Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 07, 2019 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Entity Registrant Name | OCUGEN, INC. | |
Entity Central Index Key | 0001372299 | |
Document Period End Date | Sep. 30, 2019 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 16,003,916 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 15,301,082 | $ 1,628,136 |
Prepaid expenses and other current assets | 517,562 | 313,499 |
Asset held for sale | 7,000,000 | |
Total current assets | 22,818,644 | 1,941,635 |
Property and equipment, net | 213,229 | 245,788 |
Restricted cash | 150,910 | 150,477 |
Other assets | 436,094 | 116,333 |
Total assets | 23,618,877 | 2,454,233 |
Current liabilities | ||
Accounts payable | 5,791,298 | 3,277,525 |
Accrued expenses | 1,301,304 | 1,402,750 |
Short-term debt, net | 7,483,847 | |
Derivative liabilities | 1,741,222 | |
Operating lease obligation | 151,530 | |
Financing lease obligation | 19,838 | 20,442 |
Short-term warrant liability | 27,964,986 | |
Deferred grant proceeds | 183,800 | 183,800 |
Total current liabilities | 35,412,756 | 14,109,586 |
Noncurrent liabilities | ||
Deferred rent | 3,739 | |
Operating lease obligation, less current portion | 223,853 | |
Financing lease obligation, less current portion | 17,339 | 33,720 |
Long term debt, net | 1,058,191 | 1,016,727 |
Total noncurrent liabilities | 1,299,383 | 1,054,186 |
Total liabilities | 36,712,139 | 15,163,772 |
Commitments and contingencies (Note 10) | ||
Stockholders' deficit | ||
Convertible preferred stock, $0.01 par value, 10,000,000 shares authorized, 7.0 and zero issued and outstanding at September 30, 2019 and December 31, 2018 | ||
Common stock, 200,000,000 ($0.01 par value) authorized and 10,013,605 and 4,960,552 issued and outstanding at September 30, 2019 and December 31, 2018 | 100,136 | 49,606 |
Accumulated other comprehensive income | 451 | |
Additional paidin capital | 50,668,493 | 18,477,598 |
Accumulated deficit | (63,861,891) | (31,237,194) |
Total stockholders' deficit | (13,093,262) | (12,709,539) |
Total liabilities and stockholders' deficit | $ 23,618,877 | $ 2,454,233 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Convertible Preferred stock, par value | $ 0.01 | $ 0.01 |
Convertible Preferred stock, Shares authorized | 10,000,000 | 10,000,000 |
Convertible Preferred stock, shares issued | 7 | 0 |
Convertible Preferred stock, shares outstanding | 7 | 0 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, par value (dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares issued | 10,013,605 | 4,960,552 |
Common stock, shares outstanding | 10,013,605 | 4,960,552 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating expenses | ||||
Research and development | $ 1,305,461 | $ 1,561,286 | $ 6,338,530 | $ 7,405,472 |
General and administrative | 1,408,350 | 843,165 | 3,544,847 | 3,045,562 |
Total operating expenses | 2,713,811 | 2,404,451 | 9,883,377 | 10,451,034 |
Loss from operations | (2,713,811) | (2,404,451) | (9,883,377) | (10,451,034) |
Other income (expense) | ||||
Change in fair value of derivative liabilities | (18,512,204) | 1,461,872 | (19,896,626) | 1,208,525 |
Loss on debt conversion | (341,136) | |||
Interest income | 136 | 3,762 | 1,107 | 17,393 |
Interest expense | (796,141) | (1,001,545) | (1,753,172) | (3,035,350) |
Other income (expense) | (751,261) | 7,755 | (751,493) | (2,413) |
Total other income (expense) | (20,059,470) | 471,844 | (22,741,320) | (1,811,845) |
Net loss | (22,773,281) | (1,932,607) | (32,624,697) | (12,262,879) |
Other comprehensive income (loss) | ||||
Foreign currency translation adjustment | (133) | (451) | 391 | |
Comprehensive loss | $ (22,773,281) | $ (1,932,740) | $ (32,625,148) | $ (12,262,488) |
Net loss per share of common stock - basic and diluted | $ (3.55) | $ (0.39) | $ (5.59) | $ (2.47) |
Weighted average shares outstanding - basic and diluted | 6,411,308 | 4,960,552 | 5,839,840 | 4,960,552 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Beginning balance at Dec. 31, 2017 | $ 49,606 | $ 17,402,911 | $ (13,017,530) | $ 4,434,987 | ||
Beginning balance (in shares) at Dec. 31, 2017 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 258,682 | 258,682 | ||||
Foreign currency translation adjustment | $ (34) | (34) | ||||
Net loss | (5,039,026) | (5,039,026) | ||||
Ending balance at Mar. 31, 2018 | $ 49,606 | 17,661,593 | (34) | (18,056,556) | (345,391) | |
Ending balance (in shares) at Mar. 31, 2018 | 4,960,552 | |||||
Beginning balance at Dec. 31, 2017 | $ 49,606 | 17,402,911 | (13,017,530) | 4,434,987 | ||
Beginning balance (in shares) at Dec. 31, 2017 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Foreign currency translation adjustment | 391 | |||||
Net loss | (12,262,879) | |||||
Ending balance at Sep. 30, 2018 | $ 49,606 | 18,148,994 | 391 | (25,280,409) | (7,081,418) | |
Ending balance (in shares) at Sep. 30, 2018 | 4,960,552 | |||||
Beginning balance at Mar. 31, 2018 | $ 49,606 | 17,661,593 | (34) | (18,056,556) | (345,391) | |
Beginning balance (in shares) at Mar. 31, 2018 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 261,185 | 261,185 | ||||
Foreign currency translation adjustment | 558 | 558 | ||||
Net loss | (5,291,246) | (5,291,246) | ||||
Ending balance at Jun. 30, 2018 | $ 49,606 | 17,922,778 | 524 | (23,347,802) | (5,374,894) | |
Ending balance (in shares) at Jun. 30, 2018 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 226,216 | 226,216 | ||||
Foreign currency translation adjustment | (133) | (133) | ||||
Net loss | (1,932,607) | (1,932,607) | ||||
Ending balance at Sep. 30, 2018 | $ 49,606 | 18,148,994 | 391 | (25,280,409) | (7,081,418) | |
Ending balance (in shares) at Sep. 30, 2018 | 4,960,552 | |||||
Beginning balance at Dec. 31, 2018 | $ 49,606 | 18,477,598 | 451 | (31,237,194) | (12,709,539) | |
Beginning balance (in shares) at Dec. 31, 2018 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 415,202 | 415,202 | ||||
Foreign currency translation adjustment | (282) | (282) | ||||
Net loss | (6,312,606) | (6,312,606) | ||||
Ending balance at Mar. 31, 2019 | $ 49,606 | 18,892,800 | 169 | (37,549,800) | (18,607,225) | |
Ending balance (in shares) at Mar. 31, 2019 | 4,960,552 | |||||
Beginning balance at Dec. 31, 2018 | $ 49,606 | 18,477,598 | 451 | (31,237,194) | (12,709,539) | |
Beginning balance (in shares) at Dec. 31, 2018 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Foreign currency translation adjustment | (451) | |||||
Net loss | (32,624,697) | |||||
Ending balance at Sep. 30, 2019 | $ 100,136 | 50,668,493 | (63,861,891) | (13,093,262) | ||
Ending balance (in shares) at Sep. 30, 2019 | 7 | 10,013,605 | ||||
Beginning balance at Mar. 31, 2019 | $ 49,606 | 18,892,800 | 169 | (37,549,800) | (18,607,225) | |
Beginning balance (in shares) at Mar. 31, 2019 | 4,960,552 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Stock-based compensation expense | 111,807 | 111,807 | ||||
Foreign currency translation adjustment | $ (169) | (169) | ||||
Net loss | (3,538,810) | (3,538,810) | ||||
Conversion of debt | $ 11,257 | 13,959,622 | 13,970,878 | |||
Conversion of debt (in shares) | 1,125,673 | |||||
Equity transactions | $ 1,577 | 1,956,218 | 1,957,796 | |||
Equity transactions (in shares) | 157,743 | |||||
Ending balance at Jun. 30, 2019 | $ 62,440 | 34,920,447 | (41,088,610) | (6,105,723) | ||
Ending balance (in shares) at Jun. 30, 2019 | 6,243,968 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of stock for reverse asset acquisition, net of $5.0 million of costs | $ 15,766 | 2,325,284 | 2,341,050 | |||
Issuance of stock for reverse asset acquisition, net of $5.0 million of costs (in shares) | 7 | 1,576,655 | ||||
Issuance of common stock under Pre-Merger Financing, net of $1.7 million of costs | $ 21,930 | 13,229,757 | 13,251,687 | |||
Issuance of common stock under Pre-Merger Financing, net of $1.7 million of costs (in shares) | 2,192,982 | |||||
Stock-based compensation expense | 193,005 | 193,005 | ||||
Net loss | (22,773,281) | (22,773,281) | ||||
Ending balance at Sep. 30, 2019 | $ 100,136 | $ 50,668,493 | $ (63,861,891) | $ (13,093,262) | ||
Ending balance (in shares) at Sep. 30, 2019 | 7 | 10,013,605 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Millions | 3 Months Ended |
Sep. 30, 2019USD ($) | |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) | |
Issuance costs under reverse asset acquisition | $ 5 |
Issuance costs under pre-merger | $ 1.8 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (32,624,697) | $ (12,262,879) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 34,626 | 35,053 |
Noncash interest expense | 1,718,546 | 2,825,669 |
Change in fair value of derivative liability | 19,896,626 | (1,208,525) |
Stockbased compensation expense | 720,014 | 746,083 |
Loss on debt conversion | 341,136 | |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (315,612) | (390,541) |
Other assets | 34,774 | (4,203) |
Accounts payable and accrued expenses | 2,045,228 | 1,413,621 |
Deferred rent | 1,210 | |
Net cash used in operating activities | (8,149,359) | (8,844,512) |
Cash flows from investing activities | ||
Purchase of property and equipment | (2,067) | (77,414) |
Payment of reverse asset acquisition costs | (2,334,063) | |
Net cash used in investing activities | (2,336,130) | (77,414) |
Cash flows from financing activities | ||
Financing lease principal payments | (16,985) | (4,782) |
Payment of debt issuance costs | (122,262) | |
Proceeds from issuance of convertible debt | 6,800,000 | 6,000,000 |
Repayment of convertible debt | (5,290,000) | |
Payment of equity issuance costs | (649,254) | (741,178) |
Proceeds from Pre-Merger Financing | 22,437,537 | |
Proceeds from stock subscription | 999,832 | |
Net cash provided by financing activities | 24,158,868 | 5,254,040 |
Effect of changes in exchange rate on cash | 391 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 13,673,379 | (3,667,495) |
Cash, cash equivalents and restricted cash at beginning of period | 1,778,613 | 6,301,572 |
Cash, cash equivalents and restricted cash at end of period | 15,451,992 | 2,634,077 |
Supplemental disclosure of non-cash transactions: | ||
Purchase of fixed assets by entering into capital lease (Note 10) | 63,817 | |
Conversion of convertible notes (Note 9) | 13,061,029 | |
Conversion of convertible promissory note (Note 9) | 907,502 | |
Equity issuance costs (Note 4) | 1,150,000 | $ 598,286 |
Right-of-use asset related to operating leases (Note 10) | 363,093 | |
Reverse asset acquisition costs (Note 4) | $ 2,711,431 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2019 | |
Nature of Business | |
Nature of Business | 1. Nature of Business Ocugen, Inc. (formerly known as Histogenics Corporation), together with its wholly owned subsidiaries (“Ocugen” or the “Company”), is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies to address rare and underserved eye diseases. The Company is located in Malvern, Pennsylvania. Ocugen is developing a modifier gene therapy platform for unmet medical needs in the area of retinal diseases, including inherited retinal diseases (“IRDs”). Ocugen’s modifier gene therapy platform is novel in that it targets nuclear hormone receptor (“NHR”) genes which have the potential to restore homeostasis to the retina and may target multiple genes that are associated with a range of IRDs. Unlike single-gene replacement therapies, which only target one genetic mutation, the Company believes that its gene therapy platform, through its targeting of NHRs, may impact multiple genes that are associated with a range of genetically diverse diseases. Ocugen’s first gene therapy candidate, OCU400, has received two Orphan Drug Designation (“ODD”) from the Food and Drug Administration (“FDA”), for the treatment of NR2E3 mutation-associated retinal diseases and CEP290 mutation-associated retinal diseases. OCU400 uses an adeno-associated virus vector (“AAV”). Ocugen’s second gene therapy product candidate, OCU410, is targeted for dry age-related macular degeneration (“dry AMD”). Currently, there are no FDA-approved therapies to treat this disease. Ocugen has a late-stage, Phase 3 program, OCU300, which has also received ODD from the FDA. OCU300 is a small molecule therapeutic currently in Phase 3 clinical development for patients with ocular graft-versus-host disease (“oGVHD”). Ocugen is the first and only company to receive ODD for the treatment of oGVHD and is the only company conducting Phase 3 studies in this patient population. OCU300 is formulated using the Company’s proprietary nanoemulsion technology, OcuNanoE – Ocugen’s ONE Platform™ (“OcuNanoE™”). Ocugen is also developing OCU200, a novel fusion protein for the treatment of wet age-related macular degeneration (“wet AMD”), diabetic retinopathy (“DR”) and diabetic macular edema (“DME”). Merger with Histogenics On September 27, 2019, the Company completed its reverse merger with Ocugen, OpCo Inc. (formerly known as Ocugen, Inc. (“Former Ocugen”)) in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of April 5, 2019, by and among Histogenics, Former Ocugen and Restore Merger Sub, Inc., a wholly owned subsidiary of Histogenics (“Merger Sub”), as amended (the “Merger Agreement”), pursuant to which Merger Sub merged with and into Former Ocugen, with Former Ocugen surviving as a wholly owned subsidiary of Histogenics (the “Merger”). Immediately after completion of the Merger, Histogenics changed its name to Ocugen, Inc. and the business conducted by Ocugen, Inc. became the business conducted by Former Ocugen. Former Ocugen is deemed to be the accounting acquirer. Accordingly, the historical financial statements of Former Ocugen became the Company's historical financial statements, including the comparative prior periods. See Note 4 for additional information. Reverse