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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

March 31, 2020

 

or

 

 

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

 

For the transition period from                 to                 

 

Commission File Number: 001-35076                          

 

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

 

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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 (§ 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 ☒

 

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

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 21,645,425 shares of common stock, par value $.001 per share (as of the close of business on May 1, 2020).

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		March 31, 2020				December 31, 2019
		(unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	601,355			$	1,047,159
Accounts and other receivables			1,695,422				901,339
Prepaid expenses and other			1,149,982				967,285
Total current assets			3,446,759				2,915,783
Property and equipment			1,213,996				1,207,537
Less accumulated depreciation and amortization			1,186,041				1,177,327
Property and equipment, net			27,955				30,210
Right-of-use lease assets			458,280				404,594
Less accumulated amortization			118,223				122,906
Right-of-use lease assets, net			340,057				281,688
License agreements, patents and trademarks			536,656				478,672
Less accumulated amortization			101,388				93,259
License agreements, patents and trademarks, net			435,268				385,413
Other assets			227,192				537,812
Total assets		$	4,477,231			$	4,150,906
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable		$	1,454,283			$	1,112,069
Accrued liabilities and other			2,456,346				2,150,974
Notes payable			175,919				305,955
Lease liabilities, current			268,021				250,553
Total current liabilities			4,354,569				3,819,551
Lease liabilities			513,701				512,344
Deferred revenue			700,000				700,000
Total liabilities			5,568,270				5,031,895
Commitments and contingencies (Note 10)
Stockholders’ deficit:
Preferred stock; $.001 par value; 5,000,000 shares authorized; no shares issued or outstanding at March 31, 2020 and December 31, 2019			—				—
Common stock; $.001 par value; 300,000,000 shares authorized; 21,194,248 and 19,234,960 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively			212,191				210,232
Common stock subscribed; $.001 par value, 3,020,587 and 902,162 shares subscribed at March 31, 2020 and December 31, 2019, respectively			3,021				902
Common stock subscriptions receivable			(912,500	)			—
Additional paid-in capital			349,219,656				345,847,676
Accumulated deficit			(350,344,712	)			(347,671,102	)
Total Navidea stockholders' deficit			(1,822,344	)			(1,612,292	)
Noncontrolling interest			731,305				731,303
Total stockholders’ deficit			(1,091,039	)			(880,989	)
Total liabilities and stockholders’ deficit		$	4,477,231			$	4,150,906

 

		Three Months Ended March 31,
		2020				2019
Revenue:
Royalty revenue		$	15,221			$	3,150
Grant and other revenue			141,051				38,474
Total revenue			156,272				41,624
Cost of revenue			609				6,126
Gross profit			155,663				35,498
Operating expenses:
Research and development			999,269				740,583
Selling, general and administrative			1,827,754				1,728,516
Total operating expenses			2,827,023				2,469,099
Loss from operations			(2,671,360	)			(2,433,601	)
Other income (expense):
Interest (expense) income, net			(2,372	)			9,848
Other, net			124				(1,135	)
Total other income (expense), net			(2,248	)			8,713
Loss before income taxes			(2,673,608	)			(2,424,888	)
Provision for income taxes			—				(876	)
Net loss from continuing operations			(2,673,608	)			(2,425,764	)
Loss from discontinued operations, net of tax effect			—				(3,297	)
Net loss			(2,673,608	)			(2,429,061	)
Income (loss) attributable to noncontrolling interest			2				(12	)
Net loss attributable to common stockholders		$	(2,673,610	)		$	(2,429,049	)
Loss per common share (basic and diluted):
Continuing operations		$	(0.13	)		$	(0.24	)
Attributable to common stockholders		$	(0.13	)		$	(0.24	)
Weighted average shares outstanding			20,203,636				10,017,848

 

		Three Months Ended March 31,
		2020				2019
Net loss		$	(2,673,608	)		$	(2,429,061	)
Unrealized gain on available-for-sale securities			—				958
Comprehensive loss		$	(2,673,608	)		$	(2,428,103	)

 

For the Three Months Ended March 31, 2020
		Common Stock								Common Stock Subscribed								Common Stock Subscriptions				Additional Paid-In				Accumulated				Non- controlling				Total Stockholders’
		Shares				Amount				Shares				Amount				Receivable				Capital				Deficit				Interest				Deficit
Balance, January 1, 2020			19,234,960			$	210,232				902,162			$	902			$	—			$	345,847,676			$	(347,671,102	)		$	731,303			$	(880,989	)
Issued stock in payment of services			3,810				4				—				—				—				4,797				—				—				4,801
Issued stock in payment of employee bonuses			53,315				53				—				—				—				64,458				—				—				64,511
Issued stock pursuant to private placement			902,162				902				(902,162	)			(902	)			—				—				—				—				—
Issued stock pursuant to registered direct offering, net of costs			1,000,001				1,000				—				—				—				699,000				—				—				700,000
Stock subscribed in connection with private placement			—				—				2,373,529				2,374				(912,500	)			2,015,126												1,105,000
Stock subscribed in connection with registered direct offering			—				—				647,058				647				—				549,353												550,000
Stock compensation expense			—				—				—				—				—				39,246				—				—				39,246
Comprehensive loss:
Net loss			—				—				—				—				—				—				(2,673,610	)			2				(2,673,608	)
Total comprehensive loss			—				—				—				—				—				—				—				—				(2,673,608	)
Balance, March 31, 2020			21,194,248			$	212,191				3,020,587			$	3,021			$	(912,500	)		$	349,219,656			$	(350,344,712	)		$	731,305			$	(1,091,039	)

