Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 10-Q

 


 

(Mark One)

 

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

 

For the quarterly period ended September 30, 2020

OR

 

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

 

For the transition period from                      to                     

 

Commission file number 001-32954

 


 

CLEVELAND BIOLABS, INC.

(Exact name of registrant as specified in its charter)

 


 

DELAWARE

20-0077155

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

 

73 High Street, Buffalo, New York

14203

(Address of principal executive offices)

(Zip Code)

 

(716) 849-6810

(Registrant’s telephone number, including area code) 

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒   No  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging Growth Company

 

 

 

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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐    No  ☒

 

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

 

As of October 20, 2020, there were 13,336,440 shares outstanding of the registrant’s common stock, par value $0.005 per share.

 

 

 

TABLE OF CONTENTS

 

 

PAGE

PART I – FINANCIAL INFORMATION

 

ITEM 1.

Consolidated Condensed Financial Statements

 

 

Consolidated Condensed Balance Sheets

3

 

Consolidated Condensed Statements of Operations

4

 

Consolidated Condensed Statements of Comprehensive Loss

5

 

Consolidated Condensed Statement of Stockholders’ Equity

6

 

Consolidated Condensed Statements of Cash Flows

7

 

Notes to Consolidated Condensed Financial Statements

8

ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

20

ITEM 4.

Controls and Procedures

20

 

 

PART II – OTHER INFORMATION

 

ITEM 1.

Legal Proceedings

21

ITEM 1A.

Risk Factors

21

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

21

ITEM 3.

Defaults Upon Senior Securities

21

ITEM 4.

Mine Safety Disclosures

21

ITEM 5.

Other Information

21

ITEM 6.

Exhibits

22

Signatures

 

23

 

In this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise requires, the terms "Cleveland BioLabs," the "Company," "CBLI," "we," "us" and "our" refer to Cleveland BioLabs, Inc. and its consolidated subsidiaries, BioLab 612, LLC and Panacela Labs, Inc. Our common stock, par value $0.005 per share, is referred to as "common stock."

 

 

 

CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED BALANCE SHEETS

 

 

   

September 30, 2020

   

December 31, 2019

 
   

(Unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 2,721,113     $ 1,126,124  

Short-term investments

    313,737       452,301  

Accounts receivable

    135,207       378,865  

Other current assets

    54,862       45,381  

Total current assets

    3,224,919       2,002,671  

Equipment, net

    6,369       15,514  

Other long-term assets

          18,667  

Total assets

  $ 3,231,288     $ 2,036,852  

LIABILITIES AND STOCKHOLDERS’ EQUITY

               

Current liabilities:

               

Accounts payable

  $ 280,559     $ 263,573  

Accrued expenses

    187,882       782,579  
Deferred revenue     6,825        

Accrued warrant liability

    8,607       6,414  

Total current liabilities

    483,873       1,052,566  

Non-current liabilities

           

Total liabilities

    483,873       1,052,566  

Stockholders’ equity:

               

Preferred stock, $.005 par value; 1,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 0 shares issued and outstanding as of September 30, 2020 and December 31, 2019

           

Common stock, $.005 par value; 25,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 13,016,387 and 11,298,239 shares issued and outstanding as of September 30, 2020 and December 31, 2019

    65,077       56,487  

Additional paid-in capital

    166,764,577       163,161,523  

Accumulated other comprehensive loss

    (645,022 )     (568,030 )

Accumulated deficit

    (168,409,330 )     (166,705,572 )

Total Cleveland BioLabs, Inc. stockholders’ deficit

    (2,224,698 )     (4,055,592 )

Noncontrolling interest in stockholders’ equity

    4,972,113       5,039,878  

Total stockholders’ equity

    2,747,415       984,286  

Total liabilities and stockholders’ equity

  $ 3,231,288     $ 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

   

For the Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2020

   

2019

   

2020

   

2019

 

Revenues:

                               

Grants and contracts

  $ 43,645     $ 269,635     $ 262,942     $ 744,521  

Operating expenses:

                               

Research and development

    117,844       262,410       506,059       1,375,409  

General and administrative

    698,896       525,621       1,566,501       1,449,281  

Total operating expenses

    816,740       788,031       2,072,560       2,824,690  

Loss from operations

    (773,095 )     (518,396 )     (1,809,618 )     (2,080,169 )

Other income (expense):

                               

Interest and other income

    (2,834 )     14,246       508,878       32,528  

Foreign exchange loss

    (370 )     251       (757 )     (808 )

Change in value of warrant liability

    18,337       36,532       (434,737 )     54,176  

Total other income (expense)

    15,133       51,029       73,384       85,896  

Net loss

    (757,962 )     (467,367 )     (1,736,234 )     (1,994,273 )

Net loss attributable to noncontrolling interests

    12,574       17,448       32,477       54,583  

Net loss attributable to Cleveland BioLabs, Inc.

  $ (745,388 )   $ (449,919 )   $ (1,703,757 )   $ (1,939,690 )

Net loss attributable to common stockholders per share of common stock, basic and diluted

  $ (0.06 )   $ (0.04 )     (0.14 )     (0.17 )

Weighted average number of shares used in calculating net loss per share, basic and diluted

    13,002,452       11,298,239       12,103,899       11,298,239  

 

See Notes to Consolidated Financial Statements

 

 

 

CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

   

For the Three Months Ended

   

For the Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2020

   

2019

   

2020

   

2019

 

Net loss including noncontrolling interests

  $ (757,962 )   $ (467,367 )   $ (1,736,234 )   $ (1,994,273 )

Other comprehensive loss:

                               

Foreign currency translation adjustment

    (48,575 )     (11,994 )     (112,280 )     43,336  

Comprehensive loss including noncontrolling interests

    (806,537 )     (479,361 )     (1,848,514 )     (1,950,937 )
Comprehensive loss attributable to noncontrolling interests     28,251       21,281       67,765       39,713  

Comprehensive loss attributable to Cleveland BioLabs, Inc.

  $ (778,286 )   $ (458,080 )   $ (1,780,749 )   $ (1,911,224 )

 

See Notes to Consolidated Financial Statements

 

 

 

CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENT OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

                                   

Additional

 
   

Common Stock

   

Treasury Stock

   

Paid-In

 
   

Shares

   

Amount

   

Shares

   

Amount

   

Capital

 

Balance at December 31, 2018

    11,298,239     $ 56,487           $     $ 163,161,523  

Exercise of warrants

                             

Net loss

                             
Unrealized loss on short-term investments                              

Foreign currency translation

                             

Balance at March 31, 2019

    11,298,239     $ 56,487           $ -     $ 163,161,523  

Net loss

                             
Unrealized loss on short-term investments                              

Foreign currency translation

                             
Balance at June 30, 2019     11,298,239     $ 56,487           $     $ 163,161,523  
Unrealized loss on short-term investments                              
Foreign currency translation                              
Balance at September 30, 2019     11,298,239     $ 56,487           $     $ 163,161,523  
                                         

Balance at December 31, 2019

    11,298,239     $ 56,487           $ -     $ 163,161,523  
Exercise of warrants     105,000       525                   504,381  
Net loss                              
Unrealized loss on short-term investments                              
Foreign currency translation                              

Balance at March 31, 2020

    11,403,239     $ 57,012           $ -     $ 163,665,904  
Issuance of common stock, net of offering costs     1,515,878       7,579                   2,775,846  
Exercise of warrants     8,871       44                   61,219  
Net loss                              
Unrealized loss on short-term investments                              
Foreign currency translation                              
Balance at June 30, 2020     12,927,988     $ 64,635           $     $ 166,502,969  
Issuance of common stock, net of offering costs     6,000       30                   13,470  
Exercise of warrants     82,399       412                   248,138  
Net loss                              
Unrealized loss on short-term investments                              
Foreign currency translation                              
Balance at September 30, 2020     13,016,387     $ 65,077           $     $ 166,764,577  

 

    Accumulated Other Comprehensive Income (Loss)     Accumulated Deficit    

Noncontrolling Interests

   

Total

 

Balance at December 31, 2018

  $ (611,370 )   $ (164,058,585 )   $ 5,065,972     $ 3,614,027  

Exercise of warrants

                       

Net loss

          (872,943 )     (20,369 )     (893,312 )
Unrealized loss on short-term investments                        

Foreign currency translation

    26,759             13,991       40,750  

Balance at March 31, 2019

  $ (584,611 )   $ (164,931,528 )   $ 5,059,594     $ 2,761,465  

Net loss

          (616,828 )     (16,766 )     (633,594 )
Unrealized loss on short-term investments                        

Foreign currency translation

    9,868             4,712       14,580  
Balance at June 30, 2019   $ (574,743 )   $ (165,548,356 )   $ 5,047,540     $ 2,142,451  
Unrealized loss on short-term investments     1,841                   1,841  
Foreign currency translation     (110,910 )           (54,060 )     (164,970 )
Balance at September 30, 2019   $ (683,812 )   $ (167,238,676 )   $ 4,951,308     $ 246,830  
                                 

Balance at December 31, 2019

  $ (568,030 )   $ (166,705,572 )   $ 5,039,878     $ 984,286  
Exercise of warrants                       504,906  
Net loss           (588,532 )     (13,196 )     (601,728 )
Unrealized loss on short-term investments                        
Foreign currency translation     (74,477 )           (33,623 )     (108,100 )

