Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 07, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.01 per share | |
Trading Symbol | OCGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 257,328,085 | |
Entity Central Index Key | 0001372299 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 26,375 | $ 39,462 |
Prepaid expenses and other current assets | 3,623 | 3,509 |
Total current assets | 29,998 | 42,971 |
Property and equipment, net | 17,654 | 17,290 |
Other assets | 4,142 | 4,286 |
Total assets | 51,794 | 64,547 |
Current liabilities | ||
Accounts payable | 1,731 | 3,172 |
Accrued expenses and other current liabilities | 12,434 | 13,343 |
Operating lease obligations | 589 | 574 |
Current portion of long term debt | 1,296 | 0 |
Total current liabilities | 16,050 | 17,089 |
Non-current liabilities | ||
Operating lease obligations, less current portion | 3,414 | 3,567 |
Long term debt, net | 1,533 | 2,800 |
Other non-current liabilities | 536 | 527 |
Total non-current liabilities | 5,483 | 6,894 |
Total liabilities | 21,533 | 23,983 |
Commitments and contingencies | ||
Stockholders' equity | ||
Common stock; $0.01 par value; 295,000,000 shares authorized, 257,446,764 and 256,688,304 shares issued, and 257,325,264 and 256,566,804 shares outstanding at March 31, 2024 and December 31, 2023, respectively | 2,575 | 2,567 |
Treasury stock, at cost, 121,500 shares at March 31, 2024 and December 31, 2023 | (48) | (48) |
Additional paid-in capital | 325,799 | 324,191 |
Accumulated other comprehensive income | 25 | 20 |
Accumulated deficit | (298,091) | (286,167) |
Total stockholders' equity | 30,261 | 40,564 |
Total liabilities and stockholders' equity | 51,794 | 64,547 |
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, 2024 | Dec. 31, 2023 |
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) | 257,446,764 | 256,688,304 |
Common stock, shares outstanding (in shares) | 257,325,264 | 256,566,804 |
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, 2024 | Mar. 31, 2023 | |
Total revenue | $ 1,014 | $ 443 |
Operating expenses | ||
Research and development | 6,826 | 10,172 |
General and administrative | 6,404 | 8,306 |
Total operating expenses | 13,230 | 18,478 |
Loss from operations | (12,216) | (18,035) |
Other income (expense), net | 292 | 709 |
Net loss | (11,924) | (17,326) |
Other comprehensive income (loss) | ||
Foreign currency translation adjustment | 5 | (1) |
Comprehensive loss | $ (11,919) | $ (17,327) |
Shares used in calculating net loss per common share - diluted (in shares) | 257,232,636 | 225,523,627 |
Shares used in calculating net loss per common share - basic (in shares) | 257,232,636 | 225,523,627 |
Net loss per share of common stock - basic (in USD per share) | $ (0.05) | $ (0.08) |
Net loss per share of common stock - diluted (in USD per share) | $ (0.05) | $ (0.08) |
Total revenue | $ 1,014 | $ 443 |
Collaborative Arrangements | ||
Total revenue | 1,014 | 443 |
Operating expenses | ||
Research and development | 100 | 1,500 |
Other comprehensive income (loss) | ||
Total revenue | $ 1,014 | $ 443 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Preferred Stock Series A Convertible Preferred Stock | Preferred Stock Series B Convertible Preferred Stock | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
Convertible preferred stock, beginning balance (in shares) at Dec. 31, 2022 | 0 | 54,745 | ||||||||
Common stock, beginning balance (in shares) at Dec. 31, 2022 | 221,721,182 | |||||||||
Beginning balance at Dec. 31, 2022 | $ 73,981 | $ 0 | $ 1 | $ 2,217 | $ (48) | $ 294,874 | $ 26 | $ (223,089) | ||
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 | (17,326) | (17,326) | ||||||||
Convertible preferred stock, ending balance (in shares) at Mar. 31, 2023 | 0 | 54,745 | ||||||||
Common stock, ending balance (in shares) at Mar. 31, 2023 | 226,548,693 | |||||||||
Ending balance at Mar. 31, 2023 | $ 64,901 | $ 0 | $ 1 | $ 2,265 | (48) | 303,073 | 25 | (240,415) | ||
Convertible preferred stock, beginning balance (in shares) at Dec. 31, 2023 | 0 | 54,745 | 0 | 54,745 | ||||||
Common stock, beginning balance (in shares) at Dec. 31, 2023 | 256,566,804 | 256,688,304 | ||||||||
Beginning balance at Dec. 31, 2023 | $ 40,564 | $ 0 | $ 1 | $ 2,567 | (48) | 324,191 | 20 | (286,167) | ||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Stock-based compensation expense | 1,761 | 1,761 | ||||||||
Issuance of common stock for stock option exercises and restricted stock unit vesting, net (in shares) | 758,460 | |||||||||
Issuance of common stock for stock option exercises and restricted stock unit vesting, net | (145) | $ 8 | (153) | |||||||
Other comprehensive income (loss) | 5 | 5 | ||||||||
Net loss | $ (11,924) | (11,924) | ||||||||
Convertible preferred stock, ending balance (in shares) at Mar. 31, 2024 | 0 | 54,745 | 0 | 54,745 | ||||||
Common stock, ending balance (in shares) at Mar. 31, 2024 | 257,325,264 | 257,446,764 | ||||||||
Ending balance at Mar. 31, 2024 | $ 30,261 | $ 0 | $ 1 | $ 2,575 | $ (48) | $ 325,799 | $ 25 | $ (298,091) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (11,924) | $ (17,326) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 179 | 174 |
Amortization (accretion) on marketable securities | 0 | (143) |
Non-cash interest expense | 29 | 24 |
Non-cash lease expense | 140 | 131 |
Non-cash (income) expense from collaborative arrangements, net | 913 | 1,008 |
Stock-based compensation expense | 1,761 | 2,689 |
Other | 9 | 352 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (117) | (60) |
Accounts payable and accrued expenses | (1,446) | (4,964) |
Lease obligations | (139) | (125) |
Net cash used in operating activities | (10,595) | (18,240) |
Cash flows from investing activities | ||
Purchases of marketable securities | 0 | (3,947) |
Proceeds from the maturities of marketable securities | 0 | 9,000 |
Purchases of property and equipment | (2,352) | (1,612) |
Net cash (used in) provided by investing activities | (2,352) | 3,441 |
Cash flows from financing activities | ||
Proceeds (payments) from issuance of common stock, net | (145) | 5,731 |
Payment of equity issuance costs | 0 | (173) |
Proceeds from issuance of debt | 0 | (62) |
Net cash (used in) provided by financing activities | (145) | 5,496 |
Effect of changes in exchange rate on cash and cash equivalents | 5 | (1) |
Net (decrease) in cash and cash equivalents | (13,087) | (9,304) |
Cash and cash equivalents at beginning of period | 39,462 | 77,563 |
Cash and cash equivalents at end of period | 26,375 | 68,259 |
Supplemental disclosure of non-cash investing and financing transactions: | ||
Purchases of property and equipment | $ 371 | $ 1,119 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2024 | |
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. Our technology pipeline includes: • Modifier Gene Therapy Platform — Based on the use of nuclear hormone receptors ("NHRs"), the Company believes its modifier gene therapy platform has the potential to address many retinal diseases, including rare genetic diseases such as retinitis pigmentosa ("RP") (OCU400) and Leber congenital amaurosis ("LCA") (OCU400), with a gene-agnostic approach. The Company also believes its modifier gene therapy platform has the potential to address multifactorial retinal diseases including dry age-related macular degeneration ("dAMD") using OCU410, which affects millions of patients in the United States alone, and Stargardt disease (OCU410ST), which is also a rare genetic disease. The Company received clearance from FDA to initiate a Phase 3 trial for OCU400 for the treatment of RP and intends to begin dosing patients in 2Q 2024. The Company further expects to expand OCU400 Phase 3 development in LCA patients in the second half of 2024 based on Phase 1/2 study results in LCA patients and subject to alignment with the FDA. Currently both OCU410, for the treatment of geographic atrophy ("GA"), an advanced form of dAMD, and