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Cbli 2011 05 25 barda


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CBLI Wedbush May 2011 update

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Cbli 2011 05 25 barda

  1. 1. LOS ANGELES | SAN FRANCISCO | NEW YORK | BOSTON | SEATTLE | MINNEAPOLIS | DALLAS May 25, 2011 Gregory R. Wade, Ph.D. (415) 274-6863 David M. Nierengarten, Ph.D. (415) 274-6862 Christopher N. Marai, Ph.D. (415) 274-6861 Cleveland BioLabs, Inc. (CBLI - OUTPERFORM): BARDA Contract Progress Update Price: $5.52 12-Month Price Target: $10 • We continue to anticipate that CBLI will receive a $50+ million government award for CBLB502 development (BAA-BARDA-09-34) now in the July/August timeframe. It appears to us that the contract award announcement has been delayed; however the details and our expectation of a contract award to CBLI have not changed. We have no reason to believe that BARDA’s intention to award the contract to CBLI has changed. • There is no fundamental reason for the stock to trade down as it has recently, in our opinion, and while we anticipate the contract will be awarded shortly, we note that the delay does not jeopardize the company or the CBLB502 program. Recall CBLI has historically done a lot with a very little amount of cash and currently has a low cash burn of ~11 million annually. • Recall that CBLB502, a recombinant protein, protects the two main body systems affected by sub-lethal radiation— the hematopoietic tissue and gastrointestinal tract. Competitor products in development are potentially complementary and not a threat, in our opinion, given that their mechanism of action that appears to protect the respiratory track against radiation. CBLI is also planning a Phase I/II trial in head and neck cancer patients treated with radiation to study its supportive care. • Recall, as we had noted previously, we expect that at some point Cleveland BioLabs will also be awarded a contract to supply the US government with CBLB502 to treat and prevent ARS in the event of a radiological event. Progress on this front could come in H2:11 with the publication of a Radiation Medical Countermeasure RFP. CBLI has already been awarded over $48 million in government contracts to develop CBLB502, and we expect that CBLI will submit its BLA in H1:12. With expected approval by H2:12, we believe that CBLI will be a main supplier of a radiation countermeasure to the military and Strategic National Stockpile (SNS), given the language in the BAA-BARDA-09-34 solicitation. • The broad Agency award (BAA-BARDA-09-34) that CBLI anticipates receiving funding from, has the mandate of funding research and development activities that will serve to advance the knowledge and scientific understanding of drug candidate countermeasures for chemical, biological, radiological and nuclear (CBRN) threats. This solicitation includes the anticipation that funding of activities will lead to eventual FDA approval and their inclusion in the Strategic National Stockpile (SNS). • Reiterating OUTPERFORM rating and price target of $10/share. We arrive at $10 price target by adding net profits of CBLB502 from 2011 to 2015, discounted by 30% annually, and applying an 11x multiple to our estimated net profits from 2016 CBLB502 sales also discounted by 30%. Our 11x multiple is arrived at by reducing the present S&P multiple of next year’s earnings of approximately 13.7x by the expected consensus growth rate for S&P earnings of 23% to account for the absence of expected growth in the ARS segment of CBLI’s business. • Risks to the achievement of our fair value estimate include failure to achieve any of the following: completion of CBLB502 development work under the FDA’s Animal Efficacy Rule, FDA approval of CBLB502 for ARS, eventual procurement of 37,500 doses of CBLB502 under the existing DoD/BARDA contract option, and the continued commitment of BARDA and partner agencies to both developmental funding and procurement of additional defense agents for the SNS.Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors shouldbe aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors shouldconsider this report as only a single factor in making their investment decision. Please see page 3 of this report for analystcertification and important disclosure information.