Balance at March 31, 2020

  $ (642,507 )   $ (167,294,104 )   $ 4,993,059     $ 779,364  
Issuance of common stock, net of offering costs                       2,783,425  
Exercise of warrants                       61,263  
Net loss           (369,838 )     (6,707 )     (376,545 )
Unrealized loss on short-term investments                        
Foreign currency translation     30,383             14,012       44,395  
Balance at June 30, 2020   $ (612,124 )   $ (167,663,942 )   $ 5,000,364     $ 3,291,902  
Issuance of common stock, net of offering costs                       13,500  
Exercise of warrants                       248,550  
Net loss           (745,388 )     (12,574 )     (757,962 )
Unrealized loss on short-term investments                        
Foreign currency translation     (32,898 )           (15,677 )     (48,575 )
Balance at September 30, 2020   $ (645,022 )   $ (168,409,330 )   $ 4,972,113     $ 2,747,415  

 

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,  
   

2020

   

2019

 

Cash flows from operating activities:

               

Net loss

  $ (1,736,234 )   $ (1,994,273 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation and amortization

    8,792       10,303  

Gain on equipment disposal

          (43,300 )
Noncash compensation     13,500          

Accrued liability extinguishment

    (501,892 )      

Change in value of warrant liability

    434,737       (54,176 )

Changes in operating assets and liabilities:

               

Accounts receivable and other current assets

    232,374       77,152  

Other long-term assets

    18,667       11,858  

Accounts payable and accrued expenses

    (54,605 )     (306,499 )

Net cash used in operating activities

    (1,584,661 )     (2,298,935 )

Cash flows from investing activities:

               

Purchase of short-term investments

    (353,218 )     (806,713 )

Sale of short-term investments

    395,605       921,957  

Proceeds from sale of equipment

          43,300  

Net cash provided by investing activities

    42,387       158,544  

Cash flows from financing activities:

               
Issuance of common stock, net of offering costs     2,783,425        

Exercise of warrants

    382,215        

Net cash provided by financing activities

    3,165,640        

Effect of exchange rate change on cash and equivalents

    (28,377 )     10,545  

Increase (decrease) in cash and cash equivalents

    1,594,989       (2,129,846 )

Cash and cash equivalents at beginning of period

    1,126,124       3,617,234  

Cash and cash equivalents at end of period

  $ 2,721,113     $ 1,487,388  

 

See Notes to Consolidated Financial Statements

 

 

CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

 

 

1. Description of Business

 

Cleveland BioLabs, Inc. ("CBLI" or the "Company") is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. Our proprietary platform of Toll-like immune receptor ("TLR") activators has applications in radiation protection and oncology. We combine our proven scientific expertise and our depth of knowledge about our products’ mechanisms of action into a passion for developing drugs to save lives. Our most advanced product candidate is entolimod, an immune-stimulatory agent, which we are developing as a medical radiation countermeasure and other indications in radiation oncology.

 

CBLI was incorporated in Delaware in June 2003 and is headquartered in Buffalo, New York. CBLI conducts business in the United States ("U.S.") directly and in the Russian Federation ("Russia") through two subsidiaries: one wholly owned subsidiary, BioLab 612, LLC ("BioLab 612"), which began operations in 2012 and which the Company at a September 2019 Board meeting decided to dissolve; and Panacela Labs, Inc. ("Panacela"), which was formed by us and Joint Stock Company "RUSNANO" ("RUSNANO"), our financial partner in the venture, in 2011. Unless otherwise noted, references to the "Company," "we," "us," and "our" refer to Cleveland BioLabs, Inc. together with its subsidiaries.

 

In addition, the Company has an investment in Genome Protection, Inc. ("GPI") that is recorded under the equity method of accounting in the accompanying financial statements. The Company has not recorded its 50% share of the losses of GPI through September 30, 2020 as the impact would have reduced the Company's equity method investment in GPI below zero, and there are no requirements to fund the Company's share of these losses or contribute additional capital as of the date of these statements. 

 

 

2. Summary of Significant Accounting Policies

 

Basis of Presentation and Consolidation

 

The accompanying unaudited consolidated condensed financial statements include the accounts of CBLI, BioLab 612, and Panacela. All significant intercompany balances and transactions have been eliminated in consolidation.

 

The consolidated condensed balance sheet as of December 31, 2019, which has been derived from audited financial statements, and the unaudited interim consolidated condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") for interim consolidated financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated condensed financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC (the "2019 Form 10-K").

 

In the opinion of the Company’s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to fairly present the financial position of the Company as of September 30, 2020, along with its results of operations for the three and nine month periods ended September 30, 2020 and 2019 and cash flows for the nine-month periods ended September 30, 2020 and 2019. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

 

At September 30, 2020, we had cash, cash equivalents and short-term investments of $3.0 million in the aggregate. Management believes this capital will be sufficient to support operations beyond one year from this filing. To ensure continuing operations beyond that point, management is evaluating all opportunities, including seeking additional capital through debt or equity financing, the sale or license of drug candidates, the sale of certain of our tangible and/or intangible assets, the sale of interests in our subsidiaries or joint ventures, obtaining additional government research funding, or entering into other strategic transactions. Management believes that sufficient sources of financing will be available to support operations into the future, however there can be no assurances at this time. These financial statements have been prepared under the assumption that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

 

 

Recent Accounting Pronouncements

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard-setting bodies that are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Short-Term Investments

 

The Company’s short-term investments are classified as held to maturity and are recorded at amortized cost. Short-term investments consisted of $0.3 million in certificates of deposit owned by Panacela that have maturity dates falling beyond three months and less than one year. These investments are classified as held to maturity given the intent and ability to hold the investments to maturity. Realized gains and losses, and interest and dividends on short-term investments are recorded in our Consolidated Statement of Operations as Interest and Other Income. The cost of securities sold is based on the specific identification method.

 

Significant Customers and Accounts Receivable

 

The following table presents our revenue by customer, on a proportional basis, for the three and nine months ended September 30, 2020 and 2019.

 

   

Three Months Ended

 

Nine Months Ended

   

September 30,

 

September 30,

Customer

 

2020

   

2019

   

Variance

   

2020

   

2019

   

Variance

 

Department of Defense

    100.0 %     90.0 %     10.0 %     81.2 %     60.2 %     -21.0 %

Incuron

    0.0 %     10.0 %     (10.0 )%     18.8 %     39.8 %     -21.0 %

Total

    100.0 %     100.0 %     %     100.0 %     100.0 %     %

 

Our current Department of Defense ("DoD") revenues come from development contracts that expire in 2020. Revenues from Incuron LLC, a company in which the Company previously owned an equity interest ("Incuron"), comes from a service agreement.

 

Accounts receivable consist of amounts due under reimbursement contracts with these customers. The Company extends unsecured credit to the above customers under normal trade agreements, which generally require payment within 30 days.

 

Other Comprehensive Income (Loss)

 

The Company applies the Accounting Standards Codification ("Codification") on comprehensive income (loss) that requires disclosure of all components of comprehensive income (loss) on an annual and interim basis. Other comprehensive income (loss) is defined as the change in equity of a business enterprise during a period arising from transactions and other events and circumstances from non-owner sources. The following table presents the changes in accumulated other comprehensive loss for the nine months ended September 30, 2020.

 

   

Gains and losses on foreign exchange translations

 

Beginning balance

  $ (568,030 )

Other comprehensive income (loss) before reclassifications

    (76,992 )

Amounts reclassified from accumulated other comprehensive loss

     

Ending balance

  $ (645,022 )

 

 

Accounting for Stock-Based Compensation

 

The Cleveland Biolabs, Inc. Equity Incentive Plan, adopted in 2018 (the "Plan"), authorizes CBLI to grant (i) options to purchase common stock, (ii) restricted or unrestricted stock units, and (iii) stock appreciation rights, so long as the exercise or grant price of each are at least equal to the fair market value of the stock on the date of grant. As of September 30, 2020, an aggregate of 597,557 shares of common stock were authorized for issuance under the Plan, of which a total of 520,678 shares of common stock remained available for future awards. In addition, a total of 76,879 shares of common stock reserved for issuance were subject to currently outstanding stock options granted under The Cleveland BioLabs, Inc. Equity Incentive Plan, as in effect prior to the 2018 amendment and restatement. A single participant cannot be awarded more than 100,000 shares annually. Awards granted under the Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term, and number of shares) under the Plan are specified in an award document, and approved by the Company’s board of directors or its management delegates.

 

The 2013 Employee Stock Purchase Plan (the "ESPP") provides a means by which eligible employees of the Company and certain designated related corporations may be given an opportunity to purchase shares of common stock. As of September 30, 2020, there are 725,000 shares of common stock reserved for purchase under the ESPP. The number of shares reserved for purchase under the ESPP increases on January 1 of each calendar year by the lesser of: (i) 10% of the total number of shares of common stock outstanding on December 31st of the preceding year, or (ii) 100,000 shares of common stock. The ESPP allows employees to use up to 15% of their compensation to purchase shares of common stock at an amount equal to 85% of the fair market value of the Company’s common stock on the offering date or the purchase date, whichever is less.