OCU410ST, for the treatment of Stargardt disease, are in Phase 1/2 clinical development. In OCU410 GA study, low and medium dose cohorts were completed to date. In OCU410ST Stargardt study, low dose cohort was completed to date. • Novel Biologic Therapy for Retinal Diseases — OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin. OCU200 possesses unique features which potentially enable it to treat vascular complications of diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet AMD. Tumstatin is the active component of OCU200 and binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin is expected to facilitate the targeted delivery of tumstatin into the retina and choroid and potentially help increase the interaction between tumstatin and integrin receptors. The Company continues to work with the FDA to address comments to lift the clinical hold. • Regenerative Medicine Cell Therapy Platform — Our Phase 3-ready regenerative medicine cell therapy platform technology, which includes NeoCart (autologous chondrocyte-derived neocartilage), is being developed for the repair of knee cartilage injuries in adults. The Company received concurrence from the FDA on the confirmatory Phase 3 trial design and has completed renovating an existing facility into a current Good Manufacturing Practice ("GMP") facility to support clinical study and initial commercial launch. This facility is needed to generate patient-specific NeoCart implant from chondrocytes derived from knee biopsy. • Inhaled Mucosal Vaccine Platform — The Company's next-generation, inhaled mucosal vaccine platform includes OCU500, a COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and COVID-19 vaccine. The Company is conducting IND-enabling and product development activities for OCU500. The Company is currently collaborating with the National Institute of Allergy and Infectious Diseases ("NIAID") for early clinical studies for OCU500. NIAID plans to submit an IND to initiate a Phase 1 clinical trial in mid-2024. The Company is continuing discussions with relevant government agencies as well as strategic partners regarding developmental funding for its OCU510 and OCU520 platforms. 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 $11.9 and $17.3 for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, the Company had an accumulated deficit of $298.1 million and cash and cash equivalents totaling $26.4 million. This amount will not meet the Company's capital requirements over the next 12 months after the date that the condensed consolidated financial statements are issued. The Company believes that its cash and cash equivalents will enable it to fund its operations into the fourth 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 is currently exploring options 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 continued 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, 2024 | |
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 in the United States ("GAAP") 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, 2023, included in the Company's Annual Report on Form 10-K filed with the SEC on April 16, 2024 (the "2023 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, determination of the collaborative arrangements' transaction price, calculating the progress towards the satisfaction of the performance obligations under the collaborative arrangements, and determining the value of the non-cash consideration received under collaborative arrangements. Cash and Cash Equivalents 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 consolidated statements of operations and comprehensive loss. The Company recorded $0.3 million as interest income for the three months ended March 31, 2024. 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. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents. The Company's cash and cash equivalents 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 consolidated balance sheets. At lease commencement, the Company records a lease liability based on the present value of the lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise and records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. Lease expense is recognized on a straight-line basis over the lease term and recognized as research and development expense or general and administrative expense based on the underlying nature of the expense. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rates were not readily determinable in the Company's current operating leases. As such, the incremental borrowing rates were used based on the information available at the commencement dates in determining the present value of lease payments. The lease term for the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on an index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset if reasonably certain. Variable payments not dependent on an index or rate associated with the Company's leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company's consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed lease payments. Impairment of Assets The Company reviews its assets, including property and equipment, for impairment whenever changes in circumstances or events may indicate that the carrying amounts are not recoverable. These indicators include, but are not limited to, a significant change in the extent or manner in which an asset is used or its physical condition, a significant decrease in the market price of an asset, or a significant adverse change in the business or the industry that could affect the value of an asset. An asset is tested for impairment by comparing the net carrying value of the asset to the undiscounted net cash flows to be generated from the use and eventual disposition of the asset. Stock-Based Compensation The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation ("ASC 718"). The Company has issued stock-based compensation awards including stock options, restricted stock units ("RSUs"), and market-condition based restricted stock units ("PSUs), and also accounts for certain issuances of preferred stock and warrants in accordance with ASC 718. ASC 718 requires all stock-based payments, including grants of stock options, RSUs, and PSUs, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs, the fair value of the RSU is determined by the market price of a share of the Company's common stock on the grant date. For PSUs, the Company determines fair value by using a Monte Carlo simulation technique. 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 term of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. Estimating the fair value of PSUs requires the input of subjective assumptions, including stock price volatility, total shareholder return ("TSR") ranking, the risk-free rate, and expected dividends. The assumptions used in the Company's Black-Scholes option-pricing model and Monte Carlo simulation technique represent management's best estimates and involve a number of variables, uncertainties, assumptions, and the application of management's judgment, as they are inherently subjective. If any assumptions change, the Company's stock-based compensation expense could be materially different in the future. The assumptions used in Ocugen's Black-Scholes option-pricing model for stock options and in Ocugen's Monte Carlo simulation technique for PSUs are as follows, unless noted otherwise: Expected Term. As Ocugen does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term, the expected term of employee stock options subject to service-based vesting conditions is determined using the "simplified" method, as prescribed in SEC's Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option. This expected term assumption is not an assumption used in the Company's Monte Carlo simulation technique for PSUs. The expected term of the PSUs is equal to the performance period of the PSUs. Expected Volatility. The expected volatility is based