0001628280-23-005382 | 10-K | XBRL Viewer

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Cover - USD ($) $ in Millions	12 Months Ended
Cover - USD ($) $ in Millions	Dec. 31, 2022	Feb. 21, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2022
Current Fiscal Year End Date	--12-31
Document Transition Report	false
Entity File Number	001-36751
Entity Registrant Name	OCUGEN, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	04-3522315
Entity Address, Address Line One	11 Great Valley Parkway
Entity Address, City or Town	Malvern,
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19355
City Area Code	484
Local Phone Number	328-4701
Title of 12(b) Security	Common Stock
Trading Symbol	OCGN
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	false
Entity Shell Company	false
Entity Public Float			$ 483.2
Entity Common Stock, Shares Outstanding		226,417,682
Documents Incorporated by Reference	Part III of this Annual Report on Form 10-K incorporates certain information by reference from the registrant's proxy statement for the 2023 annual meeting of stockholders to be filed no later than 120 days after the end of the registrant's fiscal year ended December 31, 2022.
Entity Central Index Key	0001372299
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Amendment Flag	false

Audit Information	12 Months Ended
Audit Information	Dec. 31, 2022
Audit Information [Abstract]
Auditor Name	Ernst & Young LLP
Auditor Location	Philadelphia, Pennsylvania
Auditor Firm ID	42

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 77,563	$ 94,958
Marketable securities	13,371	0
Prepaid expenses and other current assets	7,558	7,688
Total current assets	98,492	102,646
Property and equipment, net	6,053	1,164
Restricted cash	0	151
Other assets	4,087	1,800
Total assets	108,632	105,761
Current liabilities
Accounts payable	8,062	2,312
Accrued expenses and other current liabilities	9,900	4,325
Operating lease obligations	498	363
Total current liabilities	18,460	7,000
Non-current liabilities
Operating lease obligations, less current portion	3,587	1,231
Long term debt, net	2,289	1,712
Other non-current liabilities	244	0
Total non-current liabilities	6,120	2,943
Total liabilities	24,580	9,943
Commitments and contingencies (Note 15)
Stockholders' equity
Common stock; $0.01 par value; 295,000,000 shares authorized; 221,721,182 and 199,502,183 shares issued, and 221,599,682 and 199,380,683 shares outstanding at December 31, 2022 and 2021, respectively	2,217	1,995
Treasury stock, at cost, 121,500 shares at December 31, 2022 and 2021	(48)	(48)
Additional paid-in capital	294,874	225,537
Accumulated other comprehensive income	26	0
Accumulated deficit	(213,018)	(131,667)
Total stockholders' equity	84,052	95,818
Total liabilities and stockholders' equity	108,632	105,761
Series A Convertible Preferred Stock
Stockholders' equity
Preferred stock issued	0	0
Series B Convertible Preferred Stock
Stockholders' equity
Preferred stock issued	$ 1	$ 1

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Convertible preferred stock, par value (in USD per share)	$ 0.01	$ 0.01
Convertible preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Common stock, par value (in USD per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	295,000,000	295,000,000
Common stock, shares issued (in shares)	221,721,182	199,502,183
Common stock, shares outstanding (in shares)	221,599,682	199,380,683
Treasury stock, common, shares (in shares)	121,500	121,500
Series A Convertible Preferred Stock
Convertible preferred stock, shares outstanding (in shares)	0	7
Convertible preferred stock, shares issued (in shares)	0	7
Series B Convertible Preferred Stock
Convertible preferred stock, shares outstanding (in shares)	54,745	54,745
Convertible preferred stock, shares issued (in shares)	54,745	54,745

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating expenses
Research and development	$ 49,757	$ 35,108
General and administrative	35,111	22,920
Total operating expenses	84,868	58,028
Loss from operations	(84,868)	(58,028)
Other income (expense), net	3,517	(389)
Loss before income taxes	(81,351)	(58,417)
Income tax benefit	0	(52)
Net loss	(81,351)	(58,365)
Other comprehensive income (loss)
Foreign currency translation adjustment	25	0
Unrealized gain (loss) on marketable securities	1	0
Comprehensive loss	$ (81,325)	$ (58,365)
Shares used in calculating net loss per common share - basic (in shares)	214,600,051	195,013,043
Shares used in calculating net loss per common share - diluted (in shares)	214,600,051	195,013,043
Net loss per share of common stock - basic (in USD per share)	$ (0.38)	$ (0.30)
Net loss per share of common stock - diluted (in USD per share)	$ (0.38)	$ (0.30)

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands	Total	Common Stock	Treasury Stock	Additional Paid in Capital	Accumulated Other Comprehensive Income	Accumulated Deficit	Series A Convertible Preferred Stock	Series A Convertible Preferred Stock Preferred Stock	Series A Convertible Preferred Stock Common Stock	Series B Convertible Preferred Stock	Series B Convertible Preferred Stock Preferred Stock	Series B Convertible Preferred Stock Additional Paid in Capital
Beginning balance (in shares) at Dec. 31, 2020		184,133,384						7			0
Beginning balance at Dec. 31, 2020	$ 21,550	$ 1,841	$ (48)	$ 93,059	$ 0	$ (73,302)		$ 0			$ 0
Stock-based compensation expense	6,958			6,958
Issuance of common stock for stock option and warrant exercises (in shares)		1,381,799
Issuance of common stock for stock option and warrant exercises	1,262	$ 14		1,248
Issuance of common stock for capital raises, net (in shares)		13,987,000
Issuance of common stock for capital raises, net	119,459	$ 140		119,319
Issuance of stock (in shares)											54,745
Issuance of stock										$ 4,954	$ 1	$ 4,953
Net loss	(58,365)					(58,365)
Ending balance (in shares) at Dec. 31, 2021		199,502,183						7			54,745
Ending balance at Dec. 31, 2021	95,818	$ 1,995	(48)	225,537	0	(131,667)		$ 0			$ 1
Stock-based compensation expense	10,541			10,541
Issuance of common stock for stock option exercises and restricted stock unit vesting, net (in shares)		1,579,886
Issuance of common stock for stock option exercises and restricted stock unit vesting, net	1,262	$ 16		1,246
Issuance of common stock for capital raises, net (in shares)		20,635,998
Issuance of common stock for capital raises, net	57,756	$ 206		57,550
Series A convertible preferred stock conversion (in shares)								7	3,115
Series A convertible preferred stock conversion							$ 0
Other comprehensive income (loss)	26				26
Net loss	(81,351)					(81,351)
Ending balance (in shares) at Dec. 31, 2022		221,721,182						0			54,745
Ending balance at Dec. 31, 2022	$ 84,052	$ 2,217	$ (48)	$ 294,874	$ 26	$ (213,018)		$ 0			$ 1

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities
Net loss	$ (81,351)	$ (58,365)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense	480	229
Amortization (accretion) on marketable securities	(99)	0
Non-cash interest expense	83	78
Non-cash lease expense	593	360
Stock-based compensation expense	10,541	6,958
Income tax benefit	0	(52)
Gain on forgiveness of Paycheck Protection Program note	0	(426)
Impairment on note receivable	0	761
Other	479	26
Changes in assets and liabilities:
Prepaid expenses and other current assets	91	(742)
Accounts payable and accrued expenses	9,487	3,498
Lease obligations	(383)	(366)
Other assets	0	100
Net cash used in operating activities	(60,079)	(47,941)
Cash flows from investing activities
Purchases of marketable securities	(13,271)	0
Purchases of property and equipment	(4,457)	(939)
Asset acquisition	0	(127)
Issuance of note receivable	0	(750)
Repayment of note receivable	761	0
Net cash used in investing activities	(16,967)	(1,816)
Cash flows from financing activities
Proceeds from issuance of common stock, net	59,567	129,211
Payment of equity issuance costs	(549)	(8,525)
Proceeds from issuance of debt	500	0
Payments of debt issuance costs	(43)	0
Financing lease principal payments	0	(10)
Net cash provided by financing activities	59,475	120,676
Effect of changes in exchange rate on cash, cash equivalents, and restricted cash	25	0
Net (decrease) increase in cash, cash equivalents, and restricted cash	(17,546)	70,919
Cash, cash equivalents, and restricted cash at beginning of period	95,109	24,190
Cash, cash equivalents, and restricted cash at end of period	77,563	95,109
Supplemental disclosure of non-cash investing and financing transactions:
Series B Convertible Preferred Stock issuance	0	4,988
Exercise of warrants	0	603
Forgiveness of Paycheck Protection Program note	0	426
Purchase of property and equipment	911	16
Right-of-use assets related to operating leases	2,916	1,226
Debt issuance costs	$ 37	$ 0

