navb20210930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended

September 30, 2021

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

For the transition period from

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

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: 30,188,491 shares of common stock, par value $.001 per share (as of the close of business on November 5, 2021).

TABLE OF CONTENTS

PART I – Financial Information		3

Item 1.	Condensed Consolidated Financial Statements	3

	Condensed Consolidated Balance Sheets as of September 30, 2021 (unaudited) and December 31, 2020	3

	Condensed Consolidated Statements of Operations for the Three-Month and Nine-Month Periods Ended September 30, 2021 and 2020 (unaudited)	5

	Condensed Consolidated Statements of Stockholders’ Equity for the Nine-Month Periods Ended September 30, 2021 and 2020 (unaudited)	6

	Condensed Consolidated Statements of Cash Flows for the Nine-Month Periods Ended September 30, 2021 and 2020 (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	24

	Forward-Looking Statements	24

	The Company	24

	Technology and Product Candidates	25

	Outlook	29

	Results of Operations	29

	Liquidity and Capital Resources	31

	Off-Balance Sheet Arrangements	33

	Recent Accounting Standards	33

	Critical Accounting Policies	33

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	34

Item 4.	Controls and Procedures	34

	Disclosure Controls and Procedures	34

	Changes in Control Over Financial Reporting	35

Item 5.	Other Information	36

PART II – Other Information		36

Item 1.	Legal Proceedings	36

Item 1A.	Risk Factors	36

Item 5.	Other Information	36

Item 6.	Exhibits	37

	September 30, 2021		December 31, 2020
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	7,176,211	$	2,670,495
Stock subscriptions and other receivables		108,323		2,987,319
Inventory		178,935		169,798
Prepaid expenses and other		193,491		700,716
Total current assets		7,656,960		6,528,328
Property and equipment		861,836		845,379
Less accumulated depreciation and amortization		735,443		713,217
Property and equipment, net		126,393		132,162
Right-of-use lease assets		458,280		458,280
Less accumulated amortization		299,641		208,185
Right-of-use lease assets, net		158,639		250,095
License agreements, patents and trademarks		947,224		747,863
Less accumulated amortization		156,862		127,622
License agreements, patents and trademarks, net		790,362		620,241
Other assets		227,192		227,192
Total assets	$	8,959,546	$	7,758,018

	September 30, 2021			December 31, 2020
	(unaudited)
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,206,229		$	1,161,717
Accrued liabilities and other		2,538,800			2,512,994
Notes payable		—			745,443
Lease liabilities, current		351,487			294,951
Total current liabilities		4,096,516			4,715,105
Lease liabilities, net of current portion		29,036			296,006
Deferred revenue		700,000			700,000
Total liabilities		4,825,552			5,711,111
Commitments and contingencies (See Note 10)
Stockholders’ equity:
Preferred stock; $.001 par value; 5,000,000 shares authorized; no shares issued or outstanding as of September 30, 2021 and December 31, 2020		—			—
Series D preferred stock; $.001 par value, 150,000 shares authorized; 22,077 and 0 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively		22			—
Series D preferred stock subscribed; $.001 par value, 0 and 103,000 shares subscribed as of September 30, 2021 and December 31, 2020, respectively		—			132
Series D preferred stock subscriptions receivable		—			(10,300,000	)
Series E preferred stock; $.001 par value, 50,000 shares authorized; 50,000 and 0 shares outstanding as of September 30, 2021 and December 31, 2020, respectively		50			—
Common stock; $.001 par value; 300,000,000 shares authorized; 30,163,245 and 27,149,691 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively		221,160			218,146
Common stock subscribed; $.001 par value, 0 and 995,000 shares subscribed as of September 30, 2021 and December 31, 2020, respectively		—			995
Common stock subscriptions receivable		—			(4,975,000	)
Additional paid-in capital		370,316,910			375,428,014
Accumulated deficit		(367,135,447	)		(359,056,683	)
Navidea stockholders' equity		3,402,695			1,315,604
Noncontrolling interest		731,299			731,303
Total stockholders’ equity		4,133,994			2,046,907
Total liabilities and stockholders’ equity	$	8,959,546		$	7,758,018

	Three Months Ended September 30,						Nine Months Ended September 30,
	2021			2020			2021			2020
Revenue:
Royalty revenue	$	—		$	2,047		$	—		$	26,188
License revenue		9,116			4,726			44,665			4,726
Grant and other revenue		87,266			261,616			436,500			664,848
Total revenue		96,382			268,389			481,165			695,762
Cost of revenue		—			82			—			1,048
Gross profit		96,382			268,307			481,165			694,714
Operating expenses:
Research and development		1,048,786			1,377,998			3,769,596			3,659,046
Selling, general and administrative		1,469,375			1,788,934			5,132,730			4,946,279
Total operating expenses		2,518,161			3,166,932			8,902,326			8,605,325
Loss from operations		(2,421,779	)		(2,898,625	)		(8,421,161	)		(7,910,611	)
Other (expense) income:
Interest (expense) income, net		(2,814	)		(149	)		(4,423	)		12,822
Gain on extinguishment of debt		—			—			366,000			—
Other, net		2,800			(564	)		(3,141	)		(777	)
Total other (expense) income, net		(14	)		(713	)		358,436			12,045
Net loss before income taxes		(2,421,793	)		(2,899,338	)		(8,062,725	)		(7,898,566	)
Provision for income taxes		(16,043	)		—			(16,043	)		—
Net loss		(2,437,836	)		(2,899,338	)		(8,078,768	)		(7,898,566	)
Loss (income) attributable to noncontrolling interest		1			—			4			(1	)
Deemed dividend on Series C and Series D Preferred Stock beneficial conversion feature		—			(405,555	)		—			(483,333	)
Net loss attributable to common stockholders	$	(2,437,835	)	$	(3,304,893	)	$	(8,078,764	)	$	(8,381,900	)

