CBLI Cleveland BioLabs Inc.

2.1
0  0%
Previous Close 2.1
Open 2.09
52 Week Low 0.5
52 Week High 5
Market Cap $27,334,413
Shares 13,016,387
Float 6,480,430
Enterprise Value $23,567,711
Volume 117,577
Av. Daily Volume 527,346
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Drug Pipeline

Drug Stage Notes
ENTOLIMOD
Solid tumors
Phase 1
Phase 1
Phase 1 extension trial ongoing.

Latest News

  1. BUFFALO, NY / ACCESSWIRE / June 3, 2020 / Cleveland BioLabs, Inc. (NASDAQ:CBLI), today announced the closing of its previously announced registered direct offering to several institutional and accredited investors of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share. The offering was priced at-the-market under Nasdaq rules. Cleveland BioLabs also issued to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The warrants have an exercise price equal to $2.033 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

    The gross proceeds from the offering were approximately $3.175 million. The Company currently…

    BUFFALO, NY / ACCESSWIRE / June 3, 2020 / Cleveland BioLabs, Inc. (NASDAQ:CBLI), today announced the closing of its previously announced registered direct offering to several institutional and accredited investors of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share. The offering was priced at-the-market under Nasdaq rules. Cleveland BioLabs also issued to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The warrants have an exercise price equal to $2.033 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

    The gross proceeds from the offering were approximately $3.175 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. McGuireWoods LLP acted as legal counsel to the issuer.

    The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering of the shares of common stock was made by means of a prospectus supplement that forms a part of the registration statement. The final prospectus supplement and accompanying prospectus relating to the registered direct offering have been filed with the SEC and are be available on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at .

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Cleveland BioLabs

    Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation and oncology. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome and other indications in radiation oncology. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer 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 that involve risks and uncertainties. All statements other than statements of current or historical fact contained in press release, including statements regarding the intended use of net proceeds from the registered direct offering as well as our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, or the impact of any laws or regulations applicable to us, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions or their negatives, 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 or implied 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. Factors that may cause such differences include, but are not limited to, market and other conditions, 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 our 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 in our 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 press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments, except as required by law.

    Contact:

    Cleveland BioLabs, Inc.
    T: (716) 849-6810 ext. 101
    E:

    SOURCE: Cleveland BioLabs, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/592636/Cleveland-BioLabs-Closes-3175-Million-Registered-Direct-Offering-Priced-At-The-Market-Under-NASDAQ-Rules

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  2. BUFFALO, NY / ACCESSWIRE / June 1, 2020 / Cleveland BioLabs, Inc. (NASDAQ:CBLI), today announced that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share, in a registered direct offering priced at-the-market under Nasdaq rules. Cleveland BioLabs has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The closing of the offering is expected to occur on or about June 3, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the…

    BUFFALO, NY / ACCESSWIRE / June 1, 2020 / Cleveland BioLabs, Inc. (NASDAQ:CBLI), today announced that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share, in a registered direct offering priced at-the-market under Nasdaq rules. Cleveland BioLabs has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The closing of the offering is expected to occur on or about June 3, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The warrants have an exercise price equal to $2.033 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

    The gross proceeds from the offering are expected to be approximately $3.175 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

    The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at .

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Cleveland BioLabs

    Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation and oncology. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome and other indications in radiation oncology. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer 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 that involve risks and uncertainties. All statements other than statements of current or historical fact contained in press release, including statements regarding the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering as well as our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, or the impact of any laws or regulations applicable to us, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions or their negatives, 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 or implied 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. Factors that may cause such differences include, but are not limited to, market and other conditions, 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 our 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 in our 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 press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments, except as required by law.

    Contact:

    Cleveland BioLabs, Inc.
    T: (716) 849-6810 ext. 101
    E:

    SOURCE: Cleveland BioLabs, Inc

    View source version on accesswire.com:
    https://www.accesswire.com/592191/Cleveland-BioLabs-Announces-3175-Million-Registered-Direct-Offering-Priced-At-The-Market-Under-Nasdaq-Rules

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  3. BUFFALO, NY / ACCESSWIRE / May 15, 2020 / Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the first quarter ended March 31, 2020.