Nature of Business	12 Months Ended
Nature of Business	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of Business	Nature of Business Ocugen, Inc., together with its wholly owned subsidiaries ("Ocugen" or the "Company"), is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The Company is headquartered in Malvern, Pennsylvania, and manages its business as one operating segment. Modifier Gene Therapy Platform The Company is developing a modifier gene therapy platform designed to fulfill unmet medical needs related to retinal diseases, including inherited retinal diseases ("IRDs"), such as retinitis pigmentosa ("RP"), Leber congenital amaurosis ("LCA"), and Stargardt disease, as well as dry age-related macular degeneration ("AMD") with a single mutation-agnostic therapy. The Company's modifier gene therapy platform is based on the use of nuclear hormone receptors ("NHRs"), which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, the Company believes that its modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and potentially address complex diseases that are potentially caused by imbalances in multiple gene networks. The Company believes that OCU400 has the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs, including RP and LCA. OCU400 has received Orphan Drug Designation ("ODD") from the United States Food and Drug Administration ("FDA") for nuclear receptor subfamily 2 group E member 3 ("NR2E3")-related RP and LCA and Orphan Medicinal Product Designation ("OMPD") from the European Commission, based on the recommendation of the European Medicines Agency, for RP and LCA. The Company had previously received ODDs from the FDA for the treatment of certain disease genotypes: NR2E3, centrosomal protein 290 ("CEP290"), rhodopsin ("RHO"), and phosphodiesterase 6B mutation-associated inherited retinal degenerations. The Company is conducting a Phase 1/2 clinical trial to assess the safety of unilateral subretinal administration of OCU400 in patients with NR2E3 and RHO-related RP and CEP290-related LCA in the United States. The Company has completed dosing patients with RP in the dose-escalation portion of the clinical trial, which enrolled 10 subjects to receive a low, medium, or high dose of OCU400 in the subretinal space. The Company is continuing to enroll subjects with RP and LCA in this clinical trial to receive the high dose, which was determined to be the maximum tolerable dose from the dose-escalation portion of the clinical trial. The Company intends to initiate a Phase 1/2 pediatric clinical trial for OCU400 for the treatment of RP and LCA in the second quarter of 2023 and a Phase 3 clinical trial for OCU400 for the treatment of RP and LCA near the end of 2023, subject to discussions with the FDA. The Company is also developing OCU410 and OCU410ST to utilize the nuclear receptor genes RAR-related orphan receptor A for the treatment of dry AMD and Stargardt disease, respectively. The Company is currently executing Investigational New Drug ("IND")-enabling studies and intends to submit IND applications in the second quarter of 2023 to initiate Phase 1/2 clinical trials. Regenerative Medicine Cell Therapy Platform NeoCart is a Phase 3-ready, regenerative medicine cell therapy technology that combines breakthroughs in bioengineering and cell processing to enhance the autologous cartilage repair process. NeoCart is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes, the cells responsible for maintaining cartilage health. The chondrocytes are derived from the patient on a unique scaffold. In this therapy, healthy cartilage tissue is grown and implanted in the patient. The Company believes NeoCart has the potential to accelerate healing and reduce pain by reconstructing a patient's previously damaged knee cartilage. It is designed to treat pain at the source, improve function, and potentially prevent a patient's progression to osteoarthritis. The FDA granted a regenerative medicine advanced therapy designation to NeoCart for the repair of full-thickness lesions of knee cartilage injuries in adults. The Company received concurrence from the FDA on the confirmatory Phase 3 clinical trial design. The Company is renovating an existing facility into a current Good Manufacturing Practice facility in accordance with the FDA's regulations in support of NeoCart manufacturing for Phase 3 clinical trial material. The Company intends to initiate the Phase 3 clinical trial in the first half of 2024, subject to discussions with the FDA. Vaccines Intramuscular COVID-19 Vaccine The Company has a Co-Development, Supply and Commercialization Agreement with Bharat Biotech International Limited ("Bharat Biotech") (as amended, the "Covaxin Agreement"), pursuant to which the Company obtained an exclusive right and license under certain of Bharat Biotech's intellectual property rights, with the right to grant sublicenses, to develop, manufacture, and commercialize COVAXIN for the prevention of COVID-19, caused by SARS-CoV-2, in the United States, its territories, and possessions, Canada, and Mexico (the "Ocugen Covaxin Territory"). COVAXIN is a whole-virion inactivated intramuscular COVID-19 vaccine candidate and is formulated with the inactivated SARS-CoV-2 virus, an antigen, and an adjuvant. In January 2023, the Company announced top-line results from its Phase 2/3 immuno-bridging and broadening clinical trial in the United States evaluating COVAXIN for adults ages 18 years and older. The clinical trial was designed to evaluate whether the immune response observed in participants in a Phase 3 clinical trial previously conducted by Bharat Biotech in India is similar to a demographically representative, adult population in the United States. The clinical trial met both co-primary immunogenicity endpoints. There were no cases of adverse events or serious adverse events related to the vaccination with COVAXIN. The Company plans to work with government agencies in the United States to obtain funding in order to comply with the requirements of a Biologics License Application submission, including funding to initiate an adult safety clinical trial subject to discussions with the FDA. In July 2021, the Company completed its rolling submission to Health Canada for COVAXIN. The rolling submission process, which was conducted through the Company's Canadian subsidiary, Vaccigen Ltd., was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a New Drug Submission ("NDS") for COVID-19. In August 2022, the Company withdrew its NDS based on discussions with Health Canada and is evaluating the requirements for resubmitting an updated NDS. In Mexico, the Comisión Federal para la Protección contra Riesgos Sanitarios authorized emergency use for COVAXIN for adults ages 18 years and older, which remains active. The Company is in discussions with Consejo Nacional de Ciencia y Tecnología in Mexico regarding its submission for emergency use authorization for COVAXIN for pediatric use in ages five to 18 years. Inhaled Mucosal Vaccines In September 2022, the Company entered into an exclusive license agreement ("WU License Agreement") with The Washington University in St. Louis ("Washington University"), pursuant to which the Company obtained the rights to develop, manufacture, and commercialize an inhaled mucosal COVID-19 vaccine for the prevention of COVID-19 in the United States, Europe, and Japan. The WU License Agreement was amended in January 2023 to add the countries of South Korea, Australia, and China to the territory rights (together with the United States, Europe, and Japan, the "Mucosal Vaccine Territory"). Utilizing these rights, the Company is developing a novel inhaled mucosal vaccine platform, which includes OCU500, a bivalent COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 vaccine. As these vaccine candidates are being developed to be administered through inhalation, the Company believes they have the potential to generate rapid local immunity in the upper airways and lungs where viruses enter and infect the body, which the Company believes may help reduce or prevent infection and transmission as well as provide protection against new virus variants. OCU510 is being developed for the global market. The Company intends to initiate IND-enabling studies and work closely with government agencies to obtain funding for the development of these inhaled mucosal vaccines. Novel Biologic Therapy for Retinal Diseases We are developing OCU200, which is a novel fusion protein containing parts of human tumstatin and transferrin. OCU200 is designed to treat diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet AMD. The Company has completed the technology transfer of manufacturing processes to its contract development and manufacturing organization and has produced clinical trial materials to initiate a Phase 1 clinical trial. The Company submitted an IND application to the FDA in February 2023 to initiate a Phase 1 clinical trial targeting DME. Going Concern The Company has incurred recurring net losses since inception and has funded its operations to date through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes and debt, and grant proceeds. The Company incurred net losses of approximately $81.4 million and $58.4 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the Company had an accumulated deficit of $213.0 million and cash, cash equivalents, and investments totaling $90.9 million. This amount will not meet the Company's capital requirements over the next 12 months. The Company believes that its cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2024. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company. The Company is subject to risks, expenses, and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research, development, and commercialization efforts for its product candidates, which will require significant additional funding. If the Company is unable to obtain additional funding in the future or its research, development, and commercialization efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company plans to increase working capital through public and private placements of equity and/or debt, payments from potential strategic research and development arrangements, sales of assets, government grants, licensing and/or collaboration arrangements with pharmaceutical companies or other institutions, funding from the government, particularly for the adult safety clinical trial for COVAXIN and for the development of the Company's novel inhaled mucosal vaccine platform, or funding from other third parties. Such financing and funding may not be available at all, or on terms that are favorable to the Company. While management of the Company believes that it has a plan to fund ongoing operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital, or appropriately manage certain discretionary spending, could have a material adverse effect on the Company's ability to achieve its intended business objectives. As a result of these factors, together with the anticipated increase in spending that will be necessary to continue to research, develop, and commercialize the Company's product candidates, there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. The consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties.

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The accompanying consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP") and under the rules and regulations of the U.S. Securities and Exchange Commission ("SEC"). The consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform with current year presentation.

Use of Estimates

In preparing the consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, and the accounting and fair value measurement of equity instruments.

Segment Information

As of December 31, 2022, the Company viewed its operations and managed its business as one operating segment consistent with how the Company's chief operating decision-maker, the Company's Chief Executive Officer, makes decisions regarding resource allocation and assesses performance. As of December 31, 2022, substantially all of the Company's assets were located in the United States.

Cash, Cash Equivalents, and Restricted Cash

The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents may include bank demand deposits and money market funds that invest primarily in certificates of deposit, commercial paper, and U.S. government agency securities and treasuries. The Company records interest income received on cash and cash equivalents to other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company recorded $1.4 million as interest income for the year ended December 31, 2022. The Company's restricted cash balance as of December 31, 2021 consisted of cash held to collateralize a corporate credit card account.

The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the consolidated balance sheets to the total amount shown in the consolidated statements of cash flows (in thousands):


	As of December 31,
	2022		2021
Cash and cash equivalents	$	77,563	$	94,958
Restricted cash	—		151
Total cash, cash equivalents, and restricted cash	$	77,563	$	95,109

Fair Value Measurements

The Company follows the provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 820, Fair Value Measurements ("ASC 820"), which defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

Level 1 — quoted prices in active markets for identical assets or liabilities

Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions)

The carrying value of certain financial instruments, including cash and cash equivalents, accounts payable, and accrued expenses, approximates their fair value due to the short-term nature of these instruments.

Marketable Securities

The Company accounts for marketable securities in accordance with FASB ASC Topic 320, Investments - Debt and Equity Securities ("ASC 320"). The Company determines the appropriate classification of its investments in debt securities at the time of purchase. Debt securities are classified as trading securities if the security is bought and held primarily to be sold in the near term. Debt securities are classified as held to maturity if management has both the positive intent and ability to hold until the maturity of the security. All securities not classified as trading securities or held to maturity securities are classified as available for sale securities. The Company's current marketable securities are comprised of debt securities, including commercial paper, which are classified as available-for-sale securities in accordance with ASC 320. At the time of purchase, the Company classifies marketable securities with maturities of 90 days or less as cash equivalents on the consolidated balance sheets.

Available-for-sale securities are recorded at fair value based on inputs that are observable, either directly or indirectly, such as quoted prices for identical securities in active markets (Level 1) or quoted prices for similar securities in active markets or inputs that are observable (Level 2). Unrealized gains and losses are included in other comprehensive income (loss) in the consolidated statements of operations and comprehensive loss. Amortization of premium or accretion of discount on debt securities are included in other income (expense), net in the consolidated statements of operations and comprehensive loss.

The Company reviews investments in debt securities for other-than-temporary impairment if the fair value of the investment is less than the amortized cost basis. The assessment for other-than-temporary impairment is performed at the individual security

level. The Company did not recognize any impairments with respect to its debt securities during the year ended December 31, 2022. The Company did not invest in debt securities prior to 2022.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents, and investments. The Company's cash, cash equivalents, and investments are held in accounts at financial institutions that may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant credit risk beyond the standard credit risk associated with commercial banking relationships.

Financial Instruments

The Company evaluates all financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with FASB ASC Topic 815, Derivatives and Hedging ("ASC 815"). Additionally, the Company assesses all financial instruments to determine liability versus stockholders' equity classification in accordance with ASC 815 and FASB ASC Topic 480, Distinguishing Liabilities from Equity. For derivative instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value as a derivative liability and is then revalued at each reporting date, with changes in the fair value reported as other income (expense), net in the consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instrument should be recorded as a liability or as stockholders' equity, is evaluated at the end of each reporting period.

Property and Equipment, Net

The Company's property and equipment currently includes furniture and fixtures, machinery and equipment, leasehold improvements, and construction in progress. Property and equipment is recorded at historical cost less accumulated depreciation. Significant additions or improvements are capitalized, and expenditures for repairs and maintenance are charged to expense as incurred. Depreciation is calculated using the straight-line method and is recognized over the expected useful life of the underlying asset. Depreciation expense is included as research and development expense or general and administrative expense in the consolidated statements of operations and comprehensive loss based on the underlying nature of the associated asset. Construction in progress is not depreciated until such time that the asset is completed and placed into service. The Company's construction in progress as of December 31, 2022 related to the renovation of one of the Company's leased properties to develop a laboratory and manufacturing facility and the equipment that will be utilized in the laboratory and manufacturing facility that has not yet been placed into service. Once placed into service, this equipment will be depreciated over its expected useful life.

Expected useful lives by major asset category are as follows:


Furniture and fixtures			3 to 7 years
Machinery and equipment			5 to 7 years
Leasehold improvements			Shorter of the expected useful life or remaining lease term

Leases

The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company, if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company's lease agreements include lease and non-lease components, which the Company has elected not to account for separately for all classes of underlying assets. Lease expense for variable lease components is recognized when the obligation is probable.

The Company currently leases real estate classified as operating leases. Operating leases are included in other assets and operating lease obligations in the Company's consolidated balance sheets. At lease commencement, the Company records a lease liability based on the present value of the lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise and records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease

commencement date. Lease expense is recognized on a straight-line basis over the lease term and recognized as research and development expense or general and administrative expense based on the underlying nature of the expense. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rates were not readily determinable in the Company's current operating leases. As such, the incremental borrowing rates were used based on the information available at the commencement dates in determining the present value of lease payments.

The lease term for the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor.

Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on an index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset if reasonably certain.

Variable payments not dependent on an index or rate associated with the Company's leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company's consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed lease payments.

Impairment of Assets

The Company reviews its assets, including property and equipment, for impairment whenever changes in circumstances or events may indicate that the carrying amounts are not recoverable. These indicators include, but are not limited to, a significant change in the extent or manner in which an asset is used or its physical condition, a significant decrease in the market price of an asset, or a significant adverse change in the business or the industry that could affect the value of an asset. An asset is tested for impairment by comparing the net carrying value of the asset to the undiscounted net cash flows to be generated from the use and eventual disposition of the asset.

Stock-Based Compensation

The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation ("ASC 718"). The Company has issued stock-based compensation awards including stock options and restricted stock units ("RSUs"), and also accounts for certain issuances of preferred stock and warrants in accordance with ASC 718. ASC 718 requires all stock-based payments, including grants of stock options and RSUs, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs, the fair value of the RSU is determined by the market price of a share of the Company's common stock on the grant date. The Company recognizes forfeitures as they occur.

Expense related to stock-based compensation awards granted with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Stock-based compensation awards generally vest over a one to three year requisite service period. Stock options have a contractual term of 10 years. Expense for stock-based compensation awards with performance-based vesting conditions is only recognized when the performance-based vesting condition is deemed probable to occur. Expense related to stock-based compensation awards are recorded to research and development expense or general and administrative expense based on the underlying function of the individual that was granted the stock-based compensation award. Shares issued upon stock option exercise and RSU vesting are newly-issued common shares.

Estimating the fair value of stock options requires the input of subjective assumptions, including the expected term of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. The assumptions used in the Company's Black-Scholes option-pricing model represent management's best estimates and involve a number of variables, uncertainties, assumptions, and the application of management's judgment, as they are inherently subjective. If any assumptions change, the Company's stock-based compensation expense could be materially different in the future.

The assumptions used in Ocugen's Black-Scholes option-pricing model for stock options are as follows:

Expected Term. As Ocugen does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term, the expected term of employee stock options subject to service-based vesting conditions is determined

using the "simplified" method, as prescribed in SEC's Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option.

