Cleveland BioLabs

Company Profile

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic Foundation, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute.


Cleveland BioLabs Completes Recruitment for Phase II Hormone-Refractory Prostate Cancer Trial

Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News), announced today that it has fully enrolled its Phase II clinical trial of Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer.

This open label trial is evaluating the safety and efficacy of Curaxin CBLC102 for use in treating patients with hormone-refractory metastatic prostate cancer. Curaxins have multiple mechanisms of action, including simultaneous activation of p53 and inhibition of NF-kappaB, which are frequently deregulated in cancer. Compounds that target p53 or NF-kappaB independently have been validated as cancer therapies; however, Curaxins are the only compounds currently known to CBLI that simultaneously target both pathways.


Buyins.net Initiates Coverage on Cleveland BioLabs With SqueezeTrigger Price of $7.41

Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) announced today that Buyins.net initiated coverage on the Company after releasing the latest short sale data through May 2008.

The Buyins.net report stated that the total aggregate number of CBLI shares shorted between July 2006 and May 2008 is approximately 2.5 million shares. The report also stated that the CBLI SqueezeTrigger price of $7.41 is the volume weighted average short price of all short selling in CBLI.


Cleveland BioLabs Featured in "Gene Marcial's 7 Commandments of Stock Investing"

Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) announced today that the Company has been featured in "Gene Marcial's 7 Commandments of Stock Investing," recently published by FT Press. Gene Marcial is a senior writer and columnist at BusinessWeek where he writes the column "Inside Wall Street."

Cleveland BioLabs was cited as one of "several little-known biotechs that have outscored their peers" under the chapter titled, "Commandment 6: Don't Fear The Unknown" of "Gene Marcial's 7 Commandments of Stock Investing." The chapter includes a brief summary by the author of Cleveland BioLabs' history and stock price from its IPO in July 2006 through early 2008.


Cleveland BioLabs Management Reviews 2008 Highlights and Milestones at Annual Meeting

Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that Chief Executive Officer and President, Michael Fonstein, Ph.D. and Chief Scientific Officer, Andrei Gudkov, Ph.D, D. Sci. shared 2008 highlights and milestones at the Company's annual meeting today.

Dr. Fonstein reviewed several of the Company's recent achievements including:

  • Publication of a pivotal paper on Protectan CBLB502 in Science Magazine;

  • Receipt of a $8.9 million development contract from the Department of Defense (DoD) for CBLB502;
  • Demonstration of CBLB502's potential to reduce the side effects of a commonly used chemotherapeutic drug, Cisplatinum;
  • Extension of CBLB502's ability to mitigate hematopoietic damage from 75% lethal doses of radiation, up to 48 hours post exposure; and
  • Submission of a proposal to BARDA/HHS for a development contract potentially worth up to $13.5 million.
  • Cleveland BioLabs Hosts Conference Call Highlighting Recent Achievements and Discussing Development Strategy


    67:33 minutes (15.47 MB)

    Cleveland BioLabs, Inc. hosted a conference call today recapping recent achievements, as well as providing an update on the Company's development strategy and timeline.

    Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic Foundation, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute.


    Cleveland BioLabs to Highlight Recent Achievements and Provide Update on Development Strategy on April 17 Conference Call

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that it will host a conference call at 10:00 a.m. EDT on April 17, to recap recent achievements and provide an update on the Company's development strategy and timeline.

    Interested parties may participate by dialing 877-407-8031 (US) or 201-689-8031 (International) approximately five to ten minutes before the call start time. A live Webcast of the conference call will be available on the Cleveland BioLabs Web site at www.cbiolabs.com.

    A replay of the call will be available starting on April 17, 2008, at 1:00 p.m. EDT through April 24, 2008 at 11:59 p.m. EDT. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering account number 286 and conference ID number 281842. An archived Webcast of the conference call will be available on the Cleveland BioLabs Web site at www.cbiolabs.com.


