Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36751 | |
Entity Registrant Name | OCUGEN, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 04-3522315 | |
Entity Address, Address Line One | 11 Great Valley Parkway | |
Entity Address, City or Town | Malvern | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19355 | |
City Area Code | 484 | |
Local Phone Number | 328-4701 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | OCGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 226,430,141 | |
Entity Central Index Key | 0001372299 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 68,259 | $ 77,563 |
Marketable securities | 8,462 | 13,371 |
Prepaid expenses and other current assets | 7,680 | 7,558 |
Total current assets | 84,401 | 98,492 |
Property and equipment, net | 7,952 | 6,053 |
Other assets | 3,946 | 4,087 |
Total assets | 96,299 | 108,632 |
Current liabilities | ||
Accounts payable | 8,092 | 8,062 |
Accrued expenses and other current liabilities | 5,823 | 9,900 |
Operating lease obligations | 512 | 498 |
Current portion of long term debt | 1,256 | 0 |
Total current liabilities | 15,683 | 18,460 |
Non-current liabilities | ||
Operating lease obligations, less current portion | 3,449 | 3,587 |
Long term debt, net | 1,058 | 2,289 |
Other non-current liabilities | 309 | 244 |
Total non-current liabilities | 4,816 | 6,120 |
Total liabilities | 20,499 | 24,580 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity | ||
Common stock; $0.01 par value; 295,000,000 shares authorized, 226,548,693 and 221,721,182 shares issued, and 226,427,193 and 221,599,682 shares outstanding at March 31, 2023 and December 31, 2022, respectively | 2,265 | 2,217 |
Treasury stock, at cost, 121,500 shares at March 31, 2023 and December 31, 2022 | (48) | (48) |
Additional paid-in capital | 303,073 | 294,874 |
Accumulated other comprehensive income | 25 | 26 |
Accumulated deficit | (229,516) | (213,018) |
Total stockholders' equity | 75,800 | 84,052 |
Total liabilities and stockholders' equity | 96,299 | 108,632 |
Series A Preferred Stock | ||
Stockholders' equity | ||
Preferred stock issued | 0 | 0 |
Series B Preferred Stock | ||
Stockholders' equity | ||
Preferred stock issued | $ 1 | $ 1 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Convertible preferred stock, par value (in USD per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, par value (in USD per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 295,000,000 | 295,000,000 |
Common stock, shares issued (in shares) | 226,548,693 | 221,721,182 |
Common stock, shares outstanding (in shares) | 226,427,193 | 221,599,682 |
Treasury stock (in shares) | 121,500 | 121,500 |
Series A Preferred Stock | ||
Convertible preferred stock, shares issued (in shares) | 0 | 0 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 0 |
Series B Preferred Stock | ||
Convertible preferred stock, shares issued (in shares) | 54,745 | 54,745 |
Convertible preferred stock, shares outstanding (in shares) | 54,745 | 54,745 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses | ||
Research and development | $ 9,558 | $ 7,915 |
General and administrative | 8,193 | 10,119 |
Total operating expenses | 17,751 | 18,034 |
Loss from operations | (17,751) | (18,034) |
Other income (expense), net | 1,253 | 15 |
Net loss | (16,498) | (18,019) |
Other comprehensive income (loss) | ||
Foreign currency translation adjustment | (1) | 0 |
Comprehensive loss | $ (16,499) | $ (18,019) |
Shares used in calculating net loss per common share - basic (in shares) | 225,523,627 | 205,693,498 |
Shares used in calculating net loss per common share - diluted (in shares) | 225,523,627 | 205,693,498 |
Net loss per share of common stock - basic (in USD per share) | $ (0.07) | $ (0.09) |
Net loss per share of common stock - diluted (in USD per share) | $ (0.07) | $ (0.09) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Preferred Stock Series A Preferred Stock | Preferred Stock Series B Preferred Stock | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 7 | 54,745 | 199,502,183 | |||||
Beginning balance at Dec. 31, 2021 | $ 95,818 | $ 0 | $ 1 | $ 1,995 | $ 225,537 | $ 0 | $ (131,667) | |
Beginning balance at Dec. 31, 2021 | $ (48) | |||||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Stock-based compensation expense | 3,299 | 3,299 | ||||||
Issuance of common stock for stock option exercises and restricted stock unit vesting, net (in shares) | 277,323 | |||||||
Issuance of common stock for stock option exercises and restricted stock unit vesting, net | 180 | $ 3 | 177 | |||||
Issuance of common stock for capital raises, net (in shares) | 15,973,420 | |||||||
Issuance of common stock for capital raises, net | 49,851 | $ 160 | 49,691 | |||||
Net loss | (18,019) | (18,019) | ||||||
Ending balance (in shares) at Mar. 31, 2022 | 7 | 54,745 | 215,752,926 | |||||
Ending balance at Mar. 31, 2022 | 131,129 | $ 0 | $ 1 | $ 2,158 | 278,704 | 0 | (149,686) | |
Ending balance at Mar. 31, 2022 | (48) | |||||||
Beginning balance (in shares) at Dec. 31, 2022 | 0 | 54,745 | 221,721,182 | |||||
Beginning balance at Dec. 31, 2022 | 84,052 | $ 0 | $ 1 | $ 2,217 | 294,874 | 26 | (213,018) | |
Beginning balance at Dec. 31, 2022 | 48 | (48) | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Stock-based compensation expense | 2,689 | 2,689 | ||||||
Issuance of common stock for stock option exercises and restricted stock unit vesting, net (in shares) | 348,555 | |||||||
Issuance of common stock for stock option exercises and restricted stock unit vesting, net | (1) | $ 3 | (4) | |||||
Issuance of common stock for capital raises, net (in shares) | 4,478,956 | |||||||
Issuance of common stock for capital raises, net | 5,559 | $ 45 | 5,514 | |||||
Other comprehensive income (loss) | (1) | (1) | ||||||
Net loss | (16,498) | (16,498) | ||||||
Ending balance (in shares) at Mar. 31, 2023 | 0 | 54,745 | 226,548,693 | |||||
Ending balance at Mar. 31, 2023 | 75,800 | $ 0 | $ 1 | $ 2,265 | $ 303,073 | $ 25 | $ (229,516) | |
Ending balance at Mar. 31, 2023 | $ 48 | $ (48) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (16,498) | $ (18,019) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 174 | 76 |
Amortization (accretion) on marketable securities | (143) | 0 |
Non-cash interest expense | 24 | 19 |
Non-cash lease expense | 131 | 179 |
Stock-based compensation expense | 2,689 | 3,299 |
Other | 352 | 0 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (60) | (575) |
Accounts payable and accrued expenses | (4,784) | 131 |
Lease obligations | (125) | (176) |
Net cash used in operating activities | (18,240) | (15,066) |
Cash flows from investing activities | ||
Purchases of marketable securities | (3,947) | 0 |
Proceeds from the maturities of marketable securities | 9,000 | 0 |
Purchases of property and equipment | (1,612) | (223) |
Net cash provided by (used in) investing activities | 3,441 | (223) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net | 5,731 | 50,177 |
Payment of equity issuance costs | (173) | (75) |
Payment of debt issuance costs | (62) | 0 |
Net cash provided by financing activities | 5,496 | 50,102 |
Effect of changes in exchange rate on cash, cash equivalents, and restricted cash | (1) | 0 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (9,304) | 34,813 |
Cash, cash equivalents, and restricted cash at beginning of period | 77,563 | 95,109 |
Cash, cash equivalents, and restricted cash at end of period | 68,259 | 129,922 |
Supplemental disclosure of non-cash investing and financing transactions: | ||
Purchases of property and equipment | 1,119 | 611 |
Equity issuance costs | $ 0 | $ 71 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Ocugen, Inc., together with its wholly owned subsidiaries ("Ocugen" or the "Company"), is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The Company is headquartered in Malvern, Pennsylvania, and manages its business as one operating segment. Modifier Gene Therapy Platform The Company is developing a modifier gene therapy platform designed to fulfill unmet medical needs related to retinal diseases, including inherited retinal diseases ("IRDs"), such as retinitis pigmentosa ("RP"), Leber congenital amaurosis ("LCA"), and Stargardt disease, as well as dry age-related macular degeneration ("AMD") with a single mutation-agnostic therapy. The Company's modifier gene therapy platform is based on the use of nuclear hormone receptors ("NHRs"), which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, the Company believes that its modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential both to address multiple retinal diseases caused by mutations in multiple genes with a single unique product and to address complex diseases that are potentially caused by imbalances in multiple gene networks. The Company believes that OCU400 has the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs, including RP and LCA. OCU400 has received Orphan Drug Designation ("ODD") from the United States Food and Drug Administration ("FDA") and Orphan Medicinal Product Designation ("OMPD") from the European Commission ("EC") for the treatment of RP and LCA. The Company is conducting a Phase 1/2 trial to assess the safety and efficacy of unilateral subretinal administration of OCU400 in patients with nuclear receptor subfamily 2 group E member 3 (" NR2E3") and rhodopsin ( "RHO " ) -related RP and centrosomal protein 290 (" CEP290 " ) -related LCA in the United States. The Company has completed dosing patients with RP in the dose-escalation portion of the trial, which enrolled 10 