on historical volatilities of Ocugen and similar entities within Ocugen's industry for periods commensurate with the assumed expected term. Risk-Free Interest Rate. The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. Expected Dividends. The expected dividend yield is 0% because Ocugen has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock. TSR ranking. The Company's TSR, over a three year period, is relative to the TSR, for that same period, as related to other companies within the Nasdaq Biotechnology index. This assumption is only used for the market based PSUs. Collaborative Arrangements and Revenue Recognition The Company analyzes its collaborative arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards. This assessment is performed throughout the life of the arrangements based on changes to the arrangements. For collaborative arrangements within the scope of ASC 808 the Company may analogize to ASC 606 for certain elements. The Company identifies the goods or services promised within each collaborative arrangement and assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The allocation of the transaction price to the performance obligations in proportion to their standalone selling prices is determined at contract inception. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the counterparty and the transfer of the promised goods or services to the counterparty will be one year or less. The Company assessed its collaboration arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company recognizes as collaboration revenue the amount of the transaction price that is allocated to the respective performance obligation as each performance obligation is satisfied over time, with progress toward completion measured based on actual costs incurred relative to total estimated costs to be incurred over the life of the arrangement. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete their performance obligations under the arrangements. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Adjustments to original estimates will be required as work progresses and additional information becomes known, even though the scope of the work required under the contract may not change. Any adjustment as a result of a change in estimates is made when facts develop, events become known, or an adjustment is otherwise warranted. Under the Company’s collaborative arrangements, the timing of revenue recognition and receipt of consideration may differ, and result in assets and liabilities. Assets represent revenues recognized in excess of the consideration received under collaborative arrangement. Liabilities represent the consideration received in excess of revenues recognized under collaborative arrangement. Recently Adopted Accounting Standards 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. 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 adoption of ASU 2020-06 on January 1, 2024 did not have a material impact on the Company's condensed consolidated financial statements and related disclosures. Recent Accounting Pronouncements In March 2024, the FASB issued Accounting Standards Update, or ASU, 2024-02 “Codification Improvements — Amendments to Remove References to the Concepts Statements,” or ASU 2024-02. ASU 2024-02 amended certain definitions in the guidance. ASU 2024-02 is effective on a prospective basis, with the option for retrospective application, for annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. In March 2024, the FASB issued Accounting Standards Update, or ASU, 2024-01 “Compensation — Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards,” or ASU 2024-01. ASU 2024-01 improves clarity and operability without changing the guidance. ASU 2024-01 is effective on a prospective basis, with the option for retrospective application, for annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. |
License and Development Agreeme
License and Development Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Revenue from Contract with Customer [Abstract] | |
License and Development Agreements | License and Development Agreements Co-Development and Commercialization Agreement with CanSino Biologics, Inc. The Company entered into a co-development and commercialization agreement with CanSino Biologics, Inc. ("CanSinoBIO") with respect to the development and commercialization of the Company's modifier gene therapy product candidates, OCU400, OCU410, and OCU410ST. The co-development and commercialization agreement was originally entered into in September 2019 ("the Original CanSinoBIO Agreement") with regards to OCU400, and was subsequently amended in September 2021 and November 2022 ("the Amendments"), to include OCU410 and OCU410ST, respectively. The Company concluded that the Original CanSinoBIO Agreement and the Amendments are separate contracts (collectively referred to as the "CanSinoBio Agreements"). Pursuant to the CanSinoBIO Agreements, the Company and CanSinoBIO are collaborating on the development of the Company's modifier gene therapy platform. CanSinoBIO is responsible for the chemistry, manufacturing, and controls development and manufacture of clinical supplies of such products and is responsible for the costs associated with such activities. CanSinoBIO has an exclusive license to develop, manufacture, and commercialize the Company's modifier gene therapy platform in and for China, Hong Kong, Macau, and Taiwan (the "CanSinoBIO Territory"), and the Company maintains exclusive development, manufacturing, and commercialization rights with respect to the Company's modifier gene therapy platform outside the CanSinoBIO Territory (the "Company Territory"). Should any of the product candidates be commercialized in any of the related territories, CanSinoBIO will pay to the Company an annual royalty between mid- and high-single digits based on Net Sales (as defined in the CanSinoBIO Agreements) of the products included in the Company's modifier gene therapy platform in the CanSinoBIO Territory. The Company will pay to CanSinoBIO an annual royalty between low- and mid-single digits based on Net Sales of the products included in the Company's modifier gene therapy platform in the Company Territory. Accounting analysis and revenue recognition The Company determined the collaboration arrangements with CanSinoBIO, are within the scope of ASC 808 and has analogized to ASC 606 to account for CanSinoBIO's access to its IP as well as data generated in connection with the co-development activities to be undertaken by Ocugen. These elements of the arrangements are not distinct and are accounted for as a single performance obligation. The non-cash consideration to be received related to the Company's satisfaction of the performance obligations includes but is not limited to services related to chemistry, manufacturing, and controls development and manufacture of clinical supplies of such products through completion of pre-clinical, clinical, regulatory, and other commercialization readiness services. The estimated market value of the co-development services to be performed by CanSinoBIO, represents variable consideration that is included in the transaction price. The Company recognizes collaborative arrangement revenue over time using an input method using ratio of costs incurred to date compared to total estimated costs require to satisfy the performance obligations under the CanSinoBIO Agreements . The Company constrained the transaction price related to certain future co-development services and future royalties, as it assessed that it is probable that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. The variable consideration is reevaluated at each reporting period and as changes in circumstances occur. The services provided by CanSinoBIO are recorded as incurred and the difference between the revenue and expense recognized is recorded on the Company's balance sheet as a contract liability within Accrued expenses and other current liabilities. The related revenue recognized was recorded in the condensed consolidated statements of operations and comprehensive loss as collaborative arrangement revenue and was approximately $1.0 million and $0.4 million for the three months ended March 31, 2024 and 2023, respectively. The related expense incurred for services provided by CanSinoBIO was recorded in the consolidated statements of operations and comprehensive loss as research and development expense and was approximately $0.1 million and $1.5 million for the three months ended March 31, 2024 and 2023, respectively. The contract liability was $9.6 million and $12.3 million as of March 31, 2024 and 2023, respectively. Revenue recognized for the three months ended March 31, 2024, that was included in the contract liabilities balances as of January 1, 2024 was approximately $1.0 million. Revenue recognized for the three months ended March 31, 2023, that was included in the contract liabilities balances as of January 1, 2023, was approximately $0.4 million. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value MeasurementsThe valuation of the Company's cash and cash equivalents totaling $26.4 million, which includes $25.2 million in money markets, as of March 31, 2024, utilized Level 1 inputs. Further, the Company believes the fair value using Level 2 inputs of the borrowings under the EB-5 Loan Agreement (as defined in Note 8) approximate their carrying value. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 December 31, 2023 Furniture and fixtures $ 337 $ 337 Machinery and equipment 1,566 1,557 Leasehold improvements 2,086 2,086 Construction in progress 15,062 14,540 Total property and equipment 19,051 18,520 Less: accumulated depreciation (1,397) (1,230) Total property and equipment, net $ 17,654 $ 17,290 |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Operating Leases | Operating Leases The Company has commitments under operating leases for office, laboratory, and future manufacturing space in Malvern, Pennsylvania. The Company's corporate headquarters lease has an initial term of approximately seven years and includes options to extend the lease for up to 10 years. The Company's current GMP facility lease has an initial term of seven years and includes an option to extend the lease for up to five years, which the Company has elected to account for since it is reasonably certain that the Company will exercise such option. The Company's future minimum base rent payments are approximately as follows (in thousands): For the years ending December 31, Amount Remainder of 2024 $ 591 2025 810 2026 834 2027 858 2028 884 2029 714 Thereafter $ 978 Total $ 5,669 Less: present value adjustment (1,666) Present value of minimum lease payments $ 4,003 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 December 31, 2023 Research and development $ 245 $ 212 Clinical 96 84 Professional fees 1,139 580 Employee-related 882 1,791 Deferred revenue relating to collaborative arrangements 9,612 10,525 Other 460 151 Total accrued expenses and other current liabilities $ 12,434 $ 13,343 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2024 | |
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 provided for cumulative borrowings of up to $10.0 million from EB5 Life Sciences, L.P. ("EB-5 Life Sciences") as the lender. Pursuant to the EB-5 Loan Agreement, borrowings were made in $0.5 million increments with a fixed interest rate of 4% per annum (the "Original Offering"). The borrowings pursuant to the Original Offering 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. Under the terms and conditions of the Original Offering, the Company borrowed $1.0 million during 2016, $0.5 million during 2020, $0.5 million in September 2022, and an additional $0.5 million in May 2023. Issuance costs were recognized as a reduction to the loan balance and are amortized to interest expense over the term of each borrowing. Pursuant to the Original Offering, each outstanding borrowing, including accrued interest, becomes due upon the seventh anniversary of its disbursement date, subject to certain extension provisions. Once repaid, amounts cannot be re-drawn. The March 2022 EB-5 Reform and Integrity Act of 2022 (the "RIA") enacted changes to the EB-5 Program, including but not limited to: raising the minimum investment amount for a targeted employment area (the "TEA") from its previous level of $0.5 million to its new level of $0.8 million, as well as modifying the process for the creation of TEAs. Under the previous regime, the state in which the TEA would be located could send a letter in support of efforts to designate a TEA. Under the current regime, only U.S. Citizenship and Immigration Services can designate TEAs. In connection with the aforementioned changes to the EB-5 Program, the Original Offering was amended in May 2023 (the "Amended Offering"). Pursuant to the terms and conditions of the Amended Offering, EB-5 Life Sciences now provides for cumulative borrowings of up to $20.0 million. Future borrowings can be made in increments of $0.8 million with a fixed interest rate of 4.0% per annum. Each future borrowing pursuant to the Amended Offering, including accrued interest, will become due upon the seventh anniversary of its disbursement date. The Company has not made any borrowings pursuant to the Amended Offering as of March 31, 2024. The carrying values of the borrowings pursuant to the Original Offering as of March 31, 2024 and December 31, 2023 are summarized below (in thousands): March 31, 2024 December 31, 2023 Principal outstanding $ 2,500 $ 2,500 Plus: accrued interest 425 400 Less: unamortized debt issuance costs (96) (100) Carrying value, net 2,829 2,800 Less: current portion of long term debt (1,296) — Long term debt, net of current portion $ 1,533 $ 2,800 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Equity | Equity COVAXIN Preferred Stock Purchase Agreement On March 1, 2021, the Company entered into a preferred stock purchase agreement (the "Preferred Stock Purchase Agreement") with Bharat Biotech International Limited ("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, a monovalent vaccine, to be provided by Bharat Biotech pursuant to a Development and Commercial Supply Agreement (the "Supply Agreement"). Each share of Series B Convertible Preferred Stock was convertible, at the option of Bharat Biotech, into 10 shares of the Company's common stock (the "Conversion Ratio") only after (i) the Company received stockholder approval to increase the number of authorized shares of common stock under its Sixth Amended and Restated Certificate of Incorporation, which the Company received in April 2021, and (ii) the Company's receipt of shipments by Bharat Biotech of the first 10.0 million doses of COVAXIN manufactured by Bharat Biotech pursuant to the Supply Agreement, and further on the terms and subject to the conditions set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. The conversion rate of the Series B Convertible Preferred Stock was 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 consolidated balance sheet as of December 31, 2021. The Company utilized the traded common stock price, adjusted by the Conversion Ratio, to value the Series B Convertible Preferred Stock and the Finnerty model to estimate a 15% discount rate for the lack of marketability of the instrument. The valuation incorporated Level 3 inputs in the fair value hierarchy, including the estimated time until the instrument's liquidity and estimated volatility of the Company's common stock as of the grant date . As of December 31, 2022, the remaining balance of the short-term asset for the advanced payment for the supply of COVAXIN was $4.1 million. In April 2023, the FDA announced the cancellation of all emergency use authorizations ("EUA") issued with respect to monovalent COVID-19 vaccine formulations. Consequently, the Company determined it was no longer commercially viable to further the development of COVAXIN in its North American territories. During the three months ended June 30, 2023, the Company wrote off the remaining balance of the short-term asset for the advanced payment for the supply of COVAXIN of $4.1 million to research and development expense in the consolidated statements of operations and comprehensive loss. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Warrants | Warrants OpCo Warrants Beginning in 2016, OpCo issued warrants to purchase the Company's common stock (the "OpCo Warrants"). As of March 31, 2024 and December 31, 2023, 0.6 million OpCo Warrants were outstanding. As of March 31, 2024, 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, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for stock options, RSUs and PSUs is reflected in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three months ended March 31, 2024 2023 General and administrative $ 1,316 $ 1,952 Research and development 445 737 Total $ 1,761 $ 2,689 As of March 31, 2024, the Company had $8.7 million of unrecognized stock-based compensation expense related to stock options, RSUs and PSUs outstanding, which is expected to be recognized over a weighted-average period of 1.6 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"). On the first business day of each fiscal year, pursuant to the "Evergreen" provision of the 2019 Plan, the aggregate number of shares that may be issued under the 2019 Plan will automatically increase by a number equal to the lesser of 4% of the total number of shares of the Company's common stock outstanding on December 31st of the prior year, or a number of shares determined by the Board of Directors. As of March 31, 2024, the 2014 Plan and the 2019 Plan authorize for the granting of up to 0.8 million and 38.6 million equity awards in respect to the Company's common stock, respectively. The 2014 Plan and 2019 Plan have 0.5 million and 17.6 million equity awards remaining available for future grant, respectively, as of March 31, 2024. In addition to stock options, PSUs 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 Company's stock option activity: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (In Thousands) Options outstanding at December 31, 2023 13,161,228 $ 2.38 7.86 $ 337 Granted 2,632,054 0.70 5 Exercised (101,426) 0.42 44 Forfeited (590,947) 3.63 79 Options outstanding at March 31, 2024 15,100,909 $ 2.05 8.00 $ 6,191 Options exercisable at March 31, 2024 8,711,464 $ 2.56 7.15 $ 1,771 The weighted average grant date fair value of stock options granted during the three months ended March 31, 2024 and 2023 were $0.58 and $1.01, respectively. The total fair value of stock options vested during the three months ended March 31, 2024 and 2023 were $5.0 million and $5.6 million, respectively. RSUs The following table summarizes the Company's RSU activity: Number of Shares Weighted Average Grant Date Fair Value RSUs outstanding at December 31, 2023 2,982,661 $ 1.63 Granted 39,738 $ 0.51 Vested (940,972) $ 1.92 Forfeited (54,320) $ 1.64 RSUs outstanding at March 31, 2024 2,027,107 $ 1.48 PSUs In December 2023, pursuant to the 2019 Plan, the Compensation Committee of the Company's Board of Directors adopted a performance restricted stock unit agreement (the "PSU Agreement"). Pursuant to the PSU Agreement, the Company granted 615,467 of market-based performance stock units at target on January 2, 2024. All of these PSUs cliff vest after the requisite service period ending on December 31, 2026. The PSUs have the potential to be earned at between 0% and 200% of the number of awards granted depending on the level of growth of the Company's total shareholder return ("TSR") as compared to the TSR of the other companies within the Nasdaq Biotechnology Index over the performance period. The fair value of the market-based PSUs was determined using a Monte Carlo simulation technique. The following table summarizes the PSU activity: Number of Shares Weighted Average Grant-Date Fair Value PSUs outstanding at December 31, 2023 — $ — Granted 615,467 1.27 Vested — — Forfeited — — PSUs outstanding at March 31, 2024 615,467 $ 1.27 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 3 Months Ended |
Mar. 31, 2024 | |
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 net loss per share for the three months ended March 31, 2024 and 2023 (in thousands, except share and per share amounts): Three months ended March 31, 2024 2023 Net loss — basic and diluted $ (11,924) $ (17,326) Shares used in calculating net loss per common share — basic and diluted 257,232,636 225,523,627 Net loss per common share — basic and diluted $ (0.05) $ (0.08) 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, 2024 2023 Stock options to purchase common stock 15,100,909 13,724,164 RSUs 2,027,107 3,487,051 PSUs 615,467 — Warrants 628,834 798,352 Series B Convertible Preferred Stock (as converted to common stock) 547,450 547,450 Total 18,919,767 18,557,017 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments The Company has commitments under certain license and development agreements, lease agreements, commitments related to renovating an existing facility for GMP, and debt 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 license and development agreements are more fully described within the Company's 2023 Annual Report). Commitments under lease agreements are future minimum lease payments (see Note 6). Renovation commitments are related to retrofitting an existing facility in order to be GMP compliant (see Note 1). Commitments under debt agreements are the future payment of principal and accrued interest under the EB-5 Loan Agreement (see Note 8). Additionally, the Company does not expect to fulfill any commitments under the amended Co-Development, Supply and Commercialization Agreement (the "Covaxin Agreement") with Bharat Biotech as a result of the termination of the COVAXIN program. 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. 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. In March 2023, the Court granted the Company's motion to dismiss with prejudice. The lead plaintiff appealed to the United States Court of Appeals for the Third Circuit ("Third Circuit") regarding the order that was entered in March 2023, which dismissed the action with prejudice. The lead plaintiff's appellant's brief and joint appendix were filed in July 2023. The Company's appellees' brief was filed in August 2023, and the lead plaintiff's reply brief was filed in September 2023. In March 2024, the Third Circuit affirmed the Court's decision to dismiss with prejudice the consolidated securities class action lawsuits. 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. 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. In April 2024, the Court dismissed without prejudice the consolidated stockholder derivative lawsuits. In April 2024, a securities class action lawsuit was filed against the Company and certain of its agents in the Court (Case No. 2:24-cv-01500) that 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 statements made by the Company concerning the Company’s previously-issued audited consolidated financial statements for each fiscal year beginning January 1, 2020 and its previously-issued unaudited interim condensed consolidated financial statements for each of the first three quarters in such years and the effectiveness of the Company’s disclosure controls and procedures during each such period. The complaint seeks unspecified damages, interest, attorneys’ fees, and other costs. The Company believes that the lawsuits are without merit and intends to vigorously defend against them. At this time, no assessment can be made as to their likely outcome or whether the outcome will be material to the Company. No information is available to indicate that it is probable that a loss has been incurred and can be reasonably estimated as of the date of the condensed consolidated financial statements and, as such, no accrual for the loss has been recorded within the condensed consolidated financial statements. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net loss | $ (11,924) | $ (17,326) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation |
