Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 01, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
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 | 2020 | ||
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 | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 28.6 | ||
Entity Common Stock, Shares Outstanding | 188,088,860 | ||
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 2021 annual meeting of stockholders to be filed no later than 120 days after the end of the registrant’s fiscal year ended December 31, 2020. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 24,039,325 | $ 7,444,052 |
Prepaid expenses and other current assets | 1,838,357 | 1,322,167 |
Asset held for sale | 0 | 7,000,000 |
Total current assets | 25,877,682 | 15,766,219 |
Property and equipment, net | 632,967 | 222,464 |
Restricted cash | 151,226 | 151,016 |
Other assets | 714,477 | 667,747 |
Total assets | 27,376,352 | 16,807,446 |
Current liabilities | ||
Accounts payable | 395,034 | 1,895,613 |
Accrued expenses | 2,930,395 | 2,270,045 |
Short-term debt, net | 234,119 | 0 |
Operating lease obligation | 44,248 | 172,310 |
Other current liabilities | 9,755 | 205,991 |
Total current liabilities | 3,613,551 | 4,543,959 |
Non-current liabilities | ||
Operating lease obligation, less current portion | 389,317 | 163,198 |
Long term debt, net | 1,823,043 | 1,072,123 |
Other non-current liabilities | 0 | 9,755 |
Total non-current liabilities | 2,212,360 | 1,245,076 |
Total liabilities | 5,825,911 | 5,789,035 |
Commitments and contingencies (Note 15) | ||
Stockholders’ equity | ||
Convertible preferred stock; $0.01 par value; 10,000,000 shares authorized; seven issued and outstanding shares at December 31, 2020 and 2019 | 0 | 0 |
Common stock; $0.01 par value; 200,000,000 authorized; 184,133,384 and 52,746,728 shares issued at December 31, 2020 and 2019, respectively; 184,011,884 and 52,625,228 shares outstanding at December 31, 2020 and 2019, respectively | 1,841,334 | 527,467 |
Treasury Stock, at cost, 121,500 shares at December 31, 2020 and 2019 | (47,864) | (47,864) |
Additional paid-in capital | 93,058,748 | 62,018,632 |
Accumulated deficit | (73,301,777) | (51,479,824) |
Total stockholders’ equity | 21,550,441 | 11,018,411 |
Total liabilities and stockholders’ equity | $ 27,376,352 | $ 16,807,446 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
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 |
Convertible preferred stock, shares issued (in shares) | 7 | |
Convertible preferred stock, shares outstanding (in shares) | 7 | 7 |
Common stock, par value (in USD per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 184,133,384 | 52,746,728 |
Common stock, shares outstanding (in shares) | 184,011,884 | 52,625,228 |
Treasury stock, common, shares (in shares) | 121,500 | 121,500 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues | ||
Collaboration revenue | $ 42,620 | $ 0 |
Total revenues | 42,620 | 0 |
Operating expenses | ||
Research and development | 6,353,287 | 8,085,522 |
In-process research and development | 7,000,000 | 0 |
General and administrative | 7,974,050 | 6,077,097 |
Total operating expenses | 21,327,337 | 14,162,619 |
Loss from operations | (21,284,717) | (14,162,619) |
Other income (expense) | ||
Change in fair value of derivative liabilities | 0 | (3,187,380) |
Loss on debt conversion | 0 | (341,136) |
Interest income | 1,065 | 1,214 |
Interest expense | (720,963) | (1,767,836) |
Other income (expense) | 182,662 | (784,873) |
Total other income (expense) | (537,236) | (6,080,011) |
Net loss | (21,821,953) | (20,242,630) |
Deemed dividend related to Warrant Exchange | (12,546,340) | 0 |
Net loss to common stockholders | $ (34,368,293) | $ (20,242,630) |
Shares used in calculating net loss per common share - basic and diluted (in shares) | 112,236,110 | 13,893,819 |
Net loss per share of common stock - basic and diluted (in USD per share) | $ (0.31) | $ (1.46) |
Net loss | $ (21,821,953) | $ (20,242,630) |
Other comprehensive income (loss) | ||
Foreign currency translation adjustment | 0 | (451) |
Comprehensive loss | $ (21,821,953) | $ (20,243,081) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Subscription Agreements | Pre-Merger Financing | Reverse Asset Acquisition | Warrant Exercises | At-the-Market Issuance | Common Stock | Common StockSubscription Agreements | Common StockPre-Merger Financing | Common StockReverse Asset Acquisition | Common StockWarrant Exercises | Common StockAt-the-Market Issuance | 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 | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 4,960,552 | ||||||||||||||||||||
Beginning balance at Dec. 31, 2018 | $ (12,709,539) | $ 49,606 | $ 0 | $ 18,477,598 | $ 451 | $ (31,237,194) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||||||||||
Stock-based compensation expense | 884,089 | 884,089 | |||||||||||||||||||
Issuance of stock (in shares) | 80,569 | 4,385,964 | 1,651,748 | 40,542,222 | |||||||||||||||||
Issuance of stock | $ 1,000,000 | $ 13,150,456 | $ 3,565,788 | $ 183,034 | $ 806 | $ 43,860 | $ 16,517 | $ 405,422 | $ 999,194 | $ 13,106,596 | $ 3,549,271 | $ (222,388) | |||||||||
Conversion of debt (in shares) | 1,125,673 | ||||||||||||||||||||
Conversion of debt | 13,979,788 | $ 11,256 | 13,968,532 | ||||||||||||||||||
Reclassification of Series B Warrants from liability to equity | 11,255,740 | 11,255,740 | |||||||||||||||||||
Repurchase of treasury stock | (47,864) | (47,864) | |||||||||||||||||||
Foreign currency translation adjustment | (451) | (451) | |||||||||||||||||||
Net loss | (20,242,630) | (20,242,630) | |||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2019 | 52,746,728 | ||||||||||||||||||||
Ending balance at Dec. 31, 2019 | 11,018,411 | $ 527,467 | (47,864) | 62,018,632 | 0 | (51,479,824) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||||||||||
Stock-based compensation expense | 660,317 | 660,317 | |||||||||||||||||||
Issuance of stock (in shares) | 1,328,405 | 108,137,431 | |||||||||||||||||||
Issuance of stock | $ 331,756 | $ 36,339,786 | $ 13,284 | $ 1,081,375 | $ 318,472 | $ 35,258,411 | |||||||||||||||
Conversion of debt (in shares) | 21,920,820 | ||||||||||||||||||||
Conversion of debt | (4,977,876) | $ 219,208 | (5,197,084) | ||||||||||||||||||
Foreign currency translation adjustment | 0 | ||||||||||||||||||||
Net loss | (21,821,953) | (21,821,953) | |||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 184,133,384 | ||||||||||||||||||||
Ending balance at Dec. 31, 2020 | $ 21,550,441 | $ 1,841,334 | $ (47,864) | $ 93,058,748 | $ 0 | $ (73,301,777) |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reverse Asset Acquisition | ||
Commissions and equity issuance costs | $ 2.6 | |
At-the-Market Issuance | ||
Commissions and equity issuance costs | $ 1.5 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (21,821,953) | $ (20,242,630) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 102,110 | 60,608 |
Non-cash interest expense | 720,963 | 1,733,521 |
Non-cash lease expense | 189,424 | 250,361 |
In-process research and development | 7,000,000 | 0 |
Change in fair value of derivative liability | 0 | 3,187,380 |
Stock-based compensation expense | 660,317 | 884,089 |
Loss on debt conversion | 0 | 341,136 |
Other non-cash | (349,409) | 4,803 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (369,846) | (1,007,367) |
Accounts payable and accrued expenses | (540,847) | (1,628,621) |
Other assets | (104,000) | (227,172) |
Lease obligations | (195,489) | (249,389) |
Net cash used in operating activities | (14,708,730) | (16,893,281) |
Cash flows from investing activities | ||
Purchase of property and equipment | (306,825) | (29,446) |
Payment of reverse asset acquisition costs | 0 | (2,327,273) |
Net cash used in investing activities | (306,825) | (2,356,719) |
Cash flows from financing activities | ||
Financing lease principal payments | (23,856) | (25,866) |
Proceeds from issuance of common stock | 37,822,025 | 1,183,034 |
Payment of equity issuance costs | (1,477,806) | 0 |
Proceeds from issuance of debt | 921,415 | 6,800,000 |
Payments of debt issuance costs | (5,740) | (99,202) |
Repayments of debt | (5,625,000) | (5,290,000) |
Purchases of treasury stock | 0 | (47,864) |
Proceeds from Pre-Merger Financing | 0 | 22,546,353 |
Net cash provided by financing activities | 31,611,038 | 25,066,455 |
Net increase in cash, cash equivalents and restricted cash | 16,595,483 | 5,816,455 |
Cash, cash equivalents and restricted cash at beginning of period | 7,595,068 | 1,778,613 |
Cash, cash equivalents and restricted cash at end of period | 24,190,551 | 7,595,068 |
Supplemental disclosure of non-cash transactions: | ||
Issuance of Warrant Exchange Promissory Notes | 5,625,000 | 0 |
Obligation settled with common stock | 331,218 | 0 |
Purchase of property and equipment | 213,625 | 0 |
Conversion of convertible notes | 0 | 13,979,788 |
Right-of-use assets related to operating leases | 179,599 | 470,356 |
Equity issuance costs | 4,029 | 1,150,000 |
Reverse asset acquisition costs | $ 0 | $ 2,252,795 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Ocugen, Inc., together with its wholly owned subsidiaries (“Ocugen” or the “Company”), is a biopharmaceutical company focused on developing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. The Company is located in Malvern, Pennsylvania. Ocugen is co-developing COVAXIN, a whole-virion inactivated COVID-19 vaccine candidate, with Bharat Biotech International Limited ("Bharat Biotech") for the U.S. market. COVAXIN is being developed to prevent COVID-19 infection in humans and is formulated with the inactivated SARS-CoV-2 virus, an antigen, and an adjuvant. In February 2021, the Company entered into a Co-Development, Supply and Commercialization Agreement (the "Covaxin Agreement") with 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 in humans in the United States, its territories and possessions (the “Ocugen Covaxin Territory”). COVAXIN has been granted approval for emergency use in India. A Phase 3 clinical trial is ongoing in India. The Company is currently evaluating the clinical and regulatory path for COVAXIN in the United States including obtaining Emergency Use Authorization ("EUA") from the U.S. Food and Drug Administration (the "FDA") and, eventually, biologic license application (“BLA”) approval in the U.S. market, as well as the Company's commercialization strategy, if authorized or approved. See Note 16 for additional information about the terms, rights, and obligations under the Covaxin Agreement. Ocugen is developing a breakthrough modifier gene therapy platform to generate therapies designed to fulfill unmet medical needs in the area of retinal diseases, including inherited retinal diseases ("IRDs") and dry age-related macular degeneration ("AMD"). Ocugen'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. Unlike single-gene replacement therapies, which only target one genetic mutation, Ocugen believes that its gene therapy platform, through its use of NHRs, represents a novel approach in that it may address multiple retinal diseases with one product. OCU400 is the Company's first product candidate being developed with the Company's modifier gene therapy platform. OCU400 is a novel gene therapy product candidate with the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs, including retinitis pigmentosa ("RP") and leber congenital amaurosis ("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. Ocugen is planning to initiate two Phase 1/2a clinical trials for OCU400 in the United States in the second half of 2021. OCU400 additionally received Orphan Medicinal Product Designation from the European Commission, based on the recommendation of the European Medicines Agency, for RP and LCA in February 2021, which Ocugen believes further supports the broad spectrum application of OCU400 to treat many IRDs. Ocugen is currently evaluating options to commence OCU400 clinical trials in Europe in 2022. Ocugen'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. This candidate is currently in preclinical development. Ocugen is planning to initiate a Phase 1/2a clinical trial for OCU410 in 2022. Ocugen is also conducting preclinical development for its biologic product candidate, OCU200. OCU200 is a novel fusion protein designed to treat diabetic macular edema, diabetic retinopathy, and wet AMD. Ocugen had a pre-Investigational New Drug ("IND") meeting with the FDA in November 2020 and received guidance on IND-enabling preclinical studies to support the Phase 1/2a study. Ocugen expects to initiate IND-enabling preclinical studies for OCU200 in 2021. Ocugen plans to initiate a Phase 1/2a clinical trial for OCU200 in 2022. Ocugen was developing OCU300, a small molecule therapeutic for the treatment of symptoms associated with ocular graft-versus-host disease. The Phase 3 clinical trial for OCU300 was discontinued in 2020 based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. Ocugen is no longer pursuing the development of this product candidate. Merger with Histogenics 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, by and among OpCo, Restore Merger Sub, Inc., the Company's wholly owned subsidiary ("Merger Sub"), and the Company, as amended (the "Merger Agreement") pursuant to which Merger Sub merged with and into OpCo, with OpCo surviving as the Company's wholly owned subsidiary. Immediately after completion of the Merger, the Company changed its name to Ocugen, Inc. and the business previously conducted by OpCo became the business conducted by the Company. OpCo is deemed to be the accounting acquirer. Accordingly, the historical financial statements of OpCo became the Company’s historical financial statements, including the comparative prior periods. See Note 3 for additional information. Going Concern Consideration The audited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) assuming the Company will continue as a going concern. As of December 31, 2020, the Company had cash, cash equivalents, and restricted cash of approximately $24.2 million, and since that date the Company has received net proceeds of $4.8 million from the sale of the Company's common stock in an at-the-market offering (“ATM") commenced in August 2020 and net proceeds of $21.2 million from the sale of the Company's common stock in a registered direct offering (the "Registered Direct Offering"). See Note 9 for additional information about the August 2020 ATM. See Note 16 for additional information about the Registered Direct Offering. As a result of the Company's cash, cash equivalents, and restricted cash balance as of December 31, 2020 and the net proceeds received subsequent to December 31, 2020 from the August 2020 ATM and the Registered Direct Offering, the Company believes that its cash, cash equivalents, and restricted cash will enable the Company to fund its operating expenses and capital expenditure requirements through at least one year from the date the audited consolidated financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Basis of Presentation and Consolidation The accompanying consolidated financial statements included herein have been prepared in conformity with 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, Inc. 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 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 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 estimation of clinical trial accruals, warrant transactions, asset held for sale, and the valuation of debt and equity instruments, including embedded derivatives, and stock-based compensation. 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 (“ASC 606”). 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. The Company has two agreements accounted for as collaborative agreements within the scope of ASC 808. See Note 4 for additional information. 