Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Apr. 13, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity File Number | 001-36672 | ||
Entity Registrant Name | KIORA PHARMACEUTICALS, INC | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 98-0443284 | ||
Entity Address, Address Line One | 1371 East 2100 South | ||
Entity Address, Address Line Two | Suite 200 | ||
Entity Address, City or Town | Salt Lake City | ||
Entity Address, State or Province | UT | ||
Entity Address, Postal Zip Code | 84105 | ||
City Area Code | 781 | ||
Local Phone Number | 788-8869 | ||
Title of 12(b) Security | Common Stock, $0.01 par value | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Trading Symbol | KPRX | ||
Entity Public Float | $ 45,594,207 | ||
Entity Common Stock, Shares Outstanding | 12,663,965 | ||
Entity Central Index Key | 0001372514 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | EISNERAMPER LLP | ||
Auditor Firm ID | 274 | ||
Auditor Location | New York |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and Cash Equivalents | $ 7,854,690 | $ 1,185,677 |
Prepaid Expenses and Other Current Assets | 606,520 | 449,569 |
Other Receivables | 529,560 | 90,975 |
Total Current Assets | 8,990,770 | 1,726,221 |
Property and Equipment, Net | 73,999 | 30,566 |
Restricted Cash | 45,000 | 45,000 |
Goodwill | 0 | 3,484,607 |
Intangible Assets and In-Process R&D, Net | 8,695,850 | 9,730,164 |
Operating Lease Assets with Right-of-Use | 209,411 | 83,928 |
Other Assets | 42,964 | 57,073 |
Total Assets | 18,057,994 | 15,157,559 |
Current Liabilities: | ||
Accounts Payable | 160,621 | 434,763 |
Accrued Expenses | 1,330,141 | 1,289,261 |
Operating Lease Liabilities | 118,846 | 48,303 |
Total Current Liabilities | 1,609,608 | 1,772,327 |
Non-Current Liabilities: | ||
Contingent Consideration | 6,518,770 | 5,342,950 |
Deferred Tax Liability | 614,436 | 728,926 |
Paycheck Protection Program Loan | 278,190 | |
Non-Current Operating Lease Liabilities | 90,566 | 35,625 |
Total Non-Current Liabilities | 7,223,772 | 6,385,691 |
Total Liabilities | 8,833,380 | 8,158,018 |
Commitments and Contingencies (Note 11) | ||
Stockholders' Equity: | ||
Preferred Stock, $0.01 Par Value: 10,000,000 shares authorized at December 31, 2021 and 2020; 3,750 designated Series A, 0 shares issued and outstanding at December 31, 2021 and 2020, 10,000 designated Series B, 0 shares issued and outstanding at December 31, 2021 and 2020; 10,000 shares designated Series C, 0 shares issued and outstanding at December 31, 2021 and 2020, 20,000 shares designated Series D, 7 and 41,386 shares issued and outstanding at December 31, 2021 and 2020, respectively | 41 | |
Common Stock, $0.01 Par Value: 50,000,000 shares authorized at December 31, 2021 and 2020; 12,663,965 and 5,556,394 shares issued and outstanding at December 31, 2021 and 2020, respectively | 126,640 | 55,564 |
Additional Paid-In Capital | 133,918,158 | 115,283,572 |
Accumulated Deficit | (124,733,753) | (108,338,834) |
Accumulated Other Comprehensive Income | (86,431) | (802) |
Total Stockholders' Equity | 9,224,614 | 6,999,541 |
Total Liabilities and Stockholders' Equity | $ 18,057,994 | $ 15,157,559 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Common Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Common Stock, Shares Authorized | 50,000,000 | 50,000,000 |
Common Stock, Shares, Issued | 12,663,965 | 5,556,394 |
Common Stock, Shares, Outstanding | 12,663,965 | 5,556,394 |
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Series A Preferred Stock | ||
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Preferred Stock Designated Shares | 3,750 | 3,750 |
Series B Preferred Stock | ||
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Preferred Stock Designated Shares | 10,000 | 10,000 |
Series C Preferred Stock | ||
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Preferred Stock Designated Shares | 10,000 | 10,000 |
Series D Preferred Stock | ||
Preferred Stock, Shares Issued | 7 | 4,138 |
Preferred Stock, Shares Outstanding | 7 | 4,138 |
Preferred Stock Designated Shares | 20,000 | 20,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||
Collaboration Revenue | $ 0 | $ 12,059 |
Operating Expenses: | ||
Research and Development | 5,350,264 | 3,566,045 |
General and Administrative | 5,323,649 | 4,658,769 |
Goodwill Impairment | 4,498,234 | 0 |
Intangible Asset Impairment | 1,770,314 | 0 |
Total Operating Expenses | 16,942,461 | 8,224,814 |
Operating Loss Before Other Income | (16,942,461) | (8,212,755) |
Other Income, Net: | ||
Gain on Forgiveness of Loan | 278,190 | 0 |
Contingent Consideration Expense | (29,719) | 0 |
Gain on Disposal of Foreign Entity | 0 | 113,717 |
Interest Income | 1,141 | 23,339 |
Interest Expense | (6,851) | (4,186) |
Total Other Income, Net | 242,761 | 132,870 |
Loss Before Income Tax Benefit (Expense) | (16,699,700) | (8,079,885) |
Income Tax Benefit (Expense) | 304,781 | (12,055) |
Net Loss | $ (16,394,919) | $ (8,091,940) |
Net Loss per Common Share - Basic | $ (1.77) | $ (1.77) |
Net Loss per Common Share - Diluted | $ (1.77) | $ (1.77) |
Weighted-Average Shares Outstanding - Basic | 9,240,500 | 4,576,058 |
Weighted-Average Shares Outstanding - Diluted | 9,240,500 | 4,576,058 |
Net Loss | $ (16,394,919) | $ (8,091,940) |
Other Comprehensive Loss: | ||
Dissolution of Foreign Entity | 0 | (113,717) |
Foreign Currency Translation Adjustments | (85,629) | (26,550) |
Comprehensive Loss | $ (16,480,547) | $ (8,232,207) |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - USD ($) | Preferred StockSeries C Preferred Stock | Preferred StockSeries D Preferred Stock | Preferred Stock | Common StockSeries C Preferred Stock | Common StockSeries D Preferred Stock | Common StockPrivate Placement | Common StockRegistered direct offering | Common Stock | Additional Paid-In CapitalSeries C Preferred Stock | Additional Paid-In CapitalSeries D Preferred Stock | Additional Paid-In CapitalPrivate Placement | Additional Paid-In CapitalRegistered direct offering | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Private Placement | Registered direct offering | Total |
Balance at Dec. 31, 2019 | $ 41 | $ 40,778 | $ 106,689,065 | $ 139,465 | $ (100,246,894) | $ 6,622,455 | ||||||||||||
Balance (in shares) at Dec. 31, 2019 | 4,092 | 4,077,755 | ||||||||||||||||
Stock-Based Compensation | 723,856 | 723,856 | ||||||||||||||||
Issuance of Common Stock in Offerings, Net of Offering Costs | $ 5,000 | 4,496,313 | 4,501,313 | |||||||||||||||
Issuance of Common Stock in Offerings, Net of Offering Costs (in shares) | 500,000 | |||||||||||||||||
Issuance of Common Stock from Warrants, Net | $ 454 | 217,546 | 218,000 | |||||||||||||||
Issuance of Common Stock from Warrants, Net (in shares) | 45,417 | |||||||||||||||||
Shares Issued to Panoptes Stockholders at Acquisition | $ 8,842 | 3,157,282 | 3,166,124 | |||||||||||||||
Shares Issued to Panoptes Stockholders at Acquisition (in shares) | 46 | 884,222 | ||||||||||||||||
Dissolution of Foreign Entity | (113,717) | (113,717) | ||||||||||||||||
Issuance of Common Stock from Restricted Stock Award Grants | $ 490 | (490) | ||||||||||||||||
Issuance of Common Stock from Restricted Stock Award Grants (in shares) | 49,000 | |||||||||||||||||
Foreign Currency Translation Adjustment | (26,550) | (26,550) | ||||||||||||||||
Net Loss | (8,091,940) | (8,091,940) | ||||||||||||||||
Balance at Dec. 31, 2020 | $ 41 | $ 55,564 | 115,283,572 | (802) | (108,338,834) | 6,999,541 | ||||||||||||
Balance (in shares) at Dec. 31, 2020 | 4,138 | 5,556,394 | ||||||||||||||||
Stock-Based Compensation | 842,475 | 842,475 | ||||||||||||||||
Conversion of Preferred Stock into Common Stock | $ (41) | $ 8,525 | $ 109 | $ (8,484) | $ (109) | |||||||||||||
Conversion of Preferred Stock into Common Stock (in shares) | (4,092) | (39) | 852,500 | 10,911 | ||||||||||||||
Issuance of Common Stock in Offerings, Net of Offering Costs | $ 15,311 | $ 46,689 | $ 7,973,550 | $ 9,709,659 | $ 7,988,861 | $ 9,756,348 | ||||||||||||
Issuance of Common Stock in Offerings, Net of Offering Costs (in shares) | 1,531,101 | 4,668,844 | ||||||||||||||||
Shares issued to Bayon Shareholders at Acquisition | $ 338 | 67,598 | 67,936 | |||||||||||||||
Shares issued to Bayon Shareholders at Acquisition (in shares) | 33,798 | |||||||||||||||||
Issuance of Common Stock from Warrants, Net | $ 104 | 49,897 | 50,001 | |||||||||||||||
Issuance of Common Stock from Warrants, Net (in shares) | 10,417 | |||||||||||||||||
Dissolution of Foreign Entity | 0 | |||||||||||||||||
Conversion of Stock into Common Stock(in shares) | 4,092 | 39 | (852,500) | (10,911) | ||||||||||||||
Foreign Currency Translation Adjustment | (85,629) | (85,629) | ||||||||||||||||
Net Loss | (16,394,919) | (16,394,919) | ||||||||||||||||
Balance at Dec. 31, 2021 | $ 126,640 | $ 133,918,158 | $ (86,431) | $ (124,733,753) | $ 9,224,614 | |||||||||||||
Balance (in shares) at Dec. 31, 2021 | 7 | 12,663,965 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Offering Costs | $ 498,687 | |
Private Placement | ||
Offering Costs | $ 11,142 | |
Registered direct offering | ||
Offering Costs | $ 993,666 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Activities | ||
Net Loss | $ (16,394,919) | $ (8,091,940) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | ||
Depreciation and Amortization of Intangible Assets | 45,296 | 33,399 |
Reduction of Right-of-Use Assets | 181,977 | 166,822 |
Stock-Based Compensation | 842,475 | 723,856 |
Contingent Consideration | (212,281) | 0 |
Expiration of Prepaid Agreement | 0 | 159,848 |
Deferred Taxes | (304,782) | 12,055 |
Paycheck Protection Program Loan Forgiveness | (278,190) | 0 |
Goodwill Impairment Loss | 4,498,234 | 0 |
Intangible Asset Impairment Loss | 1,770,314 | 0 |
Changes in Operating Assets and Liabilities, Net of Effects of Business Acquired: | ||
Prepaid Expenses and Other Current Assets | (156,951) | (146,971) |
Refundable Tax Credit Receivable | (441,196) | (18,957) |
Other Assets | 14,111 | 18,916 |
Accounts Payable | (310,665) | 136,697 |
Lease Liabilities | (181,977) | (166,822) |
Deferred Revenue | 0 | 0 |
Accrued Expenses | 40,882 | (144,072) |
Net Cash Used in Operating Activities | (10,887,672) | (7,317,169) |
Investing Activities: | ||
Purchase of Property and Equipment | (63,865) | (20,077) |
Acquisition, net of cash acquired | (93,155) | (110,644) |
Dissolution of Foreign Entity | 0 | (113,717) |
Net Cash Used in Investing Activities | (157,020) | (244,438) |
Financing Activities: | ||
Proceeds from Stock Offerings | 18,750,016 | 5,000,000 |
Stock Issuance Costs | (1,004,809) | (498,687) |
Exercise of Warrants | 50,001 | 218,000 |
Paycheck Protection Program Loan Proceeds | 0 | 278,190 |
Net Cash Provided by Financing Activities | 17,795,208 | 4,997,503 |
Effect of Exchange Rate Changes on Cash | (81,503) | (26,931) |
Net Increase (Decrease) in Cash | 6,669,013 | (2,591,035) |
Cash, Including Restricted Cash, Beginning of Year | 1,230,677 | 3,821,712 |
Cash, Including Restricted Cash, End of Year | 7,899,690 | 1,230,677 |
Supplemental Disclosures of Noncash Operating and Financing Activities: | ||
