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 June 30, 20212022

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

 


 

CYTOCOM,STATERA BIOPHARMA, 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.)

 

 

2537 Research Boulevard,4333 Corbett Drive, Suite 201,1082, Fort Collins, Colorado

8052680525

(Address of principal executive offices)

(Zip Code)

 

(888) 613-8802

(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

 

CBLISTAB

 

NASDAQ Capital Market

 

As of August 9, 2021,October 24, 2022, there were 15,478,94553,295,653 shares outstanding of the registrant’s common stock, par value $0.005 per share.

 

 

 

 

TABLE OF CONTENTS

 

 

PAGE

PART I – FINANCIAL INFORMATION

 

ITEM 1.

Condensed Consolidated Condensed Financial Statements

 

 

Condensed Consolidated Condensed Balance Sheets

3

 

Condensed Consolidated Condensed Statements of Operations

4

 

Condensed Consolidated Condensed Statements of Comprehensive Loss

45

 

Condensed Consolidated Condensed Statement of Stockholders’ EquityDeficit

6

 

Condensed Consolidated Condensed Statements of Cash Flows

7

 

Notes to Condensed Consolidated Condensed Financial Statements

8

ITEM 2.

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

1519

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

2028

ITEM 4.

Controls and Procedures

2028

 

 

PART II – OTHER INFORMATION

 

ITEM 1.

Legal Proceedings

2129

ITEM 1A.

Risk Factors

2130

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

2130

ITEM 3.

Defaults Upon Senior Securities

2130

ITEM 4.

Mine Safety Disclosures

2130

ITEM 5.

Other Information

2130

ITEM 6.

Exhibits

2231

Signatures

 

2332

 

 

 

 

CYTOCOM,STATERA BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED CONDENSED BALANCE SHEETS

 

 

June 30, 2021

  

December 31, 2020

  

June 30, 2022

  

December 31, 2021

 
 

(Unaudited)

    UNAUDITED   

ASSETS

            

Current assets:

  

Cash and cash equivalents

 $13,776,955  $1,946,418  $553,754  $1,844,732 

Short-term investments

 0  324,870  163,105  134,603 

Accounts receivable

 0  11,512  218,334  216,183 

Prepaid expenses

 247,003  981,895 

Contract asset

 196,422 132,572 

Other current assets

  46,825   31,506   289,991   837,358 

Total current assets

 13,823,780  2,314,306  1,668,609  4,147,343 

Equipment, net

  4,954   3,715 

Non-current assets:

 

Operating lease right-of-use assets

 1,060,579 964,331 

Restricted cash

  5,000,000 

Goodwill

 9,267,007 9,267,007 

Intangible assets, net

 1,353,562 1,580,980 

Property and equipment, net

  184,456   201,901 

Total non-current assets

 11,865,604 17,014,219 

Assets of discontinued operation

  8,123  8,123 

Total assets

 $13,828,734  $2,318,021  $13,542,336  $21,169,685 

LIABILITIES AND STOCKHOLDERS’ EQUITY

      

LIABILITIES AND STOCKHOLDERS’ DEFICIT

      

Current liabilities:

  

Accounts payable

 $60,503  $167,773 

Accrued expenses

  240,120   136,838 

Accounts payable and accrued expenses

 $11,677,761 $5,715,956 

Current portion of operating lease liabilities

 364,830 254,998 

Deferred revenue

 550,215 373,468 

Stock issuances due

 681,028 325,828 

Notes payable

  6,396,486   4,575,000 

Total current liabilities

 19,670,320 11,245,250 

Operating lease liabilities, net of current portion

 793,289 806,140 

Long-term debt

  -  10,625,000 

Total long-term liabilities

 793,289 11,431,140 

Liabilities of discontinued operation

  63  63 

Total liabilities

  300,623   304,611   20,463,672   22,676,453 

Stockholders’ equity:

 

Preferred stock, $.005 par value; 1,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 0 shares issued and outstanding as of June 30, 2021 and December 31, 2020

 0  0 

Common stock, $.005 par value; 25,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 15,468,945 and 13,376,062 shares issued and outstanding as of June 30, 2021 and December 31, 2020

 77,340  66,876 

Stockholders’ equity (deficit):

 

Preferred stock, $.005 par value; 1,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021

    

Common stock, $.005 par value; 150,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 49,641,362 shares issued and outstanding as of June 30, 2022 and 35,484,106 shares issued and outstanding as of December 31, 2021

 248,208  177,421 

Additional paid-in capital

 179,475,602  166,762,778  133,464,596  127,743,333 

Accumulated other comprehensive loss

 (681,820) (685,680)

Accumulated other comprehensive income (loss)

 25,169  (6,651)

Accumulated deficit

  (170,301,633)  (169,104,029)  (140,726,745)  (129,482,141)

Total Cytocom, Inc. stockholders’ equity (deficit)

 8,569,489  (2,960,055)

Total Statera Biopharma, Inc. stockholders’ deficit

 (6,988,772) (1,568,038)

Noncontrolling interest in stockholders’ equity

  4,958,622   4,973,465   67,436   61,270 

Total stockholders’ equity

  13,528,111   2,013,410 

Total liabilities and stockholders’ equity

 $13,828,734  $2,318,021 

Total stockholders’ deficit

  (6,921,336)  (1,506,768)

Total liabilities and stockholders’ deficit

 $13,542,336  $21,169,685 

 

See Notes to Condensed Consolidated Financial Statements

 

3

 

 

CYTOCOM,STATERA BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

 

For the Three Months Ended

 

For the Six Months Ended

  

For the Three Months Ended

 

For the Six Months Ended

 
 

June 30,

  

June 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 

Revenues:

   

Grants and contracts

$0  $63,255  $0  $219,297  $768,827  $-  $1,766,666  $- 

Cost of goods sold

  200,936   -   554,607   - 

Gross profit

 567,891  -  1,212,059  - 

Operating expenses:

   

Research and development

 51,515  170,007  169,773  388,215  973,604  1,815,616  4,215,932  2,839,960 

Sales and marketing expense

 19,364  -  56,400  2,795 

General and administrative

 617,722   485,439   1,050,726   867,605   2,428,434   4,507,874   6,406,783   8,674,763 

Total operating expenses

 669,237   655,446   1,220,499   1,255,820   3,421,402   6,323,490   10,679,115   11,517,518 

Loss from operations

 (669,237) (592,191) (1,220,499) (1,036,523) (2,853,511) (6,323,490) (9,467,056) (11,517,518)

Other income (expense):

  

Interest and other income (expense)

 2,295  508,811  6,210  511,711 

Foreign exchange gain (loss)

 (152) (780) (10) (387)

Change in value of warrant liability

 0   (292,385)  0   (453,074)

Total other income (expense)

 2,143   215,646   6,200   58,250 

Other expense:

 

Interest and other expense

  (637,036)  (281,655)  (1,783,424)  (374,273)

Total other expense

 (637,036) (281,655) (1,783,424) (374,273)

Income from discontinued operations, net of income taxes

  -   -   -   - 

Net loss

 (667,094) (376,545) (1,214,299) (978,273) (3,490,547) (6,605,145) (11,250,480) (11,891,791)

Net loss attributable to noncontrolling interests

 7,588   6,707   16,695   19,903   3,153   -   5,876   - 

Net loss attributable to Cytocom, Inc.

$(659,506) $(369,838) $(1,197,604) $(958,370)

Net loss attributable to Statera Biopharma, Inc.

 $(3,487,394) $(6,605,145) $(11,244,604) $(11,891,791)

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

$(0.04) $(0.03) $(0.08) $(0.08) $(0.07) $(0.27) $(0.26) $(0.48)

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

 15,468,945   11,947,364   14,847,980   11,651,761  49,671,113  24,723,308  43,694,850  24,527,333 

 

See Notes to Condensed Consolidated Financial Statements

 

4

 

CYTOCOM,STATERA BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

 

For the Three Months Ended

 

For the Six Months Ended

  

For the Three Months Ended

 

For the Six Months Ended

 
 

June 30,

  

June 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 

Net loss including noncontrolling interests

$(667,094) $(376,545) $(1,214,299) $(978,273) $(3,490,547) $(6,605,145) $(11,250,480) $(11,891,791)

Other comprehensive income (loss):

  

Other comprehensive loss:

 

Foreign currency translation adjustment

 13,384   44,395   5,712   (63,705)  69,949      43,862    

Comprehensive loss including noncontrolling interests

 (653,710) (332,150) (1,208,587) (1,041,978) (3,420,598) (6,605,145) (11,206,618) (11,891,791)

Comprehensive loss attributable to noncontrolling interests

 3,248   (7,305)  14,843   39,514   (17,375)     (6,166)   

Comprehensive loss attributable to Cytocom, Inc.

$(650,462) $(339,455) $(1,193,744) $(1,002,464)

Comprehensive loss attributable to Statera Biopharma, Inc.

 $(3,437,973) $(6,605,145) $(11,212,784) $(11,891,791)

 

See Notes to Condensed Consolidated Financial Statements

 

5

 

 

CYTOCOM,STATERA BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED CONDENSED STATEMENT OF STOCKHOLDERS’ EQUITYDEFICIT

(UNAUDITED)

 

                 

Additional

        

Additional

 
 

Common Stock

  

Treasury Stock

  

Paid-In

  

Common Stock

  

Paid-In

 
 

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Shares

  

Amount

  

Capital

 

Balance at December 31, 2019

 11,298,239  $56,487  0  $0  $163,161,523 

Exercise of warrants

 105,000  53  0  0  504,853 

Net loss

   0    0  0 

Foreign currency translation

     0      0   0 

Balance at March 31, 2020

  11,403,239  $56,540   0  $0  $163,666,376 
Issuance of common stock, net of offering costs  1,515,878  7,579  0  0  2,775,846 
Exercise of warrants  8,871  44  0  0  61,219 

Net loss

   0    0  0 

Foreign currency translation

     0      0   0 

Balance at June 30, 2020

  12,927,988  $64,163   0  $0  $166,503,441 
 

Balance at December 31, 2020

 13,376,062  $66,876  0  $0  $166,762,778  13,376,062  $66,880  $166,762,778 

Exercise of warrants

 92,883  464  0  0  (464) 92,883  466  (466)

Issuance of common stock, net of offering costs

 2,000,000  10,000  12,713,074 

Net loss

   0    0  0          

Foreign currency translation

   0    0  0 

Issuance of common stock, net of offering costs

  2,000,000   10,000   0   0   12,713,074 

Balance at March 31, 2021

  15,468,945  $77,340   0  $0  $179,475,388  15,468,945 $77,346 $179,475,386 

Issuance of common stock, net of offering costs

 0  0  0  0  214      214 

Net loss

   0    0  0        

Balance at June 30, 2021

  15,468,945  $77,346  $179,475,600 
 

Balance at December 31, 2021

 35,484,106  $177,421  $127,743,333 

Issuance of common stock, net of offering costs

 14,555,555 72,778 6,383,727 

Common stock repurchase

 (160,130) (801) (50,507)

Shares issued for stock based compensation

 100,000  500  (500)

Stock based compensation

     452,537 

Foreign currency translation

     0      0   0       

Balance at June 30, 2021

  15,468,945  $77,340   0  $0  $179,475,602 

Net loss

         

Balance at March 31, 2022

 49,979,531 $249,898 $134,528,590 

Common stock repurchase

 (338,169) $(1,690) $1,690 

Stock based compensation

   (1,065,684)

Foreign currency translation

    

Net loss

       

Balance at June 30, 2022

  49,641,362  $248,208  $133,464,596 

 

 

Accumulated Other Comprehensive Income (Loss)

  

Accumulated Deficit

  

Noncontrolling Interests

  

Total

 

Balance at December 31, 2019

 $(568,030) $(166,705,572) $5,039,878  $984,286 

Exercise of warrants

 0  0  0  504,906 

Net loss

 0  (588,532) (13,196) (601,728)

Foreign currency translation

  (74,477)  0   (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  0  0  0  2,783,425 
Exercise of warrants 0  0  0  61,263 

Net loss

 0  (369,838) (6,707) (376,545)

Foreign currency translation

  30,383   0   14,012   44,395 

Balance at June 30, 2020

 $(612,124) $(167,663,942) $5,000,364 $3,291,902 
          

Accumulated Other Comprehensive Income (Loss)

  

Accumulated Deficit

  

Noncontrolling Interests

  

Total

 

Balance at December 31, 2020

 $(685,680) $(169,104,029) $4,973,465  $2,013,410  $(685,680) $(27,631,321) $4,973,465  $143,486,118 

Exercise of warrants

 0  0  0  0         

Issuance of common stock, net of offering costs

       12,723,074 

Net loss

 0 (538,098) (9,107) (547,205)     (5,286,646)     (5,286,646)

Foreign currency translation

 (5,184) 0 (2,488) (7,672)

Issuance of common stock, net of offering costs

  0   0   0   12,723,074 

Balance at March 31, 2021

 $(690,864) $(169,642,127) $4,961,870  $14,181,607  $(685,680) $(32,917,967) $4,973,465 $150,922,546 

Issuance of common stock, net of offering costs

 0 0 0 214     214 

Net loss

 0 (659,506) (7,588) (667,094)    (6,605,145)    (6,605,145)

Balance at June 30, 2021

 $(685,680) $(39,523,112) $4,973,465  $144,317,615 
 

Balance at December 31, 2021

 $(6,651) $(129,482,141) $61,270  $(1,506,768)

Issuance of common stock, net of offering costs

       6,456,505 

Common stock repurchase

       (51,308)

Shares issued for stock based compensation

        

Stock based compensation

       452,537 

Foreign currency translation

  9,044  0 ��4,340  13,384  (17,601)   (8,486) (26,087)

Balance at June 30, 2021

 $(681,820) $(170,301,633) $4,958,622 $13,528,111 

Net loss

     (7,757,210)  (2,723)  (7,759,933)

Balance at March 31, 2022

 $(24,252) $(137,239,351) $50,061 $(2,435,054)

Common stock repurchase

     

Stock based compensation

    (1,065,684)

Foreign currency translation

 49,421  20,528 69,949 

Net loss

    (3,487,394)  (3,153)  (3,490,547)

Balance at June 30, 2022

 $25,169  $(140,726,745) $67,436  $(6,921,336)

 

See Notes to Condensed Consolidated Financial Statements

 

6

 

 

CYTOCOM,STATERA BIOPHARMA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

  For the Six Months Ended June 30, 
  

2021

  

2020

 

Cash flows from operating activities:

        

Net loss

 $(1,214,299) $(978,273)

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

        

Depreciation and amortization

  3,077   5,928 

Accrued liability extinguishment

  0   (501,892)

Change in value of warrant liability

  0   453,074 

Changes in operating assets and liabilities:

        

Accounts receivable and other current assets

  (3,772)  120,157 

Other long-term assets

  0   18,667 

Accounts payable and accrued expenses

  (8,553)  (19,665)

Net cash used in operating activities

  (1,223,547)  (902,004)

Cash flows from investing activities:

        

Purchase of short-term investments

  0   (360,379)

Sale of short-term investments

  323,111   403,624 

Net cash provided by investing activities

  323,111   43,245 

Cash flows from financing activities:

        

Issuance of common stock, net of offering costs

  12,723,288   2,783,425 

Exercise of warrants

  0   382,215 

Net cash provided by financing activities

  12,723,288   3,165,640 

Effect of exchange rate change on cash and equivalents

  7,685   (23,695)

Increase in cash and cash equivalents

  11,830,537   2,283,186 

Cash and cash equivalents at beginning of period

  1,946,418   1,126,124 

Cash and cash equivalents at end of period

 $13,776,955  $3,409,310 
  For the Six Months Ended June 30, 
  

2022

  