    Cleveland BioLabs reported a net loss of $(0.6) million, excluding minority interests, for the first quarter of 2020, or $(0.05) per share, compared to a net loss, excluding minority interests, of $(0.9) million, or $(0.08) per share, for the same period in 2019 The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a increase in the non-cash adjustment to our warrant liabilities.

    As of March 31, 2020, the Company had $1.4 million in cash, cash equivalents and…

    BUFFALO, NY / ACCESSWIRE / May 15, 2020 / Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the first quarter ended March 31, 2020.

    Cleveland BioLabs reported a net loss of $(0.6) million, excluding minority interests, for the first quarter of 2020, or $(0.05) per share, compared to a net loss, excluding minority interests, of $(0.9) million, or $(0.08) per share, for the same period in 2019 The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a increase in the non-cash adjustment to our warrant liabilities.

    As of March 31, 2020, the Company had $1.4 million in cash, cash equivalents and short-term investments, which, based on the Company's current operational plan, is expected to fund operations into August 2020.

    Further Financial Results

    Revenue for the first quarter of 2020 decreased to $0.16 million compared to $0.20 million for the first quarter of 2019. The net decrease was primarily attributable to decreased revenue from our service contract with Incuron, partially offset by increased revenue from our Peer Reviewed Medical Research Program ("PRMRP") and Joint Warfighter Medical Research Program ("JWMRP") contracts from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

    Research and development costs for the first quarter of 2020 decreased to $0.2 million compared to $0.5 million for the first quarter of 2019. The reduction in research and development costs is due to a $0.17 million decrease in spending for biodefense applications of entolimod, and a $0.11 million decrease in expenses related to curaxins.

    General and administrative costs for the first quarter of 2020 decreased to $0.38 million compared to $0.47 million for the first quarter of 2019. This decrease was primarily attributable to a $0.13 million decrease in CBLI's personnel and professional fees and a $.03 million decrease in facilities costs, partially offset by a $0.10 million increase CBLI's property taxes compared to the quarter ended March 31, 2019, when we received a property tax refund.

    About Cleveland BioLabs

    Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation and oncology. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome and other indications in radiation oncology. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer 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 that involve risks and uncertainties. All statements other than statements of current or historical fact contained in press release, including statements regarding our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, or the impact of any laws or regulations applicable to us, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions or their negatives, 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 or implied 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. Factors that may cause such differences include, but are not limited to, 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 our 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 in our 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 press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

    Contact:

    Cleveland BioLabs, Inc.
    T: (716) 849-6810 ext. 101
    E:

    CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
    CONSOLIDATED CONDENSED BALANCE SHEETS

    March 31, 2020 December 31, 2019
    (Unaudited)
    ASSETS
    Current assets:
    Cash and cash equivalents
    $ 1,058,811 $ 1,126,124
    Short-term investments
    360,210 452,301
    Accounts receivable
    334,436 378,865
    Other current assets
    80,028 45,381
    Total current assets
    1,833,485 2,002,671
    Equipment, net
    12,434 15,514
    Other long-term assets
    18,667 18,667
    Total assets
    $ 1,864,586 $ 2,036,852
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable
    $ 266,058 $ 263,573
    Accrued expenses
    774,752 782,579
    Accrued warrant liability
    44,412 6,414
    Total current liabilities
    1,085,222 1,052,566
    Non-current liabilities
    - -
    Total liabilities
    1,085,222 1,052,566
    Stockholders' equity:
    Total Cleveland BioLabs, Inc. stockholders' deficit
    (4,213,695 ) (4,055,592 )
    Noncontrolling interest in stockholders' equity
    4,993,059 5,039,878
    Total stockholders' equity
    779,364 984,286
    Total liabilities and stockholders' equity
    $ 1,864,586 $ 2,036,852

    See Notes to Consolidated Financial Statements

    CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
    CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
    (UNAUDITED)

