0000810509 NAVIDEA BIOPHARMACEUTICALS, INC. false --12-31 Q2 2022 779,695 0.001 0.001 5,000,000 5,000,000 0 0 0 0 0.001 0.001 150,000 150,000 22,077 22,077 22,077 22,077 0.001 0.001 50,000 50,000 0 0 50,000 50,000 0.001 0.001 1,740 1,740 1,740 1,740 0 0 0.001 0.001 3,260 3,260 3,260 3,260 0 0 0.001 0.001 75,000 75,000 0 0 0 0 0.001 0.001 300,000,000 300,000,000 30,364,792 30,364,792 30,279,922 30,279,922 8 10 0 0 0 0 0 2 7 5 5 1,000 2 0 2 General and administrative expenses, excluding depreciation and amortization, represent costs that relate to the general administration of the Company and as such are not currently allocated to our individual reportable segments, other than those expenses directly incurred by Navidea Europe, Navidea UK and MT. Depreciation and amortization are reflected in selling, general and administrative expenses ($21,771 and $19,858 for the three-month periods ended June 30, 2022 and 2021, and $44,649 and $37,606 for the six-month periods ended June 30, 2022 and 2021, respectively). Amounts consist primarily of interest income and interest expense, which are not currently allocated to our individual reportable segments. Loss from operations does not reflect the allocation of certain selling, general and administrative expenses, excluding depreciation and amortization, to our individual reportable segments, other than those expenses directly incurred by Navidea Europe, Navidea UK and MT. 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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, 2022                                                                                                                                     

 

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: 001-35076                         

 

NAVIDEA BIOPHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

31-1080091

State or Other Jurisdiction of

Incorporation or Organization

 

IRS Employer Identification No.

 

4995 Bradenton Avenue, Suite 240, Dublin, Ohio

 

43017-3552

Address of Principal Executive Offices

 

Zip Code

 

(614) 793-7500

Registrant’s Telephone Number, Including Area Code

 


 

Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of exchange on which registered

Common Stock

NAVB

NYSE American

Preferred Stock Purchase Rights

N/A

NYSE American

 

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 (§ 232.405 of this chapter) 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, 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 12-b-2 of the Act.) Yes   No ☒

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 30,367,292 shares of common stock, par value $.001 per share (as of the close of business on August 8, 2022).

 



 

 

 

 

NAVIDEA BIOPHARMACEUTICALS, INC. AND SUBSIDIARIES

 

TABLE OF CONTENTS

 

PART I  Financial Information

 
     

Item 1.

Condensed Consolidated Financial Statements

3
     
 

Condensed Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021

3
     
 

Condensed Consolidated Statements of Operations for the Three-Month and Six-Month Periods Ended June 30, 2022 and 2021 (unaudited)

5
     
 

Condensed Consolidated Statements of Stockholders’ (Deficit) Equity for the Six-Month Periods Ended June 30, 2022 and 2021 (unaudited)

6
     
 

Condensed Consolidated Statements of Cash Flows for the Six-Month Periods Ended June 30, 2022 and 2021 (unaudited)

8
     
 

Notes to the Condensed Consolidated Financial Statements (unaudited)

9
     

Item 2.

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

26
     
 

Forward-Looking Statements         

26
     
 

The Company         

26
     
 

Technology and Product Candidates         

27
     
 

Outlook         

31
     
 

Results of Operations         

32
     
 

Liquidity and Capital Resources         

33
     
 

Off-Balance Sheet Arrangements         

35
     
 

Recent Accounting Standards         

35
     
 

Critical Accounting Policies         

35
     
 

Critical Accounting Estimates         

36
     

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

36
     

Item 4.

Controls and Procedures         

36
     
 

Disclosure Controls and Procedures         

36
     
 

Changes in Control Over Financial Reporting         

37
     

PART II  Other Information

 
     

Item 1.

Legal Proceedings         

38
     

Item 1A.

Risk Factors         

38
     

Item 6.

Exhibits         

38
 

 

2

 

PART I FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements

 

 

Navidea Biopharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

 

  

June 30,

2022

  

December 31,

2021

 

ASSETS

 

(unaudited)

     

Current assets:

        

Cash and cash equivalents

 $328,012  $4,230,865 

Receivables

  30,069   92,992 

Inventory, net

  315,670   151,155 

Prepaid expenses and other

  496,989   908,273 

Total current assets

  1,170,740   5,383,285 

Property and equipment

  821,416   866,306 

Less accumulated depreciation and amortization

  673,493   745,816 

Property and equipment, net

  147,923   120,490 

Right-of-use lease assets

  448,940   448,940 

Less accumulated amortization

  381,654   320,725 

Right-of-use lease assets, net

  67,286   128,215 

License agreements, patents and trademarks

  1,081,762   953,424 

Less accumulated amortization

  191,198   167,773 

License agreements, patents and trademarks, net

  890,564   785,651 

Other assets

  227,192   227,192 

Total assets

 $2,503,705  $6,644,833 

 

(continued)

 

3

 

Navidea Biopharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets (continued)

 

  

June 30,

2022

  

December 31,

2021

 

LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY

 

(unaudited)

     

Current liabilities:

        

Accounts payable

 $2,426,652  $1,421,317 

Accrued liabilities and other

  2,776,924   3,149,340 

Note payable, current

     453,427 

Lease liabilities, current

  118,409   275,718 

Total current liabilities

  5,321,985   5,299,802 

Lease liabilities, net of current portion

  2,062   20,288 

Deferred revenue

  700,000   700,000 

Note payable to related party, net of discount of $779,695

  720,305    

Total liabilities

  6,744,352   6,020,090 

Commitments and contingencies (See Note 10)

          

Stockholders’ (deficit) equity:

        

Preferred stock; $.001 par value; 5,000,000 shares authorized; no shares issued or outstanding as of June 30, 2022 and December 31, 2021

      

Series D preferred stock; $.001 par value, 150,000 shares authorized; 22,077 shares issued and outstanding as of June 30, 2022 and December 31, 2021

  22   22 

Series E preferred stock; $.001 par value, 50,000 shares authorized; 0 and 50,000 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

     50 

Series F preferred stock; $.001 par value, 1,740 shares authorized; 1,740 and 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

  2    

Series G preferred stock; $.001 par value, 3,260 shares authorized; 3,260 and 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

  3    

Series H preferred stock; $.001 par value, 75,000 shares authorized; 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021

      

Common stock; $.001 par value, 300,000,000 shares authorized; 30,364,792 and 30,279,922 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

  221,361   221,277 

Additional paid-in capital

  372,019,758   370,459,705 

Accumulated deficit

  (376,774,310

)

  (370,787,610

)

Total stockholders' deficit

  (4,533,164

)

  (106,556

)

Noncontrolling interest

  292,517   731,299 

Total Navidea stockholders’ (deficit) equity

  (4,240,647

)

  624,743 

Total liabilities and stockholders’ (deficit) equity

 $2,503,705  $6,644,833 

 

See accompanying notes to condensed consolidated financial statements.

 

4

 

 

Navidea Biopharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(unaudited)

 

   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
   

2022

   

2021

   

2022

   

2021

 

Revenue:

                               

Sales revenue

  $ 6,519     $     $ 6,519     $  

License revenue

          13,063             35,549  

Grant and other revenue

    51,007       247,983       51,007       349,234  

Total revenue

    57,526       261,046       57,526       384,783  

Cost of revenue

    473             473        

Gross profit

    57,053       261,046       57,053       384,783  

Operating expenses:

                               

Research and development

    1,723,988       1,498,056       2,893,242       2,720,810  

Selling, general and administrative

    1,255,666       1,432,610       3,065,695       3,663,355  

Total operating expenses

    2,979,654       2,930,666       5,958,937       6,384,165  

Loss from operations

    (2,922,601

)

    (2,669,620

)

    (5,901,884

)

    (5,999,382

)

Other (expense) income:

                               

Interest (expense) income, net

    (83,584

)

    1,266       (87,246

)

    (1,609

)

Gain on extinguishment of debt

                      366,000  

Other, net

    6,726       (5,686

)

    2,427       (5,941

)

Total other (expense) income, net

    (76,858

)

    (4,420

)

    (84,819

)

    358,450  

Net loss

    (2,999,459

)

    (2,674,040

)

    (5,986,703

)

    (5,640,932

)

Loss attributable to noncontrolling interest

    1       1       3       3  

Net loss attributable to common stockholders

  $ (2,999,458

)

  $ (2,674,039

)

  $ (5,986,700

)

  $ (5,640,929

)

                                 

Loss attributable to common stockholders per common share (basic and diluted)

  $ (0.10

)

  $ (0.09

)

  $ (0.20

)

  $ (0.20

)

Weighted average shares outstanding

    30,268,858       29,117,832       30,238,471       28,531,660  

 

See accompanying notes to condensed consolidated financial statements.

