0001628280-22-028775 | 10-Q | XBRL Viewer

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Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2022	Nov. 01, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
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, par value $0.01 per share
Trading Symbol	OCGN
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		218,886,893
Entity Central Index Key	0001372299
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 101,602	$ 94,958
Prepaid expenses and other current assets	5,895	7,688
Total current assets	107,497	102,646
Property and equipment, net	4,517	1,164
Restricted cash	0	151
Other assets	4,225	1,800
Total assets	116,239	105,761
Current liabilities
Accounts payable	6,460	2,312
Accrued expenses	8,004	4,325
Operating lease obligations	443	363
Total current liabilities	14,907	7,000
Non-current liabilities
Operating lease obligations, less current portion	3,764	1,231
Long term debt, net	2,265	1,712
Total non-current liabilities	6,029	2,943
Total liabilities	20,936	9,943
Commitments and contingencies (Note 12)
Stockholders' equity
Common stock; $0.01 par value; 295,000,000 shares authorized, 216,809,937 and 199,502,183 shares issued, and 216,688,437 and 199,380,683 shares outstanding at September 30, 2022 and December 31, 2021, respectively	2,168	1,995
Treasury stock, at cost, 121,500 shares at September 30, 2022 and December 31, 2021	(48)	(48)
Additional paid-in capital	284,231	225,537
Accumulated other comprehensive income	30	0
Accumulated deficit	(191,079)	(131,667)
Total stockholders' equity	95,303	95,818
Total liabilities and stockholders' equity	116,239	105,761
Series A Preferred Stock
Stockholders' equity
Preferred stock issued	0	0
Series B Preferred Stock
Stockholders' equity
Preferred stock issued	$ 1	$ 1

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 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)	216,809,937	199,502,183
Common stock, shares outstanding (in shares)	216,688,437	199,380,683
Treasury stock (in shares)	121,500	121,500
Series A Preferred Stock
Convertible preferred stock, shares issued (in shares)	0	7
Convertible preferred stock, shares outstanding (in shares)	0	7
Series B Preferred Stock
Convertible preferred stock, shares issued (in shares)	54,745	54,745
Convertible preferred stock, shares outstanding (in shares)	54,745	54,745

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Operating expenses
Research and development	$ 15,622	$ 6,281	$ 32,544	$ 28,006
General and administrative	7,497	4,508	28,174	15,450
Total operating expenses	23,119	10,789	60,718	43,456
Loss from operations	(23,119)	(10,789)	(60,718)	(43,456)
Other income (expense), net	1,197	(18)	1,306	(380)
Loss before income taxes	(21,922)	(10,807)	(59,412)	(43,836)
Income tax benefit	0	(52)	0	(52)
Net loss	(21,922)	(10,755)	(59,412)	(43,784)
Other comprehensive income (loss)
Foreign currency translation adjustment	20	0	30	0
Comprehensive loss	$ (21,902)	$ (10,755)	$ (59,382)	$ (43,784)
Shares used in calculating net loss per common share - basic (in shares)	216,591,011	198,790,980	212,755,746	193,599,525
Shares used in calculating net loss per common share - diluted (in shares)	216,591,011	198,790,980	212,755,746	193,599,525
Net loss per share of common stock - basic (in USD per share)	$ (0.10)	$ (0.05)	$ (0.28)	$ (0.23)
Net loss per share of common stock - diluted (in USD per share)	$ (0.10)	$ (0.05)	$ (0.28)	$ (0.23)