    For the Three Months Ended
    March 31,
    2020 2019
    Revenues:
    Grants and contracts
    $ 156,042 $ 197,919
    Operating expenses:
    Research and development
    218,208 513,421
    General and administrative
    382,166 474,670
    Total operating expenses
    600,374 988,091
    Loss from operations
    (444,332 ) (790,172 )
    Other income (expense):
    Interest and other income
    2,900 (7,648 )
    Foreign exchange gain (loss)
    393 (671 )
    Change in value of warrant liability
    (160,689 ) (94,821 )
    Total other income
    (157,396 ) (103,140 )
    Net loss
    (601,728 ) (893,312 )
    Net loss attributable to noncontrolling interests
    13,196 20,369
    Net loss attributable to Cleveland BioLabs, Inc.
    $ (588,532 ) $ (872,943 )
    Net loss attributable to common stockholders per share of common stock, basic and diluted
    $ (0.05 ) $ (0.08 )
    Weighted average number of shares used in calculating net loss per share, basic and diluted
    11,353,456 11,298,239

    See Notes to Consolidated Financial Statements

    CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
    (UNAUDITED)

    For the Three Months Ended March 31,
    2020 2019
    Net cash used in operating activities
    $ (425,593 ) $ (827,855 )
    Net cash provided by investing activities
    - -
    Net cash provided by financing activities
    382,215 -
    Effect of exchange rate change on cash and equivalents
    (23,935 ) 9,438
    Increase (decrease) in cash and cash equivalents
    (67,313 ) (818,417 )
    Cash and cash equivalents at beginning of period
    1,126,124 3,617,234
    Cash and cash equivalents at end of period
    $ 1,058,811 $ 2,798,817

    See Notes to Consolidated Financial Statements

    SOURCE: Cleveland BioLabs, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/590003/Cleveland-BioLabs-Reports-First-Quarter-2020-Financial-Results-and-Development-Progress

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  4. BUFFALO, NY / ACCESSWIRE / November 14, 2019 / Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the third quarter ended September 30, 2019.

    Cleveland BioLabs reported a net loss of $(0.4) million, excluding minority interests, for the third quarter of 2019, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(1.1) million, or $(0.10) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a decrease in the non-cash adjustment to our warrant liabilities.

    As of September 30, 2019, the Company had $1.9 million in cash, cash equivalents…

    BUFFALO, NY / ACCESSWIRE / November 14, 2019 / Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the third quarter ended September 30, 2019.

    Cleveland BioLabs reported a net loss of $(0.4) million, excluding minority interests, for the third quarter of 2019, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(1.1) million, or $(0.10) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a decrease in the non-cash adjustment to our warrant liabilities.

    As of September 30, 2019, the Company had $1.9 million in cash, cash equivalents and short-term investments, which, based on the Company's current operational plan, is expected to fund operations into September 2020.

    As previously disclosed, in recent fiscal quarters, our research and development activity related to our development of entolimod as a treatment for acute radiation syndrome has declined as we were first awaiting the results of the bioequivalence study we undertook in response to the request of the Food and Drug Administration (the "FDA"), which study compared the historical drug formulation used in prior preclinical and clinical studies with the to-be-marketed drug product lots. Thereafter, we were awaiting the FDA's confirmation that it agreed with our findings on bioequivalence, without which agreement the FDA had indicated it would not move forward to consider our pre-Emergency Use Authorization ("pre-EUA") application.

    Since our submission of the bioequivalence study results, we have not received what we believe is a complete and fully satisfactory response from the FDA. Accordingly, we have been in ongoing discussions with the FDA, but our management has not been pleased with the pace or results of these discussions. We are therefore actively seeking ways to accelerate the FDA's review and/or elevate within the management hierarchy of the FDA its consideration of our pre-EUA application.

    Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our main priority and focus."

    Further Financial Results

    Revenue for the third quarter of 2019 decreased to $0.27 million compared to $0.28 million for the third quarter of 2018. The net decrease was primarily attributable to decreased revenue from our service contract with Incuron, partially offset by increased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

    Research and development costs for the third quarter of 2019 decreased to $0.26 million compared to $0.84 million for the third quarter of 2018. The reduction in research and development costs is due to a $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, a $0.18 million decrease in spending for biodefense applications of entolimod, and a $0.14 million decrease in expenses related to curaxins.

    General and administrative costs for the third quarter of 2019 decreased to $0.53 million compared to $0.71 million for the third quarter of 2018. This decrease was primarily attributable to a $0.11 million decrease in CBLI's legal and professional fees related to the GPI investment in 2018 and a $0.04 million decrease in property taxes.