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 employee. Asset Held for Sale An asset is considered to be held for sale when all of the following criteria are met: (i) management commits to a plan to sell the asset; (ii) it is unlikely that the disposal plan will be significantly modified or discontinued; (iii) the asset is available for immediate sale in its present condition; (iv) actions required to complete the sale of the asset have been initiated; (v) sale of the asset is probable and the completed sale is expected to occur within one year; and (vi) the asset is actively being marketed for sale at a price that is reasonable given its current market value. A long-lived asset classified as held for sale is measured at the lower of its carrying amount or fair value less cost to sell. If the long-lived asset is newly acquired, the carrying amount of the long-lived asset is established based on its fair value less cost to sell at the acquisition date. A long-lived asset is not depreciated or amortized while it is classified as held for sale, and an impairment loss would be recognized to the extent the carrying amount exceeds the asset's fair value less cost to sell. As of December 31, 2019, the Company had an intangible asset held for sale. The intangible asset qualified and was recorded as held for sale as of the date of the Merger and 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 held for sale 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 during the year ended December 31, 2020 as the in-process research and development does not have an alternative future use. Although the Company has concluded that a sale of the intangible asset is no longer probable to be completed within one year from the date the intangible asset was initially recorded as held for sale, the Company is party to an Asset Purchase Agreement (as defined within Note 3) related to the intangible asset as of December 31, 2020, and continues to market the asset for sale. In the event of a sale of the intangible asset under the Asset Purchase Agreement or to another party, the Company will account for the sale in the period in which the sale occurs. Fair Value Measurements The company follows the provisions of the FASB ASC Topic 820, Fair Value Measurements (“ASC 820”), which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair measurements. The carrying value of certain financial instruments, including cash and cash equivalents, accounts payable, and accrued expenses approximates their fair values due to the short-term nature of these instruments. ASC 820 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) As of December 31, 2020, the Company believes the fair values using Level 2 inputs of the PPP Note and the borrowings under the EB-5 Loan Agreement (both as defined in Note 10) approximate their carrying values. See Note 10 for additional information. Derivative Instruments 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, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument, in accordance with FASB ASC Topic 815, Derivatives and Hedging . The Company additionally follows the provisions of ASC Topic 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity for warrants issued, which is the authoritative guidance on accounting for derivative financial instruments indexed and potentially settled in a company's own stock. In order to determine if a contract is considered indexed to the Company's own stock for the purposes of determining liability versus equity classification, the Company performs a two-step analysis: (i) evaluate whether the contract contains any exercise contingencies and, if so, whether they disqualify the contract from being classified as equity; and (ii) assess whether the settlement terms are consistent with equity classification. 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 instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. The Company had derivative instruments that were fair valued on a recurring basis using Level 3 inputs during the year ended December 31, 2019. There were no derivative instruments fair valued on a recurring basis using Level 3 inputs during the year ended December 31, 2020. 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 and 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: As of December 31, 2020 2019 Cash and cash equivalents $ 24,039,325 $ 7,444,052 Restricted cash 151,226 151,016 Total cash, cash equivalents and restricted cash $ 24,190,551 $ 7,595,068 Property and Equipment, Net Property and equipment is recorded at 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. Then Company's property and equipment includes office equipment, lab equipment, leasehold improvements, and a right-of-use asset under the Company's financing lease. The Company's office equipment includes computers and other office technology equipment with a useful life of five years as well as furniture and fixtures with a useful life of seven years. The Company's lab equipment has a useful life of five years. Leasehold improvements are amortized over the shorter of their useful lives or the remaining lease term. If a leasehold improvement transfers ownership to the Company at the end of the lease term, the leasehold improvement is amortized over its useful life. The right-of-use asset under the Company's financing lease is amortized over five years, which represents the estimated useful life of the underlying leased equipment. See Note 6 for additional information about the Company's financing lease. 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 has lease agreements which 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 on 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. The Company primarily 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. As an implicit interest rate is not readily determinable in the Company’s leases, the incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company 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. Options for lease renewals have been excluded from the lease term (and lease liability) for the Company’s leases as the reasonably certain threshold has not been met. 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 lease payments not dependent on a rate or index associated with the Company’s leases are recognized when the event, activity, or circumstance is probable. Variable lease payments include the Company's proportionate share of 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. Stock-based compensation The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and modifications to existing agreements, to be recognized in the consolidated statements of operations and comprehensive loss based on their fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of options granted. The Company recognizes forfeitures as they occur. The Company’s stock-based awards are subject to service-based vesting conditions. Compensation expense related to awards to employees and directors 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 awards generally vest over a one three Estimating the fair value of options requires the input of subjective assumptions, including expected life of the 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. These assumptions used in Ocugen’s Black-Scholes option-pricing model 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 options is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the 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. Segment Information As of December 31, 2020, 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, 2020, substantially all of the Company's assets were located in the United States. Recently Adopted Accounting Standards In August 2018, the FASB issued Accounting Standards Update ("ASU") No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement . This standard modifies certain disclosure requirements on fair value measurements and was effective for the Company on January 1, 2020. The adoption of this standard did not have a material impact on the Company's disclosures. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606. This standard clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, ASC 606 guidance should be applied, including recognition, measurement, presentation, and disclosure requirements. The standard adds unit-of-account guidance to ASC 808 to align with the guidance in ASC 606 when an entity is assessing whether the collaborative arrangement or a part of the collaborative arrangement is within the scope of ASC 606. The standard also precludes a company from presenting transactions with collaborative arrangement participants that are not directly related to sales to third parties with revenue from contracts with customers recognized under ASC 606 if the collaborative arrangement participant is not a customer. This standard was effective for the Company on January 1, 2020. Consistent with the guidance in this standard, the Company assesses whether collaboration arrangements are within the scope of ASC 606. For collaboration arrangements that are not within the scope of ASC 606, applicable transactions with collaborative arrangement participants are presented as collaboration revenue rather than revenue from contracts with customers. See above and Note 4 for additional information. Recent Accounting Pronouncements 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 2016-13, which have the same effective date and transition date of January 1, 2023. These standards require 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 these standards to have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard will have an effective date and transition date of January 1, 2021. 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 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. The Company does not currently expect the adoption of this standard to have a material impact on its 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 permitted beginning January 1, 2021. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models in ASC 470-20 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 its consolidated financial statements. |
Merger and Pre-Merger Financing
Merger and Pre-Merger Financing | 12 Months Ended |
Dec. 31, 2020 | |
Business Combinations [Abstract] | |
Merger and Pre-Merger Financing | Pre-Merger Financing In June 2019, 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 “Pre-Merger Financing Warrants”) in exchange for an aggregate purchase price of $25.0 million (the "Pre-Merger Financing"). See Note 11 for additional information. Merger with Histogenics On September 27, 2019, the Company completed the Merger in accordance with the terms of the Merger Agreement. The Merger was structured as a stock-for-stock transaction whereby all of OpCo’s outstanding shares of common stock and securities convertible into or exercisable for OpCo’s common stock were converted into the right to receive Histogenics’ common stock and securities convertible into or exercisable for Histogenics’ common stock. Immediately following the Merger, the former equity holders of OpCo owned 84.25% of the outstanding capital stock of the Company, and the equity holders of the Company immediately before the Merger owned 15.75% of the outstanding capital stock of the Company. In accordance with FASB ASC Topic 805 , Business Combinations (“ASC 805”), the Company concluded that, while Histogenics was the legal acquirer, OpCo was the accounting acquirer due to the fact that (i) OpCo’s shareholders had the majority of the voting rights in Ocugen, (ii) OpCo held all of the board seats of the combined company, and (iii) OpCo management held all key positions in the management of the combined company. The Company further concluded that Histogenics did not meet the definition of a business under ASC 805 due to the fact that substantially all of the fair value of the gross assets disposed of is concentrated in a single identifiable asset or a group of similar identifiable assets. Therefore, the Merger was accounted for as a reverse asset acquisition. NeoCart Histogenics’ product, NeoCart, is an innovative cell therapy that utilizes various aspects of its restorative cell therapies platform to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. In December 2017, Histogenics entered into the License and Commercialization Agreement with MEDINET Co., Ltd. (“MEDINET”) to grant MEDINET a license under certain patents, patent applications, know-how, and technology to develop and commercialize certain therapeutic products related to the NeoCart program. In December 2018, after receiving feedback from the FDA regarding the need for an additional clinical trial prior to submission of a BLA, Histogenics discontinued the development of NeoCart. In connection with the Merger, on May 8, 2019, Histogenics entered into an asset purchase agreement (the "Asset Purchase Agreement") with Medavate Corp., pursuant to which Histogenics agreed to sell substantially all of its assets relating to its NeoCart program for $6.5 million. The parties subsequently amended the Asset Purchase Agreement to increase the purchase price to $7.0 million with the purchase price increasing 10% per month (or any portion thereof) starting October 31, 2019 if the closing date of the Asset Purchase Agreement did not occur prior to October 31, 2019. The Company may terminate the Asset Purchase Agreement at any time without recourse. The Asset Purchase Agreement closing date did not occur as of December 31, 2020 and the Company has not terminated the Asset Purchase Agreement as of December 31, 2020. The NeoCart asset was held for sale as of December 31, 2019. The NeoCart asset qualified as held for sale as of the date of the Merger and was carried at its original fair value less cost to sell based on a quoted price of $7.0 million, which was an observable Level 2 fair value input. The Company concluded during the year ended December 31, 2020, that a sale of the NeoCart asset was no longer probable to be completed within one year from the date of the Merger and therefore the NeoCart asset did not qualify as held for sale as of December 31, 2020. See Note 2 for additional information. |
License and Development Agreeme
License and Development Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