  2. 2. MilestonesMid:2011............................Potential $50+ million BARDA development award (BAA-BARDA-09-34)Mid 2011............................Potential publication of an RFP from BARDA for radiation medical countermeasureMid 2011............................Pivotal animal study CBLB502 for BLAMid 2011............................Initiation of CBLB502 Safety Study, n=500, double-blindQ3 2011.............................IND filing for next generation curaxins2012 ..................................BLA filing for CBLB502H1:11.................................Initiation of Phase I/II trials of CBLB502 as an adjuvant therapy in head and neck cancer patientsQ4:11.................................Initiation of Phase I trial of CBLB502 in cancer patientsYE:11.................................Completion of CBLC102 PIb liver cancer trialH2:12.................................Potential FDA approval for CBLB502 as a radiation medical countermeasure Cleveland BioLabs, Inc.| 2
  3. 3. Analyst CertificationI, Gregory R. Wade, Ph.D., David M. Nierengarten, Ph.D., Christopher N. Marai, Ph.D., certify that the views expressed in this report accuratelyreflect my personal opinion and that I have not and will not, directly or indirectly, receive compensation or other payments in connection with myspecific recommendations or views contained in this report.Disclosure information regarding historical ratings and price targets is available at Rating System:Outperform: Expect the total return of the stock to outperform relative to the median total return of the analyst’s (or the analyst’s team) coverageuniverse over the next 6-12 months.Neutral: Expect the total return of the stock to perform in-line with the median total return of the analyst’s (or the analyst’s team) coverageuniverse over the next 6-12 months.Underperform: Expect the total return of the stock to underperform relative to the median total return of the analyst’s (or the analyst’s team)coverage universe over the next 6-12 months.The Investment Ratings are based on the expected performance of a stock (based on anticipated total return to price target) relative to theother stocks in the analyst’s coverage universe (or the analyst’s team coverage).*Rating Distribution Investment Banking Relationships(as of March 31, 2011) (as of March 31, 2011)Outperform: 55% Outperform: 11%Neutral: 37% Neutral: 4%Underperform: 8% Underperform: 0%The Distribution of Ratings is required by FINRA rules; however, WS’ stock ratings of Outperform, Neutral, and Underperform most closelyconform to Buy, Hold, and Sell, respectively. Please note, however, the definitions are not the same as WS’ stock ratings are on a relativebasis.The analysts responsible for preparing research reports do not receive compensation based on specific investment banking activity. Theanalysts receive compensation that is based upon various factors including WS’ total revenues, a portion of which are generated by WS’investment banking activities.Wedbush Equity Research Disclosures as of May 25, 2011 Company Disclosure Cleveland BioLabs, Inc. 1,7,10Research Disclosure Legend 1. WS makes a market in the securities of the subject company. 2. WS managed a public offering of securities within the last 12 months. 3. WS co-managed a public offering of securities within the last 12 months. 4. WS has received compensation for investment banking services within the last 12 months. 5. WS provided investment banking services within the last 12 months. 6. WS is acting as financial advisor. 7. WS expects to receive compensation for investment banking services within the next 3 months. 8. WS provided non-investment banking securities-related services within the past 12 months. 9. WS has received compensation for products and services other than investment banking services within the past 12 months. 10. The research analyst, a member of the research analyst’s household, any associate of the research analyst, or any individual directly involved in the preparation of this report has a long position in the common stocks. 11. WS or one of its affiliates beneficially own 1% or more of the common equity securities.Price ChartsWedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts forcompanies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed untilthe following quarter. Additional information on recommended securities is available on request. Cleveland BioLabs, Inc.| 3