For the Three Months Ended March 31, 2019
		Common Stock								Common Stock Subscribed								Additional Paid-In				Accumulated				Accumulated Other Compre- hensive				Non- controlling				Total Stockholders’
		Shares				Amount				Shares				Amount				Capital				Deficit				Loss				Interest				Equity
Balance, January 1, 2019			10,019,535			$	200,391				—			$	—			$	338,265,383			$	(336,722,905	)		$	(730	)		$	668,321			$	2,410,460
Issued restricted stock			15,000				300				—				—				—				—				—				—				300
Issued stock pursuant to Stock Purchase Agreement			17,857				357				—				—				49,643				—				—				—				50,000
Stock compensation expense			—				—				—				—				61,978				—				—				—				61,978
Comprehensive loss:
Net loss			—				—				—				—				—				(2,429,049	)			—				(12	)			(2,429,061	)
Unrealized gain on available-for-sale securities			—				—				—				—				—				—				958				—				958
Total comprehensive loss			—				—				—				—				—				—				—				—				(2,428,103	)
Balance, March 31, 2019			10,052,392			$	201,048				—			$	—			$	338,377,004			$	(339,151,954	)		$	228			$	668,309			$	94,635

 

		Three Months Ended March 31,
		2020				2019
Cash flows from operating activities:
Net loss		$	(2,673,608	)		$	(2,429,061	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			16,843				36,779
Stock compensation expense			39,246				61,978
Value of stock issued in payment of employee bonuses			64,511				—
Value of stock issued in payment of services			4,801				—
Changes in operating assets and liabilities:
Accounts and other receivables			860,917				11,283
Prepaid expenses, right-of-use lease assets, and other assets			69,554				(217,651	)
Accounts payable			342,214				427,894
Accrued, lease and other liabilities			324,197				(56,560	)
Net cash used in operating activities			(951,324	)			(2,165,338	)
Cash flows from investing activities:
Maturities of available-for-sale securities			—				200,000
(Payments for purchases) proceeds from disposal of equipment			(6,459	)			26,875
Patent and trademark costs			(57,984	)			—
Net cash (used in) provided by investing activities			(64,444	)			226,875
Cash flows from financing activities:
Proceeds from issuance of common stock			850,000				50,300
Payment of common stock issuance costs			(150,000	)			—
Principal payments on notes payable			(130,036	)			(117,276	)
Net cash provided by (used in) financing activities			569,964				(66,976	)
Net decrease in cash and cash equivalents			(445,804	)			(2,005,439	)
Cash and cash equivalents, beginning of period			1,047,159				3,475,881
Cash and cash equivalents, end of period		$	601,355			$	1,470,442

 

1.	Summary of Significant Accounting Policies

 

a.

Basis of Presentation: The information presented as of March 31, 2020 and for the three-month periods ended March 31, 2020 and 2019 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 prior period amounts also have been reclassified to conform to the current year’s presentation. In addition, 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. The balances as of March 31, 2020 and the results for the interim periods are not necessarily indicative of results to be expected for the year. The consolidated financial statements should be read in conjunction with Navidea’s audited consolidated financial statements for the year ended December 31, 2019, which were included as part of our Annual Report on Form 10-K.

 

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

 

In March 2020, the World Health Organization categorized the current COVID-19 outbreak as a pandemic, and the President of the United States declared the COVID-19 outbreak a national emergency.  COVID-19 continues to spread globally, including throughout the United States, which has impacted the global economy and may impact our operations, including the potential interruption of our clinical trial activities and our supply chain. To date, we do not believe there has been any appreciable impact to the Company’s clinical development and regulatory timelines resulting from COVID-19.  However, the COVID-19 pandemic has adversely affected economies and financial markets worldwide, resulting in an economic downturn that could impact our business, financial condition and results of operations, including our ability to obtain additional funding, if needed.  To date, much of the funding from the February 2020 transactions described in Note 2 below has been delayed, due in part to the COVID-19 pandemic and its devastating impact on global financial markets.  The extent to which COVID-19 impacts our operations and financial results will depend on numerous evolving factors that we are not able to accurately predict, including: the duration and scope of the pandemic, government actions taken in response to the pandemic, and the impact on our ability to continue to conduct our clinical trials.

 

b.

Financial Instruments and Fair Value: The following methods and assumptions were used to estimate the fair value of each class of financial instruments:

 

(1)

Cash and cash equivalents, accounts and other receivables, and accounts payable: The carrying amounts approximate fair value because of the short maturity of these instruments.

 

(2)

Notes payable: The carrying value of our debt at March 31, 2020 and December 31, 2019 primarily consisted of the face amount of the notes plus accrued interest. At March 31, 2020 and December 31, 2019, the fair value of our notes payable was approximately $176,000 and $306,000, both amounts equal to the carrying value of the notes payable. See Note 8.