License and Development Agreements | Collaboration Agreement with Advaite, Inc. In April 2020, the Company entered into a collaboration agreement (the “Advaite Agreement”) with Advaite, Inc. (“Advaite”) with respect to the development of Advaite’s RapCov COVID-19 Testing Kit (the “COVID-19 Test”). Advaite was co-founded and is being managed by Mr. Karthik Musunuri, the son of the Company's Chief Executive Officer, Chairman of the Board and co-founder, Dr. Shankar Musunuri. Pursuant to the Advaite Agreement, the Company has provided, and will continue to provide as required in the future, certain production, research and development, technical, regulatory, and quality support services to Advaite in connection with the development and commercialization of the COVID-19 Test (the “Ocugen Services”). Advaite is responsible for the research, development, and seeking to obtain regulatory approval of the COVID-19 Test, and where regulatory approval is obtained, commercialize the COVID-19 Test. In January 2021, the COVID-19 Test received EUA from the FDA. Advaite will solely own all data and materials, including the COVID-19 Test, generated by the Company and its representatives solely in the course of the performance of the Ocugen Services. Advaite is responsible for all preparation and submission of regulatory materials for the COVID-19 Test to regulatory authorities, and Advaite holds all regulatory approvals of the COVID-19 Test in its name and owns all related submissions. The Company is entitled to receive cost reimbursements from Advaite for (a) costs incurred by the Company related to its personnel who are subject matter experts involved in providing the Ocugen Services ("SME Costs"); and (b) Advaite's pro-rata share of all costs, other than SME Costs, incurred by the Company in providing the Ocugen Services. As partial consideration for the Company's performance of the Ocugen Services, Advaite will pay to the Company a quarterly royalty in the range of mid-to-high single digits based on net sales of the COVID-19 Tests. The Advaite Agreement is a collaborative arrangement within the scope of ASC 808. Cost reimbursements are recorded as a reduction in research and development expense in the period incurred. Royalty payments are recorded as collaboration revenue in the period in which the underlying sale occurs. For the year ended December 31, 2020, the Company recorded $0.3 million as a reduction of research and development expense. For the year ended December 31, 2020, the Company recorded $42,620 as collaboration revenue in connection with the Advaite Agreement. The Advaite Agreement expires on April 29, 2021, unless extended upon mutual agreement of both the Company and Advaite. Except as otherwise specified in the terms of the Advaite Agreement, Advaite’s obligation to make royalty payments to the Company will survive expiration of the Advaite Agreement. Co-Development and Commercialization Agreement with CanSino Biologics Inc. In September 2019, Ocugen entered into a co-development and commercialization agreement (the “CanSinoBIO Agreement”) with CanSino Biologics Inc. (“CanSinoBIO”) with respect to the development and commercialization of the gene therapy product candidate, OCU400. CanSinoBIO will be responsible for all the costs for chemistry, manufacturing and control development and manufacture of clinical supplies of OCU400 for all territories. CanSinoBIO will be solely responsible for all costs and expenses of its development activities in and for China, Hong Kong, Macau, and Taiwan (the "CanSinoBIO Territory") and Ocugen will be responsible for all costs and expenses of its development activities for any global location outside the CanSinoBIO Territory (the "Ocugen OCU400 Territory"). CanSinoBIO will pay to Ocugen an annual royalty between mid-to-high single digits based on net sales of products in the CanSinoBIO Territory, and Ocugen will pay to CanSinoBIO an annual royalty between low-to-mid single digits based on net sales of products in the Ocugen OCU400 Territory. Unless terminated earlier, 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 patent rights of Ocugen covering such product and (b) the tenth (10 th ) anniversary of the first commercial sale of such product in such country. The CanSinoBIO Agreement will also terminate upon the termination of the Exclusive License Agreement dated December 19, 2017, as amended, between Ocugen and The Schepens Eye Research Institute, Inc ("SERI"). The CanSinoBIO Agreement may be terminated by either party in its entirety upon (a) a material 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. Within forty-five (45) days after such termination by CanSinoBIO under the circumstances described in clause (a) or (b), CanSinoBIO shall provide Ocugen with a statement of the CanSinoBIO development costs and, within one (1) year after receipt of such report, Ocugen shall reimburse CanSinoBIO all such CanSinoBIO development costs. License Agreement with The Schepens Eye Research Institute In December 2017, the Company entered into an exclusive license agreement with 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 nuclear hormone receptor genes Nuclear Receptor Subfamily 1 Group D Member 1, NR2E3 (OCU400), RORA (OCU410), Nuclear Protein 1, Transcriptional Regulator, and Nuclear Receptor Subfamily 2 Group C Member 1. The January 2021 amendment to the SERI Agreement additionally grants the Company rights in co-owned intellectual property pursuant certain patent applications and provisional patent applications. Under the SERI Agreement, the Company may make, have made, use, offer to sell, sell, and import licensed products. Under this agreement, the Company must use commercially reasonable efforts to bring one or more licensed products to market as soon as reasonably practicable. The Company is additionally party to a research agreement (the "Sponsored Research Agreement") with SERI, under which the Company incurs research and development expenses for work performed. The Sponsored Research Agreement will expire in June 2023. The Company may terminate the Sponsored Research Agreement at any time upon providing 60 days notice to SERI or upon mutual consent of both SERI and the Company. 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 SERI Agreement is a collaborative arrangement within the scope of ASC 808. Payments pursuant to the SERI Agreement are recorded as research and development expense in the period the obligation is incurred. The SERI Agreement requires the Company to pay licensing fees for patent rights granted, an annual license maintenance fee of $25,000 the first two calendar years following the expiration or termination of the Sponsored Research Agreement and an annual license maintenance fee of $0.1 million for each calendar year thereafter, payment of up to $6.0 million upon the achievement of certain development and regulatory milestones, payment of up to $10.1 million upon the achievement of certain commercial milestones, and royalties in the low-single digits based on net sales. 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 patents right. 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, fail to make payments within thirty days of receiving a written notice of missed payment, fail to comply with the Company's diligence obligations, default on its obligation to procure and maintain insurance, one of its officers is convicted of 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. License Agreement with the University of Illinois at Chicago In February 2016, the Company entered into an exclusive license agreement (the “UIC Agreement”) with the University of Illinois at Chicago ("UIC"). This agreement gave the Company an exclusive, worldwide, non-transferable, sublicensable license to patents and patent rights for OCU300 to make, have made, use, import, sell, and offer for sale products claimed by and/or incorporating or derived from the licensed patents. The UIC Agreement additionally gave the Company joint patent rights for patents and patent applications covering inventions or discoveries that were jointly conceived and reduced to practice by the Company and UIC. As a result of the Company's discontinuation of the Phase 3 clinical trial for OCU300, the Company terminated the UIC Agreement effective in December 2020. Upon the termination of the UIC Agreement, all rights granted under the UIC Agreement reverted back to UIC. Joint patent rights for patents and patent applications covering inventions or discoveries that were jointly conceived by the Company and UIC remain co-owned by both the Company and UIC subsequent to the termination of the UIC Agreement. 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. Under the agreement, the Company 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 development and regulatory milestone aggregating to $1.5 million, annual minimum payments of $20,000 beginning in the third year after the effective date and increasing to a percentage rate in the mid-twenties of the previous year's royalty payments (as applicable), royalties in the low single digits 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. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | The major components of property and equipment as of December 31, 2020 and 2019 consist of the following: As of December 31, 2020 2019 Office equipment $ 165,755 $ 113,553 Lab equipment 452,128 130,132 Leasehold improvements 176,964 41,010 Financing lease right-of-use asset 63,817 63,817 Total property and equipment 858,664 348,512 Less: accumulated depreciation (225,697) (126,048) Total property and equipment, net $ 632,967 $ 222,464 Depreciation expense during each of the years ended December 31, 2020 and 2019 was $0.1 million. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Leases | Operating Leases The Company has commitments under operating leases for certain facilities used in its operations including for the use of laboratory, office, and storage space. On October 9, 2020 (the "Effective Date"), the Company entered into a lease agreement (the "Lease Agreement") with WPT Land 2 LP (the "Landlord") for a laboratory, office, and storage space located in Malvern, Pennsylvania. The Lease Agreement was determined to have two lease components per ASC 842, a laboratory space lease component (the "Initial Premises") and an office, storage, and future expanded laboratory space lease component (the "Expansion Premises"), with varying commencement dates. The Initial Premises commencement date occurred in December 2020. The Expansion Premises commencement date did not occur as of December 31, 2020. The Lease Agreement has an initial term of seven five The Company had a former lease agreement with the Landlord for the Company's former office space. Pursuant to the terms of the Lease Agreement, the Company terminated the former lease agreement with the Landlord without penalty upon the commencement of the Expansion Premises in January 2021. The termination date of the former lease agreement is January 31, 2021 and the termination was accounted for as a modification per ASC 842 as the contractual lease term was shortened. The Company has no remaining lease payments as of December 31, 2020 for the former lease agreement. The Company additionally terminated the lease agreement for the Company's former laboratory space effective December 31, 2020. The Company has no remaining lease payments as of December 31, 2020 for the former laboratory space lease agreement. The components of lease expense were as follows: Year ended December 31, 2020 2019 Operating lease cost $ 189,424 $ 250,361 Variable lease cost 84,790 79,700 Total lease cost $ 274,214 $ 330,061 Supplemental balance sheet information related to leases was as follows: As of December 31, 2020 2019 Right-of-use assets, net $ 433,649 $ 344,574 Current lease obligations $ 44,248 $ 172,310 Non-current lease obligations 389,317 163,198 Total lease liabilities $ 433,565 $ 335,508 Supplemental information related to leases was as follows: Year ended December 31, 2020 2019 Weighted-average remaining lease terms—operating leases (years) 6.9 2.0 Weighted-average discount rate—operating leases 4.6 % 7.6 % Future minimum operating minimum lease payments, exclusive of taxes and other carrying charges, are approximately as follows: For the years ending December 31, Amount 2021 $ 61,688 2022 69,399 2023 71,502 2024 73,605 2025 75,708 Thereafter 157,725 Total $ 509,627 Less: present value adjustment (76,062) Present value of minimum lease payments $ 433,565 _______________________ The future minimum operating lease payments excludes payments for the Expansion Premises for which the commencement date did not occur as of December 31, 2020. The estimated aggregate base rent payments for the Expansion Premises are $1.4 million. Financing Leases In June 2018, the Company leased specialized research equipment under a lease classified as a financing lease. The leased equipment is included in property and equipment, net and is amortized on a straight-line basis over five years. Financing lease liabilities are included in other liabilities on the Company's consolidated balance sheets. The interest rate related to the lease obligation is 7.6% and the maturity date is July 2021. The Company has a de minimis amount of remaining payments under the financing lease as of December 31, 2020. |
Leases | Operating Leases The Company has commitments under operating leases for certain facilities used in its operations including for the use of laboratory, office, and storage space. On October 9, 2020 (the "Effective Date"), the Company entered into a lease agreement (the "Lease Agreement") with WPT Land 2 LP (the "Landlord") for a laboratory, office, and storage space located in Malvern, Pennsylvania. The Lease Agreement was determined to have two lease components per ASC 842, a laboratory space lease component (the "Initial Premises") and an office, storage, and future expanded laboratory space lease component (the "Expansion Premises"), with varying commencement dates. The Initial Premises commencement date occurred in December 2020. The Expansion Premises commencement date did not occur as of December 31, 2020. The Lease Agreement has an initial term of seven five The Company had a former lease agreement with the Landlord for the Company's former office space. Pursuant to the terms of the Lease Agreement, the Company terminated the former lease agreement with the Landlord without penalty upon the commencement of the Expansion Premises in January 2021. The termination date of the former lease agreement is January 31, 2021 and the termination was accounted for as a modification per ASC 842 as the contractual lease term was shortened. The Company has no remaining lease payments as of December 31, 2020 for the former lease agreement. The Company additionally terminated the lease agreement for the Company's former laboratory space effective December 31, 2020. The Company has no remaining lease payments as of December 31, 2020 for the former laboratory space lease agreement. The components of lease expense were as follows: Year ended December 31, 2020 2019 Operating lease cost $ 189,424 $ 250,361 Variable lease cost 84,790 79,700 Total lease cost $ 274,214 $ 330,061 Supplemental balance sheet information related to leases was as follows: As of December 31, 2020 2019 Right-of-use assets, net $ 433,649 $ 344,574 Current lease obligations $ 44,248 $ 172,310 Non-current lease obligations 389,317 163,198 Total lease liabilities $ 433,565 $ 335,508 Supplemental information related to leases was as follows: Year ended December 31, 2020 2019 Weighted-average remaining lease terms—operating leases (years) 6.9 2.0 Weighted-average discount rate—operating leases 4.6 % 7.6 % Future minimum operating minimum lease payments, exclusive of taxes and other carrying charges, are approximately as follows: For the years ending December 31, Amount 2021 $ 61,688 2022 69,399 2023 71,502 2024 73,605 2025 75,708 Thereafter 157,725 Total $ 509,627 Less: present value adjustment (76,062) Present value of minimum lease payments $ 433,565 _______________________ The future minimum operating lease payments excludes payments for the Expansion Premises for which the commencement date did not occur as of December 31, 2020. The estimated aggregate base rent payments for the Expansion Premises are $1.4 million. Financing Leases In June 2018, the Company leased specialized research equipment under a lease classified as a financing lease. The leased equipment is included in property and equipment, net and is amortized on a straight-line basis over five years. Financing lease liabilities are included in other liabilities on the Company's consolidated balance sheets. The interest rate related to the lease obligation is 7.6% and the maturity date is July 2021. The Company has a de minimis amount of remaining payments under the financing lease as of December 31, 2020. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | Accrued Expenses are as follows: As of December 31, 2020 2019 Accrued expenses: Research and development $ 512,026 $ 271,322 Clinical 117,012 421,788 Professional fees 405,001 917,568 Employee-related 963,117 624,420 Severance-related (1) 711,596 — Other 221,643 34,947 Total accrued expenses $ 2,930,395 $ 2,270,045 _______________________ (1) See Note 8 for additional information regarding severance-related accrued expenses. |
Exit and Disposal Activities
Exit and Disposal Activities | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring and Related Activities [Abstract] | |
Exit and Disposal Activities | On June 15, 2020, the Company communicated notice to five employees of termination of their employment as a result of the Company's discontinuation of the Phase 3 clinical trial for OCU300. 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. For the year ended December 31, 2020, the Company recognized $0.2 million of severance-related charges within general and administrative expense and $0.9 million of severance-related charges within research and development expense. The Company expects to pay severance benefits of $0.7 million during 2021. The following table outlines the components of the severance-related charges: Amount Accrued Severance at December 31, 2019 $ — Severance-related charges 1,115,679 Severance-related payments (404,083) Accrued Severance at December 31, 2020 $ 711,596 |