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, determination of the collaborative arrangements' transaction price, calculating the progress towards the satisfaction of the performance obligations under the collaborative arrangements, and determining the value of the non-cash consideration received under collaborative arrangements. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
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. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents. The Company's cash and cash equivalents 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 consolidated balance sheets. At lease commencement, the Company records a lease liability based on the present value of the lease payments over the expected lease term including any options to extend the lease that the Company is reasonably certain to exercise and records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date. Lease expense is recognized on a straight-line basis over the lease term and recognized as research and development expense or general and administrative expense based on the underlying nature of the expense. FASB ASC Topic 842, Leases ("ASC 842") requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The implicit interest rates were not readily determinable in the Company's current operating leases. As such, the incremental borrowing rates were used based on the information available at the commencement dates in determining the present value of lease payments. The lease term for the Company's leases includes the non-cancellable period of the lease plus any additional periods covered by either an option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on an index or rate, and amounts probable to be payable under the exercise of an option to purchase the underlying asset if reasonably certain. Variable payments not dependent on an index or rate associated with the Company's leases are recognized when the event, activity, or circumstance is probable. Variable payments include the Company's proportionate share of certain utilities and other operating expenses and are presented as operating expenses in the Company's consolidated statements of operations and comprehensive loss in the same line item as expense arising from fixed lease payments. |
Impairment of Assets | Impairment of Assets The Company reviews its assets, including property and equipment, for impairment whenever changes in circumstances or events may indicate that the carrying amounts are not recoverable. These indicators include, but are not limited to, a significant change in the extent or manner in which an asset is used or its physical condition, a significant decrease in the market price of an asset, or a significant adverse change in the business or the industry that could affect the value of an asset. An asset is tested for impairment by comparing the net carrying value of the asset to the undiscounted net cash flows to be generated from the use and eventual disposition of the asset. |
Stock-Based Compensation | 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, restricted stock units ("RSUs"), and market-condition based restricted stock units ("PSUs), and also accounts for certain issuances of preferred stock and warrants in accordance with ASC 718. ASC 718 requires all stock-based payments, including grants of stock options, RSUs, and PSUs, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company uses the Black-Scholes option-pricing model to determine the fair value of stock options granted. For RSUs, the fair value of the RSU is determined by the market price of a share of the Company's common stock on the grant date. For PSUs, the Company determines fair value by using a Monte Carlo simulation technique. 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 term of the stock option, stock price volatility, the risk-free interest rate, and expected dividends. Estimating the fair value of PSUs requires the input of subjective assumptions, including stock price volatility, total shareholder return ("TSR") ranking, the risk-free rate, and expected dividends. The assumptions used in the Company's Black-Scholes option-pricing model and Monte Carlo simulation technique represent management's best estimates and involve a number of variables, uncertainties, assumptions, and the application of management's judgment, as they are inherently subjective. If any assumptions change, the Company's stock-based compensation expense could be materially different in the future. The assumptions used in Ocugen's Black-Scholes option-pricing model for stock options and in Ocugen's Monte Carlo simulation technique for PSUs are as follows, unless noted otherwise: Expected Term. As Ocugen does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term, the expected term of employee stock options subject to service-based vesting conditions is determined using the "simplified" method, as prescribed in SEC's Staff Accounting Bulletin No. 107, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option. This expected term assumption is not an assumption used in the Company's Monte Carlo simulation technique for PSUs. The expected term of the PSUs is equal to the performance period of the PSUs. Expected Volatility. The expected volatility is based on historical volatilities of Ocugen and similar entities within Ocugen's industry for periods commensurate with the assumed expected term. Risk-Free Interest Rate. The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. Expected Dividends. The expected dividend yield is 0% because Ocugen has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock. TSR ranking. The Company's TSR, over a three year period, is relative to the TSR, for that same period, as related to other companies within the Nasdaq Biotechnology index. This assumption is only used for the market based PSUs. |
Collaborative Arrangements and Revenue Recognition | Collaborative Arrangements and Revenue Recognition The Company analyzes its collaborative arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards. This assessment is performed throughout the life of the arrangements based on changes to the arrangements. For collaborative arrangements within the scope of ASC 808 the Company may analogize to ASC 606 for certain elements. The Company identifies the goods or services promised within each collaborative arrangement and assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The allocation of the transaction price to the performance obligations in proportion to their standalone selling prices is determined at contract inception. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the counterparty and the transfer of the promised goods or services to the counterparty will be one year or less. The Company assessed its collaboration arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company recognizes as collaboration revenue the amount of the transaction price that is allocated to the respective performance obligation as each performance obligation is satisfied over time, with progress toward completion measured based on actual costs incurred relative to total estimated costs to be incurred over the life of the arrangement. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete their performance obligations under the arrangements. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Adjustments to original estimates will be required as work progresses and additional information becomes known, even though the scope of the work required under the contract may not change. Any adjustment as a result of a change in estimates is made when facts develop, events become known, or an adjustment is otherwise warranted. |