Stock Split In connection with, and immediately prior to the completion of the Merger, Histogenics effected a reverse stock split of the common stock, at a ratio of 1-for-60 (the ‘‘Reverse Stock Split’’). Under the terms of the Merger Agreement, the Company issued common stock to Former Ocugen’s stockholders at an exchange rate of 0.4794 shares of common stock, after taking into account the Reverse Stock Split, for each share of Former Ocugen’s common stock outstanding immediately prior to the Merger. The capital structure, including the number of shares of common stock issued appearing in the condensed consolidated balance sheets for the periods presented, reflects that of Ocugen. All references in the condensed consolidated financial statements to the number of shares and per-share amounts of common stock have been retroactively restated to reflect the exchange rate. Going Concern The Company has incurred recurring losses and negative cash flows from operations since inception and has funded its operating losses through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes, and debt. The Company incurred net losses of approximately $32.6 million and $12.3 million for the nine months ended September 30, 2019 and 2018, respectively, and had an accumulated deficit of $63.9 million as of September 30, 2019. As of September 30, 2019, the Company had cash, cash equivalents and restricted cash totaling $15.5 million. The Company has a limited operating history and its prospects are subject to risks, expenses and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research and development efforts for its product candidates, which will require significant funding. If the Company is unable to obtain additional financing in the future or research and development efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company plans to increase working capital by raising additional capital through either private or public equity or debt financing. Such financing may not be available at all, or on terms that are favorable to the Company. While management of the Company believes that it has a plan to fund ongoing operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital through one or more financings, or appropriately manage certain discretionary spending could have a material adverse effect on the Company’s ability to achieve its intended business objectives. As a result of these factors, together with the anticipated increase in spending that will be necessary to continue to develop the Company’s products, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these unaudited condensed consolidated financial statements are issued. The unaudited 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 | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) and under the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim reporting. The accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, that are necessary to present fairly the Company’s financial position, results of operations, and cash flows. The condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and note 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 of Former Ocugen for the year ended December 31, 2018. The balance sheet data as of December 31, 2018 was derived from the Company’s audited financial statements for the year ended December 31, 2018. Principles of Consolidation The condensed consolidated financial statements include the accounts of Ocugen, Inc. and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. Foreign Currency Translation and Transactions The assets and liabilities of the Company’s foreign subsidiary are translated into U.S. dollars based on exchange rates in effect at the end of each period. Revenues and expenses are translated at average exchange rates during the periods. Currency transaction gains or losses are included in other expenses. Gains or losses from balance sheet translation are included in accumulated other comprehensive income. Use of Estimates In preparing 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 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 valuation of share-based payment arrangements, warrants, and embedded conversion features on the convertible notes. Asset Held for Sale An asset is considered to be held for sale when all of the following criteria are met: (i) management commits to a plan to sell the asset; (ii) it is unlikely that the disposal plan will be significantly modified or discontinued; (iii) the asset is available for immediate sale in its present condition; (iv) actions required to complete the sale of the asset have been initiated; (v) sale of the asset is probable and the completed sale is expected to occur within one year; and (vi) the asset is actively being marketed for sale at a price that is reasonable given its current market value. A long-lived asset classified as held for sale is measured at the lower of its carrying amount or fair value less cost to sell. If the long-lived asset is newly acquired, the carrying amount of the long-lived asset is established based on its fair value less cost to sell at the acquisition date. A long-lived asset is not depreciated or amortized while it is classified as held for sale. As of September 30, 2019, Ocugen had an intangible asset held for sale acquired from Histogenics with a fair value less cost of sell of $7.0 million. See Notes 4 and 12 for additional information. Fair Value Measurements The company follows the provisions of the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements (“ASC 820”), which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair measurements. The estimated fair value of certain financial instruments, cash and cash equivalents, accounts payable, and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 — quoted prices in active markets for identical assets or liabilities Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 — inputs that are unobservable (for example cash flow modeling inputs based on assumptions) The company has derivative instruments that are fair valued on a recurring basis using Level 3 inputs. Financial Instruments Indexed to and Potentially Settled in Common Stock The Company accounts for warrants in accordance with ASC Topic 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”), which is the authoritative guidance on accounting for derivative financial instruments indexed to and potentially settled in a company’s own stock. To determine whether a contract is considered indexed to the issuer’s own equity, the Company performs a two-step analysis: Step 1 — Evaluate whether the contract contains any exercise contingencies and, if so, whether they disqualify the contract from being classified as equity, and Step 2 — Assess whether the settlement terms are consistent with equity classification. The Company classifies the liability-designated warrants on its condensed consolidated balance sheet as a derivative liability which is recognized at fair value at each reporting period subsequent to the initial issuance. Changes in the fair value of derivatives are recognized as other income (expense) in the condensed consolidated statements of operations and comprehensive loss. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and United States government and United States government agency obligations. The Company’s restricted cash balance consists of cash held to collateralize a corporate credit card account. The following table provides a reconciliation of cash, cash equivalents, and restricted cash in the condensed consolidated balance sheets to the total amount shown in the condensed consolidated statements of cash flows: As of September 30, 2019 2018 Cash, cash equivalents and restricted cash reconciliation: Cash and cash equivalents $ 15,301,082 $ 2,483,749 Restricted cash 150,910 150,328 Total cash, cash equivalents and restricted cash $ 15,451,992 $ 2,634,077 |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2019 | |
Recent Accounting Pronouncements | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements Recently Adopted Accounting Standards In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASC 842”). In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases (“ASU 2018-10”), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, Leases (Topic 842)—Targeted Improvements (“ASU 2018-11”), which addressed implementation issues related to the new lease standard. These and certain other lease-related ASUs have generally been codified in ASC 842. ASC 842 supersedes the lease accounting requirements in ASC Topic 840, Leases (“ASC 840”). ASC 842 establishes a right-of-use model that requires a lessee to record a right-of-use (“ROU”) asset and a lease liability on the balance sheet for all leases. Under ASC 842, leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The standard also requires disclosures to help investors and other financial statement users better understand the amount, timing and uncertainty of cash flows arising from leases. ASU 2016-02 was effective for annual reporting periods beginning after December 15, 2018 and interim periods within that reporting period. The Company adopted ASC 842 on January 1, 2019 using the effective date transition method. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods. The Company has elected certain practical expedients permitted under the transition guidance within ASC 842 to leases that commenced before January 1, 2019, including the package of practical expedients. The election of the package of practical expedients resulted in the Company not reassessing prior conclusions under ASC 840 related to lease identification, lease classification and initial direct costs for expired and existing leases prior to January 1, 2019. The Company did not elect the practical expedient to not record short-term leases on its consolidated balance sheet. The adoption of ASU 2016‑02 did not have a significant impact on the Company’s consolidated results of operations or cash flows. Upon adoption, the Company recognized an ROU asset and lease liability of $0.4 million and $0.4 million, respectively. See Note 10 for additional information. |
Merge and Financing
Merge and Financing | 9 Months Ended |
Sep. 30, 2019 | |
Merger and Financing | |
Merger and Financing | 4. Merger and Financing Pre-Merger Financing In June 2019, Former Ocugen and Histogenics entered into a Securities Purchase Agreement (as amended, the “Financing SPA”) with certain accredited investors (the “Investors”). Pursuant to the Financing SPA, among other things, (i) immediately prior to the Merger, Former Ocugen issued 4,574,272 shares of common stock to the Investors (the “Initial Shares” and, as converted pursuant to the exchange rate in the Merger into the right to receive approximately 2.2 million shares the Company’s common stock, the “Converted Initial Shares”), (ii) immediately prior to the Merger, Former Ocugen issued and deposited 4,574,272 shares of common stock into escrow on behalf of the Investors (the “Additional Shares” and, as converted pursuant to the exchange rate in the Merger, into the right to receive approximately 2.2 million shares of the Company’s common stock, the “Converted Additional Shares”) and (iii) the Company agreed to issue, on the fifth trading day following the consummation of the Merger, three series of warrants to purchase shares of the Company’s common stock (the “Series A Warrants,” the “Series B Warrants” and the “Series C Warrants” and collectively, the “Pre-Merger Financing Warrants”) in exchange for an aggregate purchase price of $25.0 million (“Pre-Merger Financing”). Approximately $2.5 million of the $25.0 million Pre-Merger Financing was utilized to pay transaction costs related to the Merger and the Pre-Merger Financing in the form of equity. In addition, the Company utilized $5.3 million of the Pre-Merger Financing for the repayment of the Senior Secured Notes, as defined in Note 9. As a result, the Company received total net proceeds of $17.2 million from the Pre-Merger Financing. The Company incurred $1.8 million in equity issuance costs related to the Pre-Merger Financing, of which $0.6 million was paid in cash and $1.2 million was paid with equity as of September 30, 2019. Approximately $1.0 million of equity issuance costs was allocated to the Series A Warrants and Series C Warrants and is included in additional paid-in capital. Approximately $0.8 million of issuance costs allocated to the Series B Warrant liability were expensed and are reflected in other income (expense) on the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2019. Merger with Histogenics On September 27, 2019, the Company completed the Merger in accordance with the terms of the Merger Agreement. The Merger was structured as a stock-for-stock transaction whereby all of Former Ocugen’s outstanding shares of common stock and securities convertible into or exercisable for Former Ocugen’s common stock were converted into the right to receive Histogenics’ common stock and securities convertible into or exercisable for Histogenics’ common stock. Immediately following the Merger, the former equity holders of Former Ocugen owned 84.25% of the outstanding capital stock of the Company, and the equity holders of the Company immediately before the Merger owned 15.75% of the outstanding capital stock of the Company, including the Initial Shares but excluding the Additional Shares and the Pre-Merger Financing Warrants pursuant to the Financing SPA. In accordance with ASC Topic 805, Business Combinations (“ASC 805”) , the Company concluded that, while Histogenics is the legal acquirer, Former Ocugen is the accounting acquirer due to the fact that (i) Former Ocugen’s shareholders have the majority of the voting rights in Ocugen, (ii) Former