Equity Transactions
Equity Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Equity Transactions | At-the-Market Offerings During the year ended December 31, 2020, the Company sold an aggregate of 108.1 million shares of common stock in separate ATMs commenced in May 2020, June 2020, and August 2020. During the year ended December 31, 2020, the Company sold 34.3 million shares under the May 2020 ATM, 24.8 million shares under the June 2020 ATM, and 49.0 million shares under the August 2020 ATM. During the year ended December 31, 2020, the Company received net proceeds of $36.3 million, after deducting commissions, fees and expenses of $1.5 million. The offerings were made pursuant to the Company's effective "shelf" registration statement on Form S-3 filed with the SEC on March 27, 2020, the base prospectus contained therein dated May 5, 2020, and the prospectus supplements related to the offerings dated May 8, 2020, June 12, 2020, and August 17, 2020. As of December 31, 2020, the Company had sold all of the shares of common stock available for issuance under the prospectus supplements filed on May 8, 2020 and June 12, 2020 in connection with the May 2020 and June 2020 ATMs. As of December 31, 2020, the Company had remaining capacity to issue up to $8.3 million of common stock under the prospectus supplement filed on August 17, 2020 in connection with the August 2020 ATM. Subscription Agreements On June 6, 2020, the Company entered into a subscription agreement with an accredited investor for the issuance of 1.3 million shares of the Company's common stock in a private placement. The shares of common stock were issued as part of a transaction in settlement of an outstanding obligation of the Company to the accredited investor, in which (i) the Company agreed to make certain cash payments, (ii) the Company issued the 1.3 million shares of common stock in exchange for the accredited investor's agreement to cancel $0.3 million of the outstanding obligation and (iii) the accredited investor agreed to cancel an additional portion of the amount owed by the Company representing a discount of $0.2 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. This private placement constituted a Dilutive Issuance (as defined in Note 11) and resulted in adjustments to the Series A Warrants. On April 5, 2019, OpCo entered into a subscription agreement (the "April 2019 Subscription Agreement") with existing investors for the sale of 0.1 million shares of common stock for $1.0 million, including the sale of 40,286 shares of common stock for $0.5 million to a member of the Board of Directors. This capital raise triggered the conversion features on the convertible debt described further in Note 10. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | The following table provides a summary of the carrying values for the components of debt as reflected on the consolidated balance sheets: As of December 31, 2020 2019 PPP Note $ 421,415 $ — EB-5 Loan Agreement borrowings 1,635,747 1,072,123 Total carrying value of debt, net $ 2,057,162 $ 1,072,123 PPP Note On April 30, 2020, the Company was granted a loan from Silicon Valley Bank ("SVB"), in the aggregate 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”). On June 5, 2020, the PPP Flexibility Act of 2020 (the "PPPFA") was signed into law amending the original terms of the PPP. Among other things, the PPPFA extended the deferral period for monthly principal and interest payments from six months to either (i) the date the Small Business Administration ("SBA") compensates the lender for any forgiven amounts or (ii) 10 months after the end of the borrower's loan forgiveness covered period. The PPPFA also extended the covered period for qualifying expenses from eight weeks to the earlier of 24 weeks or December 31, 2020. Certain amounts of the loan may be forgiven if they are 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 matures on April 30, 2022 and bears interest at a rate of 1.0% per annum. Principal and interest payments are payable monthly commencing on either (i) the date the SBA compensates SVB for any forgiven amounts or (ii) 10 months after the end of the Company's covered period, which ended in October 2020. If the PPP Note is fully forgiven, the Company will not be responsible for any payments. 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 provides for customary events of default, including, among others, failure to make payment, bankruptcy, breaches of representations, and material adverse events. At December 31, 2020, the carrying value of the PPP Note was $0.4 million. Warrant Exchange Promissory Notes On April 22, 2020, in connection with the Warrant Exchange (as defined in Note 11), the Company issued to Investors certain promissory notes (the "Warrant Exchange Promissory Notes") with an aggregate principal amount of $5.6 million. The Warrant Exchange Promissory Notes had a maturity date of April 21, 2021 and did not bear interest. The Warrant Exchange Promissory Notes were recorded at a fair value of $5.0 million. The difference of $0.6 million between the fair value and the aggregate principal amount of $5.6 million was recorded as a debt discount and accreted to interest expense over the life of the Warrant Exchange Promissory Notes. The accretion amounted to $0.6 million for the year ended December 31, 2020. The Company was entitled to prepay the Warrant Exchange Promissory Notes in whole or in part at any time without penalty or premium. In the event that the Company consummated a financing transaction that generated cash to the Company, the Company was required to use 20% of the net proceeds of such transaction to prepay a portion of the outstanding amount under each Warrant Exchange Promissory Note if the transaction occurred on or prior to August 22, 2020, and 30% of the net proceeds to prepay a portion of the outstanding amount under each Warrant Exchange Promissory Note if that transaction occurred after August 22, 2020. As a result of the net proceeds from the ATMs discussed in Note 9 , the Company made payments to the Warrant Exchange Promissory Note holders of $5.6 million during the year ended December 31, 2020, causing the Warrant Exchange Promissory Notes to be repaid in full and no longer outstanding at December 31, 2020. EB-5 Loan 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. Borrowing 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 products 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 on March 26, 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, 2020 and 2019 are summarized below: As of December 31, 2020 2019 Principal outstanding $ 1,500,000 $ 1,000,000 Plus: accrued interest 181,053 127,777 Less: unamortized debt issuance costs (45,306) (55,654) Carrying value of debt $ 1,635,747 $ 1,072,123 Senior Secured Convertible Notes On May 21, 2019, the Company issued senior secured convertible notes to certain investors for $2.4 million at an original issue discount of $0.5 million, and on June 28, 2019, the Company entered into an agreement to issue additional senior secured convertible notes to the investors for $2.9 million with an original issue discount of $0.4 million (together the "Senior Secured Convertible Notes"). Immediately prior to the Merger, 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. The accretion of the original issue discount to interest expense amounted to $0.8 million during the year ended December 31, 2019. Convertible Promissory Notes On April 4, 2019, the Company issued a convertible promissory note (the "Convertible Promissory Note") to an existing stockholder for $0.9 million at an interest rate of 5% per annum. On May 16, 2019, the Convertible Promissory Note was converted into equity. OpCo issued 0.1 million shares of common stock at the conversion date to extinguish the debt at $12.41 per share. This non-cash transaction resulted in an increase of $0.9 million in additional paid-in capital, which was based on the principal balance outstanding and the unpaid interest upon conversion. Convertible Notes During the years ended December 31, 2019 and 2018, the Company issued convertible notes (the “Convertible Notes”) to new and existing stockholders in the Company, including Convertible Notes in the aggregate principal amount of $3.5 million to members of the Board of Directors. As of December 31, 2019, all of the Convertible Notes had been converted and were no longer outstanding. At issuance, the following amounts were recorded: Note Issuance Date Convertible Note Fair Value of Debt Carrying Value upon Issuance January 2018 $ 5,000,000 $ (2,657,711) $ (35,969) $ 2,306,320 June 2018 1,000,000 (724,216) (3,000) 272,784 November 2018 1,150,400 (21,127) (50,646) 1,078,627 December 2018 150,000 (2,857) (14,310) 132,833 January 2019 450,000 (182,882) (29,358) 237,760 February 2019 1,000,000 (302,379) (55,875) 641,746 Total $ 8,750,400 $ (3,891,172) $ (189,158) $ 4,670,070 All Convertible Notes accrued interest at a rate of 5% per annum and had scheduled maturity dates on the eighteen If the Company received equity financing from the issuance of stock of the Company from an investor or group of investors in a transaction or series of related transactions above a certain amount of gross proceeds, the principal amount and all interest accrued but not paid through the closing date of the qualified equity financing was to automatically convert into the same class of equity securities as those issued in the qualified equity financing ("Conversion Feature"). The price per share varied among the Convertible Notes ranging from a 0% to 30% discount to the lowest price per share being paid by investors in the qualified equity financing. The Company bifurcated the Conversion Feature for the January 2018, June 2018, January 2019, and February 2019 Convertible Notes and classified it as a derivative liability because the conversion feature did not have a fixed conversion price and conversion would be settled in a variable number of shares of common stock. There was no bifurcated conversion feature for the November 2018 and December 2018 Convertible Notes as there is no discount to the lowest equity price triggering conversion. The Company also bifurcated the Change in Control Feature for all of the Convertible Notes because it was determined to be a redemption feature not clearly and closely related to the debt host. The fair value of both of the embedded features was accounted for as a derivative liability and was recorded as a discount on the Convertible Notes with subsequent changes in fair value recorded on the Company’s consolidated statements of operations and comprehensive loss as other income (expense). The fair value at the issuance of each Convertible Note and at the end of each reporting period were estimated using an income approach model. Inputs used in the valuation were unobservable and therefore considered Level 3 in the fair value hierarchy. The debt discount was accreted into interest expense over the expected time until conversion of the Convertible Notes. The accretion amounted to $0.6 million for the year ended December 31, 2019. There was no accretion during the year ended December 31, 2020 as all Convertible Notes had been converted and were no longer outstanding as of December 31, 2019. As a result of the April 2019 Subscription Agreement as described and defined within Note 9, the triggers for conversion were met on the Convertible Notes. On April 5, 2019, the Convertible Notes were modified to change the discount percentage from the 0% discount per the terms of the November 2018 and December 2018 Convertible Notes and the 15% discount per the terms of the January 2019 and February 2019 Convertible Notes to 30% at the time of conversion. The Company issued 1.1 million shares of common stock at $8.69 per share on the date of conversion to extinguish the debt, which resulted in a loss of $0.3 million. This non-cash conversion also resulted in an increase of $13.0 million in additional paid-in capital, which was based on the principal balance outstanding and the unpaid interest upon conversion. Principal Maturities Debt maturities (excluding interest) are summarized below: For the years ending December 31, 2021 2022 2023 2024 2025 Thereafter Total Principal maturities $ 234,119 $ 187,296 $ — $ — $ — $ 1,500,000 $ 1,921,415 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2020 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Pre-Merger Financing Warrants On September 27, 2019, Ocugen completed the Merger with OpCo. Immediately prior to the Merger, Ocugen and OpCo completed the Pre-Merger Financing, a previously announced private placement transaction with certain Investors pursuant to the Financing SPA, whereby, among other things, the Company agreed to issue the Pre-Merger Financing Warrants. On November 5, 2019, the Company entered into an agreement with each Investor that amended the terms of each of the Pre-Merger Financing Warrants held by each such Investor (collectively, the “Warrant Amendments”). The terms of the Pre-Merger Financing Warrants and the Warrant Amendments are discussed below. There were no Pre-Merger Financing Warrants outstanding at December 31, 2020. Series A Warrants The Series A Warrants had an initial exercise price per share of $7.13, were exercisable upon issuance, and had a term of 60 months from the date of issuance. The Series A Warrants were exercisable for up to 8.8 million shares of Ocugen common stock. The Series A Warrants had an anti-dilution adjustment whereby if Ocugen had issued or sold, entered into a definitive, binding agreement pursuant to which Ocugen would have been required to issue or sell or would have been deemed, pursuant to the provisions of the Series A Warrants, to have issued or sold, any common stock for a price per share lower than the exercise price then in effect (a “Dilutive Issuance”), subject to certain limited exceptions, then (i) the exercise price of the Series A Warrants would have been reduced to such lower price per share and (ii) the number of shares issuable upon exercise of the Series A Warrants would have been increased to the number of shares of common stock determined by multiplying (a) the exercise price in effect immediately prior to such Dilutive Issuance by (b) the number of shares of common stock issuable upon exercise of the Series A Warrants immediately prior to such Dilutive Issuance (without giving effect to any limitation on exercise contained therein), and dividing the product thereof by the exercise price resulting from such Dilutive Issuance. All of the Series A Warrants were outstanding and exercisable as of December 31, 2019. Pursuant to the Warrant Exchange (as defined below), no Series A Warrants were outstanding as of December 31, 2020. Series B Warrants The Series B Warrants had an exercise price of $0.01, were exercisable after the completion of a 10 trading-day period following the effectiveness of a registration statement covering the resale of common stock into which such warrants were exercisable and were to expire on the date on which the Series B Warrants have been exercised in full (without giving effect to any limitation on exercise contained therein) and no shares remain issuable thereunder. The Series B Warrants were initially exercisable by the holders for 8.0 million shares of common stock. Additionally, each Series B Warrant included a Reset Period pursuant to which the number of shares issuable upon exercise of the Series B Warrants was increased during certain Reset Periods (as defined in the Series B Warrants). The Reset Period concluded in November 2019 and resulted in an aggregate of 12.6 million additional shares of common stock