and any other documents filed by the company 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 the Company and Cytocom, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. The Company also makes available free of charge at www.cbiolabs.com (in the “Investors” section), copies of materials that the Company 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. The Company 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 the Company in connection with the proposed merger. Security holders may obtain information regarding the names, affiliations and interests of the Company’s directors and officers in the Company’s 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 the Company’s securities by the Company’s directors and executive officers have changed from the amounts set forth in the Company’s 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 the Company’s website at www.cbiolabs.com.
Cautionary Note About Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this current report, including statements regarding 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 us, plans and objectives of management for future operations, the expected ownership in the combined company of the former Cytocom securityholders and securityholders of the Company as of immediately prior to the Merger, governance of the combined company and entry into the Support Agreements 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 our current expectations about future events. 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. Our actual future results may differ materially from those discussed here for various reasons. We discuss many of these risks in Item 1A under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our 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 the Company’s business and the price of Company’s common stock; the failure of either party to satisfy any of the conditions to the consummation of the proposed merger, including the approval of Company’s 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 the Company’s 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 the Company’s ongoing business operations; the outcome of any legal proceedings that may be instituted against the Company related to the merger agreement or the proposed merger; unexpected costs, charges or expenses resulting from the proposed merger; our need for additional financing to meet our business objectives; our history of operating losses; the substantial doubt expressed by our independent auditors about our ability to continue as a going concern; 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 reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of control over our company by our 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; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed below and in our other SEC filings, including our 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 current report 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.
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Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits
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Exhibit Number |
Description |
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99.1 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Cleveland BioLabs, Inc. |
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Date: October 21, 2020 |
By: |
/s/ Christopher Zosh |
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Name: Christopher Zosh |
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Title: Vice President of Finance |
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Exhibit 99.1
Cytocom, Inc. Issues Shareholder Letter
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
SOURCE Cytocom, Inc.
Related Links
http://www.cytocom.com