patients to receive a low, medium, or high dose of OCU400 in the subretinal space. Additionally, the Company has completed dosing eight patients with RP in the dose-expansion portion of the trial and is continuing to enroll patients with LCA to receive the high dose, which was determined to be the maximum tolerable dose from the dose-escalation portion of the trial. In April 2023, the Company announced positive preliminary data among RP patients treated in the first two cohorts of the Phase 1/2 trial. In Cohorts 1 and 2 of the trial, seven participants with severe vision impairment due to RP associated with the RHO and NR2E3 gene mutations received a unilateral subretinal injection of either a low dose or a medium dose of OCU400, respectively. The preliminary results showed a favorable safety profile and visual improvements after treatment with OCU400 as measured by multi-luminance mobility testing ("MLMT") and best corrected visual acuity assessment ("BCVA"). In March 2023, the FDA approved the enrollment of pediatric patients in the ongoing Phase 1/2 trial for the treatment of RP and LCA and the Company intends to dose pediatric patients in the second quarter of 2023. Additionally, the Company intends to initiate a Phase 3 trial for OCU400 for the treatment of RP and LCA near the end of 2023, subject to discussions with the FDA. The Company is also developing OCU410 and OCU410ST, utilizing the nuclear receptor genes RAR-related orphan receptor A (" RORA " ), for the treatment of dry AMD and Stargardt disease, respectively. OCU410 is a potential one-time, curative therapy with a single sub-retinal injection. OCU410ST has received ODD from the FDA for the treatment of ABCA4 -associated retinopathies, including Stargardt disease. The Company intends to submit Investigational New Drug ("IND") applications in the second quarter of 2023 to initiate Phase 1/2 trials. Regenerative Medicine Cell Therapy Platform NeoCart is a Phase 3-ready, regenerative medicine cell therapy technology that combines breakthroughs in bioengineering and cell processing to enhance the autologous cartilage repair process. NeoCart is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes, the cells responsible for maintaining cartilage health. The chondrocytes are derived from the patient on a unique scaffold. In this therapy, healthy cartilage tissue is grown and implanted in the patient. Cartilage defects often lead to osteoarthritis if left untreated. Current surgical and nonsurgical treatment options are limited in their efficacy and durability. NeoCart has the potential to accelerate healing, reduce pain, and provide regenerative native-like cartilage strength with durable benefits post transplantation. The FDA granted a regenerative medicine advanced therapy ("RMAT") designation to NeoCart for the repair of full-thickness lesions of knee cartilage injuries in adults. Additionally, the Company received concurrence from the FDA on the confirmatory Phase 3 trial design. The Company is renovating an existing facility into a current Good Manufacturing Practice ("GMP") facility in accordance with the FDA's regulations in support of NeoCart manufacturing for personalized Phase 3 trial material. The Company intends to initiate the Phase 3 trial in 2024. Vaccines The Company's vaccines platform is driven by its conviction to serve a public health concern, which requires the endorsement and support of government funding, both domestically and in licensed territories abroad, in order to develop and ultimately commercialize its vaccine candidates. Therefore, the Company's anticipated expenses for vaccines development from the second quarter of 2023 onward will be limited as it devotes its current cash, cash equivalents, and investments to developing its modifier gene therapy platform. The Company is refocusing its efforts to develop an inhalation-based, next generation mucosal vaccine platform to overcome the limitations of current intramuscular COVID-19 treatments, namely sustained durability and transmissibility inhibition. While the Company continues to incur expenses for the development of its inhaled mucosal vaccine platform to achieve IND readiness, any additional development will be reliant on government funding. Inhaled Mucosal Vaccines The Company is developing a novel inhaled mucosal vaccine platform, which includes OCU500, a bivalent COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 vaccine. As these vaccine candidates are being developed to be administered through inhalation, the Company believes they have the potential to generate rapid local immunity in the upper airways and lungs where viruses enter and infect the body, which the Company believes may help reduce or prevent infection and transmission as well as provide protection against new virus variants. The Company intends to submit an IND application near the end of 2023 or in early 2024 and is continuing to work closely with government agencies to obtain funding for the development of these inhaled mucosal vaccines. Intramuscular COVID-19 Vaccine In April 2023, the FDA announced the cancellation of emergency use authorizations ("EUA") issued to monovalent vaccines and the simplification of the vaccination schedule of bivalent vaccines that have EUAs in the United States. Accordingly, the Company has determined it is not commercially viable to continue the development of COVAXIN in its North American territory and consequently, will focus its efforts on the development of the inhaled mucosal bivalent vaccines. Novel Biologic Therapy for Retinal Diseases The Company is developing OCU200, which is a novel fusion protein containing parts of human transferrin and tumstatin. OCU200 is designed to treat diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet AMD. The Company has completed the technology transfer of manufacturing processes to its contract development and manufacturing organization ("CDMO") and has produced trial materials to initiate a Phase 1 trial. The Company submitted an IND application to the FDA in February 2023 to initiate a Phase 1 trial targeting DME. In April 2023, the FDA placed the Company's IND application for the Phase 1 trial on clinical hold as part of the FDA's request for additional information related to chemistry, manufacturing, and controls ("CMC") prior to initiating the Phase 1 trial. The Company intends to work with the FDA and provide requested information as promptly as possible, and does not currently expect the clinical hold to impact the anticipated overall timing of the OCU200 clinical development program. Going Concern The Company has incurred recurring net losses since inception and has funded its operations to date through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes and debt, and grant proceeds. The Company incurred net losses of approximately $16.5 million and $18.0 million for the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023, the Company had an accumulated deficit of $229.5 million and cash, cash equivalents, and investments totaling $76.7 million. This amount will not meet the Company's capital requirements over the next 12 months. The Company believes that its cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2024. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company. The Company is subject to risks, expenses, and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research, development, and commercialization efforts for its product candidates, which will require significant additional funding. If the Company is unable to obtain additional funding in the future and/or its research, development, and commercialization efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company plans to fund its operations through public and private placements of equity and/or debt, payments from potential strategic research and development arrangements, sales of assets, licensing and/or collaboration arrangements with pharmaceutical companies or other institutions, funding from the government, particularly for the development of the Company's novel inhaled mucosal vaccine platform, or funding from other third parties. Such financing and funding may not be available at all, or on terms that are favorable to the Company. While Company management believes that it has a plan to fund operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital, or appropriately manage certain discretionary spending, could have a material adverse effect on the Company's ability to achieve its intended business objectives. As a result of these factors, together with the anticipated increase in spending that will be necessary to continue to research, develop, and commercialize the Company's product candidates, there is substantial doubt about the Company's ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. The condensed consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements included herein have been prepared in conformity with generally accepted accounting principles ("GAAP") in the United States and under the rules and regulations of the United States Securities and Exchange Commission ("SEC") for interim reporting. The accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, that are necessary to present fairly the Company's financial position, results of operations, and cash flows. The condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosures of the Company normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted under the SEC's rules and regulations. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2022, included in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2023 (the "2022 Annual Report"). The condensed consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates In preparing the condensed consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, and the fair value measurement of equity instruments. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents may include bank demand deposits and money market funds that invest primarily in certificates of deposit, commercial paper, and U.S. government agency securities and treasuries. The Company records interest income received on its cash and cash equivalents to other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company recorded $0.7 million as interest income for the three months ended March 31, 2023. The Company's restricted cash balance as of March 31, 2022 consisted of cash held to collateralize a corporate credit card account. The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the condensed consolidated balance sheets to the total amount shown in the condensed consolidated statements of cash flows (in thousands): As of March 31, 2023 2022 Cash and cash equivalents $ 68,259 $ 129,771 Restricted cash — 151 Total cash, cash equivalents, and restricted cash $ 68,259 $ 129,922 Fair Value Measurements The Company follows the provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 820, Fair Value Measurements ("ASC 820"), which defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 — quoted prices in active markets for identical assets or liabilities Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions) The carrying value of certain financial instruments, including cash and cash equivalents, accounts payable, and accrued expenses, approximates their fair value due to the short-term nature of these instruments. Marketable Securities The Company accounts for marketable securities in accordance with FASB ASC Topic 320, Investments - Debt and Equity Securities ("ASC 320"). The Company determines the appropriate classification of its investments in debt securities at the time of purchase. Debt securities are classified as trading securities if the security is bought and held primarily to be sold in the near term. Debt securities are classified as held-to-maturity if management has both the positive intent and ability to hold until the maturity of the security. All securities not classified as trading securities or held-to-maturity securities are classified as available-for-sale securities. The Company's current marketable securities are comprised of debt securities which are classified as available-for-sale securities in accordance with ASC 320. At the time of purchase, the Company classifies marketable securities with maturities of 90 days or less as cash equivalents on the condensed consolidated balance sheets. Available-for-sale securities are recorded at fair value based on inputs that are observable, either directly or indirectly, such as quoted prices for identical securities in active markets (Level 1) or quoted prices for similar securities in active markets or inputs that are observable (Level 2). Unrealized gains and losses are included in other comprehensive income (loss) in the condensed consolidated statements of operations and comprehensive loss. Amortization of premium or accretion of discount on debt securities are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company reviews investments in debt securities for other-than-temporary impairment if the fair value of the investment is less than the amortized cost basis. The assessment for other-than-temporary impairment is performed at the individual security level. To date, the Company has not recognized any impairments with respect to its debt securities. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents, and investments. The Company's cash, cash equivalents, and investments are held in accounts at financial institutions that may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant credit risk beyond the standard credit risk associated with commercial banking relationships. Leases The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company, if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company's lease agreements include lease and non-lease components, which the Company has elected not to account for separately for all classes of underlying assets. Lease expense for variable lease components is recognized when the obligation is probable. The Company currently leases real estate classified as operating leases. Operating leases are included in other assets and operating lease obligations in the Company's condensed consolidated balance sheets. At lease commencement, the Company records a lease liability based on the present value of the lease payments over the expected lease term, including any options to extend the lease that the Company is reasonably certain to exercise, and records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. Lease expense is recognized on a straight-line basis over the lease term and recognized as research and development expense or general and administrative expense based on the underlying nature of the expense. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rates were not readily determinable in the Company's current operating leases. As such, the incremental borrowing rates were used based on the information available at the commencement dates in determining the present value of lease payments. The lease term for the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on an index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset, if reasonably certain. Variable payments not dependent on an index or rate associated with the Company's leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company's condensed 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"). The Company has issued stock-based compensation awards including stock options and restricted stock units ("RSUs"), and has also accounted for certain issuances of preferred stock and warrants in accordance with ASC 718. ASC 718 requires all stock-based payments, including grants of stock options and RSUs, to be recognized in the condensed consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs, the fair value of the RSU is determined by the market price of a share of the Company's common stock on the grant date. The Company recognizes forfeitures as they occur. Expense related to stock-based compensation awards granted with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Stock-based compensation awards generally vest over a one Estimating the fair value of stock options requires the input of subjective assumptions, including the expected life of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. The assumptions used in the Company's Black-Scholes option-pricing model represent management's best estimates and involve a number of variables, uncertainties, assumptions, and the application of management's judgment, as they are inherently subjective. If any assumptions change, the Company's stock-based compensation expense could be materially different in the future. Recently Adopted Accounting Standards In June 2016, the FASB issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The FASB subsequently issued amendments to ASU No. 2016-13, which had the same effective date and transition date of January 1, 2023. ASU No. 2016-13, as amended, requires that credit losses be reported using an expected losses model rather than the incurred losses model that was previously 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 standard was effective for the Company on January 1, 2023. The adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. Recent Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40) . This standard will have an effective and transition date of January 1, 2024. Early adoption is currently permitted. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models that require separate accounting for embedded conversion features as well as simplifies the settlement assessment that entities are required to perform to determine whether a contract qualifies for equity classification. This standard also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and includes the effect of potential share settlement (if the effect is more dilutive) for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. The standard requires new disclosures about events that occur during the reporting period that cause conversion contingencies to be met and about the fair value of a public business entity's convertible debt at the instrument level, among other things. The Company does not currently expect the adoption of this standard to have a material impact on the Company's condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following table summarizes the fair value and the classification by level of input within the fair value hierarchy of financial assets that are recurring fair value measurements (in thousands): As of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 68,259 $ — $ — $ 68,259 Marketable securities U.S. government agency securities and treasuries — 4,478 — 4,478 Commercial paper — 3,984 — 3,984 Total assets $ 68,259 $ 8,462 $ — $ 76,721 As of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 76,564 $ 999 $ — $ 77,563 Marketable securities U.S. government agency securities and treasuries — 7,433 — 7,433 Commercial paper — 5,938 — 5,938 Total assets $ 76,564 $ 14,370 $ — $ 90,934 As of March 31, 2023 and December 31, 2022, the valuation of the Company's marketable securities utilized Level 2 inputs in the fair value hierarchy. See Note 2 for additional information. Further, the Company believes the fair value using Level 2 |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The following table provides the amortized cost basis and fair value of the Company's available-for-sale investments by security type as reflected on the condensed consolidated balance sheets (in thousands): As of March 31, 2023 Amortized Cost Basis Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government agency securities and treasuries $ 4,477 $ 1 $ — $ 4,478 Commercial paper 3,984 — — 3,984 Total marketable securities $ 8,461 $ 1 $ — $ 8,462 As of December 31, 2022 Amortized Cost Basis Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government agency securities and treasuries $ 7,432 $ 1 $ — $ 7,433 Commercial paper 5,938 — — 5,938 Total marketable securities $ 13,370 $ 1 $ — $ 13,371 As of March 31, 2023 as well as December 31, 2022, the Company's marketable securities comprised of investments that mature within one year. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment The following table provides a summary of the major components of property and equipment as reflected on the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Furniture and fixtures $ 337 $ 337 Machinery and equipment 1,783 1,685 Leasehold improvements 1,907 1,603 Construction in progress 4,712 3,049 Total property and equipment 8,739 6,674 Less: accumulated depreciation (787) (621) Total property and equipment, net $ 7,952 $ 6,053 |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Leases | Operating LeasesThe Company has commitments under operating leases for office, laboratory, and future manufacturing space located in Malvern, Pennsylvania. The Company's leases have initial terms of approximately seven years and include options to extend the leases for up to 10 years. The options for extension have been excluded from the lease terms (and lease liabilities) as it is not reasonably certain that the Company will exercise such options. The Company's future minimum base rent payments are approximately as follows (in thousands): For the years ending December 31, Amount Remainder of 2023 $ 574 2024 787 2025 810 2026 834 2027 834 Thereafter 978 Total $ 4,817 Less: present value adjustment (856) Present value of minimum lease payments $ 3,961 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities The following table provides a summary of the major components of accrued expenses and other current liabilities as reflected on the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Research and development $ 1,286 $ 1,894 Clinical 117 3,310 Professional fees 615 437 Employee-related 1,592 2,752 Other 2,213 1,507 Total accrued expenses and other current liabilities $ 5,823 $ 9,900 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt In September 2016, in connection with the U.S. government's foreign national investor program, commonly known as the EB-5 Program, the Company entered into a financing arrangement (the "EB-5 Loan Agreement") which provides for cumulative borrowings of up to $10.0 million from EB5 Life Sciences, L.P. ("EB-5 Life Sciences") as the lender. Borrowings are to be utilized in the clinical development, manufacturing, and commercialization of the Company's product candidates and for the general working capital needs of the Company. Borrowings associated with the EB-5 Loan Agreement are secured by substantially all of the Company's assets, with the exception of any patents, patent applications, pending patents, patent licenses, patent sublicenses, trademarks, and other intellectual property rights held by the Company. As of March 31, 2023, borrowings associated with the EB-5 Loan Agreement were made in $0.5 million increments. Cumulative borrowing amounts associated with the EB-5 Loan Agreement may be limited by the amount of funds raised by EB-5 Life Sciences and are also subject to certain job creation requirements by the Company. Under the terms and conditions of the EB-5 Loan Agreement, the Company borrowed $1.0 million during 2016, $0.5 million during 2020, and an additional $0.5 million in September 2022. Issuance costs are recognized as a reduction to the loan balance and are amortized to interest expense over the term of each borrowing. Subsequent to March 31, 2023, the Company borrowed an additional $0.5 million under the EB-5 Loan Agreement. As of March 31, 2023, outstanding borrowings carry a fixed interest rate of 4.0% per annum. Pursuant to the EB-5 Loan Agreement, each outstanding borrowing, including accrued interest, becomes due upon the seventh anniversary of the disbursement date, subject to certain extension provisions. Once repaid, amounts cannot be re-drawn. The carrying values of the EB-5 Loan Agreement borrowings as of March 31, 2023 and December 31, 2022 are summarized below (in thousands): March 31, 2023 December 31, 2022 Principal outstanding $ 2,000 $ 2,000 Plus: accrued interest 327 307 Less: unamortized debt issuance costs (13) (18) Carrying value, net 2,314 2,289 Less: current portion of long term debt (1,256) — Long term debt, net of current portion $ 1,058 $ 2,289 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Equity | Equity Offerings of Common Stock At-the-Market Offering In June 2022, the Company entered into an At Market Issuance Sales Agreement ("Sales Agreement") with certain agents, pursuant to which the Company could, from time to time, offer and sell shares of its common stock having an aggregate gross sales price of up to $160.0 million. The offer and sale of the shares of common stock made pursuant to the Sales Agreement were made under the Company's Registration Statement on Form S-3ASR, which was previously filed with the SEC and became automatically effective on March 22, 2021, as supplemented by a prospectus supplement, dated June 10, 2022. During the three months ended March 31, 2023, the Company sold 4.5 million shares of its common stock and received net proceeds of $5.6 million after deducting issuance costs of $0.2 million. The Sales Agreement was terminated on February 27, 2023. Public Offering In February 2022, the Company entered into an underwriting agreement with an underwriter, pursuant to which the Company sold 16.0 million shares of its common stock at a public offering price of $3.13 per share (the "Public Offering"). Upon the closing of the Public Offering, the Company received net proceeds of $49.8 million, after deducting equity issuance costs payable by the Company. COVAXIN Preferred Stock Purchase Agreement On March 1, 2021, the Company entered into a preferred stock purchase agreement with Bharat Biotech, pursuant to which the Company agreed to issue and sell 0.1 million shares of the Company's Series B Convertible Preferred Stock, par value $0.01 per share (the "Series B Convertible Preferred Stock"), at a price per share equal to $109.60, to Bharat Biotech. On March 18, 2021, the Company issued the Series B Convertible Preferred Stock as an advance payment of $6.0 million for the supply of COVAXIN to be provided by Bharat Biotech pursuant to the Supply Agreement. Each share of Series B Convertible Preferred Stock is convertible, at the option of Bharat Biotech, into 10 shares of the Company's common stock (the "Conversion Ratio") only after (i) the Company received stockholder approval to increase the number of authorized shares of common stock under its Sixth Amended and Restated Certificate of Incorporation, which the Company received in April 2021, and (ii) the Company's receipt of shipments by Bharat Biotech of the first 10.0 million doses of COVAXIN manufactured by Bharat Biotech pursuant to the Development and Commercial Supply Agreement, and further on the terms and subject to the conditions set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. As of March 31, 2023, the conversion condition relating to the delivery of the first 10.0 million doses of COVAXIN had not been met. The conversion rate of the Series B Convertible Preferred Stock is subject to adjustment in the event of a stock dividend, stock split, reclassification, or similar event with respect to the Company's common stock. The Company accounted for the issuance of the Series B Convertible Preferred Stock in accordance with ASC 718 and recorded its grant date fair value of $5.0 million within stockholders' equity during the year ended December 31, 2021, with a corresponding short-term asset for the advanced payment for the supply of COVAXIN included in prepaid expenses and other current assets in the condensed consolidated balance sheet as of December 31, 2021. The Company utilized the traded common stock price, adjusted by the Conversion Ratio, to value the Series B Convertible Preferred Stock and the Finnerty model to estimate a 15% discount rate for the lack of marketability of the instrument. The valuation incorporated Level 3 inputs in the fair value hierarchy, including the estimated time until the instrument's liquidity and the estimated volatility of the Company's common stock as of the grant date. As of March 31, 2023 and December 31, 2022, the remaining balance of the short-term asset for the advanced payment for the supply of COVAXIN was $4.1 million. Subsequent to March 31, 2023 and as mentioned in Note 1, the FDA announced the cancellation of EUAs issued to monovalent vaccines. Accordingly, the Company has determined it is not commercially viable to continue the development of COVAXIN in its North American territory. The Company is currently evaluating the accounting implications of the FDA's decision with respect to the short-term asset for the advanced payment for the supply of COVAXIN recorded in the condensed consolidated balance sheet, as well as the issued Series B preferred stock within stockholders' equity. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Warrants | Warrants Canada Warrants In July 2021, the Company entered into a consulting agreement with regard to the Company's Canadian operations (the "Canada Consulting Agreement"). Compensation under the Canada Consulting Agreement included the issuance of warrants to purchase up to 0.2 million shares of the Company's common stock (the "Canada Warrants") and cash payments of up to $3.0 million, both dependent upon the achievement of certain milestones related to COVAXIN. The Canada Warrants were issued on July 15, 2021, have an exercise price of $6.36 per share, and were accounted for in accordance with ASC 718. The Canada Consulting Agreement terminates on July 15, 2023 and the Canada Warrants terminate on July 15, 2031, unless earlier terminated in accordance with their terms. As of March 31, 2023 and December 31, 2022, all of the Canada Warrants were outstanding and unvested. Subsequent to March 31, 2023 and as mentioned in Note 1, the FDA announced the cancellation of EUAs issued to monovalent vaccines. Accordingly, the Company has determined it is not commercially viable to continue the development of COVAXIN in its North American territory. The Company is currently evaluating the implications of the FDA's decision with respect to the Canada Consulting Agreement and the Canada Warrants. OpCo Warrants Beginning in 2016, OpCo issued warrants to purchase the Company's common stock (the "OpCo Warrants"). As of March 31, 2023 and December 31, 2022, 0.6 million OpCo Warrants were outstanding. As of March 31, 2023, the outstanding OpCo Warrants had a weighted-average exercise price of $6.23 per share and expire between 2026 and 2027. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for stock options and RSUs is reflected in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three months ended March 31, 2023 2022 General and administrative $ 1,952 $ 2,216 Research and development 737 1,083 Total $ 2,689 $ 3,299 As of March 31, 2023, the Company had $17.8 million of unrecognized stock-based compensation expense related to stock options and RSUs outstanding, which is expected to be recognized over a weighted-average period of 2.0 years. Equity Plans The Company maintains two equity compensation plans, the 2014 Ocugen OpCo, Inc. Stock Option Plan (the "2014 Plan") and the Ocugen, Inc. 2019 Equity Incentive Plan (the "2019 Plan", collectively with the 2014 Plan, the "Plans"). As of March 31, 2023, the 2014 Plan and the 2019 Plan authorize for the granting of up to 0.8 million and 28.4 million equity awards with respect to the Company's common stock, respectively. In addition to stock options and RSUs granted under the Plans, the Company has granted certain stock options and RSUs as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4), which were granted outside of the Plans. Stock Options to Purchase Common Stock The following table summarizes the stock option activity: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (years) Aggregate Intrinsic Value Stock options outstanding at December 31, 2022 10,851,287 $ 2.95 8.3 $ 1,385 Granted 3,700,996 $ 1.22 Exercised (200,000) $ 0.42 Forfeited (628,119) $ 2.88 Stock options outstanding at March 31, 2023 13,724,164 $ 2.53 8.5 $ 599 Stock options exercisable at March 31, 2023 5,199,957 $ 2.92 7.7 $ 322 The weighted average grant date fair values of stock options granted during the three months ended March 31, 2023 and 2022 were $1.01 and $3.61, respectively. The total fair values of stock options vested during the three months ended March 31, 2023 and 2022 were $5.6 million and $2.8 million, respectively. RSUs The following table summarizes the RSU activity: Number of Shares Weighted Average Grant-Date Fair Value RSUs outstanding at December 31, 2022 924,810 $ 4.12 Granted 3,043,066 $ 1.23 Vested (217,135) $ 4.56 Forfeited (263,690) $ 2.01 RSUs outstanding at March 31, 2023 3,487,051 $ 1.73 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share of Common Stock | Net Loss Per Share of Common Stock The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2023 and 2022 (in thousands, except share and per share amounts): Three months ended March 31, 2023 2022 Net loss — basic and diluted $ (16,498) $ (18,019) Shares used in calculating net loss per common share — basic and diluted 225,523,627 205,693,498 Net loss per common share — basic and diluted $ (0.07) $ (0.09) The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as their inclusion would have been antidilutive: Three months ended March 31, 2023 2022 Stock options to purchase common stock 13,724,164 14,002,454 RSUs 3,487,051 1,301,269 Warrants 798,352 3,110,655 Series A Convertible Preferred Stock (as converted to common stock) — 3,115 Series B Convertible Preferred Stock (as converted to common stock) 547,450 547,450 Total 18,557,017 18,964,943 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments The Company has commitments under certain license and development agreements, lease agreements, debt agreements, and consulting agreements. Commitments under certain license and development agreements include annual payments, payments upon the achievement of certain milestones, and royalty payments based on net sales of licensed products (commitments under the Company's licensing agreements are more fully described within the Company's 2022 Annual Report). Commitments under lease agreements are future minimum lease payments (see Note 6). Commitments under debt agreements are the future payments of principal and accrued interest under the EB-5 Loan Agreement (see Note 8). Commitments under consulting agreements include payments upon the achievement of certain milestones related to COVAXIN (see Note 10). Contingencies In June 2021, a securities class action lawsuit was filed against the Company and certain of its agents in the U.S. District Court for the Eastern District of Pennsylvania ("Court") (Case No. 2:21-cv-02725) that purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, based on statements made by the Company concerning the announcement of the Company's decision to pursue the submission of a BLA for COVAXIN for adults ages 18 years and older rather than pursuing an EUA for the vaccine candidate. In July 2021, a second securities class action lawsuit was filed against the Company and certain of its agents in the Court (Case No. 2:21-cv-03182) that also purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder, based on the same statements as the first complaint. The complaints seek unspecified damages, interest, attorneys' fees, and other costs. In March 2022, the Court consolidated these two related securities class action lawsuits and appointed Andre Galan Bernd Benayon to serve as lead plaintiff. The lead plaintiff's amended complaint was filed in June 2022. The Company filed a motion to dismiss the amended complaint in August 2022. The lead plaintiff's opposition to the motion to dismiss was filed in October 2022. The Company filed its reply in support of the motion to dismiss in November 2022. Oral argument on the motion to dismiss took place in January 2023. In March 2023, the Court granted the Company's motion to dismiss with prejudice. The lead plaintiff has appealed to the United States Court of Appeals for the Third Circuit regarding the order that was entered in March 2023, which dismissed the action with prejudice. In August 2021, a stockholder derivative lawsuit was filed derivatively on behalf of the Company against certain of its agents and the nominal defendant Ocugen in the Court (Case No. 2:21-cv-03876) that purported to state a claim for breach of fiduciary duty and contribution for violations of Sections 10(b) and 21(d) of the Exchange Act, based on facts and circumstances relating to the securities class action lawsuits and seeking contribution and indemnification in connection with claims asserted in the securities class action lawsuits. In September 2021, a second stockholder derivative lawsuit was filed derivatively on behalf of the Company against certain of its agents and the nominal defendant Ocugen in the Court (Case No. 2:21-cv-04169) that purported to state a claim for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and contribution for violations of Sections 10(b) and 21(d) of the Exchange Act, based on the same allegations as the first complaint. The parties to both stockholder derivative lawsuits stipulated to the consolidation of the two stockholder derivative lawsuits and submitted to the Court in each action a proposed order requesting a stay of the litigation pending a decision on any motion to dismiss filed in the securities class action lawsuits, which the Court entered in April 2022. In March 2023, the Court in the securities class action lawsuits granted the Company's motion to dismiss with prejudice. In March 2023, the parties to the stockholder derivative lawsuits stipulated to extend the stay of litigation pending resolution of any appeal filed in the securities class action lawsuits, which the Court entered in March 2023. As aforementioned, an appeal was filed by the lead plaintiff in the securities class action lawsuits in March 2023. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsSubsequent to March 31, 2023, the Company borrowed $0.5 million pursuant to the EB-5 Loan Agreement. Refer to Note 8 for the terms and conditions of the EB-5 borrowings. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and ConsolidationThe accompanying unaudited condensed consolidated financial statements included herein have been prepared in conformity with generally accepted accounting principles ("GAAP") in the United States and under the rules and regulations of the United States Securities and Exchange Commission ("SEC") for interim reporting. The accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, that are necessary to present fairly the Company's financial position, results of operations, and cash flows. The condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosures of the Company normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted under the SEC's rules and regulations. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2022, included in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2023 (the "2022 Annual Report"). |
