ocgn-20250930

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, 2025


☐			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 October 31, 2025 there were 312,320,112 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, 2025


		Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)
	Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2025 and 2024	5
	Condensed Consolidated Statements of Stockholders' Equity for the three and nine months ended September 30, 2025 and 2024	6
	Condensed Consolidated Statements of Cash Flows for t he n ine months ended Se ptember 30, 2025 and 2024	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	36
Item 4.	Controls and Procedures	36
PART II—OTHER INFORMATION		37
Item 1.	Legal Proceedings	37
Item 1A.	Risk Factors	37
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	39
Item 3.	Defaults Upon Senior Securities	39
Item 4.	Mine Safety Disclosures	39
Item 5.	Other Information	39
Item 6.	Exhibits	40
Signatures		41

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

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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 March 5, 2025 (the "2024 Annual Report") and (ii) our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and June 30, 2025 filed with the SEC on May 09, 2025 and August 4, 2025, respectively (together with this Quarterly Report on Form 10-Q, the "2025 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, our ability to continue dosing patients for our Phase 3 trial for OCU400 for the treatment of retinitis pigmentosa ("RP"), our ability to continue dosing patients for our Phase 2/3 pivotal confirmatory trial for OCU410ST for the treatment of Stargardt disease (“ST”), and our ability to complete pivotal trials;

•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;

•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, tariff policies, social unrest, political instability, terrorism, or acts of war could disrupt our

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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 2024 Annual Report, the 2025 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 2024 Annual Report and in our 2025 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, 2025		December 31, 2024
Assets
Current assets
Cash	$	32,565	$	58,514
Prepaid expenses and other current assets	5,074		3,168
Total current assets	37,639		61,682
Property and equipment, net	14,946		16,554
Restricted cash	314		307
Other assets	4,697		3,899
Total assets	$	57,596	82,442
Liabilities and stockholders' equity
Current liabilities
Accounts payable	$	4,574	$	4,243
Accrued expenses and other current liabilities	14,932		15,500
Operating lease obligations	855		519
Current portion of long term debt	—		1,326
Total current liabilities	20,361		21,588
Non-current liabilities
Operating lease obligations, less current portion	3,709		3,313
Long term debt, net	28,400		27,345
Other non-current liabilities	1,593		564
Total non-current liabilities	33,702		31,222
Total liabilities	54,063		52,810
Commitments and contingencies (Note 13)
Stockholders' equity
Preferred stock; $0.01 par value; 10,000,000 shares authorized at September 30, 2025 and December 31, 2024

Common stock; $0.01 par value; 390,000,000 shares authorized, 312,441,123 and 291,489,058 shares issued, and 312,319,623 and 291,367,558 shares outstanding at September 30, 2025 and December 31, 2024, respectively	3,125		2,915
Treasury stock, at cost, 121,500 shares at September 30, 2025 and December 31, 2024	(48)		(48)
Additional paid-in capital	390,759		366,938
Accumulated other comprehensive income	58		48
Accumulated deficit	(390,361)		(340,221)
Total stockholders' equity	3,533		29,632
Total liabilities and stockholders' equity	$	57,596	$	82,442

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,
	2025		2024		2025		2024
Collaborative arrangement revenue	$	1,752	$	1,136	$	4,606	$	3,291
Total revenue	1,752		1,136		4,606		3,291
Operating expenses
Research and development	11,149		8,108		29,081		23,836
General and administrative	8,228		6,280		21,446		20,372
Total operating expenses	19,377		14,388		50,527		44,208
Loss from operations	(17,625)		(13,252)		(45,921)		(40,917)
Other (expense) income :
Interest expense	(1,314)		(29)		(3,856)		(87)
Interest income	207		310		778		843
Other (expense) income, net	(1,319)		1		(1,141)		(13)
Total other (expense) income	(2,426)		282		(4,219)		743
Net loss	$	(20,051)	$	(12,970)	$	(50,140)	$	(40,174)
Other comprehensive income (loss)
Foreign currency translation adjustment	46		(5)		10		3
Comprehensive loss	$	(20,005)	$	(12,975)	$	(50,130)	$	(40,171)

Net loss attributable to common shareholders — basic and diluted	(20,051)		(12,970)		(50,140)		(40,128)
Weighted shares used in calculating net loss per common share — basic and diluted	304,003,247		278,171,593		296,066,314		264,303,494
Net loss per share attributable to common shareholders — basic and diluted	$	(0.07)	$	(0.05)	$	(0.17)	$	(0.15)

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, 2024	—	$	—	291,489,058	$	2,915	$	(48)	$	366,938	$	48	$	(340,221)	$	29,632
Stock-based compensation expense	—	—		—	—		—		1,885		—		—		1,885
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		660,917	7		—		(252)		—		—		(245)
Other comprehensive loss	—	—		—	—		—		—		(8)		—		(8)
Net loss	—	—		—	—		—		—		—		(15,350)		(15,350)
Balance at March 31, 2025	—	$	—	292,149,975	$	2,922	$	(48)	$	368,571	$	40	$	(355,571)	$	15,914
Stock-based compensation expense	—	—		—	—		—		1,844		—		—		1,844
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		163,586	2		—		59		—		—		61

Other comprehensive loss	—	—		—	—		—		—		(28)		—		(28)
Net loss	—	—		—	—		—		—		—		(14,739)		(14,739)
Balance at June 30, 2025	—	—		292,313,561	2,924		(48)		370,474		12		(370,310)		3,052
Stock-based compensation expense	—	—		—	—		—		1,976		—		—		1,976
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	—	—		127,562	1		—		55		—		—		56
Issuance of common stock & warrants for capital raises, net of issuance costs	—	—		20,000,000	200		—		18,254		—		—		18,454
Other comprehensive income (loss)	—	—		—	—		—		—		46		—		46
Net loss	—	—		—	—		—		—		—		(20,051)		(20,051)
Balance at September 30, 2025	—	—		312,441,123	$	3,125	$	(48)	390,759		$	58	$	(390,361)	3,533

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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, 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 of issuance costs				32,717,391	327		—		34,410						34,737
Other comprehensive income (loss)	—	—		—	—		—		—

SEC Form 10-Q filed by Ocugen Inc.