Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

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31.12.2010 18:14
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Last week, Cleveland Biolabs (NASDAQ:CBLI) announced that it had raised approximately $8.39 million in a registered direct offering with what termed "a single institutional investor." Apparently, the company agreed to sell 1,400,000 shares of its common stock at a discount price of $5.99 per share despite the fact that the stock was trading over $7 when the deal was announced.

Having a name like this take a position in the stock will bring credibility to the company and help call more attention to all the great things it has lined up for the weeks and months ahead, much less for the long term.

While it may not seem fair to the retail investors who have been paying over $7+ for shares of the stock at the time, we believe Michael S. Dell,will soon be revealed as that investor. As many on Wall Street know Dell has a strategy like Warren Buffett’s, and his investing philosophy and top holdings speak for themselves.

Our sources tell us that he went out of his way to reach out to CBLI personally and told them of his interest in the company. He wanted in and he wanted in as quickly as possible. Could it be that Dell is hearing the same things about additional government funding and orders set to start coming into the company for their FDA fast tracked anti-radiation countermeasure, CBLB502? Several analysts, think shares of the company could double or triple from current levels during Q1 of 2011. As I told readers when the shares were trading at $3 just months ago, CBLI is a multi-billion dollar company waiting to happen.

According to a recent article in Fortune magazine, Michael Dell’s personal investment is managed by MSD Capital. Since started in 1998, the firm's track record and achievements have taken them over the $12 billion mark for asset management while investing in public equity, special opportunities, private equity, real estate and partnerships.

According to the MSD website, "make long-term equity investments in a limited number of outstanding companies, both in the United States and abroad. We employ a disciplined, research-intensive analytic process in searching for businesses that possess sustainable long-term competitive advantages and are managed by honest, astute and shareholder-minded management teams. We firmly believe that businesses create wealth for their owners through the long-term generation of net free cash flow. Although we typically invest as a minority owner of publicly-traded companies, given the long-term perspective that we take when we make investments, we consider ourselves to be a partial owner of the businesses in which we invest. We focus on the absolute value of businesses, not their value relative to other "peer" companies or general stock market indices."

Dell founded Dell in 1984 and in 1992 became the youngest Chief Executive Officer of a company ever to earn a ranking on the Fortune 500. He is easily considered a visionary leader and has earned titles like “Entrepreneur of the Year” from Inc. magazine, “Man of the Year” by PC Magazine, “Top Chief Executive Officer in American Business” from Worth Magazine and “Chief Executive Officer of the Year” by Financial World and Industry Week magazines. The fact that he believes strongly enough in CBLI will speak volumes to the rest of the biotech industry.

Did the company, in essence, pay for that additional exposure and "credibility?" In a sense, yes. I think so. Will it be worth it? Definitely.

Pipe: http://www.cbiolabs.com/product.php

Aufklappen

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27.02.2012 18:46
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das ises,

das ises,

 

 

BioLabs, RPCI seek patents on cancer research

Researchers at Cleveland BioLabs Inc.   and Roswell Park Cancer Institute   have filed for patent protection for study results on structural aspects of its CBLB502 compound, being developed as a radiation countermeasure and cancer therapeutic.

http://www.bizjournals.com/buffalo/news/2012/02/27/biolabs-rpci-seek-patents-on-cancer.html

 

study results patentieren...

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27.02.2012 18:07
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nach langer zeit scheint was

nach langer zeit scheint was im busch zu sein..lol.. vlt. kaufen die chinesen den laden, die brauchen noch strahlenschutz für ihre weltraumpläne.. grins...

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03.07.2011 13:54
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland BioLabs, Inc. (NASDAQ:CBLI) announced that it received a $1,531,034 increase (including option) in the development portion of the Company's existing contract, awarded on September 16, 2010, from the United States Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to fund additional development activities for CBLB502, a medical radiation countermeasure.

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17.06.2011 16:25
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

June 17, 2011, 9:01 a.m. EDT

Cleveland BioLabs to Raise $23.5 Million in Registered Direct Offering

BUFFALO, NY, Jun 17, 2011 (MARKETWIRE via COMTEX) -- Cleveland BioLabs, Inc. CBLI -15.19% today announced it has received commitments from certain institutional and accredited investors to purchase an aggregate of $23.5 million of the Company's securities in a registered direct offering.