Ocugen holds all of the board seats of the combined company and (iii) Former Ocugen management holds all key positions in the management of the combined company. The Company has further concluded that Histogenics does not meet the definition of a business under ASC 805 due to the fact that substantially all of the fair value of the gross assets disposed of is concentrated in a single identifiable asset or a group of similar identifiable assets. Therefore, the Merger will be accounted for as a reverse asset acquisition. The Company incurred $5.0 million in transaction costs related to the Merger, of which $2.3 million was paid in cash and $2.3 million was paid with equity as of September 30, 2019. Assets and liabilities of Histogenics on September 27, 2019 were as follows (in thousands): September 27, 2019 Cash and cash equivalents $ 291 Asset held for sale 7,000 Accounts payable (1,162) Net assets acquired $ 6,129 Asset Held for Sale In connection with the Merger, on May 8, 2019, Histogenics entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Medavate Corp., a Colorado corporation (“Medavate”), pursuant to which Histogenics agreed to sell substantially all of its assets relating to its NeoCart™ program, including, without limitation, intellectual property, business and license agreements and clinical trial data (the “Assets”) in return for a cash payment of $6.5 million. On September 26, 2019, the parties entered into an amendment to the Asset Purchase Agreement whereby the closing date was amended to October 4, 2019. On October 4, 2019, the parties entered into a second amendment (the “Second Amendment”) to the Asset Purchase Agreement whereby the purchase price was increased to $7.0 million under the Asset Purchase Agreement and the closing date of the Asset Purchase Agreement was revised from October 4, 2019 to two business days after Medavate obtains financing in an amount no less than the purchase price (the “Closing Date”). The Second Amendment further provides that if the Closing Date does not occur on or prior to October 31, 2019, Ocugen may choose to terminate the Asset Purchase Agreement without recourse and, if Ocugen does not terminate the Asset Purchase Agreement, the purchase price shall increase 10% per month (or any portion thereof) between October 31, 2019 and the Closing Date. The NeoCart™ asset qualifies as held for sale as of the date of the reverse asset acquisition and is carried at a fair value less cost to sell on the condensed consolidated balance sheet as of September 30, 2019. The Closing Date did not occur as of October 31, 2019 and Ocugen did not terminate the agreement. See Note 12 for additional information. Medinet Agreement In December 2017, Histogenics entered into the License and Commercialization Agreement (the “License Agreement”) with MEDINET Co., Ltd. (“MEDINET”) to grant MEDINET a license under certain patents, patent applications, know-how, and technology to develop and commercialize certain therapeutic products related to the NeoCart™ program. As consideration for the granting of the license, MEDINET agreed to pay Histogenics a non-refundable upfront cash payment of $10.0 million which was received in January 2018. Based on the results of the NeoCart™ research, Histogenics suspended the NeoCart™ program. Subsequently, since MEDINET relied on the NeoCart™ product to supply clinical trial patients, MEDINET suspended the development of its clinical trial. As of September 30, 2019, the contract with MEDINET was wholly unperformed. As a result of the expected sale of the NeoCart™ asset, the Company does not expect to retain any future obligations related to the MEDINET agreement. The NeoCart™ asset held for sale was valued based on a quoted price of $7.0 million, which is an observable Level 2 fair value input. |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 9 Months Ended |
Sep. 30, 2019 | |
Net Loss Per Share of Common Stock | |
Net Loss Per Share of Common Stock | 5. Net Loss Per Share of Common Stock The following table sets forth the computation of Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Net loss $ (22,773,281) $ (1,932,607) $ (32,624,697) $ (12,262,879) Weighted average shares of common stock outstanding 6,411,308 4,960,552 5,839,840 4,960,552 Net loss per shares of common stock—basic and diluted $ (3.55) $ (0.39) $ (5.59) $ (2.47) The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as their inclusion would have been antidilutive: Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Options to purchase common stock 500,933 473,647 500,933 473,647 Warrants (1) 870,020 870,020 870,020 870,020 Series A Warrants 8,771,928 — 8,771,928 — Series B Warrants (2) 8,007,461 — 8,007,461 — Series C Warrants 50,000,000 — 50,000,000 — Total 68,150,342 1,343,667 68,150,342 1,343,667 (1) With the exception of the application of the exchange rate of 0.4794 to the outstanding options and warrants, the terms and conditions related to the options and warrants existing prior to the Merger were not revised. (2) Warrants do not include additional Series B Warrants that are contingent upon reset pricing as discussed in Note 11. Subsequent to September 30, 2019, the Pre-Merger Financing Warrants were amended to reduce the number of Series C Warrants, among other things. See Note 12 for additional information. |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2019 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 6. License and Collaboration Agreements Collaboration Agreement with CanSino Biologics On September 27, 2019, Ocugen entered into a co-development and commercialization agreement (the “CanSinoBIO Agreement”) with CanSino Biologics Inc. (“CanSinoBIO”) with respect to the development and commercialization of the gene therapy product candidate, OCU400, for the treatment of NR2E3 Mutation-Associated Retinal Degeneration, Leber Congenital Amaurosis, Bardet-Biedl Syndrome and Rhodopsin Mutation-Associated Retinal Degeneration. CanSinoBIO will be responsible for all the costs for chemistry, manufacturing and control development and manufacture of clinical supplies of OCU400 for all territories. CanSinoBIO will be solely responsible for all other costs and expenses of its development activities in the CanSinoBIO territory (Greater China, Hong Kong, Macao, and Taiwan) and Ocugen will be responsible for all other costs and expenses of its development activities in the Ocugen territory (outside of CanSinoBIO territory). CanSinoBIO will pay to Ocugen an annual royalty between mid to high-single digits based on net sales of products in the CanSinoBIO territory, and Ocugen will pay to CanSinoBIO an annual royalty between low to mid-single digits based on net sales of products in the Ocugen territory. Unless terminated earlier, the CanSinoBIO Agreement will continue in force on a country-by-country and product-by-product basis until the later of (a) the expiration of the last valid claim of patent rights of Ocugen covering such product and (b) the tenth (10 th ) anniversary of the first commercial sale of such product in such country. The CanSinoBIO Agreement will also terminate upon the termination of the Exclusive License Agreement, dated December 19, 2017, between Ocugen and Schepens Eye Research Institute, Inc. The CanSinoBIO Agreement may be terminated by either party in its entirety upon (a) a material breach of the Agreement by the other party, (b) a challenge by the other party or any of its affiliates of any intellectual property controlled by the terminating party or (c) bankruptcy or insolvency of the other party.Within forty-five (45) days after such termination, CanSinoBIO shall provide Ocugen with a statement of the CanSinoBIO development costs and, within one (1) year after receipt of such report, Ocugen shall reimburse CanSinoBIO all such CanSinoBIO development costs. |
Balance Sheet Detail
Balance Sheet Detail | 9 Months Ended |
Sep. 30, 2019 | |
Balance Sheet Detail | |
Balance Sheet Detail | 7. Balance Sheet Detail Accrued Expenses are as follows: September 30, December 31, 2019 2018 Accrued expenses: Research and development $ 60,315 $ 705,436 Clinical 243,461 469,473 Consulting 85,508 86,619 Employee-related 531,078 123,372 Legal 380,942 17,850 Total $ 1,301,304 $ 1,402,750 |
Equity Transactions
Equity Transactions | 9 Months Ended |
Sep. 30, 2019 | |
Equity Transactions | |
Equity Transactions | 8. Equity Transactions On April 5, 2019, Former Ocugen entered into a Stock Subscription Agreement (“Subscription Agreement”) with existing investors for the sale of 80,572 shares of common stock for $1.0 million, or $12.41 per share. This capital raise triggered the conversion features on the convertible debt described below. On December 13, 2018, Former Ocugen entered into a service agreement with a financial advisor. Pursuant to this agreement, in June 2019, 77,171 shares of common stock of Former Ocugen were issued at $12.41 per share for services rendered. These services totaling $1.0 million are related to the Merger and are therefore reflected in the supplemental disclosure of non-cash transactions included in the condensed consolidated statements of cash flows. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2019 | |
Debt | |
Debt | 9. Debt EB-5 Loan In September 2016, pursuant to the U.S. government’s Immigrant Investor Program, commonly known as the EB‑5 program (the “EB‑5 Program”), the Company entered into an arrangement (the "EB-5 Loan Agreement") to borrow up to $10.0 million from EB5 Life Sciences, L.P. (the “Lender”) in $0.5 million increments. Borrowing may be limited by the amount of funds raised by the Lender and are subject to certain job creation requirements by the Company. Borrowings are at a fixed interest rate of 4.0% per annum and are to be utilized in the clinical development, manufacturing, and commercialization of the Company’s products and for the general working capital needs of the Company. Outstanding borrowings pursuant to the EB‑5 Program become due upon the seventh anniversary of the final disbursement. Amounts repaid cannot be re‑borrowed. The EB-5 note is secured by substantially all assets of the Company, except for any patents, patent applications, pending patents, patent license, patent sublicense, trademarks, and other intellectual property rights. In September 2016, $0.5 million was borrowed by the Company followed by another borrowing of $0.5 million in December 2016. Issuance costs for these borrowings totaled $103,887. Amortization of debt issuance costs amounted to approximately $3,710 for the three months ended September 30, 2019 and 2018, and approximately $11,131 for the nine months ended September 30, 2019 and 2018, and is included in interest expense. At September 30, 2019, there is $1.0 million of principal outstanding which has accrued interest of approximately $10,000 during the three months ended September 30, 2019 and 2018, respectively, and $30,000 during the nine months ended September 30, 2019 and 2018. As of September 30, 2019, total accrued interest is approximately $118,000. As of September 30, 2019, and December 31, 2018, the Company believes the fair value of the EB‑5 note approximates its carrying value due to the nature of the loan and the similarity between the interest rate on the Note and prevailing interest rates. Convertible Notes During the year ended December 31, 2018, the Company issued convertible notes (the “Notes”) to new and existing stockholders in the Company, including Notes in the aggregate principal amount of $3.35 million to members of the Board of Directors. As of September 30, 2019, all Notes had been converted and were no longer outstanding. At issuance, the following amounts were recorded: Fair Value of Note Fair Value of Change in Debt Carrying Principal Conversion Control Issuance Amount of Note Issuance Date Amount Feature Feature Costs the Note Maturity Date January 2018 $ 5,000,000 $ (2,579,074) $ (78,637) $ (35,969) $ 2,306,320 July 2019 June 2018 1,000,000 (714,041) (10,175) (3,000) 272,784 Dec. 2019 November 2018 1,150,400 — (21,127) (50,646) 1,078,627 May 2020 December 2018 150,000 — (2,857) (14,310) 132,833 May 2020 Total $ 7,300,400 $ (3,293,115) $ (112,796) $ (103,925) $ 3,790,564 During the nine months ended September 30, 2019, the Company issued additional Notes to new and existing stockholders in the Company, including a Note in the principal amount of $0.1 million to a member of the Board of Directors. At issuance, the following amounts were recorded: Fair Value of Note Fair Value of Change in Debt Carrying Principal Conversion Control Issuance Amount of Note Issuance Date Amount Feature Feature Costs the Note Maturity Date January 2019 $ 450,000 $ (172,227) $ (10,655) $ (29,358) $ 237,760 May 2020 February 2019 1,000,000 (284,448) (17,931) (55,875) 641,746 June 2020 Total $ 1,450,000 $ (456,675) $ (28,586) $ (85,233) $ 879,506 All Notes accrued interest at a rate of 5% per annum and had scheduled maturity dates on the eighteenth month anniversary of the date of the issuance of the Notes (the “Maturity Date”). If prior to the Maturity Date, there is a consummation of the sale of all or substantially all of the assets of the Company, change in control or event of default, the Notes become due and payable at an amount equal to 1.5 times the principal amount of the Notes together with all accrued interest (the “Change in Control Feature”). With regard to the Notes issued in January 2018 and June 2018, if the Company receives equity financing from the issuance of stock of the Company from an investor or group of investors in a transaction or series of related transactions resulting in gross proceeds to the Company of at least $15.0 million, including the conversion of outstanding indebtedness under these Notes, the principal