Cover
Cover - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 21, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36751 | ||
Entity Registrant Name | OCUGEN, INC. | ||
Entity Central Index Key | 0001372299 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3522315 | ||
Entity Address, Address Line One | 263 Great Valley Parkway | ||
Entity Address, City or Town | Malvern, | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19355 | ||
City Area Code | 484 | ||
Local Phone Number | 328-4701 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | OCGN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1.6 | ||
Entity Common Stock, Shares Outstanding | 199,488,183 | ||
Documents Incorporated by Reference | Part III of this Annual Report on Form 10-K incorporates certain information by reference from the registrant’s proxy statement for the 2022 annual meeting of stockholders to be filed no later than 120 days after the end of the registrant’s fiscal year ended December 31, 2021. |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Philadelphia, Pennsylvania |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 94,958 | $ 24,039 |
Advance for COVAXIN supply | 4,988 | 0 |
Prepaid expenses and other current assets | 2,700 | 1,839 |
Total current assets | 102,646 | 25,878 |
Property and equipment, net | 1,164 | 633 |
Restricted cash | 151 | 151 |
Other assets | 1,800 | 714 |
Total assets | 105,761 | 27,376 |
Current liabilities | ||
Accounts payable | 2,312 | 395 |
Accrued expenses and other current liabilities | 4,325 | 2,941 |
Short-term debt, net | 0 | 234 |
Operating lease obligations | 363 | 44 |
Total current liabilities | 7,000 | 3,614 |
Non-current liabilities | ||
Operating lease obligations, less current portion | 1,231 | 389 |
Long term debt, net | 1,712 | 1,823 |
Total non-current liabilities | 2,943 | 2,212 |
Total liabilities | 9,943 | 5,826 |
Commitments and contingencies (Note 14) | ||
Stockholders’ equity | ||
Common stock; $0.01 par value; 295,000,000 and 200,000,000 authorized; 199,502,183 and 184,133,384 shares issued, and 199,380,683 and 184,011,884 shares outstanding at December 31, 2021 and 2020, respectively | 1,995 | 1,841 |
Treasury Stock, at cost, 121,500 shares at December 31, 2021 and 2020 | (48) | (48) |
Additional paid-in capital | 225,537 | 93,059 |
Accumulated deficit | (131,667) | (73,302) |
Total stockholders’ equity | 95,818 | 21,550 |
Total liabilities and stockholders’ equity | 105,761 | 27,376 |
Series A Convertible Preferred Stock | ||
Stockholders’ equity | ||
Preferred stock issued | 0 | 0 |
Series B Convertible Preferred Stock | ||
Stockholders’ equity | ||
Preferred stock issued | $ 1 | $ 0 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
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 | 200,000,000 |
Common stock, shares issued (in shares) | 199,502,183 | 184,133,384 |
Common stock, shares outstanding (in shares) | 199,380,683 | 184,011,884 |
Treasury stock, common, shares (in shares) | 121,500 | 121,500 |
Series A Convertible Preferred Stock | ||
Convertible preferred stock, shares outstanding (in shares) | 7 | 7 |
Convertible preferred stock, shares issued (in shares) | 7 | 7 |
Series B Convertible Preferred Stock | ||
Convertible preferred stock, shares outstanding (in shares) | 54,745 | 0 |
Convertible preferred stock, shares issued (in shares) | 54,745 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues | |||
Collaboration revenue | $ 0 | $ 43 | $ 0 |
Total revenues | 0 | 43 | 0 |
Operating expenses | |||
Research and development | 35,108 | 6,354 | 8,086 |
In-process research and development | 0 | 7,000 | 0 |
General and administrative | 22,920 | 7,974 | 6,077 |
Total operating expenses | 58,028 | 21,328 | 14,163 |
Loss from operations | (58,028) | (21,285) | (14,163) |
Other income (expense) | |||
Change in fair value of derivative liabilities | 0 | 0 | (3,187) |
Loss on debt conversion | 0 | 0 | (341) |
Interest expense | (79) | (721) | (1,768) |
Other income (expense) | (310) | 184 | (784) |
Total other income (expense) | (389) | (537) | (6,080) |
Loss before income taxes | (58,417) | (21,822) | (20,243) |
Income tax benefit | (52) | 0 | 0 |
Net loss | (58,365) | (21,822) | (20,243) |
Net comprehensive income | (58,365) | (21,822) | (20,243) |
Deemed dividend related to Warrant Exchange | 0 | (12,546) | 0 |
Net loss to common stockholders | $ (58,365) | $ (34,368) | $ (20,243) |
Shares used in calculation net loss per common share - basic (in shares) | 195,013,043 | 112,236,110 | 13,893,819 |
Shares used in calculation net loss per common share - diluted (in shares) | 195,013,043 | 112,236,110 | 13,893,819 |
Net loss per common share - basic (in USD per share) | $ (0.30) | $ (0.31) | $ (1.46) |
Net loss per common share - diluted (in USD per share) | $ (0.30) | $ (0.31) | $ (1.46) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Subscription Agreements | Pre-Merger Financing | Reverse Asset Acquisition | Warrant Exercises | At-the-Market Issuance | Registered Direct Offering | Series B Convertible Preferred Stock | Preferred StockSeries A Convertible Preferred Stock | Preferred StockSeries A Convertible Preferred StockReverse Asset Acquisition | Preferred StockSeries B Convertible Preferred Stock | Common Stock | Common StockSubscription Agreements | Common StockPre-Merger Financing | Common StockReverse Asset Acquisition | Common StockWarrant Exercises | Common StockAt-the-Market Issuance | Common StockRegistered Direct Offering | Treasury Stock | Additional Paid in Capital | Additional Paid in CapitalSubscription Agreements | Additional Paid in CapitalPre-Merger Financing | Additional Paid in CapitalReverse Asset Acquisition | Additional Paid in CapitalWarrant Exercises | Additional Paid in CapitalAt-the-Market Issuance | Additional Paid in CapitalRegistered Direct Offering | Additional Paid in CapitalSeries B Convertible Preferred Stock | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 0 | 0 | 4,960,552 | |||||||||||||||||||||||||
Beginning balance at Dec. 31, 2018 | $ (12,709) | $ 0 | $ 0 | $ 50 | $ 0 | $ 18,478 | $ (31,237) | |||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||||||||||||||||||||
Stock-based compensation expense | $ 884 | 884 | ||||||||||||||||||||||||||
Issuance of stock (in shares) | 7 | 80,569 | 4,385,964 | 1,651,748 | 40,542,222 | |||||||||||||||||||||||
Issuance of stock | $ 1,000 | $ 13,150 | $ 3,566 | $ 183 | $ 1 | $ 44 | $ 17 | $ 405 | $ 999 | $ 13,106 | $ 3,549 | $ (222) | ||||||||||||||||
Conversion of debt (in shares) | 1,100,000 | 1,125,673 | ||||||||||||||||||||||||||
Conversion of debt | $ 13,980 | $ 11 | 13,969 | |||||||||||||||||||||||||
Reclassification of Series B Warrants from liability to equity | 11,256 | 11,256 | ||||||||||||||||||||||||||
Repurchase of treasury stock | (48) | (48) | ||||||||||||||||||||||||||
Net loss | (20,243) | (20,243) | ||||||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2019 | 7 | 0 | 52,746,728 | |||||||||||||||||||||||||
Ending balance at Dec. 31, 2019 | 11,019 | $ 0 | $ 0 | $ 528 | (48) | 62,019 | (51,480) | |||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||||||||||||||||||||
Stock-based compensation expense | 660 | 660 | ||||||||||||||||||||||||||
Issuance of stock (in shares) | 1,328,405 | 108,137,431 | ||||||||||||||||||||||||||
Issuance of stock | $ 332 | $ 36,339 | $ 13 | $ 1,081 | $ 319 | $ 35,258 | ||||||||||||||||||||||
Warrant exchange (in shares) | 21,920,820 | |||||||||||||||||||||||||||
Warrant Exchange | (4,978) | $ 219 | (5,197) | |||||||||||||||||||||||||
Net loss | (21,822) | (21,822) | ||||||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 7 | 0 | 184,133,384 | |||||||||||||||||||||||||
Ending balance at Dec. 31, 2020 | 21,550 | $ 0 | $ 0 | $ 1,841 | (48) | 93,059 | (73,302) | |||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||||||||||||||||||||
Stock-based compensation expense | 6,958 | 6,958 | ||||||||||||||||||||||||||
Issuance of stock (in shares) | 54,745 | 987,000 | 13,000,000 | |||||||||||||||||||||||||
Issuance of stock | $ 4,849 | $ 114,610 | $ 4,954 | $ 1 | $ 10 | $ 130 | $ 4,839 | $ 114,480 | $ 4,953 | |||||||||||||||||||
Issuance of common stock for option and warrant exercises (in shares) | 1,381,799 | |||||||||||||||||||||||||||
Issuance of common stock for option and warrant exercises | 1,262 | $ 14 | 1,248 | |||||||||||||||||||||||||
Net loss | (58,365) | (58,365) | ||||||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2021 | 7 | 54,745 | 199,502,183 | |||||||||||||||||||||||||
Ending balance at Dec. 31, 2021 | $ 95,818 | $ 0 | $ 1 | $ 1,995 | $ (48) | $ 225,537 | $ (131,667) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities | |||
Net loss | $ (58,365) | $ (21,822) | $ (20,243) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization expense | 229 | 102 | 61 |
Non-cash interest expense | 78 | 721 | 1,734 |
Non-cash lease expense | 360 | 189 | 250 |
In-process research and development | 0 | 7,000 | 0 |
Change in fair value of derivative liability | 0 | 0 | 3,187 |
Stock-based compensation expense | 6,958 | 660 | 884 |
Loss on debt conversion | 0 | 0 | 341 |
Income tax benefit | (52) | 0 | 0 |
Gain on forgiveness of PPP Note | (426) | 0 | 0 |
Impairment on note receivable | 761 | 0 | 0 |
Other non-cash | 26 | (349) | 5 |
Changes in assets and liabilities: | |||
Prepaid expenses and other current assets | (742) | (370) | (1,007) |
Accounts payable and accrued expenses | 3,498 | (541) | (1,629) |
Other assets | 100 | (104) | (227) |
Lease obligations | (366) | (195) | (249) |
Net cash used in operating activities | (47,941) | (14,709) | (16,893) |
Cash flows from investing activities | |||
Purchase of property and equipment | (939) | (307) | (30) |
Payments for asset acquisitions | (127) | 0 | (2,327) |
Issuance of note receivable | (750) | 0 | 0 |
Net cash used in investing activities | (1,816) | (307) | (2,357) |
Cash flows from financing activities | |||
Proceeds from issuance of common stock | 129,211 | 37,822 | 1,183 |
Payment of equity issuance costs | (8,525) | (1,477) | 0 |
Purchases of treasury stock | 0 | 0 | (48) |
Proceeds from Pre-Merger Financing | 0 | 0 | 22,546 |
Proceeds from issuance of debt | 0 | 921 | 6,800 |
Payments of debt issuance costs | 0 | (6) | (99) |
Repayments of debt | 0 | (5,625) | (5,290) |
Financing lease principal payments | (10) | (24) | (26) |
Net cash provided by financing activities | 120,676 | 31,611 | 25,066 |
Net increase in cash, cash equivalents, and restricted cash | 70,919 | 16,595 | 5,816 |
Cash, cash equivalents, and restricted cash at beginning of period | 24,190 | 7,595 | 1,779 |
Cash, cash equivalents, and restricted cash at end of period | 95,109 | 24,190 | 7,595 |
Supplemental disclosure of non-cash investing and financing transactions: | |||
Exercise of warrants | 603 | 0 | 0 |
Series B Convertible Preferred Stock issuance | 4,988 | 0 | 0 |
Forgiveness of PPP Note | 426 | 0 | 0 |
Purchase of property and equipment | 16 | 214 | 0 |
Right-of-use assets related to operating leases | 1,226 | 180 | 470 |
Issuance of Warrant Exchange Promissory Notes | 0 | 5,625 | 0 |
Obligation settled with common stock | 0 | 331 | 0 |
Conversion of convertible notes | 0 | 0 | 13,980 |
Reverse asset acquisition costs | 0 | 4 | 1,150 |
Reverse asset acquisition costs | $ 0 | $ 0 | $ 2,253 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2021 | |
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 clinical-stage biopharmaceutical company focused on developing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. The Company is headquartered in Malvern, Pennsylvania, and manages its business as one operating segment. 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 COVAXIN for the prevention of COVID-19 caused by SARS-CoV-2 in the United States, its territories, and possessions. In June 2021, the Company entered into an amendment 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 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. COVAXIN requires a two-dose vaccination regimen given 28 days apart and is stored in standard vaccine storage conditions (2-8°C). COVAXIN was granted an Emergency Use Listing by the World Health Organization in November 2021. Over 295 million doses globally have been administered to date. The Company is pursuing Biologics License Application ("BLA") approval for COVAXIN in the United States based upon the recommendation of the U.S. Food and Drug Administration ("FDA"). In October 2021, the Company submitted an Investigational New Drug ("IND") application to the FDA to initiate a Phase 2/3 immuno-bridging and broadening clinical trial evaluating COVAXIN for adults ages 18 years and older. The clinical trial is designed to evaluate whether the immune response experienced in participants in a completed Phase 3 clinical trial in India is similar to a demographically representative, adult population in the United States. In November 2021, the Company was notified that the FDA issued a clinical hold on its IND application. In December 2021, the FDA sent the Company a letter setting forth the reasons for the clinical hold and specific guidance on steps that must be taken to have the clinical hold lifted. The Company provided the FDA responses to their comments and the FDA lifted its clinical hold in February 2022. The Company plans to initiate the Phase 2/3 immuno-bridging and broadening clinical trial for COVAXIN as soon as the Company is able to. The Company also plans to initiate a safety-bridging clinical trial in the first half of 2022, subject to discussions with the FDA. Subject to the foregoing, the Company anticipates submitting a BLA with the FDA near the end of 2022. In November 2021, the Company also submitted a request to the FDA for Emergency Use Authorization ("EUA") for COVAXIN for pediatric use in ages two to 18 years in the United States. The EUA submission was based on the results of a Phase 2/3 immuno-bridging pediatric clinical trial conducted by Bharat Biotech in India. The Company's EUA submission is currently under review by the FDA. In February 2022, Delta and Omicron neutralization results along with a safety database of more than 36 million teenagers who had been vaccinated with COVAXIN were submitted to the FDA to support the Company's EUA submission. The Company is also pursuing approval for COVAXIN in Canada. In July 2021, the Company completed its rolling submission to Health Canada for COVAXIN. The rolling submission process, which permits companies to submit safety and efficacy data and information as they become available, was recommended and accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a New Drug Submission ("NDS") for COVID-19. The submission was conducted through the Company's Canadian subsidiary, Vaccigen Ltd. The Company is in discussions with Health Canada regarding its NDS submission for COVAXIN. In December 2021, the Company was provided with a Notice of Deficiency ("NOD") from Health Canada regarding its NDS submission. Health Canada requested further analyses of the COVAXIN preclinical and clinical data, as well as additional information regarding chemistry, manufacturing, and controls ("CMC"). The Company has responded to and provided proposed resolutions for the deficiencies included in the NOD. The Company's responses are currently under review by Health Canada. The Company is evaluating its commercialization strategy for COVAXIN in the United States and Canada, if authorized or approved in either jurisdiction. In June 2021, the Company selected Jubilant HollisterStier as its manufacturing partner for COVAXIN to prepare for the potential commercial manufacturing for the Ocugen Covaxin Territory. The Company expects to enter into a master services agreement with Jubilant HollisterStier for the commercial manufacture of COVAXIN. The technology transfer process from Bharat Biotech to Jubilant HollisterStier for drug product manufacturing has been initiated. In September 2021, the Company entered into a Development and Commercial Supply Agreement (the “Supply Agreement”) with Bharat Biotech, pursuant to which Bharat Biotech will supply the Company with clinical trial materials and commercial supplies of COVAXIN finished drug product prior to the completion of a technology transfer. Following the completion of a technology transfer, Bharat Biotech will supply COVAXIN drug product components and continue to supply finished drug product as necessary for the commercial manufacture and supply of COVAXIN subsequent to a regulatory authorization or approval. Modifier Gene Therapy Platform The Company is developing a modifier gene therapy platform designed to fulfill unmet medical needs in the area of retinal diseases, including inherited retinal diseases ("IRDs"), such as retinitis pigmentosa ("RP") and Leber congenital amaurosis ("LCA"), and dry age-related macular degeneration ("AMD"). 