Expected Volatility. The expected volatility is based on historical volatilities of Ocugen and similar entities within Ocugen's industry for periods commensurate with the assumed expected term.

Risk-Free Interest Rate. The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term.

Expected Dividends. The expected dividend yield is 0% because Ocugen has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock.

Collaboration Arrangements

The Company assesses whether collaboration agreements are subject to FASB ASC Topic 808, Collaborative Arrangements ("ASC 808"), based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the transactions between the Company and the collaboration partner are subject to other accounting literature. If transactions with a collaboration partner are reflective of a vendor-customer relationship, the Company accounts for those payments within the scope of FASB ASC Topic 606, Revenue from Contracts with Customers. However, if the Company concludes that its collaboration partner is not a customer, the Company will record transactions with the collaboration partner under an appropriate recognition method that is determined and applied consistently either by analogy to appropriate accounting literature or be applying a reasonable accounting policy election. Classification of such transactions in the consolidated statements of operations and comprehensive loss is based on the nature of the transaction.

Income Taxes

The Company uses the asset and liability method in accounting for income taxes. Deferred tax assets and liabilities are recorded for temporary differences between the tax basis of assets and liabilities and their reported amounts in the consolidated financial statements, using statutory tax rates in effect for the year in which the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the consolidated statements of operations and comprehensive loss in the period that includes the enactment date.

The Company evaluates its deferred tax assets each period to ensure that the estimated future taxable income will be sufficient in character, amount, and timing, to result in its realizability. A valuation allowance is recorded to reduce the carrying amounts of deferred tax assets, unless it is more likely than not that those assets will be realized. Management utilizes considerable judgment when establishing deferred tax valuation allowances. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences and carryforward deferred tax assets become deductible or utilized. The Company considers the scheduled reversal of taxable temporary differences, projected future taxable income, and tax planning strategies in making this assessment. As events and circumstances change, valuation allowances are adjusted within the consolidated statement of operations and comprehensive loss when applicable.

The Company recognizes net tax benefits under the recognition and measurement criteria of FASB ASC Topic 740, Income Taxes, which prescribes requirements and other guidance for financial statement recognition and measurement of positions taken or expected to be taken on tax returns. The Company recognizes a tax benefit for positions taken for tax return purposes when it will be more likely than not that the positions will be sustained upon tax examination, based solely on the technical merits of the tax positions. Otherwise, no tax benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company recognizes potential accrued interest and penalties related to unrecognized tax benefits as a component of income tax expense in the consolidated statement of operations and comprehensive loss. Tax examinations are often complex, as tax authorities may disagree with the treatment of items reported by the Company and may require several years to resolve. As a result, the Company's provision for income taxes is recorded on the basis of available information, but amounts recorded may be impacted as a result of future examinations.

Recently Adopted Accounting Standards

In November 2021, the FASB issued Accounting Standards Update ("ASU") No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This standard increases the transparency of transactions with the government that are accounted for by applying a grant or contribution accounting model, and aims to reduce diversity that

currently exists in the recognition, measurement, presentation, and disclosure of government assistance received by business entities due to the lack of specific authoritative guidance in GAAP. This standard requires an entity to provide information regarding the nature of the transaction with a government and the related accounting policy used to account for this transaction, the line items on the consolidated balance sheet and consolidated statement of operations and comprehensive loss that are affected by the transaction and the amounts applicable to each financial statement line item, and the significant terms and conditions of the transaction, including commitments and contingencies. The standard was effective for the Company on January 1, 2022. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40). This standard clarifies and reduces diversity in an issuer's accounting for modifications or exchanges of freestanding equity-classified written call options, including warrants, that remain equity-classified after the modification or exchange. The standard requires an entity to treat a modification or an exchange of a freestanding equity-classified written call option that remains equity-classified after the modification or exchange as an exchange of the original instrument for a new instrument. The standard additionally provides guidance on measuring and recognizing the effect of a modification or an exchange. The standard was effective for the Company on January 1, 2022. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

Recent Accounting Pronouncements

In August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40). This standard will have an effective and transition date of January 1, 2024. Early adoption is currently permitted. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models that require separate accounting for embedded conversion features as well as simplifies the settlement assessment that entities are required to perform to determine whether a contract qualifies for equity classification. This standard also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of potential share settlement (if the effect is more dilutive) for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. The standard requires new disclosures about events that occur during the reporting period and cause conversion contingencies to be met and about the fair value of a public business entity's convertible debt at the instrument level, among other things. The Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The FASB subsequently issued amendments to ASU No. 2016-13, which have the same effective date and transition date of January 1, 2023. ASU No. 2016-13, as amended, requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements.

License and Development Agreements	12 Months Ended
License and Development Agreements	Dec. 31, 2022
Revenue from Contract with Customer [Abstract]
License and Development Agreements	License and Development Agreements Co-Development and Commercialization Agreement with CanSino Biologics, Inc. The Company entered into a co-development and commercialization agreement with CanSino Biologics, Inc. ("CanSinoBIO") with respect to the development and commercialization of the Company's modifier gene therapy product candidates, OCU400, OCU410, and OCU410ST. The co-development and commercialization agreement was originally entered into in September 2019 with regards to OCU400, and was subsequently amended in September 2021 and November 2022 (as so amended, the "CanSinoBIO Agreement"), to include OCU410 and OCU410ST, respectively, to the Company's existing collaboration with CanSinoBIO. Pursuant to the CanSinoBIO Agreement, the Company and CanSinoBIO are collaborating on the development of the Company's modifier gene therapy platform. CanSinoBIO is responsible for the chemistry, manufacturing, and controls development and manufacture of clinical supplies of such products and is responsible for the costs associated with such activities. CanSinoBIO has an exclusive license to develop, manufacture, and commercialize the Company's modifier gene therapy platform in and for China, Hong Kong, Macau, and Taiwan (the "CanSinoBIO Territory"), and the Company maintains exclusive development, manufacturing, and commercialization rights with respect to the Company's modifier gene therapy platform outside the CanSinoBIO Territory (the "Company Territory"). The CanSinoBIO Agreement is a collaborative arrangement within the scope of ASC 808. CanSinoBIO will pay to the Company an annual royalty between mid- and high-single digits based on Net Sales (as defined in the CanSinoBIO Agreement) of the products included in the Company's modifier gene therapy platform in the CanSinoBIO Territory. The Company will pay to CanSinoBIO an annual royalty between low- and mid-single digits based on Net Sales of the products included in the Company's modifier gene therapy platform in the Company Territory. Unless earlier terminated, the CanSinoBIO Agreement will continue in force on a country-by-country and product-by-product basis until the later of (a) the expiration of the last valid claim of the Company's patent rights covering OCU400, OCU410, and OCU410ST and (b) the tenth (10th) anniversary of the first commercial sale of OCU410 and OCU410ST in such country. The CanSinoBIO Agreement will also terminate contemporaneously upon the termination of the SERI Agreement (as defined below), provided that CanSinoBIO is not in breach or default of the CanSinoBIO Agreement. The CanSinoBIO Agreement may be terminated by either party in its entirety upon (a) a material or persistent breach of the CanSinoBIO Agreement by the other party, (b) a challenge by the other party or any of its affiliates of any intellectual property controlled by the terminating party, or (c) bankruptcy or insolvency of the other party. Exclusive License Agreement with Washington University In September 2022, the Company entered into the WU License Agreement with Washington University, pursuant to which the Company was granted an exclusive, sublicensable, royalty-bearing license to patent rights for an inhaled mucosal COVID-19 vaccine, as well as a license to certain tangible research property and technical information necessary to exploit the patent rights within the United States, Europe, and Japan. The Company paid Washington University an initial license issuance fee of $1.0 million, which was recognized as research and development expense in the consolidated statement of operations and comprehensive loss during the year ended December 31, 2022. In January 2023, the Company amended the WU License Agreement to add the countries of South Korea, Australia, and China to the Mucosal Vaccine Territory. The Company is required to pay Washington University an annual license maintenance fee, payments upon the achievement of certain development and commercial milestones in the aggregate amount of up to $37.0 million, and low single-digit percentage royalties on Net Sales of licensed products (as defined in the WU License Agreement). Pursuant to the WU License Agreement, the Company may make, have made, sell, offer for sale, use, market, promote, distribute, export, and import licensed products in the Mucosal Vaccine Territory. The Company will use commercially reasonable efforts to develop, manufacture, promote, and sell the licensed products in the Mucosal Vaccine Territory. Washington University maintains control of patent preparation, filing, prosecution, and maintenance. The Company is responsible for Washington University's out-of-pocket expenses related to the preparation, filing, prosecution, issuance, and maintenance of the licensed patent rights incurred pursuant to the WU License Agreement. The WU License Agreement will expire on a country-by-country basis and a licensed product-by-licensed product basis and end, separately in each such country and for each such licensed product, upon the latter of (a) the expiration date of the last valid claim, (b) the fifteenth (15th) anniversary of the date of the first commercial sale of a licensed product, or (c) the expiration of the last form of market exclusivity (as defined in the WU License Agreement), subject to the earlier termination of the WU License Agreement in accordance with its terms. In addition, the Company may terminate the WU License Agreement without cause by giving at least 90 days written notice. The WU License Agreement contains customary termination provisions in the event of an uncured material breach or upon certain corporate actions, including bankruptcy, receivership, or liquidation. Co-Development, Supply and Commercialization Agreement with Bharat Biotech The Company entered into the Covaxin Agreement with Bharat Biotech to co-develop COVAXIN for the Ocugen Covaxin Territory. The Covaxin Agreement was originally entered into in February 2021 with respect to the U.S. market and was subsequently amended in June 2021 to add rights to the Canadian market, for which the Company paid Bharat Biotech a non-refundable, upfront payment of $15.0 million in June 2021, which was recognized as research and development expense in the consolidated statements of operations and comprehensive loss during the year ended December 31, 2021. The Company additionally agreed to pay Bharat Biotech $10.0 million within 30 days after the first commercial sale of COVAXIN in Canada. The Covaxin Agreement was amended a second time in April 2022 to add rights to the Mexican market. The Covaxin Agreement is a collaborative arrangement within the scope of ASC 808. Pursuant to the Covaxin Agreement, the Company obtained an exclusive right and license under certain of Bharat Biotech's intellectual property rights, with the right to grant sublicenses, to develop, manufacture, and commercialize COVAXIN in the Ocugen Covaxin Territory. In consideration of the license and other rights granted to the Company by Bharat Biotech, the parties agreed to share any operating profits (as defined in the Covaxin Agreement) generated from the commercialization of COVAXIN in the Ocugen Covaxin Territory, with the Company retaining 45% of such profits, and Bharat Biotech receiving the balance of such profits. Under the Covaxin Agreement, the Company is collaborating with Bharat Biotech to develop COVAXIN for their respective territories. Except with respect to manufacturing rights under certain circumstances as described below, the Company has the exclusive right and is solely responsible for researching, developing, manufacturing, and commercializing COVAXIN for the Ocugen Covaxin Territory. Bharat Biotech is responsible for researching, developing, manufacturing, and commercializing COVAXIN outside of the Ocugen Covaxin Territory. Bharat Biotech agreed to provide to the Company preclinical and clinical data, and to transfer to the Company certain proprietary technology owned or controlled by Bharat Biotech, that is necessary for the successful commercial manufacture and supply of COVAXIN to support potential commercial sale in the Ocugen Covaxin Territory. In September 2021, the Company entered into a Development and Commercial Supply Agreement (the "Supply Agreement") with Bharat Biotech, pursuant to which Bharat Biotech will supply the Company with clinical trial materials and commercial supplies of COVAXIN finished drug product prior to the completion of a technology transfer. Following the completion of a technology transfer, Bharat Biotech will supply COVAXIN drug product components and continue to supply finished drug product as necessary for the commercial manufacture and supply of COVAXIN. In March 2021, the Company issued shares of Series B Convertible Preferred Stock (as defined in Note 10) as an advance payment for the supply of COVAXIN to be provided by Bharat Biotech under the Supply Agreement. See Note 10 for additional information about the Series B Convertible Preferred Stock issuance to Bharat Biotech. The Covaxin Agreement continues in effect for the commercial life of COVAXIN, subject to the earlier termination of the Covaxin Agreement in accordance with its terms. The Covaxin Agreement also contains customary representations and warranties made by the Company and Bharat Biotech and customary provisions relating to indemnification, limitation of liability, confidentiality, information and data sharing, and other matters. The Supply Agreement expires upon the expiration of the Covaxin Agreement and may be earlier terminated by the Company or Bharat Biotech in the event of an uncured material breach or bankruptcy of the other party. Exclusive License Agreement with The Schepens Eye Research Institute, Inc. In December 2017, the Company entered into an exclusive license agreement with The Schepens Eye Research Institute, Inc. ("SERI"), which was amended in January 2021 (as so amended, the "SERI Agreement"). The SERI Agreement gives the Company an exclusive, worldwide, sublicensable license to patent rights, biological materials, and technical information for NHR genes Nuclear Receptor Subfamily 1 Group D Member 1 ("NR1D1"), NR2E3 (OCU400), RORA (OCU410 and OCU410ST), Nuclear Protein 1, Transcriptional Regulator ("NUPR1"), and Nuclear Receptor Subfamily 2 Group C Member 1 ("NR2C1"). The January 2021 amendment to the SERI Agreement additionally granted the Company rights in co-owned intellectual property pursuant to certain patents and provisional patents at the time of the amendment. Under the SERI Agreement, the Company may make, have made, use, offer to sell, sell, and import licensed products, and must use commercially reasonable efforts to bring one or more licensed products to market as soon as reasonably practicable. The SERI Agreement requires the Company to pay licensing fees for patent rights granted, an annual license maintenance fee, payment of certain development and commercial milestones in the aggregate amount of $16.1 million, and low single-digit percentage royalties on annual net sales of products that fall under the licensed patent rights. The SERI Agreement is a collaborative arrangement within the scope of ASC 808. SERI maintains control of patent preparation, filing, prosecution, and maintenance. The Company is responsible for SERI's out-of-pocket expenses related to the filing, prosecution, and maintenance of the licensed patent rights. In the event that SERI decides to discontinue the prosecution or maintenance of the licensed patent rights, the Company has the right, but not the obligation, to file for, or continue to prosecute, maintain, or enforce such licensed patent rights. The Company has assumed prosecution of certain licensed patent rights under the SERI Agreement. The SERI Agreement will expire on the expiration date of the last to expire licensed patent rights, subject to the earlier termination of the SERI Agreement in accordance with its terms. The Company may terminate the license upon 180 days prior written notice. SERI may immediately terminate the SERI Agreement if the Company ceases to carry on its business with respect to the licensed patent rights, fails to make payments within thirty days of receiving a written notice of missed payment, fails to comply with its diligence obligations, defaults on its obligation to procure and maintain insurance, one of its officers is convicted of a felony related to the licensed products, the Company breaches any material obligation of the agreement and does not cure such breach within 90 days, or if the Company becomes bankrupt or insolvent. Exclusive License Agreement with the University of Colorado In March 2014, the Company entered into an exclusive license agreement with the University of Colorado ("CU"), which was amended in January 2017 and clarified by a letter of understanding in November 2017 (as so amended and clarified, the "CU Agreement"). The CU Agreement gives the Company an exclusive, worldwide, sublicensable license to patents for OCU200 to make, have made, use, import, offer to sell, sell, have sold, and practice the licensed products in all therapeutic applications. Under the CU Agreement, the Company must use commercially reasonable efforts to develop, manufacture, sublicense, market, and sell the licensed products, and has assumed primary responsibility for preparing, filing, and prosecuting broad patent claims for OCU200 for CU's benefit. Further, the Company assumed primary responsibility for all patent activities, including all costs associated with the perfection and maintenance of the patents for OCU200. The CU Agreement requires the payment for certain regulatory milestones aggregating to $1.5 million, an annual minimum payment that began the third year after the effective date, low single-digit percentage earned royalties on net sales, and royalties in the mid-teens on sublicense income of OCU200. The Company has made no milestone or royalty payments to date pursuant to the CU Agreement. The CU Agreement will expire on the latter of the expiration date of the last to expire licensed patent or the end of any relevant statutory or regulatory exclusivity period. The Company may terminate the CU Agreement upon 60 days prior written notice. CU may terminate the CU Agreement upon 60 days notice if the Company fails to make payments within 60 days of such payment's due date, breaches and does not cure any diligence obligation, provides any materially false report, or otherwise materially breaches and does not cure any material provision of the CU Agreement. License Agreement with Purpose Co. Ltd. In December 2005, Histogenics Corporation ("Histogenics") entered into an exclusive agreement (the "Purpose Agreement") to sublicense certain technology from Purpose Co. Ltd. ("Purpose"), which the Company assumed as a result of its reverse merger with Histogenics. Purpose entered into the original license agreement ("BWH-Purpose Agreement") with Brigham and Women's Hospital, Inc. ("BWH") in August 2001. The BWH-Purpose Agreement granted Purpose an exclusive, royalty-bearing, worldwide, sublicensable license, under its rights in licensed patents and patent applications co-owned by BWH and Purpose to make, use, and sell (1) an apparatus for cultivating a cell or tissue, (2) cell or tissue products made using such apparatus, (3) cell or tissue products made using processes for cultivating a cell or tissue as disclosed in the licensed patents and patent applications, and (4) any apparatus that cultivates cells or tissues using such processes, in each case, whose manufacture, use, or sale is covered by a valid claim of the licensed patents and patent applications, only for therapeutic use. Pursuant to the Company's sublicense from Purpose, the Company is obligated to pay minimum royalties and low single-digit royalties based on the net sales of licensed products, milestone payments, and sublicense payments due on the BWH-Purpose Agreement. Histogenics paid an aggregate of $1.0 million in minimum royalty and sublicense payments under the terms of the Purpose Agreement prior to the reverse merger. The Purpose Agreement was amended and restated in June 2012, pursuant to which Purpose granted Histogenics outside of Japan: (i) exclusive rights to all of Purpose's technology (owned or licensed) related to the exogenous tissue processors, which is used in the development of NeoCart, (ii) continued supply of exogenous tissue processors, and (iii) rights to manufacture the exogenous tissue processors at any location the Company chooses. In exchange for such consideration, Purpose was granted an exclusive license in Japan for the use of all of the Company's NeoCart technology and was reimbursed for development costs on a multi-unit exogenous tissue processor. In May 2016, the Purpose Agreement was amended, whereby Histogenics reacquired the development and commercialization rights to NeoCart in Japan. The Purpose Agreement, as amended, provides the Company with the ability, worldwide, to (i) use, make, have made, sell, offer for sale, import or otherwise exploit products or services covered by claims of Purpose's patents and (ii) use, reproduce, modify, create derivative works of and otherwise exploit Purpose's technology for the design, development, manufacture, testing, support, and commercialization of any product or service that incorporates or builds upon Purpose's technology, in each case, only in connection with articular cartilage, ligaments, tendons, and meniscus. Purpose retains the right to sell its single unit exogenous tissue processer machines to research institutes for general but noncommercial use anywhere in the world. Under the Purpose Agreement, the Company is obligated to pay Purpose up to $10.0 million upon the achievement of certain regulatory and commercial milestones as well as a royalty payment in the low single-digits on the net sales in Japan of NeoCart. Such royalty payment shall be reduced to the extent NeoCart does not rely on an outstanding Purpose patent. The BWH-Purpose Agreement remains in effect for the life of the licensed patents. The BWH-Purpose Agreement may be terminated if BWH is provided written notice at least 60 days in advance. BWH has the right to terminate the agreement if minimum royalty payments or other payments fail to be made or otherwise the BWH-Purpose Agreement is breached and such breach is not cured within 30 days of BWH providing notice. Upon the termination of the BWH-Purpose Agreement, the Company's sublicense will convert to a nonexclusive license to only Purpose's interest in the licensed products or processes. Upon written notice to Purpose of the Company's intent to stop using the technology sublicensed to the Company in the BWH-Purpose license, Purpose will reassume all responsibility under the BWH-Purpose license or at Purpose's option, allow the license to lapse.