2021

 

Cash flows from operating activities:

        

Net loss

 $(11,250,480) $(11,891,791)

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

        

Depreciation expense

  23,899   2,791 

Amortization expense

  227,418    

Noncash equity expense

     235,538 

Stock based compensation

  (613,147)  3,779,199 

Noncash lease expense

  733   711 

Services obtained for common shares

  355,200   299,000 

Changes in operating assets and liabilities:

        

Other current assets

  547,369   (196,542)

Accounts receivable

  (2,151)   

Short term investments

  (28,502)   

Prepaid expenses

  734,892    

Contract asset

  (63,850)   

Accounts payable and accrued expenses

  5,961,805   2,157,297 

Deferred revenue

  176,747    

Net cash used in operating activities

  (3,930,067)  (5,613,797)

Cash flows from investing activities:

        

Purchase of property and equipment

  (6,454)  (22,790)

Acquired net assets

     537,751 

Net cash provided by (used in) investing activities

  (6,454)  514,961 

Cash flows from financing activities:

        

Proceeds from issuance of common

  6,405,195    

Proceeds from issuance of preferred shares

     5,685,113 

Proceeds from issuance of long-term debt

  500,000   14,870,740 

Payment of debt issuance costs

     (329,260)

Repayments on notes payable

  (9,303,514)   

Net cash provided by (used in) financing activities

  (2,398,319)  20,226,593 

Effect of exchange rate change on cash and equivalents

  43,862    

Increase (decrease) in cash and cash equivalents

  (6,290,978)  15,127,757 

Cash, cash equivalents, and restricted cash, beginning of year

  6,844,732   593,869 

Cash, cash equivalents, and restricted cash end of year

 $553,754  $15,721,626 
         

SUPPLEMENTAL CASH FLOW INFORMATION:

        

Cash paid for interest

 $539,842  $279,329 
         

NON-CASH INVESTING AND FINANCING ACTIVITIES:

        

Right of use asset exchanged for lease liability

 $1,099  $229,868 

Debt principal converted to equity

     1,804,500 

Debt interest converted to equity

     490,470 

Non-cash consideration of acquisition of ImQuest through the issuance of preferred stock

     15,332,495 

Non-cash equity fees

     365,408 

 

See Notes to Condensed Consolidated Financial Statements

 

7

 

CYTOCOM,STATERA BIOPHARMA, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

 

 

1. Description of Business

 

On July 27, 2021, Cytocom,Statera Biopharma, Inc., formerly known as Cleveland BioLabs, Inc. (the "Company" or "CytocomStatera"), High Street Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of the Company ("Merger Sub"), and Cytocom Inc., a Delaware corporation ("Old Cytocom"), completed their previously announced merger transaction. The merger transaction was completed pursuant to an Agreement and Plan of Merger (the “Merger Agreement”"Merger Agreement"), dated as of October 16, 2020, pursuant to which Merger Sub merged with and into Old Cytocom, with Old Cytocom continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (the "Merger"). In connection with the closing of the Merger, Old Cytocom was renamed “Cytocom Subsidiary Inc.” and the Company was renamed “Cytocom, Inc.” 

Prior to the closing of the Merger and at all times during the period covered by this report, Effective September 1, 2021, the Company was an innovative biopharmaceutical company developing novel approacheschanged its corporate name to activate"Statera Biopharma, Inc.", and 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, as of immediately prior toCompany’s common stock began trading on The Nasdaq Capital Market with the closing of the Merger, is entolimod, an immune-stimulatory agent, which we are developing as a medical radiation countermeasure and other indications in radiation oncology.symbol “STAB.”

 

The Company was incorporated in Delaware in June 2003 and is headquartered in Fort Collins, Colorado. ThePrior to the Merger, the Company has conducted 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 was dissolved in November 2020; 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, or the context otherwise requires, the terms "CytocomStatera Biopharma," the "Company," "we," "us," and "our" refer to Cytocom,Statera Biopharma, Inc., known as "ClevelandCleveland BioLabs, Inc." prior to the Merger, BioLab 612, Panacela and priorPanacela.

On June 24, 2021, Old Cytocom completed the acquisition of ImQuest Life Sciences, Inc. and its subsidiaries ("ImQuest") in accordance with the Agreement and Plan of Merger by and among Old Cytocom and ImQuest dated as of July 17, 2020, and gained control of ImQuest. The purchase consideration due under this merger to the closingex-shareholders of ImQuest consisted of 12,000,000 shares of preferred stock of Old Cytocom which were subsequently converted into 3,282,089 shares of common stock of Statera Biopharma.  ImQuest is now a wholly-owned subsidiary of the Merger, Merger Sub, and after the Merger, Cytocom Subsidiary Inc.Company.

 

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.accounting. The Company has not recorded its 50% share of the losses of GPI through June 30, 20212022 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.

Statera Biopharma is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has one of the largest platforms of toll-like receptor ("TLR") agonists in the biopharmaceutical industry with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and GP532. TLRs are a class of protein that play a key role in the innate immune system.

Statera Biopharma is developing therapies designed to directly elicit within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, and infectious diseases and cancers. In the next 12 months, the Company expects to initiate clinical trials covering Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205).

Going Concern

At June 30, 2022, the Company had cash and cash equivalents of $0.6 million in the aggregate. The Company has incurred recurring losses from operations since inception, accumulating a deficit of approximately $140.7 million as of June 30, 2022. For the six months ended June 30, 2022 and 2021, the Company incurred net losses of approximately $11.25 million and $11.9 million, respectively. The Company may incur additional losses and negative operating cash flows in the future. Failure to generate sufficient revenues, reduce spending or raise additional capital could adversely affect its ability to achieve its intended business objectives. These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these condensed financial statements.

Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital as of June 30, 2022 was not sufficient to meet the cash requirements to fund planned operations for a period of one year after issuance of condensed financial statements without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

8

 

2. Summary of Significant Accounting Policies

 

Basis of Presentation and Consolidation

 

The accompanyingThese unaudited interim condensed consolidated condensed financial statements reflect the historical results of Old Cytocom prior to the completion of the Merger, and do notinclude the accountshistorical results of the Company BioLab 612, Panacelaprior to the completion of the Merger. All share and Merger Sub. All significant intercompany balances and transactionsper share disclosures have been eliminatedadjusted to reflect the exchange of shares in consolidation.the Merger. Under U.S. generally accepted accounting principles ("GAAP"), the Merger is treated as a “reverse merger” under the purchase method of accounting. For accounting purposes, Old Cytocom is considered to have acquired Cleveland BioLabs, Inc. See Note 3, Merger with Old Cytocom, for further details on the Merger and the U.S. GAAP accounting treatment.

 

The consolidatedaccompanying unaudited condensed balance sheet as of December 31, 2020, 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 of America pursuant to the requirements of the Securities and Exchange Commission ("GAAPSEC") for interim consolidated financial information and in accordance with the instructions to Form 10-Q and ArticleRule 8-03 of Regulation S-XX. Accordingly, they do not include all of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally includedfootnotes required by accounting principles generally accepted in the United States of America for complete financial statements. The unaudited interim condensed consolidated financial statements prepared in accordance with GAAP have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for the fair presentation of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period. These 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, 20202021, as filed with the SEC (the "2020Form 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 June 30, 2021, along with its results of operations for the three and six month periods ended June 30, 2021 and 2020 and cash flows for the six-month periods ended June 30, 2021 and 2020. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

At June 30, 2021, we had cash and cash equivalents of $13.8 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.SEC.

 

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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.

 

Significant Customers and Accounts Receivable

The following table presents our revenue by customer, on a proportional basis, for the three and six months ended June 30, 2021 and 2020.

  

Three Months Ended

      

Six Months Ended

     
  

June 30,

      

June 30,

     

Customer

 

2021

  

2020

  

Variance

  

2021

  

2020

  

Variance

 

Department of Defense

  0.0%  86.8%  (86.8)%  0.0%  77.5%  (77.5)%

Incuron

  0.0%  13.2%  (13.2)%  0.0%  22.5%  (22.5)%

Total

  0.0%  100.0%  (100.0)%  0.0%  100.0%  (100.0)%

Other Comprehensive Income (Loss)

 

The Company applies the Accounting Standards Codification ("CodificationASC") 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 six months ended June 30, 20212022.

 

 

Gains and losses on foreign exchange translations

  

Gains and losses on foreign exchange translations

 

Beginning balance

 $(685,680) $(6,651)

Other comprehensive income (loss) before reclassifications

 3,860  31,820 

Amounts reclassified from accumulated other comprehensive loss

  0    

Ending balance

 $(681,820) $25,169 

 

9


 

Accounting for Stock-Based Compensation

 

The Cleveland Biolabs, Inc. Equity Incentive Plan, adopted in 2018 (the "Plan"), authorizes the Company to grant (i) options to purchase common stock, (ii) stock appreciation rights, (iii) awards of restricted or unrestricted stock, (iv) restricted stock units, and (iii) stock appreciation rights,(v) performance awards, 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 June 30, 20212022, an aggregate of 597,5573,597,557 shares of common stock were authorized for issuance under the Plan, of which a total of 526,6602,186,964 shares of common stock remained available for future awards. This includes the Company’s approved amendments to the Plan that increased the number of shares of common stock authorized to be issued by 3,000,000 shares, removed the limit on the maximum number of shares covered by an award that may be issued in any calendar year to any single recipient, and renamed the Plan to the "Statera Biopharma Equity Incentive Plan." In addition, a total of 64,89718,378 shares of common stock reserved for issuance are 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.Plan. 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 boardBoard of directorsDirectors 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 June 30, 20212022, there are 825,0001,025,000 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. NaNA total of 1,216,149 options were granted during the six months ended June 30, 20212022 andno options were granted for the six months ended June 30, 20202021.  In addition, 60,066 restricted stock units were granted for the six months ended June 30, 2022.

 

Income Taxes

 

NaNNo income tax expense was recorded for the three and six months ended June 30, 20212022 and 20202021 as the Company does not expect to have taxable income for 20212022 and did not have taxable income in 20202021. A full valuation allowance has been recorded against the Company’s net deferred tax asset.

 

At June 30, 20212022, the Company had U.S. federal net operating loss carryforwards of approximately $148.0$197.8 million, of which $139.7$140.6 million begins to expire if not utilized by 2023, and $8.3$57.2 million which has no expiration, and approximately $4.3 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 $93.8$112.2 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.

 

10

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 June 30, 20212022.

 

 

As of June 30,

  

As of 

 

Common Equivalent Securities

 

2021

 

2020

  

June 30, 2022

  

December 31, 2021

 

Warrants

 299,519  1,068,494  33,208,944  2,431,168 

Restricted Stock Units

 621,668  1,567,368 

Options

  64,897   89,913   1,234,527   45,468 

Total

  364,416   1,158,407��  35,065,139   4,044,004 

 

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. 

 

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3. Fair Value of Financial InstrumentsRevenue Recognition

 

The Company has measured and recorded short-term investments and certain warrants as liabilities at fair valueimplemented the five steps to recognize revenue from contracts with customers under ASC 606, Revenue from Contracts with Customers ("ASC 606"), which are:

• Step 1: Identify the contract(s) with a customer

      • Step 2: Identify the performance obligations in the accompanying financial statements. Fair valuecontract

      • Step 3: Determine the transaction price

      • Step 4: Allocate the transaction price to the performance obligations in the contract

      • Step 5: Recognize revenue when (or as) a performance obligation is definedsatisfied

In the six months ended June 30, 2022, the Company generated revenue from its Clinical Research Organization services ("CRO services") provided by ImQuest.

The Company provides preclinical CRO services to evaluate the potential of new and novel pharmaceutical products for the treatment and prevention of viruses, bacteria, cancer and inflammatory diseases. These preclinical research services include compound screening, efficacy analysis, drug target validations, mechanism of action research, and toxicity studies in multiple pharmaceutical areas.

The Company has concluded that each provision of its CRO services is a distinct and single performance obligation as the exchangecustomer benefits from the services once they have the opportunity to question the findings and receive the final report which summarizes the research results. Management determined each promised good and service in the contract related to its CRO services should be bundled into a single performance obligation because even though the contract explicitly states individual promises such as consultation services combined with a range of tests that are carried out in order to conduct the preclinical research, the culmination of the individual promises is the CRO services which is a single performance obligation.

The amount the Company earns for its CRO services is typically a fixed fee per project. Revenue from the project is recognized at the point in time when the final report is delivered to the customer and thus the performance obligation is satisfied. At the time the final report is delivered: (a) the Company has the right to payment for the report, (b) the customer has legal title to the report, (c) physical transfer of the report has occurred and the customer has taken possession of the report, (d) the customer now has benefit and the risk of ownership of the report, and (e) the customer has accepted the report. Revenue collected in advance of delivery of the final report is classified as a contract liability in the consolidated balance sheet

At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that would be received for an asset or paidis allocated to transfer a liability, an exit price, in the principal or most advantageous market forrespective performance obligation when (or as) 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:performance obligation is satisfied.

 

11

Cash and Cash Equivalents

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.

 

Short-termThe Company considers all highly liquid investments primarilywith original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include certificates of deposit at commercial banking institutions,bank demand deposits, marketable securities with maturities of three months or moreless at timepurchase, and money market funds that invest primarily in certificates of purchase. Certificatesdeposits, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. As of depositJune 30, 2022 and December 31, 2021, there were no cash equivalents.  Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash deposits. Accounts at each institution are carried at amortized cost,insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. At June 30, 2022 and December 31, 2021, the Company had $0 and $331,385 in excess of the FDIC insured limit, respectively.

Restricted Cash

The Company considers all cash held for specific reasons and not available for immediate, normal business use as restricted cash. As of June 30, 2022 and December 31, 2021 the Company had $0 and $5,000,000, respectively, classified as restricted cash. In February 2022, the restricted cash was used to repay a portion of the debt to Avenue.

Accounts Receivable

Accounts receivable are recorded net of an allowance for credit losses, which approximates fair valueis recorded as an offset to accounts receivable and changes in such are includedclassified as a Level 2 measurementgeneral and administrative expense in the table below.

consolidated statements of operations. The Company assesses collectability by reviewing accounts receivable on an individual basis when the Company identifies specific customers with known disputes or collectability issues.  The Company assesses past due amounts by reviewing the payment terms of the contracts with the Company’s customers. In determining the amount of the allowance for credit losses, the Company makes judgments about the creditworthiness of customers based on ongoing credit evaluations. The Company writes off uncollectable accounts receivable against the allowance based on facts and circumstances for specific customers when management determines that collectability is remote.  There were 0 assets and liabilities measured at fair valueis no allowance for doubtful account as of June 30, 2021.2022 As of December 31, 2020, the following items were measured at fair value: 

  

As of December 31, 2020

 
  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets:

                

Short-term investments

 $0  $324,870  $0  $324,870 

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Table of Contents

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

 
    

June 30, 2020

 
    

Accrued Warrant Liability

 

Beginning Balance

   $44,412 

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

    292,385 

Settlements

    (61,303)

Ending Balance

   $275,494 

    

Six Months Ended

 
    

June 30, 2020

 
    

Accrued Warrant Liability

 

Beginning Balance

   $6,414 

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

    453,074 

Settlements

    (183,994)

Ending Balance

   $275,494 

(1)

Unrealized gains or losses related to the accrued warrant liability were included as change in value of accrued warrant liability. There were 0 realized gains or losses for the three and six months ended June 30, 2021 and 2020.