 

The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted where the vesting period is based on length of service or performance, while a Monte Carlo simulation model is used for estimating the fair value of stock options with market-based vesting conditions. No options were granted during the nine months ended September 30, 2020 and September 30, 2019.

 

Income Taxes

 

No income tax expense was recorded for the three and nine months ended September 30, 2020 and 2019 as the Company does not expect to have taxable income for 2020 and did not have taxable income in 2019. A full valuation allowance has been recorded against the Company’s net deferred tax asset.

 

At September 30, 2020, the Company had U.S. federal net operating loss carryforwards of approximately $146.7 million, of which $139.7 million begins to expire if not utilized by 2023, and $7.0 million, which has no expiration, and approximately $4.2 million of tax credit carryforwards, which begin to expire if not utilized by 2024. The Company also has state net operating loss carryforwards of approximately $92.6 million, which begin to expire if not utilized by 2027, and state tax credit carryforwards of approximately $0.3 million, which begin to expire if not utilized by 2022. The purchase of 6,459,948 shares of common stock by David Davidovich on July 9, 2015 resulted in Mr. Davidovich owning 60.2% of the Company at that time. We therefore believe it highly likely that this transaction will be viewed by the U.S. Internal Revenue Service as a change of ownership as defined by Section 382 of the Internal Revenue Code. Consequently, our ability to utilize approximately $124.8 million of U.S. federal net operating loss carryforwards, $3.65 million of U.S. tax credit carryforwards, approximately $73.4 million of state net operating loss carryforwards, and $0.3 million of state tax credit carryforwards, all of which occurred prior to July 9, 2015, are limited. As such, a significant portion of these carryforwards will likely expire before they can be utilized, even if the Company is able to generate taxable income that, except for the foregoing transaction, would have been sufficient to fully utilize these carryforwards.

 

Earnings (Loss) per Share

 

Basic net loss per share of common stock excludes dilution for potential common stock issuances and is computed by dividing net loss by the weighted average number of shares outstanding for the period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Diluted net loss per share is identical to basic net loss per share as potentially dilutive securities have been excluded from the calculation of diluted net loss per common share because the inclusion of such securities would be antidilutive.

 

The Company has excluded the following securities from the calculation of diluted net loss per share because all such securities were antidilutive for the periods presented. Additionally, there were no dilutive securities outstanding as of September 30, 2020.

 

   

As of September 30,

 

Common Equivalent Securities

 

2020

   

2019

 

Warrants

    974,090       327,253  

Options

    76,879       136,289  

Total

    1,050,969       463,542  

 

Contingencies

 

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business. The Company accrues for liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. The Company recorded a revenue loss contingency of $544,000 in the fourth quarter of 2019 related to deposits paid to a supplier in support of our JWMRP contract (as defined below) which the Company may have been responsible for repaying to the DoD.  This amount was recorded as an accrued expense in the December 31, 2019 Consolidated Balance Sheet.  During July 2020, the Company settled with the supplier for repayment of the deposit.  The Company used the proceeds from the return of the deposit to repay the DoD in settlement of any outstanding contingent event.  Accordingly, the Company recorded an extinguishment of the accrued liability to other income in the amount of $501,892 during June 2020. 

 

 

 

3. Fair Value of Financial Instruments

 

The Company measures and records warrant liabilities at fair value in the accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value, includes:

 

 

Level 1 – Observable inputs for identical assets or liabilities such as quoted prices in active markets;

 

 

Level 2 – Inputs other than quoted prices in active markets that are either directly or indirectly observable; and

 

 

Level 3 – Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.

 

Cash equivalents include United States Treasury Notes with original maturities of three months or less at time of purchase and money market funds. Short-term investments primarily include certificates of deposit at commercial banking institutions, with maturities of three months or more at time of purchase.

 

The valuation methodologies used to measure the fair value of the Company’s assets and instruments classified in stockholders’ equity are described as follows: Certificates of deposit are carried at amortized cost, which approximates fair value and are included within short-term investments as a Level 2 measurement in the table below.

 

The following tables represent the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis.

 

   

As of September 30, 2020

 
   

Level 1

   

Level 2

   

Level 3

   

Total

 

Assets:

                               

Cash and cash equivalents

  $     $     $     $  

Short-term investments

          313,737             313,737  

Total assets

  $     $ 313,737     $     $ 313,737  

Liabilities:

                               

Accrued warrant liability

  $     $     $ 8,607     $ 8,607  

    

   

As of December 31, 2019

 
   

Level 1

   

Level 2

   

Level 3

   

Total

 

Assets:

                               

Cash and cash equivalents

  $     $     $     $  

Short-term investments

          452,301             452,301  

Total assets

  $     $ 452,301     $     $ 452,301  

Liabilities:

                               

Accrued warrant liability

  $     $     $ 6,414     $ 6,414  

 

The Company uses the Black-Scholes model to measure the accrued warrant liability. The following are the assumptions used to measure the accrued warrant liability which were determined in a manner consistent with grants of options to purchase common stock:

        

   

September 30, 2020

 

December 31, 2019

Stock Price

 

$1.97

 

$0.60

Exercise Price

 

$20.40

 

$3.64 - $20.40

Term in years

 

0.29

 

1.04 - 1.60

Volatility

 

231.64%

 

84.59 - 98.24%

Annual rate of quarterly dividends

 

—%

 

—%

Discount rate- bond equivalent yield

 

0.04%

 

1.58 - 1.59%

 

 

The following table sets forth a summary of changes in the fair value of the Company’s Level 3 fair value measurements for the periods indicated:

 

   

Three Months Ended

   

Three Months Ended

 
   

September 30, 2020

   

September 30, 2019

 
    Accrued Warrant Liability     Accrued Warrant Liability  

Beginning Balance

  $ 275,494     $ 60,993  

Total (gains) or losses, realized and unrealized, included in earnings (1)

    (18,337 )     (36,532 )

Issuances

           

Settlements

    (248,550 )      

Ending Balance

  $ 8,607     $ 24,461  

 

 

   

Nine Months Ended

   

Nine Months Ended

 
   

September 30, 2020

   

September 30, 2019

 
   

Accrued Warrant Liability

   

Accrued Warrant Liability

 
Beginning Balance   $ 6,414     $ 78,637  
Total (gains) or losses, realized and unrealized, included in earnings (1)     434,737       (54,176 )

Issuances

           

Settlements

    (432,544 )      

Ending Balance

  $ 8,607     $ 24,461  

 

(1)

Unrealized gains or losses related to the accrued warrant liability were included as change in value of accrued warrant liability. There were no realized gains or losses for the three and nine months ended September 30, 2020 and 2019.

 

As of September 30, 2020 and December 31, 2019, the Company had no assets or liabilities that were measured at fair value on a nonrecurring basis.

 

The Company considers the accrued warrant liability to be Level 3 because some of the inputs into the measurements are neither directly nor indirectly observable. The accrued warrant liability uses management’s estimate for the expected term. As of September 30, 2020, the Black-Scholes pricing model was used as the valuation technique for the accrued warrant liability and used the unobservable input for the expected term of 0.29 years.

 

Management believes the value of the accrued warrant liability is more sensitive to a change in the Company’s stock price at the end of the respective reporting period as opposed to a change in the unobservable input described above.

 

The carrying amounts of the Company’s short-term financial instruments, which include cash and cash equivalents, accounts receivable and accounts payable, approximate their fair values due to their short maturities.

 

 

 

4. Stockholders’ Equity

 

During June 2020, the Company raised $2.8 million in net proceeds from the issuance of 1,515,878 shares of common stock and 871,630 stock warrants.  The stock warrants were recorded as a equity instrument and valued at $1.0 million at the date of issuance utilizing the following Black-Scholes assumptions.

 

   

June 3, 2020

Stock Price

 

$1.65

Exercise Price

 

$2.03 - $2.62

Term in years

 

5.00

Volatility

 

 98.20%

Annual rate of quarterly dividends

 

0%

Discount rate- bond equivalent yield

 

0.38%

 

Issuance costs amounted to $391,581. 

 

The Company has granted options to purchase shares of common stock. The following is a summary of option award activity during the nine months ended September 30, 2020:

    

   

Total Stock Options Outstanding

    Weighted Average Exercise Price per Share  

December 31, 2019

    136,105     $ 40.07  

Granted

           

Vested

           

Forfeited, Canceled

    (59,226 )     55.29  

September 30, 2020

    76,879     $ 28.34  

 

 

The following is a summary of outstanding stock options as of September 30, 2020:

 

   

As of September 30, 2020

 
    Stock Options Outstanding     Vested Stock Options  

Quantity

    76,879       76,879  

Weighted Average Exercise Price

  $ 28.34     $ 28.34  

Weighted Average Remaining Contractual Term (in Years)

    3.46       3.46  

Intrinsic Value

  $     $  

 

For the nine months ended September 30, 2020 and 2019, the Company granted no stock options. As of September 30, 2020 and 2019, the total fair value of options vested was $0.

 

As of September 30, 2020, there was no total compensation cost not yet recognized related to unvested stock options.

