UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q/A

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

For the quarterly period ended June 30, 2022.

☐	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: 001-32188

ORAGENICS, INC.

(Exact name of registrant as specified in its charter)

florida

59-3410522

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

4902 Eisenhower Blvd., Suite 125

Tampa, Florida 33634

(Address of principal executive offices)

813-286-7900

(Issuer’s telephone number)

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		OGEN		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 and 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, non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “accelerated filer”, “large accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (check one):

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

Indicate the number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date:

As of August 8, 2022, there were 116,394,806 shares of Common Stock, $.001 par value, outstanding.

EXPLANATORY NOTE

Oragenics Inc. (the “Company”) is filing this Amendment No. 1 on Form 10-Q/A (this “Amendment No. 1”) to amend its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, filed with the Securities and Exchange Commission (the “SEC”) on August 8, 2022 (the “Original Form 10-Q”).

Background of Restatement

This Amendment No. 1 is being filed for the sole purpose of restating certain of the financial statements included in the Original Form 10-Q (the “Restatement”) due to the Company discovering that it made the following errors in the Original Form 10-Q: (i) not properly analyzing research and development contracts. The total adjustments made resulted in a decrease in net loss of approximately $1.9 million for the six-month period ended June 30, 2022. On April 10, 2023, the Company filed a Current Report on Form 8-K disclosing that the consolidated financial statements included in the Original Form 10-Q should not be relied upon.

Internal Control Considerations

In connection with the Restatement, management has concluded that the Company had a material weakness as of June 30, 2022, as the Company’s procedures relating to the review of research and development contracts was insufficient, resulting in material errors in the financial statements. For a discussion of management’s considerations of the Company’s research and development contract procedures, and material weakness identified, refer to Controls and Procedures in Part I, Item 4.

Items Amended in this Amendment No. 1

This Amendment No. 1 sets forth the Original Form 10-Q, as modified and superseded where necessary to reflect the Restatement and the related disclosure controls and procedures and internal control considerations. Accordingly, the following items included in the Original Form 10-Q have been amended:

●Part I, Item 1, Consolidated Financial Statements

●Part I, Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations

●Part I, Item 4, Controls and Procedures

●Part II, Item 1A, Risk Factors

Additionally, in accordance with Rule 12b-15 under the Securities Exchange Act of 1934, as amended, the Company is including with this Amendment No. 1 currently dated certifications from its Chief Executive Officer and President, and Chief Financial Officer.

Except as described above and in 1A: Amendment To Previously Reported Quarterly Financial Statements, this Amendment No. 1 does not amend, update or change any other disclosures in the Original Form 10-Q. In addition, the information contained in this Amendment No. 1 does not reflect events occurring after the Original Form 10-Q and does not modify or update the disclosures therein, except to reflect the effects of the Restatement.

		Page
PART I – FINANCIAL INFORMATION		3

Item 1.	Financial Statements	3

	Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021	3

	Consolidated Statements of Operations for the three and six months ended June 30, 2022 and 2021 (unaudited)	4

	Consolidated Statement of Changes in Shareholders’ Equity for the three and six months ended June 30, 2022 and 2021 (unaudited)	5

	Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and June 30, 2021 (unaudited)	6

	Notes to Consolidated Financial Statements (unaudited)	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19

Item 3.	Quantitative and Qualitative Disclosures About Market Risk.	31

Item 4.	Controls and Procedures	31

PART II – OTHER INFORMATION		32

Item 1.	Legal Proceedings	32

Item 1A.	Risk Factors	32

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	35

Item 3.	Defaults Upon Senior Securities	35

Item 4.	Mine Safety Disclosures	35

Item 5.	Other Information	35

Item 6.	Exhibits	36

Signatures		37

PART I –	FINANCIAL INFORMATION

ITEM 1.	FINANCIAL STATEMENTS

Oragenics, Inc.