As of June 30, 2021and December 31, 2020, the Company had 0 assets or liabilities that were measured at fair value on a nonrecurring basis.

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.

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4. Stockholders’ Equity

On February 19, 2021, the Company entered into a Securities Purchase Agreement (the "Purchase Agreement") for the sale of 2,000,000 shares (the "Shares") of common stock at a purchase price of $7.00 per share, in a registered direct offering. The closing of the sale of the Shares under the Purchase Agreement occurred on February 23, 2021. The gross proceeds to the Company from the transaction were $14 million, before deducting the placement agent’s fees and other estimated offering expenses. Under the Company’s engagement letter with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which Wainwright agreed to serve as exclusive placement agent for the issuance and sale of the Shares, the Company also issued to designees of Wainwright warrants to purchase up to 150,000 shares of Common Stock (the "Placement Agent Warrants"). Subject to certain ownership limitations, the Placement Agent Warrants are immediately exercisable at a price of $8.75 per share of Common Stock, subject to customary adjustments as provided under the terms of the Placement Agent Warrants. The Warrants are exercisable for five years from the commencement of sales of the shares being offered.

The Company has granted options to purchase shares of common stock. The following is a summary of option award activity duringDuring the six months ended June 30, 2022 and 2021,: the company wrote off $0.02 million and $0.0 million of accounts receivable.

 

  

Total Stock Options Outstanding

  Weighted Average Exercise Price per Share 

December 31, 2020

  76,064  $27.35 

Forfeited, Canceled

  (11,167)  116.50 

June 30, 2021

  64,897  $12.01 

Goodwill

 

The followingCompany tests goodwill for impairment in the fourth quarter each year, or more frequently if indicators of an impairment exist, to determine whether it is a summarymore likely than not that the fair value of outstanding stock options asthe reporting unit with goodwill is less than its carrying value. For reporting units for which this assessment concludes that it is more likely than not that the fair value is more than its carrying value, goodwill is considered not impaired. Qualitative factors considered in this assessment include industry and market considerations, overall financial performance, and other relevant events and factors affecting the fair value of the reporting unit. For reporting units for which this assessment concludes that it is more likely than June 30, 2021not: that the fair value is below the carrying value, goodwill is tested for impairment by determining the fair value of each reporting unit and comparing it to the carrying value of the net assets assigned to the reporting unit. If the fair value of the reporting unit exceeds its carrying value, goodwill is considered not impaired. If the carrying value of the reporting unit exceeds its fair value, we would record an impairment loss up to the difference between the carrying value and implied fair value.

 

  

As of June 30, 2021

 
  Stock Options Outstanding  Vested Stock Options 

Quantity

  64,897   64,897 

Weighted Average Exercise Price

 $12.01  $12.01 

Weighted Average Remaining Contractual Term (in Years)

  3.40   3.40 

Intrinsic Value

 $93,481  $93,481 

Intangible Assets

 

ForThe Company has two identified finite-lived intangible assets, its customer base and tradenames and trademarks. The customer base and tradenames have a useful life of 20 years and 3 years, respectively. The intangible assets are amortized on a straight-line basis over their useful lives.

The Company reviews all finite lived intangible assets for impairment when circumstances indicate that their carrying values may not be recoverable. If the carrying value of an asset group is not recoverable, the Company recognizes an impairment loss for the excess carrying value over the fair value in its consolidated statements of operations. No impairment losses have been recorded in the six months ended June 30, 2021 2022and 20202021., the Company granted 0 stock options.

 

As of June 30, 2021, there was 0 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 $8.75. The warrants expire between one and seven years from the date of grant, and are subject to the terms applicable in each agreement.  These terms include for certain warrants the right to receive cash settlement upon the occurrence of a fundamental transaction.  The Merger meets the definition of a fundamental transaction per the terms of these warrant agreements.  

The following table summarizes the outstanding warrant activity during the six months ended June 30, 2021:

  Number of Warrants  Weighted Average Exercise Price 

December 31, 2020

  371,340  $7.28 

Granted

  150,000   8.75 

Exercised

  (92,883)  2.03 

Forfeited, Canceled

  (128,938)  16.63 

June 30, 2021

  299,519  $5.62 

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6.3. Significant Alliances and Related PartiesMerger with Old Cytocom

 

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 $0 and $0 and $1,197 in research and development expense to RPCI for the three and six months ended June 30, 2021 and 2020, respectively. 

The Cleveland Clinic

The Company has entered into an exclusive license agreement with The Cleveland Clinic pursuant to which the Company was granted an exclusive license to The Cleveland Clinic’s research base underlying entolimod's therapeutic platform and certain product candidates licensed to Panacela. The Company has the primary responsibility to fund all newly developed patents. However, The Cleveland Clinic retains ownership of those patents covered by the agreement. The Company 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, the Company sublicensed the intellectual property underlying entolimod's composition that the Company licenses from The Cleveland Clinic to GPI. There were no milestone or royalty payments paid to The Cleveland Clinic during the six months ended June 30, 2021 and 2020.  The Company incurred 0 research and development expense to The Cleveland Clinic during the six months ended June 30, 2021 and 2020.

Buffalo BioLabs and Incuron

Our Global Head of Research and Development, 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 research and development expense to BBL for the three and six months ended June 30, 2021 and 2020. The Company also recognized 0 sublease and other income from BBL for the three and six months ended June 30, 2021 and June 30, 2020. Pursuant to our real estate sublease and equipment lease with BBL, the Company had gross accounts receivables of $0 and $6,285, and net accounts receivables of $0 and $6,285 from BBL at June 30, 2021 and 2020, 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 $0 and $8,347 and $49,357 for the three and six months ended June 30, 2021 and 2020, respectively. In addition, the Company recognized 0 sublease and other income from Incuron for the three and six months ended June 30, 2021 and 2020, respectively. Pursuant to these agreements, the Company had gross accounts receivables of $130,000 and $139,357, and net accounts receivables of $0 and $139,357 from Incuron at June 30, 2021 and 2020, respectively.

Genome Protection

GPI incurred $13,440 and $26,880 and $13,440 and $26,880 in consultant expenses with members of the Company's Board of Directors and management team during the three and six months ended June 30, 2021 and 2020, respectively. 

7. Subsequent Events

Closing of the Merger with Cytocom Inc. 


On July 27, 2021, the Company, formerly known as Cleveland BioLabs, Inc., Merger Sub, and Old Cytocom completed the Merger.their previously announced merger transaction. The Mergermerger transaction was completed pursuant to the Merger Agreement, pursuant to which Merger Sub merged with and into Old Cytocom, with Old Cytocom continuing as a wholly owned subsidiary of the Company and the surviving corporation of the Merger. In connection with the closing of the Merger, Old Cytocom was renamed “Cytocom Subsidiary Inc.” and the Company was renamed “Cytocom, Inc.”

Merger Consideration. UponImmediately upon completion of the Merger, the former stockholders of Old Cytocom stockholders held a majority of the voting interest of the combined company.

Under the terms of the Merger, at the effective time of the Merger, the Company issued shares of its common stock to Old Cytocom stockholders (but excluding those Old Cytocom stockholders who had been holders of stock of ImQuest prior to the merger between Old Cytocom and ImQuest in June 2021), at an exchange ratio of 0.3384 shares of common stock (the “Exchange Ratio”) for each outstanding share of Old Cytocom common stock each outstanding immediately prior to the Merger. The Company also set aside a number of shares of its common stock for issuance to the Old Cytocom stockholders who had been holders of stock of ImQuest prior to merger between Old Cytocom and ImQuest in June 2021, which 3,282,089 shares were issued after the passage of 30 trading days following the Merger. Immediately following the closing of the Merger on July 27, 2021, the former Cleveland BioLabs, Inc. stockholders owned approximately 46% of the aggregate number of shares of common stock of the Company and the former Old Cytocom and former ImQuest stockholders owned approximately 54% of the shares of common stock of the Company.

At the effective time of the Merger, the Company also became party to a number of warrants that had been issued by Old Cytocom. At the time of the Company’s first draw under the Loan and Security Agreement, dated as of April 26, 2021, between Avenue Venture Opportunities Fund, L.P. (“Avenue”) and Old Cytocom, as supplemented by the Supplement to the Loan and Security Agreement, dated as of April 26, 2021, between Avenue and Old Cytocom (the “Avenue Facility”), which occurred July 30, 2021, the Company issued a warrant (the “Avenue Warrant”) to purchase an aggregate of 154,004 shares of the Company’s common stock at an exercise price of $0.01 per share. Avenue may exercise the Avenue Warrant at any time and from time to time until April 30, 2026. The terms of the Avenue Warrant provide that the exercise price of the Avenue Warrant, and the number of shares of common stock for which the Avenue Warrant may be exercised, are subject to adjustment to account for increases or decreases in the number of outstanding shares of common stock resulting from stock splits, reverse stock splits, consolidations, combinations and reclassifications.

In connection with the Company’s entry into the Amended and Restated Share Purchase Agreement, dated as of July 27, 2021, by and among GEM Global Yield LLC SCS, GEM Yield Bahamas Limited (such entities together, “GEM”) and the Company, as successor to Old Cytocom (the “GEM Agreement”), Old Cytocom issued a warrant (the “GEM Warrant”) to GEM. At the closing of the Merger, the GEM Warrant automatically became an obligation of the Company. The GEM Warrant is exercisable for an aggregate of 1,720,083 shares of Company common stock, or 4.99% of the Company’s outstanding stock as of immediately after the effective time of the Merger, at an exercise price of $5.01 per share. The exercise price will increase to $5.51 if on the one-year anniversary date of the effective time of the Merger, the warrant has not been exercised in full and the average closing price per share of the Company’s common stock for the 10 days preceding the anniversary date is less than 90% of the initial exercise price. GEM may exercise the GEM Warrant at any time and from time to time until July 28, 2024. The terms of the GEM Warrant provide that the exercise price of the GEM Warrant, and the number of shares of common stock for which the GEM Warrant may be exercised, are subject to adjustment to account for increases or decreases in the number of outstanding shares of common stock resulting from stock splits, reverse stock splits, consolidations, combinations and reclassifications. Additionally, the GEM Warrant contains weighted average anti-dilution provisions that provide that if the Company issues shares of common stock, or securities convertible into or exercisable or exchange for, shares of common stock at a price per share that is less than the volume-weighted average price of the common stock prior to that issuance, then the exercise price of the GEM Warrant will be proportionally reduced by application of a formula provided for in the GEM Warrant that takes into account such new issuance price in light of the number of shares issued and to be issued.  The exercise price has been adjusted to $4.86 due to the Company's equity raises in March 2022.

Immediately after the closing of the Merger, the Company issued warrants (the “2021 Warrants”) to the purchasers of Old Cytocom’s Series A-3 Preferred Stock and Series A-4 Preferred Stock, each of which were converted immediately prior to the closing of the Merger, exercisable for up to an aggregate of 952,000 shares of Company common stock. The 2021 Warrants were exercisable for an aggregate of 952,000 shares of Company common stock at an exercise price of $5.00 per share. The holders of the 2021 Warrants were able to exercise the 2021 Warrants at any time and from time to time until December 10, 2021. Upon exercise and payment of the applicable exercise price to the Company by a holder, the Company would issue to such holder (i) the underlying shares of common stock for which the exercise price is paid and (ii) a new warrant, in substantially the same form as the 2021 Warrants, that expires on December 10, 2022. The terms of the 2021 Warrants provide that the exercise price of the 2021 Warrants, and the number of shares of Common Stock for which the 2021 Warrants may be exercised, are subject to adjustment to account for increases or decreases in the number of outstanding shares of common stock resulting from stock splits, reverse stock splits, consolidations, combinations and reclassifications. As of June 30, 2021, an aggregate of 425,000 of the 2021 Warrants remain exercisable.

The Company’s management has evaluated all the terms of the warrant agreements and determined that the warrants shall be accounted for as equity instruments as no conditions exist under ASC 480 to account for these as liabilities.

All Old Cytocom preferredvested restricted stock that was not, by its terms, converted into shares of Old Cytocom common stock immediatelyunits outstanding prior to the effective time of the Merger (the "Effective Time"), and each vested restricted stock unit of Old Cytocom (excluding, in each case, dissenting shares and shares held in treasury) automatically converted into the right to receive a number ofwere exchanged for shares of Companythe Company’s common stock determined byin accordance with the application of an exchange ratio formula set forth in the Merger Agreement. 

Exchange Ratio. The exchange ratio was calculated based on the total number of outstanding shares of Company common stock and Old Cytocom common stock, each on a fully diluted basis, and the respective valuations of the Company and Old Cytocom, as of immediately prior to the Effective Time. As of the effective date of the Merger Agreement, the valuation of the Company was assumed to be $39 million and the valuation of Old Cytocom was assumed to be $61 million. For purposes of calculating the exchange ratio, the respective valuations of Old Cytocom and the Company at the Effective Time were increased or decreased, as applicable, based on the amount of each company’s net cash at closing, inclusive of certain short- and long-term liabilities. From these imputed valuation amounts, the number of shares to be issued as merger consideration to Old Cytocom security holders will be equal to a percentage of the fully diluted common stock of the combined company determined by dividing the adjusted Old Cytocom valuation by the adjusted combined company valuation.

Accordingly, based on the foregoing exchange ratio, the parties determined that 18,492,452 shares of Company common stock will be issued in the Merger, resulting in the former Old Cytocom securityholders owning, or holding rights to acquire, approximately 54% of the common stock of the combined company, on a fully diluted basis, and legacy, pre-Merger Company securityholders owning, or holding rights to acquire, approximately 46% of the common stock of the combined company, on a fully diluted basis, in each case as of immediately following the Effective Time. In addition, at the Effective Time, eachRatio. Each unvested Old Cytocom restricted stock unit was converted into a number of restricted stock units of the Company, as determined in accordance with the exchange ratio formula described above. The terms (including, without limitation, the vesting terms) of each such substitute restricted stock unit are substantially equivalent to those of the Old Cytocom restricted stock unit being replaced.

 

Financing Arrangements


As a result
Cleveland BioLabs, Inc. equity awards issued and outstanding at the time of the Merger remained issued and outstanding and were not impacted by the Company became partyMerger. As of July 27, 2021, Cleveland BioLabs, Inc. had outstanding stock options to the following material definitive agreements:purchase 45,706 shares of common stock, of which stock options to purchase 45,706 shares were vested and exercisable at a weighted average exercise price of $14.46 per share. As of June 30, 2021, an aggregate of 18,378 of these stock options remain exercisable.

Loan and Security Agreement, dated as of April 26, 2021, between Avenue Venture Opportunities Fund, L.P. ("Avenue") and Old Cytocom, as supplemented by the Supplement to the Loan and Security Agreement, dated as of April 26, 2021, between Avenue and Old Cytocom, under which the Company will (i) issue the warrant described in the next paragraph to Avenue and (ii) be obligated to issue shares of common stock upon conversion of up to $3 million of principal outstanding under the Avenue facility;

Warrant to Purchase Shares of Common Stock of Cytocom Inc, issued at the Effective Time, by the Company to Avenue, exercisable for up to 154,004 shares of Company common stock;

Share Purchase Agreement, dated as of May 21, 2021, by and among GEM Global Yield LLC SCS, GEM Yield Bahamas Limited (such entities together, "GEM") and the Company, as successor to Old Cytocom, under which the Company may sell, from time to time, up to $75 million shares of its common stock at a price per share equal to 90% of the recent trading price of the Company’s common stock;

Warrant to Purchase Shares of Cytocom Inc., dated as of May 21, 2021, issued by Old Cytocom and assumed by the Company, exercisable for up to 1,720,083 shares, or 4.99% of the outstanding shares of common stock as of immediately after the Effective Time;

The Registration Rights Agreement, dated as of May 21, 2021, between Old Cytocom, GEM Global Yield LLC SCS and GEM Yield Bahamas Limited ; and

Warrants, issued immediately after the Effective Time, by the Company to the purchasers of Old Cytocom’s Series A-3 Preferred Stock and Series A-4 Preferred Stock, each of which were converted immediately prior to the Effective Time, exercisable for up to an aggregate 952,000 shares of Company common stock.