Principles of Consolidation | The condensed consolidated financial statements include the accounts of Ocugen and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates In preparing the condensed consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, and the fair value measurement of equity instruments. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents may include bank demand deposits and money market funds that invest primarily in certificates of deposit, commercial paper, and U.S. government agency securities and treasuries. The Company records interest income received on its cash and cash equivalents to other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company recorded $0.7 million as interest income for the three months ended March 31, 2023. The Company's restricted cash balance as of March 31, 2022 consisted of cash held to collateralize a corporate credit card account. |
Fair Value Measurements | Fair Value Measurements The Company follows the provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 820, Fair Value Measurements ("ASC 820"), which defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 — quoted prices in active markets for identical assets or liabilities Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 — inputs that are unobservable (for example, cash flow modeling inputs based on assumptions) The carrying value of certain financial instruments, including cash and cash equivalents, accounts payable, and accrued expenses, approximates their fair value due to the short-term nature of these instruments. |
Marketable Securities | Marketable Securities The Company accounts for marketable securities in accordance with FASB ASC Topic 320, Investments - Debt and Equity Securities ("ASC 320"). The Company determines the appropriate classification of its investments in debt securities at the time of purchase. Debt securities are classified as trading securities if the security is bought and held primarily to be sold in the near term. Debt securities are classified as held-to-maturity if management has both the positive intent and ability to hold until the maturity of the security. All securities not classified as trading securities or held-to-maturity securities are classified as available-for-sale securities. The Company's current marketable securities are comprised of debt securities which are classified as available-for-sale securities in accordance with ASC 320. At the time of purchase, the Company classifies marketable securities with maturities of 90 days or less as cash equivalents on the condensed consolidated balance sheets. Available-for-sale securities are recorded at fair value based on inputs that are observable, either directly or indirectly, such as quoted prices for identical securities in active markets (Level 1) or quoted prices for similar securities in active markets or inputs that are observable (Level 2). Unrealized gains and losses are included in other comprehensive income (loss) in the condensed consolidated statements of operations and comprehensive loss. Amortization of premium or accretion of discount on debt securities are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company reviews investments in debt securities for other-than-temporary impairment if the fair value of the investment is less than the amortized cost basis. The assessment for other-than-temporary impairment is performed at the individual security level. To date, the Company has not recognized any impairments with respect to its debt securities. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents, and investments. The Company's cash, cash equivalents, and investments are held in accounts at financial institutions that may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant credit risk beyond the standard credit risk associated with commercial banking relationships. |
Leases | Leases The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company, if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company's lease agreements include lease and non-lease components, which the Company has elected not to account for separately for all classes of underlying assets. Lease expense for variable lease components is recognized when the obligation is probable. The Company currently leases real estate classified as operating leases. Operating leases are included in other assets and operating lease obligations in the Company's condensed consolidated balance sheets. At lease commencement, the Company records a lease liability based on the present value of the lease payments over the expected lease term, including any options to extend the lease that the Company is reasonably certain to exercise, and records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. Lease expense is recognized on a straight-line basis over the lease term and recognized as research and development expense or general and administrative expense based on the underlying nature of the expense. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rates were not readily determinable in the Company's current operating leases. As such, the incremental borrowing rates were used based on the information available at the commencement dates in determining the present value of lease payments. The lease term for the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on an index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset, if reasonably certain. Variable payments not dependent on an index or rate associated with the Company's leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company's condensed 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"). The Company has issued stock-based compensation awards including stock options and restricted stock units ("RSUs"), and has also accounted for certain issuances of preferred stock and warrants in accordance with ASC 718. ASC 718 requires all stock-based payments, including grants of stock options and RSUs, to be recognized in the condensed consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs, the fair value of the RSU is determined by the market price of a share of the Company's common stock on the grant date. The Company recognizes forfeitures as they occur. Expense related to stock-based compensation awards granted with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Stock-based compensation awards generally vest over a one Estimating the fair value of stock options requires the input of subjective assumptions, including the expected life of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. The assumptions used in the Company's Black-Scholes option-pricing model represent management's best estimates and involve a number of variables, uncertainties, assumptions, and the application of management's judgment, as they are inherently subjective. If any assumptions change, the Company's stock-based compensation expense could be materially different in the future. |
Recently Adopted Accounting Standards and Recent Accounting Pronouncements | Recently Adopted Accounting Standards In June 2016, the FASB issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The FASB subsequently issued amendments to ASU No. 2016-13, which had the same effective date and transition date of January 1, 2023. ASU No. 2016-13, as amended, requires that credit losses be reported using an expected losses model rather than the incurred losses model that was previously 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 standard was effective for the Company on January 1, 2023. The adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. Recent Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40) . This standard will have an effective and transition date of January 1, 2024. Early adoption is currently permitted. This standard simplifies an issuer's accounting for convertible instruments by eliminating two of the three models that require separate accounting for embedded conversion features as well as simplifies the settlement assessment that entities are required to perform to determine whether a contract qualifies for equity classification. This standard also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and includes the effect of potential share settlement (if the effect is more dilutive) for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. The standard requires new disclosures about events that occur during the reporting period that cause conversion contingencies to be met and about the fair value of a public business entity's convertible debt at the instrument level, among other things. The Company does not currently expect the adoption of this standard to have a material impact on the Company's condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the condensed consolidated balance sheets to the total amount shown in the condensed consolidated statements of cash flows (in thousands): As of March 31, 2023 2022 Cash and cash equivalents $ 68,259 $ 129,771 Restricted cash — 151 Total cash, cash equivalents, and restricted cash $ 68,259 $ 129,922 |
