ocgn-20240930

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, 2024


☐			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 12, 2024 there were 291,320,280 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, 2024


		Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)
	Condensed Consolidated Balance Sheets as of September 30 , 2024 and December 31, 2023	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023	5
	Condensed Consolidated Statements of Stockholders' Equity for the three and nine months ended September 30, 2024 and 2023	6
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	34
Item 4.	Controls and Procedures	34
PART II—OTHER INFORMATION		35
Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	35
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 those contained in (i) our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission ("SEC") on April 16, 2024 (the "2023 Annual Report") and (ii) our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and June 30, 2024 filed with the SEC on May 14, 2024 and August 8, 2024, respectively (together with this Quarterly Report on Form 10-Q, the "2024 Quarterly Reports") include, among other things, statements about:

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

•our activities with respect to OCU400, OCU410 and OCU410ST, including the results from our ongoing Phase 1/2 trials for OCU400 and OCU410ST, our ability to continue dosing patients for our Phase 3 trial for OCU400 for the treatment of retinitis pigmentosa ("RP"), our ability to reach alignment with the United States Food and Drug Administration ("FDA") on the Phase 3 trial design for OCU400 for the treatment of Leber congenital amaurosis ("LCA"), and our ability to subsequently initiate and complete a Phase 3 trial for the treatment of LCA;

•our ability to obtain additional funding from government agencies in the United States and/or other countries to continue the development of our inhaled mucosal vaccine platform;

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

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

•our ability to comply with regulatory schemes and other regulatory developments applicable to our business in the United States and other 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;

•the size and growth potential of the markets for our product candidates, and our ability to serve those markets;

•developments relating to our competitors and our industry;

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

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

•matters relating to or arising from the restatement of our previously issued financial statements included in our 2022 Annual Report on Form 10-K as well as unaudited interim financial statements included in our Quarterly Reports on Forms 10-Q for each of the quarterly and year to date periods ended September 30, 2022, June 30, 2022, March 31, 2022, September 30, 2023, June 30, 2023, and March 31, 2023;

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

•the extent to which health epidemics and other outbreaks of communicable diseases, geopolitical turmoil, macroeconomic conditions, social unrest, political instability, terrorism, or 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 2023 Annual Report, the 2024 Quarterly Reports, and in any other documents we have filed 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 our 2023 Annual Report and in the 2024 Quarterly Reports, particularly under the section 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, investments, or other significant transactions 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 owners 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. The name NeoCart has not been evaluated or cleared by the FDA.

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PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

OCUGEN, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)


	September 30, 2024		December 31, 2023
Assets
Current assets
Cash	$	38,696	$	39,462
Prepaid expenses and other current assets	1,977		3,509
Total current assets	40,673		42,971
Property and equipment, net	17,130		17,290
Restricted cash	305		—
Other assets	3,828		4,286
Total assets	$	61,936	64,547
Liabilities and stockholders' equity
Current liabilities
Accounts payable	$	1,494	$	3,172
Accrued expenses and other current liabilities	12,475		13,343
Operating lease obligations	477		574
Current portion of long term debt	1,316		—
Total current liabilities	15,762		17,089
Non-current liabilities
Operating lease obligations, less current portion	3,419		3,567
Long term debt, net	1,571		2,800
Other non-current liabilities	554		527
Total non-current liabilities	5,544		6,894
Total liabilities	21,306		23,983
Commitments and contingencies (Note 13)
Stockholders' equity
Convertible preferred stock; $0.01 par value; 10,000,000 shares authorized at September 30, 2024 and December 31, 2023
Series B Convertible Preferred Stock; zero shares issued and outstanding at September 30, 2024 and 54,745 shares issued and outstanding at December 31, 2023	—		1
Common stock; $0.01 par value; 390,000,000 shares authorized, 290,384,252 and 256,688,304 shares issued, and 290,262,752 and 256,566,804 shares outstanding at September 30, 2024 and December 31, 2023, respectively	2,904		2,567
Treasury stock, at cost, 121,500 shares at September 30, 2024 and December 31, 2023	(48)		(48)
Additional paid-in capital	364,092		324,191
Accumulated other comprehensive income	23		20
Accumulated deficit	(326,341)		(286,167)
Total stockholders' equity	40,630		40,564
Total liabilities and stockholders' equity	$	61,936	$	64,547

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,
	2024		2023		2024		2023
Collaborative arrangement revenue	$	1,136	$	3,699	$	3,291	$	4,627
Total revenue	1,136		3,699		3,291		4,627
Operating expenses
Research and development	8,108		7,048		23,836		31,794
General and administrative	6,280		9,082		20,372		26,839
Total operating expenses	14,388		16,130		44,208		58,633
Loss from operations	(13,252)		(12,431)		(40,917)		(54,006)
Other income (expense), net	282		714		743		1,898
Net loss	$	(12,970)	$	(11,717)	$	(40,174)	$	(52,108)
Other comprehensive income (loss)
Foreign currency translation adjustment	(5)		5		3		2
Unrealized gain (loss) on marketable securities	$	—	$	—	$	—	$	(1)
Comprehensive loss	$	(12,975)	$	(11,712)	$	(40,171)	$	(52,107)