 

c.

Revenue Recognition: We currently generate revenue primarily from grants to support various product development initiatives. We generally recognize grant revenue when expenses reimbursable under the grants have been paid and payments under the grants become contractually due.

 

We also 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 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.

 

d.

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 as identified for purposes of compensation analysis.  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.

 

e.

Recently Adopted Accounting Standards: In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 is intended to improve the effectiveness of disclosure requirements on fair value measurements in Topic 820. ASU 2018-13 modifies certain disclosure requirements and is effective for annual and interim reporting periods beginning after December 15, 2019. The adoption of ASU 2018-13 did not have any impact on our consolidated financial statements or our fair value disclosures.

 

 

f.

Recently Issued Accounting Standards: In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 is intended to improve consistent application and simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and clarifies and amends existing guidance. ASU 2019-12 is effective for annual and interim reporting periods beginning after December 12, 2020, with early adoption permitted. We do not expect the adoption of ASU 2019-12 to have a material impact on our consolidated financial statements.

 

2.

Liquidity

 

As disclosed in the Company’s Annual Report on Form 10-K and other filings, 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 which Platinum-Montaur was seeking damages of approximately $1.9 million plus interest.  See Note 10.

 

In addition, the Company is engaged in ongoing litigation with our former President and Chief Executive Officer, Dr. Michael Goldberg. See Notes 6 and 10.

 

The Company has also been engaged in ongoing litigation with Capital Royalty Partners II L.P. (“CRG”) and pursuing recovery of approximately $4.3 million and other damages. On November 27, 2019, the Court of Common Pleas of Franklin County, Ohio (the “Ohio Court”) entered a judgment in the amount of $4.3 million to Navidea, plus statutory interest from April 9, 2018 (the “Judgment”). See Note 10.

 

In February 2020, the Company executed a binding term sheet to sell the Judgment for $4.2 million of proceeds to Navidea. On May 6, 2020, the Company entered into a Stock Purchase Agreement and Letter of Investment Intent with Keystone Capital Partners, LLC (“Keystone”) pursuant to which the Company agreed to issue to Keystone 420,000 shares of newly-designated Series C Preferred Stock for an aggregate purchase price of $4.2 million. The Series C Preferred Stock will be guaranteed by a portion of the proceeds of the Judgment. See Note 16(b).

 

In December 2019, the Company executed a Stock Purchase Agreement with the investors named therein. Pursuant to the Stock Purchase Agreement, the investors agreed to purchase approximately 2.1 million shares of the Company’s Common Stock in a private placement for aggregate gross proceeds to the Company of approximately $1.9 million. Of this amount, approximately $1.1 million was received during 2019, resulting in approximately $812,000 of stock subscriptions receivable as of December 31, 2019. The remaining $812,000 of proceeds were received and the related Common Stock was issued in January 2020. See Note 11.

 

In February 2020, the Company executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s Common Stock for aggregate gross proceeds to Navidea of approximately $3.4 million. Of this amount, approximately $850,000 was received during the first quarter of 2020. An additional $1.7 million was received and the related Common Stock was issued during the second quarter of 2020 through the date of filing this Quarterly Report on Form 10-Q. As a result, the Company recorded approximately $1.7 million of stock subscriptions receivable as of March 31, 2020. The remaining $913,000 of proceeds have not been received as of the date of filing this Quarterly Report on Form 10-Q. See Notes 11 and 16(a).

 

Navidea intends to use the net proceeds from these transactions to fund its research and development programs, including continued advancement of its two Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses.

 

The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted on March 27, 2020.  Among the provisions contained in the CARES Act is the creation of the Payroll Protection Program (“PPP”) that provides for Small Business Administration (“SBA”) Section 7(a) loans for qualified small businesses. PPP loan proceeds are available to be used to pay for payroll costs, including salaries, commissions, and similar compensation, group health care benefits, and paid leaves; rent; utilities; and interest on certain other outstanding debt. The amount that will be forgiven will be calculated in part with reference to the Company’s full-time headcount during the eight-week period following the funding of the PPP loan.  On April 30, 2020, the Company was informed by its lender, Fifth Third Bank (the “Lender”), that the Lender received approval from the SBA to fund the Company’s request for a loan under the SBA’s PPP (the “PPP Loan”). Per the terms of the PPP Loan, the Company will receive total proceeds of $366,000 from the Lender.  In accordance with the loan forgiveness requirements of the CARES Act, the Company intends to use the proceeds from the PPP Loan primarily for payroll costs, rent and utilities, thus the Company anticipates that 100% of the loan will be forgiven.  See Note 16(d).

 

During the ongoing COVID-19 global pandemic, the Company’s primary focus is the safety of its employees, the employees of its clinical trial sites, and the patients enrolled in its clinical trials. The Company is working hard to mitigate any safety risk along with any long-term impact on its clinical development programs. To date, we do not believe there has been any appreciable impact to the Company’s clinical development and regulatory timelines resulting from COVID-19.  However, much of the funding from the February 2020 transactions described above has been delayed, due in part to the COVID-19 pandemic and its devastating impact on global financial markets.  The Company is working closely with the parties to these transactions to complete the funding as soon as possible.

