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 September 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 November 4, 2022, there were 117,449,809 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 September 30, 2022, filed with the Securities and Exchange Commission (the “SEC”) on November 14, 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 nine-month period ended September 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 September 30, 2022, as the Company’s procedures related to the review of research and development contracts was insufficient, resulting in material errors in the consolidated financial statements. For a discussion of management’s considerations of the Company’s disclosure controls and 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 September 30, 2022 (unaudited) and December 31, 2021	3

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

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

	Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and September 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.	30

Item 4.	Controls and Procedures	30

PART II – OTHER INFORMATION		31

Item 1.	Legal Proceedings	31

Item 1A.	Risk Factors	31

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	33

Item 3.	Defaults Upon Senior Securities	33

Item 4.	Mine Safety Disclosures	33

Item 5.	Other Information	33

Item 6.	Exhibits	34

Signatures		35

PART I – FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

Oragenics, Inc.

Consolidated Balance Sheets


	September 30, 2022 As Restated			December 31, 2021
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	13,951,054		$	27,265,703
Other receivables		—			6,987
Prepaid expenses and other current assets		2,572,033			434,699
Total current assets		16,523,087			27,707,389
Property and equipment, net		132,382			45,708
Operating lease right-of-use assets		395,435			477,882
Total assets	$	17,050,904		$	28,230,979
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable and accrued expenses	$	946,084		$	947,574
Short-term notes payable		424,924			303,416
Operating lease liabilities		201,973			194,270
Total current liabilities		1,572,981			1,445,260

Long-term liabilities:
Operating lease liabilities		204,593			299,520
Total long-term liabilities		204,593			299,520

Shareholders’ equity:
Preferred stock, no par value; 50,000,000 shares authorized; 5,417,000, and 9,417,000 Series A shares, 4,050,000 and 6,600,000 Series B shares, issued and outstanding at September 30, 2022 and December 31, 2021, respectively		1,592,723			2,656,713
Common stock, $0.001 par value; 250,000,000 and 200,000,000 shares authorized at September 30, 2022 and December 31, 2021, respectively, 117,304,809 and 116,394,806 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		117,305			116,395
Additional paid-in capital		196,888,079			194,987,219
Accumulated deficit		(183,324,777	)		(171,274,128	)
Total shareholders’ equity		15,273,330			26,486,199
Total liabilities and shareholders’ equity	$	17,050,904		$	28,230,979

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Operations

(Unaudited)


	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2022 As Restated			2021			2022 As Restated			2021
Grant revenue	$	86,047		$	—		$	131,521		$	—

Operating expenses:
Research and development		2,777,068			3,547,321			8,660,761			9,275,800
General and administrative		1,215,009			847,134			3,590,892			4,194,103
Total operating expenses		3,992,077			4,394,455			12,251,653			13,469,903
Loss from operations		(3,906,030	)		(4,394,455	)		(12,120,132	)		(13,469,903	)
Other income (expense):
Interest income		41,634			17,760			68,909			62,047
Interest expense		(5,228	)		(7,053	)		(9,290	)		(10,654	)
Local business tax		(489	)		2			(1,469	)		(1,198	)
Miscellaneous income		—			—			11,333			670
Total other income, net		35,917			10,709			69,483			50,865
Loss before income taxes		(3,870,113	)		(4,383,746	)		(12,050,649	)		(13,419,038	)
Income tax benefit		—			—			—			—
Net loss	$	(3,870,113	)	$	(4,383,746	)	$	(12,050,649	)	$	(13,419,038	)
Basic and diluted net loss per share	$	(0.03	)	$	(0.04	)	$	(0.10	)	$	(0.12	)
Shares used to compute basic and diluted net loss per share		116,744,807			116,262,938			116,511,473			111,748,586

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Changes in Shareholders’ Equity

(Unaudited)

(Restated)


	Common Stock				Preferred Stock						Additional Paid In		Accumulated			Total 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
Compensation expense relating to option issuances		—		—		—			—			468,545		—			468,545
Conversion of Series A preferred stock to common stock		400,001		400		(4,000,000	)		(415,169	)		414,769		—			—
Conversion of Series B preferred stock to common stock		510,002		510		(2,550,000	)		(648,821	)		648,311		—			—
Net loss		—		—		—			—			—		(3,870,113	)		(3,870,113	)
Balances at September 30, 2022		117,304,809	$	117,305		9,467,000.000		$	1,592,723		$	196,888,079	$	(183,324,777	)	$	15,273,330

	Common Stock				Preferred Stock						Additional Paid In		Accumulated			Total 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
Compensation expense relating to option issuances												100,769					100,769
Issuance of common stock from option exercise		200,000		200								95,800					96,000
Net loss									-					(4,383,746	)		(4,383,746	)
Balances at September 30, 2021		116,394,806		116,395		16,017,000			2,656,713			194,754,867		(168,981,552	)		28,546,423

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Cash Flows

(Unaudited)