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Series B Preferred Stock	At-the-market Issuance	Registered Direct Offering	Preferred Stock Series A Preferred Stock	Preferred Stock Series B Preferred Stock	Common Stock	Common Stock Series A Preferred Stock	Common Stock At-the-market Issuance	Common Stock Registered Direct Offering	Treasury Stock	Additional Paid-in Capital	Additional Paid-in Capital Series B Preferred Stock	Additional Paid-in Capital At-the-market Issuance	Additional Paid-in Capital Registered Direct Offering	Accumulated Other Comprehensive Income	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2020					7	0	184,133,384
Beginning balance at Dec. 31, 2020	$ 21,550				$ 0	$ 0	$ 1,841				$ (48)	$ 93,059				$ 0	$ (73,302)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	833											833
Issuance of common stock for option exercises (in shares)							157,468
Issuance of common stock for stock option exercises	176						$ 2					174
Issuance of stock (in shares)						54,745			987,000	3,000,000
Issuance of stock		$ 4,954	$ 4,849	$ 21,204		$ 1			$ 10	$ 30			$ 4,953	$ 4,839	$ 21,174
Net loss	(7,077)																(7,077)
Ending balance (in shares) at Mar. 31, 2021					7	54,745	188,277,852
Ending balance at Mar. 31, 2021	46,489				$ 0	$ 1	$ 1,883				(48)	125,032				0	(80,379)
Beginning balance (in shares) at Dec. 31, 2020					7	0	184,133,384
Beginning balance at Dec. 31, 2020	21,550				$ 0	$ 0	$ 1,841				(48)	93,059				0	(73,302)
Increase (Decrease) in Stockholders' Equity
Foreign currency translation adjustment	0
Net loss	(43,784)
Ending balance (in shares) at Sep. 30, 2021					7	54,745	199,049,329
Ending balance at Sep. 30, 2021	107,110				$ 0	$ 1	$ 1,990				(48)	222,253				0	(117,086)
Beginning balance (in shares) at Mar. 31, 2021					7	54,745	188,277,852
Beginning balance at Mar. 31, 2021	46,489				$ 0	$ 1	$ 1,883				(48)	125,032				0	(80,379)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	2,095											2,095
Issuance of stock (in shares)										10,000,000
Issuance of stock				$ 93,406						$ 100					$ 93,306
Issuance of common stock for stock option and warrant exercises (in shares)							538,893
Issuance of common stock for stock option and warrant exercises	371						$ 5					366
Net loss	(25,952)																(25,952)
Ending balance (in shares) at Jun. 30, 2021					7	54,745	198,816,745
Ending balance at Jun. 30, 2021	116,409				$ 0	$ 1	$ 1,988				(48)	220,799				0	(106,331)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	1,347											1,347
Issuance of common stock for option exercises (in shares)							232,584
Issuance of common stock for stock option exercises	109						$ 2					107
Foreign currency translation adjustment	0
Net loss	(10,755)																(10,755)
Ending balance (in shares) at Sep. 30, 2021					7	54,745	199,049,329
Ending balance at Sep. 30, 2021	107,110				$ 0	$ 1	$ 1,990				(48)	222,253				0	(117,086)
Beginning balance (in shares) at Dec. 31, 2021					7	54,745	199,502,183
Beginning balance at Dec. 31, 2021	95,818				$ 0	$ 1	$ 1,995				(48)	225,537				0	(131,667)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	3,299											3,299
Issuance of common stock for option exercises (in shares)							277,323
Issuance of common stock for stock option exercises	180						$ 3					177
Issuance of stock (in shares)							15,973,420
Issuance of stock	49,851						$ 160					49,691
Net loss	(18,019)																(18,019)
Ending balance (in shares) at Mar. 31, 2022					7	54,745	215,752,926
Ending balance at Mar. 31, 2022	131,129				$ 0	$ 1	$ 2,158				(48)	278,704				0	(149,686)
Beginning balance (in shares) at Dec. 31, 2021					7	54,745	199,502,183
Beginning balance at Dec. 31, 2021	$ 95,818				$ 0	$ 1	$ 1,995				(48)	225,537				0	(131,667)
Increase (Decrease) in Stockholders' Equity
Issuance of common stock for option exercises (in shares)	1,295,999
Foreign currency translation adjustment	$ 30
Net loss	(59,412)
Ending balance (in shares) at Sep. 30, 2022					0	54,745	216,809,937
Ending balance at Sep. 30, 2022	95,303				$ 0	$ 1	$ 2,168				(48)	284,231				30	(191,079)
Beginning balance (in shares) at Mar. 31, 2022					7	54,745	215,752,926
Beginning balance at Mar. 31, 2022	131,129				$ 0	$ 1	$ 2,158				(48)	278,704				0	(149,686)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	2,079											2,079
Issuance of common stock for option exercises (in shares)							488,843
Issuance of common stock for stock option exercises	409						$ 5					404
Issuance of common stock upon restricted stock unit vesting, net (in shares)							26,378
Issuance of common stock upon restricted stock unit vesting, net	(48)											(48)
Series A convertible preferred stock conversion (in shares)					(7)			3,115
Foreign currency translation adjustment	10															10
Net loss	(19,471)																(19,471)
Ending balance (in shares) at Jun. 30, 2022					0	54,745	216,271,262
Ending balance at Jun. 30, 2022	114,108				$ 0	$ 1	$ 2,163				(48)	281,139				10	(169,157)
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense	2,495											2,495
Issuance of common stock for option exercises (in shares)							529,833
Issuance of common stock for stock option exercises	612						$ 5					607
Issuance of common stock upon restricted stock unit vesting, net (in shares)							8,842
Issuance of common stock upon restricted stock unit vesting, net	(10)											(10)
Foreign currency translation adjustment	20															20
Net loss	(21,922)																(21,922)
Ending balance (in shares) at Sep. 30, 2022					0	54,745	216,809,937
Ending balance at Sep. 30, 2022	$ 95,303				$ 0	$ 1	$ 2,168				$ (48)	$ 284,231				$ 30	$ (191,079)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities
Net loss	$ (59,412)	$ (43,784)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense	307	151
Non-cash interest expense	58	59
Non-cash lease expense	463	200
Stock-based compensation expense	7,873	4,275
Income tax benefit	0	(52)
Gain on forgiveness of Paycheck Protection Program note	0	(426)
Impairment on note receivable	0	761
Other	(673)	0
Changes in assets and liabilities:
Prepaid expenses and other assets	1,888	845
Accounts payable and accrued expenses	6,592	2,925
Lease obligations	(261)	(191)
Other assets	0	100
Net cash used in operating activities	(43,165)	(35,137)
Cash flows from investing activities
Purchases of property and equipment	(2,433)	(747)
Asset acquisition	0	(127)
Issuance of note receivable	0	(750)
Repayment of note receivable	761	0
Net cash used in investing activities	(1,672)	(1,624)
Cash flows from financing activities
Proceeds from issuance of common stock	51,198	128,606
Tax payments for net share settlement of restricted stock units	(57)	0
Payment of equity issuance costs	(298)	(8,525)
Proceeds from issuance of debt	500	0
Payment of debt issuance costs	(43)	0
Financing lease principal payments	0	(10)
Net cash provided by financing activities	51,300	120,071
Effect of changes in exchange rate on cash, cash equivalents, and restricted cash	30	0
Net increase in cash, cash equivalents, and restricted cash	6,493	83,310
Cash, cash equivalents, and restricted cash at beginning of period	95,109	24,190
Cash, cash equivalents, and restricted cash at end of period	101,602	107,500
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
Equity issuance costs	2	0
Purchases of property and equipment	1,231	9
Right-of-use asset related to operating leases	2,916	926
Debt issuance costs	$ 19	$ 0