The Company entered into definitive purchase agreements with these investors pursuant to which the Company agreed to sell an aggregate of approximately 5.873 million shares of its common stock and warrants exercisable for up to approximately 2.936 million additional shares of its common stock. The securities will be sold in units at a price of $4.00 per unit, with each unit consisting of one share of common stock, a Series E Warrant to purchase 0.25 shares of common stock and a Series F Warrant to purchase 0.25 shares of common stock. The Series E Warrants will be exercisable at a price of $4.50 per share beginning six months following the issuance date and will expire one year from the issuance date. The Series F Warrants will be exercisable at a price of $5.00 per share beginning six months following the issuance date and will expire five years from the issuance date. The closing of the offering is expected to take place on or about June 22, 2011, subject to the satisfaction of customary closing conditions.

The estimated net proceeds to the Company from the offering are expected to be approximately $22.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, the funding of the continued development of the Company's existing drug portfolio and general working capital. Pending application of such proceeds, the Company expects to invest the proceeds in short-term, interest-bearing, investment-grade marketable securities or money market obligations.

Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. RODM +0.77% , acted as the exclusive placement agent for this transaction. Wunderlich Securities, Inc. acted as an advisor.

All of the securities in this offering were offered pursuant to an effective shelf registration statement. A prospectus supplement relating to the offering will be filed by the Company with the Securities and Exchange Commission.

This announcement shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the final prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC's website at http://www.sec.gov or from Rodman & Renshaw, LLC, 1251 Avenue of the Americas, 20th Floor, New York, NY 10020, by calling (212) 356-0549 or emailing info@rodm.com.

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com .

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.

These factors include, among others, the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and the Company's ability to win additional funding under such contracts and grants; the Company's failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company's ability to comply with various safety, environmental and other governmental regulations. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.

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05.06.2011 15:50
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Gov't unit wants more info from Biolabs

Gov't unit wants more info from Biolabs

Cleveland BioLabs Inc. will need to submit an updated funding proposal for a major federal contract.

The company announced this week it has completed advanced stages of contract negotiations for new contracts with the Biomedical Advanced Research and Development Authority (BARDA) within the federal Department of Health and Human Services.

The update clarifies the development path of the company’s radiation treatment drug with the Food & Drug Administration, which has advanced in recent months.

Michael Fonstein, president and CEO, stressed the two processes are coincidental, and shouldn’t have an impact on each other.

“The delay in funding does not look to be delaying the FDA-enabling development,” he says. “It’s basically two bureaucratic processes.”

“We don’t see significant changes to the program, though it’s important to let the market know there is a delay,” he said.

The Buffalo-based company (NASDAQ: CBLI) last fall received FDA fast-track and orphan drug designations for its CBLB502 compound, under development as a treatment to reduce the risk of death following total body irradiation during or after radiation disaster.

According to the company, BARDA has indicated that further contract-related negotiations will require clarification of the development path for the compound with FDA. The application for the compound has transferred within FDA from the Division of Biologic Oncology Products to the Division of Medical Imaging Products, which reviews drugs used to treat people exposed to particulate radioactive materials.

Fonstein says the review is an anticipated step in the drug development process and is currently underway. Once the FDA confirms there are no objections to the company continuing with its development plan, the company may resubmit an updated contract proposal to BARDA.

The company has previously received more than $50 million in federal contracts from BARDA, the Department of Defense and the National Institute of Allergy and Infectious Diseases. The new contract would continue work already underway, Fonstein says.

“We are confident in our ability to address this latest request from BARDA and secure its support for the remaining steps in the CBLB502 program,” he said. “We will move CBLB502 ahead and firmly believe that, upon FDA licensure, it will play a significant role in domestic and global biodefense preparedness.”

Additional updates will be offered at the company’s annual stockholder meeting June 7 and during an investor day June 8.

http://www.bizjournals.com/buffalo/news/2011/06/01/govt-unit-wants-more-...

