ocgn-20210630

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 June 30, 2021


☐			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.)

263 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 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 7(a)(2)(B) of the Securities 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 July 30, 2021, there were 198,755,831 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 JUNE 30, 2021


		Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)
	Condensed Consolidated Balance Sheets as of June 3 0 , 2021 and December 31, 2020	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30 , 2021 and 2020	5
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and six months ended June 30 , 2021 and 2020	6
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30 , 2021 and 2020	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	32
PART II—OTHER INFORMATION		33
Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
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

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 contained in the Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (“SEC”) on March 19, 2021 (the "2020 Annual Report") include, among other things, statements about:

•our estimates regarding expenses, future revenue, capital requirements, and timing and availability of and the need for additional financing;

•our ability to obtain sufficient additional capital to continue to advance our product candidates and our preclinical programs;

•our activities with respect to COVAXIN, our vaccine candidate for the prevention of COVID-19 caused by SARS-CoV-2, 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, if authorized or approved;

•our plans regarding submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration including the need for an additional clinical trial to support a BLA submission;

•our ability to successfully obtain adequate supply of COVAXIN from Bharat Biotech and to complete a technology transfer to a new third-party manufacturer and engage such manufacturer on commercially acceptable terms;

•anticipated market demand for COVAXIN in the United States or Canada;

•the extent to which health epidemics and other outbreaks of communicable diseases, including the COVID-19 pandemic, could disrupt our business and operations;

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

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

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

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

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

•the pricing and reimbursement of our product candidates, if authorized or approved;

•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; including with Bharat Biotech, and our ability to establish additional collaborations and/or partnerships;

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

•our ability to comply with stringent U.S., Canada, and other foreign government regulation in the manufacture of pharmaceutical products, including Good Manufacturing Practice compliance and other relevant regulatory authorities;

•the impact of the COVID-19 pandemic on our development programs, global supply chain, and collaborators and manufacturers, including Bharat Biotech; and

•other matters discussed under the heading “Risk Factors” contained in this Quarterly Report on Form 10-Q, the 2020 Annual Report, 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 this Quarterly Report on Form 10-Q and in the 2020 Annual Report, particularly under “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 that we have filed as exhibits to this Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. 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 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.

Solely for convenience, tradenames and trademarks referred to in this Quarterly Report on Form 10-Q appear without the ® or TM 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 its 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.

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OCUGEN, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)


	June 30, 2021		December 31, 2020
Assets
Current assets
Cash and cash equivalents	$	115,642	$	24,039
Advance for COVAXIN supply	4,988		—
Prepaid expenses and other current assets	996		1,839
Total current assets	121,626		25,878
Property and equipment, net	944		633
Restricted cash	151		151
Other assets	1,530		714
Total assets	$	124,251	$	27,376
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	802	$	395
Accrued expenses and other current liabilities	3,870		2,941
Short-term debt, net	—		234
Operating lease obligation	168		44
Total current liabilities	4,840		3,614
Non-current liabilities
Operating lease obligation, less current portion	1,328		389
Long term debt, net	1,674		1,823
Total non-current liabilities	3,002		2,212
Total liabilities	7,842		5,826
Commitments and contingencies (Note 13)
Stockholders’ equity
Convertible preferred stock; $0.01 par value; 10,000,000 shares authorized at June 30, 2021 and December 31, 2020
Series A; seven issued and outstanding at June 30, 2021 and December 31, 2020	—		—
Series B; 54,745 and zero issued and outstanding at June 30, 2021 and December 31, 2020, respectively	1		—
Common stock; $0.01 par value; 295,000,000 and 200,000,000 shares authorized, 198,816,745 and 184,133,384 shares issued, and 198,695,245 and 184,011,884 shares outstanding at June 30, 2021 and December 31, 2020, respectively	1,988		1,841
Treasury stock, at cost, 121,500 shares at June 30, 2021 and December 31, 2020	(48)		(48)
Additional paid-in capital	220,799		93,059
Accumulated deficit	(106,331)		(73,302)
Total stockholders’ equity	116,409		21,550
Total liabilities and stockholders’ equity	$	124,251	$	27,376

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 June 30,				Six months ended June 30,
	2021		2020		2021		2020
Revenues
Collaboration revenue	$	—	$	43	$	—	$	43
Total revenues	—		43		—		43
Operating expenses
Research and development	18,853		1,630		21,725		3,282

General and administrative	6,757		1,779		10,942		4,056
Total operating expenses	25,610		3,409		32,667		7,338
Loss from operations	(25,610)		(3,366)		(32,667)		(7,295)
Other income (expense)			—
Interest income	10		—		10		—
Interest expense	(20)		(248)		(40)		(263)
Other income (expense)	(332)		—		(332)		—
Total other income (expense)	(342)		(248)		(362)		(263)
Net loss and comprehensive loss	$	(25,952)	$	(3,614)	$	(33,029)	$	(7,558)
Deemed dividend related to Warrant Exchange	—		(12,546)		—		(12,546)
Net loss to common stockholders	$	(25,952)	$	(16,160)	$	(33,029)	$	(20,104)

Shares used in calculating net loss per common share — basic and diluted	195,572,189		83,537,463		190,960,775		68,082,346
Net loss per share of common stock — basic and diluted	$	(0.13)	$	(0.19)	$	(0.17)	$	(0.30)

See accompanying notes to condensed consolidated financial statements.

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OCUGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(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 Deficit		Total
	Shares	Amount		Shares	Amount		Shares	Amount
Balance at December 31, 2020	7	$	—	—	$	—	184,133,384	$	1,841	$	(48)	$	93,059	$	(73,302)	$	21,550
Stock-based compensation expense	—	—		—	—		—	—		—		833		—		833
Issuance of common stock for option exercises	—	—		—	—		157,468	2		—		174		—		176
At-the-market common stock issuance, net	—	—		—	—		987,000	10		—		4,839		—		4,849
Registered direct offering common stock issuance, net	—	—		—	—		3,000,000	30		—		21,174		—		21,204
Series B Convertible Preferred Stock issuance, net	—	—		54,745	1		—	—		—		4,953		—		4,954
Net loss	—	—		—	—		—	—		—		—		(7,077)		(7,077)
Balance at March 31, 2021	7	$	—	54,745	$	1	188,277,852	$	1,883	$	(48)	$	125,032	$	(80,379)	$	46,489
Stock-based compensation expense	—	—		—	—		—	—		—		2,095		—

SEC Form 10-Q filed by Ocugen, Inc.