Nature of Business	9 Months Ended
Nature of Business	Sep. 30, 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. Vaccines Intramuscular COVID-19 Vaccine Candidate In February 2021, the Company entered into a Co-Development, Supply and Commercialization Agreement with Bharat Biotech International Limited ("Bharat Biotech"), 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 BBV152, known as COVAXIN, for the prevention of COVID-19 caused by SARS-CoV-2 in the United States, its territories, and possessions. In June 2021 and April 2022, the Company entered into amendments to the Co-Development, Supply and Commercialization Agreement (as so amended, the "Covaxin Agreement"), pursuant to which the parties agreed to expand the Company's rights to develop, manufacture, and commercialize COVAXIN to include Canada and Mexico, respectively, in addition to the United States, its territories, and possessions (the "Ocugen Covaxin Territory"). COVAXIN is a whole-virion inactivated COVID-19 vaccine candidate and is formulated with the inactivated SARS-CoV-2 virus, an antigen, and an adjuvant. The Company has completed enrollment in a Phase 2/3 immuno-bridging and broadening clinical trial evaluating COVAXIN for adults ages 18 years and older, pursuant to an Investigational New Drug ("IND") application cleared by the U.S. Food and Drug Administration ("FDA"). The clinical trial was designed to evaluate whether the immune response observed in participants in a completed Phase 3 clinical trial in India is similar to a demographically representative, adult population in the United States. The Company intends to work with government agencies in the United States to obtain funding in order to comply with the requirements of a Biologics License Application ("BLA") submission. Mucosal COVID-19 Vaccine Candidate In September 2022, the Company entered into an exclusive license agreement ("WU License Agreement") with The Washington University ("Washington University"), pursuant to which the Company obtained the rights to develop, manufacture, and commercialize a mucosal COVID-19 vaccine, OCU500, in the United States, Europe, and Japan (collectively, the "Mucosal COVID-19 Vaccine Territory"). OCU500 is a recombinant, replication-deficient, adenovirus-vectored vaccine with a prefusion stabilized spike protein. As this vaccine can potentially be delivered through the mucosal route (intranasal or inhalation), the Company believes that OCU500 has the potential to generate rapid local immunity in the nose, mouth, upper airways, and lungs where SARS-CoV-2 enters and infects the body, which the Company believes may help reduce or prevent infection and transmission as well as provide protection against new COVID-19 variants. The Company intends to work closely with government agencies in the Mucosal COVID-19 Vaccine Territory to obtain funding to initiate clinical trials and manufacture OCU500. Modifier Gene Therapy Platform The Company is developing a modifier gene therapy platform designed to fulfill unmet medical needs in retinal diseases, including inherited retinal diseases ("IRDs"), such as retinitis pigmentosa ("RP"), Leber congenital amaurosis ("LCA"), dry age-related macular degeneration ("AMD"), and Stargardt disease. The Company's modifier gene therapy platform is based on nuclear hormone receptors ("NHRs"), which have the potential to restore homeostasis, the basic biological processes in the retina. 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, its first product candidate being developed with its modifier gene therapy platform, 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 Designations ("ODDs") from the FDA for the treatment of certain disease genotypes: nuclear receptor subfamily 2 group E member 3 ("NR2E3"), centrosomal protein 290 ("CEP290"), rhodopsin ("RHO"), and phosphodiesterase 6B ("PDE6ß") mutation-associated inherited retinal degenerations. Additionally, OCU400 has received Orphan Medicinal Product Designation ("OMPD") from the European Commission ("EC") based on the recommendation of the European Medicines Agency ("EMA") for RP and LCA. The Company has initiated a Phase 1/2 clinical trial, a multicenter, open-label, dose ranging study to assess the safety of unilateral subretinal administration of OCU400 in subjects with NR2E3 and RHO-related RP in the United States, pursuant to an IND application cleared by the FDA. The first patient was dosed in March 2022 and the Company has completed dosing patients in two out of three cohorts. The Company initiated dosing in the third cohort in October 2022. The Company expects to complete enrollment in the third cohort by the end of 2022. Patients with LCA associated with CEP290 mutations will be included in the current Phase 1/2 clinical trial. The Company is also developing OCU410 and OCU410ST to utilize the nuclear receptor genes RAR-related orphan receptor A ("RORA") for the treatment of dry AMD and Stargardt disease, respectively. The Company is currently executing IND-enabling studies for OCU410 consistent with FDA discussions. The Company intends to submit IND applications in the second quarter of 2023 to initiate Phase 1/2 clinical trials. The Company has engaged CanSino Biologics, Inc. ("CanSinoBIO") as its manufacturing partner for its modifier gene therapy platform. CanSinoBIO has produced the clinical trial supplies for use in the Phase 1/2 clinical trials. Novel Biologic Therapy for Retinal Diseases The Company's biologic product candidate, OCU200, is a novel fusion protein designed to treat severely sight-threatening diseases, such as 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 ("CDMO") and has produced clinical trial supplies to initiate a Phase 1 clinical trial. The Company is currently executing IND-enabling studies consistent with FDA discussions. The Company intends to submit an IND application in the first quarter of 2023 to initiate a Phase 1 clinical trial targeting DME. Regenerative Medicine – Cell Therapy Platform 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. The Company believes NeoCart has the potential to accelerate healing and reduce pain by reconstructing a patient's previously damaged knee cartilage. It treats pain at the source, creating a similar, functional joint surface as it was before the injury. Ultimately, the therapy's goal is to prevent a patient's progression toward osteoarthritis, reduce pain, and improve function of the joint. In May 2022, the FDA granted a Regenerative Medicine Advanced Therapy ("RMAT") designation to NeoCart for the repair of knee cartilage injuries in adults. The Company is currently working with the FDA to finalize the Phase 3 clinical trial protocol necessary to advance the clinical development of NeoCart for eventual market authorization. Going Concern Consideration The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") assuming the Company will continue as a going concern. As of September 30, 2022, the Company had cash and cash equivalents of approximately $101.6 million, which the Company believes will enable it to fund its operations into the fourth quarter of 2023. The cash runway is based on management's updated projections, including the removal of external expenditures for COVAXIN beyond the ongoing Phase 2/3 immuno-bridging and broadening clinical trial. The Company anticipates that the continued development of its COVID-19 vaccine candidates will require government funding to support the regulatory pathway of such candidates. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all. As the result of the updated projections, the Company believes that its cash and cash equivalents will enable the funding of its operating expenses and capital expenditure requirements through at least one year from the date the condensed consolidated financial statements are issued.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The accompanying unaudited condensed consolidated financial statements included herein have been prepared in conformity with GAAP and under the rules and regulations of the United States Securities and Exchange Commission ("SEC") for interim reporting. The accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, that are necessary to present fairly the Company's financial position, results of operations, and cash flows. The condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosures of the Company normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted under the SEC's rules and regulations. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2021, included in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2022 (the "2021 Annual Report"). The condensed consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

In preparing the condensed 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.

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, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper, and U.S. government and U.S. government agency obligations. The Company earns interest on its cash equivalents balance which is recorded as interest income in other income (expense), net within the condensed consolidated statements of operations and comprehensive loss. The Company recorded $0.5 million and $0.6 million as interest income for the three and nine months ended September 30, 2022, respectively. The Company's restricted cash balance 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 condensed consolidated balance sheets to the total amount shown in the condensed consolidated statements of cash flows (in thousands):


	As of September 30,
	2022		2021
Cash and cash equivalents	$	101,602	$	107,349
Restricted cash	—		151
Total cash, cash equivalents, and restricted cash	$	101,602	$	107,500

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.