amount and all interest accrued but not paid through the closing date of the qualified equity financing shall automatically convert into the same class of equity securities as those issued in the qualified equity financing at a price per share equal to a 30% discount to the lowest price per share being paid by investors in the qualified equity financing. With regard to the Notes issued in November 2018 and December 2018, if the Company receives equity financing from the issuance of stock of the Company from an investor or group of investors in a transaction or series of related transactions resulting in gross proceeds to the Company of at least $4.0 million, including the conversion of outstanding indebtedness under these Notes, the principal amount and all interest accrued but not paid through the closing date of the qualified equity financing shall automatically convert into the same class of equity securities as those issued in the qualified equity financing at a price per share equal to the lowest price per share being paid by investors in the qualified equity financing. With regard to the notes issued in January 2019 and February 2019, if the Company receives equity financing from the issuance of stock of the Company from an investor or group of investors in a transaction or series of related transactions resulting in gross proceeds to the Company of at least $10.0 million, including the conversion of outstanding indebtedness under these Notes, the principal amount and all interest accrued but not paid through the closing date of the qualified equity financing shall automatically convert into the same class of equity securities as those issued in the qualified equity financing at a price per share equal to a 15% discount to the lowest price per share being paid by investors in the qualified equity financing. The Company bifurcated the conversion feature upon a qualified equity financing for the January 2018, June 2018, January 2019, and February 2019 notes and classified it as a derivative liability because the conversion feature does not have a fixed conversion price and conversion will be settled in a variable number of shares of common stock. There is no bifurcated conversion feature for the November 2018 and December 2018 notes as there is no discount to the lowest equity price triggering conversion. The Company also bifurcated the Change in Control Feature for all of the Notes because it was determined to be a redemption feature not clearly and closely related to the debt host. The fair value of both of the embedded features was accounted for as a derivative liability and was recorded as a discount on the Notes. Inputs used in valuation are unobservable and therefore considered Level 3 in the fair value hierarchy. The debt discount is accreted into interest expense over the expected time until conversion of the Notes. The accretion amounted to zero and $0.9 million in the three months ended September 30, 2019 and 2018, and $0.5 million and $2.8 million, in the nine months ended September 30, 2019 and 2018, respectively. The fair value of the embedded features was classified as a liability in the Company’s condensed consolidated balance sheets at issuance, with subsequent changes in fair value during the three and nine months ended September 30, 2019 and 2018 recorded on the Company’s condensed consolidated statements of operations and comprehensive loss as a change in fair value of derivative liabilities. Change in Conversion Control feature feature Balance at January 1, 2019 $ 1,623,009 $ 118,213 Fair value at issuance — January 2019 notes 172,227 10,655 Fair value at issuance — February 2019 notes 284,448 17,931 Change in fair value of embedded derivatives 1,531,221 (146,799) Balance at April 5, 2019 $ 3,610,905 $ — The Company considered several possible outcomes in the likelihood and timing of a qualified equity financing and/or a change in control occurring that would trigger conversion or redemption and believes the amounts disclosed above based on inputs utilized in the valuation are the best estimates at each valuation date. As a result of the Subscription Agreement transaction (Note 8), the triggers for conversion were met for the Notes. On April 5, 2019, the Notes converted with a discount of 30%, which is consistent with the terms of the Notes issued in January 2018 and June 2018, but differs from the 0% discount per the terms of the November 2018, December 2018, January 2019, and February 2019 Notes and the 15% discount per the terms of the January 2019 and February 2019 Notes. The Notes were modified to change the discount percentage from 0% and 15% to 30% at the time of conversion. The Company issued 1,052,358 shares of common stock at 30% discount at $8.69 per share on the date of conversion to extinguish the debt, which resulted in a loss of $0.3 million. This non-cash transaction also resulted in an increase of $13.0 million in additional paid-in capital, which was based on the principal balance outstanding and the unpaid interest upon conversion. Convertible Promissory Notes On April 4, 2019, the Company issued the convertible promissory note (the “Promissory Note”) to existing stockholder for $900,000 at 5% interest rate per annum. As of September 30, 2019, the Promissory Note had been converted and was no longer outstanding. The Promissory Note matured at the earlier of (a) a sale of substantially all of the assets of the Company, (b) the consummation of a reorganization, merger; or consolidation of the Company with another entity or a person, (c) upon a change in control, or (d) July 30, 2019. The Promissory Note also provided the holder an option to convert the Promissory Note into common stock at a price per share equal to $12.41. The Company bifurcated the embedded redemption feature, which allows for redemption upon a change in control at 1.5 times principal and unpaid interest, as it was determined to be a redemption feature not clearly and closely related to the debt host. The redemption feature was classified it as a derivative liability and recognized at fair value. For purposes of estimating the fair market value of the derivative liability, the Company used a with and without model. The Company considered several possible outcomes in the likelihood and timing of and/or a change in control occurring that would trigger redemption and believes the amounts utilized in the valuation are the best estimates of such amounts at each valuation date. The possible outcomes are impacted by the Company’s current capital raising plans and its need for additional funding to continue its development efforts. The inputs used in valuation are unobservable and classified as Level 3 inputs in the fair value hierarchy. At issuance, the following amounts were recorded: Note Fair Value of Carrying Principal Redemption Amount of Note Issuance Date Amount Feature the Note Conversion Date April 2019 $ 900,000 $ (18,053) $ 881,947 May 2019 On May 16, 2019, the Promissory Note was converted into equity. Former Ocugen issued 73,315 shares of common stock at the conversion date to extinguish the debt at $12.41 per share. This non-cash transaction resulted in an increase of $0.9 million in additional paid-in capital, which was based on the principal balance outstanding and the unpaid interest upon conversion. Senior Secured Convertible Notes On May 21, 2019, the Company issued senior secured convertible notes to certain Investors for $2.4 million at an original issue discount of $0.5 million, and on June 28, 2019, the Company entered into an agreement to issue additional senior secured convertible notes to the Investors for $2.9 million with an original issue discount of $0.4 million (together “Senior Secured Notes”). The Senior Secured Notes were secured by the intellectual property of the Company. Immediately prior to the Merger completed on September 27, 2019, the Investors offset $5.3 million from the amount to be received under the Pre-Merger Financing and the Senior Secured Notes were deemed to have been repaid and cancelled. The holders also had an option to convert Senior Secured Notes into common stock at a price per share equal to $10.80 per share at any time after the issuance date. The conversion amount includes unpaid principal, interest and any late fees. The Company assessed the conversion feature and determined that the related value associated with the conversion feature was immaterial. The Company bifurcated the redemption feature, which allowed for redemption upon default at 1.35 times principal and unpaid interest, and classified it as a derivative liability recognized at fair value. For purposes of estimating the fair value of the embedded redemption feature, the Company used a with and without model. The inputs used in valuation are unobservable and are considered Level 3 fair value inputs, and include the likelihood and timing of a qualified financing and/or a default occurring that would trigger redemption. At issuance, the following amounts were recorded: Note Fair Value of Original Debt Carrying Principal Redemption Issue Issuance Amount of Note Issuance Date Amount Feature Discount Costs the Note Maturity Date May 2019 $ 2,415,000 $ (41,398) $ (465,000) $ (13,969) $ 1,894,633 Sept 2019 June 2019 2,875,000 (22,949) (375,000) — 2,477,051 Sept 2019 Total $ 5,290,000 $ (64,347) $ (840,000) $ (13,969) $ 4,371,684 The accretion of the original issue discount amounted to $0.7 million and $0.8 million during the three and nine months ended September 30, 2019, respectively. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2019 | |
Commitments | |
Commitments | 10. Commitments Operating Leases The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company has lease agreements which include lease and non-lease components, which the Company has elected to account for as a single lease component for all classes of underlying assets. Lease expense for variable lease components are recognized when the obligation is probable. Operating leases are included in other assets and lease obligations on the Company’s consolidated balance sheets. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Operating lease payments are recognized as lease expense on a straight-line basis over the lease term. The Company primarily leases buildings (real estate) which are classified as operating leases. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate is not readily determinable in the Company’s leases, the incremental borrowing rate is used based on the information available at commencement date in determining the present value of lease payments. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Options for lease renewals have been excluded from the lease term (and lease liability) for the majority of the Company’s leases as the reasonably certain threshold is not met. Lease payments included in the measurement of the lease liability are comprised of fixed payments, variable payments that depend on index or rate, and amounts probable to be payable under the exercise of the Company option to purchase the underlying asset if reasonably certain. Variable lease payments not dependent on a rate or index associated with the Company’s leases are recognized when the event, activity, or circumstance in the lease agreement on which those payments are assessed as probable. Variable lease payments are presented as operating expenses in the Company’s income statement in the same line item as expense arising from fixed lease payments. The Company has commitments under operating leases for certain facilities used in its operations. The Company’s leases have initial lease terms ranging from one to five years. Certain lease agreements contain provisions for future rent increases. The components of lease expense were as follows: Three Months Ended Nine Months Ended September 30, 2019 September 30, 2019 Operating lease cost $ 47,696 $ 202,665 Variable lease cost 21,284 58,163 Total lease cost $ 68,980 $ 260,828 Supplemental balance sheet information related to leases was as follows: September 30, 2019 Right-of-use assets, net $ 385,094 Current lease obligations $ 151,530 Non-current lease obligations 223,853 Total lease liabilities $ 375,383 Supplemental cash flow information and other information related to leases was as follows: Nine Months Ended September 30, 2019 Cash paid for amounts included in measurement of liabilities: Operating cash flows from operating leases $ 260,828 Right-of-use assets obtained in exchange for new operating liabilities $ 245,974 Weighted-average remaining lease terms—operating leases (years) 2.25 Weighted-average discount rate—operating leases 7.6 % Future minimum operating minimum lease payments for all leases, exclusive of taxes and other carrying charges, are approximately as follows: For the Years Ending December 31, Amount Remainder of 2019 $ 47,052 2020 191,555 2021 165,574 2022 22,707 Total $ 426,888 Less: present value adjustment Present value of minimum lease payments $ 375,383 The Company does not have any leases that have not yet commenced which are significant. Financing Leases In June 2018, the Company leased specialized research equipment under a lease classified as a financing lease. The leased equipment is amortized on a straight-line basis over five years. Total accumulated amortization related to the leased equipment is $15,954 at September 30, 2019, of which $3,191 and $9,573 were recognized in the three and nine months ended September 30, 2019. The following is a schedule showing the future minimum lease payments under financing leases by years and the present value of the minimum lease payments as of September 30, 2019. The interest rate related to the lease obligation is 7.6 percent and the maturity date is July 2021. Future minimum lease payments for all financing leases, exclusive of taxes and other carrying charges, are approximately as follows: For the Years Ending December 31, Amount Remainder of 2019 $ 5,964 2020 23,856 2021 11,929 Total $ 41,749 Less: present value adjustment (4,572) Present value of minimum lease payments $ 37,177 |