becoming issuable upon exercise of the Series B Warrants. There were 1,000 Series B Warrants outstanding at December 31, 2019. There were no Series B Warrants outstanding at December 31, 2020. Series C Warrants The Series C Warrants were exercisable upon issuance for up to 50.0 million shares of common stock at an initial exercise price of $7.13 per share. Each of the Series C Warrants was amended pursuant to the Warrant Amendments to permit the Investors, in lieu of making any cash payment otherwise contemplated to be made to the Company upon the exercise of the Series C Warrant, to elect instead to receive upon such exercise up to 20.0 million shares of common stock. Prior to the Warrant Amendments, the Series C Warrants had permitted the exercise without any cash payment of up to 50.0 million shares of common stock in the event that the volume weighted-average price of the common stock on Nasdaq was less than or equal to $1.20 per share on any five Accounting for the Pre-Merger Financing Warrants As of December 31, 2019, the Pre-Merger Financing Warrants were classified as equity. At issuance, the Series B Warrants were classified as a liability on the consolidated balance sheet 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. Upon the completion of the Reset Period in November 2019, the Series B Warrants were reassessed and determined to meet the derivative scope exception allowing for equity classification. The Series B Warrants were marked to market a final time and the remaining liability balance was reclassified to equity. The fair value of the Series B Warrants was calculated using a Monte Carlo simulation while estimating the stock price during the Reset Period, based on the terms described within the Financing SPA. Key fair value inputs included the starting stock price, expected stock volatility during the Reset Period, and additional shares issued from escrow. The methodology for measuring fair value was sensitive to the expected stock volatility assumption input. The volatility used in the fair value estimate at issuance was 96.0%. Inputs used in the valuation were unobservable and were therefore classified as Level 3 fair value inputs. The fair value of the Series B Warrants upon the end of the Reset Period was based on a Black-Scholes valuation model, which is classified as Level 3 in the fair value hierarchy. The following table provides a roll-forward of the Series B Warrant liability: Amount Balance at January 1, 2019 $ — Fair value at issuance (September 27, 2019) 9,387,760 Change in fair value of embedded derivatives 1,867,980 Amount reclassified to equity (11,255,740) Balance at December 31, 2019 $ — Warrant Exchange On April 22, 2020, the Company entered into a subscription agreement as discussed within Note 9. The subscription agreement constituted a Dilutive Issuance (as defined above) and resulted in adjustments to the number of issuable Series A Warrants and the exercise price under the Series A Warrants. Contemporaneously with the 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) the Warrant Exchange Promissory Notes (collectively the "Warrant Exchange"). Following the consummation of the Warrant Exchange and the concurrent exercise of the remaining Series B Warrants and Series C Warrants, there were no Pre-Merger Financing Warrants outstanding at December 31, 2020. 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 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 utilizing Level 2 inputs. 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 transaction by approximately $12.5 million. The excess consideration was accounted for as a deemed dividend to the warrant holders and is reflected as an additional net loss attributed to common stockholders in the calculation of basic and diluted net loss per common s hare for the year ended December 31, 2020. 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. OpCo Warrants Prior to 2018, OpCo issued warrants to investors of the Company pursuant to a stockholders' agreement and to two employees of the Company pursuant to their respective employment agreements. As of December 31, 2020 and 2019, 0.9 million warrants to purchase common stock were outstanding and exercisable and had a weighted average exercise price of $5.67 per share. The warrants expire between 2026 and 2027. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-based compensation expense for options granted are reflected in the consolidated statements of operations and comprehensive loss as follows: Year ended December 31, 2020 2019 General and administrative $ 348,810 $ 362,833 Research and development 311,507 521,256 Total $ 660,317 $ 884,089 As of December 31, 2020, the Company had $1.1 million of unrecognized compensation expense related to options outstanding under its equity plans. This expense is expected to be recognized over a weighted average period of two years as of December 31, 2020 . 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"), which replaced the Histogenics Corporation 2013 Equity Incentive Plan (the "2013 Plan"). In December 2019, Ocugen’s stockholders approved the adoption of the 2019 Plan and the 2013 Plan was frozen. No additional awards have been or will be made under the 2013 Plan and any remaining authorized shares under the 2013 Plan were recycled into the 2019 Plan. 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 31 st of the prior year, or a number of shares of Company common stock determined by the Board or Directors. As of December 31, 2020, the 2014 Plan provides for the granting of up to 0.8 million equity awards in respect to Ocugen's common stock. As of December 31, 2020, the 2019 Plan provides for the granting of up to 4.2 million equity awards in respect of Ocugen's common stock, inclusive of equity awards that were previously available for issuance under the 2013 Plan and the additional shares authorized for issuance pursuant to the 2019 Plan's "Evergreen" provision on January 1, 2020. As of December 31, 2020, an aggregate of 0.4 million and 3.8 million shares of Company common stock were issuable upon the exercise of outstanding stock options under the 2014 Plan and 2019 Plan, respectively. Options to Purchase Common Stock The assumptions utilized in the fair value calculation for options to purchase common stock as of December 31, 2020 and 2019 are as follows: Year ended December 31, 2020 2019 Weighted average expected option term (years) 6.0 6.0 Range of expected stock price volatility 110% - 117% 89% - 110% Weighted average expected stock price volatility 112% 109% Range of risk-free interest rate 0.3% – 1.7% 1.5% – 2.4% Expected dividend rate 0% 0% The following table summarizes the stock option activity under the Plans: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Options outstanding at December 31, 2019 731,189 $ 4.59 8.0 $ 24,028 Granted 4,082,950 $ 0.41 Forfeited (589,706) $ 2.55 Options outstanding at December 31, 2020 4,224,433 $ 0.84 8.9 $ 5,496,219 Options exercisable at December 31, 2020 512,288 $ 3.48 6.8 $ 286,223 The weighted average grant date fair value of stock options granted during the years ended December 31, 2020 and 2019 were $0.34 and $0.84, respectively . The total fair value of stock options vested during the years ended December 31, 2020 and 2019 were $0.5 million and $1.0 million, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | For the years ended December 31, 2020 and 2019, the Company did not recognize any current or deferred income tax expense or benefit due to the current and historical losses incurred by the Company. Losses before income taxes were $21.8 million and $20.2 million for the years ended December 31, 2020 and 2019, respectively, substantially all of which were incurred in the United States. On March 27, 2020, the United States enacted the CARES Act. The Cares Act includes provisions relating to refundable payroll tax credits, deferment of the employer portion of certain payroll taxes, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The Company considered the tax related provisions under the CARES Act and noted that the effect of such provisions was not expected to have a material impact on the Company’s results of operations, cash flows, and consolidated financial statements. The reconciliation of federal statutory income tax to the Company's provision for income taxes is as follows: As of December 31, 2020 2019 Expected provision at statutory rate 21.0 % 21.0 % State tax - net of federal benefit 7.5 % 5.3 % Tax credits 2.8 % 3.2 % Permanent differences (1.0) % (8.1) % Other 1.1 % 2.9 % Change in valuation allowance (31.4) % (24.3) % Total provision for income taxes — % — % 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, 2020 and 2019 are comprised of the following: As of December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 35,714,104 $ 31,575,288 Capital loss carryforwards 7,298,024 7,298,052 Start-up costs 11,234,623 11,234,751 Accruals and reserves 397,982 166,611 Intellectual property amortization 2,285,247 555,352 Stock-based compensation expense 1,290,212 1,123,100 Tax credits 2,541,244 1,926,677 Lease liability 125,266 96,895 Total deferred tax assets 60,886,702 53,976,726 Valuation allowance (60,761,412) (53,877,168) Deferred tax assets, net of allowance $ 125,290 $ 99,558 Deferred tax liabilities: Lease right-of-use assets (125,290) (99,558) 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 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, 2020 and 2019, respectively. The Company’s valuation allowance increased during 2020 by approximately $6.9 million primarily due to the generation of net operating losses and research and development and orphan drug credit carryforwards. As of December 31, 2020 and 2019, the Company had U.S. federal net operating loss ("NOL") carryforwards of $128.0 million and $113.6 million, respectively, which may be available to offset future income tax liabilities. The Tax Cut and Jobs Act, which was enacted in December 2017 (the "TCJA"), 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 $75.4 million, which do not expire. The federal NOLs generated prior to 2018 of $52.6 million will expire at various dates through 2037. As of December 31, 2020 and 2019, the Company also had U.S. state NOL carryforwards of $126.7 million and $112.4 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2040. As of December 31, 2020 and 2019, the Company had federal tax credit carryforwards of approximately $2.2 million and $1.6 million, respectively, which are available to offset future federal tax liabilities which expire at various dates through 2040. As of December 31, 2020 and 2019, the Company had state tax credit carryforwards of approximately $0.5 million and $0.4 million, respectively, which are available to reduce future tax liabilities which expire at various dates through 2035. 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 carryforward 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 our 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: Year ended December 31, 2020 2019 Gross unrecognized tax benefits at beginning of year $ 303,050 $ — Additions for tax positions taken in a prior year — 303,050 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 $ 303,050 $ 303,050 The uncertain tax positions giving rise to the unrecognized tax benefits of $0.3 million at December 31, 2020 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 2017 to present. |
Net Loss per Share of Common St
Net Loss per Share of Common Stock | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss per Share of Common Stock | The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2020 and 2019: Year ended December 31, 2020 2019 Net loss—basic and diluted $ (21,821,953) $ (20,242,630) Deemed dividend related to Warrant Exchange (Note 11) (12,546,340) — Net loss to common stockholders $ (34,368,293) $ (20,242,630) Shares used in calculating net loss per common share—basic and diluted 112,236,110 13,893,819 Net loss per common share—basic and diluted $ (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, 2020 2019 Options to purchase common stock 4,224,433 731,189 Warrants 870,017 9,643,945 Total 5,094,450 10,375,134 |
Commitment and Contingencies
Commitment and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments The Company has commitments under certain license agreements, lease agreements, debt agreements, and separation agreements. Commitments under certain license agreements include annual payments, payments upon the achievement of certain milestones, and royalty payments based on net sales of licensed products. See Note 4 for additional information about commitments under license agreements. Commitments under lease agreements include future minimum lease payments for both operating and financing leases. See Note 6 for additional information about commitments under lease agreements. Commitments under debt agreements include payments for any amount of principal and accrued interest under the PPP Note that is determined to be not forgiven by the SBA as well as the future payment of principal and accrued interest under the EB-5 Loan Agreement. See Note 10 for additional information about commitments under debt agreements. Commitments under separation agreements include severance payments to be paid in 2021 as a result of the reduction in force in connection with the Company's discontinuation of the Phase 3 clinical trial for OCU300. See Note 8 for additional information about commitments under separation agreements. Contingencies From time to time, the Company is subject to claims in legal proceedings arising in the normal course of its business. The Company does not believe that it is currently party to any pending legal actions that could reasonably be expected to have a material adverse effect on the business, financial condition, results of operations, or cash flows. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Covaxin Agreement On February 2, 2021, the Company entered into the Covaxin Agreement with Bharat Biotech to co-develop COVAXIN, a whole-virion inactivated COVID-19 vaccine being developed to prevent COVID-19 infection, for the U.S. market. 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, a whole-virion inactivated vaccine candidate for the prevention of COVID-19 in humans in the Ocugen Covaxin Territory. In consideration of the license and other rights granted by Bharat Biotech to the Company, the parties agreed to share any profits generated from the commercialization of COVAXIN in the Ocugen Covaxin Territory, with the Company retaining 45% of such profits, and Bharat Biotech receiving the balance of such profits. Under the Covaxin Agreement, the Company and Bharat Biotech will collaborate to develop COVAXIN for their respective territories. Except with respect to U.S. manufacturing rights under certain circumstances as described below, the Company has the exclusive right and is solely responsible for researching, developing, manufacturing, and commercializing COVAXIN for the Ocugen Covaxin Territory. Bharat Biotech has the exclusive right and is solely responsible for researching, developing, manufacturing, and commercializing COVAXIN outside of the Ocugen Covaxin Territory. Bharat Biotech has agreed to provide to the Company all 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 Territory, including pursuant to any EUA for the Ocugen Covaxin Territory approved by the FDA. In certain circumstances set forth in the Covaxin Agreement, and until the Company is capable and primarily responsible for the manufacture and supply of COVAXIN for the Ocugen Covaxin Territory, Bharat Biotech has the exclusive right to manufacture COVAXIN for the Ocugen Covaxin Territory and is responsible for manufacturing and supplying clinical testing materials required for the Company’s development activities, and all of the Company’s requirements of commercial quantities of COVAXIN. The parties will enter into supply agreements setting forth the terms of such supply. Bharat Biotech has agreed to provide a specified minimum number of doses in calendar year 2021. 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 Company is currently evaluating the clinical and regulatory path for COVAXIN in the United States including obtaining EUA from the FDA and, eventually, BLA approval in the U.S. market, as well as the Company's commercialization strategy, if authorized or approved. The impact of COVAXIN on the consolidated financial statements will be dependent the clinical, regulatory, and commercialization pathway for COVAXIN. Registered Direct Offering On February 7, 2021, the Company entered into a Securities Purchase Agreement pursuant to which the Company agreed to issue and sell in a Registered Direct Offering, 3.0 million shares of the Company's common stock at an offering price of $7.65 per share. The closing of the Registered Direct Offering occurred on February 10, 2021. The Company received net proceeds of $21.2 million from the sale of 3.0 million shares in the Registered Direct Offering, after deducting placement agent fees and related offering expenses of $1.7 million. 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 newly designated Series B Convertible Preferred Stock, par value $0.01 per share (the “Series B Preferred Stock”), at a price per share equal to $109.60, to Bharat Biotech. The Company is issuing the shares of Series B Preferred Stock as an advance payment for the supply of COVAXIN to be provided by Bharat Biotech pursuant to a supply agreement (the "Supply Agreement") expected to be entered into with respect to the parties' Covaxin Agreement. Each share of Series B Preferred Stock is convertible, at the option of Bharat Biotech, into 10 shares of the Company’s common stock only after (i) the Company’s receipt of 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation and ConsolidationThe accompanying consolidated financial statements included herein have been prepared in conformity with 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, Inc. 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 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 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 estimation of clinical trial accruals, warrant transactions, asset held for sale, and the valuation of debt and equity instruments, including embedded derivatives, and stock-based compensation. |