 

5

 

 

Navidea Biopharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders Equity

(unaudited)

 

For the Six Months Ended June 30, 2022

                   
                   
  

Preferred Stock

  

Common Stock Issued

  

 

  

 

  

 

  

 

 
  

Shares

  

Amount

  

Shares

  

Amount

   Additional Paid-In
Capital
   Accumulated Deficit   Non-controlling
Interest
  Total 

Balance, January 1, 2022

  72,077  $72   30,279,922  $221,277  $370,459,705  $(370,787,610) $731,299  $624,743 

Issued stock in lieu of cash bonuses

  -   -   16,632   17   16,948   -   -   16,965 

Issued stock to 401(k) plan

  -   -   53,238   53   44,667   -   -   44,720 

Issued stock in lieu of cash for payment of director fees

  -   -   7,500   7   6,518   -   -   6,525 

MT Preferred Stock reacquired due to Platinum settlement

  -   -   -   -   438,778   -   (438,778)  - 

Stock compensation expense

  -   -   -   -   184,850   -   -   184,850 

Net loss

  -   -   -   -   -   (2,987,242)  (3)  (2,987,245)

Balance, March 31, 2022

  72,077   72   30,357,292   221,354   371,151,466   (373,774,852)  292,518   (2,109,442)

Series E Preferred Stock exchanged for Series F and Series G Preferred Stock

  (45,000)  (45)  -   -   821,295   -   -   821,250 

Issued stock in lieu of cash for payment of director fees

  -   -   7,500   7   6,443   -   -   6,450 

Stock compensation expense

  -   -   -   -   40,554   -   -   40,554 

Net loss

  -   -   -   -   -   (2,999,458)  (1)  (2,999,459)

Balance, June 30, 2022

  27,077  $27   30,364,792  $221,361  $372,019,758  $(376,774,310) $292,517  $(4,240,647)

 

6

 

For the Six Months Ended June 30, 2021

                               
                               
  

Preferred Stock

  

Preferred Stock Subscribed

  

 

  

Common Stock Issued

  

Common Stock Subscribed

  

 

  

 

  

 

  

 

  

 

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Preferred Stock

Subscriptions

Receivable

  

Shares

  

Amount

  

Shares

  

Amount

  

Common Stock

Subscriptions

Receivable

  

 

Additional Paid-In

Capital

  Accumulated  Deficit  

Non-controlling

Interest

  Total 

Balance, January 1, 2021

    $   132,250  $132  $(10,300,000)  27,149,691  $218,146   995,000  $995  $(4,975,000) $375,428,014  $(359,056,683) $731,303  $2,046,907 

Issued restricted stock

                 12,500   13                     13 

Issued stock to 401(k) Plan

                 30,018   30            76,816         76,846 

Issued Series D Preferred Stock

  31,750   32   (31,750)  (31)  250,000                           250,001 

Issued stock upon conversion of Series D Preferred Stock

  (31,750)  (32)           1,513,978   1,514            (1,482)         

Series D Preferred Stock subscribed

              500,000                           500,000 

Issued Series E Preferred Stock, net of issuance costs

  50,000   50                           4,980,659         4,980,709 

Stock compensation expense

                                121,298         121,298 

Net loss

                                   (2,966,890)  (2)  (2,966,892)

Balance, March 31, 2021

  50,000   50   100,500   101   (9,550,000)  28,706,187   219,703   995,000   995   (4,975,000)  380,605,305   (362,023,573)  731,301   5,008,882 

Issued Series D Preferred Stock

  23,000   23   (23,000)  (23)  1,800,000                           1,800,000 

Issued stock upon conversion of Series D Preferred Stock

  (23,000)  (23)           1,437,531   1,437            (1,414)         

Series D Preferred Stock subscribed

        (55,423)  (56)  7,750,000                  (5,542,245)        2,207,699 

Incurred costs related to Series E Preferred Stock

                                (50,671)        (50,671)

Issued stock upon stock option exercise

                 2,000   2            2,118         2,120 

Reversal of common stock subscribed

                       (995,000)  (995)  4,975,000   (4,974,005)         

Stock compensation expense

                                142,180         142,180 

Net loss

                                   (2,764,039)  (1)  (2,674,040)

Balance, June 30, 2021

  50,000  $50   22,077  $22  $   30,145,718  $221,142     $  $  $370,181,268  $(364,697,612) $731,300  $6,436,170 

 

See accompanying notes to condensed consolidated financial statements.

 

7

 

 

Navidea Biopharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

  

Six Months Ended

June 30,

 
  

2022

  

2021

 

Cash flows from operating activities:

        

Net loss

 $(5,986,703

)

 $(5,640,932

)

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

        

Depreciation and amortization

  44,649   37,606 

Amortization of debt discount and issuance costs

  56,182    

Non-cash lease expense

  60,929   60,957 

Loss on abandonment of patent applications

  62,388    

Stock compensation expense

  225,404   263,478 

Gain on extinguishment of debt

     (366,000

)

Value of stock issued to 401(k) plan for employer matching contributions

  44,720   76,846 

Value of stock issued in payment of employee bonuses

  16,965    

Value of stock issued in payment of director fees

  12,975    

Changes in operating assets and liabilities:

        

Receivables

  62,924   (130,218

)

Inventory

  (164,515

)

  (9,032

)

Prepaid expenses and other assets

  411,284   350,477 

Accounts payable

  1,005,335   (81,647

)

Accrued and other liabilities

  (418,347

)

  71,825 

Lease liabilities

  (175,535

)

  (156,634

)

Deferred revenue

  45,929   45,928 

Net cash used in operating activities

  (4,695,415

)

  (5,477,346

)

Cash flows from investing activities:

        

Payments for purchases of equipment

  (48,657

)

  (2,707

)

Patent and trademark costs

  (190,727

)

  (104,067

)

Net cash used in investing activities

  (239,384

)

  (106,774

)

Cash flows from financing activities:

        

Proceeds from issuance of preferred stock, including stock subscriptions receivable

     10,475,000 

Payment of preferred stock issuance costs

     (69,962

)

Proceeds from issuance of common stock

     2,133 

Proceeds from note payable

  1,500,000    

Payment of debt issuance costs

  (14,627

)

   

Principal payments on notes payable

  (453,427

)

  (379,443

)

Net cash provided by financing activities

  1,031,946   10,027,728 

Net (decrease) increase in cash and cash equivalents

  (3,902,853

)

  4,443,608 

Cash and cash equivalents, beginning of period

  4,230,865   2,670,495 

Cash and cash equivalents, end of period

 $328,012  $7,114,103 

 

See accompanying notes to condensed consolidated financial statements.        

 

8

 

Notes to the Condensed Consolidated Financial Statements (unaudited)

 

 

1.

Summary of Significant Accounting Policies

 

 

a.

Basis of Presentation: The information presented as of June 30, 2022 and for the three-month and six-month periods ended June 30, 2022 and 2021 is unaudited, but includes all adjustments (which consist only of normal recurring adjustments) that the management of Navidea Biopharmaceuticals, Inc. (“Navidea”, the “Company,” or “we”) believes to be necessary for the fair presentation of results for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The balances as of June 30, 2022 and the results for the interim periods are not necessarily indicative of results to be expected for the year. The condensed consolidated financial statements should be read in conjunction with Navidea’s audited consolidated financial statements for the year ended December 31, 2021, which were included as part of our Annual Report on Form 10-K filed with the SEC on March 28, 2022 (“2021 Form 10-K”).

 

Our condensed consolidated financial statements include the accounts of Navidea and our wholly owned subsidiaries, Navidea Biopharmaceuticals Europe Limited (“Navidea Europe”) and Navidea Biopharmaceuticals Limited (“Navidea UK”), as well as those of our majority-owned subsidiary, Macrophage Therapeutics, Inc. (“MT”). All significant inter-company accounts were eliminated in consolidation.

 

 

b.

Revenue Recognition: We generate revenue from a grant to support one of our product development initiatives. We generally recognize grant revenue when expenses reimbursable under the grant have been paid and payments under the grant become contractually due.

 

We also earn revenue from product sales to end customers, primarily in Europe. Revenue from product sales is generally recognized at the point where the customer obtains control of the goods and we satisfy our performance obligation, which occurs upon either shipment of the product or arrival at its destination, depending upon the shipping terms of the transaction. Our customers have no right to return products purchased in the ordinary course of business, however, we may allow returns in certain circumstances based on specific agreements.

 

In addition, we earn revenues related to our licensing and distribution agreements. The consideration we are eligible to receive under our licensing and distribution agreements typically includes upfront payments, reimbursement for research and development (“R&D”) costs, milestone payments, and royalties. Each licensing and distribution agreement is unique and requires separate assessment in accordance with current accounting standards. See Note 3.

 

 

c.

Research and Development Costs: R&D expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits, and stock-based compensation, as well as travel, supplies, and other costs to support our R&D staff. External contracted services include clinical trial activities, manufacturing and control-related activities, and regulatory costs. R&D expenses are charged to operations as incurred. We review and accrue R&D expenses based on services performed and rely upon estimates of those costs applicable to the stage of completion of each project.

 

 

d.