Loss attributable to common stockholders per common share (basic and diluted)	$	(0.08	)	$	(0.13	)	$	(0.28	)	$	(0.37	)
Weighted average shares outstanding		30,122,549			25,843,732			29,067,784			22,946,201

For the Nine Months Ended September 30, 2021
	Preferred Stock						Preferred Stock Subscribed						Preferred Stock Subscriptions			Common Stock Issued				Common Stock Subscribed						Common Stock Subscriptions			Additional Paid-In			Accumulated			Non-controlling
	Shares			Amount			Shares			Amount			Receivable			Shares		Amount		Shares			Amount			Receivable			Capital			Deficit			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 (See Note 11)		—			—			(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
Issued Series D Preferred Stock		22,077			22			(22,077	)		(22	)		—			—		—		—			—			—			—			—			—			—
Issued restricted stock		—			—			—			—			—			2.500		3		—			—			—			—			—			—			3
Issued stock in lieu of cash in payment of director fees		—			—			—			—			—			15.027		15		—			—			—			27,485			—			—			27,500
Stock compensation expense		—			—			—			—			—			—		—		—			—			—			108,157			—			—			108,157
Net loss		—			—			—			—			—			—		—		—			—			—			—			(2,437,835	)		(1	)		(2,437,836	)
Balance, September 30, 2021		72,077		$	72			—		$	—		$	—			30,163,245	$	221,160		—		$	—		$	—		$	370,316,910		$	(367,135,447	)	$	731,299		$	4,133,994

For the Nine Months Ended September 30, 2020
	Preferred Stock						Preferred Stock Subscribed				Preferred Stock Subscriptions		Common Stock Issued				Common Stock Subscribed						Common Stock Subscriptions			Additional Paid-In			Accumulated			Accumulated Other Comprehensive		Non-controlling
	Shares			Amount			Shares		Amount		Receivable		Shares		Amount		Shares			Amount			Receivable			Capital			Deficit			Loss		Interest			Total
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 issuance 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	)
Issued restricted stock		-			-			-		-		-		10,000		10		-			-			-			-			-			-		-			10
Issued stock pursuant to registered direct offering		-			-			-		-		-		647,058		647		(647,058	)		(647	)		-			-			-			-		-			-
Issued stock pursuant to private placement		-			-			-		-		-		1,911,800		1,912		(1,911,800	)		(1,912	)		520,030			-			-			-		-			520,030
Issued stock to 401(k) plan		-			-			-		-		-		32,651		33		-			-			-			39,801			-			-		-			39,834
Issued stock upon exercise of warrants		-			-			-		-		-		300,595		300		-			-			-			(300	)		-			-		-			-
Issued stock in payment of employee bonuses		-			-			-		-		-		40,844		41		-			-			-			106,970			-			-		-			107,011
Issued Series C Preferred Stock		70,000			70			-		-		-		-		-		-			-			-			699,930			-			-		-			700,000
Deemed dividend on Series C Preferred Stock		-			-			-		-		-		-		-		-			-			-			77,778			(77,778	)		-		-			-
Issued stock upon conversion of Series C Preferred Stock		(70,000	)		(70	)		-		-		-		410,765		411		-			-			-			(341	)		-			-		-			-
Stock subscribed in connection with private placement		-			-			-		-		-		-		-		-			-			392,470			-			-			-		-			392,470
Stock compensation expense		-			-			-		-		-		-		-		-			-			-			34,588			-			-		-			34,588
Comprehensive loss:
Net loss		-			-			-		-		-		-		-		-			-			-			-			(2,325,618	)		-		(1	)		(2,325,619	)
Total comprehensive loss		-			-			-		-		-		-		-		-			-			-			-			-			-		-			(2,325,619	)
Balance, June 30, 2020		-			-			-		-		-		24,547,961		215,545		461,729			462			-			350,178,082			(352,748,108	)		-		731,304			(1,622,715	)
Issued Series C Preferred Stock, net of costs		350,000			350			-		-		-		-		-		-			-			-			3,462,828			-			-		-			3,463,178
Deemed dividend on Series C Preferred Stock		-			-			-		-		-		-		-		-			-			-			388,889			(388,889	)		-		-			-
Issued stock upon conversion of Series C Preferred Stock		(350,000	)		(350	)		-		-		-		1,014,311		1,014		-			-			-			(664	)		-			-		-			-
Issued stock in payment of Series C Preferred Stock fees		-			-			-		-		-		14,205		14		-			-			-			(14	)		-			-		-			-
Issued stock pursuant to private placement		-			-			-		-		-		461,729		462		(461,729	)		(462	)		-			-			-			-		-			-
Issued stock pursuant to Jubilant MOU		-			-			-		-		-		209,205		209		-			-			-