    WBB Securities Upgrades Cleveland BioLabs to Strong Buy and Reiterates $13 Price Target

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) announced today that Daniel Mallin, Ph.D. and Stephen Brozak of WBB Securities, LLC have updated coverage on the Company.

    The WBB Securities report, dated April 11, 2008, assigned a Strong Buy rating to the Company, and reiterated a 12-month target price of $13.00. The report's introduction stated, "In the past eight days, three significant events have taken place that validate CBLI's science, underscore the company's viability and improve the company's outlook." The report then summarized these events.

    Interested parties should contact WBB Securities for more information about the report. For more information on WBB Securities, please visit: www.wbbsec.com.


    Science Magazine Publishes Cleveland BioLabs Breakthrough Paper on Protectan CBLB502's Radioprotective Activity

    Department of Defense Recently Awarded $8.9 Million Development Contract for Protectan CBLB502

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that Science, the world's leading journal of original scientific research, global news, and commentary, has published breakthrough findings by Cleveland BioLabs researchers regarding Protectan CBLB502's radioprotective abilities, titled, "An Agonist of Toll-Like Receptor 5 Has Radioprotective Activity in Mouse and Primate Models." Cleveland BioLabs's paper is the first Science publication on radioprotection in more than three decades.


    Cleveland BioLabs to Submit Protectan CBLB502 for BARDA BAA for Development of Therapies . . .

    . . . to Protect Civilian Population From Radiation Exposure

    Expands Market Opportunity Beyond Recent Department of Defense Development Contract for $8.9 Million and Potential Military Purchase

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that it will submit Protectan CBLB502 for the Broad Agency Announcement (BAA) soliciting research and development proposals for "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation" published on March 6, by the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).


    Department of Defense Awards Cleveland BioLabs Contract to Develop Protectan CBLB502

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that the Department of Defense (DoD) has awarded the Company a letter contract through the Chemical Biological Medical Systems (CBMS) Joint Project Management Office Broad Agency Announcement (http://www.jpeocbd.osd.mil/page_manager.asp?pg=2&sub=66) for selected tasks in the advanced development of Protectan CBLB502 as a Medical Radiation Countermeasure to treat radiation injury following exposure to radiation from nuclear or radiological weapons. A letter contract is a written preliminary contractual instrument that authorizes initial performance prior to negotiating a definitized contract. When definitized, this contract shall not exceed $8.9 million in development funding.


    Cleveland BioLabs Protectan CBLB502 Demonstrates Strong Mitigation Of Hematopoietic Damage . . .

    . . . at 48 Hours Post-Exposure to 6.5 Gy of Radiation

    Highlights Broad Agency Announcement From BARDA for Development of Therapies for Acute Exposure to Ionizing Radiation

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that recent primate studies have demonstrated the efficacy of Cleveland BioLabs's Protectan CBLB502 as a mitigator of hematopoietic damage up to 48 hours post radiation exposure.


    Cleveland BioLabs CEO to Present at 3rd Annual Stem Cell Summit in New York City

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that the Company is scheduled to present at the 3rd Annual Stem Cell Summit in New York City on Tuesday, February 26, 2008.

    The Annual Stem Cell Summit is organized and produced by RRY Publications and Robin Young Consulting. This year's Summit will feature more than 50 speakers, including a panel of stem cell patients. The goal of the Summit is to bring together investors, industry executives, practitioners and analysts to learn about investment opportunities in the stem cell marketplace, groundbreaking stem cell products physicians are using today, and the growing market potential in terms of revenues. For additional information or to register, please visit www.stemcellsummit.com.

    Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, will give a brief presentation on the Company's Protectan CBLB612 compound at 10:44 a.m. ET on February 26.


    Cleveland BioLabs Protectan CBLB502 Demonstrates Significant Reduction of Adverse Effects of Chemotherapeutic Drug in Mice

    Phase I/II Study in Head and Neck Cancer Patients Planned for 2008

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced results of a study demonstrating Protectan CBLB502's ability to reduce the side effects of a chemotherapeutic drug, cisplatinum (Ciplatin, Platinol), broadly used for treatment of ovarian, endometrial, head and neck, lung, stomach and other types of cancer.