Conversion of Series C Preferred Stock into Common Stock | 8,525 | 0 |
Conversion of Series D Preferred Stock into Common Stock | 109 | 0 |
Creation of Right-of-Use Assets and Related Lease Liabilities | 313,312 | 166,824 |
Grant of Restricted Stock Awards | $ 0 | $ 490 |
Organization, Business
Organization, Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Business | |
Organization, Business | 1. Organization, Business, and Liquidity Kiora is a clinical-stage specialty pharmaceutical company developing and commercializing therapies for the treatment of ophthalmic diseases. On November 5, 2021, Kiora Pharmaceuticals, Inc. (formerly known as EyeGate Pharmaceuticals, Inc.) (“Kiora” or the “Company”) filed with the Secretary of State of the State of Delaware, a Certificate of Ownership and Merger, merging its wholly-owned Delaware subsidiary, Kiora Pharmaceuticals, Inc., (incorporated in October 2021) into the Company and amending the Company’s certificate of incorporation to change its name to “Kiora Pharmaceuticals, Inc.” effective November 8, 2021 (the “Name Change”). The Company also amended and restated its bylaws to reflect the change to the Company’s name (the “Bylaws Amendment”). The Name Change and the Bylaws Amendment each became effective on November 8, 2021. The Company’s common shares commenced trading on the Nasdaq Capital Market under the new ticker symbol “KPRX” and a new CUSIP number (49721T101) effective at the market open on November 8, 2021. Our lead product is KIO-301 with an initial focus on patients with later stages of disease progression due to Retinitis Pigmentosa (any and all sub-forms). KIO-301 is a potential vision-restoring small molecule that acts as a “photoswitch” specifically designed to restore vision in patients with inherited and age-related degenerative retinal diseases. The molecule is specifically designed to restore the eyes’ ability to perceive and interpret light in visually impaired patients. It selectively enters viable downstream retinal ganglion cells (no longer receiving electrical input due to degenerated rods and cones) and is intended to turn them into light sensing cells, capable of signaling the brain as to the presence or absence of light. We expect to initiate a Phase 1b clinical trial in the third quarter of 2022. On March 17, 2022, we were granted Orphan Drug Designation from the U.S. FDA for the Active Pharmaceutical Ingredient (“API”) in KIO-301. KIO-301 (formerly known as B-203) was acquired through the Bayon Therapeutics, Inc. (“Bayon”) transaction which closed October 21, 2021. KIO-101 is a product that focuses on patients with Ocular Presentation of Rheumatoid Arthritis (“OPRA”) In addition, we are developing KIO-201, for patients undergoing PRK surgery for corneal wound repair after refractive surgery. KIO-201 is a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve and maintain ocular surface integrity. KIO-201 has unique properties that help hydrate and protect the ocular surface. Since its inception, Kiora has devoted substantially all of its efforts to business planning, research and development, and raising capital. The accompanying Consolidated Financial Statements have been prepared assuming that Kiora will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. At December 31, 2021, Kiora had unrestricted Cash and Cash Equivalents of $7.855 million, and an Accumulated Deficit of $124.734 million. Kiora has incurred losses and negative cash flows since inception, and future losses are anticipated. Based on its cash on hand at December 31, 2021, the Company anticipates having sufficient cash to fund planned operations into July 2022, however, the acceleration or reduction of cash outflows by Company management can significantly impact the timing for the need to raise additional capital to complete development of its products. To continue development, Kiora will need to raise additional capital through equity financing, license agreements, and/or additional U.S. government grants. Although historically the Company has been successful at raising capital, most recently raising net proceeds of approximately $9.8 million in a registered direct offering that closed on August 11, 2021, additional capital may not be available on terms favorable to Kiora, if at all. On May 13, 2019, the SEC declared effective Kiora’s registration statement on Form S-3, registering a total of $50,000,000 of its securities for sale to the public from time to time in what is known as a “shelf offering”. The Company does not know if any future offerings, including offerings pursuant to its shelf registration statement, will succeed. Accordingly, no assurances can be given that Company management will succeed in these endeavors. The Company’s recurring losses from operations have caused management to determine there is substantial doubt about the Company’s ability to continue as a going concern. The Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying Consolidated Financial Statements include the accounts of the Company and its subsidiaries, EyeGate Pharma S.A.S. (through its dissolution on December 30, 2020), Jade Therapeutics, Inc. (“Jade”), Kiora Pharmaceuticals GmbH (“Kiora GmbH”) (formerly known as Panoptes Pharma Ges.m.b.H or “Panoptes”) (effective December 18, 2020 when the Company acquired all of the capital stock of Panoptes), Bayon (effective October 21, 2021 when the Company acquired all of the capital stock of Bayon), and Kiora Pharmaceuticals Pty Ltd (“Kiora Pty”) (formerly known as Bayon Therapeutics Pty Ltd), collectively referred to as “the Company”. All inter-company balances and transactions have been eliminated in consolidation. These Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make significant 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, and the reported amounts of expenses during the reporting periods. The Company makes significant estimates and assumptions in recording the accruals for the Company’s clinical trial and research activities, establishing the useful lives of intangible assets and property and equipment, conducting impairment reviews of long-lived assets, revenue recognition, stock-based compensation, and contingent considerations payable. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Although the Company monitors and regularly assesses these estimates, actual results could differ significantly from these estimates. The Company records changes in estimates in the period that it becomes aware of the change. Foreign Currency Translation Operations of Kiora GmbH are, and prior to its dissolution on December 31, 2020, operations of EyeGate Pharma S.A.S. were, conducted in euros which represent its functional currency. Operations of Kiora Pty are conducted in Australian dollars, which represent its functional currency. Balance sheet accounts of such subsidiaries were translated into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement accounts were translated to the average rate of exchange prevailing during the period. Translation adjustments resulting from this process, are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with a maturity of 90 days or less when acquired that are not restricted as to withdrawal, to be the equivalent of cash for the purpose of balance sheet and statement of cash flows presentation. The Company invests its cash in either U.S. government or treasury money market funds with maturities of 90 days or less. At December 31, 2021 and 2020, the Company has classified $0.045 million as restricted cash. Property and Equipment Property and equipment is stated at cost less accumulated depreciation. Depreciation is provided for on a straight-line basis over the estimated useful life of 2 to 5 years for all assets. Maintenance and repair costs are expensed as incurred. The Company reviews its property and equipment whenever events or changes in circumstances indicate that the carrying value of certain assets might not be recoverable and recognizes an impairment loss when it is probable that the estimated cash flows are less than the carrying value of the asset. 2. Summary of Significant Accounting Policies - (continued) Impairment of Long-Lived Assets The Company evaluates potential impairment of long-lived assets and long-lived assets to be disposed of and considers whether long-lived assets held for use have been impaired whenever events or changes in circumstances indicate that the related carrying amount may not be recoverable, or that the period of their recovery may have changed. Management makes significant estimates and assumptions regarding future sales, cost trends, productivity and market maturity in order to test for impairment. Management reports those long-lived assets to be disposed of and assets held for sale at the lower of carrying amount or fair value less cost to sell. Based on current facts, estimates and assumptions, management believes that no assets are impaired at December 31, 2021. There is no assurance that management’s estimates and assumptions will not change in future periods. Research and Development Expenses The Company expenses research and development (“R&D”) expenditures as incurred. R&D expenses are comprised of costs incurred in performing R&D activities, including salaries, benefits, facilities, research-related overhead, sponsored research costs, contracted services, license fees, expenses related to generating, filing, and maintaining intellectual property and other external costs. Because the Company believes that, under its current process for developing its products, the viability of the products is essentially concurrent with the establishment of technological feasibility, no costs have been capitalized to date. Goodwill Goodwill is the excess of the acquisition cost of a business over the fair value of the identifiable net assets acquired. In 2021, this consists of the goodwill of the Company’s subsidiaries Jade, Kiora GmbH, and Bayon. In 2020, this consists of the goodwill of the Company’s subsidiaries Jade and Kiora GmbH. Goodwill is not amortized and is tested for impairment on an annual basis in the fourth quarter of each fiscal year and whenever events or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. The Company performed qualitative impairment evaluations on its goodwill as of December 31, 2021. Goodwill as of December 31, 2021 was reduced to zero after taking an impairment loss of $4.498 million. The Fair Value is determined using the income approach with a reconciliation to the Company’s stock price. The impairment is reported on the consolidated statements of operations. Goodwill as of December 31, 2020 is $3.485 million. In-Process Research and Development The Company records in-process R&D projects acquired in asset acquisitions that have not reached technological feasibility and which have no alternative future use. For in-process R&D projects acquired in business combinations, the Company capitalizes the in-process R&D project and periodically evaluates this asset for impairment until the R&D process has been completed. Once the R&D process is complete, the Company amortizes the R&D asset over its remaining useful life. At December 31, 2021, there is $8.696 million of in-process R&D as part of intangible asset and in-process R&D on the Consolidated Balance Sheets. This amount includes an impairment loss of $1.770 million reported on the consolidated statements of operations. The impairment loss is for KIO-201 and is due to the fact the asset is regulated as a drug and not a device which is extending development time. At December 31, 2020, there is $9.730 million of in-process R&D as part of intangible asset and in-process R&D on the Consolidated Balance Sheet. 