ocgn-20220930

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, 2022


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

Commission File Number: 001-36751

___________________________________________________________

OCUGEN, INC.

(Exact name of registrant as specified in its charter)

___________________________________________________________


Delaware			04-3522315
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

11 Great Valley Parkway

Malvern, Pennsylvania 19355

(Address of principal executive offices, including zip code)

(484) 328-4701

(Registrant's telephone number, including area code)
___________________________________________________________

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, par value $0.01 per share

OCGN

The Nasdaq Stock Market LLC

(The Nasdaq Capital Market)

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, a 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 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 1, 2022, there were 218,886,893 outstanding shares of the registrant's common stock, $0.01 par value per share.

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OCUGEN, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022


		Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)
	Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2022 and 2021	5
	Condensed Consolidated Statements of Stockholders' Equity for the three and nin e months ended September 30, 2022 and 2021	6
	Condensed Consolidated Statements of Cash Flows for the nin e months ended September 30, 2022 and 2021	8
	Notes to Condensed Consolidated Financial Statements	10
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	23
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	31
Item 3.	Defaults Upon Senior Securities	31
Item 4.	Mine Safety Disclosures	31
Item 5.	Other Information	31
Item 6.	Exhibits	32
Signatures		33

Unless the context otherwise requires, references to the "Company," "we," "our," or "us" in this report refer to Ocugen, Inc. and its subsidiaries, and references to "OpCo" refer to Ocugen OpCo, Inc., the Company's wholly owned subsidiary.

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DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts contained in this Quarterly Report on Form 10-Q regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "will," "would," or the negative of such terms and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are based on assumptions and expectations that may not be realized and are inherently subject to risks, uncertainties, and other factors, many of which cannot be predicted with accuracy and some of which might not even be anticipated.

The forward-looking statements in this Quarterly Report on Form 10-Q and those contained in (i) our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission ("SEC") on February 28, 2022 (the "2021 Annual Report") and (ii) our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022 and June 30, 2022 filed with the SEC on May 6, 2022 and August 5, 2022, respectively (together with this Quarterly Report on Form 10-Q, the "2022 Quarterly Reports"), include, among other things, statements about:

•our estimates regarding expenses, future revenues, capital requirements, as well as the timing and availability of and the need for additional financing to continue to advance our product candidates;

•our activities with respect to BBV152, known as COVAXIN, a vaccine candidate for the prevention of COVID-19 caused by SARS-CoV-2 in humans, in collaboration with Bharat Biotech International Limited ("Bharat Biotech"), including our plans and expectations regarding clinical development, manufacturing, pricing, regulatory review and compliance, reliance on third parties, and commercialization;

•our plans regarding a Biologics License Application pathway with the U.S. Food and Drug Administration ("FDA") for COVAXIN for adults ages 18 years and older, including the results from our Phase 2/3 immuno-bridging and broadening clinical trial and our ability to obtain funding from government agencies in the United States to initiate a safety clinical trial;

•the ability of our collaboration partner, Bharat Biotech, to successfully respond to the deficiencies identified in an inspection conducted by the World Health Organization and any potential impact of these deficiencies on the regulatory and commercialization pathway, clinical and commercial supply, and the technology transfer for COVAXIN;

•our activities with respect to evaluating the requirements for resubmitting an updated New Drug Submission for COVAXIN to Health Canada;

•our activities with respect to commercializing COVAXIN in Mexico for use in adults over the age of 18 years and the submission to Comisión Federal para la Protección contra Riesgos Sanitarios for emergency use authorization for COVAXIN in Mexico for pediatric use in ages five to 18 years;

•our ability to successfully complete a technology transfer to our third-party manufacturer for COVAXIN, Jubilant HollisterStier, and engage such manufacturer on commercially acceptable terms;

•anticipated market demand for our COVID-19 vaccine product candidates for both adult and pediatric populations;

•our ability to work with government agencies in the United States, Europe, and Japan to obtain funding to initiate clinical trials and manufacture our mucosal COVID-19 vaccine;

•our ability to successfully continue and subsequently complete the Phase 1/2 clinical trial for OCU400;

•the uncertainties associated with the clinical development and regulatory approval of our product candidates, including potential delays in the initiation, commencement, enrollment, and completion of current and future clinical trials;

•our ability to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of the inherent risks and difficulties involved in successfully commercializing products and the risk that our products, if approved, will not achieve broad market acceptance;

•the uncertainties in obtaining successful clinical trial results for our product candidates and unexpected costs that may result therefrom;

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•our ability to comply with regulatory schemes and other regulatory developments applicable to our business in the United States and foreign countries; including the extent to which developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for COVID-19 vaccines in such countries;

•the performance of third-parties upon which we depend, including contract development and manufacturing organizations, suppliers, manufacturers, group purchasing organizations, distributors, and logistics providers;

•the pricing and reimbursement of our product candidates, if commercialized;

•our ability to obtain and maintain patent protection, or obtain licenses to intellectual property and defend our intellectual property rights against third-parties;

•our ability to maintain our relationships, profitability, and contracts with our key collaborators and commercial partners and our ability to establish additional collaborations and partnerships;

•our ability to recruit or retain key scientific, technical, commercial, and management personnel and to retain our executive officers;

•our ability to comply with stringent United States and applicable foreign government regulations with respect to the manufacturing of pharmaceutical products, including current Good Manufacturing Practice compliance, and other relevant regulatory authorities;

•the extent to which health epidemics and other outbreaks of communicable diseases, including the COVID-19 pandemic, geopolitical turmoil, macroeconomic conditions, social unrest, political instability, terrorism, or other acts of war could disrupt our business and operations, including impacts on our development programs, global supply chain, and collaborators and manufacturers; and

•other matters discussed under the heading "Risk Factors" contained in the 2021 Annual Report, the 2022 Quarterly Reports, and in any other documents we file with the SEC.