Fair Value Measurements

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

The following table summarizes the fair value and the classification by level of input within the fair value hierarchy of financial assets that are recurring fair value measurements (in thousands):


	As of December 31, 2022
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	76,564	$	999	$	—	$	77,563
Marketable securities:
U.S. government agency securities and treasuries	—		7,433		—		7,433
Commercial paper	—		5,938		—		5,938
Total assets	$	76,564	$	14,370	$	—	$	90,934

As of December 31, 2022, the valuation of the Company's marketable securities utilized Level 2 inputs in the fair value hierarchy. See Note 2 for additional information. The valuation of the advance for COVAXIN supply, at the time of issuance, utilized Level 3 inputs in the fair value hierarchy and is a nonrecurring fair value measurement. See Note 10 for additional information. Further, the Company believes the fair value using Level 2 inputs of the borrowings under the EB-5 Loan Agreement (as defined in Note 9) approximate their carrying value. See Note 9 for additional information.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Marketable Securities

12 Months Ended

Dec. 31, 2022

Investments, Debt and Equity Securities [Abstract]

Marketable Securities

The following table provides the amortized cost and fair value of the Company's available-for-sale investments by security type as reflected on the consolidated balance sheets (in thousands):


	As of December 31, 2022
	Amortized Cost Basis		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. government agency securities and treasuries	$	7,432	$	1	$	—	$	7,433
Commercial paper	5,938		—		—		5,938
Total marketable securities	$	13,370	$	1	$	—	$	13,371

As of December 31, 2022, marketable securities consisted of investments that mature within one year. The Company did not have marketable securities as of December 31, 2021.

Property and Equipment

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment

The following table provides a summary of the major components of property and equipment as reflected on the consolidated balance sheets (in thousands):


	As of December 31,
	2022		2021
Furniture and fixtures	$	337	$	284
Machinery and equipment	1,685		855
Leasehold improvements	1,603		167
Construction in progress	3,049		232
Total property and equipment	6,674		1,538
Less: accumulated depreciation	(621)		(374)
Total property and equipment, net	$	6,053	$	1,164

Operating Leases

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Operating Leases

The Company has commitments under operating leases for office, laboratory, and future manufacturing space in Malvern, Pennsylvania. The Company's leases have initial terms of approximately seven years and include options to extend the operating leases for up to 10 years. The options for extension have been excluded from the lease terms (and lease liabilities) as it is not reasonably certain that the Company will exercise such options.

The components of lease expense were as follows (in thousands):


	Year ended December 31,
	2022		2021
Operating lease cost	$	774	$	360
Variable lease cost	158		105
Total lease cost	$	932	$	465

Supplemental balance sheet information related to leases was as follows (in thousands):


	As of December 31,
	2022		2021
Right-of-use assets, net	$	3,910	$	1,587

Current lease obligations	$	498	$	363
Non-current lease obligations	3,587		1,231
Total lease liabilities	$	4,085	$	1,594

Supplemental information related to leases was as follows:


	Year ended December 31,
	2022		2021
Weighted-average remaining lease terms (years)	6.3		5.3
Weighted-average discount rate	6.4	%	4.1	%

Future minimum base rent payments are approximately as follows (in thousands):


For the years ending December 31,	Amount
2023	$	763
2024	787
2025	810
2026	834
2027	834
Thereafter	978
Total	$	5,006
Less: present value adjustment	(921)
Present value of minimum lease payments	$	4,085

Accrued Expenses and Other Current Liabilities

12 Months Ended

Dec. 31, 2022

Accrued Liabilities, Current [Abstract]

Accrued Expenses and Other Current Liabilities

The following table provides a summary of the major components of accrued expenses and other current liabilities as reflected on the consolidated balance sheets (in thousands):


	As of December 31,
	2022		2021
Research and development	$	1,894	$	866
Clinical	3,310		703
Professional fees	437		747
Employee-related	2,752		1,716
Other	1,507		293
Total accrued expenses and other current liabilities	$	9,900	$	4,325

Debt

12 Months Ended

Dec. 31, 2022

Debt Disclosure [Abstract]

Debt

In September 2016, pursuant to the U.S. government's Immigrant Investor Program, commonly known as the EB-5 program, the Company entered into an arrangement (the "EB-5 Loan Agreement") to borrow up to $10.0 million from EB5 Life Sciences, L.P. ("EB-5 Life Sciences") in $0.5 million increments. Borrowings may be limited by the amount of funds raised by EB-5 Life Sciences and are subject to certain job creation requirements by the Company. Borrowings are at a fixed interest rate of 4.0% per annum and are to be utilized in the clinical development, manufacturing, and commercialization of the Company's product candidates and for the general working capital needs of the Company. Outstanding borrowings pursuant to the EB-5 Loan Agreement, including accrued interest, become due upon the seventh anniversary of the disbursement, subject to certain extension provisions. Amounts repaid cannot be re-borrowed. The EB-5 Loan Agreement borrowings are secured by substantially all assets of the Company, except for any patents, patent applications, pending patents, patent licenses, patent sublicenses, trademarks, and other intellectual property rights. Under the terms and conditions of the EB-5 Loan Agreement, the Company borrowed $1.0 million during 2016, $0.5 million during 2020, and an additional $0.5 million in September 2022. Issuance costs were recognized as a reduction to the loan balance and are amortized to interest expense over the term of the loan.