 

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13

Allocation of Purchase Consideration

Pursuant to business combination accounting, the Company applied the acquisition method, which requires the assets acquired and liabilities assumed be recorded at fair value with limited exceptions.

The purchase price for Cleveland BioLabs, Inc. on July 27, 2021, the closing date of the Merger, was as follows:

  

July 27, 2021

 

Number of shares of the combined company owned by Cleveland BioLabs, Inc. stockholders

  15,478,945(1)

Multiplied by the price per share of Cleveland BioLabs, Inc. common stock

 $4.99(2)

Total purchase price

 $77,239,936 

1.

 Represents the number of shares of common stock of the combined company that Cleveland BioLabs, Inc. stockholders owned as of the closing of the Merger pursuant to the Merger Agreement.

2.

The fair value of Cleveland BioLabs, Inc. common stock used in determining the purchase price was $4.99.

Under the acquisition method of accounting, the total purchase price was allocated to tangible and identifiable intangible assets acquired and liabilities assumed of Cleveland BioLabs, Inc. on the basis of their estimated fair values as of the transaction closing date on July 27, 2021.

The following table summarizes the allocation of the purchase consideration to the assets acquired and liabilities assumed based on their fair values as of July 27, 2021:

  

July 27, 2021

 

Tangible Assets Acquired

    

Cash and cash equivalents

 $13,116,460 

Other receivables

  25,142 

Other current assets

  44,507 

Fixed assets - net

  4,954 

Panacela (67.57% ownership)

  178,388 

Total Tangible Assets

  13,369,451 
     

Assumed Liabilities

    

Accounts payable

  (426,570

)

Accrued expenses

  (41,755

)

Total Liabilities

  (468,325

)

Net Tangible Assets/Liabilities

  12,901,126 

Intangible Assets Acquired

    

Goodwill

  64,338,810 

Total Net Assets Acquired

 $77,239,936 

Goodwill

The excess of the purchase price over the assets acquired and liabilities assumed represents goodwill. The goodwill is primarily attributable to the synergies expected to arise after the acquisition and is not expected to be deductible for tax purposes.

Pro Forma Results in connection with the Merger

The unaudited financial information in the following table summarizes the combined results of operations of the Company and Cleveland BioLabs, Inc., on a pro forma basis, as if the Merger occurred at the beginning of the periods presented.

  

Six Months Ended June 30,

 
  

2021

  

2022

 

Revenue

 $1,429,473  $1,766,666 

Net loss

 $(13,653,502

)

 $(11,250,480)

The above unaudited pro forma information was determined based on historical GAAP results of Old Cytocom, ImQuest and Cleveland BioLabs, Inc. The unaudited pro forma combined results do not necessarily reflect what the Company’s combined results of operations would have been, if the acquisition was completed on January 1, 2021. The unaudited pro forma combined net loss includes pro forma adjustments primarily related to the non-recurring items directly attributable to the business combinations.

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4.Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consist of the following:

  

June 30,

2022

  

December 31,

2021

 

Accounts payable

 $8,071,281  $3,964,962 

Accrued payroll

  2,192,486   195,470 

Accrued interest and fees

  72,741   51,195 

Other accrued expenses

  1,341,253   1,504,329 
  $11,677,761  $5,715,956 

 

 

5.Notes Payable

Notes payable consist of the following:

  

June 30,

2022

  

December 31,

2021

 

Short-term portion of Avenue Ventures note payable

 $6,196,486  $4,375,000 

Short-term notes payable

  200,000   200,000 
  $6,396,486  $4,575,000 

6.Long-term Debt

Long-term debt consists of the following:

  

June 30,

2022

  

December 31,

2021

 

Long-term portion of Avenue Ventures note payable

 $-  $10,625,000 
  $-  $10,625,000 

In February 2022, Avenue withdrew $5.0 million of the Company's restricted cash to repay a portion of the debt to Avenue. On March 31, 2022, the Company received a letter (the "Letter") from Avenue regarding alleged events of default with respect to the Loan and Security Agreement, dated as of April 26, 2021, between the Company and Avenue (the "Loan Agreement"). In the Letter, Avenue alleges that certain events of default under the Loan Agreement have occurred and continue to exist. Specifically, Avenue alleged that the Company was in violation of certain provisions of the Loan Agreement as a result of which, Avenue purported to exercise its rights to suspend further loans or advances to the Company under the Loan Agreement and to accelerate the amount due under the Loan Agreement. Avenue further states in the Letter that interest will continue to accrue on the outstanding amounts at the default rate of 5.0%. In furtherance of the allegations set forth in the Letter, Avenue foreclosed on approximately $4.8 million of the Company’s cash. In April, Avenue returned $0.5 million of the amount foreclosed on. Approximately $3.8 million was applied to principal after application of prepayment fees, accrued interest, and miscellaneous expenses. Due to the accelerated payment schedule, the entire amount due on the Avenue note payable has been reclassed to short term notes payable.

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7.Leases

The Company’s leases do not provide an implicit rate that can be readily determined. Therefore, the Company uses discount rates based on the incremental borrowing rate of its current external debt of 3%, 10%, and 17%, depending on the entity and timing of the lease implementation.

The Company’s weighted-average remaining lease term relating to its operating leases is 4 years, with a weighted-average discount rate of 15.21%.

The Company incurred lease expense for its operating leases of $142,411 and $29,225, which was included in general and administrative expenses, and $134,056 and $0, which was included in research and development expenses in the condensed consolidated statements of operations for the periods ended June 30, 2022 and 2021, respectively. 

The following table presents information about the future maturity of the lease liability under the Company’s operating leases as of June 30, 2022:

Maturity of Lease Liability

 

Total

 

2022

 $258,740 

2023

  475,556 

2024

  264,955 

2025

  173,644 

2026

  182,326 

Thereafter

  223,605 

Total undiscounted lease payments

  1,578,826 

Less: Imputed interest

  437,811 

Present value of lease liabilities

 $1,141,015 

8.Intangible assets

Intangible assets consist of the following:

  

June 30, 2022

  

December 31, 2021

 

Customer base

 $1,312,000  $1,312,000 

Trade-names/marks

  502,100   502,100 

Accumulated amortization

  (460,538)  (233,120)

Net carrying value

 $1,353,562  $1,580,980 

During the six months ended June 30, 2022 and 2021, the Company recorded total amortization expense of $227,418 and $0, respectively.

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9. Stockholders’ Deficit

The Company has granted options to employees and Board members to purchase shares of common stock. The following is a summary of option award activity during the six months ended June 30, 2022:

  

Total Stock Options Outstanding

  Weighted Average Exercise Price per Share 

December 31, 2021

  45,468  $14.28 

Granted

  1,216,149   0.24 

Vested

      

Forfeited, Canceled

  (26,730)  14.89 

June 30, 2022

  1,234,887  $0.44 

The following is a summary of outstanding stock options as of June 30, 2022:

  

As of June 30, 2022

 
  Stock Options Outstanding  Vested Stock Options 

Quantity

  1,234,887   1,234,887 

Weighted Average Exercise Price

 $0.44  $0.44 

Weighted Average Remaining Contractual Term (in Years)

  9.90   9.90 

Intrinsic Value

 $  $ 

As of June 30, 2022, there was no total compensation cost not yet recognized related to unvested stock options.

As of June 30, 2022, there are 561,602 restricted stock units outstanding to employees from the old Cytocom plan.

10. 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 $0.01 to $5.00. The warrants expire between one and five years from the date of grant, and are subject to the terms applicable in each agreement.  These terms include for certain warrants the right to receive cash settlement upon the occurrence of a fundamental transaction.  The Merger meets the definition of a fundamental transaction per the terms of these warrant agreements. The Company’s management has evaluated all the terms of the warrant agreements and determined that the warrants shall be accounted for as equity instruments as no conditions exist under ASC 480 to account for the warrants as liabilities.

The following table summarizes the outstanding warrant activity during the six months ended June 30, 2022:

  Number of Warrants  Weighted Average Exercise Price 

December 31, 2021

  2,431,168  $4.48 

Granted

  30,777,776   0.46 

Exercised

      

Forfeited, Canceled

      

June 30, 2022

  33,208,944  $0.79 

11.Commitments and Contingencies

On March 24, 2021, a complaint, captioned Bednar v. Cleveland BioLabs, Inc. et al., Case 1:21-cv-02546, was filed in the U.S. District Court for the Southern District of New York in connection with the Merger (the "Bednar Action").  The Bednar Action names as defendants Cleveland BioLabs and each director on the Cleveland BioLabs board of directors.  The complaint in the Bednar Action alleges that Cleveland BioLabs and the Cleveland BioLabs board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger in violation of their fiduciary duties and the Exchange Act and related SEC regulations. The Bednar Action seeks, among other things, an injunction preventing the closing of the Merger, rescission of the Merger if it is consummated, the dissemination by the Company of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees. On October 13, 2021, Plaintiff Bednar filed a notice of dismissal.  On October 20, 2021, the Southern District entered an order dismissing the case.  On December 23, 2021, Plaintiff Bednar filed a new action in the Delaware Court of Chancery, asserting a cause of action for an equitable assessment of attorneys’ fees and expenses incurred in connection with the first lawsuit.  The new Delaware action names the same defendants as the first Bednar Action.  The Defendants in the new Delaware action have filed an answer to Plaintiff’s Delaware complaint.

On August 16, 2022, certain former employees of the Company and certain third party vendors of the Company (collectively, "Petitioning Creditors") filed an involuntary petition in the United States Bankruptcy Court for the District of Colorado (No.22-13051-JGR) against the Company seeking relief under Chapter 11 of the United States Bankruptcy Code. The Company believes the involuntary petition is improper and wrongfully filed and is seeking dismissal of the petition. The outcome of this lawsuit is uncertain. The Company believes that the claims asserted are without merit.

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12.Subsequent Events

On August 16, 2022, Petitioning Creditors filed an involuntary petition in the United States Bankruptcy Court for the District of Colorado (No.22-13051-JGR) against the Company seeking relief under Chapter 11 of the United States Bankruptcy Code. The Company believes the involuntary petition is improper and wrongfully filed and is seeking dismissal of the petition.

On August 22, 2022, the Company issued 1.5 million shares of restricted common stock pursuant to a newly executed contract to provide investors relations services to the Company.

On September 1, 2022, the Company was notified by the Listing Qualifications Staff (the "Staff") of NASDAQ that the Company’s common stock would be subject to delisting due to the Company’s non-compliance with the filing requirement set forth in Nasdaq Listing Rule 5250(c)(1) unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the "Panel"). At the time, the Company had not yet filed the Form 10-K for the fiscal year ended December 31, 2021 or the Forms 10-Q for the quarterly periods ended March 31, 2022 and June 30, 2022 (collectively, "Form 10-Qs") with the SEC. The Company intends to timely request a hearing before the Panel, which request will stay any further action by NASDAQ at least pending the issuance of a decision by the Panel and the expiration of any extension the Panel may grant to the Company following the hearing.

On September 2, 2022, the Company entered a Binding Letter of Intent ("LOI") with Lay Sciences, Inc. ("Lay"), pursuant to which the Company will manufacture, and test IgY polyclonal antibody products created by Lay. The LOI provides for an exclusivity period of ninety (90) days (the "Exclusivity Period") for negotiating and finalizing a definitive agreement (the "Definitive Agreement"). During the Exclusivity Period, which begins from the date of the LOI, Lay will not engage in activities with any third party in relation to the acquisition of the Company. Pursuant to the LOI, (i) Lay shall complete technology transfer to the Company; and (ii) the Company shall (A) assist Lay in testing its current and future products for activity and purity, In consideration of the manufacturing right granted to the Company by Lay, the Company shall (i) issue 500,000 shares of preferred stock of the Company to Lay and (ii) pay up to $500,000 to Lay within 30 days of the execution of the LOI.  As of the date of this filing the Company hasn't issued any shares of preferred stock or paid any cash consideration.

On September 2, 2022, the Board of Directors of the Company appointed John Kallassy as a director of the Company, effective September 2, 2022, to fill the vacancy created by the resignation of the chair of the audit committee. Mr. Kallassy will serve in such position until his successor is elected and qualified or until his earlier death, resignation, or removal. Mr. Kallassy will serve as a member of the Board’s audit committee, compensation committee, and nominating and corporate governance committee. The Board has affirmatively determined that Mr. Kallassy is "independent" within the meaning of the listing standards of NASDAQ. In addition, Mr. Kallassy is independent under NASDAQ heightened independence standards applicable to audit committee and compensation committee members. The Board also appointed Mr. Kallassy as an "audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K and Chairperson of the Audit Committee of the Board.

On October 6, 2022, the Company had a hearing before the Panel, the Company presented its plan to evidence full compliance with NASDAQ'S filing requirement and all other applicable requirements for continued listing on NASDAQ and request an extension of time to do so. The Company is taking definitive steps to evidence compliance with the NASDAQ listing criteria as soon as possible; however, there can be no assurance that the Panel will grant the Company’s request for continued listing or that the Company will satisfy the NASDAQ listing criteria within any extension period that may be provided to the Company by the Panel. The Company plans to update the market promptly following receipt of the Panel’s determination after the hearing.

On October 11, 2022, the Company was notified by the Staff of NASDAQ that the Company’s common stock would be subject to delisting due to the Company’s non-compliance with the minimum Stockholders' Equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) and non-compliance with Listing Rule 5250(e)(2)(D) regarding notifying Nasdaq of the Company's intention to issue additional shares. Each of these matters serve as an additional and separate basis for delisting the Company’s securities from NASDAQ. The Panel will consider these matters in their decision regarding the Company’s continued listing on NASDAQ. The Company presented its views with respect to these additional deficiencies to the Panel.

On October 18, 2022, the Company entered into the Assignment of Promissory Note with Avenue Venture Opportunities Fund, L.P. ("Avenue Venture") and Silverback Capital Corporation ("Silverback"), pursuant to which, in consideration for a cash payment of $400,000 by Silverback to Avenue Venture, Avenue Venture assigned to Silverback a $400,000 portion (the "Apportioned Note") of that certain Promissory Note in the aggregate principal amount of $15 million (the “Partial Assignment”) issued by the Company to Avenue Venture, dated as of April 26, 2021, pursuant to the Loan and Security Agreement, dated as of the even date of the Original Note, by and between the Company and Avenue Venture, as supplemented and amended (the "Loan Agreement"). Pursuant to the Partial Assignment, the Company issued an Amended and Restated Convertible Note Due May 1, 2024 (the "A&R Note") in the principal amount of $400,000.00 to Silverback as of October 18, 2022 in exchange of the Apportioned Note. The A&R Note bears interest at a variable rate of interest per annum equal to the sum of (i) the greater of (A) the Prime Rate (as defined in the Loan Agreement) and (B) 3.25% plus (ii) 7.74%. Payment of the aggregate principal amount of the A&R Note outstanding together with all accrued interest thereon is due on May 1, 2024 (the "Maturity Date"). Additionally, Silverback has the right to convert, at any time until the Maturity Date, all or any portion of the outstanding principal amount, accrued interest and fees due and payable thereon into shares of common stock of the Company at a conversion price equal to 75% of the lowest trading price of the Company’s common stock during the five trading day period preceding the conversion date inclusive of the conversion date. The Company issued 2,551,000 shares of common stock to Silverback on October 21, 2022, which represents a conversion of $277,039 of the A&R Note.