Inventory: All components of inventory are valued at the lower of cost (first-in, first-out) or net realizable value. We adjust inventory to net realizable value when the net realizable value is lower than the carrying cost of the inventory. Net realizable value is determined based on estimated sales activity and margins. We estimate a reserve for obsolete inventory based on management’s judgment of probable future commercial use, which is based on an analysis of current inventory levels, estimated future sales and production rates, and estimated shelf lives. See Note 6.

 

 

e.

Intangible Assets: Intangible assets consist primarily of license agreements and patent and trademark costs. Intangible assets are stated at cost, less accumulated amortization. License agreements and patent costs are amortized using the straight-line method over the estimated useful lives of the license agreements and patents of approximately 5 to 15 years. Patent application costs are deferred pending the outcome of patent applications. Costs associated with unsuccessful patent applications and abandoned intellectual property are expensed when determined to have no recoverable value. We evaluate the potential alternative uses of all intangible assets, as well as the recoverability of the carrying values of intangible assets, on a recurring basis. During the six-month periods ended June 30, 2022 and 2021, we capitalized patent and trademark costs of $190,727 and $104,067, respectively. During the six-month periods ended June 30, 2022 and 2021, we abandoned patent applications with previously-capitalized patent costs of $62,388 and $0, respectively.

 

 

f.

Leases: All of our leases are operating leases and are included in right-of-use lease assets, current lease liabilities and noncurrent lease liabilities on our consolidated balance sheets. These assets and liabilities are recognized at the commencement date based on the present value of remaining lease payments over the lease term using the Company’s incremental borrowing rates or implicit rates, when readily determinable. The discount rates used for each lease were based principally on the Platinum debt, which was secured and outstanding for most of 2018. We used a “build-up” method where the approach was to estimate the risk/credit spread priced into the debt rate and then adjust that for the remaining term of each lease. Additionally, some market research was completed on the Company’s peer group. Short-term operating leases which have an initial term of 12 months or less are not recorded on the consolidated balance sheets. Lease expense for operating leases is recognized on a straight-line basis over the lease term. Lease expense is included in selling, general and administrative expenses on our consolidated statements of operations. See Note 9.

 

9

 
 

g.

Contingent Liabilities: We are subject to legal proceedings and claims that arise in the normal course of business. In accordance with ASC Topic 450, Contingencies, we accrue for contingent liabilities when management determines it is probable that a liability has been incurred and the amount can be reasonably estimated. This determination requires significant judgment by management. As of the date of the filing of this Quarterly Report on Form 10-Q, we are engaged in separate matters of ongoing litigation with Capital Royalty Partners II, L.P. and our former President and Chief Executive Officer, Dr. Michael Goldberg. See Note 10.

 

 

h.

Recently Adopted Accounting Standards: In May 2021, the Financial Accounting Standards Board (“FASB”) Issued Accounting Standards Update (“ASU”) No. 2021-04, Issuers Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU 2021-04 was issued to clarify and reduce diversity in an issuer’s accounting for modifications or exchange of freestanding equity-classified written call options (for example, warrants) that remain equity-classified after modification or exchange. ASU 2021-04 requires that an entity treat a modification or exchange of a freestanding equity-classified written call option that remains equity-classified after modification or exchange be treated as an exchange of the original instrument for a new instrument. ASU 2021-04 also clarifies how an entity should measure and recognize the effect of a modification or exchange of a freestanding equity-classified written call option that remains equity-classified after modification or exchange. ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years, and should be implemented prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including in an interim period. The adoption of ASU 2021-04 did not have a material impact on our consolidated financial statements.

 

In November 2021, the FASB issued ASU No. 2021-10, Disclosures by Business Entities about Government Assistance. ASU 2021-10 was issued to increase the transparency of government assistance. ASU 2021-10 requires that entities make certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. The required disclosures include: (1) information about the nature of the transactions and the related accounting policy used to account for the transactions; (2) the line items on the balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line item; and (3) significant terms and conditions of the transactions, including commitments and contingencies. The amendments in ASU 2021-10 are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. Early application of the amendments is permitted. An entity should apply the amendments in ASU 2021-10 either (1) prospectively to all transactions within the scope of the amendments that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or (2) retrospectively to those transactions. The adoption of ASU 2021-10 did not have an impact on our consolidated financial statements, however we do expect to make the additional annual disclosures required by the update.

 

 

2.

Liquidity

 

As disclosed in the notes to the consolidated financial statements included in the Company’s 2021 Form 10-K, the Company has been engaged in litigation with Platinum-Montaur Life Sciences LLC (“Platinum-Montaur”), an affiliate of Platinum Management (NY) LLC, Platinum Partners Value Arbitrage Fund L.P., Platinum Partners Capital Opportunity Fund, Platinum Partners Liquid Opportunity Master Fund L.P., Platinum Liquid Opportunity Management (NY) LLC, and Montsant Partners LLC (collectively, “Platinum”). In addition, the Company is engaged in ongoing litigation with our former President and Chief Executive Officer, Dr. Michael Goldberg. The Company has also been engaged in ongoing litigation with Capital Royalty Partners II L.P. (“CRG”). See Note 10.

 

On April 10, 2022, the Company entered into a Stock Exchange and Loan Agreement (the “Purchase Agreement”) with John K. Scott, Jr., the current Vice Chairman of our Board of Directors, pursuant to which Mr. Scott agreed to make a loan to the Company in the principal amount of up to $2.5 million, of which $1.5 million was funded on the closing date. Mr. Scott funded an additional $1.0 million on July 1, 2022. The outstanding balance of the loan, which is evidenced by a Secured Term Note (the “Bridge Note”), bears interest at a rate of 8% per annum, with payments of interest only to be made monthly over a period of two years. All outstanding principal and accrued and unpaid interest under the Bridge Note is due and payable on the second anniversary of the Purchase Agreement. The Company’s obligations under the Bridge Note are secured by a first priority security interest in all of the Company’s assets and personal property pursuant to a Security Agreement. See Notes 8 and 16.

 

10

 

Beginning August 4, 2022 through August 17, 2022, the Company is offering its stockholders and certain warrant holders as of August 3, 2022 the right to purchase up to 35,000 units (“Units”) at a subscription price of $1,000 per Unit (the “Rights Offering”). Each Unit consists of one share of Series I Convertible Preferred Stock (“Series I Preferred Stock”) which is convertible into 1,538 shares of Common Stock and warrants to purchase an additional 1,538 shares of our Common Stock. The Rights Offering may result in aggregate gross proceeds of up to $35.0 million to the Company. Certain participants in the Rights Offering have the ability to pay the subscription price for their Units by cancelling or exchanging their shares of Series D Redeemable Convertible Preferred Stock (“Series D Preferred Stock”), Series F Redeemable Convertible Preferred Stock (“Series F Preferred Stock”) and/or Series G Redeemable Preferred Stock (“Series G Preferred Stock”) and the Company’s indebtedness evidenced by the Bridge Note, instead of paying by check or wire transfer of funds. The fair market value of the shares of each series of preferred stock and the Bridge Note to be cancelled or exchanged in the Rights Offering has been determined by the Company’s Board of Directors based on an independent appraisal obtained by the Company. The total amount of cash proceeds received by the Company will be reduced to the extent any such series of preferred stock and/or the Bridge Note are exchanged or cancelled in the Rights Offering. Net proceeds after deducting fees and expenses related to the Rights Offering will be used to fund our pivotal Phase 3 clinical trial for rheumatoid arthritis (“RA”), obtaining regulatory approvals, working capital, and for general corporate purposes.

 

We do not believe there has been a significant impact to the Company’s clinical development and regulatory timelines resulting from the ongoing COVID-19 global pandemic. However, the COVID-19 outbreak delayed enrollment in our NAV3-32 clinical study in the United Kingdom (“UK”) due to national COVID-19-related shutdowns. In addition, the regulatory approval process in India was delayed by the impact of COVID-19 in that country.

 

The current conflict between Ukraine and Russia has created extreme volatility in the global capital markets and is expected to have further global economic consequences, including disruptions of the global supply chain and energy markets. Any such volatility and disruptions may have adverse consequences on us or the third parties who operate in Europe on whom we rely. If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any debt or equity financing more difficult to obtain, more costly or more dilutive.

 

The Company has experienced recurring net losses and has used significant cash to fund its operations. The Company has considerable discretion over the extent of development project expenditures and has the ability to curtail the related cash flows as needed. The Company also continues working to establish new sources of funding, including the Rights Offering that is currently underway, other potential equity investments, collaborations and additional grant funding that can augment the balance sheet. However, based on our current working capital and our projected cash burn, management believes that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the filing of this Quarterly Report on Form 10-Q.

 

 

3.

Revenue from Contracts with Customers

 

Navidea is focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. We manage our business based on two primary types of drug products: (i) diagnostic substances, including Tc99m tilmanocept and other diagnostic applications of our Manocept platform, and (ii) therapeutic development programs, including all therapeutic applications of our Manocept platform. Tc99m tilmanocept, which the Company has a license to distribute outside of Canada, Mexico and the United States, is the only one of the Company’s drug product candidates that has been approved for sale in any market. Tc99 tilmanocept has only been approved for sale in the European Union (“EU”), the UK, India and Australia.