 

 

5. Warrants

 

In connection with previous sales of the Company’s common stock and the issuance of debt instruments, warrants were issued which presently have exercise prices ranging from $2.03 to $20.40. The warrants expire between one and seven years from the date of grant, and are subject to the terms applicable in each agreement.

 

The following table summarizes the activity in our outstanding warrants since December 31, 2019:

 

    Number of Warrants     Weighted Average Exercise Price  

December 31, 2019

    327,253     $ 8.89  

Granted

    871,630       2.11  

Exercised

    (224,793 )     2.03  

Forfeited, Canceled

           

September 30, 2020

    974,090     $ 4.03  

 

 

 

 

6. Significant Alliances and Related Parties

 

Roswell Park Cancer Institute

 

The Company has entered into several agreements with Roswell Park Cancer Institute ("RPCI"), including: various sponsored research agreements, an exclusive license agreement and clinical trial agreements for the conduct of the Phase 1 entolimod oncology study and the Phase 1 Curaxin CBL0137 ("Curaxin") intravenous administration study. Additionally, the Company’s Chief Scientific Officer, or CSO, Dr. Andrei Gudkov, is the Senior Vice President of Research Technology and Innovation at RPCI. The Company incurred $0 and $1,197, and $9,367 and $67,318 in research and development expense to RPCI for the three and nine months ended September 30, 2020 and 2019, respectively. 

 

The Cleveland Clinic

 

CBLI has entered into an exclusive license agreement with The Cleveland Clinic pursuant to which CBLI was granted an exclusive license to The Cleveland Clinic’s research base underlying our therapeutic platform and certain product candidates licensed to Panacela. CBLI has the primary responsibility to fund all newly developed patents. However, The Cleveland Clinic retains ownership of those patents covered by the agreement. CBLI also agreed to use commercially diligent efforts to bring one or more products to market as soon as practical, consistent with sound and reasonable business practices and judgments. On August 6, 2018, CBLI sublicensed the intellectual property underlying entolimod's composition that CBLI licenses from The Cleveland Clinic to GPI. There were no milestone or royalty payments paid to The Cleveland Clinic during the three and nine months ended September 30, 2020 and 2019.  The Company incurred $0 and $0, and $0 and $30,710 in research and development expense to The Cleveland Clinic during the three and nine months ended September 30, 2020 and 2019, respectively.

 

Buffalo BioLabs and Incuron

 

Our CSO, Dr. Andrei Gudkov, has business relationships with Buffalo BioLabs, LLC ("BBL"), where Dr. Gudkov was a founder and currently serves as its uncompensated Principal Scientific Advisor. The Company recognized $0 and $0, and $129 and $129 in research and development expense to BBL for the three and nine months ended September 30, 2020 and 2019, respectively. The Company also recognized $0 and $0, and $0 and $20,808 from BBL as sublease and other income for the three and nine months ended September 30, 2020 and September 30, 2019, respectively. Pursuant to our real estate sublease and equipment lease with BBL, the Company had gross accounts receivables of $6,285 and $219,108, and net accounts receivables of $0 and $16,957 from BBL at September 30, 2020 and 2019, respectively.

 

Dr. Gudkov is also an uncompensated member of the board of directors for Incuron. Pursuant to master service and development agreements we have with Incuron, the Company performs various research, business development, clinical advisory, and management services for Incuron. The Company recognized revenue of $0 and $49,357, and $26,928 and $295,958 for the three and nine months ended September 30, 2020 and 2019, respectively. In addition, the Company recognized $0 and $0, and $0 and $2,268 from Incuron for sublease and other income for the three and nine months ended September 30, 2020 and 2019, respectively. Pursuant to these agreements, the Company had accounts receivable of $130,000 and $32,512 from Incuron at September 30, 2020 and 2019, respectively.

 

Genome Protection

 

GPI incurred $13,440 and $40,320, and $54,700 and $149,550 in consultant expenses with members of the Company's Board of Directors and management team during the three and nine months ended September 30, 2020 and 2019, respectively. The Company also recognized $0 and $0, and $1,178 and $4,209 in sublease and other income from GPI during the three and nine months ended September 30, 2020 and 2019, respectively.

 

 

7. Subsequent Events

 

Merger with Cytocom, Inc.

 

On October 16, 2020, the Company, High Street Acquisition Corp. ("Merger Sub"), a Delaware corporation and a wholly owned subsidiary of the Company, and Cytocom, Inc., a Delaware corporation ("Cytocom"), entered into an Agreement and Plan of Merger (the "Merger Agreement"), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Cytocom, with Cytocom continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (the "Merger"). Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger, each outstanding share of Cytocom common stock, each outstanding share of Cytocom preferred stock that was not, by its terms, converted into shares of Cytocom common stock immediately prior to the effective time of the merger, and each vested restricted stock unit of Cytocom will be converted into the right to receive a number of shares of the Company’s common stock determined by the application of an exchange formula set forth in the Merger Agreement. The exchange formula provides that the total number of shares of the Company’s common stock to be issued as merger consideration for the Cytocom’s capital stock will, upon issuance, be equal to approximately 61% of the outstanding shares of the combined company’s common stock. Accordingly, under the exchange ratio formula in the Merger Agreement, as of immediately after the Merger, the former Cytocom stockholders are expected to own approximately 61% of the outstanding shares of the combined company’s common stock on a fully diluted basis and stockholders of the Company as of immediately prior to the Merger are expected to own approximately 39% of the outstanding shares of the combined company’s common stock on a fully diluted basis. Certain adjustments to this ratio will be made in respect of each party’s net cash at the time of the closing of the Merger, as determined in accordance with the Merger Agreement. Each unvested Cytocom restricted stock unit award will be converted into a restricted stock unit award of the Company. Immediately following the effective time of the Merger, the board of directors of the Company will consist of seven members, three of whom will be designated by the Company and four of whom will be designated by Cytocom. In addition, upon the closing of the Merger, Cytocom’s Chief Executive Officer, Michael Handley, will serve as Chief Executive Officer of the combined company. The closing of the Merger is subject to the satisfaction or waiver of certain conditions including, among other things, (i) the required approvals by the Company’s stockholders, (ii) the accuracy of the respective representations and warranties of each party, subject to certain materiality qualifications, (iii) compliance by the parties with their respective covenants, (iv) the absence of any law or order preventing the Merger and related transactions, (v) the shares of the Company’s common stock to be issued in the Merger being approved for listing (subject to official notice of issuance) on Nasdaq as of the closing and (vi) a registration statement on Form S-4 having become effective in accordance with the provisions of the Securities Act of 1933, as amended, and not being subject to any stop order or proceeding (or threatened proceeding by the SEC) seeking a stop order with respect to such registration statement that has not been withdrawn.

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This management’s discussion and analysis of financial condition and results of operations and other portions of this quarterly report on Form 10-Q contain forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this quarterly report, 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, plans and objectives of management for future operations, the expected ownership in the combined company of the former Cytocom securityholders and securityholders of the Company as of immediately prior to the Merger and governance of the combined company, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions, 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 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, the risk that the proposed merger may not be completed in a timely manner or at all, which may adversely affect the Company’s business and the price of Company’s common stock; the failure of either party to satisfy any of the conditions to the consummation of the proposed merger, including the approval of Company’s stockholders; uncertainties as to the timing of the consummation of the proposed merger; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the proposed merger on the Company’s business relationships, operating results and business generally; risks that the proposed merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the proposed merger; risks related to diverting management’s attention from the Company’s ongoing business operations; the outcome of any legal proceedings that may be instituted against the Company related to the merger agreement or the proposed merger; unexpected costs, charges or expenses resulting from the proposed merger; 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 by our majority stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; 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 below and in our other 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 quarterly report 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. This management’s discussion and analysis of financial condition and results of operations should be read in conjunction with our financial statements and the related notes included elsewhere in this filing and with our historical consolidated financial statements and the related notes thereto in our Annual Report on Form 10-K for the year ended December 31, 2019.

 

OVERVIEW

 

We are an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. Our proprietary platform of Toll-like immune receptor activators has applications in mitigation of radiation injury and radiation oncology. We combine our proven scientific expertise and our depth of knowledge about our products’ mechanisms of action into a passion for developing drugs to save lives. Our most advanced product candidate is entolimod, an immune-stimulatory agent, which we are developing as a radiation countermeasure and other indications in radiation oncology. We conduct business in the U.S. directly and in Russia through two subsidiaries, one of which is wholly owned, BioLab 612 (which the Company has decided to dissolve), and one of which is owned in collaboration with a financial partner, Panacela. In addition, we conduct business with a former subsidiary, Incuron, which will pay us a 2% royalty on future commercialization, licensing, or sale of certain technology we sold to Incuron. We also partner in a joint venture, GPI, with Everon Biosciences, Inc ("Everon").

 

Recent Developments

 

Merger with Cytocom, Inc.