Operating leases are included in other assets and operating lease obligations in the Company's condensed consolidated balance sheets. Operating lease right-of-use assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Operating lease payments are recognized as lease expense 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. The Company currently leases real estate classified as operating leases. Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 842, Leases, 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 the 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 condensed consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed payments.

Fair Value Measurements

The Company follows the provisions of FASB 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. As of September 30, 2022, the Company believes the fair value using Level 2 inputs of the borrowings under the EB-5 Loan Agreement (as defined in Note 7) approximate their carrying value. See Note 7 for additional information.

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 condensed 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. 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 life 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.

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 condensed 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 condensed 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 that 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 condensed 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 condensed consolidated financial statements.

License and Development Agreement	9 Months Ended
License and Development Agreement	Sep. 30, 2022
Revenue from Contract with Customer [Abstract]
License and Development Agreement	License and Development Agreements 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 a mucosal COVID-19 vaccine, OCU500, as well as a license to certain tangible research property and technical information necessary to exploit the patent rights within the Mucosal COVID-19 Vaccine Territory. The Company paid Washington University an initial license issuance fee of $1.0 million, which was recognized as research and development expense in the condensed consolidated statement of operations and comprehensive loss during the three and nine months ended September 30, 2022. In addition, the Company is required to pay Washington University an annual license maintenance fee, payments upon the achievement of regulatory 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 COVID-19 Vaccine Territory. The Company will use commercially reasonable efforts to develop, manufacture, promote, and sell the licensed products in the Mucosal COVID-19 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 ninety 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 at the execution of the amendment, which was recognized as research and development expense in the condensed consolidated statements of operations and comprehensive loss during the nine months ended September 30, 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 collaboration 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 subsequently described, 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 has 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. The Company has selected Jubilant HollisterStier as a manufacturing partner to prepare for the commercial manufacturing of COVAXIN. 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 the technology transfer to Jubilant HollisterStier, 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 8) as an advance payment for the supply of COVAXIN to be provided by Bharat Biotech under the Supply Agreement. See Note 8 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 both parties 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 either party in the event of an uncured material breach or bankruptcy of the other party.

Property and Equipment

9 Months Ended

Sep. 30, 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 condensed consolidated balance sheets (in thousands):


	September 30, 2022		December 31, 2021
Furniture and fixtures	$	333	$	284
Machinery and equipment	1,505		855
Leasehold improvements	1,597		167
Construction in progress	1,660		232
Total property and equipment	5,095		1,538
Less: accumulated depreciation	(578)		(374)
Total property and equipment, net	$	4,517	$	1,164

Operating Leases

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Operating Leases

The Company has commitments under operating leases for office and laboratory space located 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):


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Operating lease cost	$	196	$	66	$	578	$	200
Variable lease cost	36		26		89		79
Total lease cost	$	232	$	92	$	667	$	279

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


	September 30, 2022		December 31, 2021
Right-of-use assets, net	$	4,040	$	1,587

Current lease obligations	$	443	$	363
Non-current lease obligations	3,764		1,231
Total lease liabilities	$	4,207	$	1,594

Supplemental information related to leases was as follows:


	Nine months ended September 30,
	2022		2021
Weighted-average remaining lease term (years)	6.5		6.2
Weighted-average discount rate	6.4	%	4.6	%

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


For the Years Ending December 31,	Amount
Remainder of 2022	$	147
2023	762
2024	785
2025	809
2026	833
Thereafter	1,859
Total	$	5,195
Less: present value adjustment	(988)
Present value of minimum lease payments	$	4,207

Accrued Expenses

9 Months Ended

Sep. 30, 2022

Accrued Liabilities, Current [Abstract]

Accrued Expenses

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


	September 30, 2022		December 31, 2021
Research and development	$	1,379	$	866
Clinical	2,199		703
Professional fees	494		747
Employee-related	2,363		1,716
Other	1,569		293
Total accrued expenses	$	8,004	$	4,325

Debt

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Debt

DebtIn 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 final disbursement. 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 $1.5 million prior to 2022 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 September 30, 2022 and December 31, 2021 are summarized below (in thousands):


	September 30, 2022		December 31, 2021
Principal outstanding	$	2,000	$	1,500
Plus: accrued interest	287		241
Less: unamortized debt issuance costs	(22)		(29)
Carrying value, net	$	2,265	$	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.

+ References

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+ Details

Equity	9 Months Ended
Equity	Sep. 30, 2022
Equity [Abstract]
Equity	Equity 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. As of September 30, 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. 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 equity during the nine months ended September 30, 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 condensed 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 the estimated volatility of the Company's common stock as of the grant date. As of September 30, 2022 and December 31, 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 three months ended September 30, 2022. In February 2022, the Company entered into a supply commitment to purchase $14.3 million of COVAXIN drug product components from Bharat Biotech to utilize in the Process Performance Qualification ("PPQ") runs. The doses produced in the PPQ runs, if successfully completed, are expected to be commercially salable following regulatory approval. Subsequent to September 30, 2022, the Company withdrew this supply commitment as a result of the deficiencies identified in an inspection conducted by the World Health Organization ("WHO"). Offerings of Common Stock Public Offering In February 2022, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., 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. At-the-Market Offering During the nine months ended September 30, 2021, the Company sold 1.0 million shares of the Company's common stock in an at-the-market offering and received net proceeds of $4.8 million after deducting equity issuance costs of $0.1 million.