  4. 4. * WS changed its rating system from (Strong Buy/Buy/Hold/Sell) to (Outperform/ Neutral/Underperform) on July 14, 2009.Please access the attached hyperlink for WS’ Coverage Universe: Applicable disclosure information is also available upon request by contacting Ellen Kang in the Research Department at (213) 688-4529, by email to, or the Business Conduct Department at (213) 688-8090. You may also submit a written requestto the following: Business Conduct Department, 1000 Wilshire Blvd., Los Angeles, CA 90017. OTHER DISCLOSURES RESEARCH DEPT. * (213) 688-4505 * EQUITY TRADING Los Angeles (213) 688-4470 / (800) 421-0178 * EQUITY SALES Los Angeles (800) 444-8076 CORPORATE HEADQUARTERS (213) 688-8000The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not arepresentation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to benor should it be relied upon as a complete record or analysis; neither is it an offer nor a solicitation of an offer to sell or buy any security mentionedherein. This firm, Wedbush Securities, its officers, employees, and members of their families, or any one or more of them, and its discretionary andadvisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or salesthereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. Theherein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to theinformation contained herein may be obtained upon request. Cleveland BioLabs, Inc.| 4
  5. 5. EQUITY RESEARCH DEPARTMENT (213) 688-4529 DIRECTOR OF RESEARCH Mark D. Benson (213) 688-4435RETAIL AND CONSUMER TECHNOLOGY, MEDIA AND TELECOM LIFE SCIENCESConsumer Products Communications Equipment Biotechnology/Biopharmaceuticals/BioDefenseRommel T. Dionisio (212) 938-9934 Rohit Chopra (212) 668-9871 Gregory R. Wade, Ph.D. (415) 274-6863Kurt M. Frederick, CFA CPA (213) 688-4459 Sanjit Singh (212) 938-9922 David M. Nierengarten, Ph.D. (415) 274-6862 Christopher N. Marai, Ph.D. (415) 274-6861Entertainment: Toys Entertainment: RetailEdward Woo, CFA (213) 688-4382 Michael Pachter (213) 688-4474 Cardiac, Hepatic and RegenerativeNick McKay (213) 688-4343 Duane Nash, MD JD MBA (415) 263-6650 Entertainment: Software Akiva Felt (415) 263-6648Healthy Lifestyles Michael Pachter (213) 688-4474Kurt M. Frederick, CFA CPA (213) 688-4459 Edward Woo, CFA (213) 688-4382 Emerging Pharmaceuticals Nick McKay (213) 688-4343 Liana Moussatos, Ph.D. (415) 263-6626Specialty Retail: Hardlines Richard Lau (415) 274-6851Joan L. Storms, CFA (213) 688-4537 Computer Services: Financial Technology Christopher N. Marai, Ph.D. (415) 274-6861John Garrett (213) 688-4523 Gil B. Luria (213) 688-4501 Nick Setyan (213) 688-4519 Healthcare Services - Managed CareSpecialty Retail: Softlines Sarah James (213) 688-4503Betty Chen (415) 273-7328 Internet and E-Commerce Daniel Patt (212) 938-9937 Kerry Rice, CPA (213) 688-4538RETAIL/CONSUMER MARKET RESEARCH John Kim (213) 688-6624 Medical Technology Phillip Nalbone (415) 274-6884Gabriella Santaniello (213) 688-4557 Edward Woo, CFA (213) 688-4382 Jeffrey Chu (415) 274-6885 Nick McKay (213) 688-4343CLEAN TECHNOLOGY AND INDUSTRIAL GROWTH Medical Diagnostics and Life Sciences Tools Media Zarak Khurshid (415) 274-6823Aerospace and Defense James Dix, CFA (213) 688-4315Kenneth Herbert (415) 274-6875 Max Pinigin (213) 688-4518Andrew Doupé (415) 274-6876 Movies and EntertainmentClean Technology Michael Pachter (213) 688-4474Craig Irwin (212) 938-9926 Edward Woo, CFA (213) 688-4382David Giesecke (212) 938-9925 Nick McKay (213) 688-4343Environmental Services SemiconductorsAl Kaschalk (213) 688-4539 Betsy Van Hees (415) 274-6869Kevin Lee (213) 688-4303 Ryan Jue (415) 263-6669Industrial Biotechnology Telecommunications SoftwareLiana Moussatos, Ph.D. (415) 263-6626 Scott P. Sutherland, CFA (213) 688-4522Christopher N. Marai, Ph.D. (415) 274-6861 Suhail Chandy (213) 688-4380Water and Renewable Energy Solutions Wireless EquipmentDavid Rose, CFA (213) 688-4319 Scott P. Sutherland, CFA (213) 688-4522 Suhail Chandy (213) 688-4380 EQUITY SALES EQUITY TRADING Los Angeles (213) 688-4470 / (800) 444-8076 Los Angeles (213) 688-4470 / (800) 421-0178 San Francisco (415) 274-6800 San Francisco (415) 274-6811 New York (212) 938-9931 New York (212) 344-2382 Boston (617) 832-3700 Boston (617) 832-3700 CORPORATE HEADQUARTERS 1000 Wilshire Blvd., Los Angeles, CA 90017-2465 Tel: (213) 688-8000