2. Summary of Significant Accounting Policies - (continued) Accrued Clinical Expenses As part of the Company’s process of preparing the Consolidated Financial Statements, the Company is required to estimate its accrued expenses. This process includes reviewing open contracts and purchase orders, communicating with its applicable personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice monthly in arrears for services performed. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at the time. The Company periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary. Business Segment and Geographical Information The Company identifies operating segments as components of the enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as fully integrated and operating in one business segment (research and development), and the Company operates in three geographic segments. Income Taxes The Company will record a deferred income tax asset and liability for the expected future income tax consequences of events that have been recognized in the Company’s Consolidated Financial Statements and income tax returns. The Company will record a deferred income tax asset and liability based on differences between the financial statement carrying, or “book”, amounts of assets and liabilities, and the tax bases of the assets and liabilities using the enacted income tax regulations in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred income tax asset will be recorded if, based on the weight of available evidence, it is more likely than not that some or all of the deferred income tax assets will not be realized. As of December 31, 2021 and 2020, all of the Company’s net deferred income tax assets were subject to a full valuation allowance. As of December 31, 2021 and 2020, the Company has a net deferred tax liability of $0.614 million and $0.729 million, respectively. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. As of December 31, 2021, the Company had no unrecognized uncertain income tax positions. Refunds for Research and Development Kiora, through its Kiora GmbH subsidiary, is entitled to receive certain refunds associated with its research and development expenses in Austria. These refunds are realized in the form of a cash payment in the year following the incurred research & development expenses. The Company records the refundable payment as a reduction in expense in the year in which the research and development expenses are incurred. Concentration of Credit Risk and Off-Balance-Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash and cash equivalents. The Company invests cash in accredited financial institutions and cash equivalents in widely held money market funds. Consequently, such funds are subject to minimal credit risk. The Company has no significant off-balance-sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. 2. Summary of Significant Accounting Policies - (continued) Comprehensive Loss Comprehensive loss is defined as the change in stockholders’ equity during a period from transactions and other events and circumstances from non-owner sources. The foreign currency translation adjustments are the Company’s only component of other comprehensive loss. Stock-Based Compensation Stock-based compensation represents the cost related to stock-based awards granted to employees and others. The Company measures stock-based compensation cost to employees at grant date, based on the estimated fair value of the award, and recognizes the cost as expense on a straight-line basis over the employee requisite service period. The Company estimates the fair value of stock options using the Black-Scholes valuation model. The Company recognizes compensation expense for non-employee stock option grants at the fair value of the goods or services received or the equity instruments issued, whichever is more reliably measurable. The Company recorded compensation expense for non-employee awards with graded vesting using the accelerated expense attribution method. The Company’s policy is to record forfeitures as they occur. Net Loss per Share - Basic and Diluted Basic and diluted net loss per share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding for the period, which, for basic net loss per share, does not include the weighted-average unvested restricted common stock that has been issued but is subject to forfeiture of 41,216 shares for year ended December 31, 2021 and 77,262 shares for the year ended December 31, 2020. Dilutive common equivalent shares consist of stock options, warrants, and preferred stock and are calculated using the treasury stock method, which assumes the repurchase of common shares at the average market price during the period. Under the treasury stock method, options and warrants will have a dilutive effect when the average price of common stock during the period exceeds the exercise price of options or warrants. Common equivalent shares do not qualify as participating securities. In periods where the Company records a net loss including the years ended December 31, 2021 and 2020, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. All shares of Common Stock that may potentially be issued in the future are as follows: Year Ended December 31, 2021 2020 Common Stock Warrants 6,757,180 2,726,700 Employee Stock Options 515,922 246,893 Preferred Stock 2,089 865,500 Total Shares of Common Stock Issuable 7,275,191 3,839,093 Related-Party Transactions During the year ended December 31, 2021, the Company entered into certain related-party transactions, making payments for services to one vendor and six consultants, all of whom also are stockholders of the Company. These transactions generally are ones that involve a stockholder or option holder of the Company to whom the Company also makes payments during the year, typically as a consultant or a service provider. Additionally, on January 6, 2021, the Company completed a private placement of 1,531,101 shares of Common Stock and warrants to purchase up to 1,531,101 shares of Common Stock to an affiliate of Armistice Capital, LLC, with a combined purchase price per share and warrant of $5.225. Steven J. Boyd and Keith Maher, each of whom were members of the Company’s board of directors through August 3, 2021, are affiliates of Armistice Capital, LLC, and Mr. Boyd held voting and investment power over such entity. The total net proceeds from the private placement were approximately $8.0 million. Lastly, on October 21, 2021, the Company acquired Bayon of which the Company’s CEO, Brian Strem, was a Co-Founder and Managing Director. Except for the private placement and Bayon acquisition as described previous, the transactions with related parties during the year ended December 31, 2021 are not material to the accompanying Consolidated Financial Statements. 2. Summary of Significant Accounting Policies - (continued) During the year ended December 31, 2020, the Company entered into certain related-party transactions, making payments for services to two vendors, seven consultants and two public universities, all of whom also are stockholders of the Company. The Company made payments related to manufacturing services to one vendor in the amount of approximately $502,000. Except for the manufacturing services as described previous, the transactions with related parties during the year ended December 31, 2020 are not material to the accompanying Consolidated Financial Statements. Fair Value of Financial Instruments As of December 31, 2021 and 2020, the fair value of the Company’s contingent consideration was $6.519 million and $5.343 million, respectively. During the year ended December 31, 2021, the Company recorded contingent consideration at fair value of $1.388 million as a result of the Bayon acquisition and reduced the contingent consideration liability by $0.212 million due to a payment made in accordance with terms from the Panoptes acquisition. During the year ended December 31, 2020, the Company recorded contingent consideration at fair value of $3.633 million as a result of the Panoptes acquisition. The remaining contingent consideration arose from Series D Preferred Shares. The Company evaluates the fair value of contingent consideration on a quarterly basis and there were no fair value adjustments recorded during the years ended December 31, 2021 and 2020. At December 31, 2021 and 2020, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment | |
Property and Equipment | 3. Property and Equipment Property and equipment at December 31, 2021 and 2020 consists of the following: Estimated Useful Life (Years) 2021 2020 Laboratory Equipment 3 $ 88,399 $ 82,653 Office Equipment 3 3,614 3,888 Office Furniture 5 72,549 14,430 Leasehold Improvements 2 22,569 22,569 Total Property and Equipment, Gross 187,131 123,540 Less Accumulated Depreciation 113,132 92,974 Total Property and Equipment, Net $ 73,999 $ 30,566 Depreciation expense was $20,296 and $8,399 for the years ended December 31, 2021 and 2020, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses consist of the following: December 31, 2021 2020 Payroll and Benefits $ 937,970 $ 629,465 Professional Fees 194,425 328,420 Clinical Trials 168,785 203,646 Other 28,961 127,730 Total Accrued Expenses $ 1,330,141 $ 1,289,261 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt | |
Debt | 5. Debt In May 2020, the Company received loan funds (the “Loan”) from the Paycheck Protection Program (“PPP”) of $0.278 million. In April 2021, the Company was notified by the Small Business Administration (“SBA”) that this Loan was forgiven in full. The Company has no additional indebtedness at December 31, 2021 and 2020. |
Intangible Assets and In-Proces
Intangible Assets and In-Process R&D | 12 Months Ended |
Dec. 31, 2021 | |
Intangible Assets and In-Process R&D | |