- 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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-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 815
-SubTopic 40
-Section 50
-Paragraph 6
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

Warrants	9 Months Ended
Warrants	Sep. 30, 2022
Equity [Abstract]
Warrants	Warrants Liminal Warrants On January 24, 2022, the Company entered into a non-binding letter of intent ("LOI") with Liminal Biosciences Inc. ("Liminal") for the acquisition of Liminal's manufacturing site in Belleville, Ontario, Canada for a combination of cash and warrants to purchase the Company's common stock. Pursuant to the LOI, the Company issued warrants to purchase 2.3 million shares of the Company's common stock at an exercise price of $3.76 per share, subject to certain adjustments (the "Liminal Warrants"). As of September 30, 2022, the Liminal Warrants were cancelled as a result of the termination of the LOI. Canada Warrants In July 2021, the Company entered into a consulting agreement with an individual to provide services to the Company with regard to the Company's Canadian operations (the "Canada Consulting Agreement"). Compensation under the Canada Consulting Agreement includes, among other forms of compensation, 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 upon the achievement of certain milestones related to COVAXIN. The Canada Consulting Agreement terminates in July 2023, unless earlier terminated in accordance with its terms. The Canada Warrants were issued on July 15, 2021 in a private placement transaction. The warrant holder has the right to exercise the Canada Warrants to purchase up to 0.2 million shares of the Company's common stock at an exercise price of $6.36 per share upon the achievement of certain milestones related to COVAXIN. The Canada Warrants terminate on July 15, 2031, unless earlier terminated in accordance with their terms. As of September 30, 2022 and December 31, 2021, all of the Canada Warrants were outstanding and unvested. The Canada Warrants are accounted for in accordance with ASC 718. OpCo Warrants Beginning in 2016, OpCo issued warrants to purchase the Company's common stock (the "OpCo Warrants"). As of September 30, 2022 and December 31, 2021, 0.6 million OpCo Warrants were outstanding. As of September 30, 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

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Stock-Based Compensation

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


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
General and administrative	$	2,057	$	840	$	5,769	$	2,957
Research and development	438		507		2,104		1,318
Total	$	2,495	$	1,347	$	7,873	$	4,275

As of September 30, 2022, the Company had $18.0 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 2.0 years.

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"). As of September 30, 2022, the 2014 Plan and the 2019 Plan authorize for the granting of up to 0.8 million and 19.5 million equity awards with 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 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)
Stock options outstanding at December 31, 2021	10,086,167	$	2.59	8.8	$	24,664
Granted	5,809,257	$	3.90
Exercised	(1,295,999)	$	0.93
Forfeited	(2,872,488)	$	4.10
Stock options outstanding at September 30, 2022	11,726,937	$	3.06	8.5	$	2,448
Stock options exercisable at September 30, 2022	2,982,799	$	2.56	7.5	$	1,089

As of September 30, 2022 and December 31, 2021, there were 0.9 million and 1.2 million of stock options with performance-based vesting conditions outstanding, of which 0.7 million and 0.9 million were not yet vested and exercisable, respectively. The weighted-average grant date fair values of stock options granted during the three and nine months ended September 30, 2022 were $2.01 and $3.19, respectively. The weighted-average grant date fair values of stock options granted during the three and nine months ended September 30, 2021 were $5.97 and $2.77, respectively. The total fair values of stock options vested during the three and nine months ended September 30, 2022 were $0.6 million and $4.6 million, respectively. The total fair values of stock options vested during the three and nine months ended September 30, 2021 were $0.1 million and $0.7 million, respectively.

RSUs

The following table summarizes the RSU activity:


	Number of Shares	Weighted-Average Grant-Date Fair Value
RSUs outstanding at December 31, 2021	191,811	$	6.79
Granted	1,304,902	$	4.16
Vested	(56,807)	$	6.42
Forfeited	(507,027)	$	4.75
RSUs outstanding at September 30, 2022	932,879	$	4.24

Net Loss Per Share of Common Stock

9 Months Ended

Sep. 30, 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 three and nine months ended September 30, 2022 and 2021 (in thousands, except share and per share amounts):


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Net loss — basic and diluted	$	(21,922)	$	(10,755)	$	(59,412)	$	(43,784)
Shares used in calculating net loss per common share — basic and diluted	216,591,011		198,790,980		212,755,746		193,599,525
Net loss per common share — basic and diluted	$	(0.10)	$	(0.05)	$	(0.28)	$	(0.23)

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


	Three months ended September 30,		Nine months ended September 30,
	2022	2021	2022	2021
Options to purchase common stock	11,726,937	10,518,263	11,726,937	10,518,263
RSUs	932,879	179,051	932,879	179,051
Warrants	798,352	946,179	798,352	946,179
Series A Convertible Preferred Stock (as converted to common stock)	—	3,115	—	3,115
Series B Convertible Preferred Stock (as converted to common stock)	547,450	547,450	547,450	547,450
Total	14,005,618	12,194,058	14,005,618	12,194,058

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 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 (commitments under the Company's licensing agreements are more fully described within Note 3 and within the Company's 2021 Annual Report). Commitments under lease agreements are future minimum lease payments (see Note 5). Commitments under debt agreements are the future payment of principal and accrued interest under the EB-5 Loan Agreement (see Note 7). Commitments under consulting agreements include payments upon the achievement of certain milestones related to COVAXIN (see Note 9). The Company previously entered into a supply commitment in February 2022 for the purchase of COVAXIN drug product components from Bharat Biotech which was withdrawn by the Company subsequent to September 30, 2022 (see Note 8). 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 in the United States for COVAXIN for adults ages 18 years and older rather than pursuing emergency use authorization ("EUA") for the vaccine candidate. In July 2021, a second securities class action 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 will file its reply in support of its motion to dismiss by November 10, 2022. 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 condensed consolidated financial statements and, as such, no accrual for the loss has been recorded within the condensed consolidated financial statements.

Subsequent Events	9 Months Ended
Subsequent Events	Sep. 30, 2022
Subsequent Events [Abstract]
Subsequent Events	Subsequent EventsSubsequent to September 30, 2022, the Company sold 2.1 million shares of its 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 may, 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 $3.6 million after deducting equity issuance costs of $0.3 million.

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2022
Accounting Policies [Abstract]
Basis of Presentation and Consolidation	Basis of Presentation and ConsolidationThe accompanying unaudited condensed consolidated financial statements included herein have been prepared in conformity with GAAP and under the rules and regulations of the United States Securities and Exchange Commission ("SEC") for interim reporting. The accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, that are necessary to present fairly the Company's financial position, results of operations, and cash flows. The condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosures of the Company normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted under the SEC's rules and regulations. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2021, included in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2022 (the "2021 Annual Report").
Principles of Consolidation	The condensed consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates	Use of Estimates In preparing the condensed 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.
Cash, Cash Equivalents and Restricted Cash	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, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper, and U.S. government and U.S. government agency obligations. The Company earns interest on its cash equivalents balance which is recorded as interest income in other income (expense), net within the condensed consolidated statements of operations and comprehensive loss. The Company recorded $0.5 million and $0.6 million as interest income for the three and nine months ended September 30, 2022, respectively. The Company's restricted cash balance consisted of cash held to collateralize a corporate credit card account.
Leases	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. Operating leases are included in other assets and operating lease obligations in the Company's condensed consolidated balance sheets. Operating lease right-of-use assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Operating lease payments are recognized as lease expense 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. The Company currently leases real estate classified as operating leases. Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 842, Leases, 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 the 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 condensed consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed payments.
Fair Value Measurements	Fair Value Measurements The Company follows the provisions of FASB 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. As of September 30, 2022, the Company believes the fair value using Level 2 inputs of the borrowings under the EB-5 Loan Agreement (as defined in Note 7) approximate their carrying value. See Note 7 for additional information.
Stock-Based Compensation	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 condensed 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. 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 life 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.
Recently Adopted Accounting Standards and Recent Accounting Pronouncements	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 condensed 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 condensed 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 that 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 condensed 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 condensed consolidated financial statements.