 

We earn revenue from product sales to end customers, primarily in Europe. Revenue from product sales is generally recognized at the point where the customer obtains control of the goods and we satisfy our performance obligation, which occurs upon either shipment of the product or arrival at its destination, depending upon the shipping terms of the transaction. Our customers have no right to return products purchased in the ordinary course of business, however, we may allow returns in certain circumstances based on specific agreements. Normal payment terms generally range from 30 to 90 days from invoice date, in accordance with each contract or purchase order.

 

The Company also recognizes revenue from up-front license fees and pre-market milestones after the cash has been received from its customers and the performance obligations have been met. Payments for sales-based royalties and milestones are generally received after the related revenue has been recognized and invoiced. Normal payment terms generally range from 15 to 90 days following milestone achievement or royalty invoice, in accordance with each contract.

 

Up-front and milestone payments received related to our license and distribution agreements in India and China are deferred until Tc99m tilmanocept has been approved by the regulatory authorities and product sales are authorized to commence in each of those countries. The Company received regulatory approval for Tc99m tilmanocept in India in late March 2022, however certain additional approvals, such as an import license and authorization to use an alternative manufacturer, must be obtained prior to commercial sales launch in India. It is not possible to determine with any degree of certainty whether or when regulatory approval for this product will be achieved in China, if at all. In addition, since sales of Tc99m tilmanocept have not yet begun in India or China, there is no basis for estimating whether, to what degree, or the rate at which the product will be accepted and utilized in these markets. Therefore, it is not possible to determine with any degree of certainty the expected sales in future periods in those countries. As such, the Company intends to recognize revenue from up-front and milestone payments on a straight-line basis beginning at the time of commercial sales launch in each country through the end of the initial term of each agreement. The initial term of each agreement is eight years in India and ten years in China.

 

The transaction price of a contract is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. Transaction prices do not include amounts collected on behalf of third parties (e.g., sales taxes). To determine the transaction price of a contract, the Company considers the terms of the contract. For the purpose of determining transaction prices, the Company assumes that the goods or services will be transferred to the customer as promised in accordance with existing contracts and that the contracts will not be cancelled, renewed, or modified.

 

11

 

When estimating a contract’s transaction price, the Company considers all the information (historical, current, and forecasted) that is reasonably available to it and identifies possible consideration amounts. Most of the Company’s contracts with customers include both fixed and variable components of the transaction price. Under those contracts, some or all of the consideration for satisfied performance obligations is contingent on events over which the Company has no direct influence. For example, regulatory approval or product sales volume milestones are contingent upon the achievement of those milestones by the distributor. Additionally, the prices charged to end users of Tc99m tilmanocept, upon which royalty payments are based in India and China, are set by the distributor in each of those countries.

 

The milestone payments have a binary outcome (that is, the Company will either receive all or none of each milestone payment) and can be estimated using the most-likely-amount method. Taking into account the constraint on variable consideration, the Company has assessed the likelihood of achieving the non-sales-based milestone payments in our current contracts and has determined that it is probable the milestones will be achieved and the Company will receive the consideration. Accordingly, it is probable that including those payments in the transaction price will not result in a significant revenue reversal when the contingency is resolved. Therefore, the amount of the non-sales-based milestone payments is included in the transaction price.

 

Royalties are estimated based on the expected value method because they are based on a variable amount of sales representing a range of possible outcomes. However, when taking into account the constraint on variable consideration, the estimate of future royalties included in the transaction price is generally $0. This conclusion is based on the fact that Tc99m tilmanocept is early in the commercial launch process in Europe and Australia, and sales have not yet begun in India or China, therefore there is currently no basis for estimating whether, to what degree, or the rate at which the product will be accepted and utilized in these markets. Similarly, we currently have no basis for estimating whether sales-based milestones will ever be achieved. Accordingly, the Company recognizes revenue from royalties when the related sales occur and from sales-based milestones when they are achieved.

 

Up-front fees, milestones and royalties are generally non-refundable. Therefore, the Company does not estimate expected refunds nor do we adjust revenue downward. The Company will evaluate and update the estimated transaction prices of its contracts with customers at the end of each reporting period.

 

During the three-month periods ended June 30, 2022 and 2021, the Company recognized revenue from contracts with customers of $6,519 and $13,063, respectively. During the six-month periods ended June 30, 2022 and 2021, the Company recognized revenue from contracts with customers of $6,519 and $35,549, respectively. During the three-month and six-month periods ended June 30, 2022 and 2021, the Company did not recognize any related impairment losses, nor did the Company recognize any revenue from performance obligations associated with long-term contracts that were satisfied (or partially satisfied) in previous periods.

 

The following table disaggregates the Company’s revenue from contracts with customers for the three-month and six-month periods ended June 30, 2022 and 2021.

 

  

Three Months Ended

June 30,

  

Six Months Ended

June 30,

 
  

2022

  

2021

  

2022

  

2021

 

Sales revenue:

                

Tc99m tilmanocept - Europe

 $6,519  $  $6,519  $ 
                 

License revenue:

                

Tc99m tilmanocept - Europe

 $  $13,063  $  $35,549 

 

The following economic factors affect the nature, amount, timing and uncertainty of the Company’s revenue and cash flows as indicated:

 

Geographical Location of Customers: Drug pricing models vary among different markets, which in turn may affect the royalty rates and milestones we are able to negotiate with our distributors in those markets. Royalty rates and milestone payments vary by contract but may be based in part on the potential market size in each territory. In the case of Tc99m tilmanocept, royalty rates for Europe were lower than rates in India but higher than in China.

 

12

 

Status of Regulatory Approval: The majority of revenue from contracts with customers will generally be recognized after the product is approved for sale in each market. Each Tc99m tilmanocept customer operates in its own distinct regulatory environment, and the laws and pathways to drug product approval vary by market. Tc99m tilmanocept has been approved for sale in the EU and the UK, thus the Company recognized revenue from sales in Europe. Tc99m tilmanocept was approved for sale in India in March 2022, however product sales have not yet commenced. Tc99m tilmanocept has not yet been approved for sale in China and may never achieve approval in that market. The regulatory pathways and timelines in China will impact whether and when the Company recognizes the related royalties and milestones. Similarly, NAV4694 has not yet been approved for sale in any market, thus the timing of any revenue related to that product will be dependent on the regulatory pathways and timelines in each market in which Meilleur seeks regulatory approval.

 

Through June 30, 2022, the Company has not capitalized any contract-related costs as contract assets.

 

The following table summarizes the changes in contract liabilities, the current portion of which is included in accrued liabilities and other in the condensed consolidated balance sheets, during the three-month and six-month periods ended June 30, 2022 and 2021.

 

  

Three Months Ended

June 30,

  

Six Months Ended

June 30,

 
  

2022

  

2021

  

2022

  

2021

 

Total deferred revenue, beginning of period

 $800,000  $700,000  $700,000  $700,000 

Deferred revenue related to milestones achieved

        100,000    

Deferred revenue related to milestones achieved, written off due to contract renegotiations

  (100,000

)

     (100,000

)

   

Total deferred revenue, end of period

 $700,000  $700,000  $700,000  $700,000 

 

The Company had sales revenue receivable of $3,903 and $0 outstanding as of June 30, 2022 and December 31, 2021, respectively. The Company had license revenue receivable of $0 and $1,021 outstanding as of June 30, 2022 and December 31, 2021, respectively.

 

In addition to revenue from contracts from customers, we also generate revenue from National Institutes of Health (“NIH”) grants to support various product development initiatives. The revenue recognition standard applies to revenue from contracts with customers. A customer is defined as a party that has contracted with an entity to obtain goods or services that are an output of the entity’s ongoing major or central operations in exchange for consideration. The Company’s ongoing major or central operations consist of the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. The NIH and its various institutes are responsible for biomedical and public health research and provide major biomedical research funding to non-NIH research facilities and entities such as Navidea. While the Company will directly benefit from any knowledge gained from the project, there is also a public health benefit provided, which justifies the use of public funds in the form of the grants. Based on the nature of the Company’s operations and the terms of the grant awards, Navidea does not have a vendor-customer relationship with the NIH and the grant awards are outside the scope of the revenue recognition standard. Accordingly, the revenue recognition standard need not be applied to the NIH grants. During the three-month periods ended June 30, 2022 and 2021, the Company recognized grant revenue of $51,007 and $72,983, respectively. During the six-month periods ended June 30, 2022 and 2021, the Company recognized grant revenue of $51,007 and $74,233, respectively.

 

 

4.

Stock-Based Compensation

 

For the three-month periods ended June 30, 2022 and 2021, our total stock-based compensation expense, which includes reversals of expense for certain forfeited or cancelled awards, was $40,555 and $142,180, respectively. For the six-month periods ended June 30, 2022 and 2021, our total stock-based compensation expense, which includes reversals of expense for certain forfeited or cancelled awards, was approximately $225,405 and $263,478, respectively. We have not recorded any income tax benefit related to stock-based compensation in any of the three-month or six-month periods ended June 30, 2022 and 2021.