The carrying values of the EB-5 Loan Agreement borrowings as of December 31, 2022 and 2021 are summarized below (in thousands):


	As of December 31,
	2022		2021
Principal outstanding	$	2,000	$	1,500
Plus: accrued interest	307		241
Less: unamortized debt issuance costs	(18)		(29)
Carrying value, net	$	2,289	$	1,712

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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+ Details

Equity	12 Months Ended
Equity	Dec. 31, 2022
Equity [Abstract]
Equity	Equity Offerings of Common Stock At-the-Market Offerings During the year ended December 31, 2022, the Company sold 4.7 million shares of common stock under an At Market Issuance Sales Agreement ("Sales Agreement"), which the Company entered into in June 2022 with certain agents, pursuant to which the Company could, from time to time, offer and sell shares of its common stock having an aggregate gross sales price of up to $160.0 million. The offer and sale of the shares of common stock made pursuant to the Sales Agreement were made under the Company's Registration Statement on Form S-3ASR, which was previously filed with the SEC and became automatically effective on March 22, 2021, as supplemented by a prospectus supplement, dated June 10, 2022. The Company received net proceeds of $7.9 million after deducting equity issuance costs of $0.4 million. Subsequent to December 31, 2022, the Company sold additional shares pursuant to the Sales Agreement. See Note 16 for additional information. During the year ended December 31, 2021, the Company sold 1.0 million shares of the Company's common stock in an at-the-market offering commenced in August 2020 and received net proceeds of $4.8 million, after deducting equity issuance costs of $0.1 million. Public Offering In February 2022, the Company entered into an underwriting agreement with an underwriter, pursuant to which the Company sold 16.0 million shares of its common stock at a public offering price of $3.13 per share (the "Public Offering"). Upon the closing of the Public Offering, the Company received net proceeds of $49.8 million, after deducting equity issuance costs payable by the Company. Registered Direct Offerings In April 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company sold 10.0 million shares of its common stock at an offering price of $10.00 per share in a registered direct offering (the "April 2021 Registered Direct Offering"). Upon the closing of the April 2021 Registered Direct Offering, the Company received net proceeds of $93.4 million after deducting equity issuance costs of $6.6 million. In February 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company sold 3.0 million shares of its common stock at an offering price of $7.65 per share in a registered direct offering (the "February 2021 Registered Direct Offering"). Upon the closing of the February 2021 Registered Direct Offering, the Company received net proceeds of $21.2 million after deducting equity issuance costs of $1.7 million. COVAXIN Preferred Stock Purchase Agreement On March 1, 2021, the Company entered into a preferred stock purchase agreement with Bharat Biotech, pursuant to which the Company agreed to issue and sell 0.1 million shares of the Company's Series B Convertible Preferred Stock, par value $0.01 per share (the "Series B Convertible Preferred Stock"), at a price per share equal to $109.60, to Bharat Biotech. On March 18, 2021, the Company issued the Series B Convertible Preferred Stock as an advance payment of $6.0 million for the supply of COVAXIN to be provided by Bharat Biotech pursuant to the Supply Agreement. Each share of Series B Convertible Preferred Stock is convertible, at the option of Bharat Biotech, into 10 shares of the Company's common stock (the "Conversion Ratio") only after (i) the Company received stockholder approval to increase the number of authorized shares of common stock under its Sixth Amended and Restated Certificate of Incorporation, which the Company received in April 2021, and (ii) the Company's receipt of shipments by Bharat Biotech of the first 10.0 million doses of COVAXIN manufactured by Bharat Biotech pursuant to the Supply Agreement, and further on the terms and subject to the conditions set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (the "Certificate of Designation"). As of December 31, 2022, the conversion condition relating to the delivery of the first 10.0 million doses of COVAXIN had not been met. The conversion rate of the Series B Convertible Preferred Stock is subject to adjustment in the event of a stock dividend, stock split, reclassification, or similar event with respect to the Company's common stock. Bharat Biotech is entitled to receive dividends on the Series B Convertible Preferred Stock equal (on an as-converted to common stock basis) to and in the same form as dividends actually paid on shares of common stock, when and if such dividends are paid. Except as provided by law and certain protective provisions set forth in the Certificate of Designation, the Series B Convertible Preferred Stock has no voting rights. Upon a liquidation or dissolution of the Company, holders of Series B Convertible Preferred Stock would be entitled to receive the same amount that a holder of common stock would receive if the Series B Convertible Preferred Stock were fully converted to common stock. The Company accounted for the issuance of the Series B Convertible Preferred Stock in accordance with ASC 718 and recorded its grant date fair value of $5.0 million within stockholders' equity during the year ended December 31, 2021, with a corresponding short-term asset for the advanced payment for the supply of COVAXIN included in prepaid expenses and other current assets in the consolidated balance sheet as of December 31, 2021. The Company utilized the traded common stock price, adjusted by the Conversion Ratio, to value the Series B Convertible Preferred Stock and the Finnerty model to estimate a 15% discount rate for the lack of marketability of the instrument. The valuation incorporated Level 3 inputs in the fair value hierarchy, including the estimated time until the instrument's liquidity and estimated volatility of the Company's common stock as of the grant date. As of December 31, 2022 and 2021, the remaining balance of the short-term asset for the advanced payment for the supply of COVAXIN was $4.1 million and $5.0 million, respectively. The reduction in the advanced payment resulted from the Company's receipt of COVAXIN drug product components from Bharat Biotech, which the Company utilized to produce the demonstration batch at Jubilant HollisterStier during the year ended December 31, 2022.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

Warrants	12 Months Ended
Warrants	Dec. 31, 2022
Warrants and Rights Note Disclosure [Abstract]
Warrants	Warrants Canada Warrants In July 2021, the Company entered into a consulting agreement with regard to the Company's Canadian operations (the "Canada Consulting Agreement"). Compensation under the Canada Consulting Agreement included the issuance of warrants to purchase up to 0.2 million shares of the Company's common stock (the "Canada Warrants") and cash payments of up to $3.0 million, both dependent upon the achievement of certain milestones related to COVAXIN. The Canada Warrants were issued on July 15, 2021, have an exercise price of $6.36 per share, and were accounted for in accordance with ASC 718. The Canada Consulting Agreement terminates on July 15, 2023 and the Canada Warrants terminate on July 15, 2031, unless earlier terminated in accordance with their terms. As of December 31, 2022 and 2021, all of the Canada Warrants were outstanding and unvested. OpCo Warrants Beginning in 2016, OpCo issued warrants to purchase the Company's common stock (the "OpCo Warrants"). As of December 31, 2022 and 2021, 0.6 million OpCo Warrants were outstanding. As of December 31, 2022, the outstanding OpCo Warrants had a weighted-average exercise price of $6.23 per share and expire between 2026 and 2027.

Stock-Based Compensation

12 Months Ended

Dec. 31, 2022

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

Stock-based compensation expense for stock options and RSUs is reflected in the consolidated statements of operations and comprehensive loss as follows (in thousands):


	Year ended December 31,
	2022		2021
General and administrative	$	7,777	$	4,909
Research and development	2,764		2,049
Total	$	10,541	$	6,958

As of December 31, 2022, the Company had $14.9 million of unrecognized stock-based compensation expense related to stock options and RSUs outstanding, which is expected to be recognized over a weighted average period of 1.8 years as of December 31, 2022.

Equity Plans

The Company maintains two equity compensation plans, the 2014 Ocugen OpCo, Inc. Stock Option Plan (the "2014 Plan") and the Ocugen, Inc. 2019 Equity Incentive Plan (the "2019 Plan", collectively with the 2014 Plan, the "Plans"). On the first business day of each fiscal year, pursuant to the "Evergreen" provision of the 2019 Plan, the aggregate number of shares that may be issued under the 2019 Plan will automatically increase by a number equal to the lesser of 4% of the total number of

shares of the Company's common stock outstanding on December 31st of the prior year, or a number of shares determined by the Board of Directors. As of December 31, 2022, the 2014 Plan and the 2019 Plan authorize for the granting of up to 0.8 million and 19.5 million equity awards in respect to the Company's common stock, respectively. In addition to stock options and RSUs granted under the Plans, the Company has granted certain stock options and RSUs as material inducements to employment in accordance with Nasdaq Listing Rule 5635 (c)(4), which were granted outside of the Plans.

Stock Options to Purchase Common Stock

The assumptions utilized in the fair value calculations for stock options as of December 31, 2022 and 2021 were as follows:


	Year ended December 31,
	2022	2021
Weighted average expected option term (years)	5.9	6.0
Range of expected stock price volatility	106% – 110%	109% – 116%
Weighted average expected stock price volatility	107%	111%
Range of risk-free interest rate	1.4% – 4.2%	0.4% – 1.4%
Expected dividend rate	0%	0%

The following table summarizes the stock option activity:


	Number of Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)	Aggregate Intrinsic Value (In Thousands)
Options outstanding at December 31, 2021	10,086,167	$	2.59	8.8	$	24,664
Granted	6,024,830	3.82			—
Exercised	(1,540,142)	0.86			2,592
Forfeited	(3,719,568)	4.25			483
Options outstanding at December 31, 2022	10,851,287	$	2.95	8.3	$	1,385
Options exercisable at December 31, 2022	2,950,927	$	2.92	7.6	$	548

The weighted average grant date fair value of stock options granted during the years ended December 31, 2022 and 2021 were $3.12 and $2.87, respectively. The total fair value of stock options vested during the years ended December 31, 2022 and 2021 were $6.1 million and $2.6 million, respectively. During the years ended December 31, 2022 and 2021, the Company received $1.3 million and $0.9 million of cash proceeds from the exercises of stock options, respectively.

RSUs

The following table summarizes the RSU activity:


	Number of Shares	Weighted Average Grant-Date Fair Value		Aggregate Intrinsic Value (In Thousands)
RSUs outstanding at December 31, 2021	191,811	$	6.79	$	873
Granted	1,359,393	4.05		5,509
Vested	(63,123)	6.60		157
Forfeited	(563,271)	4.59		1,242
RSUs outstanding at December 31, 2022	924,810	$	4.12	$	1,202

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

The Company's losses before income taxes and provision (benefit) for income taxes is as follows (in thousands):


	Year ended December 31,
	2022		2021
Loss before income taxes	$	(81,351)	$	(58,417)
Provision (benefit) for income taxes	—		(52)

A reconciliation of the federal statutory income tax rate to the Company's effective income tax rate is as follows:


	Year ended December 31,
	2022		2021
Expected provision at statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	7.4	%	7.9	%
Tax credits	3.3	%	3.2	%
Change in state tax rate	(11.6)	%	—	%
Other, net	(1.7)	%	(0.1)	%
Change in valuation allowance	(18.4)	%	(31.9)	%
Effective tax rate	—	%	0.1	%

The Company's deferred tax assets (liabilities) are comprised of the following (in thousands):


	As of December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	51,884	$	52,038
Capital loss carryforwards	7,298		7,298
Start-up costs	9,699		11,235
Accruals and reserves	629		448
Intellectual property	5,057		1,960
Stock-based compensation	2,709		2,064
Capitalization of research and development expense	10,379		—
Tax credits	6,655		4,350
Lease liabilities	1,029		461
Total deferred tax assets	95,339		79,854
Valuation allowance	(94,364)		(79,395)
Deferred tax assets, net of valuation allowance	$	975	$	459

Deferred tax liabilities:
Lease right-of-use assets	(975)		(459)
Net deferred tax assets	$	—	$	—

The Company's valuation allowance increased during 2022 by approximately $15.0 million primarily due to Section 174 expenditure capitalization. The Company has evaluated both positive and negative evidence when assessing the realizability of its deferred tax assets. Management has considered the Company's history of cumulative net losses, estimated future taxable income as well as tax planning strategies and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2022 and 2021, respectively.