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31.05.2011 15:27
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- Current report filing (8-K)

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31.05.2011 15:26
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland BioLabs Provides Update on CBLB502 and BARDA Development Contract

Cleveland Biolabs, Inc. (MM) (NASDAQ:CBLI)

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Today : Tuesday 31 May 2011

Click Here for more Cleveland Biolabs, Inc. (MM) Charts.

Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Company and the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services ("BARDA") have recently concluded advanced stages of contract negotiations for funding of certain CBLB502 development activities included in the Company's 2010 Proposal to BARDA.

BARDA has indicated that further contract-related negotiations will require clarification of the development path for CBLB502 with the U.S. Food and Drug Administration ("FDA"), which is in the process of actively reviewing the Company's IND for CBLB502 as part of its recent transfer to a new FDA Division. This review, which is an anticipated step in the drug development process, is currently underway. BARDA has indicated that the Company may resubmit an updated proposal upon confirmation from the FDA there are no objections to the Company proceeding with its development plan as a result of this review. The Company is actively working toward obtaining this confirmation in the shortest time period possible.

Earlier this year, IND100480 for CBLB502 for reducing the risk of death following total body irradiation during or after a radiation disaster was transferred within the FDA from the Division of Biologic Oncology Products (DBOP) to the Division of Medical Imaging Products (DMIP), a move consistent with DMIP as the home for evaluation of decorporation agents (i.e. drugs and biologics used to treat individuals exposed to particulate radioactive materials). CBLI is in the process of updating DMIP on the results of the Phase I studies as well as other data from pre-clinical studies to design a larger, definitive Phase II human safety study and the remaining pivotal animal efficacy studies necessary for a BLA submission in cooperation with the FDA.

Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, stated, "We are confident in our ability to address this latest request from BARDA and secure its support for the remaining steps in the CBLB502 program. We believe that CBLB502 is the most effective and furthest advanced drug candidate for treatment of Acute Radiation Syndrome caused by exposure to radiation such as a nuclear or radiological weapon or from a nuclear accident. We believe that our team has all of the necessary expertise to bring CBLB502 forward to submission for FDA licensure. Substantial documentation has recently been provided to the FDA and meetings are being scheduled for discussion of clinical and pre-clinical study designs.

"CBLI has been supported by several federal agencies over the past four years, resulting in approximately $50 million (with options) in development funding for CBLB502. We believe the progress made advancing CBLB502 closer to submission for licensure makes it a strong candidate for continued funding. We continue to focus our internal resources on development of CBLB502 to assure that that our highest priority project is sufficiently supported. We will move CBLB502 ahead and firmly believe that, upon FDA licensure, it will play a significant role in domestic and global biodefense preparedness."

Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance for Cleveland BioLabs, commented, "We are proactively working with the FDA on clarifying specific details of both the biodefense and oncology pathways for CBLB502's development to expedite our program and meet BARDA's requirements. In this regard, I am especially pleased to announce the appointment of Ray Lipicky, M.D. as a strategic regulatory consultant to CBLI. His unique expertise and reputation as former Director of the FDA's Cardiovascular and Renal Drug Products division will greatly strengthen our capabilities on the regulatory front. His joining our development team provides additional assurance of the ultimate success of our mission to commercialize CBLB502."

The Company will update its stockholders on the present state of the Company and its progress with development programs at its annual stockholder meeting on June 7, 2011 at 10:00 a.m. ET, and investor day on June 8, 2011 at 9:45 a.m. ET. Live and archived audio webcasts of these events and accompanying presentations will be available at www.cbiolabs.com under the Investors tab.

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23.05.2011 15:37
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland BioLabs Receives Notice of Patent Allowance From Japan for CBLB502

Date : 05/23/2011 @ 9:00AM

Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today that it has received a Notice of Allowance from the Japan Patent Office for a CBLB502 patent application. Allowed claims cover the method of protecting a mammal from radiation using flagellin or its derivatives, including CBLB502.