Consolidated Balance Sheets

	June 30, 2022 As Restated			December 31, 2021
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	17,867,483		$	27,265,703
Other receivables		—			6,987
Prepaid expenses and other current assets		1,990,049			434,699
Total current assets		19,857,532			27,707,389
Property and equipment, net		109,780			45,708
Operating lease right-of-use assets		385,361			477,882
Total assets	$	20,352,673		$	28,230,979
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable and accrued expenses	$	1,279,598		$	947,574
Short-term notes payable		—			303,416
Operating lease liabilities		180,824			194,270
Total current liabilities		1,460,422			1,445,260

Long-term liabilities:
Operating lease liabilities		217,353			299,520
Total long-term liabilities		217,353			299,520

Shareholders’ equity:
Preferred stock, no par value; 50,000,000 shares authorized; 9,417,000 Series A shares, 6,600,000 Series B shares, issued and outstanding at June 30, 2022 and December 31, 2021, respectively		2,656,713			2,656,713
Common stock, $0.001 par value; 250,000,000 and 200,000,000 shares authorized at June 30, 2022 and December 31, 2021, respectively, 116,394,806 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		116,395			116,395
Additional paid-in capital		195,356,454			194,987,219
Accumulated deficit		(179,454,664	)		(171,274,128	)
Total shareholders’ equity		18,674,898			26,486,199
Total liabilities and shareholders’ equity	$	20,352,673		$	28,230,979

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Operations

(Unaudited)

	2022			2021			2022			2021
	For the Three Months Ended June 30,						For the Six Months Ended June 30,
	2022 As Restated			2021			2022 As Restated			2021
Grant revenue	$	30,391		$	—		$	45,474		$	—

Operating expenses:
Research and development		2,590,032			2,467,575			5,883,693			5,728,479
General and administrative		1,044,334			1,370,393			2,375,883			3,346,969
Total operating expenses		3,634,366			3,837,968			8,259,576			9,075,448
Loss from operations		(3,603,975	)		(3,837,968	)		(8,214,102	)		(9,075,448	)
Other income (expense):
Interest income		15,369			24,254			27,275			44,287
Interest expense		(816	)		(1,033	)		(4,062	)		(3,601	)
Local business tax		(490	)		(600	)		(980	)		(1,200	)
Miscellaneous income		369			—			11,333			670
Total other income, net		14,432			22,621			33,566			40,156
Loss before income taxes		(3,589,543	)		(3,815,347	)		(8,180,536	)		(9,035,292	)
Income tax benefit		—			—			—			—
Net loss	$	(3,589,543	)	$	(3,815,347	)	$	(8,180,536	)	$	(9,035,292	)
Basic and diluted net loss per share	$	(0.03	)	$	(0.03	)	$	(0.07	)	$	(0.08	)
Shares used to compute basic and diluted net loss per share		116,394,806			115,864,162			116,394,806			109,357,191

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Changes in Shareholders’ Equity

(Unaudited)

(Restated)

	Shares		Amount		Shares		Amount		Capital		Deficit			Equity
									Additional					Total
	Common Stock				Preferred Stock				Paid In		Accumulated			Shareholders’
	Shares		Amount		Shares		Amount		Capital		Deficit			Equity
Balances at December 31, 2021		116,394,806	$	116,395		16,017,000.000	$	2,656,713	$	194,987,219	$	(171,274,128	)	$	26,486,199
Compensation expense relating to option issuances		—		—		—		—		90,247		—			90,247
Net loss		—		—		—		—		—		(4,590,993	)		(4,590,993	)
Balances at March 31, 2022		116,394,806	$	116,395		16,017,000.000	$	2,656,713	$	195,077,466	$	(175,865,121	)	$	21,985,453
Compensation expense relating to option issuances		—		—		—		—		278,988		—			278,988
Net loss		—		—		—		—		—		(3,589,543	)		(3,589,543	)
Balances at June 30, 2022		116,394,806	$	116,395		16,017,000.000	$	2,656,713	$	195,356,454	$	(179,454,664	)	$	18,674,898