Recently Adopted Accounting Standards and Recent Accounting Pronouncements | Recently Adopted Accounting Standards 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. 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 adoption of ASU 2020-06 on January 1, 2024 did not have a material impact on the Company's condensed consolidated financial statements and related disclosures. Recent Accounting Pronouncements In March 2024, the FASB issued Accounting Standards Update, or ASU, 2024-02 “Codification Improvements — Amendments to Remove References to the Concepts Statements,” or ASU 2024-02. ASU 2024-02 amended certain definitions in the guidance. ASU 2024-02 is effective on a prospective basis, with the option for retrospective application, for annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. In March 2024, the FASB issued Accounting Standards Update, or ASU, 2024-01 “Compensation — Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards,” or ASU 2024-01. ASU 2024-01 improves clarity and operability without changing the guidance. ASU 2024-01 is effective on a prospective basis, with the option for retrospective application, for annual periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 December 31, 2023 Furniture and fixtures $ 337 $ 337 Machinery and equipment 1,566 1,557 Leasehold improvements 2,086 2,086 Construction in progress 15,062 14,540 Total property and equipment 19,051 18,520 Less: accumulated depreciation (1,397) (1,230) Total property and equipment, net $ 17,654 $ 17,290 |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Future Minimum Base Rent Payments | The Company's future minimum base rent payments are approximately as follows (in thousands): For the years ending December 31, Amount Remainder of 2024 $ 591 2025 810 2026 834 2027 858 2028 884 2029 714 Thereafter $ 978 Total $ 5,669 Less: present value adjustment (1,666) Present value of minimum lease payments $ 4,003 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Major Components 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, 2024 December 31, 2023 Research and development $ 245 $ 212 Clinical 96 84 Professional fees 1,139 580 Employee-related 882 1,791 Deferred revenue relating to collaborative arrangements 9,612 10,525 Other 460 151 Total accrued expenses and other current liabilities $ 12,434 $ 13,343 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The carrying values of the borrowings pursuant to the Original Offering as of March 31, 2024 and December 31, 2023 are summarized below (in thousands): March 31, 2024 December 31, 2023 Principal outstanding $ 2,500 $ 2,500 Plus: accrued interest 425 400 Less: unamortized debt issuance costs (96) (100) Carrying value, net 2,829 2,800 Less: current portion of long term debt (1,296) — Long term debt, net of current portion $ 1,533 $ 2,800 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense for stock options, RSUs and PSUs is reflected in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three months ended March 31, 2024 2023 General and administrative $ 1,316 $ 1,952 Research and development 445 737 Total $ 1,761 $ 2,689 |
Schedule of Stock Option Activity | The following table summarizes the Company's stock option activity: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (In Thousands) Options outstanding at December 31, 2023 13,161,228 $ 2.38 7.86 $ 337 Granted 2,632,054 0.70 5 Exercised (101,426) 0.42 44 Forfeited (590,947) 3.63 79 Options outstanding at March 31, 2024 15,100,909 $ 2.05 8.00 $ 6,191 Options exercisable at March 31, 2024 8,711,464 $ 2.56 7.15 $ 1,771 |
Schedule of RSU Activity | The following table summarizes the Company's RSU activity: Number of Shares Weighted Average Grant Date Fair Value RSUs outstanding at December 31, 2023 2,982,661 $ 1.63 Granted 39,738 $ 0.51 Vested (940,972) $ 1.92 Forfeited (54,320) $ 1.64 RSUs outstanding at March 31, 2024 2,027,107 $ 1.48 |
Schedule of PSU Activity | The following table summarizes the PSU activity: Number of Shares Weighted Average Grant-Date Fair Value PSUs outstanding at December 31, 2023 — $ — Granted 615,467 1.27 Vested — — Forfeited — — PSUs outstanding at March 31, 2024 615,467 $ 1.27 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Computation Basic and Diluted Earnings Per Share | The following table sets forth the computation of basic and diluted net loss per share for the three months ended March 31, 2024 and 2023 (in thousands, except share and per share amounts): Three months ended March 31, 2024 2023 Net loss — basic and diluted $ (11,924) $ (17,326) Shares used in calculating net loss per common share — basic and diluted 257,232,636 225,523,627 Net loss per common share — basic and diluted $ (0.05) $ (0.08) |
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, 2024 2023 Stock options to purchase common stock 15,100,909 13,724,164 RSUs 2,027,107 3,487,051 PSUs 615,467 — Warrants 628,834 798,352 Series B Convertible Preferred Stock (as converted to common stock) 547,450 547,450 Total 18,919,767 18,557,017 |
Nature of Business (Details)
Nature of Business (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 USD ($) segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of operating segments | segment | 1 | ||
Net loss | $ 11,924 | $ 17,326 | |
Accumulated deficit | 298,091 | $ 286,167 | |
Cash and cash equivalents | $ 26,375 | $ 39,462 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Interest income | $ 0.3 |
Expiration period | 10 years |
Share-based payment arrangement, option | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Expected dividend yield | 0% |
Minimum | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Award vesting period | 1 year |
Maximum | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
Award vesting period | 3 years |
License and Development Agree_2
License and Development Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Disaggregation of Revenue [Line Items] | |||
Total revenue | $ 1,014 | $ 443 | |
Expense incurred | 6,826 | 10,172 | |
Collaborative Arrangements | |||
Disaggregation of Revenue [Line Items] | |||
Total revenue | 1,014 | 443 | |
Expense incurred | 100 | 1,500 | |
Contract liability | $ 9,612 | $ 12,300 | $ 10,525 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 26,375 | $ 39,462 |
Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 25,200 |
Property and Equipment - (Detai
Property and Equipment - (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 19,051 | $ 18,520 |
Less: accumulated depreciation | (1,397) | (1,230) |
Total property and equipment, net | 17,654 | 17,290 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 337 | 337 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,566 | 1,557 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,086 | 2,086 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 15,062 | $ 14,540 |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Mar. 31, 2024 |
Corporate headquarters | |
Leases | |
Leases, term of contract | 7 years |
Lease renewal term | 10 years |
GMP facility | |
Leases | |
Leases, term of contract | 7 years |
Lease renewal term | 5 years |
Operating Leases - Schedule of
Operating Leases - Schedule of Future Minimum Base Rent Payments (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Leases [Abstract] | |
Remainder of 2024 | $ 591 |
2025 | 810 |
2026 | 834 |
2027 | 858 |
2028 | 884 |
2029 | 714 |
Thereafter | 978 |
Total | 5,669 |
Less: present value adjustment | (1,666) |
Present value of minimum lease payments | $ 4,003 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 |
Accrued Liabilities [Line Items] | |||
Research and development | $ 245 | $ 212 | |
Clinical | 96 | 84 | |
Professional fees | 1,139 | 580 | |
Employee-related | 882 | 1,791 | |
Other | 460 | 151 | |
Total accrued expenses and other current liabilities | 12,434 | 13,343 | |
Collaborative Arrangements | |||