Intangible Assets and In-Process R&D | 6. Intangible Assets and In-Process R&D Intangible assets at December 31, 2021 consist of the rights to trade-secrets and know-how related to the manufacturing of KIO-201. During the third quarter of 2018, the Company entered into an intellectual property license agreement with SentrX Animal Care, Inc. (“SentrX”) with respect to certain rights relating to the manufacturing of KIO-201. The intangible assets were recorded at $0.250 million, representing the upfront payment paid to SentrX. Additionally, SentrX is eligible to receive milestone payments totaling up to $4.750 million, upon and subject to the achievement of certain specified development and commercial milestones. These future milestone payments to SentrX will increase the carrying value of the intangible assets. The Company’s intangible assets are amortized on a straight-line basis over the estimated useful lives. Additionally, in-process R&D at December 31, 2021 and December 31, 2020 consists of projects acquired from the acquisitions of Jade, Bayon and Panoptes that have not reached technological feasibility and which have no alternative future use. Once the R&D process is complete, the Company will amortize the R&D asset over its remaining useful life. The Company periodically evaluates these assets for impairment. Intangible assets and in-process R&D at December 31, 2021 and 2020 consists of the following: Estimated Useful Life (Years) 2021 2020 Trade Secrets 10 $ 250,000 $ 250,000 Less: Accumulated Amortization (81,250) (56,250) Intangible Assets, Net 168,750 193,750 In-Process R&D 10,297,414 9,536,414 Impairment Loss (1,770,314) — In-Process R&D, Net $ 8,527,100 $ 9,536,414 Total Intangible Assets and In-Process R&D, Net $ 8,695,850 $ 9,730,164 Amortization expense on intangible assets was $25,000 for each of the years ended December 31, 2021 and 2020. Impairment loss was for KIO-201. |
Capital Stock
Capital Stock | 12 Months Ended |
Dec. 31, 2021 | |
Capital Stock | |
Capital Stock | 7. Capital Stock On January 3, 2020, the Company completed a registered direct offering with institutional investors for 500,000 shares of Common Stock with a purchase price of $10.00 per share. The total net proceeds to the Company, after deducting the placement agent fees and offering expenses, were approximately $4.5 million. On June 25, 2020, following the Company’s 2020 Annual Meeting of Stockholders, the Company filed a Certificate of Amendment to its Restated Certificate of Incorporation that decreased the number of authorized shares of the Company’s common stock from 120,000,000 to 50,000,000. 7. Capital Stock - (continued) In connection with the Panoptes acquisition, on December 18, 2020, the Company filed a Certificate of Designation of Preferences, Rights and Limitations for up to 20,000 shares of Series D Convertible Preferred Stock with the Delaware Secretary of State. The Series D Convertible Preferred Stock has a stated value of $1,000 per share and a conversion price of $3.5321 per share but may not be converted until stockholder approval is obtained. The Series D Preferred Stock is only entitled to dividends in the event dividends are paid on the Company’s shares of Common Stock and does not have any preferences over the Company’s shares of Common Stock or any voting rights, except in limited circumstances. On January 6, 2021, the Company completed a private placement of 1,531,101 shares of Common Stock and warrants to purchase up to 1,531,101 shares of Common Stock to an affiliate of Armistice Capital, LLC, with a combined purchase price per share and warrant of $5.225. The total net proceeds from the private placement were approximately $8.0 million. The warrants have an exercise price of $5.225 per share, subject to adjustments as provided under the terms of the warrants and will be exercisable on the six-month anniversary of their issuance date. The warrants are exercisable for five years from the issuance date. On July 27, 2021, a holder elected to convert 4,092 shares of Series C Preferred stock that were issued in a public offering on April 17, 2018 into 852,500 shares of Common Stock. On August 11, 2021, the Company completed a registered direct offering priced at-the-market under Nasdaq Rules for 4,668,844 shares of Common Stock with a purchase price of $2.3025 per share. The Company also completed a concurrent private placement of unregistered warrants to purchase up to an aggregate of 2,334,422 shares of Common Stock at an exercise price of $2.24 per share that are exercisable immediately upon issuance and will expire five On September 17, 2021, holders elected to convert 39 shares of Series D Preferred stock that were issued in connection with the Panoptes acquisition into 10,911 shares of Common Stock. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2021 | |
Warrants | |
Warrants | 8. Warrants At December 31, 2021 and 2020, the following warrants were outstanding: Weighted Weighted Average Average Number of Exercise Remaining Awards Price Term in Years Outstanding at December 31, 2019 2,875,006 $ 14.14 3.37 Issued 25,000 12.50 4.01 Exercised (45,417) 4.80 2.29 Expired (127,889) 139.28 — Outstanding at December 31, 2020 2,726,700 $ 8.41 2.45 Issued 4,098,965 3.39 4.68 Exercised (10,417) 4.80 1.29 Expired (58,068) 52.50 — Outstanding at December 31, 2021 6,757,180 $ 4.99 3.42 All of the warrant agreements provide for a cashless exercise in the event a registration statement covering the issuance of the shares of common stock underlying the warrants is not effective, whereby the number of shares to be issued upon exercise of such warrants will be reduced based on the exercise price and the market value of the shares at the time of exercise. The outstanding warrants expire from 2022 through 2027. |
Equity Incentive Plan
Equity Incentive Plan | 12 Months Ended |
Dec. 31, 2021 | |
Equity Incentive Plan | |
Equity Incentive Plan | 9. Equity Incentive Plan In 2005, the Company approved the 2005 Equity Incentive Plan (the “2005 Plan”). The 2005 Plan provides for the granting of options, restricted stock or other stock-based awards to employees, officers, directors, consultants, and advisors. During 2010, the maximum number of shares of Common Stock that may be issued pursuant to the 2005 Plan was increased to 59,414 shares. The Board of Directors (the “Board”) is responsible for administration of the 2005 Plan. The Company’s Board determines the term of each option, the option exercise price, the number of shares for which each option is granted and the rate at which each option is exercisable. Incentive stock options may be granted to any officer or employee at an exercise price per share of not less than the fair value per common share on the date of the grant (not less than 110% of fair value in the case of holders of more than 10% of the Company’s voting stock) and with a term not to exceed ten years from the date of the grant (five years for incentive stock options granted to holders of more than 10% of the Company’s voting stock). Nonqualified stock options may be granted to any officer, employee, consultant, or director at an exercise price per share of not less than the par value per share. Following adoption of the 2014 Equity Incentive Plan (the “2014 Plan”), no further grants were made under the 2005 Plan. General terms of the 2014 Plan remain the same as that of the 2005 Plan. The Company’s Board adopted the 2014 Plan and the Employee Stock Purchase Plan (the “ESPP”), and the Company’s Stockholders approved the 2014 Plan and the ESPP Plan in February 2015. As of December 31, 2021, the maximum number of shares of Common Stock that may be issued pursuant to the 2014 Plan and the ESPP was 806,005 and 11,371 shares, respectively. In January 2021, the number of shares of common stock issuable under the 2014 Plan automatically increased by 23,333 shares pursuant to the terms of the 2014 Plan. Additionally, in June 2021, the number of shares of common stock issuable under the 2014 Plan was increased by 200,000 shares, as approved by the Company’s Stockholders. These additional shares are included in the total of 806,005 shares issuable under the 2014 Plan. The following is a summary of stock option activity for the years ended December 31, 2021 and 2020: Weighted-Average Number of Weighted-Average Contractual Life Options Exercise Price (In Years) Outstanding at December 31, 2019 174,175 $ 27.42 6.22 Granted 93,165 6.31 Expired (17,114) 10.59 Forfeited (3,333) 7.20 Outstanding at December 31, 2020 246,893 $ 20.90 7.20 Exercisable at December 31, 2020 142,061 $ 31.58 5.85 Vested and Expected to Vest at December 31, 2020 246,893 $ 20.90 7.20 Granted 345,865 4.11 Expired (32,544) 25.86 Forfeited (44,292) 6.49 Outstanding at December 31, 2021 515,922 $ 10.43 8.30 Exercisable at December 31, 2021 201,653 $ 22.00 6.37 Vested and Expected to Vest at December 31, 2021 515,922 $ 10.43 8.30 During the years ended December 31, 2021 and 2020, the Board approved the grant of options to purchase 345,865 and 93,165 shares of its Common Stock, respectively. All option grants were pursuant to the 2014 Plan. In general, options granted under the 2014 Plan vest with respect to one ratably 9. Equity Incentive Plan - (continued) For the years ended December 31, 2021 and 2020, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions: 2021 2020 Risk-Free Interest Rate 1.82 % 1.82 % Expected Life 10.0 years 10.0 years Expected Average Volatility 140 % 153 % Expected Dividend Yield 0 % 0 % Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock granted during the years ended December 31, 2021 and 2020 was $4.91 and $6.26, respectively. The following is a summary of restricted stock activity for the years ended December 31, 2021 and 2020: Weighted-Average Number of Weighted-Average Remaining Shares Grant Date Fair Value Recognition Period Non-vested Outstanding at December 31, 2019 50,187 $ 8.64 1.49 Awarded 49,000 6.55 Vested (31,767) 8.69 Non-vested Outstanding at December 31, 2020 67,420 $ 7.10 1.66 Vested (46,437) 7.33 Forfeited (5,971) 6.66 Non-vested Outstanding at December 31, 2021 15,012 $ 6.55 1.09 During year ended December 31, 2021, 5,971 shares of restricted stock, which had not vested, were forfeited and returned to the Company. During the years ended December 31, 2021 and 2020, the Board approved the grant of 0 and 49,000 restricted shares of Common Stock, respectively. All grants of restricted shares were pursuant to the 2014 Plan. These vest with respect to one ratably The total stock-based compensation expense for employees and non-employees is included in the accompanying Consolidated Statements of Operations and as follows: Year Ended December 31, 2021 2020 Research and Development $ 246,386 $ 197,806 General and Administrative 596,089 526,050 Total Stock-Based Compensation Expense $ 842,475 $ 723,856 The fair value of options granted for the years ended December 31, 2021 and 2020 was approximately $1.233 million and $0.580 million, respectively. There was no restricted stock granted for the year ended December 31, 2021. As of December 31, 2021 and 2020, there was approximately $1.001 million and $0.780 million of total unrecognized compensation expense related to unvested stock-based compensation arrangements granted, which cost is expected to be recognized over a weighted average period of 2.27 and 1.95 years, respectively. The aggregate intrinsic value of stock options outstanding at December 31, 2021 and 2020 was $0. As of December 31, 2021, there were 110,874 shares of Common Stock available for grant under the 2014 Plan and 7,806 shares available under the Company’s ESPP. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | 10. Income Taxes The components of loss before income taxes are as follows: Year Ended December 31, 2021 2020 Domestic $ (13,376,230) $ (7,996,327) Foreign (3,323,470) (83,558) Total Loss Before Income Taxes $ (16,699,700) $ (8,079,885) The components of income tax expense are as follows: Year Ended December 31, 2021 2020 Deferred Taxes: Federal $ (190,937) $ (529) State (113,843) 12,584 Total Deferred Taxes $ (304,780) $ 12,055 Income Tax (Benefit) Expense $ (304,780) $ 12,055 The difference between the effective rate reflected in the provision for income taxes on loss before taxes and the amounts determined by applying the applicable statutory U.S. tax rate are analyzed below: Year Ended December 31, 2021 2020 United States Federal Income Tax Rate 21.00 % 21.00 % State Taxes, Net of Federal Benefit 3.22 (1.59) Permanent Differences (5.69) (15.00) Change in Valuation Allowance (19.81) 17.53 Research and Development Credits 0.91 1.65 Tax Rate Differential 0.83 (2.12) Stock-Based Compensation — (1.32) Gain on Dissolution of Foreign Subsidiary — (15.81) Other 1.36 (4.49) Effective Tax Rate Expense 1.82 % (0.15) % The Company’s deferred tax assets and liabilities consist of the following: Year Ended December 31, 2021 2020 Net Deferred Tax Liability: Net Operating Loss Carryforwards $ 20,689,134 $ 17,042,422 Research and Development Credit Carryforwards 2,853,598 2,695,773 Capitalized Research and Development 5,640,428 6,251,945 Stock-Based Compensation 835,432 781,252 Cash Versus Accrual Adjustments 128,188 223,674 Total Deferred Tax Assets 30,146,780 26,995,066 Valuation Allowance (28,628,836) (25,320,159) Net Deferred Tax Asset 1,517,944 1,674,907 Depreciation and Amortization (955) (1,083) In-Process Research and Development (2,131,425) (2,402,750) Net Deferred Tax Liability $ (614,436) $ (728,926) 10. Income Taxes - (continued) As of December 31, 2021, the Company has federal and state net operating loss carryforwards of approximately $72.370 million and $51.930 million, respectively, to offset future federal and state taxable income. Federal NOL carryforwards as of December 31, 2017 totaling $46.054 million, and state NOL carryforwards as of December 31, 2021 totaling $49.894 million will expire at various dates through 2041 and state NOL carryovers as of December 31, 2021 of $2.037 million can be carried forward indefinitely but limited to offset 80% of taxable income. Federal NOL carryforwards generated during the years ended December 31, 2018 and forward totaling $26.316 million will carry forward indefinitely, but their utilization will be limited to 80% of taxable income. The Company has foreign net operating loss carryforwards of $9.405 million as of December 31, 2021, which can be carried forward indefinitely. As of December 31, 2021, the Company also has federal and state research and development tax credit carryforwards of approximately $2.456 million and $0.503 million, respectively, to offset future income taxes, which expire at various times through 2041. The federal and state net operating loss and research tax credit carryforwards may be subject to the limitations provided in the Internal Revenue Code (“IRC”) Sections 382 and 383. Approximately $0.639 million of the federal net operating loss attributable to Jade is subject to a Section 382 limitation. Jade’s carryover of its research and development credits will be subject to the Section 383 limitation. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES” Act) was enacted. The CARES Act included several income tax provisions including NOL carryback provisions and other tax benefits. The Company does not expect that the CARES Act will have a material impact on its income tax provision. The Company files United States federal income tax returns and income tax returns in the Commonwealth of Massachusetts, California, North Carolina and Utah, as well as foreign tax returns for its subsidiaries in Austria and Australia. The Company filed all foreign tax returns for its former French subsidiary EyeGate Pharma S.A.S., which was dissolved December 31, 2020. The Company is not under examination by any jurisdiction for any tax year. The Company has recorded a valuation allowance against its United States deferred tax assets in each of the years ended December 31, 2021, and 2020 because the Company’s management believes that it is more likely than not that these assets will not be realized. The valuation allowance increased (decreased)by approximately $3.309 million and $(0.958) million during the years ended December 31, 2021 and 2020, respectively, primarily as a result of the increase in net operating losses and credits, adjustments for accrual to cash basis items, and capitalized research and development expenses. As of December 31, 2021 and 2020, the Company had no unrecognized tax benefits or related interest and penalties accrued. The Company will recognize interest and penalties related to income taxes in income tax expense. The Company has not, as yet, conducted a study of R&D credit carryforwards, which are fully reserved for. This study may result in an adjustment to the Company’s R&D credit carryforwards and related valuation allowance, however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. The net operating loss and tax credit carryforwards are subject to review by the Internal Revenue Service in accordance with the provisions of Section 382 of the Internal Revenue Code. Under this Internal Revenue Code section, substantial changes in the Company’s ownership may limit the amount of net operating loss carryforwards that could be utilized annually in the future to offset the Company’s taxable income. Specifically, this limitation may arise in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. Any such annual limitation may significantly reduce the utilization of the Company’s net operating loss carryforwards before they expire. The closing of the Company’s initial public offering, alone or together with transactions that have occurred or that may occur in the future, may trigger an ownership change pursuant to Section 382, which could limit the amount of research and development tax credit and net operating loss carryforwards that could be utilized annually in the future to offset the Company’s taxable income, if any. Any such limitation as the result of the Company’s additional sales of common stock by the Company could have a material adverse effect on the Company’s results of operations in future years. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 11. Commitments and Contingencies Leases The Company is a party to three real property operating leases for the rental of office or lab space. The Company has office space in Waltham, Massachusetts of up to 4,516 square feet with a term through March 31, 2022. The Company also has office and laboratory space of approximately 3,540 square feet in Salt Lake City, Utah with a term through November 30, 2023, which is now used for its corporate headquarters. The Company has office space in Vienna, Austria of approximately 1,555 square feet with a term through October 31, 2023 as a result of the Panoptes acquisition effective December 18, 2020. Additional right-of-use assets and lease liabilities were recorded upon the new lease agreements or extensions that were effective as of December 31, 2021. Operating lease assets and liabilities are recognized at the lease commencement date at the present value of lease payments to be paid. Operating lease assets represent the Company’s right to use an underlying asset and are based upon the operating lease liabilities adjusted for prepayments or accrued lease payments. To determine the present value of lease payments to be paid, the Company estimated incremental secured borrowing rates corresponding to the maturities of the leases. The Company estimated a rate of 10% based on prevailing financial market conditions, comparable company and credit analysis, and management judgment. The Company recognizes expense for its leases on a straight-line basis over the lease term. Operating lease expense, consisting of the reduction of the right-of-use asset and the imputed interest on the lease liability, totaled $0.215 million and $0.174 million for the years ended December 31, 2021 and 2020, respectively. Maturities of lease liabilities were as follows as of December 31, 2021: Operating Leases 2022 $ 133,339 2023 95,086 Less: Imputed Interest (19,014) Lease Liabilities $ 209,411 License Agreements The Company is a party to six license agreements as described below. These license agreements require the Company to pay or receive royalties or fees to or from the licensor based on revenue or milestones related to the licensed technology. On July 2, 2013, the Company (through its subsidiary, Kiora Pharmaceuticals GmbH) entered into a patent and know-how assignment agreement with 4SC Discovery GmbH (“4SC”) transferring to it all patent rights and know-how to the compound KIO-101. The Company is responsible for paying royalties of 3.25% on net sales of KIO-101. On July 2, 2013, the Company (through its subsidiary, Kiora Pharmaceuticals, GmbH) entered into an out-license agreement with 4SC granting 4SC the exclusive worldwide right to commercialize the compound KIO-101 for rheumatoid arthritis and inflammatory bowel disease, including Crohn’s Disease and Ulcerative Colitis. The Company is eligible to receive milestone payments totaling up to 155 million euros, upon and subject to the achievement of certain specified developmental and commercial milestones. We have not received any milestones from 4SC. In addition, the Company is eligible to receive royalties of 3.25% on net sales of KIO-101. On September 12, 2013, the Company (through its subsidiary,Jade Therapeutics, Inc.) entered into an agreement with Lineage Cell Therapeutics, Inc. (“Lineage”), formerly known as BioTime, Inc. granting to the Company the exclusive worldwide right to commercialize cross-linked thiolated carboxymethyl hyaluronic acid (“modified HA”) for ophthalmic treatments in humans. The agreement requires the Company to pay an annual fee of $30,000 and a royalty of 6% on net sales of KIO-201 to Lineage based on revenue relating to any product incorporating the modified HA technology. The agreement expires when patent protection for the modified HA technology lapses in August 2027. 