 

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 February 2020 transactions described above have provided approximately $2.5 million of additional working capital, with another $5.1 million to be received in the future. The Company also has funds remaining under outstanding grant awards, and continues working to establish new sources of funding, including collaborations, potential equity investments, and additional grant funding that can augment the balance sheet. However, based on our current working capital and our projected cash burn, and without definitive agreements in place for additional funding, management believes that there is substantial doubt about the Company’s ability to continue as a going concern for at least twelve months following 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.  The Company has license and distribution agreements in place in India and China, however Tc99 tilmanocept has not been approved in either of those markets. On May 11, 2020, the Company terminated its license and distribution agreement in Europe, which is the only market in which Tc99m tilmanocept has been approved. See Note 16(c).

 

The Company also has an agreement in place to provide Meilleur Technologies, Inc., (“Meilleur”), a wholly-owned subsidiary of Cerveau Technologies, Inc. (“Cerveau”), worldwide rights to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore. Meilleur also has an option to commercialize worldwide.

 

Currently, the Company 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 in each of those countries. It is not possible to determine with any degree of certainty whether or when regulatory approval for this product will be achieved in India or 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 regulatory approval 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.

 

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 Europe, 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 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 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.

 

 

The sublicense of NAV4694 to Meilleur provides for payments to Navidea including up-front payments, milestones, an option for worldwide commercial rights, royalties on net sales, and reimbursement for product development assistance during the initial transition period. In accordance with Accounting Standards Codification No. 606, Revenue from Contracts with Customers (“ASC 606”), the upfront payments were recognized upon contract inception, and reimbursement for product development assistance will be recognized on a monthly basis. Should some or all of the variable consideration from milestones, the option and royalties meet the requirements of ASC 606 to be included in the transaction price, those amounts will be recognized as revenue in future periods.

 

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 March 31, 2020 and 2019, the Company recognized revenue from contracts with customers of approximately $15,000 and $14,000. During the three-month periods ended March 31, 2020 and 2019, 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 tables disaggregate the Company’s revenue from contracts with customers for the three-month periods ended March 31, 2020 and 2019.

 

 

 

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 have been lower than rates in India but higher than in China.

 

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 Europe, thus the Company has begun to recognize royalties from sales in Europe. Tc99m tilmanocept has not yet been approved for sale in India or China, and may never achieve approval in those markets. The regulatory pathways and timelines in those markets 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 March 31, 2020, 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 consolidated balance sheets, during the three-month periods ended March 31, 2020 and 2019.

 

 

The Company had trade receivables of approximately $0 outstanding as of March 31, 2020 and December 31, 2019.

 

 

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. ASC 606 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 and the NIH do not have a vendor-customer relationship and the grant awards are outside the scope of ASC 606. Accordingly, ASC 606 need not be applied to NIH grants.

 

4.	Stock-Based Compensation

 

For the three-month periods ended March 31, 2020 and 2019, our total stock-based compensation expense, which includes reversals of expense for certain forfeited or cancelled awards, was approximately $39,000 and $62,000, respectively. We have not recorded any income tax benefit related to stock-based compensation in either of the three-month periods ended March 31, 2020 and 2019.

 

A summary of the status of our stock options as of March 31, 2020, and changes during the three-month period then ended, is presented below.

 

 

A summary of the status of our unvested restricted stock as of March 31, 2020, and changes during the three-month period then ended, is presented below.

 

 

As of March 31, 2020, there was approximately $144,000 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 debt, convertible preferred stock, options and warrants.

 

 

Diluted loss per common share for the three-month periods ended March 31, 2020 and 2019 excludes the effects of 1,515,164 and 902,050 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, 10,000 and 15,000 shares of unvested restricted stock for the three-month periods ended March 31, 2020 and 2019, respectively, were excluded in determining basic and diluted loss per share from continuing operations because such inclusion would be anti-dilutive.

 

6.	Investment in Macrophage Therapeutics, Inc.

 

In August 2018, Dr. Michael 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”), with the intent of entering into one or more additional definitive agreements, which set forth the terms of the separation from service. In February 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.

 

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 the Company and MT and Dr. Goldberg that substantially limited the claims that Dr. Goldberg can pursue against the Company and MT.  Specifically, the Court found that certain portions of Dr. Goldberg’s counterclaims against the Company and third-party claims against Macrophage failed to state a claim upon which relief can be granted. Specifically, the Court ruled that actions taken by the Company and MT, including reconstituting the MT Board, replacing Dr. Goldberg with Jed A. Latkin as Chief Executive Officer of MT, terminating the sublicense between the Company and MT, terminating certain research projects, and allowing MT intellectual property to revert back to the Company, were not breaches of an August 2018 Agreement between the Company, MT and Dr. Goldberg.

 

The Court also rejected Dr. Goldberg’s claim for wrongful termination as Chief Executive Officer of MT. In addition, the 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 the Company to the Board of MT), or to reinstate the terminated sublicense between the Company and MT.

 

In addition, the District Court found the Company’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.  The parties are in the process of submitting the issue to the District Court for resolution on how much in fees Dr. Goldberg is owed under the District Court’s order. 

 

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 has opposed the motion.