Yakov Kogan, Ph.D., MBA, Chief Operating Officer of Cleveland BioLabs, stated, "This Notice of Allowance expands validation of our claims regarding protection from radiation with CBLB502 and other flagellin derivatives in major jurisdictions worldwide including the United States, Europe, Eurasia, China, and now Japan. We remain focused on advancing CBLB502 towards a biologic license application with the FDA."

About CBLB502

CBLB502 is a rationally-designed, bio-engineered derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

CBLB502 is being developed by Cleveland BioLabs under the FDA's Animal Efficacy Rule to reduce the risk of or prevent death following total body irradiation during or after radiation disaster. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human subjects.

Evidence of CBLB502's mechanism of action and activity in animal models was published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp. 226-230). Data from 150 healthy human subjects in two clinical safety and tolerability studies indicated that administration of CBLB502 resulted in a rapid and potent cytokine and hepatic immunologic response, similar to that seen in previously conducted non-human primate studies. The most frequent adverse event associated with CBLB502 administration was a transient flu-like syndrome, which generally resolved within 24 hours.

CBLB502 was granted Fast Track and Orphan Drug designations from the FDA for reducing the risk of or preventing death following total body irradiation during or after radiation disaster. The FDA Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Such programs include expanded communications (both verbal and written), rolling BLA submission and reviews, priority review (6 month action date instead of 10 month action date) and accelerated drug approval (approval on the basis of a surrogate endpoint). The FDA orphan drug program provides incentives for sponsors to develop products for rare diseases. Such incentives include extended marketing exclusivity, waiver of BLA filing user fees, grant funding to defray the cost of clinical testing, tax credits for the costs of clinical research and assistance in clinical research study designs.

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16.05.2011 18:00
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland BioLabs Announces New US Patent Allowances for CBLB502 and CBLB612

Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for its Protectan CBLB502 U.S. Patent Application Number 11/722,682, titled "Flagellin Related Polypeptides and Uses Thereof." Allowed claims cover composition of matter and use of CBLB502 for protecting a mammal from radiation.

The U.S. Patent and Trademark Office also issued a Notice of Allowance for the Company's Protectan CBLB612 patent application number 11/917,494, titled "Methods of Protecting against Apoptosis using Lipopeptides." Allowed claims cover the various properties of Protectan CBLB612 and related compounds, including composition of matter and methods of use for protecting against apoptosis

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09.04.2011 18:54
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Radioactive Omission: Where Are the Anti-Radiation Drugs?

http://www.scientificamerican.com/article.cfm?id=radioactive-omission-where

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09.04.2011 18:08
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

heute aufm heimweg im auto, hab ich doch drs1 gelauscht.. wie es so ist, kam da wissen aktuell um 16.12 uhr

http://www.drs1.ch/www/de/drs1/sendungen.html

es ging um strahlenkranke und in dem zusammenhang wurde da doch tatsächlich über cleveland bio berichtet!

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02.04.2011 15:04
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Japan's Nuclear Crisis Puts Small Radiation Drug Companies on the Radar (CBLI) (OSIS) (AOLS)

http://www.streetinsider.com/Insiders+Blog/Japans+Nuclear+Crisis+Puts+Sm...

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22.03.2011 14:04
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland Biolabs is set to land a substantial grant from the Biomedical Advanced Research and Development Authority (BARDA) that should total more than all previous grants and contracts that the company has been awarded during the last few years combined.

Officially, the company can only confirm that they are expecting grants and/or contracts worth approximately $50 million. Analysts covering the company have begun to hint more loudly that shares are headed back over $9 shortly due to a massive influx of government funds that may actually be closer to double the publicly stated number.

As reported in an article filed by Karvy Global Services yesterday afternoon, analysts polled by Bloomberg expect the stock to gain an average 22% to $9 in value from current levels- even as the stock has more than doubled during the past 52 weeks. According to that report, of the three analysts covering the stock, 67% recommend a buy while the remaining recomend a hold. There are no sell ratings on the stock.

Pre-market: 7.48 +0.32 (4.47%)

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21.03.2011 17:12
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

7er added..

hab gehört aus dem "US Gov.grant" von 50 mio könnten nun 90-100mio werden..