11. Commitments and Contingencies - (continued) On September 26, 2018, the Company entered into an intellectual property licensing agreement (the “SentrX Agreement”) with SentrX, a veterinary medical device company that develops and manufactures veterinary wound care products. Under the SentrX Agreement, the Company in-licensed the rights to trade secrets and know-how related to the manufacturing of KIO-201. The SentrX Agreement enables the Company to pursue a different vendor with a larger capacity for manufacturing and an FDA-inspected facility for commercialization of a product for human use. Under the SentrX Agreement, SentrX is eligible to receive milestone payments totaling up to $4.75 million, upon and subject to the achievement of certain specified developmental and commercial milestones. The term of the agreement is until the Product is no longer in the commercial marketplace. On April 23, 2020, the Company (through its subsidiary, Kiora Pharmaceuticals Pty Ltd) entered into an agreement with the University of California (“UC”) granting to the Company the exclusive rights to its pipeline of photoswitch molecules. The agreement requires the Company to pay an annual fee to UC of $5,000, as well as payments to UC upon the achievement of certain development milestone and royalties based on KIO-301 revenue. The Company is obligated to pay royalties on net sales of two percent (2%) of the first $250 million of net sales, one and a quarter percent (1.25%) of net sales between $250 million and $500 million, and one half of one percent (0.5%) of net sales over $500 million. The agreement expires on the date of the last-to-expire patent included in the licensed patent portfolio which is January 2030. On May 1, 2020, the Company (through its subsidiary, Kiora Pharmaceuticals Pty Ltd) entered into an agreement with Photoswitch Therapeutics, Inc. (“Photoswitch”) granting to the Company access to certain patent applications and IP rights with last-to-expire patent terms of January 2030. The agreement calls for payments to Photoswitch upon the achievement of certain development and upon first commercial sale of the product. COVID-19 The continued spread of the COVID-19 pandemic could adversely impact the Company’s clinical studies. In addition, COVID-19 has resulted in significant governmental measures being implemented to control the spread of the virus, including quarantines, travel restrictions, and business shutdowns. COVID-19 has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which could negatively affect the Company’s ability to raise additional capital on attractive terms or at all. The extent to which COVID-19 may impact the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the emergence of new variants, and the effectiveness of actions to contain and treat COVID-19. The Company cannot presently predict the scope and severity of any potential disruptions to its business, including to ongoing and planned clinical studies. Any such shutdowns or other business interruptions could result in material and negative effects to the Company’s ability to conduct its business in the manner and on the timelines presently planned, which could have a material adverse impact on its business, results of operation, and financial condition. As of the date of this report, there have been no material adverse effects to the Company’s ongoing business operations from COVID-19. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2021 | |
Employee Benefit Plans | |
Employee Benefit Plans | 12. Employee Benefit Plans The Company has an employee benefit plan for its United States-based employees under Section 401(k) of the Internal Revenue Code. The Plan allows all eligible employees to make contributions up to a specified percentage of their compensation. Under the Plan, the Company may, but is not obligated to, match a portion of the employee contribution up to a defined maximum. The Company made no matching contribution for the year ended December 31, 2021. As a result of the 401(k) plan compliance review for the year ended December 31, 2020, the Company contributed $25,905 to eligible participants during the third quarter of 2021. As of December 31, 2021, the Company has accrued an additional estimate of $20,334 for contributions likely due as a result of the 401(k) plan compliance review to be performed for the year ended December 31, 2021. |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2021 | |
Acquisition | |
Acquisition | 13. Acquisitions Bayon Therapeutics, Inc. Acquisition Effective October 21, 2021, the Company acquired all of the capital stock of Bayon, a privately held ophthalmic specialty pharmaceutical company focused on developing light sensitive small molecules. With the Bayon acquisition, Bayon became a wholly-owned subsidiary of Kiora. The assets acquired and liabilities assumed have been recorded at fair value on the date of the acquisition. The excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill, which is not expected to be deductible for tax purposes. Under the terms of the Bayon acquisition agreement, in consideration for 100% of the outstanding equity interests in Bayon, the Company paid cash in the amount of $0.097 million to certain sellers and creditors and issued 33,798 shares of Kiora common stock. The former stockholders of Bayon are also eligible to receive up to $7.1 million in additional cash or stock payments based on clinical trial and FDA approval milestones for Bayon’s product candidates, as set forth in the Purchase Agreement. The cash or stock earn-out payments were recorded as contingent consideration and fair valued at $1.388 million at the acquisition date. The fair value of the shares issued in the Bayon acquisition was approximately $0.068 million based on the average closing price of the Company’s Common Stock for five trading days immediately preceding the closing date, or $2.01 per share. The following table summarizes the purchase price allocation and the estimated fair value of the net assets acquired and liabilities assumed in the Bayon acquisition at the date of acquisition. Bayon Current Assets (1) $ 5,290 In-Process R&D 761,000 Goodwill 1,013,627 Accounts Payable (36,525) Deferred Tax Liability (190,291) Contingent Consideration (1,388,101) Total Purchase Price $ 165,000 (1) Current Assets include cash and receivables of $3,910 and $1,380, respectively. Net loss in the Consolidated Statement of Operations for the twelve months ended December 31, 2021 includes net losses of Bayon of $0.128 million from the date of acquisition. The acquired intangible assets, which consist solely of in-process research and development, will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, the intangible assets are then accounted for as finite-lived intangible assets and amortized on a straight-line basis over its estimated useful life. The Company recognized approximately $0.090 million of acquisition-related costs for the Bayon acquisition that were expensed in the year ended December 31, 2021 as a component of general and administrative expense. Pro forma disclosure for Bayon acquisition The following table includes the pro forma results for Bayon the year ended December 31, 2021 of the combined companies as though the Bayon Acquisition had been completed as of the beginning of the period presented. Year Ended Year Ended December 31, 2021 December 31, 2020 (unaudited) (unaudited) Operating Expenses $ 16,964,040 $ 8,426,655 Net Loss $ (16,416,499) $ (8,103,868) 13. Acquisitions - (continued) The pro forma financial information is presented for information purposes only. The unaudited pro forma financial information may not necessarily reflect the Company’s future results of operations or what the results of operations would have been had the Company owned and operated Bayon as of the beginning of the period presented. Panoptes Pharma Ges.m.b.H. Acquisition Effective December 18, 2020, the Company acquired all of the capital stock of Panoptes Pharma Ges.m.b.H. (“Panoptes”), a privately held clinical stage biotech company focused on developing a novel proprietary small molecule for the treatment of severe eye diseases with a high unmet medical need, as well as for conditions outside the ocular space. With the Panoptes acquisition, Panoptes became a wholly-owned subsidiary of Kiora. The assets acquired and liabilities assumed have been recorded at fair value on the date of the acquisition. The excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill, which is not expected to be deductible for tax purposes. Under the terms of the Panoptes acquisition agreement, in consideration for 100% of the outstanding equity interests in Panoptes, the Company paid cash in the amount of $0.445 million to certain founders and creditors, issued 884,222 shares of Kiora common stock, and issued 45.893 shares (convertible into 13,000 shares of common stock) of Kiora Series D Convertible Preferred Stock. An additional cash payment is due to a creditor in December 2021 and is recorded at a fair value of $0.212 million at the acquisition date. Additionally, up to 1,500 shares of Series D Convertible Preferred Stock (convertible into 424,685 shares of common stock) will be issued after a period of 18 months from closing, subject to post-closing adjustments or indemnification obligations, and are recorded as contingent consideration and fair valued at $1.353 million at the acquisition date. The Panoptes acquisition also includes two cash or stock earn-out provisions providing for an additional cash or stock payment of $4.750 million per milestone contingent upon (1) the enrollment and randomization of a first patient into the first FDA Phase III pivotal study of a Panoptes product and (2) the FDA approval of the first New Drug Application of a Panoptes product. The cash or stock earn-out payments were recorded as contingent consideration and fair valued at $2.067 million at the acquisition date. The fair value of the shares issued in the Panoptes acquisition was approximately $3.169 million based on the 30-day volume weighted average price of the Company’s Common Stock as reported by Bloomberg on the closing date of the acquisition, or $3.5321 per share. The following table summarizes the purchase price allocation and the estimated fair value of the net assets acquired and liabilities assumed in the Panoptes acquisition at the date of acquisition. Panoptes Current Assets $ 410,863 In-Process R&D 5,624,100 Goodwill 1,958,711 Property, Plant and Equipment 2,042 Accounts Payable and Other Liabilities (87,777) Deferred Tax Liability (351,507) Contingent Consideration (3,632,950) Assumed Liabilities (312,852) Total Purchase Price $ 3,610,630 (1) Net loss in the Consolidated Statement of Operations for the twelve months ended December 31, 2020 includes net losses of Panoptes of $0.034 million from the date of acquisition. The Company’s intangible assets, which consist solely of in-process research and development, will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, the intangible assets are then accounted for as finite-lived intangible assets and amortized on a straight-line basis over its estimated useful life. 13. Acquisitions - (continued) The Company recognized approximately $0.050 million and $0.414 million of acquisition-related costs for the Panoptes acquisition that were expensed in the years ended December 31, 2021 and 2020, respectively, as a component of general and administrative expense. Pro forma disclosure for Panoptes acquisition The following table includes the pro forma results for Panoptes the year ended December 31, 2020 of the combined companies as though the Panoptes Acquisition had been completed as of the beginning of the period presented. Year Ended December 31, 2020 (unaudited) Revenues $ 558,063 Operating Expenses 9,842,685 Net Loss $ (9,172,201) The pro forma financial information is presented for information purposes only. The unaudited pro forma financial information may not necessarily reflect the Company’s future results of operations or what the results of operations would have been had the Company owned and operated Panoptes as of the beginning of the period presented. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying Consolidated Financial Statements include the accounts of the Company and its subsidiaries, EyeGate Pharma S.A.S. (through its dissolution on December 30, 2020), Jade Therapeutics, Inc. (“Jade”), Kiora Pharmaceuticals GmbH (“Kiora GmbH”) (formerly known as Panoptes Pharma Ges.m.b.H or “Panoptes”) (effective December 18, 2020 when the Company acquired all of the capital stock of Panoptes), Bayon (effective October 21, 2021 when the Company acquired all of the capital stock of Bayon), and Kiora Pharmaceuticals Pty Ltd (“Kiora Pty”) (formerly known as Bayon Therapeutics Pty Ltd), collectively referred to as “the Company”. All inter-company balances and transactions have been eliminated in consolidation. These Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make significant 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, and the reported amounts of expenses during the reporting periods. The Company makes significant estimates and assumptions in recording the accruals for the Company’s clinical trial and research activities, establishing the useful lives of intangible assets and property and equipment, conducting impairment reviews of long-lived assets, revenue recognition, stock-based compensation, and contingent considerations payable. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Although the Company monitors and regularly assesses these estimates, actual results could differ significantly from these estimates. The Company records changes in estimates in the period that it becomes aware of the change. |
Foreign Currency Translation | Foreign Currency Translation Operations of Kiora GmbH are, and prior to its dissolution on December 31, 2020, operations of EyeGate Pharma S.A.S. were, conducted in euros which represent its functional currency. Operations of Kiora Pty are conducted in Australian dollars, which represent its functional currency. Balance sheet accounts of such subsidiaries were translated into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement accounts were translated to the average rate of exchange prevailing during the period. Translation adjustments resulting from this process, are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with a maturity of 90 days or less when acquired that are not restricted as to withdrawal, to be the equivalent of cash for the purpose of balance sheet and statement of cash flows presentation. The Company invests its cash in either U.S. government or treasury money market funds with maturities of 90 days or less. At December 31, 2021 and 2020, the Company has classified $0.045 million as restricted cash. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost less accumulated depreciation. Depreciation is provided for on a straight-line basis over the estimated useful life of 2 to 5 years for all assets. Maintenance and repair costs are expensed as incurred. The Company reviews its property and equipment whenever events or changes in circumstances indicate that the carrying value of certain assets might not be recoverable and recognizes an impairment loss when it is probable that the estimated cash flows are less than the carrying value of the asset. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates potential impairment of long-lived assets and long-lived assets to be disposed of and considers whether long-lived assets held for use have been impaired whenever events or changes in circumstances indicate that the related carrying amount may not be recoverable, or that the period of their recovery may have changed. Management makes significant estimates and assumptions regarding future sales, cost trends, productivity and market maturity in order to test for impairment. Management reports those long-lived assets to be disposed of and assets held for sale at the lower of carrying amount or fair value less cost to sell. Based on current facts, estimates and assumptions, management believes that no assets are impaired at December 31, 2021. There is no assurance that management’s estimates and assumptions will not change in future periods. |
Research and Development Expenses | Research and Development Expenses The Company expenses research and development (“R&D”) expenditures as incurred. R&D expenses are comprised of costs incurred in performing R&D activities, including salaries, benefits, facilities, research-related overhead, sponsored research costs, contracted services, license fees, expenses related to generating, filing, and maintaining intellectual property and other external costs. Because the Company believes that, under its current process for developing its products, the viability of the products is essentially concurrent with the establishment of technological feasibility, no costs have been capitalized to date. |
Goodwill | Goodwill Goodwill is the excess of the acquisition cost of a business over the fair value of the identifiable net assets acquired. In 2021, this consists of the goodwill of the Company’s subsidiaries Jade, Kiora GmbH, and Bayon. In 2020, this consists of the goodwill of the Company’s subsidiaries Jade and Kiora GmbH. Goodwill is not amortized and is tested for impairment on an annual basis in the fourth quarter of each fiscal year and whenever events or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. The Company performed qualitative impairment evaluations on its goodwill as of December 31, 2021. Goodwill as of December 31, 2021 was reduced to zero after taking an impairment loss of $4.498 million. The Fair Value is determined using the income approach with a reconciliation to the Company’s stock price. The impairment is reported on the consolidated statements of operations. Goodwill as of December 31, 2020 is $3.485 million. |
In-process Research and Development | In-Process Research and Development The Company records in-process R&D projects acquired in asset acquisitions that have not reached technological feasibility and which have no alternative future use. For in-process R&D projects acquired in business combinations, the Company capitalizes the in-process R&D project and periodically evaluates this asset for impairment until the R&D process has been completed. Once the R&D process is complete, the Company amortizes the R&D asset over its remaining useful life. At December 31, 2021, there is $8.696 million of in-process R&D as part of intangible asset and in-process R&D on the Consolidated Balance Sheets. This amount includes an impairment loss of $1.770 million reported on the consolidated statements of operations. The impairment loss is for KIO-201 and is due to the fact the asset is regulated as a drug and not a device which is extending development time. At December 31, 2020, there is $9.730 million of in-process R&D as part of intangible asset and in-process R&D on the Consolidated Balance Sheet. |
Accrued Clinical Expenses | Accrued Clinical Expenses As part of the Company’s process of preparing the Consolidated Financial Statements, the Company is required to estimate its accrued expenses. This process includes reviewing open contracts and purchase orders, communicating with its applicable personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice monthly in arrears for services performed. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at the time. The Company periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary. |
Business Segment and Geographical Information | Business Segment and Geographical Information The Company identifies operating segments as components of the enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as fully integrated and operating in one business segment (research and development), and the Company operates in three geographic segments. |
Income Taxes | Income Taxes The Company will record a deferred income tax asset and liability for the expected future income tax consequences of events that have been recognized in the Company’s Consolidated Financial Statements and income tax returns. The Company will record a deferred income tax asset and liability based on differences between the financial statement carrying, or “book”, amounts of assets and liabilities, and the tax bases of the assets and liabilities using the enacted income tax regulations in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred income tax asset will be recorded if, based on the weight of available evidence, it is more likely than not that some or all of the deferred income tax assets will not be realized. As of December 31, 2021 and 2020, all of the Company’s net deferred income tax assets were subject to a full valuation allowance. As of December 31, 2021 and 2020, the Company has a net deferred tax liability of $0.614 million and $0.729 million, respectively. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. As of December 31, 2021, the Company had no unrecognized uncertain income tax positions. |
Refunds for Research and Development | Refunds for Research and Development Kiora, through its Kiora GmbH subsidiary, is entitled to receive certain refunds associated with its research and development expenses in Austria. These refunds are realized in the form of a cash payment in the year following the incurred research & development expenses. The Company records the refundable payment as a reduction in expense in the year in which the research and development expenses are incurred. |
Concentration of Credit Risk and Off-Balance-Sheet Risk | Concentration of Credit Risk and Off-Balance-Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash and cash equivalents. The Company invests cash in accredited financial institutions and cash equivalents in widely held money market funds. Consequently, such funds are subject to minimal credit risk. The Company has no significant off-balance-sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in stockholders’ equity during a period from transactions and other events and circumstances from non-owner sources. The foreign currency translation adjustments are the Company’s only component of other comprehensive loss. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation represents the cost related to stock-based awards granted to employees and others. The Company measures stock-based compensation cost to employees at grant date, based on the estimated fair value of the award, and recognizes the cost as expense on a straight-line basis over the employee requisite service period. The Company estimates the fair value of stock options using the Black-Scholes valuation model. The Company recognizes compensation expense for non-employee stock option grants at the fair value of the goods or services received or the equity instruments issued, whichever is more reliably measurable. The Company recorded compensation expense for non-employee awards with graded vesting using the accelerated expense attribution method. The Company’s policy is to record forfeitures as they occur. |