Accrued Liabilities [Line Items] | |||
Deferred revenue relating to collaborative arrangements | $ 9,612 | $ 10,525 | $ 12,300 |
Debt - Narrative (Details)
Debt - Narrative (Details) - Loans payable - EB-5 Loan Agreement - USD ($) | 1 Months Ended | 12 Months Ended | ||||
May 31, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2016 | Dec. 31, 2020 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | ||||||
Maximum borrowing | $ 20,000,000 | $ 10,000,000 | ||||
Borrowing increments | $ 800,000 | $ 800,000 | $ 500,000 | |||
Interest rate | 4% | 4% | ||||
Proceeds from secured lines of credit | $ 500,000 | $ 500,000 | $ 500,000 | $ 1,000,000 |
Debt - Schedule of Debt (Detail
Debt - Schedule of Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||
Less: current portion of long term debt | $ (1,296) | $ 0 |
Long term debt, net of current portion | 1,533 | 2,800 |
Loans payable | EB-5 Loan Agreement | ||
Debt Instrument [Line Items] | ||
Principal outstanding | 2,500 | 2,500 |
Plus: accrued interest | 425 | 400 |
Less: unamortized debt issuance costs | (96) | (100) |
Carrying value, net | 2,829 | 2,800 |
Less: current portion of long term debt | (1,296) | 0 |
Long term debt, net of current portion | $ 1,533 | $ 2,800 |
Equity (Details)
Equity (Details) $ / shares in Units, $ in Thousands, vaccine_dose in Millions, shares in Millions | Mar. 18, 2021 USD ($) vaccine_dose | Mar. 31, 2024 USD ($) $ / shares | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Mar. 01, 2021 $ / shares shares |
Subsidiary, Sale of Stock [Line Items] | ||||||
Convertible preferred stock, par value (in USD per share) | $ / shares | $ 0.01 | $ 0.01 | ||||
Series B Preferred Stock | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Preferred stock issued | $ | $ 1 | $ 1 | $ 5,000 | |||
Preferred stock, outstanding | $ | $ 4,100 | |||||
Series B Preferred Stock | Fair Value, Inputs, Level 3 | Discount Rate | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Preferred stock, measurement input | 0.15 | |||||
Series B Preferred Stock | COVAXIN Preferred Stock Purchase Agreement | ||||||
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 | $ | $ 6,000 | |||||
Conversion ratio (in shares) | 10 | |||||
Supply agreement, number of doses | vaccine_dose | 10 |
Warrants (Details)
Warrants (Details) - OpCo Warrants - $ / shares shares in Millions | Mar. 31, 2024 | Dec. 31, 2023 |
Class of Warrant or Right | ||
Number of warrants outstanding (in shares) | 0.6 | 0.6 |
Initial exercise price (in USD per share) | $ 6.23 |
Stock-Based Compensation -Sched
Stock-Based Compensation -Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,761 | $ 2,689 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 1,316 | 1,952 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 445 | $ 737 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended | ||
Jan. 02, 2024 shares | Mar. 31, 2024 USD ($) equity_compensation_plan $ / shares shares | Mar. 31, 2023 USD ($) $ / shares | Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation expense | $ | $ 8.7 | |||
Unrecognized compensation expense related to options outstanding, weighted average period for expense to be recognized | 1 year 7 months 6 days | |||
Number of equity compensation plans | equity_compensation_plan | 2 | |||
Weighted average grant date fair value (in USD per share) | $ / shares | $ 0.58 | $ 1.01 | ||
Options, vested in period, fair value | $ | $ 5 | $ 5.6 | ||
PSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Units granted (in shares) | 615,467 | |||
2019 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Automatic increase in shares to be issued | 4% | |||
Number of shares authorized for grant (in shares) | 38,600,000 | |||
Number of shares available for grant (in shares) | 17,600,000 | |||
2019 Plan | PSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Units granted (in shares) | 615,467 | |||
2019 Plan | PSUs | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage of the awards granted | 200% | |||
2019 Plan | PSUs | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage of the awards granted | 0% | |||
2014 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares authorized for grant (in shares) | 800,000 | |||
Number of shares available for grant (in shares) | 500,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Beginning balance (in shares) | 13,161,228 | |
Granted (in shares) | 2,632,054 | |
Exercised (in shares) | (101,426) | |
Forfeited (in shares) | (590,947) | |
Ending balance (in shares) | 15,100,909 | 13,161,228 |
Exercisable (in shares) | 8,711,464 | |
Weighted Average Exercise Price | ||
Beginning balance (in USD per share) | $ 2.38 | |
Granted (in USD per share) | 0.70 | |
Exercised (in USD per share) | 0.42 | |
Forfeited (in USD per share) | 3.63 | |
Ending balance (in USD per share) | 2.05 | $ 2.38 |
Exercisable (in USD per share) | $ 2.56 | |
Weighted Average Remaining Contractual Life (Years) | ||
Weighted average remaining contractual life | 8 years | 7 years 10 months 9 days |
Weighted average remaining contractual life, options exercisable | 7 years 1 month 24 days | |
Aggregate Intrinsic Value (In Thousands) | ||
Options outstanding, beginning balance | $ 337 | |
Granted in period, intrinsic value | 5 | |
Exercises in period, intrinsic value | 44 | |
Forfeited in period, intrinsic value | 79 | |
Options outstanding, ending balance | 6,191 | $ 337 |
Options exercisable | $ 1,771 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of RSU and PSU Activity (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
RSUs | |
Number of Shares | |
Beginning balance outstanding (in shares) | shares | 2,982,661 |
Granted (in shares) | shares | 39,738 |
Vested (in shares) | shares | (940,972) |
Forfeited (in shares) | shares | (54,320) |
Ending balance outstanding (in shares) | shares | 2,027,107 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 1.63 |
Granted (in USD per share) | $ / shares | 0.51 |
Vested (in USD per share) | $ / shares | 1.92 |
Forfeited (in USD per share) | $ / shares | 1.64 |
Ending balance (in USD per share) | $ / shares | $ 1.48 |
PSUs | |
Number of Shares | |
Beginning balance outstanding (in shares) | shares | 0 |
Granted (in shares) | shares | 615,467 |
Vested (in shares) | shares | 0 |
Forfeited (in shares) | shares | 0 |
Ending balance outstanding (in shares) | shares | 615,467 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 0 |
Granted (in USD per share) | $ / shares | 1.27 |
Vested (in USD per share) | $ / shares | 0 |
Forfeited (in USD per share) | $ / shares | 0 |
Ending balance (in USD per share) | $ / shares | $ 1.27 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock - Schedule of Computation Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share [Abstract] | ||
Net loss - basic | $ (11,924) | $ (17,326) |
Net loss - diluted | $ (11,924) | $ (17,326) |
Shares used in calculating net loss per common share - basic (in shares) | 257,232,636 | 225,523,627 |
Shares used in calculating net loss per common share - diluted (in shares) | 257,232,636 | 225,523,627 |
Net loss per share of common stock - basic (in USD per share) | $ (0.05) | $ (0.08) |
Net loss per share of common stock - diluted (in USD per share) | $ (0.05) | $ (0.08) |
Net Loss Per Share of Common _4
Net Loss Per Share of Common Stock - Schedule of Potentially Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares) | 18,919,767 | 18,557,017 |
Stock options to purchase common stock | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares) | 15,100,909 | 13,724,164 |
RSUs | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares) | 2,027,107 | 3,487,051 |
PSUs | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares) | 615,467 | 0 |
Warrants | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares) | 628,834 | 798,352 |
Series B Convertible Preferred Stock | ||
Earnings Per Share | ||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding (in shares) | 547,450 | 547,450 |