 

13

 

A summary of the status of our stock options as of June 30, 2022, and changes during the six-month period then ended, is presented below.

 

  

Six Months Ended June 30, 2022

 
  

Number of

Options

  

Weighted

Average

Exercise

Price

  

Weighted

Average

Remaining

Contractual

Life
(in years)

  

Aggregate

Intrinsic

Value

 

Outstanding, January 1, 2022

  919,790  $5.67   6.5  $ 

Granted

  12,500   0.83         

Cancelled/Forfeited

  (152,455

)

  2.38         

Expired

  (53,755

)

  29.32         

Outstanding, June 30, 2022

  726,080  $4.52   6.0  $ 

Exercisable, June 30, 2022

  545,665  $5.52   4.9  $ 

 

The weighted average grant date fair value per stock option granted during the six-month period ended June 30, 2022 was $0.65. Key assumptions used in the Black-Scholes option pricing model for stock options granted during the six-month period ended June 30, 2022 were the Company’s stock price, an expected volatility rate of 93.94%, a risk-free rate of 2.34%, and an expected life of 6.25 years. 

 

A summary of the status of our unvested restricted stock as of June 30, 2022, and changes during the six-month period then ended, is presented below.

 

  

Six Months Ended

June 30, 2022

 
  

Number of

Shares

  

Weighted

Average

Grant-Date

Fair Value

 

Unvested, January 1, 2022

  95,000  $1.40 

Vested

  (5,000

)

  1.96 

Unvested, June 30, 2022

  90,000  $1.37 

 

 

As of June 30, 2022, there was $136,148 of total unrecognized compensation expense related to unvested stock-based awards, which we expect to recognize over the remaining weighted average vesting term of 1.6 years.

 

 

5.

Loss Per Share

 

Basic loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of common shares. Diluted loss per share reflects additional common shares that would have been outstanding if dilutive potential common shares had been issued. Potential common shares that may be issued by the Company include convertible preferred stock, options and warrants.

 

Diluted loss per common share for the six-month periods ended June 30, 2022 and 2021 excludes the effects of 1,148,404 and 1,684,694 common share equivalents, respectively, since such inclusion would be anti-dilutive. The excluded shares consist of common shares issuable upon exercise of outstanding stock options and warrants.

 

The Company’s unvested restricted stock awards contain nonforfeitable rights to dividends or dividend equivalents, whether paid or unpaid (referred to as “participating securities”). Therefore, the unvested restricted stock awards are required to be included in the number of shares outstanding for both basic and diluted earnings per share calculations. However, due to our loss from continuing operations, 90,000 and 60,000 shares of unvested restricted stock for the six-month periods ended June 30, 2022 and 2021, respectively, were excluded in determining basic and diluted loss per share from continuing operations because such inclusion would be anti-dilutive.

 

14

 
 

6.

Inventory, Net

 

The components of inventory, net as of June 30, 2022 and December 31, 2021 are as follows:

 

  

June 30,

2022

  

December 31,
2021

 

Materials

 $193,806  $50,000 

Finished goods

  123,066   101,155 

Reserve for obsolete finished goods

  (1,202

)

   

Total inventory, net

 $315,670  $151,155 

 

During the three-month and six-month periods ended June 30, 2021, we allocated approximately $1,000 and $5,000, respectively, of finished goods inventory for use in clinical trials. These transactions were recorded in research and development expense in the condensed consolidated statements of operations. No inventory was allocated for use in clinical trials during the three-month and six-month periods ended June 30, 2022.

 

 

7.

Accounts Payable, Accrued Liabilities and Other

 

Accounts payable as of June 30, 2022 and December 31, 2021 includes an aggregate of $172,932 and $57,099, respectively, due to related parties for director fees. Accrued liabilities and other as of June 30, 2022 and December 31, 2021 includes an aggregate of $1,061,163 and $1,194,719, respectively, due to related parties for accrued separation costs, bonuses, salaries and benefits. The Company pays director fees in both cash and stock. As a result, the cash portion of director fees due are included in accounts payable and the stock portion are included in accrued liabilities and other in the condensed consolidated balance sheet as of June 30, 2022 and December 31, 2021. Certain directors have elected to defer receipt of both cash and stock for director fees until the Company raises sufficient additional capital.

 

 

8.

Notes Payable

 

Bridge Note from John K. Scott, Jr.

 

On April 10, 2022, the Company entered into a Purchase Agreement with John K. Scott, Jr., the current Vice Chairman of our Board of Directors, pursuant to which Mr. Scott agreed to make a loan to the Company in the principal amount of up to $2.5 million, of which $1.5 million was funded on the closing date. Mr. Scott funded an additional $1.0 million on July 1, 2022. The outstanding balance of the loan, which is evidenced by a Bridge Note, bears interest at a rate of 8% per annum, with payments of interest only to be made monthly over a period of two years. All outstanding principal and accrued and unpaid interest under the Bridge Note is due and payable on the second anniversary of the Purchase Agreement. The Company’s obligations under the Bridge Note are secured by a first priority security interest in all of the Company’s assets and personal property pursuant to a Security Agreement. See Notes 11 and 16.

 

As consideration and partial inducement for Mr. Scott to enter into the Bridge Note, the Company exchanged all 50,000 shares of Mr. Scott’s Series E Redeemable Convertible Preferred Stock (“Series E Preferred Stock”) for 1,740 shares of Series F Preferred Stock and 3,260 shares of Series G Preferred Stock. In accordance with current accounting guidance, the Company recorded a debt discount of $835,876 including $821,250 related to the difference in the value of Mr. Scott’s Series E Preferred Stock and the Series F and Series G Preferred Stock and $14,626 of debt issuance costs. The debt discount is being amortized as non-cash interest expense using the effective interest method over the term of the Bridge Note. The balance of the debt discount was $779,695 as of June 30, 2022.

 

Interest expense related to the Bridge Note totaled $83,182 during the three-month and six-month periods ended June 30, 2022. The principal balance of the Bridge Note was $1.5 million as of June 30, 2022.

 

IPFS Corporation

 

In November 2020, we prepaid $442,041 of insurance premiums through the issuance of a note payable to IPFS Corporation (“IPFS”) with an interest rate of 3.5%. The note was payable in seven monthly installments of $63,888, with the final payment made in June 2021. In November 2021, we prepaid $565,760 of insurance premiums through the issuance of a note payable to IPFS with an interest rate of 4.36%. The note was payable in five monthly installments of $114,388, with the final payment made in April 2022.

 

Interest expense related to the IPFS notes payable totaled $414 and $1,113 during the three-month periods ended June 30, 2022 and 2021, respectively. Interest expense related to the IPFS notes payable totaled $4,126 and $3,883 during the six-month periods ended June 30, 2022 and 2021, respectively. The balance of the IPFS note was $0 as of June 30, 2022.

 

15

 

Summary

 

During the three-month periods ended June 30, 2022 and 2021, we recorded interest expense of $83,596 and $1,113, respectively, related to our notes payable. During the six-month periods ended June 30, 2022 and 2021, we recorded interest expense of $87,308 and $3,883, respectively, related to our notes payable.

 

 

9.

Leases

 

We currently lease approximately 5,000 square feet of office space at 4995 Bradenton Avenue, Dublin, Ohio, as our principal offices, at a monthly base rent of $3,012. The current least term expires in June 2023.

 

In addition, we currently lease approximately 25,000 square feet of office space at 5600 Blazer Parkway, Dublin, Ohio, formerly our principal offices, at a monthly base rent of $28,149 in 2022. The current lease term expires in October 2022 with an option to extend for an additional five years. The Company does not intend to renew this lease. In June 2017, the Company executed a sublease arrangement for the Blazer Parkway space, providing for monthly sublease payments to Navidea of $39,124 through October 2022.

 

We currently lease office equipment at a monthly payment of $136, expiring in October 2024. We also leased a vehicle at a monthly payment of $287, which expired in September 2021.

 

Total operating lease expense was $35,497 and $43,913 for the three-month periods ended June 30, 2022 and 2021, respectively. Total operating lease expense was $73,173 and $89,745 for the six-month periods ended June 30, 2022 and 2021, respectively. Operating lease expense was recorded in selling, general and administrative expenses on our condensed consolidated statements of operations.

 

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of June 30, 2022.

 

Maturity of Lease Liabilities

 

Operating

Lease
Payments

 

2022 (remaining)

 $103,332 

2023

  19,699 

2024

  1,355 

Total undiscounted operating lease payments

  124,386 

Less imputed interest

  3,915 

Present value of operating lease liabilities

 $120,471 

 

Balance Sheet Classification

    

Current lease liabilities

 $118,409 

Noncurrent lease liabilities

  2,062 

Total operating lease liabilities

 $120,471 

 

Other Information

    

Weighted-average remaining lease term for operating leases (in years)

  0.6 

Weighted-average discount rate for operating leases

  10.9%

 

Cash paid for amounts included in the present value of operating lease liabilities was $187,779 and $185,421 during the six-month periods ended June 30, 2022 and 2021, respectively, and is included in operating cash flows.