On October 26, 2022, the Company received a determination from the Panel granting the Company’s request for the continued listing of its common stock on Nasdaq, subject to the Company’s satisfaction of certain interim milestones and, ultimately, the Company’s compliance with all applicable criteria for continued listing on Nasdaq, including the $1.00 bid price and $2.5 million stockholders’ equity requirements as set forth in Nasdaq Listing Rules 5550(a)(1) and 5550(b)(2), respectively, by no later than January 31, 2023. The Company is taking definitive steps to timely evidence compliance with the terms of the Panel’s decision; however, there can be no assurance that it will be able to do so.

18

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 and plans and objectives of management for future operations are forward-looking statements.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, 2020.2021. Factors that may cause such differences include, but are not limited to, the substantial doubt expressed about our ability to continue as a going concern, the outcome of any legal proceedings that have been or may be instituted against the Company related to the merger agreement or the Merger; unexpected costs, charges or expenses resulting from the 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 historical reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual 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, 2020.2021.

 

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, 2020.2021.

 

OVERVIEW

 

We are a clinical-stage biopharmaceutical company developing multiple product candidates to address unmet medical needs. Prior to the closing of the Merger, we focused exclusively on developing novel approaches to activate the immune system. 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 in this field is entolimod, an immune-stimulatory agent, which we are developing as a radiation countermeasure and other indications in radiation oncology. 

 

Following the closing of the Merger, as a result of the integration of Cytocom’s business, we are also now developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases and cancers based on a proprietary, multi receptor platform, or the AIMS platform, designed to rebalance the body’s immune system and restore homeostasis. These therapies are designed to elicit directly within patients a robust and durable response of antigen-specific killer T cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. We believe that our technologies can meaningfully leverage the human immune system for prophylactic and therapeutic purposes by eliciting killer T-cell response levels not achieved by other published immunotherapy approaches. Our immunomodulatory technology restores the balance between the cellular (Th1) and the humoral (Th2) immune systems. Immune balance is regulated through T-helper cells that produce cytokines. The Th1 lymphocytes help fight pathogens within cells like cancer and viruses through interferon-gamma and macrophages. The Th2 lymphocytes target external pathogens like cytotoxic parasites, allergens, toxins through the activation of B-cells and antibody production to effect to dendritic cells, which are natural activators of killer T cells, also known as cytotoxic T -cells, or CD8+ T cells. Furthermore, the Cytocom technology antagonizes the toll-like receptors to inhibit proinflammatory cytokines.


Prior to the closing of the Merger, we conducted business in the U.S. directly and in Russia through two subsidiaries, one of which is wholly owned, BioLab 612 (which was dissolved in November 2020), and one of which is owned in collaboration with a financial partner, Panacela. As of the closing of the Merger, we also now conduct business through Old Cytocom and its subsidiaries, ImQuest Life Sciences Inc, ImQuest BioSciences Inc., ImQuest Pharmaceuticals, Inc., and Lubrinovation Inc. 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").

 

The Company is developing therapies designed to directly elicit within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Statera has clinical or preclinical programs for Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205).

In the next 12 months, the Company expects to initiate several clinical trials, including a pivotal Phase 3 trial for its lead drug candidate, STAT-201, in pediatric Crohn’s disease, as well as studies of STAT-205 in ‘long haul’ COVID-19, STAT-401 in pancreatic cancer, and the TLR5 agonist entolimod as a treatment for anemia and neutropenia in cancer patients.

19

Recent Developments

 

Closing of the MergerNasdaq Noncompliance

 

On July 27, 2021,October 6, 2022, the Company Merger Sub,had a hearing before the Panel, the Company presented its plan to evidence full compliance with NASDAQ'S filing requirement and Old Cytocom completedall other applicable requirements for continued listing on NASDAQ and request an extension of time to do so. The Company is taking definitive steps to evidence compliance with the Merger. The Merger was completed pursuantNASDAQ listing criteria as soon as possible; however, there can be no assurance that the Panel will grant the Company’s request for continued listing or that the Company will satisfy the NASDAQ listing criteria within any extension period that may be provided to the Merger Agreement, pursuantCompany by the Panel. The Company plans to which, Merger Sub merged with and into Old Cytocom, with Old Cytocom continuing as a wholly owned subsidiaryupdate the market promptly following receipt of the Panel’s determination after the hearing.

On October 11, 2022, the Company was notified by the Staff of NASDAQ that the Company’s common stock would be subject to delisting due to the Company’s non-compliance with the minimum Stockholders' Equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) and the surviving corporationnon-compliance with Listing Rule 5250(e)(2)(D) regarding notifying Nasdaq of the Merger. In connectionCompany's intention to issue additional shares. Each of these matters serve as an additional and separate basis for delisting the Company’s securities from NASDAQ. The Panel will consider these matters in their decision regarding the Company’s continued listing on NASDAQ. The Company intends to present its views with respect to these additional deficiencies to the Panel in writing no later than October 18, 2022.

On October 26, 2022, the Company received a determination from the Panel granting the Company’s request for the continued listing of its common stock on Nasdaq, subject to the Company’s satisfaction of certain interim milestones and, ultimately, the Company’s compliance with all applicable criteria for continued listing on Nasdaq, including the $1.00 bid price and $2.5 million stockholders’ equity requirements as set forth in Nasdaq Listing Rules 5550(a)(1) and 5550(b)(2), respectively, by no later than January 31, 2023. The Company is taking definitive steps to timely evidence compliance with the closingterms of the Merger. Old Cytocom was renamed "Cytocom Subsidiary Inc."Panel’s decision; however, there can be no assurance that it will be able to do so.

Forbearance Agreement

On April 18, 2022, Avenue and the Company was renamed "Cytocom, Inc."

Upon completion ofentered into a Forbearance Agreement regarding the Merger, each outstanding share of Old Cytocom common stock, each outstanding share of Old Cytocom preferred stock that was not, by its terms, converted into shares of Old Cytocom common stock immediately priorLoan Agreement. Pursuant to the Effective Time, and each vested restricted stock unit of Old Cytocom (excluding, in each case, dissenting shares and shares held in treasury) automatically converted intoForbearance Agreement, the right to receive a number of shares of Company common stock determined by the application of an exchange ratio formula set forth in the Merger Agreement. 

The exchange ratio was calculated based on the total number of outstanding shares of Company common stock and Old Cytocom common stock, each on a fully diluted basis, and the respective valuations of the Company and Old Cytocom, as of immediately prior to the Effective Time. As ofparties agreed that from the effective date of the MergerLoan Agreement until May 31, 2022 (the “Forbearance Period”), it will refrain and forbear from exercising certain remedies arising out of the valuationevents of default or any other present or future event of default under the Loan Agreement or supplement. Under the Forbearance Agreement, Avenue shall not seize, sweep, or by any means take control of, directly or indirectly, any funds from any of the Company’s bank accounts; and (ii) during the Forbearance Period, the Loans may be prepaid in whole or in part at any time, subject to the repayment and prepayment terms of the Loan Agreement. In addition to the terms of the Forbearance Agreement, certain terms of the Loan Agreement were amended, including changing the Agreement Effective Date to April 18, 2022, and revisions to certain definitions of Agreement terminology.

Bankruptcy Petition

On August 16, 2022, certain former employees of the Company was assumed to be $39 million and the valuation of Old Cytocom was assumed to be $61 million. For purposes of calculating the exchange ratio, the respective valuations of Old Cytocom and the Company at the Effective Time were increased or decreased, as applicable, based on the amount of each company’s net cash at closing, inclusive of certain short- and long-term liabilities. From these imputed valuation amounts, the number of shares to be issued as merger consideration to Old Cytocom securityholders will be equal to a percentage of the fully diluted common stock of the combined company determined by dividing the adjusted Old Cytocom valuation by the adjusted combined company valuation.

Accordingly, based on the foregoing exchange ratio, the parties determined that 18,492,452 shares of Company common stock will be issued in the Merger, resulting in the former Old Cytocom securityholders owning, or holding rights to acquire, approximately 54% of the common stock of the combined company, on a fully diluted basis, and legacy, pre-Merger Company securityholders owning, or holding rights to acquire, approximately 46% of the common stock of the combined company, on a fully diluted basis, in each case as of immediately following the Effective Time.


In addition, at the Effective Time, each unvested Old Cytocom restricted stock unit was converted into a number of restricted stock units
third-party vendors of the Company as determined in accordance with the exchange ratio formula described above. The terms (including, without limitation, the vesting terms) of each such substitute restricted stock unit are substantially equivalent to those of the Old Cytocom restricted stock unit being replaced.


(collectively, "Financing ArrangementsPetitioning Creditors


As a result of the Merger, the Company became party to the following material definitive agreements:

Loan and Security Agreement, dated as of April 26, 2021, between Avenue Venture Opportunities Fund, L.P. ("Avenue") and Old Cytocom, as supplemented by the Supplement to the Loan and Security Agreement, dated as of April 26, 2021, between Avenue and Old Cytocom, under which the Company will (i) issue the warrant described in the next paragraph to Avenue and (ii) be obligated to issue shares of common stock upon conversion of up to $3 million of principal outstanding under the Avenue facility;

Warrant to Purchase Shares of Common Stock of Cytocom Inc, issued at the Effective Time, by the Company to Avenue, exercisable for up to 154,004 shares of Company common stock;

Share Purchase Agreement, dated as of May 21, 2021, by and among GEM Global Yield LLC SCS, GEM Yield Bahamas Limited (such entities together, "GEM") and the Company, as successor to Old Cytocom, under which the Company may sell, from time to time, up to $75 million shares of its common stock at a price per share equal to 90% of the recent trading price of the Company’s common stock;

Warrant to Purchase Shares of Cytocom Inc., dated as of May 21, 2021, issued by Old Cytocom and assumed by the Company, exercisable for up to 1,720,083 shares, or 4.99% of the outstanding shares of common stock as of immediately after the Effective Time;

The Registration Rights Agreement, dated as of May 21, 2021, between Old Cytocom, GEM Global Yield LLC SCS and GEM Yield Bahamas Limited ; and

Warrants, issued immediately after the Effective Time, by the Company to the purchasers of Old Cytocom’s Series A-3 Preferred Stock and Series A-4 Preferred Stock, each of which were converted immediately prior to the Effective Time, exercisable for up to an aggregate 952,000 shares of Company common stock.

Certain of these arrangements are discussed in greater deal under the heading " – Liquidity and Capital Resources."

COVID-19 Pandemic

The COVID-19 pandemic has continued to affect most countries around the world, including the United States, where a national emergency was declared. The continued spread of COVID-19) filed an involuntary petition in the United States and worldwide, as well as the government-ordered shutdown and shelter-in-place orders imposed to counter the pandemic, led to severe disruptions to the global economy, especiallyBankruptcy Court for the year ended December 31, 2020. In this connection, on March 20, 2020,District of Colorado (No. 22-13051-JGR) against the GovernorCompany seeking relief under Chapter 11 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 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.  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 effectiveness of vaccination efforts, ultimate geographic spread of the disease, the duration of the outbreak, the impact of any new variants of the virus, the extent and duration of travel restrictions and social distancing in the United States Bankruptcy Code. The Company believes the involuntary petition is improper and other countries, business closures or business disruptionswrongfully filed and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. Furthermore, if we or anyis seeking dismissal of the third parties with whom we engage were to experience renewed 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.petition.

 

Registered Direct OfferingLay Sciences

 

As previously disclosed, on February 19, 2021,On September 2, 2022, the Company entered into a Securities Purchase Agreement (the "Purchase Agreement"Binding Letter of Intent ("LOI") with several healthcare-focused and institutional investors for the sale by the Company of 2,000,000 shares (the "Shares") of the Company’s common stock at a purchase price of $7.00 per share in a registered direct offering. The closing of the sale of the Shares under the Purchase Agreement occurred on February 23, 2021. The gross proceeds to the Company from the transaction were $14 million, before deducting the placement agent’s fees and other estimated offering expenses. The Shares were offered and sold by the Company under a prospectus supplement and accompanying prospectus filed with the SEC pursuant to an effective shelf registration statement on Form S-3, which was filed with the SEC on May 21, 2020 and subsequently declared effective on May 29, 2020 (File No. 333-238578). Under the Company’s engagement letter (the "Engagement Letter") with H.C. Wainwright & Co., LLCLay Sciences, Inc. ("Wainwright"Lay"), pursuant to which Wainwright agreed to serve as exclusive placement agentthe Company will manufacture, and test IgY polyclonal antibody products created by Lay. The LOI provides for an exclusivity period of ninety (90) days (the "Exclusivity Period") for negotiating and finalizing a definitive agreement (the "Definitive Agreement"). During the issuance and saleExclusivity Period, which begins from the date of the Shares,LOI, Lay will not engage in activities with any third party in relation to the Company agreed to pay Wainwright an aggregate fee equal to 7.25%acquisition of the gross proceeds received by the Company from the sale of the securities in the transaction as well as a management fee equal to 1.0% of the gross proceeds received by the Company from the sale of the securities in the transactions.Company. Pursuant to the Engagement Letter,LOI, (i) Lay shall complete technology transfer to the Company; and (ii) the Company also issuedshall (A) assist Lay in testing its current and future products for activity and purity, In consideration of the manufacturing right granted to designeesthe Company by Lay, the Company shall (i) issue 500,000 shares of Wainwright warrantspreferred stock of the Company to purchaseLay and (ii) pay up to 7.5%$500,000 to Lay within 30 days of the aggregate numberexecution of the LOI.  As of the date of this filing the Company hasn't issued any shares of Common Stock soldpreferred stock or paid any cash consideration.

Continuing Capital Needs

We are a clinical-stage company and we have generated insignificant revenue from product sales to date. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Since inception, we have incurred significant operating losses. For the six months ended June 30, 2022 and 2021, we incurred net losses of $11.2 million and $11.9 million, respectively. As of June 30, 2022, we had an accumulated deficit of $140.7 million.

We expect to incur significant expenses and operating losses for the foreseeable future as we advance our lead candidates through clinical trials, progress our pipeline candidates from discovery through pre-clinical development, and seek regulatory approval and pursue commercialization of our candidates. In addition, if we obtain regulatory approval for any of our candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution. In addition, we may incur expenses in connection with the transactions,in-license or warrantsacquisition of additional technology to purchase upaugment or enable development of future candidates. Furthermore, we expect to 150,000 sharesincur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that Old Cytocom, our predecessor for accounting purposes, did not incur as a private company prior to the Merger.

As a result, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of Common Stock (the "Placement Agent Warrants"). Subjectpublic or private equity and debt financings or other sources, which may include collaborations with third parties. We do not expect that our existing cash and cash equivalents will enable us to certain ownership limitations,fund our operating expenses and capital expenditure requirements beyond the Placement Agent Warrants are immediately exercisablethird quarter of 2022.

Adequate additional financing may not be available to us on acceptable terms, or at an exercise price of $8.75 per share of Common Stock, subjectall. Our inability to customary adjustmentsraise capital as provided under the termsand when needed could have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so. For these reasons, our financial statements contain a paragraph in substantial doubt is expressed about our ability to continue as a going concern within one year of the Placement Agent Warrants. The Warrants are exercisable for five years from the commencementdate of sales of the shares being offered.financial statements.