	Shares		Amount		Shares			Amount			Capital		Deficit			Equity

											Additional					Total
	Common Stock				Preferred Stock						Paid In		Accumulated			Shareholders’
	Shares		Amount		Shares			Amount			Capital		Deficit			Equity
Balances at December 31, 2020		91,766,928	$	91,767		16,017,133.483		$	7,174,854		$	164,022,957	$	(154,444,983	)	$	16,844,595
Compensation expense relating to option issuances		—		—		—			—			1,123,761		—			1,123,761
Series C dividend		—		—		33.016			1,117,531			—		(1,117,531	)		—
Series C redemption						(166.499	)		(5,635,672	)							(5,635,672	)
ATM offering - net of expenses		21,398,765		21,399		—			—			26,654,993		—			26,676,392
Issuance of common stock from warrant exercise		2,472,573		2,472		—			—			2,258,864		—			2,261,336
Net loss		—		—		—			—			—		(5,219,945	)		(5,219,945	)
Balances at March 31, 2021		115,638,266		115,638		16,017,000			2,656,713			194,060,575		(160,782,459	)		36,050,467
Compensation expense relating to option issuances		—		—		—			—			231,140		—			231,140
Issuance of common stock from option exercise		556,540		557		—			—			266,583		—			267,140
Net loss		—		—		—			—			—		(3,815,347	)		(3,815,347	)
Balances at June 30, 2021		116,194,806		116,195		16,017,000			2,656,713			194,558,298		(164,597,806	)		32,733,400

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Cash Flows

(Unaudited)

	2022			2021
	For the Six Months Ended June 30,
	2022 As Restated			2021
Cash flows from operating activities:
Net loss	$	(8,180,536	)	$	(9,035,292	)
Depreciation and amortization		18,847			25,176
Gain on sale of property and equipment		(10,964	)		—
Stock-based compensation expense		369,235			1,354,901
Changes in operating assets and liabilities:
Other receivables		6,987			—
Prepaid expenses and other current assets		(1,555,350	)		256,189
Accounts payable and accrued expenses		332,024			993,251
Net cash used in operating activities		(9,019,757	)		(6,405,775	)
Cash flows from investing activities:
Proceeds from sale of property and equipment		12,000			—
Purchase of property and equipment		(87,047	)		—
Net cash used in investing activities		(75,047	)		—
Cash flows from financing activities:
Payments on short-term notes payable		(303,416	)		(228,227	)
Redemption of Series C Preferred stock		—			(5,635,672	)
Proceeds from issuance of common stock for option exercise		—			267,140
Proceeds from issuance of common stock for warrant exercise		—			2,261,336
Net proceeds from issuance of common stock		—			26,676,392
Net cash provided by (used in) financing activities		(303,416	)		23,340,969
Net increase (decrease) in cash and cash equivalents		(9,398,220	)		16,935,194
Cash and cash equivalents at beginning of period		27,265,703			17,639,575
Cash and cash equivalents at end of period	$	17,867,483		$	34,574,769
Supplemental disclosure of cash flow information:
Interest paid	$	4,062		$	3,601
Non-cash investing and financing activities:
Stock dividend on Series C Preferred stock	$	—		$	1,117,531

See accompanying notes.

Oragenics, Inc.

Notes to Consolidated Financial Statements

(Unaudited)

1. Organization

Oragenics, Inc. (the “Company” or “we”) is focused on the development of the NT-CoV2-1 intranasal vaccine candidate to combat the novel Severe Acute Respiratory Syndrome coronavirus (“SARS-CoV-2”) and further development of effective treatments for novel antibiotics against infectious disease.

1A: Amendment To Previously Reported Quarterly Financial Statements

The Company’s previously issued unaudited consolidated financial statements for the three- and six-month periods ended June 30, 2022 have been restated related to the Company’s accounting for certain research and development expense; certain upfront and prepayments made to vendors, and their classification on the Company’s unaudited consolidated financial statements.