Restrictions on Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the condensed consolidated balance sheets to the total amount shown in the condensed consolidated statements of cash flows (in thousands): As of March 31, 2023 2022 Cash and cash equivalents $ 68,259 $ 129,771 Restricted cash — 151 Total cash, cash equivalents, and restricted cash $ 68,259 $ 129,922 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Assets and Liabilities | The following table summarizes the fair value and the classification by level of input within the fair value hierarchy of financial assets that are recurring fair value measurements (in thousands): As of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 68,259 $ — $ — $ 68,259 Marketable securities U.S. government agency securities and treasuries — 4,478 — 4,478 Commercial paper — 3,984 — 3,984 Total assets $ 68,259 $ 8,462 $ — $ 76,721 As of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 76,564 $ 999 $ — $ 77,563 Marketable securities U.S. government agency securities and treasuries — 7,433 — 7,433 Commercial paper — 5,938 — 5,938 Total assets $ 76,564 $ 14,370 $ — $ 90,934 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule Of The Major Components Of Marketable Securities | The following table provides the amortized cost basis and fair value of the Company's available-for-sale investments by security type as reflected on the condensed consolidated balance sheets (in thousands): As of March 31, 2023 Amortized Cost Basis Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government agency securities and treasuries $ 4,477 $ 1 $ — $ 4,478 Commercial paper 3,984 — — 3,984 Total marketable securities $ 8,461 $ 1 $ — $ 8,462 As of December 31, 2022 Amortized Cost Basis Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. government agency securities and treasuries $ 7,432 $ 1 $ — $ 7,433 Commercial paper 5,938 — — 5,938 Total marketable securities $ 13,370 $ 1 $ — $ 13,371 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Major Components of Property, Plant and Equipment | The following table provides a summary of the major components of property and equipment as reflected on the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Furniture and fixtures $ 337 $ 337 Machinery and equipment 1,783 1,685 Leasehold improvements 1,907 1,603 Construction in progress 4,712 3,049 Total property and equipment 8,739 6,674 Less: accumulated depreciation (787) (621) Total property and equipment, net $ 7,952 $ 6,053 |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Maturities of Operating Leases | The Company's future minimum base rent payments are approximately as follows (in thousands): For the years ending December 31, Amount Remainder of 2023 $ 574 2024 787 2025 810 2026 834 2027 834 Thereafter 978 Total $ 4,817 Less: present value adjustment (856) Present value of minimum lease payments $ 3,961 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | The following table provides a summary of the major components of accrued expenses and other current liabilities as reflected on the condensed consolidated balance sheets (in thousands): March 31, 2023 December 31, 2022 Research and development $ 1,286 $ 1,894 Clinical 117 3,310 Professional fees 615 437 Employee-related 1,592 2,752 Other 2,213 1,507 Total accrued expenses and other current liabilities $ 5,823 $ 9,900 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The carrying values of the EB-5 Loan Agreement borrowings as of March 31, 2023 and December 31, 2022 are summarized below (in thousands): March 31, 2023 December 31, 2022 Principal outstanding $ 2,000 $ 2,000 Plus: accrued interest 327 307 Less: unamortized debt issuance costs (13) (18) Carrying value, net 2,314 2,289 Less: current portion of long term debt (1,256) — Long term debt, net of current portion $ 1,058 $ 2,289 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense for Options Granted Reflected in the Consolidate Statement of Operations and Comprehensive Loss | Stock-based compensation expense for stock options and RSUs is reflected in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three months ended March 31, 2023 2022 General and administrative $ 1,952 $ 2,216 Research and development 737 1,083 Total $ 2,689 $ 3,299 |
Schedule of Stock Option Activity | The following table summarizes the stock option activity: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (years) Aggregate Intrinsic Value Stock options outstanding at December 31, 2022 10,851,287 $ 2.95 8.3 $ 1,385 Granted 3,700,996 $ 1.22 Exercised (200,000) $ 0.42 Forfeited (628,119) $ 2.88 Stock options outstanding at March 31, 2023 13,724,164 $ 2.53 8.5 $ 599 Stock options exercisable at March 31, 2023 5,199,957 $ 2.92 7.7 $ 322 |
Share-based Payment Arrangement, Restricted Stock Unit, Activity | The following table summarizes the RSU activity: Number of Shares Weighted Average Grant-Date Fair Value RSUs outstanding at December 31, 2022 924,810 $ 4.12 Granted 3,043,066 $ 1.23 Vested (217,135) $ 4.56 Forfeited (263,690) $ 2.01 RSUs outstanding at March 31, 2023 3,487,051 $ 1.73 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Earnings Per Share | The following table sets forth the computation of basic and diluted earnings per share for the three months ended March 31, 2023 and 2022 (in thousands, except share and per share amounts): Three months ended March 31, 2023 2022 Net loss — basic and diluted $ (16,498) $ (18,019) Shares used in calculating net loss per common share — basic and diluted 225,523,627 205,693,498 Net loss per common share — basic and diluted $ (0.07) $ (0.09) |
Schedule of Potentially Dilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as their inclusion would have been antidilutive: Three months ended March 31, 2023 2022 Stock options to purchase common stock 13,724,164 14,002,454 RSUs 3,487,051 1,301,269 Warrants 798,352 3,110,655 Series A Convertible Preferred Stock (as converted to common stock) — 3,115 Series B Convertible Preferred Stock (as converted to common stock) 547,450 547,450 Total 18,557,017 18,964,943 |
Nature of Business - Narrative
Nature of Business - Narrative (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 USD ($) segment | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of operating segments | segment | 1 | ||
Net loss | $ (16,498) | $ (18,019) | |
Accumulated deficit | (229,516) | $ (213,018) | |
Cash and Investments | $ 76,700 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Interest income | $ 0.7 |
Expiration period (in years) | 10 years |
Minimum | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Award vesting period (in years) | 1 year |
Maximum | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Award vesting period (in years) | 3 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 68,259 | $ 77,563 | $ 129,771 | |
Restricted cash | 0 | 151 | ||
Total cash, cash equivalents, and restricted cash | $ 68,259 | $ 77,563 | $ 129,922 | $ 95,109 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 8,462 | $ 13,371 |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 68,259 | 77,563 |
Total assets | 76,721 | 90,934 |
U.S. government agency securities and treasuries | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 4,478 | 7,433 |
U.S. government agency securities and treasuries | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 4,478 | 7,433 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 3,984 | 5,938 |
Commercial paper | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 3,984 | 5,938 |
Level 1 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 68,259 | 76,564 |
Total assets | 68,259 | 76,564 |
Level 1 | U.S. government agency securities and treasuries | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Level 1 | Commercial paper | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Level 2 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 999 |
Total assets | 8,462 | 14,370 |
Level 2 | U.S. government agency securities and treasuries | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 4,478 | 7,433 |
Level 2 | Commercial paper | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 3,984 | 5,938 |
Level 3 | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Total assets | 0 | 0 |
Level 3 | U.S. government agency securities and treasuries | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Level 3 | Commercial paper | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost Basis | $ 8,461 | $ 13,370 |
Gross Unrealized Gains | 1 | 1 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 8,462 | 13,371 |
U.S. government agency securities and treasuries | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost Basis | 4,477 | 7,432 |
Gross Unrealized Gains | 1 | 1 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 4,478 | 7,433 |
Commercial paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost Basis | 3,984 | 5,938 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 3,984 | $ 5,938 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 8,739 | $ 6,674 |