As of December 31, 2022 and 2021, the Company had U.S. federal net operating loss ("NOL") carryforwards of $200.5 million and $184.4 million, respectively, which may be available to offset future income tax liabilities. The 2017 Tax Cut and Jobs Act generally allows federal losses generated after 2017 to be carried over indefinitely, but also limits the NOL deduction to the lesser of the NOL carryover or 80% of a corporation's taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended ("IRC")). Additionally, there is no carryback for losses generated after 2017. Losses generated prior to 2018 are deductible using the lesser of a corporation's NOL carryover or 100% of a corporation's taxable income and have a 20 year carryforward period. The Company has federal NOLs generated after 2017 of $147.9 million, which do not expire. The federal NOLs generated prior to 2018 of $52.6 million will expire at various dates through 2037. In addition, the Company has a capital loss carryforward of $26.7 million, which may be available to offset future capital gains and expires in 2024.

As of December 31, 2022 and 2021, the Company had U.S. state NOL carryforwards of $198.9 million and $183.1 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2042. As of December 31, 2022 and 2021, the Company had federal tax credit carryforwards of approximately $6.5 million and $3.8 million, respectively, which are available to offset future federal tax liabilities which expire at various dates through 2042. As of December 31, 2022 and 2021, the Company had state tax credit carryforwards of approximately $0.2 million and $0.7 million, respectively, which are available to reduce future tax liabilities and expire at various dates through 2034.

NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and relevant state tax authorities. Utilization of NOL and tax credit carryforwards may be subject to a substantial annual limitation under Section 382 and Section 383 of the IRC and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and tax credit carryforwards that can be utilized annually to offset future federal and state tax liabilities.

The Company has not yet conducted a comprehensive study to assess whether any ownership change has occurred since its inception. A limitation may result in the expiration of a portion of the NOL or tax credit carryforwards before utilization, which would be offset by a change in the Company's valuation allowance. Until a study is completed by the Company, no NOL carryforward amounts will be offset by an unrecognized tax benefit related to Section 382.

A full valuation allowance has also been recorded against the Company's tax credits. If an adjustment is required, it would be offset by a corresponding change in the valuation allowance.

A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands):


	Year ended December 31,
	2022		2021
Gross unrecognized tax benefits at beginning of year	$	303	$	303
Additions for tax positions taken in a prior year	—		—
Additions for tax positions taken in the current year	—		—
Reductions for tax positions taken in the prior year due to settlement	—		—
Reductions for tax positions taken in the prior year due to statutes lapsing	—		—
Gross unrecognized tax benefits at end of year	$	303	$	303

The uncertain tax positions giving rise to the unrecognized tax benefits of $0.3 million at December 31, 2022 and 2021 relate to the timing of certain income and deductions for federal income tax purposes taken by Histogenics prior to the Company's reverse merger with Histogenics. The reversal of unrecognized tax benefits would not have any impact on the effective tax rate in the future and is not expected to create cash liability.

The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In a normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company's tax years are still open from 2019 to present.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

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+ Details

Net Loss per Share of Common Stock

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Net Loss per Share of Common Stock

The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts):


	Year ended December 31,
	2022		2021
Net loss — basic and diluted	$	(81,351)	$	(58,365)
Shares used in calculating net loss per common share — basic and diluted	214,600,051		195,013,043
Net loss per common share — basic and diluted	$	(0.38)	$	(0.30)

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding, as their inclusion would have been antidilutive:


	Year ended December 31,
	2022	2021
Options to purchase common stock	10,851,287	10,086,167
RSUs	924,810	191,811
Warrants	798,352	799,251
Series A Convertible Preferred Stock (as converted to common stock)	—	3,115
Series B Convertible Preferred Stock (as converted to common stock)	547,450	547,450
Total	13,121,899	11,627,794

Commitment and Contingencies	12 Months Ended
Commitment and Contingencies	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies Commitments The Company has commitments under certain license and development agreements, lease agreements, debt agreements, and consulting agreements. Commitments under certain license and development agreements include annual payments, payments upon the achievement of certain milestones, and royalty payments based on net sales of licensed products (see Note 3). Commitments under lease agreements are future minimum lease payments (see Note 7). Commitments under debt agreements are the future payment of principal and accrued interest under the EB-5 Loan Agreement (see Note 9). Commitments under consulting agreements include payments upon the achievement of certain milestones related to COVAXIN (see Note 11). Contingencies In June 2021, a securities class action lawsuit was filed against the Company and certain of its agents in the U.S. District Court for the Eastern District of Pennsylvania ("Court") (Case No. 2:21-cv-02725) that purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, based on statements made by the Company concerning the announcement of the Company's decision to pursue the submission of a BLA for COVAXIN for adults ages 18 years and older rather than pursuing an EUA for the vaccine candidate. In July 2021, a second securities class action lawsuit was filed against the Company and certain of its agents in the Court (Case No. 2:21-cv-03182) that also purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, based on the same statements as the first complaint. The complaints seek unspecified damages, interest, attorneys' fees, and other costs. In March 2022, the Court consolidated these two related securities class action lawsuits and appointed Andre Galan Bernd Benayon to serve as lead plaintiff. The lead plaintiff's amended complaint was filed in June 2022. The Company filed a motion to dismiss the amended complaint in August 2022. The lead plaintiff's opposition to the motion to dismiss was filed in October 2022. The Company filed its reply in support of the motion to dismiss in November 2022. Oral argument on the motion to dismiss took place in January 2023 and no decision has been made to date by the Court. As with any litigation, the Company cannot predict the outcome with certainty, but the Company expects to provide further updates on the status of the motion to dismiss as available. In August 2021, a stockholder derivative lawsuit was filed derivatively on behalf of the Company against certain of its agents and the nominal defendant Ocugen in the Court (Case No. 2:21-cv-03876) that purported to state a claim for breach of fiduciary duty and contribution for violations of Sections 10(b) and 21(d) of the Exchange Act, based on facts and circumstances relating to the securities class action lawsuits and seeking contribution and indemnification in connection with claims asserted in the securities class action lawsuits. In September 2021, a second stockholder derivative lawsuit was filed derivatively on behalf of the Company against certain of its agents and the nominal defendant Ocugen in the Court (Case No. 2:21-cv-04169) that purported to state a claim for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and contribution for violations of Sections 10(b) and 21(d) of the Exchange Act, based on the same allegations as the first complaint. The parties to both stockholder derivative lawsuits have stipulated to the consolidation of the two stockholder derivative lawsuits and also have submitted to the Court in each action a proposed order requesting a stay of the litigation pending a decision on any motion to dismiss filed in the securities class action lawsuits, which the Court entered in April 2022. The Company believes that the lawsuits are without merit and intends to vigorously defend against them. At this time, no assessment can be made as to their likely outcome or whether the outcome will be material to the Company. No information is available to indicate that it is probable that a loss has been incurred and can be reasonably estimated as of the date of the consolidated financial statements and, as such, no accrual for the loss has been recorded within the consolidated financial statements.

Subsequent Events	12 Months Ended
Subsequent Events	Dec. 31, 2022
Subsequent Events [Abstract]
Subsequent Events	Subsequent EventsSubsequent to December 31, 2022, the Company sold 4.5 million shares of its common stock under the Sales Agreement. The Company received net proceeds of $5.6 million after deducting equity issuance costs of $0.2 million. See Note 10 for additional information regarding the Sales Agreement

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation and ConsolidationThe accompanying consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP") and under the rules and regulations of the U.S. Securities and Exchange Commission ("SEC").

Principles of Consolidation

The consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform with current year presentation.

Use of Estimates

Segment Information

Cash, Cash Equivalents, and Restricted Cash

Fair Value Measurements

Level 1 — quoted prices in active markets for identical assets or liabilities

Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions)

Marketable Securities

level. The Company did not recognize any impairments with respect to its debt securities during the year ended December 31, 2022. The Company did not invest in debt securities prior to 2022.

Concentration of Credit Risk

Financial Instruments

Property and Equipment, Net

Expected useful lives by major asset category are as follows:


Furniture and fixtures			3 to 7 years
Machinery and equipment			5 to 7 years
Leasehold improvements			Shorter of the expected useful life or remaining lease term

Leases

Impairment of Assets

Stock-based compensation

Stock-Based Compensation

The assumptions used in Ocugen's Black-Scholes option-pricing model for stock options are as follows:

Expected Volatility. The expected volatility is based on historical volatilities of Ocugen and similar entities within Ocugen's industry for periods commensurate with the assumed expected term.

Expected Dividends. The expected dividend yield is 0% because Ocugen has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock.

Collaboration Arrangements

Income Taxes

Recently Adopted Accounting Standards; Recent Accounting Pronouncements

Recently Adopted Accounting Standards

Recent Accounting Pronouncements

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Schedule of Cash and Cash Equivalents


	As of December 31,
	2022		2021
Cash and cash equivalents	$	77,563	$	94,958
Restricted cash	—		151
Total cash, cash equivalents, and restricted cash	$	77,563	$	95,109

Schedule of Restricted Cash


	As of December 31,
	2022		2021
Cash and cash equivalents	$	77,563	$	94,958
Restricted cash	—		151
Total cash, cash equivalents, and restricted cash	$	77,563	$	95,109

Schedule of Major Components of Property, Plant and Equipment

Expected useful lives by major asset category are as follows:


Furniture and fixtures			3 to 7 years
Machinery and equipment			5 to 7 years
Leasehold improvements			Shorter of the expected useful life or remaining lease term

The following table provides a summary of the major components of property and equipment as reflected on the consolidated balance sheets (in thousands):


	As of December 31,
	2022		2021
Furniture and fixtures	$	337	$	284
Machinery and equipment	1,685		855
Leasehold improvements	1,603		167
Construction in progress	3,049		232
Total property and equipment	6,674		1,538
Less: accumulated depreciation	(621)		(374)
Total property and equipment, net	$	6,053	$	1,164

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Schedule of Fair Value of Financial Assets and Liabilities

The following table summarizes the fair value and the classification by level of input within the fair value hierarchy of financial assets that are recurring fair value measurements (in thousands):


	As of December 31, 2022
	Level 1		Level 2		Level 3		Total
Assets:
Cash and cash equivalents	$	76,564	$	999	$	—	$	77,563
Marketable securities:
U.S. government agency securities and treasuries	—		7,433		—		7,433
Commercial paper	—		5,938		—		5,938
Total assets	$	76,564	$	14,370	$	—	$	90,934

Marketable Securities (Tables)

12 Months Ended

Dec. 31, 2022

Investments, Debt and Equity Securities [Abstract]

Schedule of the major components of marketable securities

The following table provides the amortized cost and fair value of the Company's available-for-sale investments by security type as reflected on the consolidated balance sheets (in thousands):


	As of December 31, 2022
	Amortized Cost Basis		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. government agency securities and treasuries	$	7,432	$	1	$	—	$	7,433
Commercial paper	5,938		—		—		5,938
Total marketable securities	$	13,370	$	1	$	—	$	13,371

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Schedule of Major Components of Property, Plant and Equipment

Expected useful lives by major asset category are as follows:


Furniture and fixtures			3 to 7 years
Machinery and equipment			5 to 7 years
Leasehold improvements			Shorter of the expected useful life or remaining lease term

The following table provides a summary of the major components of property and equipment as reflected on the consolidated balance sheets (in thousands):


	As of December 31,
	2022		2021
Furniture and fixtures	$	337	$	284
Machinery and equipment	1,685		855
Leasehold improvements	1,603		167
Construction in progress	3,049		232
Total property and equipment	6,674		1,538
Less: accumulated depreciation	(621)		(374)
Total property and equipment, net	$	6,053	$	1,164

Operating Leases (Tables)

12 Months Ended

Dec. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Schedule of Components of Lease Expense

The components of lease expense were as follows (in thousands):


	Year ended December 31,
	2022		2021
Operating lease cost	$	774	$	360
Variable lease cost	158		105
Total lease cost	$	932	$	465

Supplemental information related to leases was as follows:


	Year ended December 31,
	2022		2021
Weighted-average remaining lease terms (years)	6.3		5.3
Weighted-average discount rate	6.4	%	4.1	%

Schedule of Supplemental Balance Sheet Information Related to Leases

Supplemental balance sheet information related to leases was as follows (in thousands):