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17.03.2011 11:08
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Joe Salvani Discusses Significance Of Cleveland BioLabs Radiation Antidote To Nuclear Crisis In Fukushima, Japan

http://www.thestreet.com/story/11049054/1/video-joe-salvani-discusses-si...

.......

Joe concludes by saying, "The world is fortunate to have Cleveland BioLabs' drug this close to approval. The drug was designed exactly for emergencies such as this. If the Emergency Use Authorization is granted, the stock could reach well over $20 per share."

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16.03.2011 13:54
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Re: Drug may have role in Japan N-crisis

b00n wrote:

“Obviously, our drug is highly relevant. However, it is unlicensed,” Fonstein said. “We have doses of the drug that can be made available, with the understanding that this is not an approved drug.”

...in der not...

ich bin wieder rein. werde noch versuchen +1,00 USD mitzunehmen. dann erst wieder an tiefpunkten

Handelnder Holländer

15.03.2011 14:48
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

# Mkt cap 247.07M aktuell ...........

schon bissl mehr wert..

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15.03.2011 14:43
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Drug may have role in Japan N-crisis

Michael Fonstein, Cleveland BioLabs’ president and chief executive officer, said the company has been in touch with U. S. government health agencies to offer doses of Protectan that could be used if there was a catastrophic radiation leak from the troubled Japanese nuclear plants.

“Obviously, our drug is highly relevant. However, it is unlicensed,” Fonstein said. “We have doses of the drug that can be made available, with the understanding that this is not an approved drug.”

:!: (hab mir sowas schon gedacht..)

http://www.buffalonews.com/business/local-business/article367334.ece

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14.03.2011 22:10
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seekingalpha

Leaks From Japan's Nuclear Plants Could Send Cleveland Biolabs' Shares Beyond $20

As reports of out of Japan show the aftermath of a powerful earthquake and a devastating tsunami, government and public officials are scrambling to avert another catastrophe: a widespread release of radiation from damaged nuclear power plants.

Several Japanese nuclear plants were struck and at least one explosion has the crews and emergency personnel who are trying to contain the meltdowns exposed to elevated levels of radiation and several people have already tested positive to life-threatening exposure.

According to late-breaking news reports from Japan, officials do not know for certain whether there have already been meltdowns at facilities in the northeast, but they are working under the presumption that such meltdowns have taken place as they attempt to cool down radioactive material and release pressure inside the reactors.

A meltdown is a catastrophic failure of the reactor core, with a potential for widespread radiation release and authorities have been distributing iodine tablets to at least some of the 200,000 residents which have already been evacuated. Networks like CNN and others have been erroneously reporting that there are currently no highly effective and non-toxic anti-radiation treatments available for any of those workers or residents who have already been exposed. They are wrong and as soon as they and the rest of the world begin to understand differently, they will also understand why shares of Cleveland BioLabs (Nasdaq:CBLI) experienced 5x the recent average daily call volume as the nuclear reactor story began to take on a life of its own last Friday afternoon.

Apparently, for some time now, Cleveland Biolabs has been developing a drug candidate to protect humans from acute stresses such as radiation, chemotherapy or nuclear bomb exposure with the help of the U.S. Department of Defense, the Armed Forces Radiobiology Research Institute and others. The company’s leading Protectan compounds CBLB502 and CBLB600 have significant activity as both radio-protectants (injected prior to radiation exposure) and mitigators of radiation damage (injected after radiation exposure).

According to several reports by Seeking Alpha’s biotech opinion leader, M.E. Garza, the drug candidate, CBLB502 is set to be stockpiled as a nuclear counter-measure by the Biomedical Advanced Research and Development Authority (BARDA), the drug has also been assigned an FDA Fast-Track approval designation and has been safety tested on animals and human beings- showing great efficacy. Garza reports that company has very strong intellectual property positions covering these technologies and products, including granted patents for CBLB502.

Joe Salvani, another authority in biotechnology who began his career on Wall Street as Senior Vice President and Chemical Industry Analyst at Goldman Sachs, has been recommending the company in video interviews since 2009; predicting that CBLI shares could go to $30 this year.