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 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, such as dry AMD, 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 IRDs, including RP and LCA. OCU400 has received four Orphan Drug Designations 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. In November 2021, the Company submitted an IND application to the FDA for OCU400 for the treatment of the NR2E3 and RHO disease genotypes. The Company's IND application was accepted by the FDA in December 2021. The Company has initiated a Phase 1/2 clinical trial in the United States for the treatment of these disease genotypes and the first patient is expected to be dosed in the first half of 2022. This Phase 1/2 clinical trial is a multicenter, open-label, dose ranging study to assess the safety of unilateral subretinal administration of OCU400 in subjects with NR2E3- related RP. OCU400 has additionally received Orphan Medicinal Product Designation from the European Commission, based on the recommendation of the European Medicines Agency, for RP and LCA. The Company believes OCU400 has the potential for broad spectrum applications to treat many IRDs. The Company is currently evaluating options to initiate OCU400 clinical trials in Europe. The Company's second gene therapy candidate, OCU410, is being developed to utilize the nuclear receptor genes RAR-related orphan receptor A ( "RORA" ) for the treatment of dry AMD. The Company is currently executing pre-IND studies consistent with FDA discussions to support a Phase 1/2 clinical trial. The Company has engaged CanSino Biologics, Inc. ("CanSinoBIO") to manufacture clinical supplies and be responsible for the CMC development for OCU400 and OCU410. See Note 3 for additional information about the Company's collaboration with CanSinoBIO. Novel Biologic Therapy for Retinal Diseases The Company's pipeline also includes a biologic product candidate, OCU200, a novel fusion protein designed to treat severely sight-threatening diseases such as diabetic macular edema, diabetic retinopathy, and wet AMD. The Company is currently establishing a current Good Manufacturing Practice process for the production of clinical trial materials and executing pre-IND studies consistent with FDA discussions to support a Phase 1/2a clinical trial. The Company has completed the technology transfer of manufacturing processes to its contract development and manufacturing organization that will manufacture OCU200 clinical supplies. Going Concern The Company has incurred recurring net losses since inception and has funded its operations to date through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes, debt, and grant proceeds. The Company incurred net losses of approximately $58.4 million, $21.8 million, and $20.2 million for the years ended December 31, 2021, 2020, and 2019, respectively. As of December 31, 2021, the Company had an accumulated deficit of $131.7 million and cash, cash equivalents, and restricted cash totaling $95.1 million. The Company is subject to risks, expenses, and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research, development, and commercialization efforts for its product candidates, which will require significant additional funding. If the Company is unable to obtain additional financing in the future or its research, development, and commercialization efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company plans to increase working capital through public and private placements of equity and/or debt, payments from potential strategic research and development arrangements, sales of assets, government grants, licensing and/or collaboration arrangements with pharmaceutical companies or other institutions, or other funding from the government or other third parties. Such financing may not be available at all, or on terms that are favorable to the Company. While management of the Company believes that it has a plan to fund ongoing operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital, or appropriately manage certain discretionary spending could have a material adverse effect on the Company’s ability to achieve its intended business objectives. As a result of these factors, together with the anticipated increase in spending that will be necessary to continue to research, develop, and commercialize the Company’s product candidates and the uncertainty of futures revenues associated with COVAXIN, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. The consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Consolidation The accompanying consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP") and under the rules and regulations of the U.S. Securities and Exchange Commission ("SEC"). The consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform with current year presentation. Use of Estimates In preparing the consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, debt and equity instruments (including derivative liabilities), asset held for sale, and the collectibility of the note receivable. Segment Information As of December 31, 2021, the Company viewed its operations and managed its business as one operating segment consistent with how the Company's chief operating decision-maker, the Company's Chief Executive Officer, makes decisions regarding resource allocation and assessing performance. As of December 31, 2021, substantially all of the Company's assets were located in the United States. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents may include bank demand deposits, 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’s restricted cash balance consists of cash held to collateralize a corporate credit card account. The following table provides a reconciliation of cash, cash equivalents, and restricted cash in the consolidated balance sheets to the total amount shown in the consolidated statements of cash flows (in thousands): As of December 31, 2021 2020 Cash and cash equivalents $ 94,958 $ 24,039 Restricted cash 151 151 Total cash, cash equivalents, and restricted cash $ 95,109 $ 24,190 Collaboration Arrangements The Company assesses whether collaboration agreements are subject to Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 808, Collaborative Arrangements ("ASC 808"), based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the Company and the collaboration partner are subject to other accounting literature. If payments from the collaboration partner represent consideration from a customer, the Company accounts for those payments within the scope of FASB ASC Topic 606, Revenue from Contracts with Customers . However, if the Company concludes that its collaboration partner is not a customer, the Company will record royalty payments received as collaboration revenue in the period in which the underlying sale occurs and record expenses and expense reimbursements as either research and development expense or general and administrative expense, or a reduction thereof, based on the underlying nature of the expense or expense reimbursement. During the year ended December 31, 2020, the Company recorded collaboration revenue from an agreement accounted for as a collaborative arrangement within the scope of ASC 808. No collaboration revenue was recorded during the years ended December 31, 2021 and 2019. Asset Held for Sale During 2019, the Company had an intangible asset held for sale that was carried at its original fair value less cost to sell of $7.0 million. The Company concluded during the year ended December 31, 2020 that a sale of the intangible asset was no longer probable to be completed within one year from the date the intangible asset was initially recorded as held for sale. As such, the carrying value of the intangible asset was reduced to zero with the corresponding charge of $7.0 million recognized as in-process research and development expense in the consolidated statements of operations and comprehensive loss during the year ended December 31, 2020 as the in-process research and development did not have an alternative future use. Property and Equipment, Net The Company's property and equipment currently includes furniture and fixtures, machinery and equipment, leasehold improvements, and construction in progress. Property and equipment is recorded at historical cost. Significant additions or improvements are capitalized, and expenditures for repairs and maintenance are charged to expense as incurred. Gains and losses on disposal of assets are included in the consolidated statements of operations and comprehensive loss. Depreciation is calculated using the straight-line method and is recognized over the expected useful life of the underlying asset. Construction in progress is not depreciated until such time that the asset is completed and placed into service. Once placed into service, the asset is depreciated over its expected useful life. Expected useful lives by major asset category are as follows: Furniture and fixtures 3 to 7 years Machinery and equipment 5 to 7 years Leasehold improvements Lower of the expected useful life or remaining lease term Leases The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company's current and historical 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 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. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rate was not readily determinable in the Company’s current and historical operating leases. As such, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments. The lease term for the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset if reasonably certain. Variable payments not dependent on an index or rate associated with the Company’s leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company’s consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed lease payments. Exit and Disposal Activities The Company records liabilities for one-time termination benefits in accordance with FASB ASC Topic 420, Exit and Disposal Cost Obligations ("ASC 420"). In accordance with ASC 420, an arrangement for one-time termination benefits exists at the date the plan of the termination meets the following criteria: (i) management commits to a plan of termination; (ii) the plan identifies the impacted employees and expected completion date; (iii) the plan identifies the terms of the benefits arrangement; (iv) it is unlikely significant changes to the plan will be made or the plan will be withdrawn; and (v) the plan has been communicated to employees. Costs for one-time termination benefits in which the employee is required to render service until termination in order to receive the benefits, are recognized ratably over the future service period. The Company records liabilities for employee termination benefits covered by ongoing benefit arrangements in accordance with FASB ASC Topic 712, Compensation—Nonretirement Postemployment Benefits ("ASC 712"). In accordance with ASC 712, costs for termination benefits under ongoing benefits arrangements are recognized when management has committed to a plan of termination and the costs are probable and estimable. Severance-related charges, once incurred, are recognized as either research and development expense or general and administrative expense within the consolidated statements of operations and comprehensive loss depending on the job function of the former employee. 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 approximate their fair values due to the short-term nature of these instruments. As of December 31, 2021, the Company has concluded that the fair value of the borrowings under the EB-5 Loan Agreement (as defined in Note 8), using Level 2 inputs, approximate their carrying value. See Note 8 for additional information. Financial Instruments and Derivatives The Company does not have derivative hedging instruments used to mitigate risk. The Company evaluates all financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with FASB ASC Topic 815, Derivatives and Hedging ("ASC 815"). Additionally, the Company assesses warrants to purchase common stock to determine liability versus stockholders' equity classification in accordance with ASC 815 and FASB ASC Topic 480, Distinguishing Liabilities from Equity . For derivative instruments that are accounted for as liabilities, including liability-designated warrants, the derivative instrument is initially recorded at its fair value as a derivative liability and is then revalued at each reporting date, with changes in the fair value reported as other income (expense) in the consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instrument should be recorded as a liability or as stockholders' equity, is evaluated at the end of each reporting period. In 2018 and 2019, the Company issued convertible notes in the aggregate principal amount of $8.8 million (the "Convertible Notes"). During the year ended December 31, 2019, the Company issued 1.1 million shares of common stock at $8.69 per share to extinguish the Convertible Notes, resulting in a loss of $0.3 million and an increase of $13.0 million in additional paid-in capital. The Convertible Notes contained embedded conversion and change-in-control features, which were recorded at fair value as derivative liabilities and revalued at each reporting date. The Company additionally had Series B Warrants (as defined in Note 10) that were classified as derivative liabilities at issuance and revalued each reporting period until they met the derivative scope exception allowing for stockholders' equity classification. The change in fair value of derivative liabilities related to the Convertible Notes and the Series B Warrants was $3.2 million during the year ended December 31, 2019. There were no derivative instruments revalued on a recurring basis during the years ended December 31, 2021 and 2020. Stock-Based Compensation The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation ("ASC 718"). The Company has issued stock-based compensation awards including stock options and restricted stock units ("RSUs"), and also accounts for certain issuances of preferred stock and warrants in accordance with ASC 718. ASC 718 requires all stock-based payments, including grants of stock options and RSUs, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of options granted. For RSUs, the fair value of the RSUs 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. Compensation 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 Estimating the fair value of stock options requires the input of subjective assumptions, including the expected term of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. The assumptions used in the Company’s Black-Scholes option-pricing model represent management’s best estimates and involve a number of variables, uncertainties, assumptions, and the application of management’s judgment, as they are inherently subjective. If any assumptions change, the Company’s stock-based compensation expense could be materially different in the future. The assumptions used in Ocugen’s Black-Scholes option-pricing model for stock options are as follows: Expected Term. Due to the historical lack of a public market for the trading of Ocugen common stock and the lack of sufficient company-specific historical data, the expected term of employee stock options subject to service-based vesting conditions is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option. Expected Volatility. The expected volatility is based on historical volatilities of Ocugen and similar entities within Ocugen’s industry for periods commensurate with the expected term assumption. Risk-Free Interest Rate. The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. Expected Dividends. The expected dividend yield is 0% because Ocugen has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or the Company’s tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established. The Company accounts for uncertain tax positions recognized in the consolidated financial statements by prescribing a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Recently Adopted Accounting Standards In December 2019, the FASB issued Accounting Standards Update ("ASU") No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocations, and calculating income taxes in interim periods. This standard also adds guidance to reduce complexity in certain areas, including recognizing franchise tax, recognizing deferred taxes for tax basis of goodwill, allocating taxes to the members of a consolidated group, and recognizing the effect of enacted changes in tax laws or rates during an interim period. This standard was effective for the Company on January 1, 2021. The adoption of this standard did not have a material impact on the Company's consolidated financial statements. Recent Accounting Pronouncements In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance . This standard has an effective and transition date of January 1, 2022. 