 

On January 31, 2020, Dr. 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.  The discovery deadline in the New York Action is June 15, 2020.

 

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.   MT’s claims for breach of fiduciary duty and conversion against Dr. Goldberg remain pending.  As a result of the Delaware Court’s ruling and Navidea’s prior termination of the sublicense between itself and MT, all of the intellectual property related to the Manocept platform is now directly controlled by Navidea. A trial on MT’s claims against Goldberg for breach of fiduciary duty and conversion is presently scheduled for June 2020. However, due to COVID-19 impacts on the judicial system, the Company expects that the trial date will be adjourned to a future date.

 

Derivative Action Involving Dr. Goldberg

 

On July 26, 2019, Dr. Goldberg served shareholder demands on the Boards of Navidea and MT repeating many of the claims made in the lawsuits described above.  On or about November 20, 2019, Dr. Goldberg commenced a derivative action purportedly on behalf of MT in the District Court against Dr. Claudine Bruck, Y. Michael Rice, and Jed Latkin alleging a claim for breach of fiduciary duty based on the actions alleged in the demands.  On April 3, 2020, Dr. Goldberg dismissed the derivative action in New York without prejudice and retains the ability to re-file the action in Delaware.  See Notes 2 and 10.

 

 

 

7.	Accounts Payable, Accrued Liabilities and Other

 

Accounts payable at March 31, 2020 and December 31, 2019 includes an aggregate of $65,000 in both periods due to related parties for director fees. Accrued liabilities and other at March 31, 2020 and December 31, 2019 includes an aggregate of $914,000 and $925,000, respectively, due to related parties for accrued termination costs and bonuses.

 

8.	Notes Payable

 

IPFS Corporation

 

In November 2018, we prepaid $393,000 of insurance premiums through the issuance of a note payable to IPFS Corporation (“IPFS”) with an interest rate of 5.1%. The note was payable in ten monthly installments of $40,000, with the final payment made in August 2019.

 

Interest expense related to the IPFS note payable totaled $4,000 during the three-month period ended March 31, 2019.

 

First Insurance Funding

 

In November 2019, we prepaid $349,000 of insurance premiums through the issuance of a note payable to First Insurance Funding (“FIF”) with an interest rate of 5.0%. The note is payable in eight monthly installments of $44,000, with the final payment due in July 2020.

 

Interest expense related to the FIF note payable totaled $3,000 during the three-month period ended March 31, 2020. The balance of the FIF note was approximately $176,000 and $306,000 as of March 31, 2020 and December 31, 2019, respectively, and was included in notes payable, current in the consolidated balance sheets.

 

Summary

 

During the three-month periods ended March 31, 2020 and 2019, we recorded interest expense of $3,000 and $4,000, 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 approximately $3,000. The current least term expires in June 2023.

 

We also leased approximately 2,000 square feet of office space at 560 Sylvan Avenue, Englewood Cliffs, New Jersey, at a monthly base rent of approximately $3,000. The lease for the New Jersey office space expired on March 31, 2019 and we did not renew.

 

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 approximately $27,000 in 2020. 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 space, providing for monthly sublease payments to Navidea of approximately $39,000 through October 2022.

 

We also currently lease a vehicle at a monthly payment of approximately $300, expiring in September 2021, and office equipment at a monthly payment of approximately $100, expiring in October 2024.

 

Total operating lease expense was $51,000 and $66,000 for the three-month periods ended March 31, 2020 and 2019, respectively, and was recorded in selling, general and administrative expenses.

 

 

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of March 31, 2020.

 

 

 

 

Cash paid for amounts included in the present value of operating lease liabilities was $91,000 and $97,000 during the three-month periods ended March 31, 2020 and 2019, 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.

 

CRG Litigation

 

As disclosed in the Company’s Annual Report on Form 10-K and other filings, 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 “Lenders”), in the District Court of Harris County, Texas (the “Texas Court”) relating to CRG’s claims of default under the terms the CRG Loan Agreement. Following a trial in December 2017, the Texas Court ruled that the Company’s total obligation to CRG was in excess of $66.0 million, limited to $66.0 million under the Global Settlement Agreement. The Texas Court acknowledged only the $59.0 million payment made in March 2017, concluding that the Company owed CRG another $7.0 million, however the Texas Court did not expressly take the Company’s June 2016 payment of $4.1 million into account and awarded, as part of the $66.0 million, amounts that had already been paid as part of the $4.1 million. The Company believes that this $4.1 million should be credited against the $7.0 million and has appealed the Texas Court’s judgment. The Court of Appeals dismissed the Company’s appeal without reaching the merits due to a contractual waiver of appeal.

 

On April 9, 2018, CRG drew approximately $7.1 million on the Cardinal Health 414 letter of credit.  These were funds to which Navidea would otherwise have been entitled. This was in addition to the $4.1 million and the $59.0 million that Navidea had previously paid to CRG.