The United States government has already spent millions in grants and development funds with the company, but other countries like Israel and the U.K. also want the drug for their stockpiles. According to Salvani, “you can inject yourself up to 72 hours after exposure to nuclear fallout” to prevent cell death.

The stock’s climb to those higher levels may have begun on Friday when the stock jumped from $6.80 at the intra-day low to a close of $7.19 and then jumped another five and a half percent after hours to $7.59.

I would not be surprised to see the stock run much higher if the situation in Japan continues to worsen.

We have seen new technologies suddenly cast into the disaster news mainstream before. When they do, share values jump.

In the late spring of 2007, Shares of SIGA Technologies (Nasdaq:SIGA) went from $1 to $6 after the New York Times ran a story about a 2-year-old boy who spent seven weeks in the hospital and nearly died from a viral infection he got from the smallpox vaccination his father received before shipping out to Iraq.

The boy recovered after doctors worked with the Food and Drug Administration to allow the compassionate use of an experimental drug for smallpox, ST-246, from Siga Technologies.

Dr. Madelyn Kahana, the chief of pediatric intensive care medicine at the hospital, said in an interview that the child was close to dying had been covered with “mounds of pox” that reminded her of photos of bees swarming over beekeepers. “I’m a veteran of 25 years of practice in the I.C.U.’s, and I thought I’d seen it all,” Dr. Kahana said. “But this was stunning to the eye.”

It is also interesting to point out that at the time, the SIGA drug was neither as far along in clinical development or had been proven as safe as Cleveland's drug candidate is today.

Another recent example is the one involving a small company founded by actor Kevin Costner, which was awarded an opportunity to help clean up the BP Oil Spill disaster last May. Even though Costner had spent $26 million to develop and license his oil spill cleanup centrifuge machines back in the early nineties. It wasn’t until last year that BP purchased 32 centrifugal oil separators, marketed under the brand name Ocean Therapy Solutions, for a cost of around $52 million.

Just last month, a former investor in the company, actor Stephen Baldwin and his business associate announced that they were suing Costner, alleging that they were fooled into selling their shares of the company.

In addition to the very real possibility of getting called into the spotlight due to the terrible developments in Japan, Cleveland Biolabs is reportedly ready to receive tens of millions in additional government funding for its anti-radiation drug. In CBLI’s recent presentation at BIO CEO, management noted that it expects a grant from BARDA-HHS to be over $50 million. That development alone would send shares higher given the immediate impact on its relatively undervalued market-cap.

That pending news makes the Cleveland Biolabs play a two-for one and it also makes it my stock to watch this week.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in CBLI over the next 72 hours.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

14.03.2011 18:57
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

OUT @ 8.40

14.03.2011 18:46
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

8.27

+1.08 (15.02%)

14.03.2011 16:38
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

If we had to bet on one stock set to get play due to thie terrible news it has to be Cleveland Biolabs (NASDAQ:CBLI). On Friday, as the news of the potential meltdowns began to spread, traders began to scoop up shares of the company whose late-stage, FDA fast-tracked drug dandidate, CBLB502 was born for precisely this type of scenario.

It's a story that I know extremely well.

Just a couple of weeks ago, during BIO CEO in New York City, I spoke to CBLI's CEO, Michael Fonstein, specifically about the drug, on camera, as part of television special that will air nationally once additional photography and post-production are completed. While I am contractually prohibited from speaking or publishing too much about the project, I can tell you that news magazine is described by producers as "60 minutes meets Wired Magazine" and will feature a 12-15 minute segment about the history and journey of the ground-breaking technology which was invented by Cleveland BioLabs’s Chief Scientific Officer, Andrei Gudkov, Ph.D., D. Sci. while he was leading a broad research program focused on virology and cancer drug resistance in Moscow.

It was fascinating to learn that Gudkov's idea of creating a drug to protect humans from acute stresses such as radiation, or nuclear contamination exposure was born while he watched the infamous Chernobyl Nuclear Power Station Disaster unfold. The scientist was forever impacted by the deaths of the heroic firefighters who had climbed to the roof of the burning power plant to extinguish the fires. Fifty units responded to the fire and while they were successful in extinguishing all but the fire in the reactor, they were not wearing appropriate protective clothing.