- Definition

Disclosure of accounting policy for award under share-based payment arrangement. Includes, but is not limited to, methodology and assumption used in measuring cost.

+ References + Details

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Schedule of Cash and Cash Equivalents


	As of September 30,
	2022		2021
Cash and cash equivalents	$	101,602	$	107,349
Restricted cash	—		151
Total cash, cash equivalents, and restricted cash	$	101,602	$	107,500

Restrictions on Cash and Cash Equivalents


	As of September 30,
	2022		2021
Cash and cash equivalents	$	101,602	$	107,349
Restricted cash	—		151
Total cash, cash equivalents, and restricted cash	$	101,602	$	107,500

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Schedule of Major Components of Property, Plant and Equipment

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


	September 30, 2022		December 31, 2021
Furniture and fixtures	$	333	$	284
Machinery and equipment	1,505		855
Leasehold improvements	1,597		167
Construction in progress	1,660		232
Total property and equipment	5,095		1,538
Less: accumulated depreciation	(578)		(374)
Total property and equipment, net	$	4,517	$	1,164

Operating Leases (Tables)

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Schedule of Components of Lease Expense

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


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Operating lease cost	$	196	$	66	$	578	$	200
Variable lease cost	36		26		89		79
Total lease cost	$	232	$	92	$	667	$	279

Supplemental information related to leases was as follows:


	Nine months ended September 30,
	2022		2021
Weighted-average remaining lease term (years)	6.5		6.2
Weighted-average discount rate	6.4	%	4.6	%

Supplemental Balance Sheet Information Related to Leases

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


	September 30, 2022		December 31, 2021
Right-of-use assets, net	$	4,040	$	1,587

Current lease obligations	$	443	$	363
Non-current lease obligations	3,764		1,231
Total lease liabilities	$	4,207	$	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
Remainder of 2022	$	147
2023	762
2024	785
2025	809
2026	833
Thereafter	1,859
Total	$	5,195
Less: present value adjustment	(988)
Present value of minimum lease payments	$	4,207

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2022

Accrued Liabilities, Current [Abstract]

Schedule of Accrued Expenses

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


	September 30, 2022		December 31, 2021
Research and development	$	1,379	$	866
Clinical	2,199		703
Professional fees	494		747
Employee-related	2,363		1,716
Other	1,569		293
Total accrued expenses	$	8,004	$	4,325

Debt (Tables)

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Schedule of Debt

The carrying values of the EB-5 Loan Agreement borrowings as of September 30, 2022 and December 31, 2021 are summarized below (in thousands):


	September 30, 2022		December 31, 2021
Principal outstanding	$	2,000	$	1,500
Plus: accrued interest	287		241
Less: unamortized debt issuance costs	(22)		(29)
Carrying value, net	$	2,265	$	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.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
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-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 3
-Subparagraph (SX 210.12-04(a))
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-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 1A
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-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
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-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
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-Section 55
-Paragraph 69B
-URI https://asc.fasb.org/extlink&oid=123466577&loc=SL123495735-112612

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 7: http://www.xbrl.org/2003/role/exampleRef
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-Name Accounting Standards Codification
-Topic 470
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-Section 55
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-URI https://asc.fasb.org/extlink&oid=123466577&loc=SL123495743-112612

Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
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+ Details

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

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

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


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
General and administrative	$	2,057	$	840	$	5,769	$	2,957
Research and development	438		507		2,104		1,318
Total	$	2,495	$	1,347	$	7,873	$	4,275

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)
Stock options outstanding at December 31, 2021	10,086,167	$	2.59	8.8	$	24,664
Granted	5,809,257	$	3.90
Exercised	(1,295,999)	$	0.93
Forfeited	(2,872,488)	$	4.10
Stock options outstanding at September 30, 2022	11,726,937	$	3.06	8.5	$	2,448
Stock options exercisable at September 30, 2022	2,982,799	$	2.56	7.5	$	1,089

Share-based Payment Arrangement, Restricted Stock Unit, Activity

The following table summarizes the RSU activity:


	Number of Shares	Weighted-Average Grant-Date Fair Value
RSUs outstanding at December 31, 2021	191,811	$	6.79
Granted	1,304,902	$	4.16
Vested	(56,807)	$	6.42
Forfeited	(507,027)	$	4.75
RSUs outstanding at September 30, 2022	932,879	$	4.24

Net Loss Per Share of Common Stock (Tables)

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Schedule of Basic and Diluted Earnings Per Share


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Net loss — basic and diluted	$	(21,922)	$	(10,755)	$	(59,412)	$	(43,784)
Shares used in calculating net loss per common share — basic and diluted	216,591,011		198,790,980		212,755,746		193,599,525
Net loss per common share — basic and diluted	$	(0.10)	$	(0.05)	$	(0.28)	$	(0.23)

Schedule of Potentially Dilutive Securities Excluded from Computation of Earnings Per Share

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


	Three months ended September 30,		Nine months ended September 30,
	2022	2021	2022	2021
Options to purchase common stock	11,726,937	10,518,263	11,726,937	10,518,263
RSUs	932,879	179,051	932,879	179,051
Warrants	798,352	946,179	798,352	946,179
Series A Convertible Preferred Stock (as converted to common stock)	—	3,115	—	3,115
Series B Convertible Preferred Stock (as converted to common stock)	547,450	547,450	547,450	547,450
Total	14,005,618	12,194,058	14,005,618	12,194,058