 

The Company has also been engaged in ongoing litigation with CRG in the Court of Common Pleas of Franklin County, Ohio related to Navidea’s claims that the Lenders fraudulently induced Navidea to enter into a settlement agreement and breached the terms of the same through certain actions taken by the Lenders in connection with the Global Settlement Agreement reached in 2017, pursuant to which Navidea agreed to pay up to $66.0 million to Lenders, as well as through actions and misrepresentations by CRG after the Global Settlement Agreement was executed.  The claims in that suit are for breach of contract, conversion and unjust enrichment against the Lenders for their collection of more than $66.0 million, the maximum permitted under the Global Settlement Agreement, 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 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 Global Settlement Agreement.  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 is a final appealable order and terminates 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. Oral argument may be held on the appeal, but if and when the oral argument will be held is uncertain due to the disruption caused by the COVID-19 pandemic.  At present, it is unknown how long the disruptions due to the pandemic emergency will last, and thus uncertain as to the timeline under which the matter will progress in the Ohio Court of Appeals.

 

 

CRG filed another lawsuit in the Texas Court in April 2018. This suit seeks a declaratory judgment that CRG did not breach the Global Settlement Agreement by drawing the entire $7.1 million on the Cardinal Health 414 letter of Credit. CRG also alleges that the Company breached the Global Settlement Agreement by appealing the Texas Court’s judgment and by filing the suit in Franklin County, Ohio. The Company moved to dismiss CRG’s claims under the Texas Citizens’ Participation Act. The Texas Court denied the motion to dismiss. The Company filed an interlocutory appeal of the denial of its motion to dismiss. That appeal is fully briefed, and the parties await the court of appeals’ ruling. Proceedings in the Texas Court are stayed pending resolution of that appeal. See Note 2.

 

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 (the “District Court”).  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. A preliminary conference was set for April 28, 2020 but was cancelled due to the COVID-19 pandemic.  In addition, the New York Supreme Court stopped accepting non-emergency filings due to the pandemic emergency.  At present, it is unknown how long the disruptions due to the pandemic emergency will last, and thus uncertain as to the timeline under which the matter will progress in the New York Supreme Court. See Note 2.

 

Goldberg Agreement and Litigation

 

In August 2018, Dr. Michael 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 the Goldberg Agreement, with the intent of entering into one or more additional definitive agreements, 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 will 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 Michael Rice and Dr. Claudine Bruck. Mr. Rice and Dr. Bruck remain members of the board of directors of Navidea. The MT Board then appointed Jed A. Latkin to serve as President and Chief Executive Officer of MT.

 

 

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, 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 Macrophage failed to state a claim upon which relief can be granted. Specifically, the District Court ruled that actions taken by Navidea and MT, including reconstituting the MT Board, 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. The parties are in the process of submitting the issue to the District Court for resolution on how much in fees Dr. Goldberg is owed under the District Court’s order. 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 has opposed the motion.

 

On January 31, 2020, Dr. 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. The discovery deadline in the New York Action is June 15, 2020.

 

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, 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.   MT’s claims for breach of fiduciary duty and conversion against Dr. Goldberg remain pending.  As a result of the Delaware Court’s ruling and Navidea’s prior termination of the sublicense between itself and MT, all of the intellectual property related to the Manocept platform is now directly controlled by Navidea.  A trial on MT’s claims against Goldberg for breach of fiduciary duty and conversion is presently scheduled for June 2020. However, due to COVID-19 impacts on the judicial system, the Company expects that the trial date will be adjourned to a future date.

 

Derivative Action Involving Dr. Goldberg

 

On July 26, 2019, Dr. Goldberg served shareholder demands on the Boards of Navidea and MT repeating many of the claims made in the lawsuits described above.  On or about November 20, 2019, Dr. Goldberg commenced a derivative action purportedly on behalf of MT in the District Court against Dr. Claudine Bruck, Y. Michael Rice, and Jed Latkin alleging a claim for breach of fiduciary duty based on the actions alleged in the demands.  On April 3, 2020, Dr. Goldberg dismissed the derivative action in New York without prejudice and retains the ability to re-file the action in Delaware. See Notes 2 and 6.

 

 

NYSE American Continued Listing Standards

 

On August 14, 2018, the Company received a Deficiency Letter from the NYSE American stating that Navidea was not in compliance with certain NYSE American continued listing standards relating to stockholders’ equity. Specifically, Navidea was not in compliance with Sections 1003(a)(i), (ii) and (iii) of the NYSE American Company Guide (the “Guide”), the highest of such standards requiring an issuer to have stockholders’ equity of $6.0 million or more if it has reported losses from continuing operations and/or net losses in its five most recent fiscal years. In addition, the Deficiency Letter stated that the NYSE American staff (the “Staff”) determined that the Company’s securities had been selling for a low price per share for a substantial period of time and, pursuant to Section 1003(f)(v) of the Guide, Navidea’s continued listing was predicated on it effecting a reverse stock split of our Common Stock or otherwise demonstrating sustained price improvement within a reasonable period of time.

 

The Company regained compliance with the minimum trading price standard following a one-for-twenty reverse split of its issued and outstanding Common Stock on April 26, 2019. 

 

On February 14, 2020, the Company announced the execution of several funding transactions resulting in stockholders’ equity of $6.0 million, which brought the Company back into compliance with Sections 1003(a)(i), (ii) and (iii) of the Guide within the timeframe permitted by the NYSE American.  However, much of the funding from these transactions has been delayed, due in part to the COVID-19 pandemic and its devastating impact on global financial markets. The Company is working closely with the parties to these transactions to complete the funding as soon as possible. The Company had a stockholders’ deficit of approximately $1.8 million as of March 31, 2020.