"One by one they began to experience pressure in the chest, severe coughing, nausea, vomiting, and fainting," writes Grigori Medvedev in his book, The Truth About Chernobyl. "At first they thought it was from the smoke and heat of the fire. They were unaware that they had been walking on radioactive material that was emitting 20,000 roentgens per hour. Doctors found the fire fighters extremely agitated and nervous- suffering from "nuclear frenzy of the nervous system." They had extinguished the fires, but they were burned, many fatally, by the invisible flame of gamma and neutron radiation"

Not long after the fall of the Soviet Union, Gudkov moved to the U.S. and reestablished his lab at the University of Illinois at Chicago where he became a tenured faculty member in the Department of Molecular Genetics. It was that initial impact that led Gudkov and the team at Cleveland Biolabs to be prepared for a disastrous moment precisely like the one we are seeing play out in Japan.

CBLI’s unique approach of pharmacological modulation of apoptosis (programmed cell death) is ideally suited to address the need for effective radiation countermeasures and we would not be surprised to see the company take steps to get doses of their late-stage drug candidate to victims who may need it.

Whether or not a full meltdown can be averted is only part of the equation here. At best, full containment and clean-up efforts will take time and could see more workers and emergency personnel exposed to high levels of radiation. Sadly, the risk still exists for radiation to spread and affect hundreds or thousands in the areas around the power plants as well.

Speculators on Wall Street appeared to sense that too. On Friday we watched option calls of CBLI trade at 5x the average volume and prices jump from $6.80 to $7.19 before closing even higher- at $7.59- after hours.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

14.03.2011 16:26
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Incredibly, the short interest at CBLI has been growing since late August and is near the all-time high. If we are correct and the stock continues to push higher, the shorts will be squeezed and forced to cover.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

14.03.2011 13:16
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

sharewatch wrote:

Schade, ich habe das nicht geschnallt am Freitag. Habe noch die Shares bei meinem Einstieg zu 6.85. Werde heute bei den Dips dabei sein.

jup.. werd wahrscheinlich, auch ausbauen.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

14.03.2011 13:07
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Schade, ich habe das nicht geschnallt am Freitag. Habe noch die Shares bei meinem Einstieg zu 6.85. Werde heute bei den Dips dabei sein.

13.03.2011 13:21
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Re: CBLB502

b00n wrote:

Cleveland BioLabs, Inc.'s CBLB502 Granted Orphan Drug Status From FDA

Tuesday, 30 Nov 2010 11:26am EST

Cleveland BioLabs, Inc. announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review, which may result in an abbreviated review time of six months.

ich gehe von äusserst guter performance ab montag aus

beachtet auch was am freitag geschehen ist als die unsagbar tragische fukushima sache kam..

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

11.03.2011 19:00
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

News of possible nuke reactor meltdown has people buying $CBLI. They should be buying for upcoming BARDA money grant too.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

02.03.2011 15:20
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upcoming news event..

Cleveland BioLabs Inc.(NASDAQ: CBLI) looks primed to hear news about a government grant related to their CBLB502 program. In just the past few weeks, the US Biomedical Advanced Research and Development Authority (BARDA) has filled several contracts that had been expected for sometime. It appears that BARDA-HHS is finally making it’s way through their backlog of applications and getting funding out there. In CBLI’s recent presentation at BIO CEO, management noted that they expect a grant from BARDA-HHS to be over $50 million. We think that more financial commitment from the US government could eventually lead to foreign development contracts with countries like Israel. This grant also sets them up for a potential buying Request for Proposal(RFP) from BARDA for a radiation countermeasure later this year. Of companies competing for these contracts, CBLI is by far the most advanced program in this field, in terms of their lead drug and time to market. Their treatment protects 2 important body systems, the blood and gastrointestinal(GI) tract, that are crucial to improving survival in ARS. All of this additional funding will help CBLI further support CBLB502 thru development in acute-radiation syndrome(ARS) to eventual FDA approval and stockpiling.