Pre-Merger Financing Warrants
Pre-Merger Financing Warrants | 9 Months Ended |
Sep. 30, 2019 | |
Pre-Merger Financing Warrants | |
Pre-Merger Financing Warrants | 11. Pre-Merger Financing Warrants On September 27, 2019, Ocugen completed the Merger with Former Ocugen. Immediately prior to the Merger, Ocugen and Former Ocugen completed a previously announced private placement transaction with certain Investors pursuant to the Financing SPA, whereby, among other things, (i) Former Ocugen issued to the Investors shares of Former Ocugen’s common stock, (ii) Former Ocugen issued and deposited additional shares of Former Ocugen’s common stock into escrow, and (iii) the Company agreed to issue on the fifth trading day following the consummation of the Merger, Series A Warrants, Series B Warrants, and Series C Warrants. The Pre-Merger Financing Warrants are subject to blocker provisions which restricts the exercise of the Pre-Merger Financing Warrants if, as a result of such exercise, the holder, together with its affiliates would beneficially own in excess of 4.99% or 9.99% of the outstanding common stock, including the common shares issuable upon such exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Merger Financing Warrants. If Ocugen fails to issue to a holder of the Pre-Merger Financing Warrants the number of shares of common stock to which such holder is entitled upon such holder's exercise of the such warrants, then Ocugen shall be obligated to pay the holder on each day while such failure is continuing an amount equal to 2.0% of the market value of the undelivered shares determined using any trading price of the common stock selected by the holder while the failure is continuing and if the holder purchases shares of common stock in connection with such failure, then Ocugen must, at the holder's discretion, reimburse the holder for the cost of such shares or deliver the owed shares and reimburse the holder for the difference between the price such holder paid for the shares and the market price of such shares, measured at any time of the holder's choosing while the delivery failure was continuing. Series A Warrants The Series A Warrants have an initial exercise price per share of $7.13, were exercisable upon issuance and have a term of 60 months from the date of issuance. The Series A Warrants are exercisable for an amount of Ocugen common stock up to the amount issuable upon consummation of the Merger in exchange for 200% of the sum of (i) the number of Converted Initial Shares and (ii) the number of Converted Additional Shares without giving effect to any limitation on delivery contained in the Finance SPA, purchased by the holder. The Series A Warrants have an anti-dilution adjustment whereby if Ocugen issues or sells, enters into a definitive, binding agreement pursuant to which Ocugen is required to issue or sell or is deemed, pursuant to the provisions of the Series A Warrants, to have issued or sold, any common stock for a price per share lower than the exercise price then in effect (a "Dilutive Issuance"), subject to certain limited exceptions, then (i) the exercise price of the Series A Warrants shall be reduced to such lower price per share and (ii) the number of shares issuable upon exercise of the Series A Warrants shall be increased to the number of shares of common stock determined by multiplying (a) the exercise price in effect immediately prior to such Dilutive Issuance by (b) the number of shares of common stock issuable upon exercise of the Series A Warrants immediately prior to such Dilutive Issuance (without giving effect to any limitation on exercise contained therein), and dividing the product thereof by the exercise price resulting from such Dilutive Issuance. Series B Warrants The Series B Warrants have an exercise price of $0.01, were exercisable upon issuance and will expire on the day following the later to occur of (i) the 45 th trading day immediately following the earlier to occur of (a) the first date on which the holders can sell all the shares issuable upon exercise of the Series A Warrants and Series B Warrants without restriction or limitation pursuant to Rule 144 under the Securities Act, and without the requirement to be in compliance with Rule 144(c)(1) and (b) October 4, 2020, and (ii) the date on which the Series B Warrants have been exercised in full (without giving effect to any limitation on exercise contained therein) and no shares remain issuable thereunder. The Series B Warrants will be initially exercisable by a holder for an amount of Ocugen common stock equal to the number (if positive) obtained by subtracting (i) the sum of (a) the number of Converted Initial Shares and (b) the number of Converted Additional Shares delivered or deliverable to the holder pursuant to the Financing SPA, from (ii) the quotient determined by dividing (a) the pro rata portion of the purchase price paid by such holder by (b) greater of (x) 80% of the sum of the volume-weighted average prices of a share of Ocugen common stock on the Nasdaq Capital Market (“Nasdaq”) for the first three trading days immediately following the closing date of the Pre-Merger Financing divided by three and (y) $1.00. Additionally, every ninth trading day up to and including the 45 th trading day (each, a "Reset Date") following (i) each date on which a registration statement registering any registrable securities for resale by a holder of Purchased Securities is declared effective and/or is available for use, (ii) if there is no effective registration statement that is available for use registering all of the shares issuable upon exercise of the Series A Warrants and the Series B Warrants, the earlier to occur of (a) the first date on which the holders can sell all the shares issuable upon exercise of the Series A Warrants and the Series B Warrants without restriction or limitation pursuant to Rule 144 under the Securities Act, and (b) April 4, 2020 (such earlier date, the "Six Month Reset Date") and (iii) in the event of a Public Information Failure (as defined in the Financing SPA) at any time following the Six Month Reset Date, then the earlier to occur of (a) the date the Public Information Failure is cured and no longer prevents the holder from selling all of the shares issuable upon exercise of the Series A Warrants and the Series B Warrants pursuant to Rule 144 without restriction or limitation, (b) the first date on which the holders can sell all the shares issuable upon exercise of the Series A Warrants and the Series B Warrants without restriction or limitation pursuant to Rule 144 under the Securities Act and without the requirement to be in compliance with Rule 144(c)(1), and (c) October 4, 2020 (such 45 trading day period, the "Reset Period" and each such 45 th trading day after (i), (ii), or (iii), the "End Reset Date"), the number of shares issuable upon exercise of the Series B Warrants shall be increased to the number (if positive) obtained by subtracting (i) the sum of (a) the number of Converted Initial Shares and (b) the number of Converted Additional Shares delivered or deliverable to the holder pursuant to the Securities Purchase Agreement, from (ii) the quotient determined by dividing (a) the pro rata portion of the purchase price paid by such holder, by (b) the greater of (y) 80% of the arithmetic average of the two lowest dollar volume-weighted average prices of a share of Ocugen common stock on Nasdaq during the applicable Reset Period immediately preceding the applicable Reset Date to date and (z) $1.00 (which amount shall not be adjusted for reverse stock splits or other similar events). Series C Warrants The Series C Warrants are exercisable upon issuance for up to 50.0 million shares of common stock at an exercise price of $7.13 per share and will expire upon the 45 th trading day immediately following the earlier to occur of (i) the date the holder can sell all shares issuable upon exercise of the Series C Warrants pursuant to Rule 144 without restriction or limitation and without the requirement to be in compliance with Rule 144(c)(1) and (ii) October 4, 2020, provided that if such date falls on a day other than a business day or on which trading does not take place on Nasdaq (a “Holiday”), the next day that is not a Holiday. If the volume-weighted average trading price of a share of Ocugen common stock on Nasdaq is less than or equal to $1.20 per share on any five trading days following the date of issuance and prior to the expiration date of the Series C Warrants, the holder may, in lieu of making any cash payment in connection with the exercise of the Series C Warrants, elect to receive a number of shares of common stock equal to the number of Series C Warrants. Subsequent to September 30, 2019, the Pre-Merger Financing Warrants were amended to, among other things, reduce the number of Series C Warrants from 50.0 million to 20.0 million. Accounting for the Pre-Merger Financing Warrants As of September 30, 2019, the Series A Warrants and Series C Warrants are classified as equity and the Series B Warrants are classified as a liability on the condensed consolidated balance sheet. The Series B Warrants are classified as a liability as they do not meet the derivative scope exception to be accounted for within stockholders’ equity. The Series B Warrants do not qualify for criteria related to equity indexation because the reset date is triggered based on effective date of the S-3 Registration Statement (as defined in Note 12) and the timing of when a registration statement for the underlying shares is available is not an input in an option pricing model. Series B Warrants were treated as a derivative liability in the condensed consolidated balance sheet, measured at fair value and marked to market each reporting period. The fair value of the Series B Warrants was calculated using Monte Carlo simulation while estimating the stock price during the 45-day reset period, based on the terms described within the Financing SPA. Key fair value inputs included the starting stock price, expected stock volatility during the 45-day reset period, and additional shares issued from escrow. The methodology for measuring fair value is sensitive to the expected stock volatility assumption input mentioned above. The volatility used in the fair value estimate was 96.0% and 97.0% as of September 27, 2019 and September 30, 2019, respectively. Inputs used in the valuation are unobservable and are therefore classified as Level 3 fair value inputs. The following table provides a reconciliation of Series B Warrant liability measured at fair value using Level 3 significant unobservable inputs: September 30, 2019 Balance at January 1, 2019 $ — Fair value at issuance — September 27, 2019 9,387,760 Change in fair value of embedded derivatives 18,577,226 Balance at September 30, 2019 $ 27,964,986 Although the Pre-Merger Financing Warrants were issued on October 4, 2019, the agreement for issuance of the Pre-Merger Financing Warrants was a firm commitment reached between Ocugen and the Investors as part of the Financing SPA upon the closing of the Merger. Therefore, the derivative liability related to the Series B Warrants was valued as of the date of the Merger and subsequently remeasured as of September 30, 2019. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Events Warrant Issuance The Series A, B, and C Warrants were issued on October 4, 2019 as follows: · The Series A Warrants were issued at an initial exercise price of $7.13, were immediately exercisable upon issuance. The Series A Warrants are exercisable for 8,771,928 common stock in the aggregate. · The Series B Warrants were issued at an exercise price of $0.01 and were immediately exercisable upon issuance. The Series B Warrants are initially exercisable for 8,007,461 common stock subject to adjustment based on reset provision in the warrant agreement. After factoring this initial issuance, the potential maximum additional warrants issuable under the Series B Warrants, during the reset period, is 12.6 million warrants. · The Series C Warrants were issued at an initial exercise price of $7.13, were immediately exercisable upon issuance. The Series C Warrants were exercisable for up to 50.0 million shares of common stock prior to the Warrant Amendments, as defined below. Issuance of Converted Additional Shares from Escrow On October 4, 2019, the Converted Additional Shares were released from escrow to the investors because, as determined at the close of business on October 2, 2019, 80% of the volume-weighted average trading price of a share of Ocugen’s common stock as quoted on Nasdaq for the first three trading days immediately following the closing date of the Pre-Merger Financing was lower than the price paid by the Investors for the Initial Shares. NeoCart ™ Intangible Asset Held for Sale As described in Note 4, Histogenics entered into the Asset Purchase Agreement with Medavate, the closing of which was subject to and conditioned upon the consummation of the Merger. On September 26, 2019, the parties entered into an amendment to the Asset Purchase Agreement whereby the closing date was amended to October 4, 2019. On October 4, 2019, the parties entered into the Second Amendment to the Asset Purchase Agreement whereby the purchase price was increased to $7.0 million under the Asset Purchase Agreement and the Closing Date of the Asset Purchase Agreement was revised from October 4, 2019 to two business days after Medavate obtains