	For the Nine Months Ended September 30,
	2022 As Restated			2021
Cash flows from operating activities:
Net loss	$	(12,050,649	)	$	(13,419,038	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		31,594			34,817
Gain on sale of property and equipment		(10,964	)		—
Stock-based compensation expense		837,780			1,455,670
Changes in operating assets and liabilities:
Other receivables		6,987			—
Prepaid expenses and other current assets		(1,608,905	)		356,756
Accounts payable and accrued expenses		(1,490	)		586,177
Net cash used in operating activities		(12,795,647	)		(10,985,618	)
Cash flows from investing activities:
Proceeds from sale of property and equipment		12,000			—
Purchase of property and equipment		(124,081	)		(24,123	)
Net cash used in investing activities		(112,081	)		(24,123	)
Cash flows from financing activities:
Payments on short-term notes payable		(406,921	)		(346,138	)
Redemption of Series C Preferred stock		—			(5,635,672	)
Proceeds from issuance of common stock for option exercise		—			363,140
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 financing activities		(406,921	)		23,319,058
Net increase (decrease) in cash and cash equivalents		(13,314,649	)		12,309,317
Cash and cash equivalents at beginning of period		27,265,703			17,639,575
Cash and cash equivalents at end of period	$	13,951,054		$	29,948,892
Supplemental disclosure of cash flow information:
Interest paid	$	9,290		$	10,654
Non-cash investing and financing activities:
Borrowings under short term notes payable for prepaid expense	$	528,429		$	600,169
Value of Series A preferred stock converted into common stock	$	415,169		$	—
Value of Series B preferred stock converted into common stock	$	648,821		$	—
Par value of common stock issued in connection with Series A Preferred Stock Conversion	$	400		$	—
Par value of common stock issued in connection with Series B Preferred Stock Conversion	$	510		$	—
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 consolidated financial statements for the three and nine months ended September 30, 2022 have been restated related to the Company’s accounting for research and development expenses; certain upfront or prepayments made to vendors and expenses to be accrued, and their classification on the Company’s financial statements for the three- and nine- month periods ended September 30, 2022.

Management reviewed the terms and conditions of the contracts and the payments and concluded that during the three- and nine-month periods ending September 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 for future research and development; and determined that the financial statements originally reported for the three-and nine-month periods ended September 30, 2022 classified expense on the Company’s unaudited consolidated statement of operations that should be classified as prepaid expense on the Company’s unaudited consolidated balance sheet. Management also determined that during the three- and nine-month periods ending September 30, 2022, expenses had been incurred for research and development activities completed that should have been reflected as expense on the Company’s unaudited consolidated statement of operations and accrued liabilities on the Company’s unaudited consolidated balance sheet.

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

As a result of these adjustments, net loss for the three and nine months ended September 30, 2022 was reduced by $0.05 million and $1.9 million respectively. The total assets reported for the nine-month period ended September 30, 2022 increased by $2.0 million. Total accumulated deficit for the nine-month period ending September 30, 2022 was reduced by $1.9 million. The Company has reported an amended net loss of $3.9 million and $12 million for the three- and nine-month periods ended September 30, 2022 respectively; versus the previously reported net loss of approximately $3.9 million and $14 million. For the nine-month period ended September 30, 2022 the Company has also reported amended total assets of $17 million and accumulated deficit of $183 million versus $15 million and $185 million respectively.

The following tables summarize the effects of the restatement on the Company’s consolidated unaudited financial statements for the three- and nine-months ended September 30, 2022:

Oragenics, Inc.

Consolidated Balance Sheets

September 30, 2022

	As Previously Reported			Adjustment		As Restated
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	13,951,054				$	13,951,054
Other receivables		—					-
Prepaid expenses and other current assets		561,952			2,010,081		2,572,033
Total current assets		14,513,006					16,523,087
Property and equipment, net		132,382					132,382
Operating lease right-of-use assets		395,435					395,435
Total assets	$	15,040,823				$	17,050,904
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable and accrued expenses	$	871,084			75,000	$	946,084
Short-term notes payable		424,924					424,924
Operating lease liabilities		201,973					201,973
Total current liabilities		1,497,981					1,572,981

Long-term liabilities:
Operating lease liabilities		204,593					204,593
Total long-term liabilities		204,593					204,593

Shareholders’ equity:
Preferred stock, no par value; 50,000,000 shares authorized; 5,417,000, and 9,417,000 Series A shares, 4,050,000 and 6,600,000 Series B shares, issued and outstanding at September 30, 2022 and December 31, 2021, respectively		1,592,723					1,592,723
Common stock, $0.001 par value; 250,000,000 and 200,000,000 shares authorized at September 30, 2022 and December 31, 2021, respectively, 117,304,809 and 116,394,806 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		117,305					117,305
Additional paid-in capital		196,888,079					196,888,079
Accumulated deficit		(185,259,858	)		1,935,081		(183,324,777	)
Total shareholders’ equity		13,338,249					15,273,330
Total liabilities and shareholders’ equity	$	15,040,823				$	17,050,904

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Operations

(Unaudited)

	As Previously Reported			Adjustment			As Restated
	For the Three Months Ended September 30, 2022
	As Previously Reported			Adjustment			As Restated
Grant revenue	$	86,047					$	86,047

Operating expenses:
Research and development		2,824,598			(47,530	)		2,777,068
General and administrative		1,215,009						1,215,009
Total operating expenses		4,039,607						3,992,077
Loss from operations		(3,953,560	)					(3,906,030	)
Other income (expense):
Interest income		41,634						41,634
Interest expense		(5,228	)					(5,228	)
Local business tax		(489	)					(489	)
Miscellaneous income		-						-
Total other income, net		35,917						35,917
Loss before income taxes		(3,917,643	)					(3,870,113	)
Income tax benefit		-						-
Net loss	$	(3,917,643	)				$	(3,870,113	)
Basic and diluted net loss per share	$	(0.03	)				$	(0.03	)
Shares used to compute basic and diluted net loss per share		116,744,807						116,744,807

Oragenics, Inc.

Consolidated Statements of Operations

(Unaudited)

	As Previously Reported		Adjustment			As Restated
	For the Nine Months Ended September 30, 2022
	As Previously Reported		Adjustment			As Restated
Grant revenue	$	131,521				$	131,521

Operating expenses:
Research and development		10,595,842		(1,935,081	)		8,660,761
General and administrative		3,590,892					3,590,892
Total operating expenses		14,186,734

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