 

20

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. Additionally, we expect that as a result of the Merger, our business, financial condition, results of operations and cash flows will be materially different in future periods than in the past. Accordingly, our past results are not likely to be indicative of our future performance.

 

15

Revenue

 

OurThe Company generates revenue has historically originated from grants and contracts from both United States(i) its Clinical Research Organization services ("U.S.CRO services") federal governmentprovided by its ImQuest subsidiary, and (ii) grant awards from the National Institutes of Health for multiple studies in research.  We have no products approved for sale. Other than the sources of revenue described above, we do not expect to receive any revenue from any candidates that we develop until we obtain regulatory approval and commercializes such products, or until we potentially enter into collaborative agreements with third parties for the development and commercialization of such candidates.

At the inception of a contract for CRO services, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service contracts with Incuron. U.S. federal grants and contracts have been provided to advance research and developmentis distinct. The Company then recognizes as revenue the amount of entolimod, our lead product candidate, priorthe transaction price that is allocated to the Merger, which we believerespective performance obligation when (or as) the performance obligation is satisfied. 

There is no explicit guidance within ASC 606 to account for grant revenue, and since the Company is a for-profit entity, it must look to other Financial Accounting Standards Board guidance in order to account for funds received from grants. The Company has determined it is appropriate to apply ASC 450 - Contingencies.

Under ASC 450, the recognition of interest for potential salea gain contingency occurs at the earlier of when the gain has been realized or the gain is realizable. The gain is realized when the Company performs the research under the grant and submits the expense reimbursements to the DoD, orNIH and is approved under the Biomedical Advanced Research and Development Authorityterms of the U.S. Departmentgrant the funds are then received. The Company determined ASC 450 is appropriate because the realization of Healththe gain is contingent on whether the Company meets the performance requirement. Once the Company performs the research, submits the financial report for approval, and Human Services ("BARDA"). We also have provided various research, management, business development,the cash disbursement occurs, the contingency is thus resolved, and clinical advisory services to Incuron.the recognition of grant revenue is realized.

 

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, benefits 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.

Advertising and Marketing Costs

Advertising costs are expensed as incurred and included in operating expenses on the statements of operations. The Company incurred advertising and marketing expense for the six months ended June 30, 2022 and 2021 of $56,400 and $2,795, respectively.

 

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 criticalThe condensed consolidated financial statements include estimates made in accordance with generally accepted accounting policiesprinciples that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations. These significant accounting estimates are detailedinclude the inputs to level 3 valuation techniques for valuing the identified intangible assets in our Annual Report on Form 10-K for the year ended December 31, 2020. Our critical accounting policiesImQuest acquisition, valuation allowances associated with deferred tax assets, and significant estimates have not changed substantially from those previously disclosedrevenue recognition in our Annual Report on Form 10-K for the year ended December 31, 2020.

accordance with ASC 606.

 

16
21

 

 

Three Months Ended June 30, 20212022 Compared to Three Months Ended June 30, 20202021

 

Revenue

 

Revenue decreasedincreased from approximately $0.06$0 for the three months ended June 30, 2021 to $0.8 million for the three months ended June 30, 20202022. This increase is due entirely to $0.00the revenues from sales of CRO services by ImQuest BioSciences. There were no CRO services revenues in the corresponding period of 2021, as the merger with ImQuest took place in June 2021.

Cost of Revenues

Cost of revenue increased from $0 for the three months ended June 30, 2021 to $0.2 million for the three months ended June 30, 2021, representing a 100% decrease.2022. This decreaseincrease is primarily due entirely to the cessationcost of revenues recorded from our JWMRP contract with the DoD for continued preclinical developmentsales to CROs by ImQuest BioSciences.  There were no cost of entolimod, decreases in revenue from our PRMRP contract with the DoD for continued clinical development of entolimod, and decreases in revenue from our service contract with Incuron. The cessation of revenue is due to the completion of the DoD contracts and grants in 2020 and the discontinuation of all revenue and service contracts with Incuron. Accordingly, unless we obtain new contract or grant awards, we may not generate significant revenue until we can commercialize one or more of our product candidates. Differences in our revenue sources, by program, between the years are set forthrevenues in the following table. corresponding period of 2021, as the ImQuest Merger took place in June 2021.

   

Three Months Ended June 30,

     

Funding Source

Program

 

2021

  

2020

  

Variance

 

DoD

JWMRP Contract (1)

 $-  $44,544  $(44,544)

DoD

PRMRP Contract (2)

  -   10,364   (10,364)

Incuron

Service contract

  -   8,347   (8,347)
   $-  $63,255  $(63,255)

(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 $0.17 million for the three months ended June 30, 2020 to $0.05$1.8 million for the three months ended June 30, 2021 to $1.0 million for the three months ended June 30, 2022, representing a decrease of $0.12$0.8 million, or 69.7%46.4%. Variances in individual development programs are noted in the table below. The net decrease is primarily attributable to a $0.11decrease in other expenses for the three months ended June 30, 2022 to $0.06 million, compared to $1.1 million for the three months ended June 30, 2021 primarily due to a decrease in R&D employees, partially offset by increased spending on specific R&D programs for biodefense applicationsthe three months ended June 30, 2022 of entolimod$0.9 million, compared to $0.7 million for the three months ended June 30, 2021  primarily due to a reductionincreases in personnel costs. The remaining variances are not significant.R&D employees.

 

  

Three Months Ended June 30,

     
  

2021

  

2020

  

Variance

 

Entolimod for Biodefense Applications

 $48,888  $163,505  $(114,617)

Curaxins

     1,146   (1,146)

Panacela product candidates

  2,627   5,356   (2,729)

Total research & development expenses

 $51,515  $170,007  $(118,492)
  

Three Months Ended June 30,

     
  

2022

  

2021

  

Variance

 

STAT-201: Crohn's disease

 $639,060  $251,118  $387,942 

STAT-205: Acute and post-acute Covid-19

  159,982   484,259   (324,277)

STAT-401: Pancreatic cancer

  49,362      49,362 

STAT-601: Entolimod for acute radiation

  63,639      63,639 

Other expenses

  61,561   1,080,239   (1,018,678

)

Total research & development expenses

 $973,604  $1,815,616  $(842,012

)

22

 

General and Administrative Expenses

 

G&A expenses increaseddecreased from $0.50 million for the three months ended June 30, 2020 to $0.60$4.5 million for the three months ended June 30, 2021 to $2.4 million for the three months ended June 30, 2022, representing an increasea decrease of $0.10$2.1 million or 20.0%46.1%ThisVariances are noted in the table and discussed below.

  

Three Months Ended June 30,

     
  

2022

  

2021

  

Variance

 

Payroll (including benefits)

 $1,259,899  $2,859,364  $(1,599,465)

Stock listing expenses

  113,075   293,331   (180,256)

Professional fees

  307,316   763,223   (455,907)

Consultants and contractors

  195,482   339,274   (143,792)

Insurance

  220,387   143,132   77,255 

Travel

  3,338   30,012   (26,674)

Other G&A expenses

  328,937   79,538   249,399 

Total general & administrative expenses

 $2,428,434  $4,507,874  $(2,079,440)

Payroll (including benefits) incudes salaries, health benefits and related payroll costs.  The decrease in payroll expense was primarily attributable to a reduction of costs of $2.6 million for stock-based compensation incurred in the second quarter of 2022 over the comparative cost in the same period in 2021, partially offset by the increase is primarilyin costs related to professional fees primarily relating to negotiationthe increased employee headcount. Growth in headcount for G&A purposes between 2021 and completion2022 reflects (i) the addition of four employees in 2021 as result of the Merger and the ImQuest Merger, and (ii) the addition of seven new employees in total, several of whom were hired in senior executive roles to complete the Company’s leadership team plus the addition of staff in finance, human resources, information technology and investor relations, offset by the transfer of two employees to R&D.

Stock listing expenses are made up of fees paid to maintain the listing of the Company’s common stock on The NASDAQ, the costs of an investor relations program using outside consultants and databases, costs incurred with advisors to raise new debt and equity required by the Company, and the costs charged by stock transfer agents to maintain the Company’s share registers. The decreased costs in the three months ended June 30, 2022 compared to the three months ended June 30, 2021 primarily reflect stock sale commissions incurred in 2021.

Professional fees comprise fees paid for services to lawyers (other than lawyers who are engaged for services related to R&D), accountants, and the Company’s firm of auditors.  Fees paid to lawyers in the three months ended June 30, 2022 and 2021 totaled $0.1 million and $0.7 million, respectively.  The decrease in fees arose primarily from increased services in the three months ended June 30, 2021 related to the Merger and the ImQuest Merger. 

Fees paid to the audit firms engaged by the Company in the three months ended June 30, 2022 and 2021 totaled $0.2 million and $0.05 million, respectively. The higher in fees 2022 arose primarily from fees paid to audit 2020 and 2021 in the second quarter of 2022.

Consultants and contractors are individuals and firms hired by the Company to provide certain investment banking and advisory services, to assist the Company with the implementation of a new enterprise resource planning ("ERP") system, to provide valuation reports required to complete the accounting for the Merger and to assist with other general matters.  Fees paid to consultants and contractors in the three months ended June 30, 2022 and 2021 totaled $0.2 million and $0.3 million, respectively.  The decrease in costs was attributable primarily to increased services in the three months ended June 30, 2021 to complete the Merger.

Insurance expenses comprise fees and premiums paid to insurance companies from which the Company purchased policies to protect against loss or damage to its assets and intellectual property, to protect itself against claims for damage caused to third parties by its clinical trials or products used in trials or sold to customers, coverage for workers’ compensation payable for injuries suffered by its employees, and losses incurred by its directors and officers in certain circumstances in the performance of their duties.  Insurance premiums and costs in the three months ended June 30, 2022 and 2021 totaled $0.2 million and $0.1 million, respectively.  The increase was attributable primarily to additional insurance added in 2021 to protect the Company against claims for damage caused to third parties by its clinical trials or products used in trials or sold to customers, and losses incurred by its directors and officers in certain circumstances in the performance of their duties.

Travel. The Company maintains offices in a number of locations in the United States.  As a result of the Merger, new offices were added in 2021 in Colorado, California, Maryland, and New York, requiring an increase in travel between locations.   Travel expenses decreased between the three months ended June 30, 2021 and 2022 from $0.03 million to $0.00 million, respectively.

Other G&A expenses comprise costs to operate and lease office space, non-capital expenditures incurred for office furniture and equipment, telecommunication and internet expenses, postage and courier costs, and bank charges. Other G&A expenses increased year over year primarily as well asa result of the defense against litigation incident thereto.addition of new office locations and employees in 2021 in Colorado, California, Maryland, and New York. 

 

Other Income and Expenses

 

Other income decreased from $0.22Interest and other expense of $0.64 million forin the three months ended June 30, 2020 to $0.0022022 was made up of a $0.28 million of interest expense and $0.36 of shares issued for services.

Interest and other expense of $0.28 million in the three months ended June 30, 2021 representing a decrease of $0.22 million or approximately 100%. This decrease primarily relatedrelate to non-cash income during the three months ended June 30, 2020 resulting from a $0.5 million extinguishment of an accrued liability, offset by $0.3 million in expense related to the change in valuation of our warrant liability as a result of stock price changes.interest expense.

 

1723

 

Six Months Ended June 30, 20212022 Compared to Six Months Ended June 30, 20202021

 

Revenue

 

Revenue decreasedincreased from approximately $0.22$0 for the six months ended June 30, 2021 to $1.8 million for the six months ended June 30, 20202022. This increase is due entirely to $0.00the revenues from sales of CRO services by ImQuest BioSciences. There were no CRO services revenues in the corresponding period of 2021, as the merger with ImQuest took place in June 2021.

Cost of Revenues

Cost of revenue increased from $0 for the six months ended June 30, 2021 to $0.55 million for the six months ended June 30, 2021, representing a 100% decrease.2022. This decreaseincrease is primarily due to cessation in revenues from our JWMRP contract with the DoD for continued preclinical development of entolimod, cessation in revenue from our PRMRP contract with the DoD for continued clinical development of entolimod, and cessation in revenue from our service contract with Incuron. The decreases in revenues are dueentirely to the completioncost of the DoD contracts and grants in 2020 and the discontinuationrevenues recorded from sales to CROs by ImQuest BioSciences.  There were no cost of all revenue and service contracts with Incuron. Accordingly, unless we obtain new contract or grant awards, we may not generate significant revenue until we can commercialize one or more of our product candidates. Differences in our revenue sources, by program, between the years are set forthrevenues in the following table. corresponding period of 2021, as the ImQuest Merger took place in June 2021.

   

Six Months Ended June 30,

     

Funding Source

Program

 

2021

  

2020

  

Variance

 

DoD

JWMRP Contract (1)

 $-  $113,555  $(113,555)

DoD

PRMRP Contract (2)

  -   56,385   (56,385)

Incuron

Service contract

  -   49,357   (49,357)
   $-  $219,297  $(219,297)

(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 decreasedincreased from $0.39 million for the six months ended June 30, 2020 to $0.17$2.8 million for the six months ended June 30, 2021 to $4.2 million for the six months ended June 30, 2022, representing a decreasean increase of $0.22$1.4 million, or 56.2%48.5%. Variances in individual development programs are noted in the table below. The net decreaseincrease is primarily attributable to a $0.20increased spending on specific R&D programs for the six months ended June 30, 2022 of $1.6 million, decreasecompared to $1.0 million for the six months ended June 30, 2021 as well as increased other expenses for the six months ended June 30, 2022 of $2.7 million, compared to $1.9 million for the six months ended June 30, 2021 primarily due to increases in R&D spending for biodefense applications of entolimod due to a reduction in personnel costs. The remaining variances are not significant.employees.

 

  

Six Months Ended June 30,

     
  

2021

  

2020

  

Variance

 

Entolimod for Biodefense Applications

 $164,441  $364,460  $(200,019)

Curaxins

     12,690   (12,690)

Panacela product candidates

  5,332   11,065   (5,733)

Total research & development expenses

 $169,773  $388,215  $(218,442)
  

Six Months Ended June 30,

     
  

2022

  

2021

  

Variance

 

STAT-201: Crohn's disease

 $639,060  $309,742  $329,318 

STAT-205: Acute and post-acute Covid-19

  556,815   676,141   (119,326)

STAT-401: Pancreatic cancer

  184,294      184,294 

STAT-601: Entolimod for acute radiation

  172,652      172,652 

Other expenses

  2,663,111   1,854,077   809,034

 

Total research & development expenses

 $4,215,932  $2,839,960  $1,375,972

 

24

 

General and Administrative Expenses

 

G&A expenses increaseddecreased from $0.87 million for the six months ended June 30, 2020 to $1.05$8.7 million for the six months ended June 30, 2021 to $6.4 million for the six months ended June 30, 2022, representing an increasea decrease of $0.18$2.3 million or 21.0%26.1%ThisVariances are noted in the table and discussed below.

  

Six Months Ended June 30,

     
  

2022

  

2021

  

Variance

 

Payroll (including benefits)

 $3,506,472  $5,494,554  $(1,988,082)

Stock listing expenses

  331,211   384,907   (53,696)

Professional fees

  851,183   1,482,148   (630,965)

Consultants and contractors

  490,314   810,563   (320,249)

Insurance

  440,586   260,370   180,216 

Travel

  39,570   46,276   (6,706)

Other G&A expenses

  747,447   195,945   551,502 

Total general & administrative expenses

 $6,406,783  $8,674,763  $(2,267,980)

Payroll (including benefits) incudes salaries, health benefits and related payroll costs.  The decrease in payroll expense was primarily attributable to a reduction of costs of $4.0 million for stock-based compensation incurred in the six months of 2022 over the comparative cost in the same period in 2021, partially offset by the increase consisted primarily of an increase of $0.18 million in professional fees in part for activitiescosts related to the negotiationincreased employee headcount. Growth in headcount for G&A purposes between 2021 and completion2022 reflects (i) the addition of four employees in 2021 as result of the Merger and the ImQuest Merger, and (ii) the addition of seven new employees in total, several of whom were hired in senior executive roles to complete the Company’s leadership team plus the addition of staff in finance, human resources, information technology and investor relations, offset by the transfer of two employees to R&D.