financing in an amount no less than the purchase price. The Second Amendment further provides that if the Closing Date does not occur on or prior to October 31, 2019, Ocugen may choose to terminate the Asset Purchase Agreement and, if Ocugen does not terminate the Asset Purchase Agreement, the purchase price shall increase 10% per month (or any portion thereof) between October 31, 2019 and the Closing Date. Ocugen has not terminated the Asset Purchase Agreement and as of November 1, 2019, the purchase price has increased to $7.7 million. Form S-3 Registration Statement Registration statement number 333-234127 filed on Form S-3 by Ocugen (the “Registration Statement”) became effective on November 5, 2019. The Registration Statement relates solely to the resale by certain investors listed therein (in the section titled “Selling Stockholders”), of up to 111,540,825 shares of the Company’s common stock. Share Repurchase On October 9, 2019, Ocugen announced that its Board of Directors unanimously approved a share repurchase program authorizing the repurchase of up to $2.0 million in value of the outstanding common stock. Pursuant to this repurchase program, Ocugen plans to repurchase the common stock provided that the timing, actual number and price per share of the common stock to be purchased will be subject to management discretion and board guidance, market conditions, applicable legal requirements, including Rule 10b-18 of the Exchange Act and various other factors. Warrant Amendments On November 5, 2019, the Company entered into an agreement with each Investor that amends the terms of each of the Pre-Merger Financing Warrants held by each such Investor (collectively, the “Warrant Amendments”). Pursuant to the Warrant Amendments, the Company and each Investor agreed, among other things, to the following: The Series C Warrants were amended such that they are exercisable, in the aggregate for up to 20 million shares of common stock. They had previously been exercisable for up to 50 million shares of common stock. Each of the Series C Warrants was also amended to permit the Investors, in lieu of making any cash payment otherwise contemplated to be made to the Company upon the exercise of the Series C Warrant, to elect instead to receive upon such exercise up to 20 million shares of common stock. Prior to the Warrant Amendments, the Series C Warrants had permitted the exercise without any cash payment of up to 50.0 million shares of common stock in the event that the volume weighted-average price of the common stock on Nasdaq was less than or equal to $1.20 per share on any five trading days following the issuance of the Series C Warrants. Each Series A Warrant was amended such that an equity financing involving a research or non-profit foundation or organization qualified under Section 501(c) of the Internal Revenue Code of 1986, as amended, in an amount of gross proceeds not to exceed $10,000,000 and closing on or prior to May 31, 2020, will be excluded from the anti-dilution adjustment, as set forth in the Series A Warrant. Concurrently with the effectiveness of the Warrant Amendments, the Investors exercised an aggregate of 3,797,329 Series C Warrants each for one share of common stock. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements included herein have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) and under the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim reporting. The accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, that are necessary to present fairly the Company’s financial position, results of operations, and cash flows. The condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and note 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 of Former Ocugen for the year ended December 31, 2018. The balance sheet data as of December 31, 2018 was derived from the Company’s audited financial statements for the year ended December 31, 2018. |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include the accounts of Ocugen, Inc. and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The assets and liabilities of the Company’s foreign subsidiary are translated into U.S. dollars based on exchange rates in effect at the end of each period. Revenues and expenses are translated at average exchange rates during the periods. Currency transaction gains or losses are included in other expenses. Gains or losses from balance sheet translation are included in accumulated other comprehensive income. |
Use of Estimates | Use of Estimates In preparing 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 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 valuation of share-based payment arrangements, warrants, and embedded conversion features on the convertible notes. |
Asset Held for Sale | Asset Held for Sale An asset is considered to be held for sale when all of the following criteria are met: (i) management commits to a plan to sell the asset; (ii) it is unlikely that the disposal plan will be significantly modified or discontinued; (iii) the asset is available for immediate sale in its present condition; (iv) actions required to complete the sale of the asset have been initiated; (v) sale of the asset is probable and the completed sale is expected to occur within one year; and (vi) the asset is actively being marketed for sale at a price that is reasonable given its current market value. A long-lived asset classified as held for sale is measured at the lower of its carrying amount or fair value less cost to sell. If the long-lived asset is newly acquired, the carrying amount of the long-lived asset is established based on its fair value less cost to sell at the acquisition date. A long-lived asset is not depreciated or amortized while it is classified as held for sale. As of September 30, 2019, Ocugen had an intangible asset held for sale acquired from Histogenics with a fair value less cost of sell of $7.0 million. See Notes 4 and 12 for additional information. |
Fair Value Measurements | Fair Value Measurements The company follows the provisions of the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements (“ASC 820”), which defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair measurements. The estimated fair value of certain financial instruments, cash and cash equivalents, accounts payable, and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 — quoted prices in active markets for identical assets or liabilities Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 — inputs that are unobservable (for example cash flow modeling inputs based on assumptions) The company has derivative instruments that are fair valued on a recurring basis using Level 3 inputs. |
Financial Instruments Indexed to and Potentially Settled in Common Stock | Financial Instruments Indexed to and Potentially Settled in Common Stock The Company accounts for warrants in accordance with ASC Topic 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”), which is the authoritative guidance on accounting for derivative financial instruments indexed to and potentially settled in a company’s own stock. To determine whether a contract is considered indexed to the issuer’s own equity, the Company performs a two-step analysis: Step 1 — Evaluate whether the contract contains any exercise contingencies and, if so, whether they disqualify the contract from being classified as equity, and Step 2 — Assess whether the settlement terms are consistent with equity classification. The Company classifies the liability-designated warrants on its condensed consolidated balance sheet as a derivative liability which is recognized at fair value at each reporting period subsequent to the initial issuance. Changes in the fair value of derivatives are recognized as other income (expense) in the condensed consolidated statements of operations and comprehensive loss. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and United States government and United States government agency obligations. The Company’s restricted cash balance consists of cash held to collateralize a corporate credit card account. The following table provides a reconciliation of cash, cash equivalents, and restricted cash in the condensed consolidated balance sheets to the total amount shown in the condensed consolidated statements of cash flows: As of September 30, 2019 2018 Cash, cash equivalents and restricted cash reconciliation: Cash and cash equivalents $ 15,301,082 $ 2,483,749 Restricted cash 150,910 150,328 Total cash, cash equivalents and restricted cash $ 15,451,992 $ 2,634,077 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies | |
Schedule of cash, cash equivalents, and restricted cash | As of September 30, 2019 2018 Cash, cash equivalents and restricted cash reconciliation: Cash and cash equivalents $ 15,301,082 $ 2,483,749 Restricted cash 150,910 150,328 Total cash, cash equivalents and restricted cash $ 15,451,992 $ 2,634,077 |
Merger and Financing (Tables)
Merger and Financing (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Merger and Financing | |
Summary of assets and liabilities to be sold pursuant to Asset Purchase Agreement | September 27, 2019 Cash and cash equivalents $ 291 Asset held for sale 7,000 Accounts payable (1,162) Net assets acquired $ 6,129 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Net Loss Per Share of Common Stock | |
Schedule of basic and diluted earnings per share of common stock | Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Net loss $ (22,773,281) $ (1,932,607) $ (32,624,697) $ (12,262,879) Weighted average shares of common stock outstanding 6,411,308 4,960,552 5,839,840 4,960,552 Net loss per shares of common stock—basic and diluted $ (3.55) $ (0.39) $ (5.59) $ (2.47) |
Schedule of potentially dilutive securities excluded from computation of diluted weighted average shares | Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Options to purchase common stock 500,933 473,647 500,933 473,647 Warrants (1) 870,020 870,020 870,020 870,020 Series A Warrants 8,771,928 — 8,771,928 — Series B Warrants (2) 8,007,461 — 8,007,461 — Series C Warrants 50,000,000 — 50,000,000 — Total 68,150,342 1,343,667 68,150,342 1,343,667 (1) With the exception of the application of the exchange rate of 0.4794 to the outstanding options and warrants, the terms and conditions related to the options and warrants existing prior to the Merger were not revised. (2) Warrants do not include additional Series B Warrants that are contingent upon reset pricing as discussed in Note 11. |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Balance Sheet Detail | |
Schedule of accrued expenses | September 30, December 31, 2019 2018 Accrued expenses: Research and development $ 60,315 $ 705,436 Clinical 243,461 469,473 Consulting 85,508 86,619 Employee-related 531,078 123,372 Legal 380,942 17,850 Total $ 1,301,304 $ 1,402,750 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Convertible Notes | |
Debt | |
Schedule of principal, imbedded derivatives and carrying value of debts | Fair Value of Note Fair Value of Change in Debt Carrying Principal Conversion Control Issuance Amount of Note Issuance Date Amount Feature Feature Costs the Note Maturity Date January 2018 $ 5,000,000 $ (2,579,074) $ (78,637) $ (35,969) $ 2,306,320 July 2019 June 2018 1,000,000 (714,041) (10,175) (3,000) 272,784 Dec. 2019 November 2018 1,150,400 — (21,127) (50,646) 1,078,627 May 2020 December 2018 150,000 — (2,857) (14,310) 132,833 May 2020 Total $ 7,300,400 $ (3,293,115) $ (112,796) $ (103,925) $ 3,790,564 Fair Value of Note Fair Value of Change in Debt Carrying Principal Conversion Control Issuance Amount of Note Issuance Date Amount Feature Feature Costs the Note Maturity Date January 2019 $ 450,000 $ (172,227) $ (10,655) $ (29,358) $ 237,760 May 2020 February 2019 1,000,000 (284,448) (17,931) (55,875) 641,746 June 2020 Total $ 1,450,000 $ (456,675) $ (28,586) $ (85,233) $ 879,506 |
Schedule of changes of embedded derivative of convertible notes | Change in Conversion Control feature feature Balance at January 1, 2019 $ 1,623,009 $ 118,213 Fair value at issuance — January 2019 notes 172,227 10,655 Fair value at issuance — February 2019 notes 284,448 17,931 Change in fair value of embedded derivatives 1,531,221 (146,799) Balance at April 5, 2019 $ 3,610,905 $ — |
Convertible Promissory Notes | |
Debt | |
Schedule of principal, imbedded derivatives and carrying value of debts | Note Fair Value of Carrying Principal Redemption Amount of Note Issuance Date Amount Feature the Note Conversion Date April 2019 $ 900,000 $ (18,053) $ 881,947 May 2019 |
Senior Secured Convertible Notes | |
Debt | |
Schedule of principal, imbedded derivatives and carrying value of debts | Note Fair Value of Original Debt Carrying Principal Redemption Issue Issuance Amount of Note Issuance Date Amount Feature Discount Costs the Note Maturity Date May 2019 $ 2,415,000 $ (41,398) $ (465,000) $ (13,969) $ 1,894,633 Sept 2019 June 2019 2,875,000 (22,949) (375,000) — 2,477,051 Sept 2019 Total $ 5,290,000 $ (64,347) $ (840,000) $ (13,969) $ 4,371,684 |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments | |
Schedule of components of lease expense | Three Months Ended Nine Months Ended September 30, 2019 September 30, 2019 Operating lease cost $ 47,696 $ 202,665 Variable lease cost 21,284 58,163 Total lease cost $ 68,980 $ 260,828 |
Schedule of supplemental balance sheet information related to leases | September 30, 2019 Right-of-use assets, net $ 385,094 Current lease obligations $ 151,530 Non-current lease obligations 223,853 Total lease liabilities $ 375,383 |