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 item 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 Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) . This standard will have an effective and transition date of January 1, 2022. 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 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 Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40) . This standard will have an effective and transition date of January 1, 2024. Early adoption is currently permitted. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models that require separate accounting for embedded conversion features as well as simplifies the settlement assessment that entities are required to perform to determine whether a contract qualifies for equity classification. This standard also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of potential share settlement (if the effect is more dilutive) for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. The standard requires new disclosures about events that occur during the reporting period and cause conversion contingencies to be met and about the fair value of a public business entity's convertible debt at the instrument level, among other things. The Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The FASB subsequently issued amendments to ASU No. 2016-13, which have the same effective date and transition date of January 1, 2023. ASU No. 2016-13, as amended, requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. |
License and Development Agreeme
License and Development Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
License and Development Agreements | License and Development Agreements 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. In consideration of the expansion of the Ocugen Covaxin Territory to include Canada, the Company paid Bharat Biotech a non-refundable, upfront payment of $15.0 million in June 2021, which was recognized as research and development expense in the consolidated statements of operations and comprehensive loss during the year ended December 31, 2021. The Company additionally agreed to pay Bharat Biotech $10.0 million within 30 days after the first commercial sale of COVAXIN in Canada. The Covaxin Agreement 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 Operating 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 commercial sale in the Ocugen Covaxin Territory, if authorized or approved. In September 2021, the Company entered into the Supply Agreement with Bharat Biotech, pursuant to which Bharat Biotech will supply the Company with clinical trial materials and commercial supplies of COVAXIN finished drug product prior to the completion of a technology transfer. Following the completion of a technology transfer, Bharat Biotech will supply COVAXIN drug product components and continue to supply finished drug product as necessary for commercial manufacture and supply of COVAXIN subsequent to a regulatory authorization or approval. The technology transfer process from Bharat Biotech to Jubilant HollisterStier for drug product manufacturing has been initiated. In March 2021, the Company issued shares of Series B Convertible Preferred Stock (as defined in Note 9) as an advance payment for the supply of COVAXIN to be provided by Bharat Biotech under the Supply Agreement. See Note 9 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 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. License Agreement with The Schepens Eye Research Institute, Inc. In December 2017, the Company entered into an exclusive license agreement with The Schepens Eye Research Institute ("SERI"), which was amended in January 2021 (as so amended, the "SERI Agreement"). The SERI Agreement gives the Company an exclusive, worldwide, sublicensable license to patent rights, biological materials, and technical information for NHR genes Nuclear Receptor Subfamily 1 Group D Member 1 (" NR1D1") , NR2E3 (OCU400), RORA (OCU410), Nuclear Protein 1, Transcriptional Regulator ( "NUPR1" ), and Nuclear Receptor Subfamily 2 Group C Member 1 ( "NR2C1" ). The January 2021 amendment to the SERI Agreement additionally granted the Company rights in co-owned intellectual property pursuant to certain patent applications and provisional patent applications at the time of the amendment. Under the SERI Agreement, the Company may make, have made, use, offer to sell, sell, and import licensed products, and must use commercially reasonable efforts to bring one or more licensed products to market as soon as reasonably practicable. SERI maintains control of patent preparation, filing, prosecution, and maintenance. The Company is responsible for SERI’s out-of-pocket expenses related to the filing, prosecution, and maintenance of the licensed patent rights. In the event that SERI decides to discontinue the prosecution or maintenance of the licensed patent rights, the Company has the right, but not the obligation, to file for, or continue to prosecute, maintain, or enforce such licensed patent rights. The Company has assumed prosecution of certain licensed patent rights under the SERI Agreement. The SERI Agreement is a collaborative arrangement within the scope of ASC 808. The SERI Agreement requires the Company to pay licensing fees for patent rights granted, an annual license maintenance fee, payment of certain regulatory and commercial milestones in the aggregate amount of $16.1 million, and low single-digit percentage royalties on annual net sales of products that fall under the licensed patent rights. The Company has made no milestone or royalty payments to date pursuant to the SERI Agreement. The SERI Agreement will expire on the expiration date of the last to expire licensed patent rights, subject to the earlier termination of the SERI Agreement in accordance with its terms. The Company may terminate the license upon 180 days’ prior written notice. SERI may immediately terminate the SERI Agreement if the Company ceases to carry on its business with respect to the licensed patent rights, fails to make payments within thirty days of receiving a written notice of missed payment, fails to comply with its diligence obligations, defaults on its obligation to procure and maintain insurance, one of its officers is convicted of a felony related to the licensed products, the Company breaches any material obligation of the agreement and does not cure such breach within 90 days, or if the Company becomes bankrupt or insolvent. Co-Development and Commercialization Agreement with CanSinoBIO The Company entered into a co-development and commercialization agreement with CanSinoBIO with respect to the development and commercialization of the Company's modifier gene therapy product candidates, OCU400 and OCU410. The co-development and commercialization agreement was originally entered into in September 2019 with regards to OCU400, and was subsequently amended in September 2021 (as so amended, the "CanSinoBIO Agreement"), to include OCU410 to the Company's existing collaboration with CanSinoBIO. Pursuant to the CanSinoBIO Agreement, the Company and CanSinoBIO will collaborate on the development of OCU400 and OCU410. CanSinoBIO will be responsible for the CMC development and manufacture of clinical supplies of such products and be responsible for the costs associated with such activities. CanSinoBIO has an exclusive license to develop, manufacture, and commercialize OCU400 and OCU410 in and for China, Hong Kong, Macau, and Taiwan (the "CanSinoBIO Territory"), and the Company maintains exclusive development, manufacturing, and commercialization rights with respect to OCU400 and OCU410 outside the CanSinoBIO Territory (the "Company Territory"). CanSinoBIO will pay to the Company an annual royalty between mid- and high-single digits based on Net Sales (as defined in the CanSinoBIO Agreement) of OCU400 and OCU410 in the CanSinoBIO Territory. The Company will pay to CanSinoBIO an annual royalty between low- and mid-single digits based on Net Sales of OCU400 and OCU410 in the Company Territory. Unless earlier terminated in accordance with its terms, the CanSinoBIO Agreement will continue in force on a country-by-country and product-by-product basis until the later of (a) the expiration of the last valid claim of the Company's patent rights covering OCU400 and OCU410 and (b) the tenth (10th) anniversary of the first commercial sale of OCU410 in such country. The CanSinoBIO Agreement will also terminate contemporaneously upon the termination of the SERI Agreement, provided that CanSinoBIO is not in breach or default of the CanSinoBIO Agreement. The CanSinoBIO Agreement may be terminated by either party in its entirety upon (a) a material or persistent breach of the CanSinoBIO Agreement by the other party, (b) a challenge by the other party or any of its affiliates of any intellectual property controlled by the terminating party, or (c) bankruptcy or insolvency of the other party. License Agreement with the University of Colorado In March 2014, the Company entered into an exclusive license agreement with University of Colorado ("CU"), which was amended in January 2017 and clarified by a letter of understanding in November 2017 (as so amended and clarified, the "CU Agreement"). The CU Agreement gives the Company an exclusive, worldwide, sublicensable license to patents for OCU200 to make, have made, use, import, offer to sell, sell, have sold, and practice the licensed products in all therapeutic applications. Under the CU Agreement, the Company must use commercially reasonable efforts to develop, manufacture, sublicense, market, and sell the licensed products, and has assumed primary responsibility for preparing, filing, and prosecuting broad patent claims for OCU200 for CU's benefit. Further, the Company assumed primary responsibility for all patent activities, including all costs associated with the perfection and maintenance of the patents for OCU200. The CU Agreement requires the payment of certain regulatory milestones aggregating to $1.5 million, an annual minimum payment that began the third year after the effective date, low single-digit percentage earned royalties on net sales, and royalties in the mid-teens on sublicense income of OCU200. The Company has made no milestone or royalty payments to date pursuant to the CU Agreement. The CU Agreement will expire on the later of the expiration date of the last to expire licensed patent or the end of any relevant statutory or regulatory exclusivity period. The Company may terminate the CU Agreement upon 60 days’ prior written notice. CU may terminate the CU Agreement upon 60 days’ notice if the Company fails to make payments within 60 days of such payment’s due date, breach and do not cure any diligence obligation, provide any materially false report, or otherwise materially breach and do not cure any material provision of the CU Agreement. |
Notes Receivable
Notes Receivable | 12 Months Ended |
Dec. 31, 2021 | |
Receivables [Abstract] | |
Notes Receivable | Notes Receivable On April 13, 2021, the Company received a promissory note in the principal amount of $0.8 million from a company in connection with a potential collaboration. The promissory note bore interest at a rate per annum of 5% and the outstanding principal balance of the promissory note plus any accrued and unpaid interest thereon was payable in full on April 13, 2022 (the "Maturity Date"). Effective July 2021, the Company accepted an amended and restated promissory note (as so amended and restated, the "Promissory Note") pursuant to which the parties agreed to extend the Maturity Date of the Promissory Note to June 30, 2022 and increase the interest rate per annum to 9% with quarterly interest payments. The Promissory Note may be prepaid in whole or in part at any time, together with accrued and unpaid interest. The Promissory Note contains customary covenants and events of default, including, among others, failure to make payment, breach of agreement, and bankruptcy. The Company evaluated the probability of collecting the full principal and accrued interest balance under the terms of the Promissory Note and determined that collection was not probable. During the year ended December 31, 2021, the Company wrote off the full principal and accrued interest balance of the Promissory Note and recorded the write-off as a loss within other income (expense) within the consolidated statements of operations and comprehensive loss. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment The following table provides a summary of the major components of property and equipment as reflected on the consolidated balance sheets (in thousands): As of December 31, 2021 2020 Furniture and fixtures $ 284 $ 166 Machinery and equipment 855 452 Leasehold improvements 167 177 Construction in progress 232 — Financing lease right-of-use asset — 64 Total property and equipment 1,538 859 Less: accumulated depreciation (374) (226) Total property and equipment, net $ 1,164 $ 633 The Company recognized depreciation expense of $0.2 million, $0.1 million, and $0.1 million during the years ended December 31, 2021, 2020, and 2019, respectively. |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Leases | Operating Leases The Company has commitments under operating leases for its current headquarters as well as for additional office space. The Company's operating lease for its current headquarters includes the use of laboratory, office, and storage space located in Malvern, Pennsylvania (the "Lease Agreement"). The Lease Agreement was determined to have two lease components per ASC 842 with commencement dates in December 2020 and January 2021. The Lease Agreement has an initial term of seven years and the Company has the option to extend the Lease Agreement for one additional five-year term. The option for extension has been excluded from the lease term (and lease liability) for the Lease Agreement as it is not reasonably certain that the Company will exercise such option. The Company had a lease agreement for its former headquarters, which was terminated in January 2021 without penalty pursuant to the terms of the Lease Agreement. The termination was accounted for as a modification per ASC 842 as the contractual lease term of the former lease agreement was shortened. The Company also had a lease agreement for a former laboratory space, which was terminated in December 2020. The components of lease expense were as follows (in thousands): Year ended December 31, 2021 2020 2019 Operating lease cost $ 360 $ 189 $ 250 Variable lease cost 105 85 80 Total lease cost $ 465 $ 274 $ 330 Supplemental balance sheet information related to leases was as follows (in thousands): As of December 31, 2021 2020 Right-of-use assets, net $ 1,587 $ 434 Current lease obligations $ 363 $ 44 Non-current lease obligations 1,231 389 Total lease liabilities $ 1,594 $ 433 Supplemental information related to leases was as follows: Year ended December 31, 2021 2020 2019 Weighted-average remaining lease terms — operating leases (years) 5.3 6.9 2.0 Weighted-average discount rate — operating leases 4.1 % 4.6 % 7.6 % Future minimum operating lease base rent payments are approximately as follows (in thousands): For the years ending December 31, Amount 2022 $ 440 2023 261 2024 269 2025 277 2026 285 Thereafter 293 Total $ 1,825 Less: present value adjustment (231) Present value of minimum lease payments $ 1,594 In October 2021, the Company entered into a lease agreement for additional office space located in Malvern, Pennsylvania. The lease has an expected commencement date in the first half of 2022 and has an initial term of seven years. The aggregate estimated base rent payments due over the initial seven-year term is $3.8 million, which is excluded from the future minimum operating base rent payments above as the lease agreement has not yet commenced per ASC 842. Additionally, the Company will be responsible for the operating expenses and utilities associated with the leased premises. The Company has the option to extend the lease agreement for two additional five-year terms, provided the Company is not under an event of default pursuant to the terms of the lease agreement. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities are as follows (in thousands): As of December 31, 2021 2020 Research and development $ 866 $ 512 Clinical 703 117 Professional fees 747 405 Employee-related 1,716 963 Severance-related (1) — 712 Other 293 232 Total accrued expenses and other current liabilities $ 4,325 $ 2,941 (1) In June 2020, the Company communicated notice to five employees of the termination of their employment as a result of the discontinuation of a product candidate. This reduction represented one-third of the Company’s workforce at the time of communication. All terminations were “without cause” and each employee received termination benefits upon departure. The termination dates varied for each employee and ranged from June 30, 2020 to December 31, 2020. The following table provides a summary of the severance-related charges and severance payments during the years ended December 31, 2021 and 2020 related to the June 2020 reduction in workforce (in thousands): Amount Accrued Severance at December 31, 2019 $ — Severance-related charges 1,116 Severance-related payments 404 Accrued Severance at December 31, 2020 $ 712 Severance-related charges — Severance-related payments 712 Accrued Severance at December 31, 2021 $ — As of December 31, 2021, the Company has satisfied its commitments under the separation agreements with the five former employees. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Debt The following table provides a summary of the carrying values for the components of debt as reflected on the consolidated balance sheets (in thousands): As of December 31, 2021 2020 PPP Note $ — $ 421 EB-5 Loan Agreement 1,712 1,636 Total carrying value of debt, net $ 1,712 $ 2,057 PPP Note In April 2020, the Company was granted a loan from Silicon Valley Bank ("SVB"), in the amount of $0.4 million, pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the “CARES Act”). Under the PPP, the loan was eligible for forgiveness to the extent the funds received were used for qualifying expenses as described by the CARES Act. The loan was in the form of a promissory note dated April 30, 2020 in favor of SVB (the "PPP Note"). The PPP Note had a maturity date of April 30, 2022 and bore interest at a rate of 1.0% per annum. The Company did not provide any collateral or guarantees for the loan, nor did the Company pay any facility charge to obtain the loan. The PPP Note provided for customary events of default, including, among others, failure to make payment, bankruptcy, breaches of representations, and material adverse events. In May 2021, the Company received notice from the Small Business Administration that the PPP Note was forgiven in its entirety, including both principal and accrued interest. The Company recognized a $0.4 million gain on loan extinguishment within other income (expense) for the forgiveness of the PPP Note within the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021. EB-5 Loan Agreement In September 2016, pursuant to the U.S. government’s Immigrant Investor Program, commonly known as the EB-5 program, the Company entered into an arrangement (the “EB-5 Loan Agreement”) to borrow up to $10.0 million from EB5 Life Sciences, L.P. ("EB-5 Life Sciences") in $0.5 million increments. Borrowings may be limited by the amount of funds raised by the 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 license, patent sublicense, trademarks, and other intellectual property rights. Under the terms and conditions of the EB-5 Loan Agreement, the Company borrowed $1.0 million in 2016 and an additional $0.5 million in March 2020. Issuance costs were recognized as a reduction to the loan balance and are amortized to interest expense over the term of the loan. The carrying values of the EB-5 Loan Agreement borrowings as of December 31, 2021 and 2020 are summarized below (in thousands): As of December 31, 2021 2020 Principal outstanding $ 1,500 $ 1,500 Plus: accrued interest 241 181 Less: unamortized debt issuance costs (29) (45) Carrying value $ 1,712 $ 1,636 |
Equity
Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Equity | Equity COVAXIN Preferred Stock Purchase Agreement On March 1, 2021, the Company entered into a preferred stock purchase agreement, 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 for the supply of COVAXIN to be provided by Bharat Biotech pursuant to the Supply Agreement. Subsequent to December 31, 2021, the Company entered into supply commitments related to COVAXIN, which the advanced payment will be applied to. 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 and (ii) the Company’s receipt of shipments by Bharat Biotech of the first 10.0 million doses of COVAXIN manufactured by Bharat Biotech pursuant to the Supply Agreement, and further on the terms and subject to the conditions set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (the "Certificate of Designation"). In April 2021, the Company's stockholders approved an increase in the number of the Company's authorized shares of common stock from 200.0 million to 295.0 million. As of December 31, 2021, the conversion condition relating to the delivery of the first 10.0 million doses of COVAXIN had not been met. The conversion rate of the Series B Convertible Preferred Stock is subject to adjustment in the event of a stock dividend, stock split, reclassification, or similar event with respect to the Company’s common stock. Bharat Biotech is entitled to receive dividends on the Series B Convertible Preferred Stock equal (on an as-converted to common stock basis) to and in the same form as dividends actually paid on shares of common stock, when and if such dividends are paid. Except as provided by law and certain protective provisions set forth in the Certificate of Designation, the Series B Convertible Preferred Stock has no voting rights. Upon a liquidation or dissolution of the Company, holders of Series B Convertible Preferred Stock would be entitled to receive the same amount that a holder of common stock would receive if the Series B Convertible Preferred Stock were fully converted to common stock. The Company accounted for the issuance of the Series B Convertible Preferred Stock in accordance with ASC 718 and recorded its grant date fair value of $5.0 million within stockholders' equity during the year ended December 31, 2021, with a corresponding short-term asset for the advanced payment for the doses of COVAXIN. 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 incorporates Level 3 inputs in the fair value hierarchy, including the estimated time until the instrument's liquidity and estimated volatility of the Company's common stock as of the grant date . Registered Direct Offerings On April 23, 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company agreed to issue and sell in a registered direct offering (the "April 2021 Registered Direct Offering") an aggregate of 10.0 million shares of the Company's common stock at an offering price of $10.00 per share. The closing of the April 2021 Registered Direct Offering occurred on April 27, 2021, and the Company received net proceeds of $93.4 million, after deducting equity issuance costs of $6.6 million. On February 7, 2021, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company agreed to issue and sell in a registered direct offering (the "February 2021 Registered Direct Offering") an aggregate of 3.0 million shares of the Company's common stock at an offering price of $7.65 per share. The closing of the February 2021 Registered Direct Offering occurred on February 10, 2021, and the Company received net proceeds of $21.2 million, after, deducting equity issuance costs of $1.7 million. At-the-Market Offerings The Company commenced three separate at-the-market offerings ("ATMs") in May 2020, June 2020, and August 2020 (the "August 2020 ATM"). During the year ended December 31, 2021, the Company sold 1.0 million shares of common stock under the August 2020 ATM and received net proceeds of $4.8 million, after deducting equity issuance costs of $0.1 million. During the year ended December 31, 2020, the Company sold an aggregate of 108.1 million shares of common stock under the ATMs and received net proceeds of $36.3 million, after deducting equity issuance costs of $1.5 million. Pre-Merger Financing On September 27, 2019, the Company, which was formerly known as Histogenics Corporation ("Histogenics"), completed a reverse merger (the "Merger") with Ocugen OpCo, Inc. ("OpCo") in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of April 5, 2019, in which OpCo was deemed to be the accounting acquirer. In June 2019 prior to the Merger, OpCo and Histogenics entered into a Securities Purchase Agreement (as amended, the "Financing SPA") with certain accredited investors (the "Investors"). Pursuant to the Financing SPA, among other things, (i) immediately prior to the Merger, OpCo issued 2.2 million shares of common stock to the Investors, (ii) on October 4, 2019, the Company issued 2.2 million shares of the Company's common stock to the Investors and (iii) on October 4, 2019, the Company issued three series of warrants to purchase shares of the Company’s common stock (the “Series A Warrants,” the “Series B Warrants” and the “Series C Warrants” and collectively, the “SPA Warrants”) in exchange for an aggregate purchase price of $25.0 million (the "Pre-Merger Financing"). See Note 10 for additional information. In 2019, prior to the Pre-Merger Financing, the Company issued two senior secured convertible notes (the "Senior Secured Convertible Notes") in the aggregate principal amount of $5.3 million. The Investors offset $5.3 million from the amount to be received under the Pre-Merger Financing and the Senior Secured Convertible Notes were deemed to have been repaid and cancelled. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Warrants Canada Warrants On July 15, 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 on July 15, 2023, unless earlier terminated in accordance with its terms. The Canada Warrants were issued on July 15, 2021 in a private placement transaction. The warrantholder 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 December 31, 2021, all of the Canada Warrants were outstanding and unvested. The Canada Warrants are accounted for in accordance with ASC 718. SPA Warrants On October 4, 2019, the Company issued the SPA Warrants as a component of the Pre-Merger Financing. During the year ended December 31, 2019, the Company issued 8.8 million Series A Warrants, 20.6 million Series B Warrants, and 20.0 million Series C Warrants. During the year ended December 31, 2019, 20.6 million Series B Warrants and 20.0 million Series C Warrants were exercised. The Series A Warrants and the Series C Warrants were classified as stockholders' equity at issuance. The Series B Warrants were classified as a liability as they did not meet the derivative scope exception to be accounted for within stockholders' equity. The Series B Warrants were initially measured at fair value and marked to market each reporting period until November 2019 when the Series B Warrants were reassessed and determined to meet the derivative scope exception allowing for stockholders' equity classification. The Series B Warrants were marked to market a final time and the remaining liability balance was reclassified to equity. The change in derivative liability related to the Series B Warrants for the year ended December 31, 2019 was $1.9 million. On April 22, 2020, the Company entered into a subscription agreement with an accredited investor for the sale of 1,000 shares of the Company's common stock in a private placement for an aggregate offering price of $395 (the "April 2020 Subscription Agreement"), which represented a dilutive issuance per the terms of the Series A Warrants as the sale price of the Company's common stock under the April 2020 Subscription Agreement was lower than the exercise price ("Dilutive Issuance"). The Dilutive Issuance resulted in adjustments to the number of issuable Series A Warrants and the exercise price of the Series A Warrants. Immediately prior to the Company entering into the April 2020 Subscription Agreement, 8.8 million Series A Warrants, 1,000 Series B Warrants, and 1,000 Series C Warrants were outstanding. Contemporaneously with the April 2020 Subscription Agreement, the Company and OpCo entered into Amendment and Exchange Agreements (each an "Exchange Agreement" and collectively, the "Exchange Agreements") with the Investors. Pursuant to the Exchange Agreements, the Company, OpCo, and the Investors agreed, among other things, after giving effect to the dilutive issuance, to amend the Series A Warrants to provide for an adjustment to the number of common stock issuable upon the exercise of the Series A Warrants. Concurrently with such amendments, the Investors exchanged the Series A Warrants for (i) an aggregate of 21.9 million shares of common stock and (ii) a promissory notes of $5.6 million (the "Warrant Exchange Promissory Notes" and collectively with the common stock issued, the "Warrant Exchange"). The Warrant Exchange Promissory Notes were recorded at a fair value of $5.0 million. During the year ended December 31, 2020, the Company made payments to the Warrant Exchange Promissory Note holders of $5.6 million, causing the Warrant Exchange Promissory Notes to be repaid in full and no longer outstanding. Immediately following the consummation of the Warrant Exchange and the concurrent exercise of the remaining Series B Warrants and Series C Warrants, there were no SPA Warrants outstanding. The Company accounted for the Warrant Exchange by recognizing the fair value of the consideration transferred in excess of the carrying value of the Series A Warrants as a reduction of additional paid-in capital. The fair value of the Series A Warrants immediately prior to the Warrant Exchange was $1.1 million, which was estimated using a Black-Scholes valuation model utilizing Level 3 inputs. The fair value of the consideration transferred to settle the Series A Warrants was approximately $13.6 million, comprised of $8.6 million in shares of common stock and the fair value of the Warrant Exchange Promissory Notes of $5.0 million. The fair value of consideration transferred to settle the Series A Warrants was in excess of the fair value of the Series A Warrants immediately prior to the Warrant Exchange by approximately $12.5 million. The excess consideration was accounted for as a deemed dividend to the Series A Warrant holders and was reflected as an additional net loss to common stockholders in the calculation of basic and diluted net loss per common share for the year ended December 31, 2020. OpCo Warrants Beginning in 2016, OpCo issued warrants to purchase the Company's common stock (the "OpCo Warrants"). As of December 31, 2021 and 2020, 0.6 million and 0.9 million OpCo Warrants were outstanding, respectively. As of December 31, 2021, the outstanding OpCo Warrants had a weighted-average exercise price of $6.23. The outstanding OpCo Warrants expire between 2026 and 2027. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for stock options and RSUs is reflected in the consolidated statements of operations and comprehensive loss as follows (in thousands): Year ended December 31, 2021 2020 2019 General and administrative $ 4,909 $ 349 $ 363 Research and development 2,049 311 521 Total $ 6,958 $ 660 $ 884 Stock-based compensation expense during the year ended December 31, 2021 included $2.1 million of expense related to stock options with performance-based vesting conditions. There were no stock options with performance-based vesting conditions granted prior to 2021. As of December 31, 2021, the Company had $12.6 million of unrecognized stock-based compensation expense related to stock options and RSUs outstanding. This expense is expected to be recognized over a weighted average period of 2.1 years as of December 31, 2021. Equity Plans The Company maintains two equity compensation plans, the 2014 Ocugen OpCo, Inc. Stock Option Plan (the "2014 Plan") and the Ocugen, Inc. 2019 Equity Incentive Plan (the "2019 Plan", collectively with the 2014 Plan, the "Plans"). On the first business day of each fiscal year, pursuant to the "Evergreen" provision of the 2019 Plan, the aggregate number of shares that may be issued under the 2019 Plan will automatically increase by a number equal to the lesser of 4% of the total number of shares of Company common stock outstanding on December 31st of the prior year, or a number of shares determined by the Board of Directors. As of December 31, 2021, the 2014 Plan and the 2019 Plan authorize for the granting of up to 0.8 million and 11.5 million equity awards in respect to the Company's common stock, respectively. In addition to options and RSUs granted under the Plans, the Company has granted certain options and RSUs as material inducements to employment in accordance with Nasdaq Listing Rule 5635 (c)(4), which were granted outside of the Plans. Stock Options to Purchase Common Stock The assumptions utilized in the fair value calculation for stock options as of December 31, 2021, 2020, and 2019 were as follows: Year ended December 31, 2021 2020 2019 Weighted average expected option term (years) 6.0 6.0 6.0 Range of expected stock price volatility 109% – 116% 110% – 117% 89% – 110% Weighted average expected stock price volatility 111% 112% 109% Range of risk-free interest rate 0.4% – 1.4% 0.3% – 1.7% 1.5% – 2.4% Expected dividend rate 0% 0% 0% The following table summarizes the stock option activity: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (In Thousands) Options outstanding at December 31, 2020 4,224,433 $ 0.84 8.9 $ 5,496 Granted 7,728,260 3.45 — Exercised (1,208,631) 0.70 11,144 Forfeited (657,895) 4.79 1,277 Options outstanding at December 31, 2021 10,086,167 $ 2.59 8.8 $ 24,664 Options exercisable at December 31, 2021 1,281,244 $ 2.92 8.1 $ 2,990 The stock option activity above includes 1.5 million of stock options with performance-based vesting conditions granted during the year ended December 31, 2021, of which 0.9 million are not yet vested and exercisable as of December 31, 2021. The weighted average grant date fair value of stock options granted during the years ended December 31, 2021, 2020, and 2019 were $2.87, $0.34, and $0.84, respectively. The total fair value of stock options vested during the years ended December 31, 2021, 2020, and 2019 were $2.6 million, $0.5 million, and $1.0 million, respectively. During the year ended December 31, 2021, the Company received $0.9 million of cash proceeds from the exercises of stock options. There were no stock option exercises prior to 2021. RSUs The following table summarizes the RSU activity: Number of Shares Weighted- Aggregate Intrinsic Value (In Thousands) RSUs outstanding at December 31, 2020 — $ — $ — Granted 204,901 6.87 1,483 Forfeited (13,090) 8.05 108 RSUs outstanding at December 31, 2021 191,811 $ 6.79 $ 873 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the year ended December 31, 2021, the Company recognized a deferred income tax benefit of $0.1 million due to an asset acquisition. For the years ended December 31, 2020 and 2019, the Company did not recognize any current or deferred income tax expense or benefit. Losses before income taxes were $58.4 million, $21.8 million, and $20.2 million for the years ended December 31, 2021, 2020, and 2019 respectively, substantially all of which were incurred in the United States. The reconciliation of federal statutory income tax to the Company's provision for income taxes is as follows: As of December 31, 2021 2020 2019 Expected provision at statutory rate 21.0 % 21.0 % 21.0 % State tax - net of federal benefit 7.9 % 7.5 % 5.3 % Tax credits 3.2 % 2.8 % 3.2 % Permanent differences (0.1) % (1.0) % (8.1) % Other — % 1.1 % 2.9 % Change in valuation allowance (31.9) % (31.4) % (24.3) % Total provision for income taxes 0.1 % — % — % Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets and liabilities as of December 31, 2021 and 2020 are comprised of the following (in thousands): As of December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 52,038 $ 35,714 Capital loss carryforwards 7,298 7,298 Start-up costs 11,235 11,235 Accruals and reserves 448 398 Intellectual property amortization 1,960 2,285 Stock-based compensation expense 2,064 1,290 Tax credits 4,350 2,541 Lease liability 461 125 Total deferred tax assets 79,854 60,886 Valuation allowance (79,395) (60,761) Deferred tax assets, net of allowance $ 459 $ 125 Deferred tax liabilities: Lease right-of-use assets (459) (125) Net deferred tax assets $ — $ — The Company has evaluated the positive and negative evidence bearing upon its ability to realize its deferred tax assets. Management has considered the Company’s history of cumulative net losses, estimated future taxable income, and prudent and feasible tax planning strategies and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. Accordingly, a full valuation allowance has been established against these net deferred tax assets as of December 31, 2021 and 2020, respectively. The Company’s valuation allowance increased during 2021 by approximately $18.6 million primarily due to the generation of net operating losses and research and development and orphan drug credit carryforwards. As of December 31, 2021 and 2020, the Company had U.S. federal net operating loss ("NOL") carryforwards of $184.4 million and $128.0 million, respectively, which may be available to offset future income tax liabilities. The Tax Cut and Jobs Act, which was enacted in December 2017, will generally allow federal losses generated after 2017 to be carried over indefinitely, but will generally limit the NOL deduction to the lesser of the NOL carryover or 80% of a corporation’s taxable income (subject to Section 382 of the Internal Revenue Code of 1986, as amended ("IRC")). In addition, there will be no carryback for losses generated after 2017. Losses generated prior to 2018 will generally be deductible to the extent of the lesser of a corporation’s NOL carryover or 100% of a corporation’s taxable income and will be available for twenty years from the period the loss was generated. The Company has federal NOLs generated after 2017 of $131.8 million, which do not expire. The federal NOLs generated prior to 2018 of $52.6 million will expire at various dates through 2037. In addition, the Company has a capital loss carryforward of $26.7 million which may be available to offset future capital gains and does not expire until 2024. As of December 31, 2021 and 2020, the Company also had U.S. state NOL carryforwards of $183.1 million and $126.7 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2041. As of December 31, 2021 and 2020, the Company had federal tax credit carryforwards of approximately $3.8 million and $2.2 million, respectively, which are available to offset future federal tax liabilities which expire at various dates through 2041. As of December 31, 2021 and 2020, the Company had state tax credit carryforwards of approximately $0.7 million and $0.5 million, respectively, which are available to reduce future tax liabilities and expire at various dates through 2036. Under the provisions of the IRC, the NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Utilization of U.S. federal and state NOL and tax credit carryforwards may be subject to a substantial annual limitation under Section 382 and Section 383 of the IRC, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and tax credit carryforwards that can be utilized annually to offset future taxable income and tax liabilities, respectively. The Company acquired a significant amount of federal and state NOL carryforwards and federal and state tax credit carryforwards as a result of the Merger. The Company has not yet conducted a comprehensive study to assess whether a change of ownership has occurred, or whether there have been multiple ownership changes since its formation. Any limitation may result in expiration of a portion of the NOL carryforwards or tax credit carryforwards before utilization, which would be offset by a change in the Company's valuation allowance. Further, until a study is completed by the Company and any limitation is known, no amounts are being presented as an uncertain tax position. The Company has not yet conducted a study of tax credit carryforwards. Such a study, once undertaken by the Company, may result in an adjustment to its tax credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s tax credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheets or consolidated statements of operations and comprehensive loss if an adjustment is required. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): Year ended December 31, 2021 2020 2019 Gross unrecognized tax benefits at beginning of year $ 303 $ 303 $ — Additions for tax positions taken in a prior year — — 303 Additions for tax positions taken in the current year — — — Reductions for tax positions taken in the prior year due to settlement — — — Reductions for tax positions taken in the prior year due to statutes lapsing — — — Gross unrecognized tax benefits at end of year $ 303 $ 303 $ 303 The uncertain tax positions giving rise to the unrecognized tax benefits of $0.3 million at December 31, 2021 relate to the timing of certain income and deductions for federal income tax purposes taken by Histogenics prior to the Merger. The reversal of unrecognized tax benefits would not have any impact on the effective tax rate in the future and is not expected to create cash liability. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In a normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company’s tax years are still open under status from 2018 to present. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | Net Loss per Share of Common Stock The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2021, 2020, and 2019 (in thousands): Year ended December 31, 2021 2020 2019 Net loss — basic and diluted $ (58,365) $ (21,822) $ (20,243) Deemed dividend related to Warrant Exchange — (12,546) — Net loss to common stockholders $ (58,365) $ (34,368) $ (20,243) Shares used in calculating net loss per share attributable to common stockholders — basic and diluted 195,013,043 112,236,110 13,893,819 Net loss per share attributable to common stockholders — basic and diluted $ (0.30) $ (0.31) $ (1.46) The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding, as their inclusion would have been antidilutive: Year ended December 31, 2021 2020 2019 Options to purchase common stock 10,086,167 4,224,433 731,189 RSUs 191,811 — — Warrants 799,251 870,017 9,643,945 Series A Convertible Preferred Stock (as converted to common stock) 3,115 — — Series B Convertible Preferred Stock (as converted to common stock) 547,450 — — Total 11,627,794 5,094,450 10,375,134 |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments The Company has commitments under certain license and development agreements, lease agreements, debt agreements, and consulting agreements. Commitments under certain license and development agreements include annual payments, payments upon the achievement of certain milestones, and royalty payments based on net sales of licensed products (see Note 3). Commitments under lease agreements are future minimum lease payments (see Note 6). Commitments under debt agreements are the future payment of principal and accrued interest under the EB-5 Loan Agreement (see Note 8). Commitments under consulting agreements include payments upon the achievement of certain milestones related to COVAXIN (see Note 10). Additionally, subsequent to December 31, 2021, the Company entered into supply commitments related to COVAXIN. See Note 15 for additional information. Contingencies On June 17, 2021, a securities class action lawsuit was filed against the Company and certain of its officers and directors in the U.S. District Court for the Eastern District of Pennsylvania (Case No. 2:21-cv-02725) that purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, based on statements made by the Company concerning the announcement of the Company's decision to pursue the submission of a BLA for COVAXIN for adults ages 18 years and older rather than pursuing EUA for the vaccine candidate. On July 16, 2021, a second securities class action was filed against the Company and certain of its officers and directors in the U.S. District Court for the Eastern District of Pennsylvania (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. On August 30, 2021, a stockholder derivative lawsuit was filed derivatively on behalf of the Company against certain of its officers and directors and the nominal defendant Ocugen in the U.S. District Court for the Eastern District of Pennsylvania (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. On September 22, 2021, a second stockholder derivative lawsuit was filed derivatively on behalf of the Company against certain of its officers and directors and the nominal defendant Ocugen in the U.S. District Court for the Eastern District of Pennsylvania (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 remains pending before each court, and this status could change. The Company believes that the lawsuits are without merit and intends to vigorously defend against them. At this time, no assessment can be made as to their likely outcome or whether the outcome will be material to the Company. No information is available to indicate that it is probable that a loss has been incurred and can be reasonably estimated as of the date of the consolidated financial statements and, as such, no accrual for the loss has been recorded within the consolidated financial statements. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Non-Binding Letter of Intent with Liminal Biosciences Inc. 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 for a combination of cash and warrants to purchase the Company's common stock. As consideration for entering into 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, subject to certain adjustments. The Liminal Warrants vest and become exercisable upon closing of the transactions contemplated by the LOI and terminate on the ten anniversary of the issuance date, unless earlier terminated in accordance with their terms. The Liminal Warrants are cancellable by the Company in the event the transactions contemplated by the LOI are not consummated. Completion of the transaction proposed in the LOI is subject to finalization of due diligence investigations by the parties, the negotiation and execution of definitive transaction agreements, and other customary closing conditions including certain funding requirements. The LOI may be terminated at any time by mutual written consent of the Company and Liminal, among the other termination provisions contained in the LOI. COVAXIN Drug Product Components Purchase In February 2022, the Company entered into a commitment to purchase $14.3 million of COVAXIN drug product components from Bharat Biotech to support the technology transfer from Bharat Biotech to Jubilant HollisterStier. The Company previously issued the Series B Convertible Preferred Stock in March 2021 as an advance payment of $6.0 million for the supply of COVAXIN to be provided by Bharat Biotech pursuant to the Supply Agreement, which will be applied to this commitment. Public Offering of Common Stock On February 22, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) pursuant to which the Company agreed to issue and sell 16.0 million shares of the Company’s common stock to Cantor at an offering price of $3.13 per share (the “Public Offering”). Pursuant to the terms of the Underwriting Agreement, the Company also granted Cantor a 30-day option to purchase up to an additional 2.4 million shares of the Company’s common stock at a price of $3.13 per share. The closing of the Public Offering occurred on February 25, 2022, and the Company received net proceeds of $49.8 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company. The Public Offering was made pursuant to the Company’s Registration Statement on Form S-3ASR (File No. 333-254550), which was previously filed with the SEC and became automatically effective on March 22, 2021, as supplemented by a prospectus supplement, dated February 22, 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation and ConsolidationThe accompanying consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP") and under the rules and regulations of the U.S. Securities and Exchange Commission ("SEC"). |