 

11.

Equity

 

In December 2019, the Company executed a Stock Purchase Agreement with the investors named therein. Pursuant to the Stock Purchase Agreement, the investors agreed to purchase approximately 2.1 million shares of the Company’s Common Stock in a private placement for aggregate gross proceeds to the Company of approximately $1.9 million. Of this amount, approximately $1.1 million was received during 2019, resulting in approximately $812,000 of stock subscriptions receivable as of December 31, 2019. The remaining $812,000 of proceeds were received and the related Common Stock was issued in January 2020. In accordance with current accounting guidance, the $812,000 of stock subscriptions receivable was included in accounts and other receivables in the consolidated balance sheet at December 31, 2019.

 

In February 2020, the Company executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s Common Stock for aggregate gross proceeds to Navidea of approximately $3.4 million. Of this amount, approximately $850,000 was received during the first quarter of 2020. An additional $1.7 million was received and the related Common Stock was issued during the second quarter of 2020 through the date of filing this Quarterly Report on Form 10-Q. As a result, the Company recorded approximately $1.7 million of stock subscriptions receivable as of March 31, 2020. The remaining $913,000 of proceeds have not been received as of the date of filing this Quarterly Report on Form 10-Q. In accordance with current accounting guidance, the $1.7 million of stock subscriptions receivable was included in accounts and other receivables, and the $913,000 of stock subscriptions receivable was included in common stock subscriptions receivable in the consolidated balance sheet at March 31, 2020.

 

Navidea intends to use the net proceeds from these transactions to fund its research and development programs, including continued advancement of its two Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses. See Note 2.

 

During the three-month period ended March 31, 2020, we issued 53,315 shares of our common stock valued at $65,000 to our employees as partial payment in lieu of cash for their 2019 bonuses.

 

12.	Stock Warrants

 

At March 31, 2020, there are 1.4 million 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 $13.26 per share. The warrants have remaining outstanding terms ranging from one to 15.4 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 at March 31, 2020 and December 31, 2019, except the alternative minimum tax (“AMT”) credit carryforward amount described below.

 

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 March 31, 2020, except for the AMT credit carryforward.

 

The Tax Cuts and Jobs Act (the “Tax Act”) was signed into law on December 22, 2017. The Tax Act repealed the AMT for corporations, and permits any existing AMT credit carryforwards to be used to reduce the regular tax obligation in 2018, 2019 and 2020. Under the Tax Act, companies may continue using AMT credits to offset any regular income tax liability in years 2018 through 2020, with 50% of remaining AMT credits refunded in each of the 2018, 2019 and 2020 tax years, and all remaining credits refunded in tax year 2021. This results in full realization of an existing AMT credit carryforward irrespective of future taxable income. Accordingly, the Company recorded AMT credit carryforwards of $621,000 as of December 31, 2019, 50% of which was included in prepaid expenses and other current assets, and 50% of which was included in other noncurrent assets as of December 31, 2019.

 

The CARES Act was signed into law on March 27, 2020. Under the CARES Act, corporate AMT credits are now 100% refundable as early as the 2018 tax year. Accordingly, the Company has filed for the refund of all $621,000 of AMT credit carryforwards, and they are included in prepaid expenses and other current assets as of March 31, 2020.

 

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 March 31, 2020 or December 31, 2019 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 March 31, 2020, tax years 2016-2019 remained subject to examination by federal and state tax authorities.

 

As of March 31, 2020, we had approximately $142.2 million of federal and $20.1 million of state net operating loss carryforwards, as well as approximately $8.8 million of federal R&D credit carryforwards.

 

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 NAV4694 (sublicensed in April 2018), and (ii) therapeutic development programs, including therapeutic applications of our Manocept platform.

 

Certain prior period amounts also have been reclassified to conform to the current period presentation. An adjustment has been made to the Consolidated Statements of Operations for the three-month period ended March 31, 2019, to classify sublease revenue of $94,000 as a reduction in Selling, General and Administrative Expense. This change in classification does not affect previously reported net loss on the Consolidated Statement of Operations.

 

 

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

 

 

 

(1)

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.

(2)

Depreciation and amortization are reflected in selling, general and administrative expenses ($16,843 and $36,779 for the three-month periods ended March 31, 2020 and 2019, respectively).

(3)

Income (loss) from operations does not reflect the allocation of certain selling, general and administrative expenses, excluding depreciation and amortization, to our individual reportable segments.

(4)

Amounts consist primarily of interest income and interest expense, which are not currently allocated to our individual reportable segments.

 

15.	Supplemental Disclosure for Statements of Cash Flows

 

During the three-month periods ended March 31, 2020 and 2019, we paid interest aggregating $3,000 and $4,000, respectively. During the three-month period ended March 31, 2020, we issued 53,315 shares of our common stock valued at $65,000 to our employees as partial payment in lieu of cash for their 2019 bonuses.

 

 

 

16.	Subsequent Events

 

The Company has evaluated events and transactions subsequent to March 31, 2020 and through the date these consolidated financial statements were included in this Quarterly Report on Form 10-Q and filed with the SEC.