Nature of Business - Narrative (Details) $ in Thousands	9 Months Ended
Nature of Business - Narrative (Details) $ in Thousands	Sep. 30, 2022 USD ($) segment product	Dec. 31, 2021 USD ($)	Sep. 30, 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
Cash and cash equivalents \| $	$ 101,602	$ 94,958	$ 107,349

Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Millions	3 Months Ended	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2022
RECENT ACCOUNTING PRONOUNCEMENTS
Interest income	$ 0.5	$ 0.6
Expiration period (in years)		10 years
Minimum
RECENT ACCOUNTING PRONOUNCEMENTS
Award vesting period (in years)		1 year
Maximum
RECENT ACCOUNTING PRONOUNCEMENTS
Award vesting period (in years)		3 years

Summary of Significant Accounting Policies - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021	Sep. 30, 2021	Dec. 31, 2020
Accounting Policies [Abstract]
Cash and cash equivalents	$ 101,602	$ 94,958	$ 107,349
Restricted cash	0	151	151
Total cash, cash equivalents, and restricted cash	$ 101,602	$ 95,109	$ 107,500	$ 24,190

License and Development Agreement (Details) - USD ($) $ in Millions	1 Months Ended
	Sep. 30, 2022	Jun. 30, 2021	Apr. 30, 2022
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Initial license Issuance fee	$ 1.0
Regulatory and commercial milestone payment	$ 37.0
Covaxin Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment		$ 15.0
Additional payment		$ 10.0
Profits generated, shared percentage			45.00%

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 5,095	$ 1,538
Less: accumulated depreciation	(578)	(374)
Property and equipment, net	4,517	1,164
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	333	284
Machinery and equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	1,505	855
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	1,597	167
Construction in progress
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 1,660	$ 232

Operating Leases - Narrative (Details)	Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]
Leases, term of contract (in years)	7 years
Lease renewal term (in years)	10 years

Operating Leases - Components Of Lease Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Commitments and Contingencies Disclosure [Abstract]
Operating lease cost	$ 196	$ 66	$ 578	$ 200
Variable lease cost	36	26	89	79
Total lease cost	$ 232	$ 92	$ 667	$ 279

Operating Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Right-of-use assets, net	$ 4,040	$ 1,587
Current lease obligations	443	363
Non-current lease obligations	3,764	1,231
Total lease liabilities	$ 4,207	$ 1,594

Operating Leases - Supplemental Information Related To Leases (Details)	Sep. 30, 2022	Sep. 30, 2021
Commitments and Contingencies Disclosure [Abstract]
Weighted-average remaining lease terms—operating leases (years)	6 years 6 months	6 years 2 months 12 days
Weighted-average discount rate—operating leases	6.40%	4.60%

Operating Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Remainder of 2022	$ 147
2023	762
2024	785
2025	809
2026	833
Thereafter	1,859
Total	5,195
Less: present value adjustment	(988)
Present value of minimum lease payments	$ 4,207	$ 1,594

Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Accrued Liabilities, Current [Abstract]
Research and development	$ 1,379	$ 866
Clinical	2,199	703
Professional fees	494	747
Employee-related	2,363	1,716
Other	1,569	293
Total accrued expenses	$ 8,004	$ 4,325

Debt - EB 5 Loan Agreement Borrowings (Details) - EB-5 Loan Agreement - Loans payable - USD ($)		1 Months Ended
	Dec. 31, 2021	Sep. 30, 2022	Sep. 30, 2016
Debt Instrument [Line Items]
Maximum borrowing			$ 10,000,000
Borrowing increments			$ 500,000
Interest rate			4.00%
Proceeds from secured lines of credit	$ 1,500,000	$ 500,000

Debt - Summary of the Carrying Values of the Loan Agreement Borrowings (Details) - EB-5 Loan Agreement - Loans payable - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Debt Instrument [Line Items]
Principal outstanding	$ 2,000	$ 1,500
Plus: accrued interest	287	241
Less: unamortized debt issuance costs	(22)	(29)
Carrying value, net	$ 2,265	$ 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, shares in Millions, dose in Millions, $ in Millions		1 Months Ended			9 Months Ended
	Mar. 18, 2021 USD ($)	Feb. 28, 2022 USD ($) $ / shares shares	Apr. 30, 2021 USD ($) $ / shares shares	Feb. 28, 2021 USD ($) $ / shares shares	Sep. 30, 2021 USD ($) shares	Sep. 30, 2022 USD ($) dose $ / shares	Dec. 31, 2021 USD ($) $ / shares	Mar. 01, 2021 dose $ / shares shares
Subsidiary, Sale of Stock [Line Items]
Convertible preferred stock, par value (in USD per share) \| $ / shares						$ 0.01	$ 0.01
Purchase obligation		$ 14.3
Series B Warrants
Subsidiary, Sale of Stock [Line Items]
Preferred stock, outstanding					$ 5.0	$ 4.1	$ 5.0
Series B Warrants \| Level 3 \| Discount Rate
Subsidiary, Sale of Stock [Line Items]
Preferred stock, measurement input					0.15
COVAXIN Preferred Stock Purchase Agreement \| Series B Warrants
Subsidiary, Sale of Stock [Line Items]
Agreement to sell, number of shares issued in transaction (in shares) \| shares								0.1
Convertible preferred stock, par value (in USD per share) \| $ / shares								$ 0.01
Agreement to sell, price per share (in USD per share) \| $ / shares								$ 109.60
Advance payment amount	$ 6.0
Conversion ratio (in shares)								10
Supply agreement, number of doses \| dose						10.0		10.0
Public Offering Of Common Stock
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares		16.0
Price per share (in USD per share) \| $ / shares		$ 3.13
Proceeds from sale of stock		$ 49.8
Registered Direct Offering
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares			10.0	3.0
Price per share (in USD per share) \| $ / shares			$ 10.00	$ 7.65
Proceeds from sale of stock			$ 93.4	$ 21.2
Commissions, fees and expenses			$ 6.6	$ 1.7
ATMs
Subsidiary, Sale of Stock [Line Items]
Number of shares issued and sold (in shares) \| shares					1.0
Proceeds from sale of stock					$ 4.8
Commissions, fees and expenses					$ 0.1