Stock listing expenses are made up of fees paid to maintain the listing of the Company’s common stock on The NASDAQ, the costs of an investor relations program using outside consultants and databases, costs incurred with advisors to raise new debt and equity required by the Company, and the costs charged by stock transfer agents to maintain the Company’s share registers. The decreased costs in the six months ended June 30, 2022 compared to the six months ended June 30, 2021 reflect stock sale commissions incurred in 2021, partially offset by increased public company costs following the Merger in 2022.

Professional fees comprise fees paid for services to lawyers (other than lawyers who are engaged for services related to R&D), accountants, and the Company’s firm of auditors.  Fees paid to lawyers in the six months ended June 30, 2022 and 2021 totaled $0.5 million and $1.3 million, respectively.  The decrease in fees arose primarily from increased services in the six months ended June 30, 2021 related to the Merger and the ImQuest Merger. 

Fees paid to accountants in the six months ended June 30, 2022 and 2021 totaled $0.1 million and $0.04 million, respectively.  The higher in fees 2022 arose primarily from the use of outside accounting consultants to assist with the compilation of reports and filings required under securities laws.

Fees paid to the audit firms engaged by the Company in the six months ended June 30, 2022 and 2021 totaled $0.1 million and $0.1 million, respectively.  

Consultants and contractors are individuals and firms hired by the Company to provide certain investment banking and advisory services, to assist the Company with the implementation of a new enterprise resource planning (“ERP”) system, to provide valuation reports required to complete the accounting for the Merger and to assist with other general matters.  Fees paid to consultants and contractors in the six months ended June 30, 2022 and 2021 totaled $0.3 million and $0.5 million, respectively.  The decrease in costs was attributable primarily to increased services in the six months ended June 30, 2021 to complete the Merger.

Insurance expenses comprise fees and premiums paid to insurance companies from which the Company purchased policies to protect against loss or damage to its assets and intellectual property, to protect itself against claims for damage caused to third parties by its clinical trials or products used in trials or sold to customers, coverage for workers’ compensation payable for injuries suffered by its employees, and losses incurred by its directors and officers in certain circumstances in the performance of their duties.  Insurance premiums and costs in the six months ended June 30, 2022 and 2021 totaled $0.4 million and $0.3 million, respectively.  The increase was attributable primarily to additional insurance added in 2021 to protect the Company against claims for damage caused to third parties by its clinical trials or products used in trials or sold to customers, and losses incurred by its directors and officers in certain circumstances in the performance of their duties.

Travel. The Company maintains offices in a number of locations in the United States.  As a result of the Merger, new offices were added in 2021 in Colorado, California, Maryland, and New York, requiring an increase in travel between locations.   Travel expenses decreased between the six months ended June 30, 2021 and 2022 from $0.04 million to $0.05 million, respectively.

Other G&A expenses comprise costs to operate and lease office space, non-capital expenditures incurred for office furniture and equipment, telecommunication and internet expenses, postage and courier costs, and bank charges. Other G&A expenses increased year over year primarily as well asa result of the defense against litigation incident thereto.addition of new office locations and employees in 2021 in Colorado, California, Maryland, and New York. 

 

Other Income and Expenses

 

Other income decreased from $0.06Interest and other expense of $1.8 million forin the six months ended June 30, 2020 to $0.0062022 was made up of a $1.2 million of interest expense, $0.25 million of prepayment fees, and $0.35 million for shares issued for services.

Interest and other expense of $0.4 million in the six months ended June 30, 2021 representing a decrease of $0.06 million or approximately 100%. This decrease primarily relatedrelate to non-cash income during the three months ended June 30, 2020 resulting from a $0.5 million extinguishment of an accrued liability, offset by $0.45 million in expense related to the change in valuation of our warrant liability as a result of stock price changes. interest expense.

 

1825

 

Liquidity and Capital Resources

 

We have incurred net losses of approximately $170 million from our inception through June 30, 2021. 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 June 30, 2021, we have raised $160.6 million of net equity capital, including amounts received in connection with our February 2021 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 June 30, 2021;

 •     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 the Company contributed $3.0 million plus intellectual property to Panacela. As of the date of this filing, the Company 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.

Since the end of the fiscal quarter ended June 30, 2021, as a result of the Merger, we have become party to several new financing arrangements, including a credit facility and equity line-of-credit agreement, that have provided us with additional cash in the aggregate amount of approximately $10 million. We have the capacity to make further borrowings and drawings under these facilities, which can provide us with additional working capital. See “ – Avenue Facility” and “ – GEM Equity Line Agreement” below.

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 and our contracts and grants with the DoD were completed in 2020, meaning that we are currently not generating any revenues or cash from operations. At June 30, 2021,2022, we had cash and cash equivalents of $13.8$0.6 million, which represents a increasedecrease of $11.5$6.2 million since the end of our last fiscal year. This increasedecrease was caused by our capital raise in the first quarter of 2022, offset by our net cash used in operations of $1.2$3.9 million during the six months ended June 30, 2021.2022 and repayment of debt. As discussed above, we are a clinical-stage company, have generated only insignificant revenues to date, and have incurred cumulative net losses and expect to incur significant expenses and operating losses for the foreseeable future as we advance our lead candidates through clinical trials, progress our pipeline candidates from discovery through pre-clinical development, and seek regulatory approval and pursue commercialization of our candidates. We do not have commercial products other than CRO services, we have limited capital resources, meaning that we are currently generating limited revenues and cash from operations.  We do not expect our cash and cash equivalents will be sufficient to fund our projected operating requirements andor allow us to fund our operating plan, in each case, into Augustbeyond the third quarter of 2022.  However, until we are able to commercialize our product candidates atAs a level that covers our cash expenses,result, we will need additional financing to raise substantial additional capital,support our continuing operations.  Historically, we have funded our operations through the sale of equity and debt securities, as well as the receipt of funded grants. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity and debt financings or other sources, 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,collaborations with third parties, 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. ThereHowever, we can beprovide no assurance that we will be able to obtain future financing onraise cash in sufficient amounts, when needed or at acceptable terms, obtain additional government financing forterms. We do not expect that 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 conditionsexisting cash and may reduce opportunities forcash equivalents will enable us to seek out additional funding.fund our operating expenses and capital expenditure requirements beyond the third quarter of 2022. 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 included elsewhere in this Quarterly Report on Form 10-Q 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 sixthree months ended June 30, 20212022 and 2020:2021:

 

  For the Six Months Ended June 30, 
  

2021

  

2020

  

Variance

 

Cash flows used in operating activities

 $(1,223,547) $(902,004) $(321,543)

Cash flows provided by investing activities

  323,111   43,245   279,866 

Cash flows provided by financing activities

  12,723,288   3,165,640   9,557,648 

Effect of exchange rate change on cash and equivalents

  7,685   (23,695)  31,380 

Increase in cash and cash equivalents

  11,830,537   2,283,186   9,547,351 

Cash and cash equivalents at beginning of period

  1,946,418   1,126,124   820,294 

Cash and cash equivalents at end of period

 $13,776,955  $3,409,310  $10,367,645 

19

  

For the Six Months Ended June 30,

 
  

2022

  

2021

  

Variance

 

Cash flows used in operating activities

 $(3,930,067

)

 $(5,613,797

)

 $1,683,730

 

Cash flows provided by (used in) investing activities

  (6,454)  514,961

 

  (521,415) 

Cash flows provided by (used in) financing activities

  (2,398,319)  20,226,593   (22,624,912)
Effect of exchange rate on cash and cash equivalents   43,862   -   43,862 

Increase (decrease) in cash and cash equivalents

  (6,290,978)  15,127,757   (21,418,735)

Cash, cash equivalents, and restricted cash at beginning of period

  6,844,732   593,869   6,250,863 

Cash, cash equivalents, and restricted cash at end of period

 $553,754  $15,721,626  $(15,167,872)

 

Operating Activities

 

Net cash used in operating activities increaseddecreased by $0.3$1.7 million to $1.2$3.9 million for the six months ended June 30, 20212022 from $0.90$5.6 million for the six months ended June 30, 2020.2021. Net cash used in operating activities for the period ending June 30, 20212022 consisted of a reported net loss of $1.2 million.

Net cash used in operating activities for the six months ended June 30, 2020 of $0.90 million consisted of a reported net loss of $0.98$11.3 million, which was further increaseddecreased by $0.05 million of net non-cash operating activities, and offset by $0.13$7.3 million of changes in operating assets and liabilities.  The $0.05 million of net non-cash operating activities was due to a $0.5 million gain on extinguishment of an accrued liability, offset by $0.45 million in expense related to the change in valuation of our warrant liability as a result of stock price changes. The $0.13$7.3 million of changes in operating assets and liabilities was due primarily to a decreasean increase in accounts receivablepayable and accrued expenses and decreases in prepaid expenses and other current assets.

Net cash used in operating activities for the three months ended June 30, 2021 of $5.6 million consisted of a reported net loss of $11.9 million, which was decreased by $4.3 million of net non-cash operating activities and $2.0 million of changes in operating assets and liabilities. The $4.3 million changes in net non-cash operating activities was primarily related to stock based compensation. The $2.0 million of changes in operating assets and liabilities was due primarily to changes in working capital items. 

 

Investing Activities

 

Net cash provided byused in investing activities increaseddecreased to $0.3$0.006 million for the six months ended June 30, 20212022 from $0.04$0.5 million of net cash provided by investing activities for the six months ended June 30, 202031, 2021, primarily due to the sale of short-term investments duringacquired net assets related to the six months ended June 30, 2021.ImQuest acquisition. 

 

Financing Activities

 

Net cash provided byused in financing activities increased to $12.7$2.4 million for the six months ended June 30, 20212022 from $3.2$20.2 million of net cash provided by financing activities for the six months ended June 30, 20202021 due to anthe repayment of $9.3 million of long-term notes payable, partially offset by $6.4 million due to the issuance of common stock net of offering costs during the six months ended June 30, 2022. Net cash provided by financing activities of $20.2 million was primarily due to the issuance of long-term debt and the issuance of preferred stock during the six months ended June 31, 2021.

 

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, 2021 and June 30, 2021, this rate fluctuated by 1.1%. For calendar year 2020, this rate fluctuated by 18.9%. 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 lossesgain of $0.04 million for the six months ended June 30, 2022 are recorded as other comprehensive income or loss in the equity section of the balance sheet.

 

26

Sources of Liquidity

Avenue Facility


Under the terms of the Avenue Facility, Avenue agreed to make term loans to Old Cytocom from time to time in the aggregate principal amount of up to $15,000,000. Each loan made by Avenue under the Avenue Facility will be evidenced by a separate promissory note payable to Avenue. The loans will bear interest at a variable rate of interest equal to the sum of (i) the greater of (A) the Prime Rate and (B) 3.25% plus (ii) 7.74%. Repayment of the loans owed under the Avenue Facility are secured by a security interest in substantially all of Old Cytocom’s assets, including equipment, fixtures, inventory, deposit accounts and personal property, as well as the securities it holds in its wholly owned subsidiaries. The making of each loan requested by Old Cytocom is subject to certain customary conditions, including the provision of a legal opinion, certified copies of resolutions and organizational documents, the company’s good standing and other matters.


The aggregate loan amounts were deposited by Avenue into a controlled account. Old Cytocom transferred $10 million into its general operating account during July 2021, which was assigned to the Company, and accordingly, the Company’s assets are subject to a security interest in favor of Avenue. The Company will be able to transfer an additional $5 million into its general operating account, which will be subject to a control agreement with Avenue, upon the Company raising at least $20 million in additional capital in the form of subordinated indebtedness or equity from a follow-on transaction entered into after the Effective Time. The loans may then be drawn down from the controlled account and will be evidenced by a promissory note. The note will provide that the Company will be required to make only monthly interest payments, calculated as described above, until April 2022 (which may be extended to April 2023 upon the Company’s raising of an additional $20 million in capital). Thereafter, the Company will also be required to make monthly payments of principal in equal installments until the maturity date of May 1, 2024.


The Avenue Facility documents contain customary representations and warranties of Old Cytocom, as well as various affirmative and negative covenants. Among such covenants are requirements that the Company:


•     provide notice of certain events;
•     deliver monthly financial statements to Avenue, until the Company has a market capitalization of at least $250 million and maintains at least a minimum of $4 million in unrestricted cash, after which it will only need to provide quarterly statements;
•     execute regular compliance certificates;
•     provide copies of all board of directors materials and minutes of meetings to Avenue;
•     maintain its existence and comply with all applicable laws;
•     may not become indebted for borrowed money, the deferred purchase price for property or enter into any leases that would be capitalized in accordance with GAAP, subject to certain exceptions, including indebtedness for the acquisition of supplies, subordinated indebtedness and certain other items;
•     maintain a minimum of $5 million in unrestricted cash and cash equivalents in accounts subject to control agreements with Avenue;
•     may not create, incur or assume any liens on its property;
•     may not undergo any fundamental or change-in-control transactions or sell all its assets;
•     may not make any loans or investments, subject to certain exceptions;
•     may not enter into any transactions with related parties;
•     may not prepay any other indebtedness; or
•     may not create, acquire or sell any subsidiaries.

The Avenue Facility documents also grant certain additional rights to Avenue. Under the Avenue Facility, Avenue has a preemptive right to purchase up to $1 million of Company equity securities on the same terms, conditions and prices offered by the Company to any investor in connection with any equity or debt financing until October 16, 2022. Additionally, Avenue has the right to convert up to $3 million of outstanding principal into shares of Company common stock. The number of shares issuable upon conversion will be determined by dividing the amount of indebtedness being converted by 120% of the 5-day volume weighted average price (VWAP) of Company common stock prior to the date of the issuance of the Avenue Warrant. As of June 30, 2022, there was $6.2 million in outstanding principal and interest under the Avenue Facility, and no unused further borrowing capacity. We paid an aggregate of $9.6 million in interest, principal, and other fees to Avenue during the six months ended June 30, 2022.

 

GEM Equity LineAs discussed above under " – Recent Developments," on March 25, 2022, we received the Default Letter from Avenue regarding alleged events of default with respect to the Avenue Facility.  In the Default Letter, Avenue alleges that certain events of default under the Avenue Facility have occurred and continue to exist. Specifically, Avenue alleges that the Company is in violation of certain provisions of the Avenue Facility as a result of the Company’s failure to:

timely deliver monthly financial statements for certain periods;

obtain Avenue’s consent to repurchase certain securities from stockholders;

pay principal and interest when due, including on March 1, 2022; and

maintain unrestricted cash and cash equivalents in one or more accounts subject to control agreements in favor of Avenue in amount of at least $5 million.

In the Default Letter, Avenue purported to exercise its rights to suspend further loans or advances to the Company under the Avenue Facility and to declare accelerate the amount due under the Avenue Facility, which it asserts to be approximately $11.2 million, inclusive of fees of penalties. Avenue further states in the Default Letter that interest will continue to accrue on the outstanding amounts at the default rate of 5.0%. In furtherance of the allegations set forth in the Default Letter, Avenue foreclosed on approximately $4.8 million of the Company’s cash.