	As of December 31,
	2022		2021
Right-of-use assets, net	$	3,910	$	1,587

Current lease obligations	$	498	$	363
Non-current lease obligations	3,587		1,231
Total lease liabilities	$	4,085	$	1,594

Schedule of Maturities of Operating Leases

Future minimum base rent payments are approximately as follows (in thousands):


For the years ending December 31,	Amount
2023	$	763
2024	787
2025	810
2026	834
2027	834
Thereafter	978
Total	$	5,006
Less: present value adjustment	(921)
Present value of minimum lease payments	$	4,085

Accrued Expenses and Other Current Liabilities (Tables)

12 Months Ended

Dec. 31, 2022

Accrued Liabilities, Current [Abstract]

Schedule of Accrued Expenses and Other Current Liabilities

The following table provides a summary of the major components of accrued expenses and other current liabilities as reflected on the consolidated balance sheets (in thousands):


	As of December 31,
	2022		2021
Research and development	$	1,894	$	866
Clinical	3,310		703
Professional fees	437		747
Employee-related	2,752		1,716
Other	1,507		293
Total accrued expenses and other current liabilities	$	9,900	$	4,325

Debt (Tables)

12 Months Ended

Dec. 31, 2022

Debt Disclosure [Abstract]

Schedule of Debt

The carrying values of the EB-5 Loan Agreement borrowings as of December 31, 2022 and 2021 are summarized below (in thousands):


	As of December 31,
	2022		2021
Principal outstanding	$	2,000	$	1,500
Plus: accrued interest	307		241
Less: unamortized debt issuance costs	(18)		(29)
Carrying value, net	$	2,289	$	1,712

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

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+ Details

Stock-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2022

Share-Based Payment Arrangement [Abstract]

Schedule of Stock-based Compensation Expense for Options Granted Reflected in the Consolidated Statement of Operations and Comprehensive Loss

Stock-based compensation expense for stock options and RSUs is reflected in the consolidated statements of operations and comprehensive loss as follows (in thousands):


	Year ended December 31,
	2022		2021
General and administrative	$	7,777	$	4,909
Research and development	2,764		2,049
Total	$	10,541	$	6,958

Schedule of Weighted Average Assumptions Utilized in Fair Value Calculation

The assumptions utilized in the fair value calculations for stock options as of December 31, 2022 and 2021 were as follows:


	Year ended December 31,
	2022	2021
Weighted average expected option term (years)	5.9	6.0
Range of expected stock price volatility	106% – 110%	109% – 116%
Weighted average expected stock price volatility	107%	111%
Range of risk-free interest rate	1.4% – 4.2%	0.4% – 1.4%
Expected dividend rate	0%	0%

Schedule of Stock Option Activity

The following table summarizes the stock option activity:


	Number of Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)	Aggregate Intrinsic Value (In Thousands)
Options outstanding at December 31, 2021	10,086,167	$	2.59	8.8	$	24,664
Granted	6,024,830	3.82			—
Exercised	(1,540,142)	0.86			2,592
Forfeited	(3,719,568)	4.25			483
Options outstanding at December 31, 2022	10,851,287	$	2.95	8.3	$	1,385
Options exercisable at December 31, 2022	2,950,927	$	2.92	7.6	$	548

Schedule of Share-based Payment Arrangement, Restricted Stock Unit, Activity

The following table summarizes the RSU activity:


	Number of Shares	Weighted Average Grant-Date Fair Value		Aggregate Intrinsic Value (In Thousands)
RSUs outstanding at December 31, 2021	191,811	$	6.79	$	873
Granted	1,359,393	4.05		5,509
Vested	(63,123)	6.60		157
Forfeited	(563,271)	4.59		1,242
RSUs outstanding at December 31, 2022	924,810	$	4.12	$	1,202

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Schedule of Company's losses before income taxes and provision (benefit) for income taxes

The Company's losses before income taxes and provision (benefit) for income taxes is as follows (in thousands):


	Year ended December 31,
	2022		2021
Loss before income taxes	$	(81,351)	$	(58,417)
Provision (benefit) for income taxes	—		(52)

Schedule of Effective Income Tax Rate Reconciliation

A reconciliation of the federal statutory income tax rate to the Company's effective income tax rate is as follows:


	Year ended December 31,
	2022		2021
Expected provision at statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	7.4	%	7.9	%
Tax credits	3.3	%	3.2	%
Change in state tax rate	(11.6)	%	—	%
Other, net	(1.7)	%	(0.1)	%
Change in valuation allowance	(18.4)	%	(31.9)	%
Effective tax rate	—	%	0.1	%

Schedule of Deferred Tax Assets

The Company's deferred tax assets (liabilities) are comprised of the following (in thousands):


	As of December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	51,884	$	52,038
Capital loss carryforwards	7,298		7,298
Start-up costs	9,699		11,235
Accruals and reserves	629		448
Intellectual property	5,057		1,960
Stock-based compensation	2,709		2,064
Capitalization of research and development expense	10,379		—
Tax credits	6,655		4,350
Lease liabilities	1,029		461
Total deferred tax assets	95,339		79,854
Valuation allowance	(94,364)		(79,395)
Deferred tax assets, net of valuation allowance	$	975	$	459

Deferred tax liabilities:
Lease right-of-use assets	(975)		(459)
Net deferred tax assets	$	—	$	—

Schedule of Income Tax Contingencies

A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands):


	Year ended December 31,
	2022		2021
Gross unrecognized tax benefits at beginning of year	$	303	$	303
Additions for tax positions taken in a prior year	—		—
Additions for tax positions taken in the current year	—		—
Reductions for tax positions taken in the prior year due to settlement	—		—
Reductions for tax positions taken in the prior year due to statutes lapsing	—		—
Gross unrecognized tax benefits at end of year	$	303	$	303

Net Loss per Share of Common Stock (Tables)

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Schedule of Basic and Diluted Earnings per Share of Common Stock

The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts):


	Year ended December 31,
	2022		2021
Net loss — basic and diluted	$	(81,351)	$	(58,365)
Shares used in calculating net loss per common share — basic and diluted	214,600,051		195,013,043
Net loss per common share — basic and diluted	$	(0.38)	$	(0.30)

Schedule of Potentially Dilutive Securities Excluded From Computation of Diluted Weighted Average Shares

The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding, as their inclusion would have been antidilutive:


	Year ended December 31,
	2022	2021
Options to purchase common stock	10,851,287	10,086,167
RSUs	924,810	191,811
Warrants	798,352	799,251
Series A Convertible Preferred Stock (as converted to common stock)	—	3,115
Series B Convertible Preferred Stock (as converted to common stock)	547,450	547,450
Total	13,121,899	11,627,794

Nature of Business (Details) $ in Thousands	12 Months Ended
Nature of Business (Details) $ in Thousands	Dec. 31, 2022 USD ($) segment product	Dec. 31, 2021 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of operating segments \| segment	1
Modifier gene therapy platform, number of products \| product	1
Net loss	$ (81,351)	$ (58,365)
Accumulated deficit	213,018	$ 131,667
Cash and investments	$ 90,900

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Summary of Significant Accounting Policies - Additional Information (Details) $ in Millions	12 Months Ended
	Dec. 31, 2022 USD ($) segment	Dec. 31, 2021
RECENT ACCOUNTING PRONOUNCEMENTS
Number of operating segments \| segment	1
Interest income \| $	$ 1.4
Contractual term	10 years
Stock options
RECENT ACCOUNTING PRONOUNCEMENTS
Expected dividend yield	0.00%	0.00%
Minimum
RECENT ACCOUNTING PRONOUNCEMENTS
Vesting period	1 year
Maximum
RECENT ACCOUNTING PRONOUNCEMENTS
Vesting period	3 years

Summary of Significant Accounting Policies - Summary Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash, cash equivalents and restricted cash reconciliation:
Cash and cash equivalents	$ 77,563	$ 94,958
Restricted cash	0	151
Total cash, cash equivalents, and restricted cash	$ 77,563	$ 95,109	$ 24,190

Summary of Significant Accounting Policies - Expected Useful Lives by Major Asset Category (Details)	12 Months Ended
	Dec. 31, 2022
Furniture and fixtures \| Minimum
Property, Plant and Equipment [Line Items]
Useful life	3 years
Furniture and fixtures \| Maximum
Property, Plant and Equipment [Line Items]
Useful life	7 years
Machinery and equipment \| Minimum
Property, Plant and Equipment [Line Items]
Useful life	5 years
Machinery and equipment \| Maximum
Property, Plant and Equipment [Line Items]
Useful life	7 years

License and Development Agreements (Details) - USD ($)		1 Months Ended							72 Months Ended
License and Development Agreements (Details) - USD ($)	Dec. 31, 2018	Jan. 31, 2023	Sep. 30, 2022	Jun. 30, 2021	Dec. 31, 2017	Jan. 31, 2017	May 31, 2016	Aug. 31, 2001	Dec. 31, 2022	Apr. 30, 2022
License agreements:
Initial license Issuance fee			$ 1,000,000
Milestone payment							$ 10,000,000
License agreement, minimum royalty and sublicense, paid	$ 1,000,000
Subsequent events
License agreements:
Payment annual development and commercial milestones		$ 37,000,000
Cancellation period, notice		90 days
Collaborative Arrangement
License agreements:
Upfront payment				$ 15,000,000
Additional payment				$ 10,000,000
Profits generated, shared percentage										45.00%
Schepens Eye Research Institute Research Agreement
License agreements:
Payment annual development and commercial milestones					$ 16,100,000
Cancellation period, notice					180 days
Missed payment threshold					30 days
Period to cure breach					90 days
Collaboration agreement with University of Colorado
License agreements:
Cancellation period, notice						60 days
Potential development and regulatory milestone payments						$ 1,500,000
Milestone payment									$ 0
Royalty payments									$ 0
Cancellation notice, payments period						60 days
Collaboration Agreement With Purpose Co. Ltd
License agreements:
Cancellation period, notice								60 days
Cancellation notice, payments period								30 days

Fair Value Measurements (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Assets:
Marketable securities	$ 13,371	$ 0
Fair Value, Recurring
Assets:
Cash and cash equivalents	77,563
Total assets	90,934
U.S. government agency securities and treasuries
Assets:
Marketable securities	7,433
U.S. government agency securities and treasuries \| Fair Value, Recurring
Assets:
Marketable securities	7,433
Commercial paper
Assets:
Marketable securities	5,938
Commercial paper \| Fair Value, Recurring
Assets:
Marketable securities	5,938
Level 1 \| Fair Value, Recurring
Assets:
Cash and cash equivalents	76,564
Total assets	76,564
Level 1 \| U.S. government agency securities and treasuries \| Fair Value, Recurring
Assets:
Marketable securities	0
Level 1 \| Commercial paper \| Fair Value, Recurring
Assets:
Marketable securities	0
Level 2 \| Fair Value, Recurring
Assets:
Cash and cash equivalents	999
Total assets	14,370
Level 2 \| U.S. government agency securities and treasuries \| Fair Value, Recurring
Assets:
Marketable securities	7,433
Level 2 \| Commercial paper \| Fair Value, Recurring
Assets:
Marketable securities	5,938
Level 3 \| Fair Value, Recurring
Assets:
Cash and cash equivalents	0
Total assets	0
Level 3 \| U.S. government agency securities and treasuries \| Fair Value, Recurring
Assets:
Marketable securities	0
Level 3 \| Commercial paper \| Fair Value, Recurring
Assets:
Marketable securities	$ 0

Marketable Securities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost Basis	$ 13,370
Gross Unrealized Gains	1
Gross Unrealized Losses	0
Fair Value	13,371	$ 0
U.S. government agency securities and treasuries
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost Basis	7,432
Gross Unrealized Gains	1
Gross Unrealized Losses	0
Fair Value	7,433
Commercial paper
Debt Securities, Available-for-Sale [Line Items]
Amortized Cost Basis	5,938
Gross Unrealized Gains	0
Gross Unrealized Losses	0
Fair Value	$ 5,938

Property and Equipment - Summary of the Major Components of Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 6,674	$ 1,538
Less: accumulated depreciation	(621)	(374)
Total property and equipment, net	6,053	1,164
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Property, plant and equipment	337	284
Machinery and equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment	1,685	855
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property, plant and equipment	1,603	167
Construction in progress
Property, Plant and Equipment [Line Items]
Property, plant and equipment	$ 3,049	$ 232