Supplemental cash flow information | Nine Months Ended September 30, 2019 Cash paid for amounts included in measurement of liabilities: Operating cash flows from operating leases $ 260,828 Right-of-use assets obtained in exchange for new operating liabilities $ 245,974 Weighted-average remaining lease terms—operating leases (years) 2.25 Weighted-average discount rate—operating leases 7.6 % |
Schedule of maturities of operating leases | For the Years Ending December 31, Amount Remainder of 2019 $ 47,052 2020 191,555 2021 165,574 2022 22,707 Total $ 426,888 Less: present value adjustment Present value of minimum lease payments $ 375,383 |
Schedule of maturities of finance leases | For the Years Ending December 31, Amount Remainder of 2019 $ 5,964 2020 23,856 2021 11,929 Total $ 41,749 Less: present value adjustment (4,572) Present value of minimum lease payments $ 37,177 |
Pre-Merger Financing Warrants (
Pre-Merger Financing Warrants (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Pre-Merger Financing Warrants | |
Schedule of reconciliation of Series B Warrant liability measured at fair value using Level 3 significant unobservable inputs | September 30, 2019 Balance at January 1, 2019 $ — Fair value at issuance — September 27, 2019 9,387,760 Change in fair value of embedded derivatives 18,577,226 Balance at September 30, 2019 $ 27,964,986 |
Nature of Business - Reverse St
Nature of Business - Reverse Stock Split (Details) - Histogenics | 9 Months Ended |
Sep. 30, 2019$ / shares | |
Nature of Business | |
Reverse stock split ratio | 0.0167 |
Shares issued exchange rate to former Ocugen's stockholders | $ 0.4794 |
Nature of Business - Going Conc
Nature of Business - Going Concern (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Nature of Business | ||||||||||
Net Loss | $ 22,773,281 | $ 3,538,810 | $ 6,312,606 | $ 1,932,607 | $ 5,291,246 | $ 5,039,026 | $ 32,624,697 | $ 12,262,879 | ||
Accumulated deficit | (63,861,891) | (63,861,891) | $ (31,237,194) | |||||||
Cash, cash equivalents and restricted cash | $ 15,451,992 | $ 2,634,077 | $ 15,451,992 | $ 2,634,077 | $ 1,778,613 | $ 6,301,572 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 |
Cash, cash equivalents and restricted cash reconciliation: | ||||
Asset held for sale | $ 7,000,000 | |||
Cash and cash equivalents | 15,301,082 | $ 1,628,136 | $ 2,483,749 | |
Restricted cash | 150,910 | 150,477 | 150,328 | |
Total cash, cash equivalents and restricted cash | $ 15,451,992 | $ 1,778,613 | $ 2,634,077 | $ 6,301,572 |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements (Details) - USD ($) | Sep. 30, 2019 | Jan. 01, 2019 |
RECENT ACCOUNTING PRONOUNCEMENTS | ||
Right-of-use assets, net | $ 385,094 | |
Lease liability | $ 375,383 | |
Accounting Standards Update 2016-02 | ||
RECENT ACCOUNTING PRONOUNCEMENTS | ||
Right-of-use assets, net | $ 400,000 | |
Lease liability | $ 400,000 |
Merger and Financing - Pre-Merg
Merger and Financing - Pre-Merger Financing (Details) - USD ($) | Sep. 30, 2019 | Sep. 27, 2019 | Sep. 07, 2019 | Jun. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 |
Reverse Merger and Financing | ||||||
Repayment of senior secured notes | $ 5,300,000 | |||||
Equity issuance costs paid in cash | $ 649,254 | $ 741,178 | ||||
Series A warrants And Series C warrants | ||||||
Reverse Merger and Financing | ||||||
Equity issuance cost | $ 1,000,000 | |||||
Series B Warrants | ||||||
Reverse Merger and Financing | ||||||
Equity issuance cost | 800,000 | |||||
Financing SPA | ||||||
Reverse Merger and Financing | ||||||
Number of shares agreed to issue immediately prior to the merger | 4,574,272 | |||||
Number of converted initial shares, agreed to be issued | 2,200,000 | |||||
Number of shares in the form of escrow agreed to issue immediately prior to the merger | 4,574,272 | |||||
Number of converted additional shares in the form of escrow agreed to issue immediately prior to the merger | 2,200,000 | |||||
Aggregate purchase price | $ 25,000,000 | |||||
Acquisition cost incurred | 2,500,000 | |||||
Proceeds from Warrant Exercises | $ 25,000,000 | |||||
Net proceeds from pre-merger financing | $ 17,200,000 | |||||
Equity issuance cost | 1,800,000 | |||||
Equity issuance costs paid in cash | 600,000 | |||||
Equity issuance costs paid with equity | $ 1,200,000 |
Merger and Financing - Equity O
Merger and Financing - Equity Ownership Held (Details) - Histogenics | Sep. 27, 2019 |
Former Ocugen equity holders | |
Reverse Merger and Financing | |
Ownership (as a percent) | 84.25% |
Stockholders of Histogenics immediately before the Merger | |
Reverse Merger and Financing | |
Ownership (as a percent) | 15.75% |
Merger and Financing - Merger w
Merger and Financing - Merger with Histogenics (Details) - USD ($) | Oct. 31, 2019 | Oct. 04, 2019 | Sep. 30, 2019 | May 08, 2019 | Jan. 31, 2018 | Sep. 27, 2019 | Dec. 31, 2018 | Sep. 30, 2018 |
Merger and Financing | ||||||||
Cash and cash equivalents | $ 15,301,082 | $ 1,628,136 | $ 2,483,749 | |||||
Accounts payable | (5,791,298) | $ (3,277,525) | ||||||
Level 2 | ||||||||
Merger and Financing | ||||||||
Quoted price of assets held for sale of NeoCart | 7,000,000 | |||||||
Histogenics | ||||||||
Merger and Financing | ||||||||
Acquisition cost incurred | 5,000,000 | |||||||
Acquisition cost paid in cash | 2,300,000 | |||||||
Acquisition cost paid with equity | $ 2,300,000 | |||||||
Cash and cash equivalents | $ 291,000 | |||||||
Asset held for sale | 7,000,000 | |||||||
Accounts payable | (1,162,000) | |||||||
Net assets acquired | $ 6,129,000 | |||||||
Asset purchase agreement, cash consideration | $ 7,000,000 | $ 6,500,000 | ||||||
Percentage of Increase In Purchase Price Of Asset Per Month | 10.00% | |||||||
Histogenics | ||||||||
Merger and Financing | ||||||||
Upfront cash payment received for license granted to MEDINET | $ 10,000,000 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share | ||||||||
Net loss | $ (22,773,281) | $ (3,538,810) | $ (6,312,606) | $ (1,932,607) | $ (5,291,246) | $ (5,039,026) | $ (32,624,697) | $ (12,262,879) |
Weighted average shares of common stock outstanding | 6,411,308 | 4,960,552 | 5,839,840 | 4,960,552 | ||||
Net loss per shares of common stock-basic and diluted | $ (3.55) | $ (0.39) | $ (5.59) | $ (2.47) | ||||
Potentially dilutive securities | ||||||||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 68,150,342 | 1,343,667 | 68,150,342 | 1,343,667 | ||||
Options to purchase Common Stock | ||||||||
Potentially dilutive securities | ||||||||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 500,933 | 473,647 | 500,933 | 473,647 | ||||
Warrants | ||||||||
Potentially dilutive securities | ||||||||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 870,020 | 870,020 | 870,020 | 870,020 | ||||
Exchange rate per share | $ 0.4794 | $ 0.4794 | $ 0.4794 | $ 0.4794 | ||||
Series A Warrants | ||||||||
Potentially dilutive securities | ||||||||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 8,771,928 | 8,771,928 | ||||||
Series B Warrants | ||||||||
Potentially dilutive securities | ||||||||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 8,007,461 | 8,007,461 | ||||||
Series C Warrants | ||||||||
Potentially dilutive securities | ||||||||
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares outstanding | 50,000,000 | 50,000,000 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - Collaboration Agreement with CanSino Biologics | Sep. 27, 2019 |
License agreements: | |
Term (in years) | 10 years |
Period within with Cansino to provide development cost statement | 45 days |
Period within which to reimburse Cansino of development costs | 1 year |
Balance Sheet Detail (Details)
Balance Sheet Detail (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Balance Sheet Detail | ||
Research and development | $ 60,315 | $ 705,436 |
Clinical | 243,461 | 469,473 |
Consulting | 85,508 | 86,619 |
Employee-related | 531,078 | 123,372 |
Legal | 380,942 | 17,850 |
Total | $ 1,301,304 | $ 1,402,750 |
Equity Transactions (Details)
Equity Transactions (Details) - USD ($) | Apr. 05, 2019 | Dec. 13, 2018 | Sep. 30, 2019 |
Equity transactions | |||
Proceeds from stock subscription | $ 999,832 | ||
Existing investors - Subscription Agreement | |||
Equity transactions | |||
Shares issued (in shares) | 80,572 | ||
Proceeds from stock subscription | $ 1,000,000 | ||
Price per share | $ 12.41 | ||
Financial advisor - Service Agreement | |||
Equity transactions | |||
Shares issued (in shares) | 77,171 | ||
Sale of stock, consideration received | $ 1,000,000 | ||
Price per share | $ 12.41 |
Debt - EB 5 LOAN (Details)
Debt - EB 5 LOAN (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 4 Months Ended | 9 Months Ended | |||
Dec. 31, 2016 | Sep. 30, 2016 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2016 | Sep. 30, 2019 | Sep. 30, 2018 | |
Debt | |||||||
Issuance costs | $ 122,262 | ||||||
EB-5 Loan | |||||||
Debt | |||||||
Maximum borrowing | $ 10,000,000 | ||||||
Borrowing increments | $ 500,000 | ||||||
Interest rate (as a percent) | 4.00% | ||||||
Amount borrowed | $ 500,000 | $ 500,000 | |||||
Issuance costs | $ 103,887 | ||||||
Amortization of debt issuance costs | $ 3,710 | $ 3,710 | 11,131 | $ 11,131 | |||
Principal outstanding | 1,000,000 | 1,000,000 | |||||
Accrued interest | 10,000 | $ 10,000 | 30,000 | $ 30,000 | |||
Total accrued interest | $ 118,000 | $ 118,000 |
Debt - Convertible Notes (Detai
Debt - Convertible Notes (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Apr. 05, 2019USD ($) | Feb. 28, 2019USD ($) | Jan. 31, 2019USD ($) | Nov. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Jan. 31, 2018USD ($) | |
Convertible Debt, Conversion Feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (1,623,009) | $ (3,610,905) | |||||||||
Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | (118,213) | ||||||||||
Convertible Notes | |||||||||||
Debt | |||||||||||
Note principal amount | 7,300,400 | $ 1,450,000 | |||||||||
Note principal outstanding | $ 0 | $ 0 | |||||||||
Debt issuance costs | (103,925) | (85,233) | |||||||||
Carrying amount | $ 3,790,564 | 879,506 | |||||||||
Interest rate (as a percent) | 5.00% | 5.00% | 5.00% | ||||||||
Maturity term (in months) | 18 months | 18 months | |||||||||
Redemption multiple upon default | 1.5 | 1.5 | 1.5 | ||||||||
Accretion of debt discount | $ 0 | $ 900,000 | $ 500,000 | $ 2,800,000 | |||||||
Convertible Notes | Convertible Debt, Conversion Feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (3,293,115) | (456,675) | |||||||||
Convertible Notes | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | (112,796) | (28,586) | |||||||||
Convertible Notes | Board members | |||||||||||
Debt | |||||||||||
Note principal amount | $ 100,000 | $ 100,000 | 3,350,000 | ||||||||
Convertible Note - January 2018 | |||||||||||
Debt | |||||||||||
Note principal amount | $ 5,000,000 | ||||||||||
Debt issuance costs | (35,969) | ||||||||||
Carrying amount | 2,306,320 | ||||||||||
Equity financing proceeds that triggers conversion | $ 10,000,000 | $ 15,000,000 | |||||||||
Conversion price discount per original agreement (as a percent) | 15.00% | 30.00% | |||||||||
Convertible Note - January 2018 | Convertible Debt, Conversion Feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (2,579,074) | ||||||||||
Convertible Note - January 2018 | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (78,637) | ||||||||||
Convertible Note - June 2018 | |||||||||||
Debt | |||||||||||
Note principal amount | $ 1,000,000 | ||||||||||
Debt issuance costs | (3,000) | ||||||||||
Carrying amount | 272,784 | ||||||||||
Equity financing proceeds that triggers conversion | $ 15,000,000 | ||||||||||
Conversion price discount per original agreement (as a percent) | 30.00% | ||||||||||
Convertible Note - June 2018 | Convertible Debt, Conversion Feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (714,041) | ||||||||||
Convertible Note - June 2018 | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (10,175) | ||||||||||
Convertible Note - November 2018 | |||||||||||
Debt | |||||||||||
Note principal amount | $ 1,150,400 | ||||||||||
Debt issuance costs | (50,646) | ||||||||||
Carrying amount | 1,078,627 | ||||||||||
Equity financing proceeds that triggers conversion | $ 4,000,000 | ||||||||||
Conversion price discount per original agreement (as a percent) | 0.00% | ||||||||||
Convertible Note - November 2018 | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (21,127) | ||||||||||
Convertible Note - December 2018 | |||||||||||
Debt | |||||||||||
Note principal amount | 150,000 | ||||||||||
Debt issuance costs | (14,310) | ||||||||||
Carrying amount | 132,833 | ||||||||||
Equity financing proceeds that triggers conversion | $ 4,000,000 | ||||||||||
Conversion price discount per original agreement (as a percent) | 0.00% | ||||||||||
Convertible Note - December 2018 | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (2,857) | ||||||||||
Convertible Note - January 2019 | |||||||||||
Debt | |||||||||||
Note principal amount | $ 450,000 | ||||||||||
Debt issuance costs | (29,358) | ||||||||||
Carrying amount | 237,760 | ||||||||||
Convertible Note - January 2019 | Convertible Debt, Conversion Feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | (172,227) | ||||||||||
Convertible Note - January 2019 | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (10,655) | ||||||||||
Convertible Note - February 2019 | |||||||||||
Debt | |||||||||||
Note principal amount | 1,000,000 | ||||||||||
Debt issuance costs | (55,875) | ||||||||||
Carrying amount | 641,746 | ||||||||||
Equity financing proceeds that triggers conversion | $ 10,000,000 | ||||||||||
Conversion price discount per original agreement (as a percent) | 15.00% | 15.00% | |||||||||
Convertible Note - February 2019 | Convertible Debt, Conversion Feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (284,448) | ||||||||||
Convertible Note - February 2019 | Change in Control feature | |||||||||||
Debt | |||||||||||
Fair value of embedded derivative | $ (17,931) |