 

As previously disclosed, on October 16, 2020, the Company, High Street Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of the Company ("Merger Sub"), and Cytocom, Inc., a Delaware corporation ("Cytocom"), entered into an Agreement and Plan of Merger (the "Merger Agreement"), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Cytocom, with Cytocom continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (the "Merger"). Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger, each outstanding share of Cytocom common stock, each outstanding share of Cytocom preferred stock that was not, by its terms, converted into shares of Cytocom common stock immediately prior to the effective time of the merger, and each vested restricted stock unit of Cytocom will be converted into the right to receive a number of shares of the Company’s common stock determined by the application of an exchange formula set forth in the Merger Agreement. The exchange formula provides that the total number of shares of the Company’s common stock to be issued as merger consideration for the Cytocom’s capital stock will, upon issuance, be equal to approximately 61% of the outstanding shares of the combined company’s common stock. Accordingly, under the exchange ratio formula in the Merger Agreement, as of immediately after the Merger, the former Cytocom stockholders are expected to own approximately 61% of the outstanding shares of the combined company’s common stock on a fully diluted basis and stockholders of the Company as of immediately prior to the Merger are expected to own approximately 39% of the outstanding shares of the combined company’s common stock on a fully diluted basis. Certain adjustments to this ratio will be made in respect of each party’s net cash at the time of the closing of the Merger, as determined in accordance with the Merger Agreement. Each unvested Cytocom restricted stock unit award will be converted into a restricted stock unit award of the Company. Immediately following the effective time of the Merger, the board of directors of the Company will consist of seven members, three of whom will be designated by the Company and four of whom will be designated by Cytocom. In addition, upon the closing of the Merger, Cytocom’s Chief Executive Officer, Michael Handley, will serve as Chief Executive Officer of the combined company. The closing of the Merger is subject to the satisfaction or waiver of certain conditions including, among other things, (i) the required approvals by the Company’s stockholders, (ii) the accuracy of the respective representations and warranties of each party, subject to certain materiality qualifications, (iii) compliance by the parties with their respective covenants, (iv) the absence of any law or order preventing the Merger and related transactions, (v) the shares of the Company’s common stock to be issued in the Merger being approved for listing (subject to official notice of issuance) on Nasdaq as of the closing and (vi) a registration statement on Form S-4 having become effective in accordance with the provisions of the Securities Act of 1933, as amended, and not being subject to any stop order or proceeding (or threatened proceeding by the SEC) seeking a stop order with respect to such registration statement that has not been withdrawn.

 

NASDAQ Listing Status

 

As previously disclosed, on August 21, 2020, the Company received a letter from The Nasdaq Stock Market informing the Company that the Company had regained compliance with Nasdaq Listing Rule 5550(b), which requires that the Company maintain a minimum stockholders’ equity of at least $2.5 million (the "Rule"). As a result, the Nasdaq Hearings Panel (the "Panel") determined to continue the listing of the Company’s securities on The Nasdaq Stock Market. However, due to the marginal nature of compliance in the projections provided to the Panel and the staff of the Nasdaq Stock Market (the “Staff”) on August 17, 2020, the Staff has recommended, and the Panel has determined to impose, a Panel Monitor until February 10, 2021. The Company is under certain notification obligations during this time period, including the obligation to notify the Panel Monitor if it fails to comply with the Rule or any other applicable listing requirement. Additionally, if at any time during this time period the Company fails to satisfy any continued listing standard, the Panel will promptly conduct a hearing with respect to the deficiency, and the Company’s securities may be immediately delisted from The Nasdaq Stock Market.

 

COVID-19 Pandemic

 

The COVID-19 pandemic has continued to affect multiple countries, including the United States, where a national emergency was declared, and several European and Asian countries. The continued spread of COVID-19 in the United States and worldwide, as well as the government-ordered shutdown and shelter-in-place orders imposed to counter the pandemic, have led to severe disruptions to the global economy. In this connection, on March 20, 2020, the Governor of New York announced that 100% of the workforce of all businesses, excluding essential services, must stay home. During the effectiveness of this order , we implemented a work-from-home policy for all employees based in our Buffalo, New York headquarters.  Under new applicable state orders, our offices may be occupied at 50% of their normal capacity if other safety precautions are taken, however, generally very few of our employees have returned to the office.  We are continuing to monitor the situation and will take such further action  as may be required by federal, state or local authorities, or that we determine are in the best interests of our employees.  COVID-19 and the governmental responses to it may cause us to experience disruptions that could severely impact our business, operations, preclinical studies and clinical trials. The global outbreak of COVID-19 continues to rapidly evolve and has begun to have indeterminable adverse effects on general commercial activity and the world economy. The extent to which COVID-19 may impact our business, research and development efforts, preclinical studies, clinical trials, prospects for regulatory approval of our drug candidates, and operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the extent and duration of travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business prospects and the value of our common stock.  Furthermore, if we or any of the third parties with whom we engage were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted, which could have a material adverse effect on our business, financial condition and results of operations.

 

Financial Overview

 

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues, and expenses.

 

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, income taxes, stock-based compensation, investments, and in-process research and development. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results may differ from these estimates.

 

Our revenue, operating results, and profitability have varied, and we expect that they will continue to vary on a quarterly basis, primarily due to the timing of work completed under new and existing grants, development contracts, and collaborative relationships.

 

 

Revenue

 

Our revenue originates from grants and contracts from both United States ("U.S.") federal government sources and service contracts with Incuron. U.S. federal grants and contracts are provided to advance research and development of entolimod, our lead product candidate, which we believe is of interest for potential sale to the DoD, or the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services ("BARDA"). We provide various research, management, business development, and clinical advisory services to Incuron.

 

Research and Development Expenses

 

Research and development ("R&D") costs are expensed as incurred. Advance payments are deferred and expensed as performance occurs. R&D costs include the cost of our personnel (which consists of salaries and incentive and stock-based compensation), out-of-pocket pre-clinical and clinical trial costs usually associated with contract research organizations, drug product manufacturing and formulation, and a pro-rata share of facilities expense and other overhead items.

 

General and Administrative Expenses

 

General and administrative ("G&A") functions include executive management, finance and administration, government affairs and regulations, corporate development, human resources, and legal and compliance. The specific costs include the cost of our personnel consisting of salaries, incentive and stock-based compensation, out-of-pocket costs usually associated with attorneys (both corporate and intellectual property), bankers, accountants, and other advisors and a pro-rata share of facilities expense and other overhead items.

 

Other Income and Expenses

 

Other recurring income and expenses primarily consists of interest income on our investments, changes in the market value of our derivative financial instruments, and foreign currency transaction gains or losses.

 

Critical Accounting Policies and Significant Estimates

 

Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2019. Other than as set forth below, our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019.

 

Fair Value of Financial Instruments

 

We use the held-to-maturity accounting method to determine the fair value of certain cash equivalents and short-term investments in U.S. Treasury Notes or certificates of deposit. As of September 30, 2020, we held approximately $0.3 million in certificates of deposit which we classified as Level 2.

 

We use the Black-Scholes model to determine the fair value of certain common stock warrants on a recurring basis, and classify such warrants as Level 3 in the fair value hierarchy. The Black-Scholes model utilizes inputs consisting of: (i) the closing price of our common stock; (ii) the expected remaining life; (iii) the expected volatility using a weighted average of historical volatilities of CBLI common stock and a group of comparable companies; and (iv) the risk-free market rate.

 

As of September 30, 2020, we held approximately $0.01 million in accrued expenses related to warrants to purchase common stock, which we classified as Level 3.

 

 

Three Months Ended September 30, 2020 Compared to Three Months Ended September 30, 2019

 

Revenue

 

Revenue decreased from approximately $0.27 million for the three months ended September 30, 2019 to approximately $0.04 million for the three months ended September 30, 2020, representing a decrease of approximately $0.23 million, or 83.8%. This decrease is primarily due to decreases in revenues from our JWMRP contract with the DoD for continued preclinical development of entolimod, decreases in revenue from our PRMRP contract (as defined below) with the DoD for continued clinical development of entolimod, and decreases in revenue from our service contract with Incuron during the fiscal quarter ended June 30, 2020. The decrease in Incuron service contract revenue is due to the expiration of our service contract with Incuron. Differences in our revenue sources, by program, between the years are set forth in the following table. 

 

     

Three Months Ended September 30,

         

Funding Source

Program

 

2020

   

2019

   

Variance

 

DoD

JWMRP Contract (1)

  $ 43,130     $ 236,405     $ (193,275 )

DoD

PRMRP Contract (2)

    515       6,302       (5,787 )

Incuron

Service contract

    -       26,928       (26,928 )
      $ 43,645     $ 269,635     $ (225,990 )

 

(1)

The Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) contract was awarded on September 1, 2015.

(2)

The CDMRP Peer Reviewed Medical Research Program (PRMRP) grant was awarded effective as of September 30, 2015.

 

We anticipate a decrease in revenue from the DoD over the next quarter as the period of performance of the JWMRP and PRMRP Contracts has expired. We anticipate a decrease in Incuron revenue as the service contract has not been extended. The following table sets forth information regarding our revenues:

 

                     

As of September 30, 2020

 

Funding Source

Program

  Total Award Value    

Funded Award Value

   

Cumulative Revenue

    Funded Backlog     Unfunded Backlog  

DoD

JWMRP Contract

  $ 9,226,455     $ 3,558,603     $ 3,558,603     $ -     $  

DoD

PRMRP Contract

    6,573,992       214,860       214,860       -        
      $ 15,800,447     $ 3,773,463     $ 3,773,463     $ -     $  

 

As previously disclosed, contract modifications with the DoD were entered into during the quarter that reduced the JWMRP and PRMRP funded awards from an aggregate of $15,800,447 to an aggregate of $3,773,463, as reflected in the table above. 