As mentioned above, the Company entered into a Forbearance Agreement


Under
on April 18, 2022 regarding the Avenue Facility with Avenue. Pursuant to the Forbearance Agreement, the parties agreed that they will refrain and forbear from exercising certain remedies arising out of the events of default or any other present or future event of default under the Loan Agreement or supplement during the Forbearance Period. Additionally, the parties agreed that Avenue shall not seize, sweep, or by any means take control of, directly or indirectly, any funds from any of the Company’s bank accounts; and (ii) during the Forbearance Period, the Loans may be prepaid in whole or in part at any time, subject to the repayment and prepayment terms of the Loan Agreement. In addition to the terms of the GEM Equity LineForbearance Agreement, the agreement became immediately binding upon the Company at the Effective Time. Under the GEM Equity Line Agreement, the Company may elect to issue and sell to GEM up to $75 million of its common stock. Upon the electioncertain terms of the CompanyLoan Agreement were amended, including changing the Agreement Effective Date to make such a sale, it will deliver a draw-down notice to GEM,April 18, 2022, and if all applicable conditions are satisfied, GEM will purchase newly issued shares for the amount specified in the draw-down notice. The purchase price of the shares to be sold is set at 90% of the recent average daily closing price of the Company’s common stock on the Nasdaq Capital Market or other market on which the stock may be listed. The Company is not permitted to make a draw-down request in an amount that exceeds 400% of the average daily trading volume of the Company’s stock for the 30 trading days preceding the draw-down date. Each draw down is subjectrevisions to certain closing conditions, including (i) the continued accuracydefinitions of the representations and warranties made in the Agreement terminology.

GEM Equity Line Agreement (ii) a registration statement registering the resale of the shares sold under the GEM Equity Line Agreement having been declared effective by the Securities and Exchange Commission ("SEC"), (ii) the absence of any law, order, ruling or injunction prohibiting the consummation of the transactions contemplated by the GEM Equity Line Agreement, (iii) the Company’s common stock not being suspended from trading by the Nasdaq Capital Market or other market on which the shares are then listed, (iv) the absence of any litigation commenced, or governmental investigation commenced or threated, against the Company in connection with the GEM Equity Line Agreement transactions and (v) with respect to the first draw down only, the delivery by the Company’s counsel of a negative assurance letter and delivery by the Company’s independent auditors of a comfort letter. However, the Company will be permitted to make a draw-down request for the sale of up to $15 million of shares in the period immediately following the Effective Time without having to have an effective resale registration statement in effect. The resale of the shares sold pursuant to this initial drawdown request will not be required to be registered immediately.


Upon the Company’s issuance of shares in connection with any draw-down purchase made by GEM, the Company will be required to pay GEM, in cash or additional shares of stock, a commitment fee in an amount equal to 2% of the amount purchased in such drawdown.


The GEM Equity Line Agreement terminates on the earliest to occur of (i) three years from the Effective Time,effective time of the Merger, (ii) May 21, 2026 or (iii) the date on which GEM has purchased $75 million in the aggregate of Company stock. Upon payment of $1.5 million to GEM, the Company may terminate the GEM Equity Line Agreement following the settlement in full of the issuance of the shares made for the first $15 million draw-down purchase.
The GEM Equity Line Agreement contains customary representations and warranties

As of June 30, 2022, the Company as well as various affirmativehas issued 2.99 million shares of common stock of which 1.84 million shares of common stock were sold for total net proceeds of $3.7 million after commission and negative covenants. Among such covenants are requirements that the Company:


•     comply with applicable laws, including the securities laws;
•     file a registration statement with the SEC to register the resale
expenses of theapproximately $0.075 million, and 1.15 million shares soldremained available for sale under the GEM Equity Line Agreement and undertake best efforts to maintain the effectiveness of the registration statement;
•     not enter into any other agreement that would restrict or impair the Company’s ability to perform under the GEM Equity Line Agreement, including any other equity line arrangement; and
•     keep reserved an adequate number of shares for issuance under the GEM Equity Line Agreement.

 

Material Cash Requirements

The Company’s material cash requirements include the following contractual obligations:

As of June 30, 2022, the Company had $6.4 million of debt outstanding. This balance is composed of a $6.2 million short-term note payable to Avenue and $0.2 million in additional short-term debt. See Note 5, "Note Payable" & Note 6, "Note Payable, net of current portion" to the Consolidated Financial Statements for additional information. Avenue has declared us in default under the Avenue Facility and purported to accelerate the balance due under the facility.

As of June 30, 2022, the Company had $1.6 million of future lease commitments. See Note 7 "Leases" to the Condensed Consolidated Financial Statements for additional detail on future lease commitments.

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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 Chief Executive Officer and ChiefInterim 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 June 30, 2021.2022. 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 June 30, 2021,2022, our Chief Executive Officer and ChiefInterim Principal Financial Officer concluded that, as of such date, our disclosure controls and procedures were 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 Chief Executive Officer and ChiefInterim Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

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 June 30, 20212022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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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, other than those set forth below, as of June 30, 2021,2022, 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.

 

On March 12, 2021, a complaint, captioned Teo v. Cleveland BioLabs, Inc. et al., Case 1:21-cv-02187, was filed in the U.S. District Court for the Southern District of New York in connection with the Merger (the "Teo Action"). The Teo Action names as defendants Cleveland BioLabs, each director on the Cleveland BioLabs board of directors, Merger Sub and Cytocom. The complaint in the Teo Action alleges that (i) the Cleveland BioLabs board of directors breached its fiduciary duties to the plaintiff stockholder in entering into the Merger Agreement and (ii) Cleveland BioLabs and the Cleveland BioLabs board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, of which this proxy statement/prospectus forms a part, in violation of the Securities Exchange Act of 1934, as amended (the "Exchange Act") and related SEC regulations.  On July 14, 2021, Plaintiff Teo filed a notice of dismissal.  On July 16, 2021, the Southern District entered an order dismissing the case.

On March 17, 2021, a complaint, captioned Steudte v. Cleveland BioLabs, Inc. et al., Case 1:21-cv-02314, was filed in the U.S. District Court for the Southern District of New York in connection with the Merger (the "Steudte Action").  The Steudte Action names as defendants Cleveland BioLabs and each director on the Cleveland BioLabs board of directors.  The complaint in the Steudte Action alleges that Cleveland BioLabs and the Cleveland BioLabs board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, of which this proxy statement/prospectus forms a part,  in violation of their fiduciary duties and the Exchange Act and related SEC regulations. The Steudte Action seeks, among other things, an injunction preventing the closing of the merger, rescission of the merger if it is consummated, the dissemination by the Company of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees.  Defendants have filed a letter seeking permission to file a motion to dismiss.  The parties have until August 15, 2021 to inform the Southern District whether the case has or will be dismissed and whether the issue of attorneys’ fees has been resolved.

On March 19, 2021, a putative class action complaint, captioned Litwin v. Cleveland BioLabs, Inc. et al., Case 2021-0242, was filed in the Delaware Court of Chancery in connection with the Merger (the “Litwin Action”). The Litwin Action names as  defendants Cleveland BioLabs, each director on the Cleveland BioLabs board of directors, and the Vice President of Finance of Cleveland BioLabs. The complaint in the Litwin Action alleges that Defendants omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, of which this proxy statement/prospectus forms a part, in breach of their fiduciary duties. The Litwin Action seeks, among other things, an injunction preventing the closing of the Merger, rescission of the merger if it is consummated, the dissemination by Cleveland BioLabs of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees. Plaintiff in the Litwin Action has filed a motion for expedited proceedings, which Defendants have opposed. Plaintiff’s motion for expedited proceedings was granted in part and denied in part by the court on April 30, 2021. Defendants have also filed a motion to dismiss the Litwin Action.  On July 7, 2021, Plaintiff filed a stipulation and proposed order voluntarily dismissing the case, but reserving the right to seek attorneys’ fees.  On July 8, 2021, the Delaware Court of Chancery entered an order dismissing the case, but reserving jurisdiction to determine whether to award Plaintiff’s counsel any fees, should Plaintiff’s counsel file a motion for such.

On March 18, 2021, a complaint, captioned Wang v. Cleveland BioLabs, Inc. et al., Case 1:21-cv-02395, was filed in the U.S. District Court for the Southern District of New York in connection with the Merger (the "Wang Action").  The Wang Action names as defendants the Company, each director on the Company’s board of directors, Merger Sub and Cytocom.  The complaint in the Wang Action alleges that the Company and the Company’s board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, of which this proxy statement/prospectus forms a part, in violation of the Exchange Act and related SEC regulations. The Wang Action seeks, among other things, an injunction preventing the closing of the Merger, rescission of the Merger if it is consummated, the dissemination by the Company of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees. On July 29, 2021, Plaintiff Wang filed a notice of dismissal.  On August 2, 2021, the Southern District entered an order dismissing the case.

On March 23, 2021, a complaint, captioned Morgan v. Cleveland BioLabs, Inc. et al., Case 1:21-cv-00418, was filed in the U.S. District Court for the District of Delaware in connection with the Merger (the "Morgan Action").  The Morgan Action names as defendants Cleveland BioLabs and each director on the Cleveland BioLabs board of directors.  The complaint in the Morgan Action alleges that Cleveland BioLabs and the Cleveland BioLabs board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, of which this proxy statement/prospectus forms a part, in violation of the Exchange Act and related SEC regulations. The Morgan Action seeks, among other things, an injunction preventing the closing of the Merger, rescission of the Merger if it is consummated, the dissemination by Cleveland BioLabs of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees.

On March 24, 2021, a complaint, captioned Bednar v. Cleveland BioLabs, Inc. et al., Case 1:21-cv-02546, was filed in the U.S. District Court for the Southern District of New York in connection with the Merger (the "Bednar Action"). The Bednar Action names as defendants Cleveland BioLabs and each director on the Cleveland BioLabs board of directors. The complaint in the Bednar Action alleges that Cleveland BioLabs and the Cleveland BioLabs board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger of which this proxy statement/prospectus forms a part, in violation of their fiduciary duties
and the Exchange Act and related SEC regulations. The Bednar Action seeks, among other things, an injunction preventing the closing of the Merger, rescission of the Merger if it is consummated, the dissemination by the Company of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees. The parties have until August 15, 2021 to inform the Southern District whether the case has or will be dismissed and whether the issue of attorneys’ fees has been resolved.

On April 1, 2021, a complaint, captioned Hoenecke v. Cleveland BioLabs, Inc., et al., Case 1:21-cv-1789, was filed in the U.S. District Court for the Eastern District of New York in connection with the Merger (the “Hoenecke Action”).  The Hoenecke Action names as defendants Cleveland BioLabs and each director on the Cleveland BioLabs board of directors.  The complaint in the Hoenecke Action alleges that Cleveland BioLabs and the Cleveland BioLabs board of directors omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, of which this proxy statement/prospectus forms a part, in violation of the Exchange Act and related SEC regulations.  The Hoenecke Action seeks, among other things, an injunction preventing the closing of the Merger, rescission of the Merger if it is consummated, the dissemination by the Company of a revised registration statement on Form S-4 and an award of plaintiffs’ attorneys’ and experts’ fees. On June 29,October 13, 2021, Plaintiff filed a notice of dismissal.  That same day, the Southern District entered an order dismissing the case.

On March 23, 2021, a complaint captioned Stickel v. Cleveland Biolabs, Inc., et al., Case 1:21-cv-02489, was filed in the U.S. District Court for the Southern District of New York in connection with the Merger (the “Stickel Action”).  The Stickel Action names as defendants Cleveland BioLabs and each director on the Cleveland BioLabs board of directors. The complaint alleges that Cleveland BioLabs and the Cleveland BioLabs board of director omitted and/or provided misleading information in the registration statement on Form S-4 filed with the SEC in connection with the Merger, in violation of the Exchange Act and SEC regulations.  Stickel seeks to enjoin the company from consummating the Merger, to force the Company to amend the registration statement, and to collect damages and attorneys’ fees. On July 15, 2021, PlaintiffBednar filed a notice of dismissal. On July 16,October 20, 2021, the Southern District entered an order dismissing the case. On December 23, 2021, Plaintiff Bednar filed a new action in the Delaware Court of Chancery, asserting a cause of action for an equitable assessment of attorneys’ fees and
expenses incurred in connection with the first lawsuit. The new Delaware action names the same defendants as the first Bednar Action. The Defendants in the new Delaware action have filed an answer to Plaintiff’s Delaware complaint.

 

On August 16, 2022, certain former employees of the Company and certain third party vendors of the Company (collectively, "Petitioning Creditors") filed an involuntary petition in the United States Bankruptcy Court for the District of Colorado (No. 22-13051-JGR) against the Company seeking relief under Chapter 11 of the United States Bankruptcy Code. The Company believes the involuntary petition is improper and wrongfully filed and is seeking dismissal of the petition.

The Company cannot predict the outcome of these lawsuits.

 

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Item 1A. Risk Factors

 

None.As a smaller reporting company (as defined in Rule 12b-2 of the Exchange Act), we are not required to provide the information called for by this Item 1A.

 

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

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

None.

 

Item 5. Other Information

 

None.

 

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30

 

Item 6. Exhibits

 

 

(a)

The following exhibits are included as part of this report:

 

Exhibit

Number

 

Description of Document

 

 

 

3.1*

   10.1

Restated Certificate of Incorporation, as amended.

3.2

Forbearance and Second Amended and Restated By-Laws (IncorporatedAmendment to Loan Documents, dated April 18, 2022 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on December 5, 2007).

3.3

Amendment to Second Amended and Restated By-Laws of Cleveland BioLabs, Inc. (Incorporated by reference to Exhibit 3.11.1 to Form 8-K filed on May 18, 2015)27, 2022).

   10.2†Form of Independent Director’s Agreement (incorporated by reference to Exhibit 10.1 to Form 8-K filed on June 22, 2022).
10.3*Warrant Agency Agreement dated March 24, 2022.
   

31.1*

 

Rule 13a-14(a)/15d-14(a) Certification of Michael K. Handley.

   
    31.2* Rule 13a-14(a)/15d-14(a) Certification of Peter Aronstam.Christopher Zosh.

 

 

 

32.1*

 

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

 

 

 

101.1

 

The following information from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021,2022, formatted in Inline Extensible Business Reporting Language (XBRL)(iXBRL): (i) Condensed Consolidated Condensed Balance Sheets as of June 30, 20212022 and December 31, 2020;2021; (ii) Condensed Consolidated Condensed Statements of Operations for the Three and Six Months Ended June 30, 20212022 and 2020;2021; (iii) Condensed Consolidated Condensed Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 20212022 and 2020;2021; (iv) Condensed Consolidated Condensed Statement of Stockholders’ EquityDeficit for the Six Months Ended June 30, 20212022 and 2020;2021; (v) Condensed Consolidated Condensed Statements of Cash Flows for the Six Months Ended June 30, 20212022 and 2020;2021; and (vi) Notes to Condensed Consolidated Condensed Financial Statements.

 

 

 

    104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
   

*

 

Filed herewith.

    †Includes management contracts and compensation plans and arrangements.

 

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31

 

Signatures

 

In accordance with the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

CYTOCOM,STATERA BIOPHARMA, INC.

 

 

 

Dated: August 16, 2021October 28, 2022

By:

/s/ Peter AronstamChristopher Zosh

 

 

Peter AronstamChristopher Zosh

  Chief Financial OfficerExecutive Vice President of Finance

 

 

(Interim Principal Financial Officer)

 

 

 

 

 

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