Principles of Consolidation | The consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform with current year presentation. |
Use of Estimates | Use of Estimates In preparing the consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, debt and equity instruments (including derivative liabilities), asset held for sale, and the collectibility of the note receivable. |
Segment Information | Segment Information As of December 31, 2021, the Company viewed its operations and managed its business as one operating segment consistent with how the Company's chief operating decision-maker, the Company's Chief Executive Officer, makes decisions regarding resource allocation and assessing performance. As of December 31, 2021, substantially all of the Company's assets were located in the United States. |
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’s restricted cash balance consists of cash held to collateralize a corporate credit card account. |
Collaboration Arrangements | Collaboration Arrangements The Company assesses whether collaboration agreements are subject to Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 808, Collaborative Arrangements ("ASC 808"), based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the Company and the collaboration partner are subject to other accounting literature. If payments from the collaboration partner represent consideration from a customer, the Company accounts for those payments within the scope of FASB ASC Topic 606, Revenue from Contracts with Customers . However, if the Company concludes that its collaboration partner is not a customer, the Company will record royalty payments received as collaboration revenue in the period in which the underlying sale occurs and record expenses and expense reimbursements as either research and development expense or general and administrative expense, or a reduction thereof, based on the underlying nature of the expense or expense reimbursement. During the year ended December 31, 2020, the Company recorded collaboration revenue from an agreement accounted for as a collaborative arrangement within the scope of ASC 808. No collaboration revenue was recorded during the years ended December 31, 2021 and 2019. |
Asset Held for Sale | Asset Held for Sale During 2019, the Company had an intangible asset held for sale that was carried at its original fair value less cost to sell of $7.0 million. The Company concluded during the year ended December 31, 2020 that a sale of the intangible asset was no longer probable to be completed within one year from the date the intangible asset was initially recorded as held for sale. As such, the carrying value of the intangible asset was reduced to zero with the corresponding charge of $7.0 million recognized as in-process research and development expense in the consolidated statements of operations and comprehensive loss during the year ended December 31, 2020 as the in-process research and development did not have an alternative future use. |
Property and Equipment, Net | Property and Equipment, Net The Company's property and equipment currently includes furniture and fixtures, machinery and equipment, leasehold improvements, and construction in progress. Property and equipment is recorded at historical cost. Significant additions or improvements are capitalized, and expenditures for repairs and maintenance are charged to expense as incurred. Gains and losses on disposal of assets are included in the consolidated statements of operations and comprehensive loss. Depreciation is calculated using the straight-line method and is recognized over the expected useful life of the underlying asset. Construction in progress is not depreciated until such time that the asset is completed and placed into service. Once placed into service, the asset is depreciated over its expected useful life. Expected useful lives by major asset category are as follows: Furniture and fixtures 3 to 7 years Machinery and equipment 5 to 7 years Leasehold improvements Lower of the expected useful life or remaining lease term |
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 current and historical 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 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. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rate was not readily determinable in the Company’s current and historical operating leases. As such, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments. The lease term for the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset if reasonably certain. Variable payments not dependent on an index or rate associated with the Company’s leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company’s consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed lease payments. |
Exit and Disposal Activities | Exit and Disposal Activities The Company records liabilities for one-time termination benefits in accordance with FASB ASC Topic 420, Exit and Disposal Cost Obligations ("ASC 420"). In accordance with ASC 420, an arrangement for one-time termination benefits exists at the date the plan of the termination meets the following criteria: (i) management commits to a plan of termination; (ii) the plan identifies the impacted employees and expected completion date; (iii) the plan identifies the terms of the benefits arrangement; (iv) it is unlikely significant changes to the plan will be made or the plan will be withdrawn; and (v) the plan has been communicated to employees. Costs for one-time termination benefits in which the employee is required to render service until termination in order to receive the benefits, are recognized ratably over the future service period. The Company records liabilities for employee termination benefits covered by ongoing benefit arrangements in accordance with FASB ASC Topic 712, Compensation—Nonretirement Postemployment Benefits ("ASC 712"). In accordance with ASC 712, costs for termination benefits under ongoing benefits arrangements are recognized when management has committed to a plan of termination and the costs are probable and estimable. Severance-related charges, once incurred, are recognized as either research and development expense or general and administrative expense within the consolidated statements of operations and comprehensive loss depending on the job function of the former employee. |
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 approximate their fair values due to the short-term nature of these instruments. As of December 31, 2021, the Company has concluded that the fair value of the borrowings under the EB-5 Loan Agreement (as defined in Note 8), using Level 2 inputs, approximate their carrying value. See Note 8 for additional information. |
Financial Instruments and Derivatives | Financial Instruments and Derivatives The Company does not have derivative hedging instruments used to mitigate risk. The Company evaluates all financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with FASB ASC Topic 815, Derivatives and Hedging ("ASC 815"). Additionally, the Company assesses warrants to purchase common stock to determine liability versus stockholders' equity classification in accordance with ASC 815 and FASB ASC Topic 480, Distinguishing Liabilities from Equity . For derivative instruments that are accounted for as liabilities, including liability-designated warrants, the derivative instrument is initially recorded at its fair value as a derivative liability and is then revalued at each reporting date, with changes in the fair value reported as other income (expense) in the consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instrument should be recorded as a liability or as stockholders' equity, is evaluated at the end of each reporting period. |
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 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 options granted. For RSUs, the fair value of the RSUs 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. Compensation 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 Estimating the fair value of stock options requires the input of subjective assumptions, including the expected term of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. The assumptions used in the Company’s Black-Scholes option-pricing model represent management’s best estimates and involve a number of variables, uncertainties, assumptions, and the application of management’s judgment, as they are inherently subjective. If any assumptions change, the Company’s stock-based compensation expense could be materially different in the future. The assumptions used in Ocugen’s Black-Scholes option-pricing model for stock options are as follows: Expected Term. Due to the historical lack of a public market for the trading of Ocugen common stock and the lack of sufficient company-specific historical data, the expected term of employee stock options subject to service-based vesting conditions is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option. Expected Volatility. The expected volatility is based on historical volatilities of Ocugen and similar entities within Ocugen’s industry for periods commensurate with the expected term assumption. Risk-Free Interest Rate. The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. Expected Dividends. The expected dividend yield is 0% because Ocugen has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or the Company’s tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established. The Company accounts for uncertain tax positions recognized in the consolidated financial statements by prescribing a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. |
Recently Adopted Accounting Standards; Recent Accounting Pronouncements | Recently Adopted Accounting Standards In December 2019, the FASB issued Accounting Standards Update ("ASU") No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocations, and calculating income taxes in interim periods. This standard also adds guidance to reduce complexity in certain areas, including recognizing franchise tax, recognizing deferred taxes for tax basis of goodwill, allocating taxes to the members of a consolidated group, and recognizing the effect of enacted changes in tax laws or rates during an interim period. This standard was effective for the Company on January 1, 2021. The adoption of this standard did not have a material impact on the Company's consolidated financial statements. Recent Accounting Pronouncements In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance . This standard has an effective and transition date of January 1, 2022. 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 item 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 Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) . This standard will have an effective and transition date of January 1, 2022. 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 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 Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40) . This standard will have an effective and transition date of January 1, 2024. Early adoption is currently permitted. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models that require separate accounting for embedded conversion features as well as simplifies the settlement assessment that entities are required to perform to determine whether a contract qualifies for equity classification. This standard also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of potential share settlement (if the effect is more dilutive) for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. The standard requires new disclosures about events that occur during the reporting period and cause conversion contingencies to be met and about the fair value of a public business entity's convertible debt at the instrument level, among other things. The Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The FASB subsequently issued amendments to ASU No. 2016-13, which have the same effective date and transition date of January 1, 2023. ASU No. 2016-13, as amended, requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, these standards now require allowances to be recorded instead of reducing the amortized cost of the investment. These standards limit the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases. The Company does not currently expect the adoption of this standard to have a material impact on the Company's consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents, and restricted cash in the consolidated balance sheets to the total amount shown in the consolidated statements of cash flows (in thousands): As of December 31, 2021 2020 Cash and cash equivalents $ 94,958 $ 24,039 Restricted cash 151 151 Total cash, cash equivalents, and restricted cash $ 95,109 $ 24,190 |
Schedule of Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash in the consolidated balance sheets to the total amount shown in the consolidated statements of cash flows (in thousands): As of December 31, 2021 2020 Cash and cash equivalents $ 94,958 $ 24,039 Restricted cash 151 151 Total cash, cash equivalents, and restricted cash $ 95,109 $ 24,190 |
Major Components of Property, Plant and Equipment | Expected useful lives by major asset category are as follows: Furniture and fixtures 3 to 7 years Machinery and equipment 5 to 7 years Leasehold improvements Lower of the expected useful life or remaining lease term The following table provides a summary of the major components of property and equipment as reflected on the consolidated balance sheets (in thousands): As of December 31, 2021 2020 Furniture and fixtures $ 284 $ 166 Machinery and equipment 855 452 Leasehold improvements 167 177 Construction in progress 232 — Financing lease right-of-use asset — 64 Total property and equipment 1,538 859 Less: accumulated depreciation (374) (226) Total property and equipment, net $ 1,164 $ 633 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Major Components of Property, Plant and Equipment | Expected useful lives by major asset category are as follows: Furniture and fixtures 3 to 7 years Machinery and equipment 5 to 7 years Leasehold improvements Lower of the expected useful life or remaining lease term The following table provides a summary of the major components of property and equipment as reflected on the consolidated balance sheets (in thousands): As of December 31, 2021 2020 Furniture and fixtures $ 284 $ 166 Machinery and equipment 855 452 Leasehold improvements 167 177 Construction in progress 232 — Financing lease right-of-use asset — 64 Total property and equipment 1,538 859 Less: accumulated depreciation (374) (226) Total property and equipment, net $ 1,164 $ 633 |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense were as follows (in thousands): Year ended December 31, 2021 2020 2019 Operating lease cost $ 360 $ 189 $ 250 Variable lease cost 105 85 80 Total lease cost $ 465 $ 274 $ 330 Supplemental information related to leases was as follows: Year ended December 31, 2021 2020 2019 Weighted-average remaining lease terms — operating leases (years) 5.3 6.9 2.0 Weighted-average discount rate — operating leases 4.1 % 4.6 % 7.6 % |