Less: accumulated depreciation | (787) | (621) |
Property and equipment, net | 7,952 | 6,053 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 337 | 337 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,783 | 1,685 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,907 | 1,603 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 4,712 | $ 3,049 |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Mar. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | |
Leases, term of contract (in years) | 7 years |
Lease renewal term (in years) | 10 years |
Operating Leases - Future Minim
Operating Leases - Future Minimum Lease Payments (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Remainder of 2023 | $ 574 |
2024 | 787 |
2025 | 810 |
2026 | 834 |
2027 | 834 |
Thereafter | 978 |
Total | 4,817 |
Less: present value adjustment | (856) |
Present value of minimum lease payments | $ 3,961 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Research and development | $ 1,286 | $ 1,894 |
Clinical | 117 | 3,310 |
Professional fees | 615 | 437 |
Employee-related | 1,592 | 2,752 |
Other | 2,213 | 1,507 |
Accrued expenses and other current liabilities | $ 5,823 | $ 9,900 |
Debt - EB 5 Loan Agreement Borr
Debt - EB 5 Loan Agreement Borrowings (Details) - EB-5 Loan Agreement - Loans payable - USD ($) | 1 Months Ended | 12 Months Ended | |||
May 05, 2023 | Sep. 30, 2022 | Sep. 30, 2016 | Dec. 31, 2020 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | |||||
Maximum borrowing | $ 10,000,000 | ||||
Borrowing increments | $ 500,000 | ||||
Proceeds from secured lines of credit | $ 500,000 | $ 500,000 | $ 1,000,000 | ||
Interest rate | 4% | ||||
Subsequent Event | |||||
Debt Instrument [Line Items] | |||||
Proceeds from secured lines of credit | $ 500,000 |
Debt - Summary of the Carrying
Debt - Summary of the Carrying Values of the Loan Agreement Borrowings (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Less: current portion of long term debt | $ (1,256) | $ 0 |
Long term debt, net | 1,058 | 2,289 |
EB-5 Loan Agreement | Loans payable | ||
Debt Instrument [Line Items] | ||
Principal outstanding | 2,000 | 2,000 |
Plus: accrued interest | 327 | 307 |
Less: unamortized debt issuance costs | (13) | (18) |
Carrying value, net | 2,314 | 2,289 |
Less: current portion of long term debt | (1,256) | 0 |
Long term debt, net | $ 1,058 | $ 2,289 |
Equity (Details)
Equity (Details) $ / shares in Units, shares in Millions, dose in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | |||||
Mar. 18, 2021 USD ($) | Jun. 30, 2022 USD ($) | Feb. 28, 2022 USD ($) $ / shares shares | Mar. 31, 2023 USD ($) dose $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | Mar. 01, 2021 dose $ / shares shares | |
Subsidiary, Sale of Stock [Line Items] | |||||||
Convertible preferred stock, par value (in USD per share) | $ / shares | $ 0.01 | $ 0.01 | |||||
Series B Warrants | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Preferred stock, outstanding | $ 4.1 | $ 4.1 | $ 5 | ||||
Series B Warrants | Level 3 | Discount Rate | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Preferred stock, measurement input | 0.15 | ||||||
ATMs | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Aggregate gross number of shares that may be issued in transaction, value | $ 160 | ||||||
Number of shares issued and sold (in shares) | shares | 4.5 | ||||||
Proceeds from sale of stock | $ 5.6 | ||||||
Commissions, fees and expenses | $ 0.2 | ||||||
Public Offering Of Common Stock | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of shares issued and sold (in shares) | shares | 16 | ||||||
Proceeds from sale of stock | $ 49.8 | ||||||
Price per share (in USD per share) | $ / shares | $ 3.13 | ||||||
COVAXIN Preferred Stock Purchase Agreement | Series B Warrants | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Agreement to sell, number of shares issued in transaction (in shares) | shares | 0.1 | ||||||
Convertible preferred stock, par value (in USD per share) | $ / shares | $ 0.01 | ||||||
Agreement to sell, price per share (in USD per share) | $ / shares | $ 109.60 | ||||||
Advance payment amount | $ 6 | ||||||
Conversion ratio (in shares) | 10 | ||||||
Supply agreement, number of doses | dose | 10 | 10 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | |||
Jul. 31, 2021 | Mar. 31, 2023 | Dec. 31, 2022 | Jul. 15, 2021 | |
Canada Consulting Warrants | ||||
Class of Warrant or Right | ||||
Class of warrant or right, not yet vested (in shares) | 0.2 | |||
Expected milestone payment | $ 3 | |||
Initial exercise price (in USD per share) | $ 6.36 | |||
OpCo Warrants | ||||
Class of Warrant or Right | ||||
Initial exercise price (in USD per share) | $ 6.23 | |||
Number of warrants outstanding (in shares) | 0.6 | 0.6 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Compensation Expense for Options Granted (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 2,689 | $ 3,299 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 1,952 | 2,216 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 737 | $ 1,083 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | |
Mar. 31, 2023 USD ($) equityCompensationPlan $ / shares shares | Mar. 31, 2022 USD ($) $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense | $ | $ 17.8 | |
Unrecognized compensation expense related to options outstanding, weighted average period for expense to be recognized | 2 years | |
Number of equity compensation plans | equityCompensationPlan | 2 | |
Options, grants in period, weighted average grant date fair value (in USD per share) | $ / shares | $ 1.01 | $ 3.61 |
Options, vested in period, fair value | $ | $ 5.6 | $ 2.8 |
2014 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized for grant (in shares) | shares | 0.8 | |
2019 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized for grant (in shares) | shares | 28.4 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule Options to Purchase Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Number of shares, stock options outstanding, beginning balance (in shares) | 10,851,287 | |
Granted (in shares) | 3,700,996 | |
Exercised (in shares) | (200,000) | |
Forfeited (in shares) | (628,119) | |
Number of shares, stock options outstanding, ending balance (in shares) | 13,724,164 | 10,851,287 |
Stock options exercisable (in shares) | 5,199,957 | |
Weighted Average Exercise Price | ||
Beginning balance, weighted average exercise price (in USD per share) | $ 2.95 | |
Weighted average exercise price, granted (in USD per share) | 1.22 | |
Weighted average exercise price, exercised (in USD per share) | 0.42 | |
Weighted average exercise price, cancelled (in USD per share) | 2.88 | |
Ending balance, weighted average exercise price (in USD per share) | 2.53 | $ 2.95 |
Weighted average exercise price, options exercisable (in USD per share) | $ 2.92 | |
Additional Disclosures | ||
Weighted average remaining contractual life | 8 years 6 months | 8 years 3 months 18 days |
Weighted average remaining contractual life, options exercisable | 7 years 8 months 12 days | |
Aggregate intrinsic value | $ 599 | $ 1,385 |
Aggregate intrinsic value, stock options exercisable | $ 322 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of RSU Activity (Details) - RSUs | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Shares | |
Beginning balance outstanding (in shares) | shares | 924,810 |
Granted (in shares) | shares | 3,043,066 |
Vested (in shares) | shares | (217,135) |
Forfeited (in shares) | shares | (263,690) |
Ending balance outstanding (in shares) | shares | 3,487,051 |
Weighted Average Grant-Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 4.12 |
Granted (in USD per share) | $ / shares | 1.23 |
Vested (in USD per share) | $ / shares | 4.56 |
Forfeited (in USD per share) | $ / shares | 2.01 |
Ending balance (in USD per share) | $ / shares | $ 1.73 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock - Computation of Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss - basic and diluted | $ (16,498) | $ (18,019) |
Shares used in calculating net loss per common share - basic (in shares) | 225,523,627 | 205,693,498 |
Shares used in calculating net loss per common share - diluted (in shares) | 225,523,627 | 205,693,498 |
Net loss per share of common stock - basic (in USD per share) | $ (0.07) | $ (0.09) |
Net loss per share of common stock - diluted (in USD per share) | $ (0.07) | $ (0.09) |
Net Loss Per Share of Common _4
Net Loss Per Share of Common Stock - Potentially Dilutive Securities have been Excluded from the Computation of Diluted Weighted Average Shares Outstanding (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 18,557,017 | 18,964,943 |
Stock options to purchase common stock | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 13,724,164 | 14,002,454 |
RSUs | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 3,487,051 | 1,301,269 |
Warrants | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 798,352 | 3,110,655 |
Series A Preferred Stock | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 0 | 3,115 |
Series B Preferred Stock | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 547,450 | 547,450 |
Subsequent Events (Details)
Subsequent Events (Details) - EB-5 Loan Agreement - Loans payable - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 05, 2023 | Sep. 30, 2022 | Dec. 31, 2020 | Dec. 31, 2016 | |
Subsequent Events | ||||
Proceeds from secured lines of credit | $ 500 | $ 500 | $ 1,000 | |
Subsequent Event | ||||
Subsequent Events | ||||
Proceeds from secured lines of credit | $ 500 |