 

Research and Development Expenses

 

R&D expenses decreased from $0.26 million for the three months ended September 30, 2019 to $0.12 million for the three months ended September 30, 2020, representing a decrease of $0.14 million, or 55.1%. Variances in individual development programs are noted in the table below. The net decrease is primarily attributable to a $0.12 million decrease in R&D spending for biodefense applications of entolimod, and a $0.03 decrease in R&D spending on Curaxins. The decrease in spending for biodefense applications of entolimod is primarily due to a reduction in personnel costs. The remaining variances are not significant.

 

   

Three Months Ended September 30,

         
   

2020

   

2019

   

Variance

 

Entolimod for Biodefense Applications

  $ 109,726     $ 231,082     $ (121,356 )

CBLB612

          (554 )     554  

Entolimod for Oncology Indications

          (729 )     729  
      109,726       229,799       (120,073 )

Curaxins

    (4 )     25,269       (25,273 )

Panacela product candidates

    8,122       7,342       780  

Total research & development expenses

  $ 117,844     $ 262,410     $ (144,566 )

 

General and Administrative Expenses

 

G&A expenses increased from $0.53 million for the three months ended September 30, 2019 to $0.70 million for the three months ended September 30, 2020, representing an increase of $0.17 million, or 33.0%. This increase consisted primarily of an increase of $0.16 million in professional fees in part for activities related to the potential Merger, and an increase of $0.15 million increase in other costs for cash awards to certain members of the Company's board of directors, offset in part by a $0.13 million decrease in personnel and consulting costs.

 

Other Income and Expenses

 

Other income decreased from $0.05 million of other income for the three months ended September 30, 2019 to $0.02 million of other income for the three months ended September 30, 2020, representing an other income decrease of $0.03 million, or 70.3%. This decrease primarily related to a decrease in non-cash income related to the change in valuation of our warrant liability as a result of stock price changes.

 

 

Nine Months Ended September 30, 2020 Compared to Nine Months Ended September 30, 2019

 

Revenue

 

Revenue decreased from approximately $0.74 million for the nine months ended September 30, 2019 to approximately $0.26 million for the nine months ended September 30, 2020, representing a decrease of approximately $0.48 million, or 64.7%. This decrease is primarily due to decreases in revenues from our service contract with Incuron and JWMRP contract with the DoD for continued preclinical development of entolimod, offset in part by an increase in revenues from our PRMRP contract with the DoD for continued clinical development of entolimod. The decrease in Incuron service contract revenue is due to delays in clinical trial activities being undertaken by Incuron as well as by the expiration of the service contract with Incuron during the fiscal quarter ended June 30, 2020. Differences in our revenue sources, by program, between the years are set forth in the following table. 

 

     

Nine Months Ended September 30,

         

Funding Source

Program

 

2020

   

2019

   

Variance

 

DoD

JWMRP Contract (1)

  $ 156,685     $ 439,464     $ (282,779 )

DoD

PRMRP Contract (2)

    56,900       9,099       47,801  

Incuron

Service contract

    49,357       295,958       (246,601 )
      $ 262,942     $ 744,521     $ (481,579 )

 

(1)

The Congressionally Directed Medical Research Programs (CDMRP) Joint Warfighter Medical Research Program (JWMRP) contract was awarded on September 1, 2015.

(2)

The CDMRP Peer Reviewed Medical Research Program (PRMRP) grant was awarded effective as of September 30, 2015.

 

Research and Development Expenses

 

R&D expenses decreased from $1.38 million for the nine months ended September 30, 2019 to $0.51 million for the nine months ended September 30, 2020, representing a decrease of $0.87 million, or 63.2%. Variances in individual development programs are noted in the table below. The net decrease is primarily attributable to a $0.56 million decrease in R&D spending for biodefense applications of entolimod, and a $0.29 decrease in R&D spending on Curaxins. The decrease in spending for biodefense applications of entolimod is primarily due to comparison against the first nine months of  2019 during which certain studies that were completed in 2019 were still ongoing, as well as a reduction in personnel costs. The remaining variances are not significant.

 

   

Nine Months Ended September 30,

         
   

2020

   

2019

   

Variance

 

Entolimod for Biodefense Applications

  $ 474,186     $ 1,033,006     $ (558,820 )

CBLB612

          5,886       (5,886 )

Entolimod for Oncology Indications

          7,745       (7,745 )
      474,186       1,046,637       (572,451 )

Curaxins

    12,686       306,086       (293,400 )

Panacela product candidates

    19,187       22,686       (3,499 )

Total research & development expenses

  $ 506,059     $ 1,375,409     $ (869,350 )

 

General and Administrative Expenses

 

G&A expenses increased from $1.5 million for the nine months ended September 30, 2019 to $1.6 million for the nine months ended September 30, 2020, representing an increase of $0.1 million, or 8.1%. This increase consisted primarily of a $0.36 million increase in professional fees associated with activities related to the potential Merger and the filing of the Company's Form S-3 Registration Statement, a $0.15 million increase in other costs for cash awards to certain members of the Company's board of directors, and $0.08 million increase in CBLI's property taxes compared to the quarter ended September 30, 2019 when we received a property tax refund, partially offset by a $0.36 million decrease in personnel and consulting costs, and a $0.05 reduction in facilities costs.

 

Other Income and Expenses

 

Other income decreased from $0.09 million of other income for the nine months ended September 30, 2019 to $0.07 million of other income for the nine months ended September 30, 2020, representing a decrease in other income of $0.02 million, or 14.6%. This decrease primarily related to a decrease in non-cash income related to the change in valuation of our warrant liability as a result of stock price changes.

 

 

Liquidity and Capital Resources

 

We have incurred net losses of approximately $168 million from our inception through September 30, 2020. Historically, we have not generated, and do not expect to generate in the immediate future, revenue from sales of product candidates. Since our founding in 2003, we have funded our operations through a variety of means:

 

•     From inception through September 30, 2020, we have raised $147.9 million of net equity capital, including amounts received in connection with our June 2020 registered direct offering and from the exercise of options and warrants. We have also received $7.3 million in net proceeds from the issuance of long-term debt instruments;

 

 •     DoD and BARDA have funded grants and contracts totaling $49 million for the development of entolimod for its biodefense indication;

 

 •     The government of the Russian Federation has funded a series of our contracts totaling $17.3 million, based on the exchange rates in effect on the date of funding. These contracts included a requirement for us to contribute matching funds, which we have satisfied;

 

 •     We have been awarded $4.0 million in grants and contracts not described above, all of which have been recognized at September 30, 2020;

 

 •     Incuron was formed to develop and commercialize the Curaxins product line, including its lead oncology drug candidate CBL0137. In 2015, we sold our ownership interest in Incuron for approximately $4.0 million and retain a 2% royalty interest in the CBL0137 technology;

 

 •    Panacela was formed to develop and commercialize preclinical compounds, which were transferred to Panacela through assignment and lease agreements. RUSNANO contributed $9.0 million to Panacela and CBLI contributed $3.0 million plus intellectual property to Panacela. As of the date of this filing, CBLI owns 67.57% of Panacela; and

 

 •    The Company formed its GPI joint venture with Everon. GPI, which is currently 50% owned by the Company and 50% owned by Everon, is undertaking a research and development program aimed at clinical testing of entolimod and GP532 (a variant of our entolimod drug candidate) and the development of medications with anti-aging and other indications associated with genome damage. GPI has been funded by an initial investment of $10.5 million from venture capital fund Norma Investments Limited.

 

As discussed above, the Company filed the Form S-3 Registration Statement on May 21, 2020, which was subsequently declared effective on May 29, 2020 (File No. 333-238578).  The Form S-3 Registration Statement allows the Company to raise an aggregate of $50,000,000 of common stock, preferred stock, warrants and/or units, subject to the limitations on the use thereof by certain smaller public companies, giving the Company greater flexibility to access capital markets quickly.

 

We have incurred cumulative net losses and expect to incur additional losses related to our R&D activities. We do not have commercial products and have limited capital resources. At September 30, 2020, we had cash, cash equivalents and short-term investments of $3.0 million, which represents a increase of $1.5 million, or 92.3%, since the end of our last fiscal year. This increase was caused by our capital raise and warrant exercises, offset by our net cash used in operations of $1.6 million during the nine months ended September 30, 2020. We expect our cash, cash equivalents, and short-term investments, to fund our projected operating requirements and allow us to fund our operating plan, in each case, into November 2021. However, until we are able to commercialize our product candidates at a level that covers our cash expenses, we will need to raise substantial additional capital, which we may be unable to raise in sufficient amounts, when needed and at acceptable terms. Our plans with regard to these matters may include seeking additional capital through debt or equity financing, the sale or license of drug candidates, the sale of certain of our tangible and/or intangible assets, the sale of interests in our subsidiaries or joint ventures, obtaining additional government research funding, or entering into other strategic transactions. There can be no assurance that we will be able to obtain future financing on acceptable terms, obtain additional government financing for our operations, or enter into other strategic transactions. In addition, the recent outbreak of the novel coronavirus known as COVID-19 has significantly disrupted world financial markets, negatively impacted U.S. market conditions and may reduce opportunities for us to seek out additional funding. If we are unable to raise adequate capital and/or achieve profitable operations, future operations might need to be scaled back or discontinued. The financial statements do not include any adjustments relating to the recoverability of the carrying amount of recorded assets and liabilities that might result from the outcome of these uncertainties.