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 (“ASC 606”). 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. |
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 employee. |
Asset Held for Sale | Asset Held for Sale An asset is considered to be held for sale when all of the following criteria are met: (i) management commits to a plan to sell the asset; (ii) it is unlikely that the disposal plan will be significantly modified or discontinued; (iii) the asset is available for immediate sale in its present condition; (iv) actions required to complete the sale of the asset have been initiated; (v) sale of the asset is probable and the completed sale is expected to occur within one year; and (vi) the asset is actively being marketed for sale at a price that is reasonable given its current market value. A long-lived asset classified as held for sale is measured at the lower of its carrying amount or fair value less cost to sell. If the long-lived asset is newly acquired, the carrying amount of the long-lived asset is established based on its fair value less cost to sell at the acquisition date. A long-lived asset is not depreciated or amortized while it is classified as held for sale, and an impairment loss would be recognized to the extent the carrying amount exceeds the asset's fair value less cost to sell. |
Fair Value Measurements | Fair Value Measurements The company follows the provisions of the FASB ASC Topic 820, Fair Value Measurements (“ASC 820”), which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair measurements. The carrying value of certain financial instruments, including cash and cash equivalents, accounts payable, and accrued expenses approximates their fair values due to the short-term nature of these instruments. ASC 820 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) As of December 31, 2020, the Company believes the fair values using Level 2 inputs of the PPP Note and the borrowings under the EB-5 Loan Agreement (both as defined in Note 10) approximate their carrying values. See Note 10 for additional information. |
Derivative Instruments | Derivative Instruments 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, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument, in accordance with FASB ASC Topic 815, Derivatives and Hedging . The Company additionally follows the provisions of ASC Topic 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity for warrants issued, which is the authoritative guidance on accounting for derivative financial instruments indexed and potentially settled in a company's own stock. In order to determine if a contract is considered indexed to the Company's own stock for the purposes of determining liability versus equity classification, the Company performs a two-step analysis: (i) evaluate whether the contract contains any exercise contingencies and, if so, whether they disqualify the contract from being classified as equity; and (ii) assess whether the settlement terms are consistent with equity classification. 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 instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. |
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 and 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. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment is recorded at 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. Then Company's property and equipment includes office equipment, lab |
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 has lease agreements which 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 on 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. The Company primarily 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. As an implicit interest rate is not readily determinable in the Company’s leases, the incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company 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. Options for lease renewals have been excluded from the lease term (and lease liability) for the Company’s leases as the reasonably certain threshold has not been met. 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 lease payments not dependent on a rate or index associated with the Company’s leases are recognized when the event, activity, or circumstance is probable. Variable lease payments include the Company's proportionate share of 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. |
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”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options and modifications to existing agreements, to be recognized in the consolidated statements of operations and comprehensive loss based on their fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of options granted. The Company recognizes forfeitures as they occur. The Company’s stock-based awards are subject to service-based vesting conditions. Compensation expense related to awards to employees and directors 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 awards generally vest over a one three Estimating the fair value of options requires the input of subjective assumptions, including expected life of the 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. These assumptions used in Ocugen’s Black-Scholes option-pricing model 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 options is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the 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. |
Segment Information | Segment Information As of December 31, 2020, 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, 2020, substantially all of the Company's assets were located in the United States. |
Recently Adopted Accounting Standards; Recent Accounting Pronouncements | Recently Adopted Accounting Standards In August 2018, the FASB issued Accounting Standards Update ("ASU") No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement . This standard modifies certain disclosure requirements on fair value measurements and was effective for the Company on January 1, 2020. The adoption of this standard did not have a material impact on the Company's disclosures. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606. This standard clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, ASC 606 guidance should be applied, including recognition, measurement, presentation, and disclosure requirements. The standard adds unit-of-account guidance to ASC 808 to align with the guidance in ASC 606 when an entity is assessing whether the collaborative arrangement or a part of the collaborative arrangement is within the scope of ASC 606. The standard also precludes a company from presenting transactions with collaborative arrangement participants that are not directly related to sales to third parties with revenue from contracts with customers recognized under ASC 606 if the collaborative arrangement participant is not a customer. This standard was effective for the Company on January 1, 2020. Consistent with the guidance in this standard, the Company assesses whether collaboration arrangements are within the scope of ASC 606. For collaboration arrangements that are not within the scope of ASC 606, applicable transactions with collaborative arrangement participants are presented as collaboration revenue rather than revenue from contracts with customers. See above and Note 4 for additional information. Recent Accounting Pronouncements 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 2016-13, which have the same effective date and transition date of January 1, 2023. These standards require 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 these standards to have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . This standard will have an effective date and transition date of January 1, 2021. 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 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. The Company does not currently expect the adoption of this standard to have a material impact on its 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 permitted beginning January 1, 2021. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models in ASC 470-20 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 its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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: As of December 31, 2020 2019 Cash and cash equivalents $ 24,039,325 $ 7,444,052 Restricted cash 151,226 151,016 Total cash, cash equivalents and restricted cash $ 24,190,551 $ 7,595,068 |
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: As of December 31, 2020 2019 Cash and cash equivalents $ 24,039,325 $ 7,444,052 Restricted cash 151,226 151,016 Total cash, cash equivalents and restricted cash $ 24,190,551 $ 7,595,068 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Major Components of Property, Plant and Equipment | The major components of property and equipment as of December 31, 2020 and 2019 consist of the following: As of December 31, 2020 2019 Office equipment $ 165,755 $ 113,553 Lab equipment 452,128 130,132 Leasehold improvements 176,964 41,010 Financing lease right-of-use asset 63,817 63,817 Total property and equipment 858,664 348,512 Less: accumulated depreciation (225,697) (126,048) Total property and equipment, net $ 632,967 $ 222,464 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense were as follows: Year ended December 31, 2020 2019 Operating lease cost $ 189,424 $ 250,361 Variable lease cost 84,790 79,700 Total lease cost $ 274,214 $ 330,061 Supplemental information related to leases was as follows: Year ended December 31, 2020 2019 Weighted-average remaining lease terms—operating leases (years) 6.9 2.0 Weighted-average discount rate—operating leases 4.6 % 7.6 % |
Schedule of Supplemental Balance Sheet Information Related to Leases | Supplemental balance sheet information related to leases was as follows: As of December 31, 2020 2019 Right-of-use assets, net $ 433,649 $ 344,574 Current lease obligations $ 44,248 $ 172,310 Non-current lease obligations 389,317 163,198 Total lease liabilities $ 433,565 $ 335,508 |
Schedule of Maturities of Operating Leases | Future minimum operating minimum lease payments, exclusive of taxes and other carrying charges, are approximately as follows: For the years ending December 31, Amount 2021 $ 61,688 2022 69,399 2023 71,502 2024 73,605 2025 75,708 Thereafter 157,725 Total $ 509,627 Less: present value adjustment (76,062) Present value of minimum lease payments $ 433,565 _______________________ |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued Expenses are as follows: As of December 31, 2020 2019 Accrued expenses: Research and development $ 512,026 $ 271,322 Clinical 117,012 421,788 Professional fees 405,001 917,568 Employee-related 963,117 624,420 Severance-related (1) 711,596 — Other 221,643 34,947 Total accrued expenses $ 2,930,395 $ 2,270,045 _______________________ (1) See Note 8 for additional information regarding severance-related accrued expenses. |
Exit and Disposal Activities (T
Exit and Disposal Activities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Severance-Related Charges | The following table outlines the components of the severance-related charges: Amount Accrued Severance at December 31, 2019 $ — Severance-related charges 1,115,679 Severance-related payments (404,083) Accrued Severance at December 31, 2020 $ 711,596 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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: As of December 31, 2020 2019 PPP Note $ 421,415 $ — EB-5 Loan Agreement borrowings 1,635,747 1,072,123 Total carrying value of debt, net $ 2,057,162 $ 1,072,123 The carrying values of the EB-5 Loan Agreement borrowings as of December 31, 2020 and 2019 are summarized below: As of December 31, 2020 2019 Principal outstanding $ 1,500,000 $ 1,000,000 Plus: accrued interest 181,053 127,777 Less: unamortized debt issuance costs (45,306) (55,654) Carrying value of debt $ 1,635,747 $ 1,072,123 |
Schedule of Principal, Embedded Derivatives and Carrying Value of Debts | At issuance, the following amounts were recorded: Note Issuance Date Convertible Note Fair Value of Debt Carrying Value upon Issuance January 2018 $ 5,000,000 $ (2,657,711) $ (35,969) $ 2,306,320 June 2018 1,000,000 (724,216) (3,000) 272,784 November 2018 1,150,400 (21,127) (50,646) 1,078,627 December 2018 150,000 (2,857) (14,310) 132,833 January 2019 450,000 (182,882) (29,358) 237,760 February 2019 1,000,000 (302,379) (55,875) 641,746 Total $ 8,750,400 $ (3,891,172) $ (189,158) $ 4,670,070 |
Schedule of Maturities | Debt maturities (excluding interest) are summarized below: For the years ending December 31, 2021 2022 2023 2024 2025 Thereafter Total Principal maturities $ 234,119 $ 187,296 $ — $ — $ — $ 1,500,000 $ 1,921,415 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Warrants and Rights Note Disclosure [Abstract] | |
Schedule of Reconciliation of Series B Warrant Liability Measured at Fair Value Using Level 3 Significant Unobservable Inputs | The following table provides a roll-forward of the Series B Warrant liability: Amount Balance at January 1, 2019 $ — Fair value at issuance (September 27, 2019) 9,387,760 Change in fair value of embedded derivatives 1,867,980 Amount reclassified to equity (11,255,740) Balance at December 31, 2019 $ — |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 options granted are reflected in the consolidated statements of operations and comprehensive loss as follows: Year ended December 31, 2020 2019 General and administrative $ 348,810 $ 362,833 Research and development 311,507 521,256 Total $ 660,317 $ 884,089 |