We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in the 2021 Annual Report and in the 2022 Quarterly Reports, particularly under the sections titled "Risk Factors," that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations, or investments we may make.

You should read this Quarterly Report on Form 10-Q and the documents we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not assume any obligation to update any forward-looking statements.

In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Solely for convenience, tradenames and trademarks referred to in this Quarterly Report on Form 10-Q appear without the ® or ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert their rights, to these tradenames or trademarks, as applicable. All tradenames, trademarks, and service marks included or incorporated by reference in this Quarterly Report on Form 10-Q are the property of their respective owners. Further, for ease of reference, the name "COVAXIN" is used throughout this Quarterly Report on Form 10-Q to refer to the vaccine candidate, BBV152. The name COVAXIN has not been evaluated or cleared by the FDA or Health Canada.

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OCUGEN, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)


	September 30, 2022		December 31, 2021
Assets
Current assets
Cash and cash equivalents	$	101,602	$	94,958
Prepaid expenses and other current assets	5,895		7,688
Total current assets	107,497		102,646
Property and equipment, net	4,517		1,164
Restricted cash	—		151
Other assets	4,225		1,800
Total assets	$	116,239	$	105,761
Liabilities and stockholders' equity
Current liabilities
Accounts payable	$	6,460	$	2,312
Accrued expenses	8,004		4,325
Operating lease obligations	443		363
Total current liabilities	14,907		7,000
Non-current liabilities
Operating lease obligations, less current portion	3,764		1,231
Long term debt, net	2,265		1,712
Total non-current liabilities	6,029		2,943
Total liabilities	20,936		9,943
Commitments and contingencies (Note 12)
Stockholders' equity
Convertible preferred stock; $0.01 par value; 10,000,000 shares authorized at September 30, 2022 and December 31, 2021
Series A; zero and seven shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	—		—
Series B; 54,745 shares issued and outstanding at September 30, 2022 and December 31, 2021	1		1
Common stock; $0.01 par value; 295,000,000 shares authorized, 216,809,937 and 199,502,183 shares issued, and 216,688,437 and 199,380,683 shares outstanding at September 30, 2022 and December 31, 2021, respectively	2,168		1,995
Treasury stock, at cost, 121,500 shares at September 30, 2022 and December 31, 2021	(48)		(48)
Additional paid-in capital	284,231		225,537
Accumulated other comprehensive income	30		—
Accumulated deficit	(191,079)		(131,667)
Total stockholders' equity	95,303		95,818
Total liabilities and stockholders' equity	$	116,239	$	105,761

See accompanying notes to condensed consolidated financial statements.

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OCUGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Operating expenses
Research and development	$	15,622	$	6,281	$	32,544	$	28,006
General and administrative	7,497		4,508		28,174		15,450
Total operating expenses	23,119		10,789		60,718		43,456
Loss from operations	(23,119)		(10,789)		(60,718)		(43,456)
Other income (expense), net	1,197		(18)		1,306		(380)
Loss before income taxes	(21,922)		(10,807)		(59,412)		(43,836)
Income tax benefit	—		(52)		—		(52)
Net loss	$	(21,922)	$	(10,755)	$	(59,412)	$	(43,784)
Other comprehensive income (loss)
Foreign currency translation adjustment	20		—		30		—
Comprehensive loss	$	(21,902)	$	(10,755)	$	(59,382)	$	(43,784)

Shares used in calculating net loss per common share — basic and diluted	216,591,011		198,790,980		212,755,746		193,599,525
Net loss per share of common stock — basic and diluted	$	(0.10)	$	(0.05)	$	(0.28)	$	(0.23)

See accompanying notes to condensed consolidated financial statements.

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OCUGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(in thousands, except share amounts)

(Unaudited)


	Series A Convertible Preferred Stock			Series B Convertible Preferred Stock			Common Stock			Treasury Stock		Additional Paid-in Capital		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
	Shares	Amount		Shares	Amount		Shares	Amount
Balance at December 31, 2021	7	$	—	54,745	$	1	199,502,183	$	1,995	$	(48)	$	225,537	$	—	$	(131,667)	$	95,818
Stock-based compensation expense	—	—		—	—		—	—		—		3,299		—		—		3,299
Issuance of common stock for stock option exercises	—	—		—	—		277,323	3		—		177		—		—		180
Issuance of common stock for underwritten offering, net	—	—		—	—		15,973,420	160		—		49,691		—		—		49,851
Net loss	—	—		—	—		—	—		—		—		—		(18,019)		(18,019)
Balance at March 31, 2022	7	$	—	54,745	$	1	215,752,926	$	2,158	$	(48)	$	278,704	$	—	$	(149,686)	$	131,129
Stock-based compensation expense	—	—		—	—		—	—		—		2,079		—		—		2,079
Issuance of common stock for stock option exercises	—	—		—	—		488,843	5		—		404		—		—		409
Issuance of common stock upon restricted stock unit vesting, net	—	—		—	—		26,378	—		—		(48)		—		—		(48)
Series A convertible preferred stock conversion	(7)	—		—	—		3,115	—		—		—		—		—		—
Foreign currency translation adjustment	—	—		—	—		—	—		—		—		10		—		10
Net loss	—	—		—	—		—	—		—		—		—		(19,471)		(19,471)
Balance at June 30, 2022	—	$

SEC Form 10-Q filed by Ocugen Inc.