 

a.

Common Stock: In February 2020, the Company executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s Common Stock for aggregate gross proceeds to Navidea of approximately $3.4 million. Of this amount, approximately $850,000 was received during the first quarter of 2020. An additional $1.7 million was received and the related Common Stock was issued during the second quarter of 2020 through the date of filing this Quarterly Report on Form 10-Q. As a result, the Company recorded approximately $1.7 million of stock subscriptions receivable as of March 31, 2020. The remaining $913,000 of proceeds have not been received as of the date of filing this Quarterly Report on Form 10-Q.

 

b.

Preferred Stock:  In February 2020, the Company executed a binding term sheet to sell the Judgment entered by the Ohio Court of Common Pleas in favor of Navidea in the amount of $4.3 million plus interest, for $4.2 million of proceeds to Navidea.  On May 6, 2020, the Company entered into a Stock Purchase Agreement and Letter of Investment Intent with Keystone pursuant to which the Company agreed to issue to Keystone 420,000 shares of newly-designated Series C Preferred Stock for an aggregate purchase price of $4.2 million.  Pursuant to the Stock Purchase Agreement, Keystone will purchase shares of Series C Preferred Stock in amounts to be determined by Keystone in one or more closings (each, a “Call Closing”) on or before November 6, 2020, provided that all of the Series C Preferred Stock must be purchased by such date.

 

Holders of the Series C Preferred Stock may convert some or all of the Series C Preferred Stock into shares of the Company’s Common Stock at a 10% discount to market (the “Conversion Shares”), provided that the Company may not issue such Conversion Shares in excess of 19.99% of the number of shares of Company common stock outstanding as of the date of the investment (the “Exchange Cap”) without shareholder approval, which the Company is not required to seek. In the event that (a) the Company does not have enough Conversion Shares registered for resale so as to allow for a requested conversion and immediate resale, or (b) if the number of Conversion Shares issued reaches the Exchange Cap, then the Company will be required to redeem the difference in cash at $11 per share of Series C Preferred Stock, but only if, when and to the extent that the Company has received cash proceeds as a result of the Judgment being affirmed.

 

c.

License Termination:  On May 11, 2020 (the “Termination Date”), the Company entered into a Termination Agreement (the “Termination Agreement”) with SpePharm AG (“SpePharm”) and Norgine BV (“Norgine”) which terminated that certain Exclusive License Agreement dated March 5, 2015 (as amended to date, the “License Agreement”). Under the License Agreement, SpePharm had the exclusive right to develop, manufacture and commercialize the Company’s products approved for radiolabeling with Tc99m and containing Lymphoseek® (collectively, the “Products”) in several jurisdictions abroad, including the United Kingdom, France, Germany, Australia and New Zealand (collectively, the “Licensed Territory”). In exchange for such rights, the Company was entitled to certain royalty payments.

 

Pursuant to the Termination Agreement, the parties agreed that neither owed the other any payments due under the License Agreement as of the Termination Date and that, among other things, SpePharm will no longer have any right in, nor claim to, any intellectual property owned by the Company or its affiliates anywhere in the world. SpePharm also agreed to perform certain wind-down activities (the “Wind-Down Activities”) during the six-month period following the Termination Date (the “Transition Period”). The Wind-Down Activities include, without limitation, SpePharm transferring to the Company or its designee(s) the regulatory approvals controlled by SpePharm or its affiliates for the purpose of marketing, distributing and selling the Products in the Licensed Territory. SpePharm will also transfer to the Company certain tenders and other customer and sales contracts related to the Products. Subject to the terms of the Termination Agreement, Norgine, an affiliate of SpePharm, agreed to guarantee SpePharm’s performance of its obligations under the Termination Agreement.

 

d.

Payroll Protection Program Loan:  The CARES Act was enacted on March 27, 2020.  Among the provisions contained in the CARES Act is the creation of the PPP that provides for SBA Section 7(a) loans for qualified small businesses.  PPP Loan proceeds are available to be used to pay for payroll costs, including salaries, commissions, and similar compensation, group health care benefits, and paid leaves; rent; utilities; and interest on certain other outstanding debt. The amount that will be forgiven will be calculated in part with reference to the Company’s full-time headcount during the eight-week period following the funding of the PPP loan.  On April 30, 2020, the Company was informed by the Lender that the Lender received approval from the SBA to fund the Company’s request for a PPP Loan.  Per the terms of the PPP Loan, the Company will receive total proceeds of $366,000 from the Lender.  In accordance with the loan forgiveness requirements of the CARES Act, the Company intends to use the proceeds from the PPP Loan primarily for payroll costs, rent and utilities, thus the Company anticipates that 100% of the loan will be forgiven.  The interest rate on the PPP Loan is a fixed rate of 1% per annum. To the extent that the amounts owed under the PPP Loan, or a portion of them, are not forgiven, the Company will be required to make principal and interest payments in monthly installments beginning six months from the date of the PPP Loan. The PPP Loan matures in two years.  The PPP Loan includes events of default. Upon the occurrence of an event of default, the Lender will have the right to exercise remedies against the Company, including the right to require immediate payment of all amounts due under the PPP Note.