Debt - Convertible Notes Deriva
Debt - Convertible Notes Derivative Liability Activity (Details) | 3 Months Ended |
Apr. 05, 2019USD ($) | |
Convertible Debt, Conversion Feature | |
Debt | |
Fair value of embedded derivative | $ 1,623,009 |
Change in fair value of embedded derivatives | 1,531,221 |
Fair value of embedded derivative | 3,610,905 |
Change in Control feature | |
Debt | |
Fair value of embedded derivative | 118,213 |
Change in fair value of embedded derivatives | (146,799) |
Convertible Note - January 2019 | Convertible Debt, Conversion Feature | |
Debt | |
Fair value at issuance | 172,227 |
Convertible Note - January 2019 | Change in Control feature | |
Debt | |
Fair value at issuance | 10,655 |
Convertible Note - February 2019 | Convertible Debt, Conversion Feature | |
Debt | |
Fair value at issuance | 284,448 |
Convertible Note - February 2019 | Change in Control feature | |
Debt | |
Fair value at issuance | $ 17,931 |
Debt - Convertible Notes Other
Debt - Convertible Notes Other Information (Details) - USD ($) $ / shares in Units, $ in Millions | Apr. 05, 2019 | Feb. 28, 2019 | Jan. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | Jun. 30, 2018 | Jan. 31, 2018 |
Convertible Notes | |||||||
Debt | |||||||
Actual conversion price discount per revised agreement (as a percent) | 30.00% | ||||||
Common stock issued upon conversion | 1,052,358 | ||||||
Conversion price per share (USD per share) | $ 8.69 | ||||||
Extinguishment of debt loss | $ 0.3 | ||||||
Increase in Additional paid-in capital from conversion | $ 13 | ||||||
Convertible Note - January 2018 | |||||||
Debt | |||||||
Conversion price discount per original agreement (as a percent) | 15.00% | 30.00% | |||||
Convertible Note - June 2018 | |||||||
Debt | |||||||
Conversion price discount per original agreement (as a percent) | 30.00% | ||||||
Convertible Note - November 2018 | |||||||
Debt | |||||||
Conversion price discount per original agreement (as a percent) | 0.00% | ||||||
Convertible Note - December 2018 | |||||||
Debt | |||||||
Conversion price discount per original agreement (as a percent) | 0.00% | ||||||
Convertible Note - February 2019 | |||||||
Debt | |||||||
Conversion price discount per original agreement (as a percent) | 15.00% | 15.00% |
Debt - Convertible Promissory N
Debt - Convertible Promissory Notes (Details) - Convertible Promissory Notes | Apr. 04, 2019USD ($)$ / shares | May 15, 2019$ / shares |
Debt | ||
Amount borrowed | $ | $ 900,000 | |
Interest rate (as a percent) | 5.00% | |
Conversion price per share (USD per share) | $ / shares | $ 12.41 | $ 12.41 |
Redemption multiple upon default | 1.5 |
Debt - Convertible Promissory_2
Debt - Convertible Promissory Notes - Table (Details) - USD ($) | May 15, 2019 | Apr. 04, 2019 | Dec. 31, 2018 |
Debt | |||
Carrying amount | $ 7,483,847 | ||
Convertible Promissory Notes | |||
Debt | |||
Note principal amount | $ 900,000 | ||
Carrying amount | $ 881,947 | ||
Common stock issued upon conversion | 73,315 | ||
Conversion price per share (USD per share) | $ 12.41 | $ 12.41 | |
Increase in Additional paid-in capital from conversion | $ 900,000 | ||
Convertible Promissory Notes | Embedded Redemption Feature | |||
Debt | |||
Fair value of embedded derivative | $ (18,053) |
Debt - Senior Secured Convertib
Debt - Senior Secured Convertible Notes (Details) - Senior Secured Convertible Notes | May 28, 2019USD ($) | May 21, 2019USD ($)$ / shares | Sep. 27, 2019USD ($) | Jun. 30, 2019USD ($) |
Debt | ||||
Amount borrowed | $ 2,900,000 | $ 2,400,000 | ||
Issued discount | $ 400,000 | $ 500,000 | $ 840,000 | |
Amount that will offset from the remaining amount to be received from the investors | $ 5,300,000 | |||
Conversion price per share (USD per share) | $ / shares | $ 10.80 | |||
Redemption multiple upon default | 1.35 | |||
Embedded Redemption Feature | ||||
Debt | ||||
Fair value of embedded derivative | $ 64,347 |
Debt - Senior Secured Convert_2
Debt - Senior Secured Convertible Notes - Table (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Jun. 28, 2019 | May 28, 2019 | May 21, 2019 | Dec. 31, 2018 | |
Debt | |||||||
Carrying amount | $ 7,483,847 | ||||||
Senior Secured Convertible Notes | |||||||
Debt | |||||||
Note principal amount | $ 5,290,000 | ||||||
Original Issue Discount | (840,000) | $ (400,000) | $ (500,000) | ||||
Debt issuance costs | (13,969) | ||||||
Carrying amount | 4,371,684 | ||||||
Accretion of the original issue discount | $ 700,000 | $ 800,000 | |||||
Senior Secured Convertible Notes | Embedded Redemption Feature | |||||||
Debt | |||||||
Fair value of embedded derivative | $ (64,347) | ||||||
Senior Secured Convertible Notes - May 2019 | |||||||
Debt | |||||||
Note principal amount | 2,415,000 | ||||||
Original Issue Discount | (465,000) | ||||||
Debt issuance costs | (13,969) | ||||||
Carrying amount | 1,894,633 | ||||||
Senior Secured Convertible Notes - May 2019 | Embedded Redemption Feature | |||||||
Debt | |||||||
Fair value of embedded derivative | $ (41,398) | ||||||
Senior Secured Convertible Notes - June 2019 | |||||||
Debt | |||||||
Note principal amount | $ 2,875,000 | ||||||
Original Issue Discount | (375,000) | ||||||
Carrying amount | 2,477,051 | ||||||
Senior Secured Convertible Notes - June 2019 | Embedded Redemption Feature | |||||||
Debt | |||||||
Fair value of embedded derivative | $ (22,949) |
Commitments (Details)
Commitments (Details) | Sep. 30, 2019 |
Minimum | |
Leases | |
Leases, term of contract (in years) | 1 year |
Maximum | |
Leases | |
Leases, term of contract (in years) | 5 years |
Commitments - Operating leases,
Commitments - Operating leases, components of lease expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Commitments | ||
Operating lease cost | $ 47,696 | $ 202,665 |
Variable lease cost | 21,284 | 58,163 |
Total lease cost | $ 68,980 | $ 260,828 |
Commitments - Operating lease_2
Commitments - Operating leases, supplemental balance sheet information (Details) | Sep. 30, 2019USD ($) |
Commitments | |
Right-of-use assets, net | $ 385,094 |
Current lease obligations | 151,530 |
Non-current lease obligations | 223,853 |
Present value of minimum lease payments | $ 375,383 |
Commitments - Operating lease_3
Commitments - Operating leases, supplemental cash flow information (Details) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Commitments | |
Operating cash flows from operating leases | $ 260,828 |
Right-of-use assets obtained in exchange for new operating liabilities | $ 245,974 |
Weighted-average remaining lease terms-operating leases (years) | 2 years 3 months |
Weighted-average discount rate-operating leases | 7.60% |
Commitments - Operating lease_4
Commitments - Operating leases, future minimum lease payments (Details) | Sep. 30, 2019USD ($) |
Commitments | |
Remainder of 2019 | $ 47,052 |
2020 | 191,555 |
2021 | 165,574 |
2022 | 22,707 |
Total | 426,888 |
Less: present value adjustment | (51,505) |
Present value of minimum lease payments | $ 375,383 |
Commitments - Finance leases (D
Commitments - Finance leases (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Finance leases | ||
Finance lease, term (in years) | 5 years | 5 years |
Finance Lease, Amortization | $ 3,191 | $ 9,573 |
Interest rate (as a percent) | 7.60% | 7.60% |
Specialized research equipment | ||
Finance leases | ||
Accumulated amortization | $ 15,954 | $ 15,954 |
Commitments - Finance leases, f
Commitments - Finance leases, future minimum lease payments (Details) | Sep. 30, 2019USD ($) |
Commitments | |
Remainder of 2019 | $ 5,964 |
2020 | 23,856 |
2021 | 11,929 |
Total | 41,749 |
Less: present value adjustment | (4,572) |
Present value of minimum lease payments | $ 37,177 |
Pre-Merger Financing Warrants_2
Pre-Merger Financing Warrants (Details) $ / shares in Units, shares in Millions | Sep. 27, 2019DUSD ($)$ / sharesshares | Sep. 30, 2019USD ($)shares | Oct. 01, 2019shares |
Pre-Merger Financing Warrants | |||
Class Of Warrant Or Rights, Issuance, Number Of Trading Days After The Consummation Of Merger | D | 5 | ||
Percentage of excess common stock on pre-merger financing warrants exercised one | 4.99% | ||
Percentage of excess common stock on pre-merger financing warrants exercised two | 9.99% | ||
Percentage of amount on market value for failure to issue common stock on pre-merger financing warrants | 2.00% | ||
Warrants Expiration, trading day | D | 45 | ||
Price Volatility | |||
Pre-Merger Financing Warrants | |||
Warrants fair value estimate volatility | 96 | 97 | |
Series A Warrants | |||
Pre-Merger Financing Warrants | |||
Initial exercise price | $ 7.13 | ||
Term of the warrants | 60 months | ||
Percentage of volume-weighted average trading price of a share of common stock that triggered release od converted additional shares | 200.00% | ||
Series B Warrants | |||
Pre-Merger Financing Warrants | |||
Initial exercise price | $ 0.01 | ||
Percentage of volume-weighted average trading price of a share of common stock that triggered release od converted additional shares | 80.00% | ||
Price over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | $ 1 | ||
Period over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | 3 days | ||
Warrants, exercise price determination, dividing factor | $ | 3 | ||
Warrants Expiration, trading day | D | 45 | ||
Reconciliation of Series B Warrant liability | |||
Fair value at issuance | $ | $ 9,387,760 | ||
Change in fair value of embedded derivatives | $ | 18,577,226 | ||
Balance at end | $ | $ 27,964,986 | ||
Series C Warrants | |||
Pre-Merger Financing Warrants | |||
Initial exercise price | $ 7.13 | ||
Price over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | $ 1.20 | ||
Number of common shares in to which the warrants are exercisable | shares | 50 | ||
Warrants, exercise price determination, number of trading days | D | 5 | ||
Number of warrants outstanding | shares | 50 | 20 |
Subsequent - Issuance Of Warran
Subsequent - Issuance Of Warrants (Details) - $ / shares | Nov. 05, 2019 | Oct. 04, 2019 | Sep. 27, 2019 |
Series A Warrants | |||
Subsequent Events | |||
Initial exercise price | $ 7.13 | ||
Term of the warrants | 60 months | ||
Percentage of volume-weighted average trading price of a share of common stock that triggered release od converted additional shares | 200.00% | ||
Series B Warrants | |||
Subsequent Events | |||
Initial exercise price | $ 0.01 | ||
Percentage of volume-weighted average trading price of a share of common stock that triggered release od converted additional shares | 80.00% | ||
Period over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | 3 days | ||
Series C Warrants | |||
Subsequent Events | |||
Initial exercise price | $ 7.13 | ||
Number of common shares in to which the warrants are exercisable | 50,000,000 | ||
Subsequent events | |||
Subsequent Events | |||
Percentage of volume-weighted average trading price of a share of common stock that triggered release od converted additional shares | 80.00% | ||
Period over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | 3 days | ||
Subsequent events | Series A Warrants | |||
Subsequent Events | |||
Initial exercise price | $ 7.13 | ||
Number of common shares in to which the warrants are exercisable | 8,771,928 | ||
Subsequent events | Series B Warrants | |||
Subsequent Events | |||
Initial exercise price | $ 0.01 | ||
Number of common shares in to which the warrants are exercisable | 8,007,461 | ||
Maximum additional warrants issuable | 12.6 | ||
Subsequent events | Series C Warrants | |||
Subsequent Events | |||
Initial exercise price | $ 7.13 | ||
Number of common shares in to which the warrants are exercisable | 50,000,000 | ||
Period over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | 5 days |
Subsequent Events - NeoCart Int
Subsequent Events - NeoCart Intangible Asset Held for Sale (Details) - Subsequent events - Histogenics - USD ($) $ in Millions | Nov. 01, 2019 | Oct. 31, 2019 | Oct. 04, 2019 |
Subsequent Events | |||
Asset Purchase Agreement, cash consideration | $ 7.7 | $ 7 | |
Percentage of increase in purchase price of asset per month | 10.00% |
Subsequent Events - Form S-3 Re
Subsequent Events - Form S-3 Registration Statement and Share Repurchase (Details) - USD ($) | Nov. 05, 2019 | Oct. 04, 2019 | Sep. 27, 2019 | Nov. 04, 2019 | Oct. 09, 2019 |
Subsequent events | |||||
Subsequent Events | |||||
Period over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | 3 days | ||||
Subsequent events | Maximum | |||||
Subsequent Events | |||||
Common stock, Shares to be sold by selling shareholders | 111,540,825 | ||||
Share repurchase program, Authorized amount | $ 2,000,000 | ||||
Series A Warrants | Subsequent events | |||||
Subsequent Events | |||||
Number of common shares in to which the warrants are exercisable | 8,771,928 | ||||
Series A Warrants | Subsequent events | Maximum | |||||
Subsequent Events | |||||
Gross proceeds on issue of warrants | $ 10,000,000 | ||||
Series C Warrants | |||||
Subsequent Events | |||||
Number of common shares in to which the warrants are exercisable | 50,000,000 | ||||
Price over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | $ 1.20 | ||||
Series C Warrants | Subsequent events | |||||
Subsequent Events | |||||
Number of common shares in to which the warrants are exercisable | 50,000,000 | ||||
Price over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | $ 1.20 | ||||
Period over which trading price of common stock as quoted on the Nasdaq Capital Market was considered for the release of converted additional shares | 5 days | ||||
Number of warrants exercised | 3,797,329 | ||||
Number of common stock issued for each warrant | 1 | ||||
Series C Warrants | Subsequent events | Maximum | |||||
Subsequent Events | |||||
Number of common shares in to which the warrants are exercisable | 20,000,000 | 50,000,000 |