Schedule of Weighted Average Assumptions Utilized in Fair Value Calculation | The assumptions utilized in the fair value calculation for options to purchase common stock as of December 31, 2020 and 2019 are as follows: Year ended December 31, 2020 2019 Weighted average expected option term (years) 6.0 6.0 Range of expected stock price volatility 110% - 117% 89% - 110% Weighted average expected stock price volatility 112% 109% Range of risk-free interest rate 0.3% – 1.7% 1.5% – 2.4% Expected dividend rate 0% 0% |
Schedule of Stock Option Activity | The following table summarizes the stock option activity under the Plans: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Options outstanding at December 31, 2019 731,189 $ 4.59 8.0 $ 24,028 Granted 4,082,950 $ 0.41 Forfeited (589,706) $ 2.55 Options outstanding at December 31, 2020 4,224,433 $ 0.84 8.9 $ 5,496,219 Options exercisable at December 31, 2020 512,288 $ 3.48 6.8 $ 286,223 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 Expected provision at statutory rate 21.0 % 21.0 % State tax - net of federal benefit 7.5 % 5.3 % Tax credits 2.8 % 3.2 % Permanent differences (1.0) % (8.1) % Other 1.1 % 2.9 % Change in valuation allowance (31.4) % (24.3) % Total provision for income taxes — % — % |
Schedule of Deferred Tax Assets | The significant components of the Company’s deferred tax assets and liabilities as of December 31, 2020 and 2019 are comprised of the following: As of December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 35,714,104 $ 31,575,288 Capital loss carryforwards 7,298,024 7,298,052 Start-up costs 11,234,623 11,234,751 Accruals and reserves 397,982 166,611 Intellectual property amortization 2,285,247 555,352 Stock-based compensation expense 1,290,212 1,123,100 Tax credits 2,541,244 1,926,677 Lease liability 125,266 96,895 Total deferred tax assets 60,886,702 53,976,726 Valuation allowance (60,761,412) (53,877,168) Deferred tax assets, net of allowance $ 125,290 $ 99,558 Deferred tax liabilities: Lease right-of-use assets (125,290) (99,558) 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 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, 2020 and 2019, respectively. The Company’s valuation allowance increased during 2020 by approximately $6.9 million primarily due to the generation of net operating losses and research and development and orphan drug credit carryforwards. |
Summary of Income Tax Contingencies | A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows: Year ended December 31, 2020 2019 Gross unrecognized tax benefits at beginning of year $ 303,050 $ — Additions for tax positions taken in a prior year — 303,050 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 $ 303,050 $ 303,050 |
Net Loss per Share of Common _2
Net Loss per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 and 2019: Year ended December 31, 2020 2019 Net loss—basic and diluted $ (21,821,953) $ (20,242,630) Deemed dividend related to Warrant Exchange (Note 11) (12,546,340) — Net loss to common stockholders $ (34,368,293) $ (20,242,630) Shares used in calculating net loss per common share—basic and diluted 112,236,110 13,893,819 Net loss per common share—basic and diluted $ (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, 2020 2019 Options to purchase common stock 4,224,433 731,189 Warrants 870,017 9,643,945 Total 5,094,450 10,375,134 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Subsidiary, Sale of Stock [Line Items] | |||
Cash, cash equivalents and restricted cash | $ 24,190,551 | $ 7,595,068 | $ 1,778,613 |
August 2020 ATM | |||
Subsidiary, Sale of Stock [Line Items] | |||
Proceeds from sale of stock | 4,800,000 | ||
Registered Direct Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Proceeds from sale of stock | $ 21,200,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2020USD ($)segmentagreement | Dec. 31, 2019USD ($) | Jun. 30, 2018 | |
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Number of agreements | agreement | 2 | ||
Asset held for sale | $ 0 | $ 7,000,000 | |
In-process research and development | $ 7,000,000 | $ 0 | |
Finance lease, term of contract (in years) | 5 years | 5 years | |
Contractual term | 10 years | ||
Number of operating segments | segment | 1 | ||
Stock options | |||
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Expected dividend yield | 0.00% | 0.00% | |
Minimum | |||
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Vesting period | 1 year | ||
Maximum | |||
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Vesting period | 3 years | ||
Office Equipment | |||
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Useful life | 5 years | ||
Furniture and Fixtures | |||
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Useful life | 7 years | ||
Lab Equipment | |||
RECENT ACCOUNTING PRONOUNCEMENTS | |||
Useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Cash, cash equivalents and restricted cash reconciliation: | |||
Cash and cash equivalents | $ 24,039,325 | $ 7,444,052 | |
Restricted cash | 151,226 | 151,016 | |
Total cash, cash equivalents and restricted cash | $ 24,190,551 | $ 7,595,068 | $ 1,778,613 |
Merger and Pre-Merger Financi_2
Merger and Pre-Merger Financing - Pre-Merger Financing (Details) - Financing SPA shares in Millions, $ in Millions | 1 Months Ended |
Jun. 30, 2019USD ($)shares | |
Reverse Merger and Financing | |
Number of converted initial shares, agreed to be issued (in shares) | 2.2 |
Number of converted additional shares in the form of escrow agreed to issue immediately prior to the merger (in shares) | 2.2 |
Aggregate purchase price | $ | $ 25 |
Merger and Pre-Merger Financi_3
Merger and Pre-Merger Financing - Merger with Histogenics (Details) - Histogenics | Sep. 27, 2019 | Sep. 26, 2019 |
Former Ocugen equity holders | ||
Merger and Financing | ||
Ownership (as a percent) | 84.25% | |
Stockholders of Histogenics immediately before the Merger | ||
Merger and Financing | ||
Ownership (as a percent) | 15.75% |
Merger and Pre-Merger Financi_4
Merger and Pre-Merger Financing - NeoCart (Details) - USD ($) $ in Millions | Oct. 31, 2019 | May 08, 2019 | Dec. 31, 2020 |
Histogenics | |||
Merger and Financing | |||
Asset purchase agreement, cash consideration | $ 7 | $ 6.5 | |
Percentage of purchase price increase per month | 10.00% | ||
Neocart | Level 2 | |||
Merger and Financing | |||
Quoted price of assets held for sale of NeoCart | $ 7 |
License and Development Agree_2
License and Development Agreements (Details) - USD ($) | Sep. 27, 2019 | Jan. 31, 2017 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2017 |
License agreements: | |||||
Collaboration revenue | $ 42,620 | $ 0 | |||
Collaborative Agreement | Advaite, Inc. | |||||
License agreements: | |||||
Reduction of research and development expense | 300,000 | ||||
Collaboration revenue | 42,620 | ||||
Collaboration Agreement with CanSino Biologics | |||||
License agreements: | |||||
Term (in years) | 10 years | ||||
Period within with CanSino to provide development cost statement | 45 days | ||||
Period within which to reimburse CanSino of development costs | 1 year | ||||
Schepens Eye Research Institute | |||||
License agreements: | |||||
Cancellation period, notice | 180 days | ||||
License maintenance fee, year one | $ 25,000 | ||||
License maintenance fee, year two | 25,000 | ||||
License maintenance fee, thereafter | 100,000 | ||||
Potential development and regulatory milestone payments | 6,000,000 | ||||
Potential commercial milestone payment | $ 10,100,000 | ||||
Milestone payment | 0 | ||||
Royalty payments | $ 0 | ||||
Cancellation notice, payments period | 30 days | ||||
Cancellation notice, breach cure period, bankruptcy | 90 days | ||||
Schepens Eye Research Institute Research Agreement | |||||
License agreements: | |||||
Cancellation period, notice | 60 days | ||||
Collaboration agreement with University of Colorado | |||||
License agreements: | |||||
Cancellation period, notice | 60 days | ||||
Potential development and regulatory milestone payments | $ 1,500,000 | ||||
Milestone payment | $ 0 | ||||
Royalty payments | $ 0 | ||||
Cancellation notice, payments period | 60 days | ||||
Minimum annual royalty payment | $ 20,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 858,664 | $ 348,512 |
Less: accumulated depreciation | (225,697) | (126,048) |
Total property and equipment, net | 632,967 | 222,464 |
Depreciation expense | 102,110 | 60,608 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 165,755 | 113,553 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 452,128 | 130,132 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 176,964 | 41,010 |
Financing lease right-of-use asset | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 63,817 | $ 63,817 |
Leases - Operating Leases (Deta
Leases - Operating Leases (Details) | Oct. 09, 2020segment |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease, term of contract (in years) | 7 years |
Operating lease, number of renewal terms | 1 |
Operating lease, renewal term (in years) | 5 years |
Leases - Operating Leases, Comp
Leases - Operating Leases, Components Of Lease Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 189,424 | $ 250,361 |
Variable lease cost | 84,790 | 79,700 |
Total lease cost | $ 274,214 | $ 330,061 |
Leases - Operating Leases, Supp
Leases - Operating Leases, Supplemental Balance Sheet Information (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Right-of-use assets, net | $ 433,649 | $ 344,574 |
Current lease obligations | 44,248 | 172,310 |
Non-current lease obligations | 389,317 | 163,198 |
Total lease liabilities | $ 433,565 | $ 335,508 |
Leases - Operating Leases, Su_2
Leases - Operating Leases, Supplemental Information Related To Leases (Details) | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted-average remaining lease terms—operating leases (years) | 6 years 10 months 24 days | 2 years |
Weighted-average discount rate—operating leases | 4.60% | 7.60% |
Leases - Operating Leases, Futu
Leases - Operating Leases, Future Minimum Lease Payments (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
2021 | $ 61,688 | |
2022 | 69,399 | |
2023 | 71,502 | |
2024 | 73,605 | |
2025 | 75,708 | |
Thereafter | 157,725 | |
Total | 509,627 | |
Less: present value adjustment | (76,062) | |
Total lease liabilities | 433,565 | $ 335,508 |
Rent payments | $ 1,400,000 |
Leases - Financing Leases (Deta
Leases - Financing Leases (Details) | Dec. 31, 2020 | Jun. 30, 2018 |
Commitments and Contingencies Disclosure [Abstract] | ||
Finance lease, term of contract (in years) | 5 years | 5 years |
Interest rate (as a percent) | 7.60% |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities, Current [Abstract] | ||
Research and development | $ 512,026 | $ 271,322 |
Clinical | 117,012 | 421,788 |
Professional fees | 405,001 | 917,568 |
Employee-related | 963,117 | 624,420 |
Severance-related | 711,596 | 0 |
Other | 221,643 | 34,947 |
Total accrued expenses | $ 2,930,395 | $ 2,270,045 |
Exit and Disposal Activities -
Exit and Disposal Activities - Additional Information (Details) - Severance-related charges | Jun. 15, 2020employee | Dec. 31, 2020USD ($) |
Restructuring Cost and Reserve [Line Items] | ||
Number of employees given notice of termination | employee | 5 | |
Workforce reduction as a result of terminations (as a percent) | 33.33% | |
Severance-related charges | $ 1,115,679 | |
Expected severance benefits to be paid | 700,000 | |
General and administrative | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance-related charges | 200,000 | |
Research and development expense | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance-related charges | $ 900,000 |
Exit and Disposal Activities _2
Exit and Disposal Activities - Schedule of Severance-Related Charges (Details) - Severance-related charges | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Restructuring Reserve | |
Accrued Severance, beginning balance | $ 0 |
Severance-related charges | 1,115,679 |
Severance-related payments | (404,083) |
Accrued Severance, ending balance | $ 711,596 |
Equity Transactions (Details)
Equity Transactions (Details) - USD ($) | Jun. 06, 2020 | Apr. 05, 2019 | Aug. 31, 2020 | Jun. 30, 2020 | May 31, 2020 | Dec. 31, 2020 | Apr. 22, 2020 | May 16, 2019 |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Common stock, shares agreed to be sold, stock subscription agreement (in shares) | 100,000 | |||||||
ATMs | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Number of shares issued and sold | 49,000,000 | 24,800,000 | 34,300,000 | 108,100,000 | ||||
Proceeds from sale of stock | $ 36,300,000 | |||||||
Commissions, fees and expenses | 1,500,000 | |||||||
Number of shares outstanding, remaining capacity | $ 8,300,000 | |||||||
Subscription Agreements | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Number of shares issued and sold | 1,300,000 | 100,000 | ||||||
Proceeds from sale of stock | $ 1,000,000 | |||||||
Accredited investors agreement to cancel outstanding obligation | $ 300,000 | |||||||
Accredited investors agreement to cancel additional portion owed representing a discount | $ 200,000 | |||||||
Number of shares sold in subscription agreement | 1,000 | |||||||
Aggregate offering price | $ 395 | |||||||
Subscription Agreements | Board members | ||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||
Common stock, shares agreed to be sold, stock subscription agreement (in shares) | 40,286 | |||||||
Common stock, value, subscriptions | $ 500,000 |
Debt - PPP Note (Details)
Debt - PPP Note (Details) - USD ($) | Dec. 31, 2020 | Apr. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2016 |
Debt | ||||
Total carrying value of debt, net | $ 2,057,162 | $ 1,072,123 | ||
PPP Note | ||||
Debt | ||||
Total carrying value of debt, net | 400,000 | |||
Principal outstanding | $ 400,000 | |||
Interest rate (as a percent) | 1.00% | |||
PPP Note | Notes payable | ||||
Debt | ||||
Total carrying value of debt, net | 421,415 | 0 | ||
EB-5 Loan Agreement borrowings | Loans payable | ||||
Debt | ||||
Total carrying value of debt, net | $ 1,635,747 | $ 1,072,123 | ||
Interest rate (as a percent) | 4.00% |
Debt - Warrant Exchange Promiss
Debt - Warrant Exchange Promissory Notes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Apr. 22, 2020 | |
Debt | ||
Principal outstanding | $ 1,921,415 | |
Warrant Exchange Promissory Notes | Notes payable | ||
Debt | ||
Principal outstanding | $ 5,600,000 | |
Fair value | 5,000,000 | |
Original issue discount | $ 600,000 | |
Interest expense | 600,000 | |
Payments to note holders | $ 5,600,000 | |
Warrant Exchange Promissory Notes | Notes payable | Period one | ||
Debt | ||
Percentage of principal amount required to be redeemed - financing | 20.00% | |
Warrant Exchange Promissory Notes | Notes payable | Period two | ||
Debt | ||
Percentage of principal amount required to be redeemed - financing | 30.00% |
Debt - EB-5 Loan Agreement Borr
Debt - EB-5 Loan Agreement Borrowings (Details) - USD ($) | 4 Months Ended | ||||
Dec. 31, 2016 | Dec. 31, 2020 | Mar. 26, 2020 | Dec. 31, 2019 | Sep. 30, 2016 | |
Debt | |||||
Principal outstanding | $ 1,921,415 | ||||
Carrying value of debt | 2,057,162 | $ 1,072,123 | |||
EB-5 Loan | Loans payable | |||||
Debt | |||||
Maximum borrowing | $ 10,000,000 | ||||
Borrowing increments | $ 500,000 | ||||
Interest rate (as a percent) | 4.00% | ||||
Amount borrowed | $ 1,000,000 | $ 500,000 | |||
Principal outstanding | 1,500,000 | 1,000,000 | |||
Plus: accrued interest | 181,053 | 127,777 | |||
Less: unamortized debt issuance costs | (45,306) | (55,654) | |||
Carrying value of debt | $ 1,635,747 | $ 1,072,123 |
Debt - Senior Secured Convertib
Debt - Senior Secured Convertible Notes (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Jun. 28, 2019 | May 21, 2019 | |
Debt | ||||
Interest expense | $ 720,963 | $ 1,767,836 | ||
Senior Secured Convertible Notes - May 2019 | ||||
Debt | ||||
Principal outstanding | $ 2,400,000 | |||
Original issue discount | $ 500,000 | |||
Senior Secured Convertible Notes - June 2019 | ||||
Debt | ||||
Principal outstanding | $ 2,900,000 | |||
Original issue discount | 400,000 | |||
Senior Secured Convertible Notes | ||||
Debt | ||||
Principal outstanding | $ 5,300,000 | |||