Schedule of Supplemental Balance Sheet Information Related to Leases | Supplemental balance sheet information related to leases was as follows (in thousands): As of December 31, 2021 2020 Right-of-use assets, net $ 1,587 $ 434 Current lease obligations $ 363 $ 44 Non-current lease obligations 1,231 389 Total lease liabilities $ 1,594 $ 433 |
Schedule of Maturities of Operating Leases | Future minimum operating lease base rent payments are approximately as follows (in thousands): For the years ending December 31, Amount 2022 $ 440 2023 261 2024 269 2025 277 2026 285 Thereafter 293 Total $ 1,825 Less: present value adjustment (231) Present value of minimum lease payments $ 1,594 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities are as follows (in thousands): As of December 31, 2021 2020 Research and development $ 866 $ 512 Clinical 703 117 Professional fees 747 405 Employee-related 1,716 963 Severance-related (1) — 712 Other 293 232 Total accrued expenses and other current liabilities $ 4,325 $ 2,941 (1) In June 2020, the Company communicated notice to five employees of the termination of their employment as a result of the discontinuation of a product candidate. This reduction represented one-third of the Company’s workforce at the time of communication. All terminations were “without cause” and each employee received termination benefits upon departure. The termination dates varied for each employee and ranged from June 30, 2020 to December 31, 2020. |
Schedule of Severance-related Charges and Severance Payments | The following table provides a summary of the severance-related charges and severance payments during the years ended December 31, 2021 and 2020 related to the June 2020 reduction in workforce (in thousands): Amount Accrued Severance at December 31, 2019 $ — Severance-related charges 1,116 Severance-related payments 404 Accrued Severance at December 31, 2020 $ 712 Severance-related charges — Severance-related payments 712 Accrued Severance at December 31, 2021 $ — |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The following table provides a summary of the carrying values for the components of debt as reflected on the consolidated balance sheets (in thousands): As of December 31, 2021 2020 PPP Note $ — $ 421 EB-5 Loan Agreement 1,712 1,636 Total carrying value of debt, net $ 1,712 $ 2,057 The carrying values of the EB-5 Loan Agreement borrowings as of December 31, 2021 and 2020 are summarized below (in thousands): As of December 31, 2021 2020 Principal outstanding $ 1,500 $ 1,500 Plus: accrued interest 241 181 Less: unamortized debt issuance costs (29) (45) Carrying value $ 1,712 $ 1,636 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense for Options Granted Reflected in the Consolidated Statement of Operations and Comprehensive Loss | Stock-based compensation expense for stock options and RSUs is reflected in the consolidated statements of operations and comprehensive loss as follows (in thousands): Year ended December 31, 2021 2020 2019 General and administrative $ 4,909 $ 349 $ 363 Research and development 2,049 311 521 Total $ 6,958 $ 660 $ 884 |
Schedule of Weighted Average Assumptions Utilized in Fair Value Calculation | The assumptions utilized in the fair value calculation for stock options as of December 31, 2021, 2020, and 2019 were as follows: Year ended December 31, 2021 2020 2019 Weighted average expected option term (years) 6.0 6.0 6.0 Range of expected stock price volatility 109% – 116% 110% – 117% 89% – 110% Weighted average expected stock price volatility 111% 112% 109% Range of risk-free interest rate 0.4% – 1.4% 0.3% – 1.7% 1.5% – 2.4% Expected dividend rate 0% 0% 0% |
Schedule of Stock Option Activity | The following table summarizes the stock option activity: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (In Thousands) Options outstanding at December 31, 2020 4,224,433 $ 0.84 8.9 $ 5,496 Granted 7,728,260 3.45 — Exercised (1,208,631) 0.70 11,144 Forfeited (657,895) 4.79 1,277 Options outstanding at December 31, 2021 10,086,167 $ 2.59 8.8 $ 24,664 Options exercisable at December 31, 2021 1,281,244 $ 2.92 8.1 $ 2,990 |
Schedule of Share-based Payment Arrangement, Restricted Stock Unit, Activity | The following table summarizes the RSU activity: Number of Shares Weighted- Aggregate Intrinsic Value (In Thousands) RSUs outstanding at December 31, 2020 — $ — $ — Granted 204,901 6.87 1,483 Forfeited (13,090) 8.05 108 RSUs outstanding at December 31, 2021 191,811 $ 6.79 $ 873 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation of federal statutory income tax to the Company's provision for income taxes is as follows: As of December 31, 2021 2020 2019 Expected provision at statutory rate 21.0 % 21.0 % 21.0 % State tax - net of federal benefit 7.9 % 7.5 % 5.3 % Tax credits 3.2 % 2.8 % 3.2 % Permanent differences (0.1) % (1.0) % (8.1) % Other — % 1.1 % 2.9 % Change in valuation allowance (31.9) % (31.4) % (24.3) % Total provision for income taxes 0.1 % — % — % |
Schedule of Deferred Tax Assets | The significant components of the Company’s deferred tax assets and liabilities as of December 31, 2021 and 2020 are comprised of the following (in thousands): As of December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 52,038 $ 35,714 Capital loss carryforwards 7,298 7,298 Start-up costs 11,235 11,235 Accruals and reserves 448 398 Intellectual property amortization 1,960 2,285 Stock-based compensation expense 2,064 1,290 Tax credits 4,350 2,541 Lease liability 461 125 Total deferred tax assets 79,854 60,886 Valuation allowance (79,395) (60,761) Deferred tax assets, net of allowance $ 459 $ 125 Deferred tax liabilities: Lease right-of-use assets (459) (125) Net deferred tax assets $ — $ — |
Summary of Income Tax Contingencies | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): Year ended December 31, 2021 2020 2019 Gross unrecognized tax benefits at beginning of year $ 303 $ 303 $ — Additions for tax positions taken in a prior year — — 303 Additions for tax positions taken in the current year — — — Reductions for tax positions taken in the prior year due to settlement — — — Reductions for tax positions taken in the prior year due to statutes lapsing — — — Gross unrecognized tax benefits at end of year $ 303 $ 303 $ 303 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Earnings per Share of Common Stock | The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2021, 2020, and 2019 (in thousands): Year ended December 31, 2021 2020 2019 Net loss — basic and diluted $ (58,365) $ (21,822) $ (20,243) Deemed dividend related to Warrant Exchange — (12,546) — Net loss to common stockholders $ (58,365) $ (34,368) $ (20,243) Shares used in calculating net loss per share attributable to common stockholders — basic and diluted 195,013,043 112,236,110 13,893,819 Net loss per share attributable to common stockholders — basic and diluted $ (0.30) $ (0.31) $ (1.46) |
Schedule of Potentially Dilutive Securities Excluded From Computation of Diluted Weighted Average Shares | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding, as their inclusion would have been antidilutive: Year ended December 31, 2021 2020 2019 Options to purchase common stock 10,086,167 4,224,433 731,189 RSUs 191,811 — — Warrants 799,251 870,017 9,643,945 Series A Convertible Preferred Stock (as converted to common stock) 3,115 — — Series B Convertible Preferred Stock (as converted to common stock) 547,450 — — Total 11,627,794 5,094,450 10,375,134 |
Nature of Business (Details)
Nature of Business (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2022teenager | Dec. 31, 2021USD ($)orphan_drug_designationsegmentdose | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Subsequent Events | |||||
Number of operating segments | segment | 1 | ||||
Number of vaccination dose regimen | dose | 2 | ||||
Vaccination dose regimen, duration apart | 28 days | ||||
Number of vaccination doses administered globally | dose | 295,000,000 | ||||
Number of ODDs received (orphan drug designation) | orphan_drug_designation | 4 | ||||
Net loss | $ (58,365) | $ (21,822) | $ (20,243) | ||
Loss before income taxes | (58,417) | (21,822) | (20,243) | ||
Accumulated deficit | 131,667 | 73,302 | |||
Cash, cash equivalents and restricted cash | $ 95,109 | $ 24,190 | $ 7,595 | $ 1,779 | |
Subsequent events | |||||
Subsequent Events | |||||
Number of teenagers vaccinated | teenager | 36,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) $ / shares in Units, $ in Thousands, shares in Millions | 12 Months Ended | |||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | |
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Number of operating segments | segment | 1 | |||
Asset held for sale | $ 0 | $ 7,000 | ||
In-process research and development | $ 0 | 7,000 | $ 0 | |
Common stock issued upon conversion | shares | 1.1 | |||
Gain (loss) on extinguishment of debt | 426 | 0 | $ 0 | |
Change in fair value of derivative liabilities | $ 0 | $ 0 | (3,187) | |
Contractual term | 10 years | |||
Series B Warrants | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Change in fair value of derivative liabilities | 1,900 | |||
Convertible notes | The Convertible Notes | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Debt instrument, face amount | $ 8,800 | $ 8,800 | ||
Price per share (in USD per share) | $ / shares | $ 8.69 | |||
Gain (loss) on extinguishment of debt | $ (300) | |||
Convertible notes | The Convertible Notes | Series B Warrants | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Change in fair value of derivative liabilities | 3,200 | |||
Convertible notes | The Convertible Notes | Additional Paid in Capital | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Gain (loss) on extinguishment of debt | $ 13,000 | |||
Stock options | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |
Minimum | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Vesting period | 1 year | |||
Maximum | ||||
RECENT ACCOUNTING PRONOUNCEMENTS | ||||
Vesting period | 3 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Cash, cash equivalents and restricted cash reconciliation: | ||||
Cash and cash equivalents | $ 94,958 | $ 24,039 | ||
Restricted cash | 151 | 151 | ||
Total cash, cash equivalents, and restricted cash | $ 95,109 | $ 24,190 | $ 7,595 | $ 1,779 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Expected useful lives by major asset category (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Furniture and fixtures | Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Furniture and fixtures | Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 7 years |
Machinery and equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Machinery and equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life | 7 years |
License and Development Agree_2
License and Development Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 60 Months Ended | |
Jun. 30, 2021 | Jan. 31, 2017 | Dec. 31, 2021 | Dec. 31, 2021 | |
COVAXIN Preferred Stock Purchase Agreement | ||||
License agreements: | ||||
Profits generated, shared percentage | 45.00% | 45.00% | ||
Collaborative Arrangement | ||||
License agreements: | ||||
Upfront payment | $ 15,000,000 | |||
Additional payment | $ 10,000,000 | |||
Schepens Eye Research Institute Research Agreement | ||||
License agreements: | ||||
Payment annual license maintenance fee | $ 16,100,000 | |||
Collaboration agreement with University of Colorado | ||||
License agreements: | ||||
Potential development and regulatory milestone payments | $ 1,500,000 | |||
Milestone payment | $ 0 | |||
Royalty payments | $ 0 | |||
Cancellation period, notice | 60 days | |||
Cancellation notice, payments period | 60 days |
Notes Receivable (Details)
Notes Receivable (Details) - USD ($) $ in Millions | Jul. 31, 2021 | Apr. 13, 2021 |
Receivables [Abstract] | ||
Promissory note | $ 0.8 | |
Promissory note, interest rate | 9.00% | 5.00% |
Property and Equipment - Summar
Property and Equipment - Summary of the Major Components of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Financing lease right-of-use asset | $ 0 | $ 64 |
Total property and equipment | 1,538 | 859 |
Less: accumulated depreciation | (374) | (226) |
Total property and equipment, net | 1,164 | 633 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 284 | 166 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 855 | 452 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 167 | 177 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 232 | $ 0 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 0.2 | $ 0.1 | $ 0.1 |
Operating Leases - Additional I
Operating Leases - Additional Information (Details) $ in Millions | Oct. 09, 2020segment | Oct. 31, 2021USD ($)extension | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease, term of contract (in years) | 7 years | 7 years | |
Operating lease, number of renewal terms | segment | 1 | ||
Operating lease, renewal term (in years) | 5 years | ||
Base rent payments, expected cost | $ | $ 3.8 | ||
Number of additional lease agreement extensions | extension | 2 | ||
Term of contract for additional lease agreement | 5 years |
Operating Leases - Components O
Operating Leases - Components Of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease cost | $ 360 | $ 189 | $ 250 |
Variable lease cost | 105 | 85 | 80 |
Total lease cost | $ 465 | $ 274 | $ 330 |
Operating Leases - Supplemental
Operating Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Right-of-use assets, net | $ 1,587 | $ 434 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other assets | Other assets |
Current lease obligations | $ 363 | $ 44 |
Non-current lease obligations | 1,231 | 389 |
Total lease liabilities | $ 1,594 | $ 433 |
Operating Leases - Operating Le
Operating Leases - Operating Leases, Supplemental Information Related To Leases (Details) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | |||
Weighted-average remaining lease terms — operating leases (years) | 5 years 3 months 18 days | 6 years 10 months 24 days | 2 years |
Weighted-average discount rate — operating leases | 4.10% | 4.60% | 7.60% |
Operating Leases - Future Minim
Operating Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 | $ 440 | |
2023 | 261 | |
2024 | 269 | |
2025 | 277 | |
2026 | 285 | |
Thereafter | 293 | |
Total | 1,825 | |
Less: present value adjustment | (231) | |
Total lease liabilities | $ 1,594 | $ 433 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) $ in Thousands | 1 Months Ended | 19 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2021USD ($)employee | Dec. 31, 2020USD ($) | |
Restructuring Cost and Reserve [Line Items] | |||
Research and development | $ 866 | $ 512 | |
Clinical | 703 | 117 | |
Professional fees | 747 | 405 | |
Employee-related | 1,716 | 963 | |
Severance-related | 0 | 712 | |
Other | 293 | 232 | |
Total accrued expenses and other current liabilities | $ 4,325 | $ 2,941 | |
Severance-related charges | |||
Restructuring Cost and Reserve [Line Items] | |||
Number of employees given notice of termination | employee | 5 | ||
Number of positions eliminated, period percent | 33.00% |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities - Schedule of Severance-related Charges and Severance Payments (Details) - Severance-related charges - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Restructuring Reserve | ||
Accrued Severance, beginning balance | $ 712 | $ 0 |
Severance-related charges | 0 | 1,116 |
Severance-related payments | 712 | 404 |
Accrued Severance, ending balance | $ 0 | $ 712 |
Debt - Summary of the Carrying
Debt - Summary of the Carrying Values for the Components of Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt | ||
Carrying Value upon Issuance | $ 1,712 | $ 2,057 |
PPP Note | Notes payable | ||
Debt | ||
Carrying Value upon Issuance | 0 | 421 |
EB-5 Loan | Loans payable | ||
Debt | ||
Carrying Value upon Issuance | $ 1,712 | $ 1,636 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | 4 Months Ended | 12 Months Ended | |||||