Net loss attributable to common shareholders— basic and diluted	(12,970)		(11,717)		(40,128)		(52,108)
Weighted shares used in calculating net loss per common share — basic and diluted	278,171,593		256,492,558		264,303,494		240,222,667
Net loss per share attributable to common shareholders — basic and diluted	$	(0.05)	$	(0.05)	$	(0.15)	$	(0.22)

Net loss attributable to Series B Convertible Preferred shareholders — basic and diluted	—		—		(46)		—
Weighted shares used in calculating net loss per Series B Convertible Preferred Stock — basic and diluted	—		—		54,745		—
Net loss per share attributable to Series B Convertible Preferred shareholders — basic and diluted	$	—	$	—	$	(0.84)	$	—

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 B Convertible Preferred Stock			Common Stock			Treasury Stock		Additional Paid-in Capital		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
	Shares	Amount		Shares	Amount
Balance at December 31, 2023	54,745	$	1	256,688,304	$	2,567	$	(48)	$	324,191	$	20	$	(286,167)	$	40,564
Stock-based compensation expense	—	—		—	—		—		1,761		—		—		1,761
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		758,460	8		—		(153)		—		—		(145)
Other comprehensive income (loss)	—	—		—	—		—		—		5		—		5
Net loss	—	—		—	—		—		—		—		(11,924)		(11,924)
Balance at March 31, 2024	54,745	$	1	257,446,764	$	2,575	$	(48)	$	325,799	$	25	$	(298,091)	$	30,261
Stock-based compensation expense	—	—		—	—		—		1,898		—		—		1,898
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		95,860	1		—		44		—		—		45
Series B Convertible Preferred Stock reacquisition	(54,745)	(1)		—	—		—		1		—		—		—
Other comprehensive income (loss)	—	—		—	—		—		—		3		—		3
Net loss	—	—		—	—		—		—		—		(15,280)		(15,280)
Balance at June 30, 2024	—	$	—	257,542,624	$	2,576	$	(48)	$	327,742	$	28	$	(313,371)	$	16,927
Stock-based compensation expense	—	—		—	—		—		1,892		—		—		1,892
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		124,237	1		—		48		—		—		49
Issuance of Common Stock for capital raises, net	—	—		32,717,391	327		—		34,410		—		—		34,737
Other comprehensive income (loss)	—	—		—	—		—		—		(5)		—		(5)
Net loss	—	—		—	—		—		—		—		(12,970)		(12,970)
Balance at September 30, 2024	—	$	—	290,384,252	$	2,904	$	(48)	$	364,092	$	23	$	(326,341)	$	40,630

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OCUGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (CONTINUED)

(in thousands, except share amounts)

(Unaudited)


	Series B Convertible Preferred Stock			Common Stock			Treasury Stock		Additional Paid-in Capital		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
	Shares	Amount		Shares	Amount
Balance at December 31, 2022	54,745	$	1	221,721,182	$	2,217	$	(48)	$	294,874	$	26	$	(223,089)	$	73,981
Stock-based compensation expense	—	—		—	—		—		2,689		—		—		2,689
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		348,555	3		—		(4)		—		—		(1)
Issuance of common stock for capital raises, net	—	—		4,478,956	45		—		5,514		—		—		5,559
Other comprehensive income (loss)	—	—		—	—		—		—		(1)		—		(1)
Net loss	—	—		—	—		—		—		—		(17,326)		(17,326)
Balance at March 31, 2023	54,745	$	1	226,548,693	$	2,265	$	(48)	$	303,073	$	25	$	(240,415)	$	64,901
Stock-based compensation expense	—	—		—	—		—		2,632		—		—		2,632
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		59,859	1		—		9		—		—		10
Issuance of common stock for capital raises, net	—	—		30,000,000	300		—		14,467		—		—		14,767
Other comprehensive income (loss)	—	—		—	—		—		—		(3)		—		(3)
Net loss	—	—		—	—		—		—		—		(23,065)		(23,065)
Balance at June 30, 2023	54,745	$	1	256,608,552	$	2,566	$	(48)	$	320,181	$	22	$	(263,480)	$	59,242
Stock-based compensation expense	—	—		—	—		—		2,174		—		—		2,174
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		12,935	—		—		97		—		—		97
Other comprehensive income (loss)	—	—		—	—		—		—		5		—		5
Net loss	—	—		—	—		—		—		—		(11,717)		(11,717)
Balance at September 30, 2023	54,745	$	1	256,621,487	$	2,566	$	(48)	$	322,452	$	27	$	(275,197)	$	49,801

See accompanying notes to condensed consolidated financial statements.

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OCUGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)


	Nine months ended September 30,
	2024		2023
Cash flows from operating activities
Net loss	$	(40,174)	$	(52,108)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense	1,370		525
Amortization (accretion) on marketable securities	—		(182)
Non-cash interest expense	87		87
Non-cash lease expense	634		401
Non-cash (income) expense from collaborative arrangements, net	(2,406)		(1,134)
Stock-based compensation expense	5,551		7,495
Impairment of advance for COVAXIN supply	—		4,074
Loss on disposal of fixed assets related to COVAXIN	—		363
Other	28		379

SEC Form 10-Q filed by Ocugen Inc.