Management reviewed the terms and conditions of the contracts and the payments and concluded that during the three- and six-month period ended June 30, 2022 amounts were paid as part of a prepayment arrangement. Management reviewed Accounting Standards Codification Topic 730 Research and Development guidance related to recording initial upfront payments to vendors and determined that the unaudited consolidated financial statements originally reported for the three- and six- month periods ended June 30, 2022 classified research and development expense on the unaudited consolidated statement of operations that should be classified as prepaid expense on the Company’s unaudited consolidated balance sheet.

The Company has restated its accounting for these prepaid research and development expenses and recorded them as prepaid assets on its unaudited consolidated balance sheet with changes to the amount of research and development expense recorded on its unaudited consolidated statement of operations for the three-and six- month periods ended June 30, 2022.

As a result of these adjustments, net loss for the three and six months ended June 30, 2022 was reduced by approximately $0.4 million and $1.9 million respectively. The total assets reported for the six-month period ended June 30, 2022 increased by approximately $1.9 million. Total accumulated deficit for the six-month period ending June 30, 2022 was reduced by approximately $1.9 million. The Company has reported an amended net loss of $3.6 million and $8.2 million for the three and six months ended June 30, 2022 respectively; versus the previously reported net loss of approximately $4 million and $10 million. For the same six-month period ended June 30, 2022 the Company has also reported amended total assets of $20 million and accumulated deficit of $179 million versus $18 million and $181 million respectively.

The following table summarizes the effect of the restatement on the Company’s unaudited consolidated financial statements for the three- and six- months ended June 30, 2022:

Oragenics, Inc.

Consolidated Balance Sheets

June 30, 2022

	As Previously Reported			Adjustment		As Restated
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	17,867,483				$	17,867,483
Other receivables		-					-
Prepaid expenses and other current assets		102,498			1,887,551		1,990,049
Total current assets		17,969,981					19,857,532
Property and equipment, net		109,780					109,780
Operating lease right-of-use assets		385,361					385,361
Total assets	$	18,465,122				$	20,352,673
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable and accrued expenses	$	1,279,598				$	1,279,598
Short-term notes payable		-					-
Operating lease liabilities		180,824					180,824
Total current liabilities		1,460,422					1,460,422

Long-term liabilities:
Operating lease liabilities		217,353					217,353
Total long-term liabilities		217,353					217,353

Shareholders’ equity:
Preferred stock, no par value; 50,000,000 shares authorized; 9,417,000 Series A shares, 6,600,000 Series B shares, issued and outstanding at June 30, 2022 and December 31, 2021, respectively		2,656,713					2,656,713
Preferred stock, no par value; 50,000,000 shares authorized; 9,417,000 Series A shares, 6,600,000 Series B shares, issued and outstanding at June 30, 2022 and December 31, 2021, respectively		2,656,713					2,656,713
Common stock, $0.001 par value; 250,000,000 and 200,000,000 shares authorized at June 30, 2022 and December 31, 2021, respectively, 116,394,806 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		116,395					116,395
Additional paid-in capital		195,356,454					195,356,454
Accumulated deficit		(181,342,215	)		1,887,551		(179,454,664	)
Total shareholders’ equity		16,787,347					18,674,898
Total liabilities and shareholders’ equity	$	18,465,122				$	20,352,673

Oragenics, Inc.

Consolidated Statements of Operations

(Unaudited)

	Reported			Adjustment			As Restated

	For the Three Months Ended June 30, 2022
	As Previously Reported			Adjustment			As Restated
Grant revenue	$	30,391					$	30,391

Operating expenses:
Research and development		3,033,182			(443,150	)		2,590,032
General and administrative		1,044,334						1,044,334
Total operating expenses		4,077,516						3,634,366
Loss from operations		(4,047,125	)					(3,603,975	)
Other income (expense):
Interest income		15,369						15,369
Interest expense		(816	)					(816	)
Local business tax		(490	)					(490	)
Miscellaneous income		369

SEC Form 10-Q/A filed by Oragenics Inc. (Amendment)