Dec. 31, 2016 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Apr. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2016 | |
Debt | |||||||
Gain on forgiveness of PPP Note | $ 426,000 | $ 0 | $ 0 | ||||
Paycheck Protection Program Loan | |||||||
Debt | |||||||
Principal outstanding | $ 400,000 | ||||||
Interest rate (as a percent) | 1.00% | ||||||
EB-5 Loan | Loans payable | |||||||
Debt | |||||||
Interest rate (as a percent) | 4.00% | ||||||
Maximum borrowing | $ 10,000,000 | ||||||
Borrowing increments | $ 500,000 | ||||||
Amount borrowed | $ 1,000,000 | $ 500,000 |
Debt - EB-5 Loan Agreement Borr
Debt - EB-5 Loan Agreement Borrowings (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2016 |
Debt | ||||
Carrying value | $ 1,712 | $ 2,057 | ||
EB-5 Loan | Loans payable | ||||
Debt | ||||
Principal outstanding | 1,500 | 1,500 | ||
Plus: accrued interest | 241 | 181 | ||
Less: unamortized debt issuance costs | (29) | (45) | ||
Carrying value | $ 1,712 | $ 1,636 | ||
Amount borrowed | $ 500 | $ 1,000 |
Equity (Details)
Equity (Details) $ / shares in Units, dose in Millions, $ in Millions | Apr. 27, 2021USD ($) | Apr. 23, 2021$ / sharesshares | Mar. 01, 2021dose$ / sharesshares | Feb. 10, 2021USD ($) | Feb. 07, 2021$ / sharesshares | Jun. 30, 2019USD ($)shares | Aug. 31, 2020at-the-marketOffering | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Apr. 30, 2021shares | Apr. 29, 2021shares | Dec. 31, 2019USD ($) |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Convertible preferred stock, par value (in USD per share) | $ / shares | $ 0.01 | $ 0.01 | ||||||||||
Common stock, shares authorized (in shares) | shares | 295,000,000 | 200,000,000 | 295,000,000 | 200,000,000 | ||||||||
Number of At-the-Market offerings | at-the-marketOffering | 3 | |||||||||||
Senior Secured Convertible Notes | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Debt instrument, face amount | $ | $ 5.3 | |||||||||||
Series B Convertible Preferred Stock | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock, outstanding | $ | $ 5 | |||||||||||
Series B Convertible Preferred Stock | Level 3 | Measurement Input, Discount Rate | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock, measurement input | 0.15 | |||||||||||
COVAXIN Preferred Stock Purchase Agreement | Series B Convertible Preferred Stock | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of shares agreed to issue and sell | shares | 100,000 | |||||||||||
Convertible preferred stock, par value (in USD per share) | $ / shares | $ 0.01 | |||||||||||
Price per share ( in USD per share) | $ / shares | $ 109.60 | |||||||||||
Shares issued upon conversion (in shares) | shares | 10 | |||||||||||
Supply agreement, number of doses | dose | 10 | |||||||||||
Registered Direct Offering | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of shares issued and sold | shares | 10,000,000 | 3,000,000 | ||||||||||
Price per share (in USD per share) | $ / shares | $ 10 | $ 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 | shares | 1,000,000 | 108,100,000 | ||||||||||
Proceeds from sale of stock | $ | $ 4.8 | $ 36.3 | ||||||||||
Commissions, fees and expenses | $ | $ 0.1 | $ 1.5 | ||||||||||
Financing SPA | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of converted initial shares, agreed to be issued (in shares) | shares | 2,200,000 | |||||||||||
Number of converted additional shares in the form of escrow agreed to issue immediately prior to the merger (in shares) | shares | 2,200,000 | |||||||||||
Sale of stock, consideration received | $ | $ 25 |
Warrants (Details)
Warrants (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Apr. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 15, 2021 | Apr. 22, 2020 | Apr. 21, 2020 | |
Class of Warrant or Right [Line Items] | |||||||
Change in fair value of derivative liabilities | $ 0 | $ 0 | $ (3,187,000) | ||||
Repayments of debt | $ 0 | 5,625,000 | $ 5,290,000 | ||||
Level 3 | Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants outstanding (in shares) | $ 1,100,000 | ||||||
Warrant Exchange Promissory Notes | Notes payable | |||||||
Class of Warrant or Right [Line Items] | |||||||
Principal outstanding | 5,600,000 | ||||||
Fair value | $ 5,000,000 | ||||||
Repayments of debt | $ 5,600,000 | ||||||
Subscription Agreements | |||||||
Class of Warrant or Right [Line Items] | |||||||
Number of shares sold in subscription agreement | 1,000 | ||||||
Aggregate offering price | $ 395 | ||||||
Warrants Exchanged For Common Stock | |||||||
Class of Warrant or Right [Line Items] | |||||||
Number of shares issued and sold | 21,900,000 | ||||||
Canada Consulting Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants exercisable (in shares) | 200,000 | ||||||
Expected milestone payment | $ 3,000,000 | ||||||
Initial exercise price (in USD per share) | $ 6.36 | ||||||
Series A Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Class of warrant or right, issued (in shares) | 8,800,000 | ||||||
Number of warrants outstanding (in shares) | 8,800,000 | ||||||
Fair value of consideration transferred to settle warrants | $ 13,600,000 | ||||||
Fair value of consideration transferred to settle warrants, common stock | 8,600,000 | ||||||
Fair value of consideration transferred to settle warrants, promissory note | 5,000,000 | ||||||
Consideration transferred in excess of fair value | $ 12,500,000 | ||||||
Series B Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants exercisable (in shares) | 20,600,000 | ||||||
Class of warrant or right, issued (in shares) | 20,600,000 | ||||||
Change in fair value of derivative liabilities | $ 1,900,000 | ||||||
Number of warrants outstanding (in shares) | 1,000 | ||||||
Series C Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants exercisable (in shares) | 20,000,000 | ||||||
Class of warrant or right, issued (in shares) | 20,000,000 | ||||||
Number of warrants outstanding (in shares) | 1,000 | ||||||
SPA Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Number of warrants outstanding (in shares) | 0 | ||||||
OpCo Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants exercisable (in shares) | 600,000 | 900,000 | |||||
Initial exercise price (in USD per share) | $ 6.23 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Compensation Expense for Options Granted (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 6,958 | $ 660 | $ 884 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 4,909 | 349 | 363 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 2,049 | $ 311 | $ 521 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021USD ($)equityCompensationPlan$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 6,958 | $ 660 | $ 884 |
Unrecognized compensation expense | $ 12,600 | ||
Unrecognized compensation expense related to options outstanding, weighted average period for expense to be recognized | 2 years 1 month 6 days | ||
Number of equity compensation plans | equityCompensationPlan | 2 | ||
Weighted average grant date fair value (in USD per share) | $ / shares | $ 2.87 | $ 0.34 | $ 0.84 |
Options vested in period, fair value | $ 2,600 | $ 500 | $ 1,000 |
Proceeds from stock options exercised | $ 900 | $ 0 | $ 0 |
2019 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Automatic increase in shares to be issue (in percentage) | 4.00% | ||
Performance based option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 2,100 | ||
Granted (in shares) | shares | 1,500,000 | 0 | 0 |
Options not yet exercisable (in shares) | shares | 900,000 | ||
Stock options | 2019 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for grant (in shares) | shares | 11,500,000 | ||
Stock options | 2014 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares available for grant (in shares) | shares | 800,000 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Valuation Assumptions (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average expected option term (years) | 6 years | 6 years | 6 years |
Weighted average expected stock price volatility (in percentage) | 111.00% | 112.00% | 109.00% |
Expected dividend rate (in percentage) | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of expected stock price volatility (in percentage) | 109.00% | 110.00% | 89.00% |
Risk-free interest rate (in percentage) | 0.40% | 0.30% | 1.50% |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of expected stock price volatility (in percentage) | 116.00% | 117.00% | 110.00% |
Risk-free interest rate (in percentage) | 1.40% | 1.70% | 2.40% |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule Options to Purchase Common Stock (Details) - 2019 Plan - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares | ||
Options outstanding, beginning balance (in shares) | 4,224,433 | |
Granted (in shares) | 7,728,260 | |
Exercised (in shares) | (1,208,631) | |
Forfeited (in shares) | (657,895) | |
Options outstanding, ending balance (in shares) | 10,086,167 | 4,224,433 |
Options exercisable (in shares) | 1,281,244 | |
Weighted Average Exercise Price | ||
Options outstanding, beginning balance (in USD per share) | $ 0.84 | |
Granted (in USD per share) | 3.45 | |
Exercised (in USD per share) | 0.70 | |
Forfeited (in USD per share) | 4.79 | |
Options outstanding, ending balance (in USD per share) | 2.59 | $ 0.84 |
Options exercisable (in USD per share) | $ 2.92 | |
Weighted Average Remaining Contractual Life (Years) | ||
Options outstanding (in years) | 8 years 9 months 18 days | 8 years 10 months 24 days |
Options exercisable (in years) | 8 years 1 month 6 days | |
Aggregate Intrinsic Value (In Thousands) | ||
Options outstanding, beginning balance | $ 5,496 | |
Exercises in period, intrinsic value | 11,144 | |
Forfeited in period, intrinsic value | 1,277 | |
Options outstanding, ending balance | 24,664 | $ 5,496 |
Options exercisable | $ 2,990 |
Stock-based Compensation - Sc_4
Stock-based Compensation - Schedule of RSU Activity (Details) - RSUs $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Number of Shares | |
Beginning balance outstanding (in shares) | shares | 0 |
Granted (in shares) | shares | 204,901 |
Forfeited (in shares) | shares | (13,090) |
Ending balance outstanding (in shares) | shares | 191,811 |
Weighted- Average Grant-Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 0 |
Granted (in USD per share) | $ / shares | 6.87 |
Forfeited (in USD per share) | $ / shares | 8.05 |
Ending balance (in USD per share) | $ / shares | $ 6.79 |
Aggregate Intrinsic Value (in thousands) | |
Beginning balance | $ | $ 0 |
Aggregate intrinsic value, granted | $ | 1,483 |
Aggregate intrinsic value, forfeited | $ | 108 |
Ending balance | $ | $ 873 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | ||||
Income tax benefit | $ (52) | $ 0 | $ 0 | |
Loss before income taxes | (58,417) | (21,822) | (20,243) | |
Net change in valuation allowance | (18,600) | |||
Operating loss carryforwards, not subject to expiration | 131,800 | |||
Operating loss carryforwards, subject to expiration | 52,600 | |||
Unrecognized tax benefits | 303 | 303 | $ 303 | $ 0 |
Capital Loss Carryforward | ||||
Operating Loss Carryforwards [Line Items] | ||||
Tax credit carryforward, amount | 26,700 | |||
State and local | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | 183,100 | 126,700 | ||
Tax credit carryforward, amount | 700 | 500 | ||
Federal | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | 184,400 | 128,000 | ||
Tax credit carryforward, amount | $ 3,800 | $ 2,200 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||||
Federal income tax benefit at statutory rate (in percentage) | 21.00% | 21.00% | 21.00% | |
State and local tax, net of federal benefit (in percentage) | 7.90% | 7.50% | 5.30% | |
Research and development credit (in percentage) | 3.20% | 2.80% | 3.20% | |
Effective Income Tax Rate Reconciliation, Permanent Differences, Percent | (0.10%) | (1.00%) | (8.10%) | |
Other (in percentage) | 0.00% | 1.10% | 2.90% | |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Percent | (31.90%) | (31.40%) | (24.30%) | |
Total provision for income taxes | 0.10% | 0.00% | 0.00% | |
Unrecognized tax benefits | $ 303 | $ 303 | $ 303 | $ 0 |
Additions for tax positions taken in a prior year | 0 | 0 | 303 | |
Additions for tax positions taken in the current year | 0 | 0 | 0 | |
Reductions for tax positions taken in the prior year due to settlement | 0 | 0 | 0 | |
Reductions for tax positions taken in the prior year due to statutes lapsing | $ 0 | $ 0 | $ 0 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 52,038 | $ 35,714 |
Capital loss carryforwards | 7,298 | 7,298 |
Start-up costs | 11,235 | 11,235 |
Accruals and reserves | 448 | 398 |
Intellectual property amortization | 1,960 | 2,285 |
Stock-based compensation expense | 2,064 | 1,290 |
Tax credits | 4,350 | 2,541 |
Lease liability | 461 | 125 |
Total deferred tax assets | 79,854 | 60,886 |
Valuation allowance | (79,395) | (60,761) |
Deferred tax assets, net of allowance | 459 | 125 |
Deferred tax liabilities: | ||
Lease right-of-use assets | (459) | (125) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized Tax Benefits Reconciliation | |||
Unrecognized tax benefits, beginning balance | $ 303 | $ 303 | $ 0 |
Additions for tax positions taken in a prior year | 0 | 0 | 303 |
Additions for tax positions taken in the current year | 0 | 0 | 0 |
Reductions for tax positions taken in the prior year due to settlement | 0 | 0 | 0 |
Reductions for tax positions taken in the prior year due to statutes lapsing | 0 | 0 | 0 |
Unrecognized tax benefits, ending balance | $ 303 | $ 303 | $ 303 |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share | |||
Net loss | $ (58,365) | $ (21,822) | $ (20,243) |
Deemed dividend related to Warrant Exchange | 0 | (12,546) | 0 |
Net loss to common stockholders | (58,365) | (34,368) | (20,243) |
Net Loss-diluted | $ (58,365) | $ (34,368) | $ (20,243) |
Shares used in calculation net loss per common share - basic (in shares) | 195,013,043 | 112,236,110 | 13,893,819 |
Shares used in calculation net loss per common share - diluted (in shares) | 195,013,043 | 112,236,110 | 13,893,819 |
Net loss per common share - basic (in USD per share) | $ (0.30) | $ (0.31) | $ (1.46) |
Net loss per common share - diluted (in USD per share) | $ (0.30) | $ (0.31) | $ (1.46) |
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | |||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 11,627,794 | 5,094,450 | 10,375,134 |
Options to purchase common stock | |||
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | |||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 10,086,167 | 4,224,433 | 731,189 |
RSUs | |||
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | |||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 191,811 | 0 | 0 |
Warrants | |||
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | |||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 799,251 | 870,017 | 9,643,945 |
Series A Convertible Preferred Stock | |||
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | |||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 3,115 | 0 | 0 |
Series B Convertible Preferred Stock | |||
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | |||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 547,450 | 0 | 0 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | Feb. 25, 2022 | Feb. 22, 2022 | Jan. 24, 2022 | Mar. 31, 2021 | Feb. 28, 2022 |
COVAXIN Preferred Stock Purchase Agreement | Series B Convertible Preferred Stock | |||||
Subsequent Events | |||||
Advance payment amount | $ 6 | ||||
Subsequent events | |||||
Subsequent Events | |||||
Purchase commitment | $ 14.3 | ||||
Subsequent events | Public Offering Of Common Stock | |||||
Subsequent Events | |||||
Number of shares issued and sold | 16 | ||||
Price per share (in USD per share) | $ 3.13 | ||||
Proceeds from sale of stock | $ 49.8 | ||||
Subsequent events | Over-Allotment Option | |||||
Subsequent Events | |||||
Number of shares issued and sold | 2.4 | ||||
Price per share (in USD per share) | $ 3.13 | ||||
Subsequent events | Warrants | |||||
Subsequent Events | |||||
Business combination, consideration transferred, equity interests issued and issuable (in shares) | $ 2.3 | ||||
Initial exercise price (in USD per share) | $ 3.76 | ||||
Warrants outstanding, term | 10 years |