    Cleveland BioLabs CEO to Present at Roth Capital 20th Annual OC Growth Stock Conference

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that the Company is scheduled to present at Roth Capital's 20th Annual OC Growth Stock Conference February 18-21, in Dana Point, California. Cleveland BioLabs management will be available for meetings February 19-20.

    Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, will give a presentation on the Company's lead compounds and development strategy on February 19, at 5:00 p.m. PT. The presentation will be broadcast live over the Internet. Interested parties may tune in to the live presentation by visiting the Investor Information section of the Company's website at: www.cbiolabs.com.


    Cleveland BioLabs CEO to Share Ongoing Development Strategy at BIO CEO and Investor Conference

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that the Company is scheduled to present at the 2008 BIO CEO and Investor Conference to be held February 11-13, in New York City. Cleveland BioLabs management will be available for meetings in New York City during the conference.

    Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, will give a presentation on the Company's lead compounds and development strategy on February 12, at 3:30 p.m. ET. The presentation will be broadcast live over the Internet. Interested parties may tune in to the live presentation by visiting the Investor Information section of the Company's website at: www.cbiolabs.com.


    Cleveland BioLabs Protectan CBLB612 Outperforms Market Leading Hematopoietic Stem Cell Stimulator in Mouse Study

    Demonstrates Potential Breakthrough for Minimally Invasive and More Effective Blood Stem Cell Collection

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced the results of a study of the effects of CBLB612, the lead compound in the Protectans 600 series, on propagation and mobilization to peripheral blood of hematopoietic (bone marrow/blood) stem cells (HSC) in comparison with G-CSF, the current market leading product, in mice.

    Direct comparisons of CBLB612 and G-CSF, injected as single agents or in combination with AMD3100, a promising clinical-stage stem cell mobilizer developed by AnorMED Inc., demonstrated much stronger efficacy of CBLB612 as a stimulator and mobilizer of HSC in peripheral blood.


    Cleveland BioLabs Achieves Recovery From Neutropenia and Thrombocytopenia in Primates 48Hrs Post-Irradiation w/Protectan CBLB502

    Demonstrates Potential for Radiation Antidote Stockpiling

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced results of a primate study demonstrating the efficacy of Protectan CBLB502 as a mitigator of hematopoietic (bone marrow/blood production) damage up to 48 hours post-radiation exposure.


    Cleveland BioLabs Launches Phase II Advanced Renal Cell Carcinoma Trial for Curaxin CBLC102

    Oral Compound With Historical Safety Profile; Currently in Phase II Trial for Hormone-Refractory Prostate Cancer

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced the initiation of its Phase II efficacy study
    for Curaxin CBLC102 in advanced renal cell carcinoma (a highly fatal form of kidney cancer) at ClinWorks Cancer Research Center in Charlotte, NC.

    Curaxin CBLC102 is a safe, oral drug that was used to treat malaria during World War II. In addition to its anti-malaria effects, laboratory results have shown that it is effective against several malignancies, including renal cell carcinoma. The Company has a "method of use" patent application pending on Curaxin CBLC102.


    Cleveland BioLabs to Present at 19th Annual Piper Jaffray Health Care Conference

    Cleveland BioLabs, Inc. (NasdaqGM:CBLI - News) today announced that the Company is scheduled to present at the 19th Annual Piper Jaffray Global Health Care Conference, on November 27-29, in New York City.

    Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs, will give a presentation on November 27, at 8:00 a.m. EST on the Company's technology platform and lead products. The presentation will be followed by a question and answer session and a live webcast may be accessed at the Company's website, www.cbiolabs.com or at http://www.piperjaffray.com/conferences. A replay of the presentation will be archived for 30 days after the conference, at the same locations.

    Cleveland BioLabs management will be available for meetings in New York on November 27-28.


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