 

Cash Flows

 

The following table provides information regarding our cash flows for the nine months ended September 30, 2020 and 2019:

 

    For the Nine Months Ended September 30,  
   

2020

   

2019

   

Variance

 

Cash flows used in operating activities

  $ (1,584,661 )   $ (2,298,935 )   $ 714,274  

Cash flows provided by investing activities

    42,387       158,544       (116,157 )

Cash flows provided by financing activities

    3,165,640             3,165,640  

Effect of exchange rate change on cash and equivalents

    (28,377 )     10,545       (38,922 )

Increase (decrease) in cash and cash equivalents

    1,594,989       (2,129,846 )     3,724,835  

Cash and cash equivalents at beginning of period

    1,126,124       3,617,234       (2,491,110 )

Cash and cash equivalents at end of period

  $ 2,721,113     $ 1,487,388     $ 1,233,725  

 

 

Operating Activities

 

Net cash used in operating activities decreased by $0.7 million to $1.6 million for the nine months ended September 30, 2020 from $2.3 million for the nine months ended September 30, 2019. Net cash used in operating activities for the period ending September 30, 2020 consisted of a reported net loss of $1.7 million, which was increased by $0.04 million of net non-cash operating activities, and offset by $0.2 million of changes in operating assets and liabilities. The $0.04 million of net non-cash operating activities was due primarily to $0.5 million of other income from an accrued liability extinguishment offset by a $0.4 million change in the valuation of our warrant liability. The $0.2 million of changes in operating assets and liabilities consisted primarily of a $0.2 million decrease in accounts receivable, offset by a $0.05 million decrease in accounts payable and accrued expenses.

 

Net cash used in operating activities for the nine months ended September 30, 2019 of $2.3 million consisted of a reported net loss of $2.0 million, which was increased by $0.09 million of net non-cash operating activities, and further increased by $0.2 million of changes in operating assets and liabilities. The $0.09 million of net non-cash operating activities was due primarily to changes in the valuation of our warrant liability and a gain on disposal of equipment. The $0.2 million of changes in operating assets and liabilities consisted primarily of a $0.3 million decrease in accounts payable and accrued expenses, offset by a $0.08 million decrease in accounts receivable and other current assets.

 

Investing Activities

 

Net cash provided by investing activities decreased by $0.1 million to $0.04 million for the nine months ended September 30, 2020 from $0.2 million for the nine months ended September 30, 2019. The net cash provided by investing activities for the nine months ended September 30, 2020 consisted of $0.04 million of net sales of short-term investments. Net cash provided by investing activities for the nine months ended September 30, 2019 consisted of $0.1 million of net sales of short-term investments and $0.04 million from the sale of equipment.

 

Financing Activities

 

Net cash provided by financing activities increased by $3.2 million for the nine months ended September 30, 2020 from $0.00 million for the nine months ended September 30, 2019 due to an issuance of common stock and a cash payment from the exercise of warrants during the nine months ended September 30, 2020.

 

Impact of Exchange Rate Fluctuations

 

Our reported financial results are affected by changes in foreign currency exchange rates between the U.S. dollar and the Russian ruble. Between January 1, 2020 and September 30, 2020, this rate fluctuated by 28.7%. For calendar year 2019, this rate fluctuated by 10.9%. Translation gains or losses result primarily from the impact of exchange rate fluctuations on the reported U.S. dollar equivalent of ruble-denominated cash and cash equivalents, and short-term investments. Variances in the exchange rate for these items have not been realized; as such the resulting gains or losses are recorded as other comprehensive income or loss in the equity section of the balance sheet.

 

Off-Balance Sheet Arrangements

 

We have not entered into any off-balance sheet arrangements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not required for smaller reporting company filers.

 

Item 4. Controls and Procedures

 

Effectiveness of Disclosure

 

Our management, with the participation of our Vice President of Finance (performing the functions of the Company's principal executive officer and principal financial officer), evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2020. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2020, our Vice President of Finance (performing the functions of the Company's principal executive officer and principal financial officer) concluded that, as of such date, our disclosure controls and procedures were not effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and (2) accumulated and communicated to our management, including our Vice President of Finance (performing the functions of the Company's principal executive officer and principal financial officer), as appropriate to allow timely decisions regarding required disclosure due to the material weakness described below.

 

Material Weaknesses in Internal Control Over Financial Reporting

 

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.  As previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019, we identified material weaknesses in our accounting for revenue transactions. Specifically, the Company does not have adequate controls in place to monitor revenue recognition with respect to specific elements of contracts. In addition, controls to prevent or detect material misstatements on a timely basis related to contract compliance and proper revenue recognition are not operating effectively.

 

Remediation of Previously Reported Material Weakness

 

Management has been implementing changes to strengthen our internal controls over the monitoring of revenue recognition and the prevention or detection of material misstatements on a timely basis related to contract compliance and proper revenue recognition.  These changes are intended to address the identified material weaknesses and to enhance our overall control environment and include the ongoing activities described below.

 

Management has performed a comprehensive review of all contracts to which the Company is party, including a review of underlying schedules, to ensure a more complete understanding of these agreements to ensure compliance and proper application of revenue recognition principles. Upon completion of this review, management  implemented certain system controls to ensure compliance and prevent the recognition of revenue in excess of specific elements of the contract agreements. In addition, new processes have been implemented related to periodic invoicing and revenue recognition analysis designed to detect any potential issues and correct as applicable.

 

We believe the measures described above will facilitate the remediation of the control deficiencies we have identified and strengthen our internal control over financial reporting. However, these material weaknesses will not be considered remediated until the applicable remediated controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. We are committed to continuing to improve our internal control processes and will continue to review, optimize and enhance our financial reporting controls and procedures. As we continue to evaluate and work to improve our internal control over financial reporting, we may take additional measures to address control deficiencies, or we may modify, or, in appropriate circumstances, not complete, certain of the remediation measures described above.

 

Changes in Internal Control over Financial Reporting

 

Other than the mitigating controls referenced above, there was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act) during the fiscal quarter ended September 30, 2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II – Other Information

 

Item 1. Legal Proceedings

 

In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially affect our results of operations, cash flows, or financial position. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management resources, and other factors.

 

While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of September 30, 2020, that, in the opinion of management, might have a material adverse effect on our financial position, results of operations or cash flows, or that are required to be disclosed under the rules of the SEC.

 

Item 1A. Risk Factors

 

Risks Related to the Merger with Cytocom

 

The exchange ratio will not be adjusted based on the market price of our common stock so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement was signed.

 

At the effective time of the Merger, outstanding shares of Cytocom capital stock will be converted into shares of the Company’s common stock. Applying the exchange ratio, the former Cytocom securityholders immediately before the Merger are expected to own approximately 61% of the aggregate number of shares of the combined company’s common stock following the Merger on a fully diluted basis and our securityholders immediately before the Merger are expected to own approximately 39% of the aggregate number of shares of the combined company’s common stock following the Merger on a fully diluted basis. Certain adjustments to the exchange ratio will be made in respect of net cash, as determined in the Merger Agreement. Any changes in the market price of our stock before the completion of the Merger will not affect the number of shares Cytocom stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger, the market price of our common stock increases from the market price on the date of the Merger Agreement, then Cytocom stockholders could receive merger consideration with substantially more value for their shares of Cytocom capital stock than the parties had negotiated when they established the exchange ratio. Similarly, if before the completion of the Merger the market price of our common stock declines from the market price on the date of the Merger Agreement, then Cytocom stockholders could receive merger consideration with substantially lower value. The Merger Agreement does not include a price-based termination right.

 

Failure to complete the Merger may result in either the Company paying a termination fee and/or expense reimbursement amounts to Cytocom or Cytocom paying expense reimbursement amounts to us, which could harm the common stock price of our common stock and future business and operations of each company.

 

If the Merger is not completed, the Company and Cytocom are subject to the following risks:

 

●              if the Merger Agreement is terminated under specified circumstances, we may be required to pay Cytocom a termination fee of $300,000 and/or Cytocom’s expenses up to $200,000;

●              the price of our common stock may decline and could fluctuate significantly; and

●              costs related to the Merger, such as financial advisor, legal and accounting fees, which must be paid even if the Merger is not completed.

 

If the Merger Agreement is terminated and the board of directors of the Company or Cytocom determines to seek another business combination, there can be no assurance that either the Company or Cytocom will be able to find a partner with whom a business combination would yield greater benefits than the benefits to be provided under the Merger Agreement.

 

If the conditions to the Merger are not satisfied or waived, the Merger may not occur.

 

Even if the Merger is approved by the stockholders of Cytocom, specified conditions must be satisfied or waived to complete the Merger. These conditions are set forth in the Merger Agreement. The Company and Cytocom cannot assure you

that all of the conditions to the consummation of the Merger will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or the closing may be delayed, and the Company and Cytocom each may lose some or all of

the intended benefits of the Merger.

 

The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes.