Another benefit of CBLB502 is the reduced regulatory pathway due to the Animal Efficacy Rule, which is applied to drugs where the efficacy cannot be directly tested in humans due to ethical reasons. This allows them to bypass large Phase 3 studies, by demonstrating safety in humans and efficacy in 2 animal models along with GMP validation(related to manufacturing). They will be meeting later this year with the FDA to plan out their definitive safety study in humans and complete their pivotal animal effifacy study in primates. The expectation is that these studies, in conjunction with scaling up manufacturing, could lead to a BLA filing with the FDA in early 2012. They are also exploring CBLB502’s role as supportive therapy for cancer patients that have recently received total body irradiation. Their pipeline is also full of potential with CBLB612, as a stem cell inducing agent, which one could see as a competitor to Amgen’s billion dollar drug, Neupogen. They have adequate funding for 2011 and beyond; we expect additional government support to provide more financial stability.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

02.02.2011 19:25
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Another analyst thinks Cleveland Biolabs (Nasdaq:CBLI) is headed higher. The stock has been initiated with an Outperform rating and a target price of $10 by Wedbush.

Close-Up: Cleveland BioLabs' Anti-Cancer Effect Excites Investors

Presentation sheds light on significant upcoming developments for Cleveland Biolabs

Wedbush Securities is one of the largest securities firms and investment banks in the nation. The firm notes the company is developing CBLB502, an injectable protein, as a treatment for Acute Radiation Syndrome and as a radio-protectant in radiation oncology.

It further notes that human studies have shown CBLB502 to be safe in a Phase I/II study; animal studies have demonstrated protection against ARS.

The estimates for the total market for CBLB502 is $300 million in annual revenues, taking into account military, civilian and likely foreign demand. Wedbush expects that the company will be awarded a contract to supply the US government with CBLB502 to prevent ARS in the event of a radiological event.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

02.02.2011 19:07
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Cleveland BioLabs, Inc. (Public, NASDAQ:CBLI)

Cleveland Biolabs (NASDAQ: CBLI) set for significant capital appreciation

Tuesday, 01 February 2011

On January 20, 2011 Cleveland BioLabs, Inc. (NASDAQ:CBLI) announced that they had accumulated preclinical data demonstrating that CBLB502, a drug under development to treat exposure to radiation poisoning from nuclear or radiological weapons or from a nuclear accident, has direct anticancer effect in several cancer models including colon and lung cancer, lymphoma and melanoma.

The company shared some very exciting preclinical data in the recent press release. They stated that CBLB502 had shown potential to suppress tumors. In one animal model, it was said that CBLB502 led to complete regression of tumors with little –to-no recurrence.

CBLI also stated that they will be looking at starting Phase I/II trials in cancer patients this year to look at both this new anticancer ability, and the previously discussed potential to offset the horrible side effects of radio and chemotherapy.

For those of you who follow developments in the $50 billion cancer market, both of these potential indications represent huge market dollars, if safety and trends of efficacy are seen in some of these trials.

The company’s first potential line to revenues is still the defense application, however, and we remain bullish on upcoming developments there as well. For example, CBLI has been working with the BARDA (Biomedical Advanced Research and Development Authority) of the Department of Health and Human Services on a potentially significant additional grant to fund remaining development of CBLB502 through and past FDA approval.

Five Reasons to Buy:

1. Potential Direct Anticancer Effect of CBLB502

2. CBLI already received its first conditional purchase order for CBLB502 from the Department of Defense back in September and is moving steadily towards submission for FDA licensure with both fast track and orphan drug status.

3. Expected news on BARDA publishing a formal Request for Proposal or RFP for buying of doses of radiation countermeasures for the national stockpile to protect civilians in this country. If you all recall, BARDA is the agency that has been spending hundreds of millions of dollars on these countermeasures over the past few years.

4. The recent infusion of capital from a single institutional investor, which we believe to be Michael Dell.

5. CBLI is well positioned to continue its climb in valuation.

We are reiterating our strong buy for Cleveland BioLabs based on expected near term drivers in the defense business with more development money from BARDA and hopefully a request for buying of doses.

We also believe that the start of medical trials for CBLB502 in cancer patients will bring a lot more attention from more traditional biotech investors and push the stock to significantly higher levels.

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

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