Operating Leases - Additional Information (Details)	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Operating lease, term of contract (in years)	7 years
Operating lease, renewal term (in years)	10 years

Operating Leases - Components Of Lease Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Operating lease cost	$ 774	$ 360
Variable lease cost	158	105
Total lease cost	$ 932	$ 465

Operating Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Right-of-use assets, net	$ 3,910	$ 1,587
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration]	Other assets	Other assets
Current lease obligations	$ 498	$ 363
Non-current lease obligations	3,587	1,231
Total lease liabilities	$ 4,085	$ 1,594

Operating Leases - Operating Leases, Supplemental Information Related To Leases (Details)	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Weighted-average remaining lease terms (years)	6 years 3 months 18 days	5 years 3 months 18 days
Weighted-average discount rate	6.40%	4.10%

Operating Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
2023	$ 763
2024	787
2025	810
2026	834
2027	834
Thereafter	978
Total	5,006
Less: present value adjustment	(921)
Total lease liabilities	$ 4,085	$ 1,594

Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Accrued Liabilities, Current [Abstract]
Research and development	$ 1,894	$ 866
Clinical	3,310	703
Professional fees	437	747
Employee-related	2,752	1,716
Other	1,507	293
Total accrued expenses and other current liabilities	$ 9,900	$ 4,325

Debt - Additional Information (Details) - EB-5 Loan - Loans payable - USD ($)		1 Months Ended	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2022	Dec. 31, 2020	Dec. 31, 2016
Debt
Maximum borrowing	$ 10,000,000
Borrowing increments	$ 500,000
Interest rate (as a percent)	4.00%
Proceeds from secured lines of credit		$ 500,000	$ 500,000	$ 1,000,000

Debt - EB-5 Loan Agreement Borrowings (Details) - EB-5 Loan - Loans payable - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Debt
Principal outstanding	$ 2,000	$ 1,500
Plus: accrued interest	307	241
Less: unamortized debt issuance costs	(18)	(29)
Carrying value, net	$ 2,289	$ 1,712

- Definition

Amount, excluding unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Equity (Details) $ / shares in Units, $ in Thousands, shares in Millions, dose in Millions			1 Months Ended				12 Months Ended
	Mar. 18, 2021 USD ($)	Mar. 01, 2021 dose $ / shares shares	Jun. 30, 2022 USD ($)	Feb. 28, 2022 USD ($) $ / shares shares	Apr. 30, 2021 USD ($) $ / shares shares	Feb. 28, 2021 USD ($) $ / shares shares	Dec. 31, 2022 USD ($) dose $ / shares shares	Dec. 31, 2021 USD ($) $ / shares shares
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares							4.5
Proceeds from sale of stock							$ 5,600
Commissions, fees and expenses							$ 200
Convertible preferred stock, par value (in USD per share) \| $ / shares							$ 0.01	$ 0.01
Series B Convertible Preferred Stock
Subsidiary, Sale of Stock [Line Items]
Preferred stock, outstanding							$ 4,100	$ 5,000
Series B Convertible Preferred Stock \| Level 3 \| Measurement Input, Discount Rate
Subsidiary, Sale of Stock [Line Items]
Preferred stock, measurement input								0.15
ATMs
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares							4.7	1.0
Aggregate gross number of shares that may be issued in transaction, value			$ 160,000
Proceeds from sale of stock							$ 7,900	$ 4,800
Commissions, fees and expenses							$ 400	$ 100
Public Offering Of Common Stock
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares				16.0
Proceeds from sale of stock				$ 49,800
Price per share (in USD per share) \| $ / shares				$ 3.13
Registered Direct Offering
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares					10.0	3.0
Proceeds from sale of stock					$ 93,400	$ 21,200
Commissions, fees and expenses					$ 6,600	$ 1,700
Price per share (in USD per share) \| $ / shares					$ 10.00	$ 7.65
COVAXIN Preferred Stock Purchase Agreement \| Series B Convertible Preferred Stock
Subsidiary, Sale of Stock [Line Items]
Number of shares agreed to issue and sell (in shares) \| shares		0.1
Convertible preferred stock, par value (in USD per share) \| $ / shares		$ 0.01
Price per share ( in USD per share) \| $ / shares		$ 109.60
Advance payment amount	$ 6,000
Preferred stock, convertible, conversion ratio		10
Supply agreement, number of doses \| dose		10.0					10.0

Warrants (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Millions	Dec. 31, 2022	Dec. 31, 2021	Jul. 15, 2021
Canada Consulting Warrants
Class of Warrant or Right [Line Items]
Warrants exercisable (in shares)			200
Expected milestone payment			$ 3.0
Initial exercise price (in USD per share)			$ 6.36
OpCo Warrants
Class of Warrant or Right [Line Items]
Number of warrants outstanding (in shares)	600	600
Initial exercise price (in USD per share)	$ 6.23

Stock-Based Compensation - Schedule of Compensation Expense for Options Granted (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 10,541	$ 6,958
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	7,777	4,909
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 2,764	$ 2,049

Stock-Based Compensation - Additional Information (Details) $ / shares in Units, shares in Millions, $ in Millions	12 Months Ended
	Dec. 31, 2022 USD ($) equityCompensationPlan $ / shares shares	Dec. 31, 2021 USD ($) $ / shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation expense	$ 14.9
Unrecognized compensation expense related to options outstanding, weighted average period for expense to be recognized	1 year 9 months 18 days
Number of equity compensation plans \| equityCompensationPlan	2
Weighted average grant date fair value (in USD per share) \| $ / shares	$ 3.12	$ 2.87
Options vested in period, fair value	$ 6.1	$ 2.6
Proceeds from stock options exercised	$ 1.3	$ 0.9
2019 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Automatic increase in shares to be issued (in percentage)	4.00%
Number of shares authorized for grant (in shares) \| shares	19.5
2014 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares authorized for grant (in shares) \| shares	0.8

Stock-Based Compensation - Schedule of Valuation Assumptions (Details) - Stock options	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average expected option term (years)	5 years 10 months 24 days	6 years
Range of expected stock price volatility (in percentage), minimum	106.00%	109.00%
Range of expected stock price volatility (in percentage), maximum	110.00%	116.00%
Weighted average expected stock price volatility (in percentage)	107.00%	111.00%
Range of risk-free interest rate (in percentage), minimum	1.40%	0.40%
Range of risk-free interest rate (in percentage), maximum	4.20%	1.40%
Expected dividend rate (in percentage)	0.00%	0.00%

Stock-Based Compensation - Schedule Options to Purchase Common Stock (Details) - 2014 Plan, 2019 Plan, and Inducement Grants - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Number of Shares
Options outstanding, beginning balance (in shares)	10,086,167
Granted (in shares)	6,024,830
Exercised (in shares)	(1,540,142)
Forfeited (in shares)	(3,719,568)
Options outstanding, ending balance (in shares)	10,851,287	10,086,167
Options exercisable (in shares)	2,950,927
Weighted Average Exercise Price
Options outstanding, beginning balance (in USD per share)	$ 2.59
Granted (in USD per share)	3.82
Exercised (in USD per share)	0.86
Forfeited (in USD per share)	4.25
Options outstanding, ending balance (in USD per share)	2.95	$ 2.59
Options exercisable (in USD per share)	$ 2.92
Weighted Average Remaining Contractual Life (Years)
Options outstanding (in years)	8 years 3 months 18 days	8 years 9 months 18 days
Options exercisable (in years)	7 years 7 months 6 days
Aggregate Intrinsic Value (In Thousands)
Options outstanding, beginning balance	$ 24,664
Granted in period, intrinsic value	0
Exercises in period, intrinsic value	2,592
Forfeited in period, intrinsic value	483
Options outstanding, ending balance	1,385	$ 24,664
Options exercisable	$ 548

Stock-based Compensation - Schedule of RSU Activity (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($) $ / shares shares
Aggregate Intrinsic Value (In Thousands)
Aggregate intrinsic value, Vested \| $	$ 157
RSUs
Number of Shares
Beginning balance outstanding (in shares) \| shares	191,811
Granted (in shares) \| shares	1,359,393
Vested (in shares) \| shares	(63,123)
Forfeited (in shares) \| shares	(563,271)
Ending balance outstanding (in shares) \| shares	924,810
Weighted Average Grant-Date Fair Value
Beginning balance (in USD per share) \| $ / shares	$ 6.79
Granted (in USD per share) \| $ / shares	4.05
Vested (in USD per share) \| $ / shares	6.60
Forfeited (in USD per share) \| $ / shares	4.59
Ending balance (in USD per share) \| $ / shares	$ 4.12
Aggregate Intrinsic Value (In Thousands)
Beginning balance \| $	$ 873
Aggregate intrinsic value, granted \| $	5,509
Aggregate intrinsic value, forfeited \| $	1,242
Ending balance \| $	$ 1,202

Income Taxes - Schedule of Company's losses before income taxes and provision (benefit) for income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Loss before income taxes	$ (81,351)	$ (58,417)
Provision (benefit) for income taxes	$ 0	$ (52)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

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+ Details

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Taxes - Schedule of Effective Income Tax Rate (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Expected provision at statutory rate	21.00%	21.00%
State income tax, net of federal benefit	7.40%	7.90%
Tax credits	3.30%	3.20%
Change in state tax rate	(11.60%)	0.00%
Other, net	(1.70%)	(0.10%)
Change in valuation allowance	(18.40%)	(31.90%)
Effective tax rate	0.00%	0.10%

Income Taxes - Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Deferred tax assets:
Net operating loss carryforwards	$ 51,884	$ 52,038
Capital loss carryforwards	7,298	7,298
Start-up costs	9,699	11,235
Accruals and reserves	629	448
Intellectual property	5,057	1,960
Stock-based compensation	2,709	2,064
Capitalization of research and development expense	10,379	0
Tax credits	6,655	4,350
Lease liabilities	1,029	461
Total deferred tax assets	95,339	79,854
Valuation allowance	(94,364)	(79,395)
Deferred tax assets, net of valuation allowance	975	459
Deferred tax liabilities:
Lease right-of-use assets	(975)	(459)
Net deferred tax assets	$ 0	$ 0

Income Taxes - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Operating Loss Carryforwards [Line Items]
Net change in valuation allowance	$ (15,000)
Operating loss carryforwards, not subject to expiration	147,900
Operating loss carryforwards, subject to expiration	52,600
Unrecognized tax benefits, beginning balance	303	$ 303	$ 303
Capital Loss Carryforward
Operating Loss Carryforwards [Line Items]
Tax credit carryforward, amount	26,700
State and local
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	198,900	183,100
Tax credit carryforward, amount	200	700
Federal
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	200,500	184,400
Tax credit carryforward, amount	$ 6,500	$ 3,800

Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Unrecognized Tax Benefits Reconciliation
Unrecognized tax benefits, beginning balance	$ 303	$ 303
Additions for tax positions taken in a prior year	0	0
Additions for tax positions taken in the current year	0	0
Reductions for tax positions taken in the prior year due to settlement	0	0
Reductions for tax positions taken in the prior year due to statutes lapsing	0	0
Unrecognized tax benefits, ending balance	$ 303	$ 303

Net Loss Per Share of Common Stock - Computation of Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Earnings Per Share [Abstract]
Net loss - basic and diluted	$ (81,351)	$ (58,365)
Shares used in calculating net loss per common share - basic (in shares)	214,600,051	195,013,043
Shares used in calculating net loss per common share - diluted (in shares)	214,600,051	195,013,043
Net loss per share of common stock - basic (in USD per share)	$ (0.38)	$ (0.30)
Net loss per share of common stock - diluted (in USD per share)	$ (0.38)	$ (0.30)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Net Loss Per Share of Common Stock - Potentially Dilutive Securities have been Excluded from the Computation of Diluted Weighted Average Shares Outstanding (Details) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares)	13,121,899	11,627,794
Options to purchase common stock
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares)	10,851,287	10,086,167
RSUs
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares)	924,810	191,811
Warrants
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares)	798,352	799,251
Series A Convertible Preferred Stock
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares)	0	3,115
Series B Convertible Preferred Stock
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares)	547,450	547,450

Subsequent Events (Details) shares in Millions, $ in Millions	12 Months Ended
	Dec. 31, 2022 USD ($) shares
Subsequent Events [Abstract]
Number of shares issued and sold (in shares) \| shares	4.5
Proceeds from sale of stock	$ 5.6
Commissions, fees and expenses	$ 0.2