 

 

10.

Commitments and Contingencies

 

We are subject to legal proceedings and claims that arise in the ordinary course of business. In accordance with ASC Topic 450, Contingencies, we make a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Although the outcome of any litigation is uncertain, in our opinion, the amount of ultimate liability, if any, with respect to these actions, will not materially affect our financial position.

 

16

 

CRG Litigation

 

As disclosed in the notes to the financial statements included in the Company’s Annual Report on Form 10-K, the Company has been engaged in ongoing litigation with CRG, in its capacity as a lender and as control agent for other affiliated lenders party to the CRG Loan Agreement (collectively, the “CRG Lenders”), in the District Court of Harris County, Texas (the “Texas Court”). In April 2018, the Plaintiffs asserted claims against Navidea and Macrophage Therapeutics, Inc. for alleged breaches of a Global Settlement Agreement (“GSA”) and Loan Agreement entered into by Navidea arising from the Navidea’s challenge to the Plaintiffs’ drawing down on letters of credit in the full amount of $7,153,000 which Navidea claims resulted in an overpayment of approximately $4.2 million under the Loan Agreement. The Plaintiffs also seek declaratory judgment relief that essentially mirrors their claims for affirmative relief, i.e., that the Company breached the GSA and indemnification provision of the Loan Agreement, and that the Plaintiffs did not breach the GSA.

 

On November 21, 2021, the Texas Court entered an interlocutory judgment declaring that CRG did not breach the GSA, but that Navidea did breach the GSA and the indemnification provision of the CRG Loan Agreement. In the interlocutory order, the Texas Court sua sponte awarded as damages reasonable attorneys' fees in an amount, if any, to be determined at trial. The case is set for a bench trial on August 26, 2022. CRG has made a claim of approximately $2.8 million in attorneys' fees they contend they are entitled to in connection with the alleged breaches of the agreements. Navidea contends CRG have received payments in excess of the amounts owed under the CRG Loan Agreement and are not entitled to an award of attorney’s fees under the GSA or Loan Agreement. Discovery has been completed and a motion to amend the interlocutory partial summary judgment is pending. The amount of ultimate liability, if any, with respect to this action is unknown.

 

The Company had also been engaged in ongoing litigation with CRG in the Court of Common Pleas of Franklin County, Ohio (the “Ohio Court”) related to Navidea’s claims that the CRG Lenders fraudulently induced Navidea to enter into a settlement agreement and breached the terms of the same through certain actions taken by the CRG Lenders in connection with the GSA, pursuant to which Navidea agreed to pay up to $66.0 million to the CRG Lenders, as well as through actions and misrepresentations by CRG after the GSA was executed. The claims in that suit were for breach of contract, conversion and unjust enrichment against the CRG Lenders for their collection of more than $66.0 million, the maximum permitted under the GSA, and their double recovery of amounts paid as part of the $4.1 million paid in June 2016 and recovered again as part of the $66.0 million. CRG’s double recovery and recovery of more than $66.0 million are due to CRG drawing the entire $7.1 million on the Cardinal Health 414 letter of credit. The CRG Lenders sought a Writ of Prohibition in the Ohio Supreme Court to prevent this case from moving forward, which was denied, and proceedings resumed in front of the Ohio Court. Following an unsuccessful mediation on May 7, 2019, Navidea moved for summary judgment on June 28, 2019. On November 27, 2019, the Ohio Court found that when CRG collected more than $66.0 million, they took an excess recovery and breached the GSA. The Ohio Court awarded approximately $4.3 million to Navidea, plus statutory interest from April 9, 2018, the date CRG drew on the Cardinal Health 414 letter of credit. The Ohio Court also found that there was no unjust enrichment or conversion by CRG since this was a matter of contract and only contract damages were appropriate. The decision was a final appealable order and terminated the case before the Ohio Court. On December 5, 2019, CRG filed a notice of appeal with Ohio’s 10th District Court of Appeals regarding the judgment in favor of Navidea. The briefing of the appeal concluded on March 27, 2020, and oral argument on the appeal was held on September 23, 2020. On March 16, 2021, Ohio’s 10th District Court of Appeals issued a decision which reversed the Ohio Court’s November 27, 2019 ruling that CRG breached the GSA and its award of $4.3 million plus statutory interest to Navidea. The Ohio Court of Appeals held that the Ohio Court did not have jurisdiction to adjudicate Navidea’s claims and therefore did not rule on the factual merits of Navidea’s claims regarding CRG’s recovery in excess of the contractually agreed maximum amount. The Ohio Supreme Court declined to hear the case so the Ohio litigation has concluded.

 

Platinum Litigation

 

In November 2017, Platinum-Montaur commenced an action against the Company in the Supreme Court of the State of New York, County of New York (the “New York Supreme Court”), seeking damages of approximately $1.9 million purportedly due as of March 3, 2017, plus interest accruing thereafter. The claims asserted were for breach of contract and unjust enrichment in connection with funds received by the Company under the Platinum Loan Agreement. The action was subsequently removed to the United States District Court for the Southern District of New York. On October 31, 2018, the District Court granted judgment for Navidea and dismissed all claims in the case. The District Court stated that Platinum-Montaur had no standing to assert any contractual interest in funds that might be due under the Platinum Loan Agreement. The District Court also disagreed with Platinum-Montaur’s claim of unjust enrichment on similar grounds and found that Platinum-Montaur lacked any sufficient personal stake to maintain claims against Navidea. The claims against Navidea were dismissed without prejudice on the grounds of lack of standing to pursue the claims asserted.

 

On November 30, 2018, Platinum-Montaur filed a notice of appeal with the United States Court of Appeals for the Second Circuit (the “Second Circuit”) claiming that the District Court erred in dismissing Platinum-Montaur’s claims for breach of contract and unjust enrichment. On January 22, 2019, Platinum-Montaur filed its brief in the Second Circuit, asking the Second Circuit to reverse the District Court and remand the case to the District Court for further proceedings. The Second Circuit held oral argument in this matter on September 5, 2019. On November 25, 2019, the Second Circuit issued a decision which remanded the case to the District Court for further consideration of whether the District Court had jurisdiction over the case following removal from the New York Supreme Court. The Second Circuit did not address the merits of Platinum-Montaur’s allegations against Navidea. By agreement of the parties, the case was remanded from the District Court to the New York Supreme Court. Navidea filed a Motion to Dismiss on June 4, 2020, and on September 2, 2020, the New York Supreme Court granted the Motion to Dismiss. Platinum-Montaur filed a Notice of Appeal of the New York Supreme Court’s decision on September 23, 2020 and the appeal was docketed with the Appellate Department-First Division. Platinum-Montaur perfected an appeal of the judgment in favor of the Company on or about June 28, 2021. In January 2022, Platinum and the Company settled their dispute and Platinum’s lawsuit was dismissed. See Note 11.

 

17

 

Goldberg Agreement and Litigation

 

In August 2018, Dr. Goldberg resigned from his positions as an executive officer and a director of Navidea. In connection with Dr. Goldberg’s resignation, Navidea and Dr. Goldberg entered into an Agreement (the “Goldberg Agreement”) which set forth the terms of the separation from service. Among other things, the Goldberg Agreement provided that Dr. Goldberg would be entitled to 1,175,000 shares of our Common Stock, representing in part payment of accrued bonuses and payment of the balance of the Platinum debt. A portion of the 1,175,000 shares to be issued to Dr. Goldberg would be held in escrow for up to 18 months in order to reimburse Navidea in the event that Navidea is obligated to pay any portion of the Platinum debt to a party other than Dr. Goldberg. Further, the Goldberg Agreement provided that the Company’s subsidiary, MT, would redeem all of Dr. Goldberg’s preferred stock and issue to Dr. Goldberg super voting common stock equal to 5% of the outstanding shares of MT. In November 2018, the Company issued 925,000 shares of our Common Stock to Dr. Goldberg, 250,000 of which were placed in escrow in accordance with the Goldberg Agreement.

 

On February 11, 2019, Dr. Goldberg represented to the MT Board that he had, without MT Board or shareholder approval, created a subsidiary of MT, transferred all of the assets of MT into the subsidiary, and then issued himself stock in the subsidiary. On February 19, 2019, Navidea notified MT that it was terminating the sublicense in accordance with its terms, effective March 1, 2019, due to MT’s insolvency. On February 20, 2019, the MT Board removed Dr. Goldberg as President and Chief Executive Officer of MT and from any other office of MT to which he may have been appointed or in which he was serving. Dr. Goldberg remains a member of the MT Board, together with John K. Scott, Jr. and Dr. Michael S. Rosol. Mr. Scott is also the Vice Chair of the Board of Directors of Navidea. On or about February 17, 2022, the Joint Official Liquidators and Foreign Representatives of PPVA executed the necessary paperwork to transfer its preferred stock in MT to Navidea.