Original issue discount | $ 800,000 |
Debt - Convertible Promissory N
Debt - Convertible Promissory Note (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | May 16, 2019 | Apr. 05, 2019 | Apr. 04, 2019 |
Debt | |||
Common stock, shares agreed to be sold, stock subscription agreement (in shares) | 0.1 | ||
Price per share (in USD per share) | $ 12.41 | ||
Increase in additional paid-in capital from conversion | $ 0.9 | $ 13 | |
Convertible promissory notes | |||
Debt | |||
Principal outstanding | $ 0.9 | ||
Interest rate (as a percent) | 5.00% |
Debt - Convertible Notes (Detai
Debt - Convertible Notes (Details) - USD ($) | May 16, 2019 | Apr. 05, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 28, 2019 | Jan. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | Jun. 30, 2018 | Jan. 31, 2018 |
Debt | ||||||||||
Carrying value of debt | $ 2,057,162 | $ 1,072,123 | ||||||||
Common stock, shares issued (in shares) | 184,133,384 | 52,746,728 | ||||||||
Increase in additional paid-in capital from conversion | $ 900,000 | $ 13,000,000 | ||||||||
Convertible notes | ||||||||||
Debt | ||||||||||
Common stock, shares issued (in shares) | 1,100,000 | |||||||||
Shares issued, price per share (in USD per share) | $ 8.69 | |||||||||
Loss on extinguishment of debt | $ 300,000 | |||||||||
Convertible notes | Minimum | ||||||||||
Debt | ||||||||||
Conversion price discount per original agreement (as a percent) | 0.00% | |||||||||
Convertible notes | Maximum | ||||||||||
Debt | ||||||||||
Conversion price discount per original agreement (as a percent) | 30.00% | |||||||||
Convertible notes | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 8,750,400 | |||||||||
Debt Issuance Costs | (189,158) | |||||||||
Carrying value of debt | $ 4,670,070 | |||||||||
Maturity term (in months) | 18 months | |||||||||
Accretion of debt discount | $ 0 | $ 600,000 | ||||||||
Convertible notes | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (3,891,172) | |||||||||
Convertible notes | Convertible notes | ||||||||||
Debt | ||||||||||
Note principal outstanding | 0 | |||||||||
Interest rate (as a percent) | 5.00% | |||||||||
Redemption multiple upon default | 1.5 | |||||||||
Convertible Notes - Board of Directors | Convertible notes | Board members | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 3,500,000 | $ 3,500,000 | ||||||||
Convertible Note - January 2018 | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 5,000,000 | |||||||||
Debt Issuance Costs | (35,969) | |||||||||
Carrying value of debt | 2,306,320 | |||||||||
Convertible Note - January 2018 | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (2,657,711) | |||||||||
Convertible Note - June 2018 | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 1,000,000 | |||||||||
Debt Issuance Costs | (3,000) | |||||||||
Carrying value of debt | 272,784 | |||||||||
Convertible Note - June 2018 | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (724,216) | |||||||||
Convertible Note - November 2018 | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 1,150,400 | |||||||||
Debt Issuance Costs | (50,646) | |||||||||
Carrying value of debt | 1,078,627 | |||||||||
Convertible Note - November 2018 | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (21,127) | |||||||||
Convertible Note - December 2018 | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | 150,000 | |||||||||
Debt Issuance Costs | (14,310) | |||||||||
Carrying value of debt | 132,833 | |||||||||
Convertible Note - December 2018 | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (2,857) | |||||||||
Convertible Note - January 2019 | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 450,000 | |||||||||
Debt Issuance Costs | (29,358) | |||||||||
Carrying value of debt | 237,760 | |||||||||
Convertible Note - January 2019 | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (182,882) | |||||||||
Convertible Note - February 2019 | ||||||||||
Debt | ||||||||||
Convertible Note Principal Amount | $ 1,000,000 | |||||||||
Debt Issuance Costs | (55,875) | |||||||||
Carrying value of debt | 641,746 | |||||||||
Convertible Note - February 2019 | Convertible debt, conversion feature | ||||||||||
Debt | ||||||||||
Fair Value of Embedded Derivatives | $ (302,379) | |||||||||
November 2018 and December 2018 notes | Convertible notes | Minimum | ||||||||||
Debt | ||||||||||
Conversion price discount per original agreement (as a percent) | 0.00% | |||||||||
January 2019 and February 2019 notes | Convertible notes | ||||||||||
Debt | ||||||||||
Conversion price discount per original agreement (as a percent) | 15.00% |
Debt - Schedule of Debt Maturit
Debt - Schedule of Debt Maturities (Excluding Interest) (Details) | Dec. 31, 2020USD ($) |
Debt Disclosure [Abstract] | |
2021 | $ 234,119 |
2022 | 187,296 |
2023 | 0 |
2024 | 0 |
2025 | 0 |
Thereafter | 1,500,000 |
Total | $ 1,921,415 |
Warrants - Additional Informati
Warrants - Additional Information (Details) $ / shares in Units, $ in Millions | Apr. 22, 2020USD ($)shares | Apr. 21, 2020USD ($) | Nov. 05, 2019$ / sharesshares | Sep. 27, 2019$ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2020measurementInput$ / sharesshares | Nov. 30, 2019shares | Nov. 04, 2019$ / sharesshares | Dec. 31, 2018employee |
Class of Warrant or Right [Line Items] | |||||||||
Number of former employees with warrants | employee | 2 | ||||||||
Level 3 | Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding (in shares) | $ | $ 1.1 | ||||||||
Warrants Exchanged For Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of shares issued and sold | 21,900,000 | ||||||||
Price Volatility | Level 3 | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants fair value estimate volatility (in percentage) | measurementInput | 0.960 | ||||||||
Pre-Merger Financing | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of warrants outstanding (in shares) | 0 | ||||||||
Series A Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of warrants outstanding (in shares) | 0 | ||||||||
Initial exercise price (in USD per share) | $ / shares | $ 7.13 | ||||||||
Warrants outstanding, term | 60 months | ||||||||
Number of common shares in to which the warrants are exercisable (in shares) | 8,800,000 | ||||||||
Fair value of consideration transferred to settle warrants | $ | $ 13.6 | ||||||||
Fair value of consideration transferred to settle warrants, common stock | $ | 8.6 | ||||||||
Consideration transferred in excess of fair value | $ | $ 12.5 | ||||||||
Series A Warrants | Level 2 | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Fair value of consideration transferred to settle warrants, promissory note | $ | $ 5 | ||||||||
Series B Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of warrants outstanding (in shares) | 8,000,000 | 1,000 | 0 | ||||||
Initial exercise price (in USD per share) | $ / shares | $ 0.01 | ||||||||
Warrants, exercise price determination, number of trading days | 10 days | ||||||||
Common stock, issuable upon exercise of warrant (in shares) | 12,600,000 | ||||||||
Series C Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of warrants outstanding (in shares) | 1,000 | 0 | |||||||
Initial exercise price (in USD per share) | $ / shares | $ 7.13 | ||||||||
Number of common shares in to which the warrants are exercisable (in shares) | 50,000,000 | ||||||||
Warrants, exercise price determination, number of trading days | 5 days | ||||||||
Price over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares (in USD per share) | $ / shares | $ 1.20 | ||||||||
Series C Warrants | Maximum | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of common shares in to which the warrants are exercisable (in shares) | 20,000,000 | 50,000,000 | |||||||
OpCo Warrants | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Initial exercise price (in USD per share) | $ / shares | $ 5.67 | $ 5.67 | |||||||
Warrants exercisable (in shares) | 900,000 | 900,000 |
Warrants - Schedule of Roll-for
Warrants - Schedule of Roll-forward of Series B Warrant Liability (Details) - Level 3 - Series B Warrants | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Reconciliation of Series B Warrant liability | |
Balance at beginning of period | $ 0 |
Fair value at issuance (September 27, 2019) | 9,387,760 |
Change in fair value of embedded derivatives | 1,867,980 |
Amount reclassified to equity | (11,255,740) |
Balance at end of period | $ 0 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Compensation Expense for Options Granted (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 660,317 | $ 884,089 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 348,810 | 362,833 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 311,507 | $ 521,256 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) $ / shares in Units, shares in Millions, $ in Millions | 12 Months Ended | |
Dec. 31, 2020USD ($)equityCompensationPlan$ / sharesshares | Dec. 31, 2019USD ($)$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense | $ | $ 1.1 | |
Number of equity compensation plans | equityCompensationPlan | 2 | |
Automatic increase in shares to be issue (in percentage) | 4.00% | |
Weighted average grant date fair value (in USD per share) | $ / shares | $ 0.34 | $ 0.84 |
Options vested in period, fair value | $ | $ 0.5 | $ 1 |
Options to purchase common stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to options outstanding, weighted average period for expense to be recognized | 2 years | |
Stock options | 2014 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares available for grant (in shares) | 0.8 | |
Options outstanding (in shares) | 0.4 | |
Stock options | 2019 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares available for grant (in shares) | 4.2 | |
Options outstanding (in shares) | 3.8 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Valuation Assumptions (Details) - Stock options | 12 Months Ended | |
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 |
Weighted average expected stock price volatility (in percentage) | 112.00% | 109.00% |
Expected dividend rate (in percentage) | 0.00% | 0.00% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Range of expected stock price volatility (in percentage) | 110.00% | 89.00% |
Risk-free interest rate (in percentage) | 0.30% | 1.50% |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Range of expected stock price volatility (in percentage) | 117.00% | 110.00% |
Risk-free interest rate (in percentage) | 1.70% | 2.40% |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule Options to Purchase Common Stock (Details) - 2019 Plan - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | ||
Options outstanding, beginning balance (in shares) | 731,189 | |
Granted (in shares) | 4,082,950 | |
Forfeited (in shares) | (589,706) | |
Options outstanding, ending balance (in shares) | 4,224,433 | 731,189 |
Options exercisable (in shares) | 512,288 | |
Weighted Average Exercise Price | ||
Options outstanding, beginning balance (in USD per share) | $ 4.59 | |
Granted (in USD per share) | 0.41 | |
Forfeited (in USD per share) | 2.55 | |
Options outstanding, ending balance (in USD per share) | 0.84 | $ 4.59 |
Options exercisable (in USD per share) | $ 3.48 | |
Weighted Average Remaining Contractual Life (Years) | ||
Options outstanding (in years) | 8 years 10 months 24 days | 8 years |
Options exercisable (in years) | 6 years 9 months 18 days | |
Aggregate Intrinsic Value | ||
Options outstanding, beginning balance | $ 24,028 | |
Options outstanding, ending balance | 5,496,219 | $ 24,028 |
Options exercisable | $ 286,223 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rate (in percentage) | 21.00% | 21.00% |
State and local tax, net of federal benefit (in percentage) | 7.50% | 5.30% |
Research and development credit (in percentage) | 2.80% | 3.20% |
Effective Income Tax Rate Reconciliation, Permanent Differences, Percent | (1.00%) | (8.10%) |
Other (in percentage) | 1.10% | 2.90% |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Percent | (31.40%) | (24.30%) |
Total provision for income taxes | 0.00% | 0.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 35,714,104 | $ 31,575,288 |
Capital loss carryforwards | 7,298,024 | 7,298,052 |
Start-up costs | 11,234,623 | 11,234,751 |
Accruals and reserves | 397,982 | 166,611 |
Intellectual property amortization | 2,285,247 | 555,352 |
Stock-based compensation expense | 1,290,212 | 1,123,100 |
Tax credits | 2,541,244 | 1,926,677 |
Lease liability | 125,266 | 96,895 |
Total deferred tax assets | 60,886,702 | 53,976,726 |
Valuation allowance | (60,761,412) | (53,877,168) |
Deferred tax assets, net of allowance | 125,290 | 99,558 |
Deferred tax liabilities: | ||
Lease right-of-use assets | (125,290) | (99,558) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | |||
Net loss | $ (21,821,953) | $ (20,242,630) | |
Net change in valuation allowance | (6,900,000) | ||
Unrecognized tax benefits | 303,050 | 303,050 | $ 0 |
State and local | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 126,700,000 | 112,400,000 | |
Tax credit carryforward, amount | 500,000 | 400,000 | |
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | 128,000,000 | 113,600,000 | |
Operating loss carryforwards, not subject to expiration | 75,400,000 | ||
Operating loss carryforwards, subject to expiration | 52,600,000 | ||
Tax credit carryforward, amount | $ 2,200,000 | $ 1,600,000 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized Tax Benefits Reconciliation | ||
Unrecognized tax benefits, beginning balance | $ 303,050 | $ 0 |
Additions for tax positions taken in a prior year | 0 | 303,050 |
Additions for tax positions taken in the current year | 0 | 0 |
Reductions for tax positions taken in the prior year due to settlement | 0 | 0 |
Reductions for tax positions taken in the prior year due to statutes lapsing | 0 | 0 |
Unrecognized tax benefits, ending balance | $ 303,050 | $ 303,050 |
Net Loss per Share of Common _3
Net Loss per Share of Common Stock (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share | ||
Net loss | $ (21,821,953) | $ (20,242,630) |
Deemed dividend related to Warrant Exchange | (12,546,340) | 0 |
Net loss to common stockholders | $ (34,368,293) | $ (20,242,630) |
Shares used in calculation net loss per common share - basic and diluted (in shares) | 112,236,110 | 13,893,819 |
Net loss per common share - basic and diluted (in USD per share) | $ (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 | 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 | 4,224,433 | 731,189 |
Warrants | ||
Incremental Weighted Average Shares Attributable to Dilutive Effect [Abstract] | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 870,017 | 9,643,945 |
Subsequent Events (Details)
Subsequent Events (Details) $ / shares in Units, dose in Millions, $ in Millions | Mar. 01, 2021dose$ / sharesshares | Feb. 07, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / shares | Feb. 02, 2021 | Dec. 31, 2019$ / shares | May 16, 2019$ / shares |
Subsequent Events | ||||||
Price per share (in USD per share) | $ 12.41 | |||||
Convertible preferred stock, par value (in USD per share) | $ 0.01 | $ 0.01 | ||||
Registered Direct Offering | ||||||
Subsequent Events | ||||||
Proceeds from sale of stock | $ | $ 21.2 | |||||
Subsequent events | Registered Direct Offering | ||||||
Subsequent Events | ||||||
Number of shares issued and sold | shares | 3,000,000 | |||||
Price per share (in USD per share) | $ 7.65 | |||||
Proceeds from sale of stock | $ | $ 21.2 | |||||
Commissions, fees and expenses | $ | $ 1.7 | |||||
Subsequent events | COVAXIN Preferred Stock Purchase Agreement | ||||||
Subsequent Events | ||||||
Profits generated, shared percentage | 45.00% | |||||
Subsequent events | COVAXIN Preferred Stock Purchase Agreement | Series B Preferred Stock | ||||||
Subsequent Events | ||||||
Number of shares agreed to issue and sell | shares | 100,000 | |||||
Convertible preferred stock, par value (in USD per share) | $ 0.01 | |||||
Price per share ( in USD per share) | $ 109.60 | |||||
Shares issued upon conversion (in shares) | shares | 10 | |||||
Supply Agreement, Number of Doses | dose | 10 |