Warrants (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions			1 Months Ended	9 Months Ended	12 Months Ended
	Jan. 24, 2022	Jul. 15, 2021	Jul. 31, 2021	Sep. 30, 2022	Dec. 31, 2021
Canada Consulting Warrants
Class of Warrant or Right
Initial exercise price (in USD per share)		$ 6.36
Class of warrant or right, exercisable (in shares)		0.2	0.2
Expected milestone payment			$ 3.0
OpCo Warrants
Class of Warrant or Right
Initial exercise price (in USD per share)				$ 6.23
Class of warrant or right, exercisable (in shares)				0.6	0.6
Warrants
Class of Warrant or Right
Business combination, consideration transferred, equity interests issued and issuable (in shares)	$ 2.3
Initial exercise price (in USD per share)	$ 3.76

Stock-Based Compensation - Schedule of Compensation Expense for Options Granted (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 2,495	$ 1,347	$ 7,873	$ 4,275
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	2,057	840	5,769	2,957
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 438	$ 507	$ 2,104	$ 1,318

Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2022 USD ($) equityCompensationPlan $ / shares shares	Sep. 30, 2021 USD ($) $ / shares	Sep. 30, 2022 USD ($) equityCompensationPlan $ / shares shares	Sep. 30, 2021 USD ($) $ / shares	Dec. 31, 2021 shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation expense \| $	$ 18.0		$ 18.0
Unrecognized compensation expense related to options outstanding, weighted average period for expense to be recognized			2 years
Number of equity compensation plans \| equityCompensationPlan	2		2
Options outstanding (in shares)	11,726,937		11,726,937		10,086,167
Options, grants in period, weighted average grant date fair value (in USD per share) \| $ / shares	$ 2.01	$ 5.97	$ 3.19	$ 2.77
Options, vested in period, fair value \| $	$ 0.6	$ 0.1	$ 4.6	$ 0.7
2014 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares authorized for grant (in shares)	800,000		800,000
2019 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares authorized for grant (in shares)	19,500,000		19,500,000
Share-based Payment Arrangement, Performance Based Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options outstanding (in shares)	900,000		900,000		1,200,000
Options not yet exercisable (in shares)	700,000		700,000		900,000

Stock-Based Compensation - Schedule Options to Purchase Common Stock (Details) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2022 USD ($) $ / shares shares	Dec. 31, 2021 USD ($) $ / shares shares
Number of Shares
Number of shares, stock options outstanding, beginning balance (in shares) \| shares	10,086,167
Granted (in shares) \| shares	5,809,257
Exercised (in shares) \| shares	(1,295,999)
Forfeited (in shares) \| shares	(2,872,488)
Number of shares, stock options outstanding, ending balance (in shares) \| shares	11,726,937	10,086,167
Stock options exercisable (in shares) \| shares	2,982,799
Weighted-Average Exercise Price
Beginning balance, weighted average exercise price (in USD per share) \| $ / shares	$ 2.59
Weighted average exercise price, granted (in USD per share) \| $ / shares	3.90
Weighted average exercise price, exercised (in USD per share) \| $ / shares	0.93
Weighted average exercise price, cancelled (in USD per share) \| $ / shares	4.10
Ending balance, weighted average exercise price (in USD per share) \| $ / shares	3.06	$ 2.59
Weighted average exercise price, options exercisable (in USD per share) \| $ / shares	$ 2.56
Additional Disclosures
Weighted average remaining contractual life	8 years 6 months	8 years 9 months 18 days
Weighted average remaining contractual life, options exercisable	7 years 6 months
Aggregate intrinsic value \| $	$ 2,448	$ 24,664
Aggregate intrinsic value, stock options exercisable \| $	$ 1,089

Stock-Based Compensation - Schedule of RSU Activity (Details) - RSUs	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of Shares
Beginning balance outstanding (in shares) \| shares	191,811
Granted (in shares) \| shares	1,304,902
Vested (in shares) \| shares	(56,807)
Forfeited (in shares) \| shares	(507,027)
Ending balance outstanding (in shares) \| shares	932,879
Weighted-Average Grant-Date Fair Value
Beginning balance (in USD per share) \| $ / shares	$ 6.79
Granted (in USD per share) \| $ / shares	4.16
Vested (in USD per share) \| $ / shares	6.42
Forfeited (in USD per share) \| $ / shares	4.75
Ending balance (in USD per share) \| $ / shares	$ 4.24

Net Loss Per Share of Common Stock - Computation of Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021
Earnings Per Share [Abstract]
Net loss - basic and diluted	$ (21,922)	$ (19,471)	$ (18,019)	$ (10,755)	$ (25,952)	$ (7,077)	$ (59,412)	$ (43,784)
Shares used in calculating net loss per common share - basic (in shares)	216,591,011			198,790,980			212,755,746	193,599,525
Shares used in calculating net loss per common share - diluted (in shares)	216,591,011			198,790,980			212,755,746	193,599,525
Net loss per share of common stock - basic (in USD per share)	$ (0.10)			$ (0.05)			$ (0.28)	$ (0.23)
Net loss per share of common stock - diluted (in USD per share)	$ (0.10)			$ (0.05)			$ (0.28)	$ (0.23)

- 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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- Definition

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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+ Details

- 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

Net Loss Per Share of Common Stock - Potentially Dilutive Securities have been Excluded from the Computation of Diluted Weighted Average Shares Outstanding (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding	14,005,618	12,194,058	14,005,618	12,194,058
Options to purchase common stock
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding	11,726,937	10,518,263	11,726,937	10,518,263
RSUs
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding	932,879	179,051	932,879	179,051
Warrants
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding	798,352	946,179	798,352	946,179
Series A Preferred Stock
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding	0	3,115	0	3,115
Series B Preferred Stock
Earnings Per Share
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding	547,450	547,450	547,450	547,450

Subsequent Events (Details) - USD ($) $ in Thousands, shares in Millions	1 Months Ended	9 Months Ended
	Nov. 08, 2022	Sep. 30, 2022	Sep. 30, 2021
Subsequent Events
Commissions and equity issuance costs		$ 298	$ 8,525
Subsequent Event \| Sales Agreement \| Common Stock
Subsequent Events
Number of shares issued and sold (in shares)	2.1
Aggregate gross sales price (up to)	$ 160,000
Proceeds from sale of stock	3,600
Commissions and equity issuance costs	$ 300