 

New York Litigation Involving Dr. Goldberg

 

On February 20, 2019, Navidea filed a complaint against Dr. Goldberg in the United States District Court, Southern District of New York (the “District Court”), alleging breach of the Goldberg Agreement, as well as a breach of the covenant of good faith and fair dealing and to obtain a declaratory judgment that Navidea’s performance under the Goldberg Agreement is excused and that Navidea is entitled to terminate the Goldberg Agreement as a result of Dr. Goldberg’s actions. On April 26, 2019, Navidea filed an amended complaint against Dr. Goldberg which added a claim for breach of fiduciary duty seeking damages related to certain actions Dr. Goldberg took while CEO of Navidea. On June 13, 2019, Dr. Goldberg answered the amended complaint and asserted counterclaims against Navidea and third-party claims against MT for breach of the Goldberg Agreement, wrongful termination, injunctive relief, and quantum meruit.

 

On December 26, 2019, the District Court ruled on several motions related to Navidea and MT and Dr. Goldberg that substantially limited the claims that Dr. Goldberg can pursue against Navidea and MT. Specifically, the District Court found that certain portions of Dr. Goldberg’s counterclaims against Navidea and third-party claims against MT failed to state a claim upon which relief can be granted. Additionally, the District Court ruled that actions taken by Navidea and MT, including reconstituting the MT board of directors, replacing Dr. Goldberg with Mr. Latkin as Chief Executive Officer of MT, terminating the sublicense between Navidea and MT, terminating certain research projects, and allowing MT intellectual property to revert back to Navidea, were not breaches of the Goldberg Agreement.

 

The District Court also rejected Dr. Goldberg’s claim for wrongful termination as Chief Executive Officer of MT. In addition, the District Court found that Dr. Goldberg lacked standing to seek injunctive relief to force the removal of Dr. Claudine Bruck and Michael Rice from MT’s Board of Directors, to invalidate all actions taken by the MT Board on or after November 29, 2018 (the date upon which Dr. Bruck and Mr. Rice were appointed by Navidea to the Board of MT), or to reinstate the terminated sublicense between Navidea and MT.

 

In addition, the District Court found Navidea’s breach of fiduciary duty claim against Dr. Goldberg for conduct occurring more than three years prior to the filing of the complaint to be time-barred and that Dr. Goldberg is entitled to an advancement of attorneys’ fees solely with respect to that claim. To avoid further litigation expenses, the Company agreed to indemnify Dr. Goldberg solely with respect to the breach of fiduciary duty claim.

 

On January 31, 2020, Goldberg filed a motion for leave to amend his complaint to add back in claims for breach of contract, breach of the implied covenant of good faith and fair dealing, quantum meruit and injunctive relief. On April 1, 2020, the District Court denied Dr. Goldberg’s motion for leave to amend in its entirety.

 

18

 

On January 27, 2020, Dr. Goldberg filed a motion seeking additional advancement from Navidea for fees in connection with the New York Action and the Delaware Action. Navidea opposed the motion and the District Court referred the matters to a Magistrate Judge. On July 9, 2020, the Magistrate Judge issued her Report and Recommendation which recommended that: (1) the District Court decline to exercise jurisdiction over Dr. Goldberg’s motion as it pertained to expenses and fees incurred in defense of the Delaware Action; (2) the District Court decline to award any fees to Dr. Goldberg for the breach of fiduciary duty without additional motion practice on the issue; (3) the District Court find that Dr. Goldberg is entitled to advancement of his expenses and fees reasonably incurred in the defense of the remainder of the New York action subject to Dr. Goldberg’s posting of an undertaking; and (4) establish a protocol by which Dr. Goldberg could establish the amounts due for advancement.

 

On August 24, 2020, in connection with Dr. Goldberg’s motion for advancement, the District Court adopted the Magistrate Judge’s report and recommendation and found that while Dr. Goldberg was not being granted advancement of fees and expenses incurred in connection with either the Delaware Action or the assertion of third-party claims against MT, the Court ruled that Dr. Goldberg was entitled to advancement for the defense of the remaining claims asserted against him by Navidea in the New York action. The Court adopted a protocol by which additional motion practice will occur to determine the appropriate amount of fees to be advanced. Once that decision is made by the Magistrate Judge, subject to review by the District Court, Navidea will need to advance those fees to Dr. Goldberg conditioned upon Dr. Goldberg agreeing to pay those fees back to Navidea if it is determined that he is not entitled to indemnification. 

 

On May 27, 2021, the District Court ordered that: (1) Dr. Goldberg be awarded $14,955 for indemnification for his attorneys’ fees for his defense of the breach of fiduciary duty claim; (2) Dr. Goldberg be advanced $1,237.50 for his attorneys’ fees subject to repayment; (3) Navidea should not be required to indemnify or advance any of the costs sought by Dr. Goldberg; (4) Dr. Goldberg is not entitled to advancement for the prosecution of his counterclaims and third-party claims; (5) Dr. Goldberg’s motion to hold Navidea in contempt be denied; and (6) Navidea should not be required to advance any additional fees or costs unless Dr. Goldberg presents his time records and costs in compliance with the District Court’s orders. The Company has made the payments ordered by the District Court.

 

On August 6, 2021, the Company moved for reconsideration of its obligations to advance fees in light of the Delaware Court’s decision dated June 23, 2021 (described below). On October 14, 2021, the Magistrate Judge recommended that Navidea’s motion for reconsideration be denied. On March 7, 2022, the District Court adopted the Report and Recommendation in part and permitted Dr. Goldberg to seek advancement for his fees incurred in defense of his claims since September 1, 2020. On April 8, 2022, Dr. Goldberg submitted a fee application seeking advancement of $143,172.55 for attorneys’ fees and disbursements for the time period September 1, 2020 through March 31, 2022. The Company has opposed the fee application on numerous grounds and Dr. Goldberg’s reply is due on May 19, 2022. The matter will then be referred to the Magistrate Judge for resolution.

 

Fact discovery and expert discovery in the New York Action have been completed. The Company has moved to disqualify Dr. Goldberg’s damages expert and briefing in the District Court was submitted on April 1, 2022. The District Court has not yet ruled on the Company’s motion. The Company anticipates that once the District Court rules on the expert issues, the District Court will schedule briefing on summary judgment.

 

Delaware Litigation Involving Dr. Goldberg

 

On February 20, 2019, MT initiated a suit against Dr. Goldberg in the Court of Chancery of the State of Delaware (the “Delaware Court”), alleging, among other things, breach of fiduciary duty as a director and officer of MT and conversion, and to obtain a declaratory judgment that the transactions Dr. Goldberg caused MT to effect are void. On June 12, 2019, the Delaware Court found that Dr. Goldberg’s actions were not authorized in compliance with the Delaware General Corporate Law. Specifically, the Delaware Court found that Dr. Goldberg’s creation of a new subsidiary of MT and the purported assignment by Dr. Goldberg of MT’s intellectual property to that subsidiary were void. The Delaware Court’s ruling follows the order on May 23, 2019 in the case, in which it found Dr. Goldberg in contempt of its prior order holding Dr. Goldberg responsible for the payment of MT’s fees and costs to cure the damages caused by Dr. Goldberg’s contempt.

 

On June 23, 2021, the Delaware Court ruled in favor of MT and against Dr. Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT. Specifically, the Delaware Court ruled: “Dr. Goldberg attempted to take for himself that which belonged to [MT]. In doing so, he breached his duty of loyalty to [MT] stockholders. [MT] was absolutely justified in bringing this action to remedy (in this case undo) the harm caused by Dr. Goldberg’s misconduct.” The Delaware Court disagreed with MT’s arguments regarding damages and, other than awarding nominal damages, declined to award additional relief beyond that which it had previously granted. With respect to MT’s claim for conversion, the Delaware Court found that the claim was not supported because “Dr. Goldberg confirmed that he currently does not own or possess any intellectual property related to either Navidea or [MT]” and that “any IP Dr. Goldberg created while at Navidea or any of its subsidiaries was and remains the property of Navidea and its subsidiaries.” In addition, the Delaware Court denied Dr. Goldberg’s motion to hold MT’s directors and CEO in contempt, denied Dr. Goldberg’s motion to dismiss the lawsuit against him, and granted MT’s motion to dismiss Dr. Goldberg’s petition to remove MT’s board members. On December 9, 2021, Dr. Goldberg was ordered to reimburse MT in the amount of $66,796.33 and has paid that amount to MT. Neither party has appealed the Delaware Court’s decision and the Delaware Court’s decisions are now final.

 

19

 

NYSE American Continued Listing Standards

 

On January 28, 2022, the Company received a notification from the NYSE American LLC (the “NYSE American”) stating that the Company was not in compliance the $6.0 million stockholders’ equity requirement of Section 1003(a)(iii) of the NYSE American Company Guide. As required by the NYSE American, the Company submitted a plan to the NYSE American by February 28, 2022 advising of actions it has taken or will take to regain compliance with the continued listing standards by July 28, 2023.

