UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): May 15, 2019

 
Cleveland BioLabs, Inc.
(Exact Name of Registrant as Specified in Charter)
 

DELAWARE
001-32954
20-0077155
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
 
73 High Street
Buffalo, NY 14203
 
(Address of Principal Executive Offices and zip code)
 
 
 
 
(716) 849-6810
 
(Registrant's Telephone Number, Including Area Code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common stock, par value $0.005
CBLI
NASDAQ Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).                             
Emerging growth company o





If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
 





Item 2.02 Results of Operations and Financial Conditions.

On May 15, 2019, Cleveland BioLabs, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2019. The information in this Item 2.02 of Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference.

Item 9.01 Financial Statements and Exhibits.
(d)

Exhibit
No.
    Description
99.1
Press Release titled “Cleveland BioLabs Reports First Quarter 2019 Financial Results and Development Progress”, dated May 15, 2019






SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Cleveland BioLabs, Inc.

Date: May 15, 2019
By: /s/ YAKOV KOGAN
Name: Yakov Kogan
Title: Chief Executive Officer



Exhibit

Exhibit 99.1

FOR IMMEDIATE RELEASE

CLEVELAND BIOLABS REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS AND DEVELOPMENT PROGRESS

Buffalo, NY - May 15, 2019 - Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the first quarter ended March 31, 2019.

Cleveland BioLabs reported a net loss of $(0.9) million, excluding minority interests, for the first quarter of 2019, or $(0.08) per share, compared to a net loss, excluding minority interests, of $(1.2) million, or $(0.11) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced research and development activity due to previously disclosed vendor delays in in the analytical analyses required to complete the biocomparability study and a decrease in General and Administrative costs partially offset by an increase in the non-cash adjustment to our warrant liabilities. The biocomparability study was completed during the first quarter.

As of March 31, 2019, the Company had $3.3 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into December 2019.

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


Further Financial Results

Revenue for the first quarter of 2019 decreased to $0.20 million compared to $0.23 million for the first quarter of 2018. The net decrease was primarily attributable to decreased 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 partially offset by increased revenue from our service contract with Incuron.

Research and development costs for the first quarter of 2019 decreased to $0.5 million compared to $1.3 million for the first quarter of 2018. The reduction in research and development costs is due to a $0.57 million reduction in spending for biodefense applications of entolimod, $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, and a $0.04 million reduction in spending on Panacela's product candidates partially offset by a $0.05 million increase in expenses related to the Curaxins.

General and administrative costs for the first quarter of 2019 decreased to $0.47 million compared to $0.73 million for the first quarter of 2018. This decrease was primarily attributable to $0.15 million decrease in property tax expense, $0.06 million decrease in expense relating to a one-time settlement for the previously completed research contracts with the Russian Ministry of Trade, and $0.05 million decrease in legal and professional fees.


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 companys 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. 329
E: investor.relations@cbiolabs.com




CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS
 
 
March 31, 2019
 
December 31, 2018
 
(Unaudited)
 
 
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
2,798,817

 
$
3,617,234

Short-term investments
540,668

 
503,810

Accounts receivable
269,778

 
251,846

Other current assets
115,818

 
103,397

Total current assets
3,725,081

 
4,476,287

Equipment, net
23,833

 
27,747

Other long-term assets
30,824

 
30,373

Total assets
$
3,779,738

 
$
4,534,407

LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
245,247

 
$
139,120

Accrued expenses
592,409

 
694,164

Accrued warrant liability
173,458

 
78,637

Total current liabilities
1,011,114

 
911,921

Non-current liabilities
7,159

 
8,459

Total liabilities
1,018,273

 
920,380

Stockholders’ deficit:
 
 
 
Total Cleveland BioLabs, Inc. stockholders’ equity
(2,298,129
)
 
(1,451,945
)
Noncontrolling interest in stockholders’ equity
5,059,594

 
5,065,972

Total stockholders’ equity
2,761,465

 
3,614,027

Total liabilities and stockholders’ equity
$
3,779,738

 
$
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
March 31,
 
2019
 
2018
Revenues:
 
 
 
Grants and contracts
$
197,919

 
$
227,576

Operating expenses:
 
 
 
Research and development
513,421

 
1,336,470

General and administrative
474,670

 
727,193

Total operating expenses
988,091

 
2,063,663

Loss from operations
(790,172
)
 
(1,836,087
)
Other income (expense):
 
 
 
Interest and other income
(7,648
)
 
69,476

Foreign exchange gain (loss)
(671
)
 
(383
)
Change in value of warrant liability
(94,821
)
 
508,542

Total other income (expense)
(103,140
)
 
577,635

Net loss
(893,312
)
 
(1,258,452
)
Net loss attributable to noncontrolling interests
20,369

 
33,842

Net loss attributable to Cleveland BioLabs, Inc.
$
(872,943
)
 
$
(1,224,610
)
Net loss attributable to common stockholders per share of common stock, basic and diluted
$
(0.08
)
 
$
(0.11
)
Weighted average number of shares used in calculating net loss per share, basic and diluted
11,298,239

 
11,280,553

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,
 
2019
 
2018
Cash flows used in operating activities
$
(827,855
)
 
$
(1,199,863
)
Cash flows provided by investing activities

 
1,501,145

Cash flows provided by financing activities

 
55,215

Effect of exchange rate change on cash and equivalents
9,438

 
(705
)
Increase (decrease) in cash and cash equivalents
(818,417
)
 
355,792

Cash and cash equivalents at beginning of period
3,617,234

 
4,230,548

Cash and cash equivalents at end of period
$
2,798,817

 
$
4,586,340

 
 
 
 
See Notes to Consolidated Financial Statements