 

In general, neither we nor Cytocom is obligated to complete the Merger if there is a material adverse effect affecting the other party between October 16, 2020, the date of the Merger Agreement, and the closing of the Merger. However, certain types

of changes are excluded from the concept of a “material adverse effect.” Such exclusions include but are not limited to changes in general economic or political conditions, industry wide changes, changes resulting from the announcement of the Merger, natural disasters, pandemics (including the COVID-19 pandemic), other public health events and changes in GAAP. Therefore, if any of these events were to occur impacting the Company or Cytocom, the other party would still be obliged to consummate the closing of the Merger. If any such adverse changes occur and the Company and Cytocom consummate the closing of the Merger, the stock price of the combined company may suffer. This in turn may reduce the value of the Merger to the stockholders of the Company, Cytocom or both.

 

Our stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will

experience in connection with the Merger.

 

If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the Merger, our stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate

benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

 

If the Merger is not completed, the price of our common stock may decline significantly.

 

The market price of our common stock is subject to significant fluctuations. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of our common stock will likely be volatile based on whether stockholders and other investors believe that the Company can complete the Merger or otherwise raise additional capital to support our operations if the Merger is not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all. The volatility of the market price of our common stock is exacerbated by low trading volume. Additional factors that may cause the market price of our common stock to fluctuate include:

 

●              the initiation of, material developments in, or conclusion of litigation to enforce or defend its intellectual property rights or defend against claims involving the intellectual property rights of others;

●              the entry into, or termination of, key agreements, including commercial partner agreements;

●              announcements by commercial partners or competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

●              adverse publicity relating to the combined company’s product candidates, including with respect to other products and potential products in that market;

●              the introduction of technological innovations or new therapies that compete with its future products;

●              the loss of key employees;

●              future sales of its common stock;

●              general and industry-specific economic conditions that may affect its research and development expenditures;

●              the failure to meet industry analyst expectations; and

●              period-to-period fluctuations in financial results.

 

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of

our common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

 

Company and Cytocom securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the completion of the Merger as compared to their

current ownership and voting interests in the respective companies.

 

After the completion of the Merger, the current stockholders of the Company and Cytocom will own a smaller percentage of the combined company than their ownership of their respective companies prior to the Merger. Immediately after the Merger, Company securityholders as of immediately prior to the Merger are expected to own approximately 39% of the outstanding shares of the combined company on a fully diluted basis and former Cytocom securityholders are expected to own approximately 61% of the outstanding shares of the combined company on a fully diluted basis. The Chief Executive Officer of Cytocom will serve as the Chief Executive Officer of the combined company following the completion of the Merger.

 

During the pendency of the Merger, the Company and Cytocom may not be able to enter into a business combination with another party on more favorable terms because of restrictions in the Merger Agreement, which could adversely affect

their respective business prospects.

 

Covenants in the Merger Agreement impede the ability of the Company and Cytocom to make acquisitions during the pendency of the Merger, subject to specified exceptions. As a result, if the Merger is not completed, the parties may be at a

disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, proposing, seeking or knowingly encouraging, facilitating or supporting any inquiries, indications of interest, proposals or offers that constitute or may reasonably be expected to lead to certain transactions involving a third party, including a merger, sale of assets or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them.

 

Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement.

 

The terms of the Merger Agreement prohibit each of the Company and Cytocom from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances. In addition, if the Company

terminates the Merger Agreement under specified circumstances, the Company may be required to pay Cytocom a termination fee of $300,000 and in some circumstances one party may be required to pay the other party such party’s expenses up to

$200,000. This termination fee may discourage third parties from submitting competing proposals to the Company or its stockholders, and may cause our board of directors to be less inclined to recommend a competing proposal.

 

Because the lack of a public market for Cytocom’s capital stock makes it difficult to evaluate the fair market value of Cytocom’s capital stock, we may pay more than the fair market value of Cytocom’s capital stock and/or the stockholders of

Cytocom may receive consideration in the Merger that is less than the fair market value of Cytocom’s capital stock.

 

The outstanding capital stock of Cytocom is privately held and is not traded in any public market. The lack of a public market makes it difficult to determine the fair market value of Cytocom’s capital stock. Because the percentage of our equity to

be issued to Cytocom stockholders was determined based on negotiations between the parties, it is possible that the value of our common stock to be received by Cytocom stockholders will be less than the fair market value of Cytocom’s capital stock, or the Company may pay more than the aggregate fair market value for Cytocom’s capital stock.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

As previously disclosed, on July 15, 2020, the Company issued 82,399 shares of its common stock upon the exercise of previously outstanding warrants to purchase an aggregate of 94,404 shares of common stock.  In connection with such exercise, the Company amended the warrant to lower the exercise price thereof pursuant to that certain Settlement and General Release Agreement (the "Release Agreement") between the Company and the holder of such warrant. The parties to the Release Agreement also each released one another from any liabilities arising out of the warrants. The exercise was made on a “cashless” basis pursuant to the terms of the warrants and the Release Agreement, and accordingly, the Company did not receive any proceeds upon such exercise. The exercise of the warrants did not involve any underwriters, underwriting discounts or commissions, or any public offering, and the Company believes that such transactions were exempt from the registration requirements of the Securities Act in reliance on Section 4(a)(2) of the Securities Act as transactions by an issuer not involving a public offering.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

None.

 

Item 5. Other Information

 

None.

 

 

Item 6. Exhibits

 

 

(a)

The following exhibits are included as part of this report:

 

Exhibit

Number

 

Description of Document

 

 

 

    2.1*   Merger Agreement, dated as of October 16, 2020, among Cleveland Biolabs, Inc., High Street Acquisition Corp. and Cytocom, Inc. (Incorporated by reference to Exhibit 2.1 to Form 8-K filed October 19, 2020).
     

3.1

 

Restated Certificate of Incorporation filed with the Secretary of State of Delaware on March 18, 2010 (Incorporated by reference to Exhibit 3.1 to Form 10-K for the year ended December 31, 2009, filed on March 22, 2010).

 

 

 

3.2

 

Certificate of Amendment to the Restated Certificate of Incorporation, filed with the Secretary of State of Delaware on June 20, 2013 (Incorporated by reference to Exhibit 3.1 to Form 10-Q for the period ended June 30, 2013, filed on August 9, 2013).

 

 

 

3.3

 

Certificate of Amendment of Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Form 8-K filed on January 27, 2015).

 

 

 

3.4

 

Certificate of Amendment to Restated Certificate of Incorporation, filed with the Secretary of State of Delaware on April 20, 2016 (incorporated by reference to Exhibit 3.4 to Form 10-Q for the period ended March 31, 2016, filed May 16, 2016.

 

 

 

3.5

 

Certificate of Amendment to Restated Certificate of Incorporation, filed with the Secretary of State of Delaware on April 21, 2017 (incorporated by reference to Exhibit 3.5 to Form 10-Q for the period ended March 31, 2017, filed May 15, 2017.

 

 

 

3.6

 

Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Form 8-K filed on February 9, 2015).

 

 

 

3.7

 

Certificate of Amendment of Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 to Form 8-K filed on February 9, 2015).

 

 

 

3.8

 

Second Amended and Restated By-Laws (Incorporated by reference to Exhibit 3.1 to Form 8-K filed on December 5, 2007).

 

 

 

3.9

 

Amendment to Second Amended and Restated By-Laws of Cleveland BioLabs, Inc. (Incorporated by reference to Exhibit 3.1 to Form 8-K filed on May 18, 2015).

     
   10.1   Consulting Agreement, dated as of August 10, 2020, between Cleveland BioLabs, Inc. and Sound Clinical Solutions, SP (Incorporated by reference to Exhibit 10.1 to Form 8-K filed on August 14, 2020).
     
   10.2**   Award/Contract W81XWH-15-0101 modification dated September 29, 2020 issued by USA Med Research ACQ Activity
     
   10.3**   Award/Contract W81XWH-15-0570 modification dated September 29, 2020 issued by USA Med Research ACQ Activity
     
   10.4   Consulting Agreement, dated as of October 11, 2020, between Cleveland BioLabs, Inc. and Andrei Gudkov, Ph.D., D. Sci. (Incorporated by reference to Exhibit 10.1 to Form 8-K filed on October 13, 2020).
     
   10.5   Form of Voting and Support Agreement (Incorporated by reference to Exhibit 10.1 to Form 8-K filed on October 19, 2020).

 

 

 

31.1**

 

Rule 13a-14(a)/15d-14(a) Certification of Christopher Zosh.

 

 

 

32.1**

 

Certification pursuant to 18 U.S.C. Section 1350.

 

 

 

101.1

 

The following information from CBLI’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Condensed Balance Sheets as of September 30, 2020 and December 31, 2019; (ii) Consolidated Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019; (iii) Consolidated Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2020 and 2019; (iv) Consolidated Condensed Statement of Stockholders’ Equity for the Nine Months Ended September 30, 2020 and 2019; (v) Consolidated Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019; and (vi) Notes to Consolidated Condensed Financial Statements.

 

 

 

    *   Pursuant to Item 601(a)(5) of Regulation S-K, certain schedules have been omitted. A copy of any omitted schedule will be furnished supplementally to the Securities and Exchange Commission upon request.
     

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