    About Cleveland BioLabs

    Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation and oncology. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome and other indications in radiation oncology. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer 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 that involve risks and uncertainties. All statements other than statements of current or historical fact contained in press release, including statements regarding our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, or the impact of any laws or regulations applicable to us, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions or their negatives, 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 or implied 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, 2018. Factors that may cause such differences include, but are not limited to, our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our 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 our 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 in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2018.

    Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

    Contact:

    Yakov Kogan, Chief Executive Officer
    Cleveland BioLabs, Inc.
    T: (716) 849-6810 ext. 103
    E:

    CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
    CONSOLIDATED CONDENSED BALANCE SHEETS

    September 30, 2019 December 31, 2018
    (Unaudited)
    ASSETS
    Current assets:
    Cash and cash equivalents
    $ 1,487,388 $ 3,617,234
    Short-term investments
    426,915 503,810
    Accounts receivable
    210,805 251,846
    Other current assets
    67,552 103,397
    Total current assets
    2,192,660 4,476,287
    Equipment, net
    17,445 27,747
    Other long-term assets
    18,667 30,373
    Total assets
    $ 2,228,772 $ 4,534,407
    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable
    $ 99,529 $ 139,120
    Accrued expenses
    441,692 694,164
    Accrued warrant liability
    24,461 78,637
    Total current liabilities
    565,682 911,921
    Non-current liabilities
    - 8,459
    Total liabilities
    565,682 920,380
    Stockholders' equity:
    Total Cleveland BioLabs, Inc. stockholders' deficit
    (3,363,169 ) (1,451,945 )
    Noncontrolling interest in stockholders' equity
    5,026,259 5,065,972
    Total stockholders' equity
    1,663,090 3,614,027
    Total liabilities and stockholders' equity
    $ 2,228,772 $ 4,534,407

    See Notes to Consolidated Financial Statements

    CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
    CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
    (UNAUDITED)

    For the Three Months Ended For the Nine Months Ended
    September 30, September 30,
    2019 2018 2019 2018
    Revenues:
    Grants and contracts
    $ 269,635 $ 283,307 $ 744,521 $ 902,474
    Operating expenses:
    Research and development
    262,410 839,413 1,375,409 3,084,790
    General and administrative
    525,621 711,660 1,449,281 1,989,596
    Total operating expenses
    788,031 1,551,073 2,824,690 5,074,386
    Loss from operations
    (518,396 ) (1,267,766 ) (2,080,169 ) (4,171,912 )
    Other income (expense):
    Interest and other income
    14,246 16,191 32,528 109,591
    Foreign exchange gain (loss)
    251 1,772 (808 ) 2,868
    Change in value of warrant liability
    36,532 121,442 54,176 800,055
    Total other income
    51,029 139,405 85,896 912,514
    Net loss
    (467,367 ) (1,128,361 ) (1,994,273 ) (3,259,398 )
    Net loss attributable to noncontrolling interests
    17,448 23,917 54,583 79,307
    Net loss attributable to Cleveland BioLabs, Inc.
    $ (449,919 ) $ (1,104,444 ) $ (1,939,690 ) $ (3,180,091 )
    Net loss attributable to common stockholders per share of common stock, basic and diluted
    $ (0.04 ) $ (0.10 ) $ (0.17 ) $ (0.28 )
    Weighted average number of shares used in calculating net loss per share, basic and diluted
    11,298,239 11,298,239 11,298,239 11,292,365

    See Notes to Consolidated Financial Statements

    CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
    (UNAUDITED)

    For the Nine Months Ended September 30,
    2019 2018
    Net cash used in operating activities
    $ (2,298,935 ) $ (3,441,076 )
    Net cash provided by investing activities
    158,544 3,560,750
    Net cash provided by financing activities
    - 55,215
    Effect of exchange rate change on cash and equivalents
    10,545 (26,698 )
    Increase (decrease) in cash and cash equivalents
    (2,129,846 ) 148,191
    Cash and cash equivalents at beginning of period
    3,617,234 4,230,548
    Cash and cash equivalents at end of period
    $ 1,487,388 $ 4,378,739

    See Notes to Consolidated Financial Statements

    SOURCE: Cleveland BioLabs, Inc.

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    https://www.accesswire.com/566607/Cleveland-BioLabs-Reports-Third-Quarter-2019-Financial-Results-and-Development-Progress

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