 

On April 8, 2022, the Company received a notification (the “Acceptance Letter”) from the NYSE American that the Company’s plan to regain compliance was accepted. The Acceptance Letter also stated that the Company is also not in compliance with Sections 1003(a)(i) and 1003(a)(ii) of the NYSE American Company Guide, which require an issuer to have stockholders’ equity of (i) $2.0 million or more if it has reported losses from continuing operations and/or net losses in two out of its three most recent fiscal years, and (ii) $4.0 million or more if it has reported losses from continuing operations in three out of its four most recent fiscal years. The Acceptance Letter noted that the Company had stockholders’ equity of $624,743 as of December 31, 2021 and has reported net losses from continuing operations in its five most recent fiscal years ended December 31, 2021.

 

The NYSE American has granted the Company a plan period through July 28, 2023 to regain compliance with Sections 1003(a)(i), (ii) and (iii). If the Company is not in compliance with all continued listing standards by that date or if the Company does not make progress consistent with the plan during the plan period, the NYSE American may commence delisting procedures.

 

 

11.

Equity

 

Platinum Settlement

 

As discussed in Note 10, Platinum and the Company settled their dispute and Platinum’s lawsuit was dismissed in January 2022. As part of the settlement, Platinum returned their six shares of MT Preferred Stock, representing 60% of the noncontrolling interest in MT, to the Company. Prior to the settlement, the carrying amount of the noncontrolling interest in MT was $731,299. As a result of the settlement and the return of six shares of MT Preferred Stock, the Company recorded a reduction of the noncontrolling interest in MT and an increase in additional paid-in capital of $438,778.

 

Series E Preferred Stock

 

On January 31, 2022, pursuant to the Certificate of Designations of the Series E Preferred Stock dated March 2, 2021, the holder of the Series E Preferred Stock, John K. Scott, Jr., notified the Company that he was exercising his option to extend the Conversion Deadline (as defined therein) for an additional period of six months.

 

NOL Rights Agreement

 

On April 7, 2022, the Company’s Board of Directors adopted an NOL rights plan in the form of a Section 382 Rights Agreement (“NOL Rights Agreement”) to preserve and protect the Company’s net operating loss carryforwards (“NOLs”) and other tax assets. As of December 31, 2021, the Company had approximately $164 million of NOLs available to offset future federal taxable income.

 

Under the NOL Rights Agreement, the Board declared a non-taxable dividend of one preferred share purchase right for each outstanding share of common stock of the Company, each right initially representing the right to purchase one one-thousandth of a share of our Series H Junior Participating Preferred Stock. The rights will be exercisable only if a person or group acquires 4.99% or more of Navidea common stock. Existing shareholders that beneficially own in excess of 4.99% of Navidea common stock are “grandfathered in” at their current ownership level and the rights then become exercisable if any of those stockholders acquire an additional 0.5% or more of Navidea common stock. If the rights become exercisable, all holders of rights, other than the person or group triggering the rights, will be entitled to purchase Navidea common stock at a 50 percent discount or the Company may exchange each right held by such holders for five shares of common stock. Rights held by the person or group triggering the rights will become void and will not be exercisable. The Board has the discretion to exempt any person or group from the provisions of the NOL Rights Agreement.

 

The rights issued under the NOL Rights Agreement will expire on the earliest of (i) April 6, 2025; (ii) the effective date of the repeal of Section 382 or any successor statute if the Board determines in its sole discretion that the NOL Rights Agreement is no longer necessary or desirable for the preservation of NOLs or other tax benefits; (iii) the first day of a taxable year of the Company to which the Board determines in its sole discretion that no NOLs or other Tax Benefits may be carried forward; or (iv) the day following the certification of the voting results of the Company’s 2022 annual meeting of stockholders if at or before such annual meeting a proposal to approve the NOL Rights Agreement has not been approved by stockholders, unless the Rights are earlier redeemed or exchanged by the Company, or upon the occurrence of certain transactions.

 

20

 

Stock Exchange and Loan Agreement

 

On April 10, 2022, the Company entered into a Purchase Agreement with John K. Scott, Jr., pursuant to which Mr. Scott agreed to make a loan to the Company in the principal amount of up to $2.5 million, of which $1.5 million was funded on the closing date. The outstanding balance of the loan, which is evidenced by a Bridge Note, bears interest at a rate of 8% per annum, with payments of interest only to be made monthly over a period of two years. All outstanding principal and accrued and unpaid interest under the Bridge Note is due and payable on the second anniversary of the Purchase Agreement. The Company’s obligations under the Bridge Note are secured by a first priority security interest in all of the Company’s assets and personal property pursuant to a Security Agreement.

 

As consideration and a partial inducement for Mr. Scott to make the loan, at the closing, Mr. Scott delivered 50,000 shares of Series E Preferred Stock, representing 100% of the outstanding Series E Preferred Stock, to the Company in exchange for the Company’s issuance of 1,740 shares of Series F Convertible Preferred Stock and 3,260 shares of Series G Preferred Stock. The number of shares of Common Stock that the Company may issue to Mr. Scott upon conversion of the Series F Preferred stock may not exceed that number of shares that would result in Mr. Scott owning more than 33.33% of the Company’s then outstanding shares of Common Stock unless the Company obtains stockholder approval to issue more than the 33.33% cap. The closing of the loan and stock exchange took place on April 12, 2022.

 

In connection with the Purchase Agreement, the Company entered into a Registration Rights Agreement with Mr. Scott, pursuant to which the Company agreed to file a registration statement with the SEC to register the resale of the shares issuable to Mr. Scott upon conversion of the Series F Preferred Stock.

 

401(k) Employer Match

 

During the six-month periods ended June 30, 2022 and 2021, we issued 53,238 and 30,018 shares of our Common Stock as matching contributions to our 401(k) Plan which were valued at $44,720 and $76,846, respectively.

 

Bonuses Paid in Stock

 

During the six-month period ended June 30, 2022, we issued 16,632 shares of our Common Stock to certain of our employees as partial payment in lieu of cash for their 2021 bonuses, which were valued at $16,965.

 

 

12.

Stock Warrants

 

On March 3, 2022, 550,000 Series NN warrants with an exercise price of $30.00 expired under the terms of the Series NN warrant agreements.

 

As of June 30, 2022, there are 422,324 warrants outstanding to purchase Navidea's Common Stock. The warrants are exercisable at prices ranging from $0.20 to $49.80 per share with a weighted average exercise price of $2.30 per share. The warrants have remaining outstanding terms ranging from 1.0 to 13.1 years.

 

 

13.

Income Taxes

 

Income taxes are accounted for under the asset and liability method in accordance with Accounting Standards Codification 740, Income Taxes. Deferred tax assets (“DTAs”) and deferred tax liabilities (“DTLs”) are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and tax credit carryforwards. DTAs and DTLs are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on DTAs and DTLs of a change in tax rates is recognized in income in the period that includes the enactment date.

 

Current accounting standards require a valuation allowance against DTAs if, based on the weight of available evidence, it is more likely than not that some or all of the DTAs may not be realized. Due to the uncertainty surrounding the realization of these DTAs in future tax returns, all of the DTAs have been fully offset by a valuation allowance as of June 30, 2022 and December 31, 2021.

 

In assessing the realizability of DTAs, management considers whether it is more likely than not that some portion or all of the DTAs will not be realized. The ultimate realization of DTAs is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities (including the impact of available carryback and carryforward periods) and projected future taxable income in making this assessment. Based upon the level of historical taxable income and projections for future taxable income over the periods in which the DTAs are deductible, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences or tax carryforwards as of June 30, 2022.

 

21

 

Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no liability for uncertain tax positions was recorded as of June 30, 2022 or December 31, 2021 and we do not expect any significant changes in the next twelve months. Should we need to accrue interest or penalties on uncertain tax positions, we would recognize the interest as interest expense and the penalties as a selling, general and administrative expense. As of June 30, 2022, tax years 2018-2021 remained subject to examination by federal and state tax authorities.

 

As of June 30, 2022, we had approximately $164.1 million of federal and $20.1 million of state net operating loss carryforwards, as well as approximately $9.1 million of federal R&D credit carryforwards which expire from 2022 to 2037.

 

 

14.

Segments

 

We report information about our operating segments using the “management approach” in accordance with current accounting standards. This information is based on the way management organizes and reports the segments within the enterprise for making operating decisions and assessing performance. Our reportable segments are identified based on differences in products, services and markets served. There were no inter-segment sales. We manage our business based on two primary types of drug products: (i) diagnostic substances, including Tc99m tilmanocept and other diagnostic applications of our Manocept platform, and (ii) therapeutic development programs, including therapeutic applications of our Manocept platform.

 

The information in the following tables is derived directly from each reportable segment’s financial reporting.

 

22

 

Three Months Ended June 30, 2022

 

Diagnostics

  

Therapeutics

  

Corporate

  

Total

 

Sales revenue:

                

United States

 $  $  $  $ 

International

  6,519         6,519 

Grant and other revenue

  51,007         51,007 

Total revenue