Related Party Transactions | Related-Party Transactions During the year ended December 31, 2021, the Company entered into certain related-party transactions, making payments for services to one vendor and six consultants, all of whom also are stockholders of the Company. These transactions generally are ones that involve a stockholder or option holder of the Company to whom the Company also makes payments during the year, typically as a consultant or a service provider. Additionally, on January 6, 2021, the Company completed a private placement of 1,531,101 shares of Common Stock and warrants to purchase up to 1,531,101 shares of Common Stock to an affiliate of Armistice Capital, LLC, with a combined purchase price per share and warrant of $5.225. Steven J. Boyd and Keith Maher, each of whom were members of the Company’s board of directors through August 3, 2021, are affiliates of Armistice Capital, LLC, and Mr. Boyd held voting and investment power over such entity. The total net proceeds from the private placement were approximately $8.0 million. Lastly, on October 21, 2021, the Company acquired Bayon of which the Company’s CEO, Brian Strem, was a Co-Founder and Managing Director. Except for the private placement and Bayon acquisition as described previous, the transactions with related parties during the year ended December 31, 2021 are not material to the accompanying Consolidated Financial Statements. 2. Summary of Significant Accounting Policies - (continued) During the year ended December 31, 2020, the Company entered into certain related-party transactions, making payments for services to two vendors, seven consultants and two public universities, all of whom also are stockholders of the Company. The Company made payments related to manufacturing services to one vendor in the amount of approximately $502,000. Except for the manufacturing services as described previous, the transactions with related parties during the year ended December 31, 2020 are not material to the accompanying Consolidated Financial Statements. |
Net Loss per Share - Basic and Diluted | Net Loss per Share - Basic and Diluted Basic and diluted net loss per share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding for the period, which, for basic net loss per share, does not include the weighted-average unvested restricted common stock that has been issued but is subject to forfeiture of 41,216 shares for year ended December 31, 2021 and 77,262 shares for the year ended December 31, 2020. Dilutive common equivalent shares consist of stock options, warrants, and preferred stock and are calculated using the treasury stock method, which assumes the repurchase of common shares at the average market price during the period. Under the treasury stock method, options and warrants will have a dilutive effect when the average price of common stock during the period exceeds the exercise price of options or warrants. Common equivalent shares do not qualify as participating securities. In periods where the Company records a net loss including the years ended December 31, 2021 and 2020, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. All shares of Common Stock that may potentially be issued in the future are as follows: Year Ended December 31, 2021 2020 Common Stock Warrants 6,757,180 2,726,700 Employee Stock Options 515,922 246,893 Preferred Stock 2,089 865,500 Total Shares of Common Stock Issuable 7,275,191 3,839,093 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments As of December 31, 2021 and 2020, the fair value of the Company’s contingent consideration was $6.519 million and $5.343 million, respectively. During the year ended December 31, 2021, the Company recorded contingent consideration at fair value of $1.388 million as a result of the Bayon acquisition and reduced the contingent consideration liability by $0.212 million due to a payment made in accordance with terms from the Panoptes acquisition. During the year ended December 31, 2020, the Company recorded contingent consideration at fair value of $3.633 million as a result of the Panoptes acquisition. The remaining contingent consideration arose from Series D Preferred Shares. The Company evaluates the fair value of contingent consideration on a quarterly basis and there were no fair value adjustments recorded during the years ended December 31, 2021 and 2020. At December 31, 2021 and 2020, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Schedule of unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share | Year Ended December 31, 2021 2020 Common Stock Warrants 6,757,180 2,726,700 Employee Stock Options 515,922 246,893 Preferred Stock 2,089 865,500 Total Shares of Common Stock Issuable 7,275,191 3,839,093 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment | |
Schedule of property and equipment | Property and equipment at December 31, 2021 and 2020 consists of the following: Estimated Useful Life (Years) 2021 2020 Laboratory Equipment 3 $ 88,399 $ 82,653 Office Equipment 3 3,614 3,888 Office Furniture 5 72,549 14,430 Leasehold Improvements 2 22,569 22,569 Total Property and Equipment, Gross 187,131 123,540 Less Accumulated Depreciation 113,132 92,974 Total Property and Equipment, Net $ 73,999 $ 30,566 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, 2021 2020 Payroll and Benefits $ 937,970 $ 629,465 Professional Fees 194,425 328,420 Clinical Trials 168,785 203,646 Other 28,961 127,730 Total Accrued Expenses $ 1,330,141 $ 1,289,261 |
Intangible Assets and In-Proc_2
Intangible Assets and In-Process R&D (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Intangible Assets and In-Process R&D | |
Schedule of intangible assets and in-process R&D | Intangible assets and in-process R&D at December 31, 2021 and 2020 consists of the following: Estimated Useful Life (Years) 2021 2020 Trade Secrets 10 $ 250,000 $ 250,000 Less: Accumulated Amortization (81,250) (56,250) Intangible Assets, Net 168,750 193,750 In-Process R&D 10,297,414 9,536,414 Impairment Loss (1,770,314) — In-Process R&D, Net $ 8,527,100 $ 9,536,414 Total Intangible Assets and In-Process R&D, Net $ 8,695,850 $ 9,730,164 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Warrants | |
Schedule of warrant activity | Weighted Weighted Average Average Number of Exercise Remaining Awards Price Term in Years Outstanding at December 31, 2019 2,875,006 $ 14.14 3.37 Issued 25,000 12.50 4.01 Exercised (45,417) 4.80 2.29 Expired (127,889) 139.28 — Outstanding at December 31, 2020 2,726,700 $ 8.41 2.45 Issued 4,098,965 3.39 4.68 Exercised (10,417) 4.80 1.29 Expired (58,068) 52.50 — Outstanding at December 31, 2021 6,757,180 $ 4.99 3.42 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity Incentive Plan | |
Schedule of stock option activity | Weighted-Average Number of Weighted-Average Contractual Life Options Exercise Price (In Years) Outstanding at December 31, 2019 174,175 $ 27.42 6.22 Granted 93,165 6.31 Expired (17,114) 10.59 Forfeited (3,333) 7.20 Outstanding at December 31, 2020 246,893 $ 20.90 7.20 Exercisable at December 31, 2020 142,061 $ 31.58 5.85 Vested and Expected to Vest at December 31, 2020 246,893 $ 20.90 7.20 Granted 345,865 4.11 Expired (32,544) 25.86 Forfeited (44,292) 6.49 Outstanding at December 31, 2021 515,922 $ 10.43 8.30 Exercisable at December 31, 2021 201,653 $ 22.00 6.37 Vested and Expected to Vest at December 31, 2021 515,922 $ 10.43 8.30 |
Schedule of weighted average assumptions | 2021 2020 Risk-Free Interest Rate 1.82 % 1.82 % Expected Life 10.0 years 10.0 years Expected Average Volatility 140 % 153 % Expected Dividend Yield 0 % 0 % |
Schedule of restricted stock activity | Weighted-Average Number of Weighted-Average Remaining Shares Grant Date Fair Value Recognition Period Non-vested Outstanding at December 31, 2019 50,187 $ 8.64 1.49 Awarded 49,000 6.55 Vested (31,767) 8.69 Non-vested Outstanding at December 31, 2020 67,420 $ 7.10 1.66 Vested (46,437) 7.33 Forfeited (5,971) 6.66 Non-vested Outstanding at December 31, 2021 15,012 $ 6.55 1.09 |
Schedule of stock-based compensation expense | Year Ended December 31, 2021 2020 Research and Development $ 246,386 $ 197,806 General and Administrative 596,089 526,050 Total Stock-Based Compensation Expense $ 842,475 $ 723,856 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of components of loss before income taxes | Year Ended December 31, 2021 2020 Domestic $ (13,376,230) $ (7,996,327) Foreign (3,323,470) (83,558) Total Loss Before Income Taxes $ (16,699,700) $ (8,079,885) |
Schedule of components of income tax expense | Year Ended December 31, 2021 2020 Deferred Taxes: Federal $ (190,937) $ (529) State (113,843) 12,584 Total Deferred Taxes $ (304,780) $ 12,055 Income Tax (Benefit) Expense $ (304,780) $ 12,055 |
Schedule of effective income tax rate reconciliation | Year Ended December 31, 2021 2020 United States Federal Income Tax Rate 21.00 % 21.00 % State Taxes, Net of Federal Benefit 3.22 (1.59) Permanent Differences (5.69) (15.00) Change in Valuation Allowance (19.81) 17.53 Research and Development Credits 0.91 1.65 Tax Rate Differential 0.83 (2.12) Stock-Based Compensation — (1.32) Gain on Dissolution of Foreign Subsidiary — (15.81) Other 1.36 (4.49) Effective Tax Rate Expense 1.82 % (0.15) % |
Schedule of deferred tax assets and liabilities | Year Ended December 31, 2021 2020 Net Deferred Tax Liability: Net Operating Loss Carryforwards $ 20,689,134 $ 17,042,422 Research and Development Credit Carryforwards 2,853,598 2,695,773 Capitalized Research and Development 5,640,428 6,251,945 Stock-Based Compensation 835,432 781,252 Cash Versus Accrual Adjustments 128,188 223,674 Total Deferred Tax Assets 30,146,780 26,995,066 Valuation Allowance (28,628,836) (25,320,159) Net Deferred Tax Asset 1,517,944 1,674,907 Depreciation and Amortization (955) (1,083) In-Process Research and Development (2,131,425) (2,402,750) Net Deferred Tax Liability $ (614,436) $ (728,926) |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Schedule of maturities of lease Liabilities | Maturities of lease liabilities were as follows as of December 31, 2021: Operating Leases 2022 $ 133,339 2023 95,086 Less: Imputed Interest (19,014) Lease Liabilities $ 209,411 |
Acquisition (Tables)
Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Acquisition | |
Summary of purchase price allocation and estimated fair value | Bayon Current Assets (1) $ 5,290 In-Process R&D 761,000 Goodwill 1,013,627 Accounts Payable (36,525) Deferred Tax Liability (190,291) Contingent Consideration (1,388,101) Total Purchase Price $ 165,000 (1) Current Assets include cash and receivables of $3,910 and $1,380, respectively. Panoptes Current Assets $ 410,863 In-Process R&D 5,624,100 Goodwill 1,958,711 Property, Plant and Equipment 2,042 Accounts Payable and Other Liabilities (87,777) Deferred Tax Liability (351,507) Contingent Consideration (3,632,950) Assumed Liabilities (312,852) Total Purchase Price $ 3,610,630 (1) |
Schedule of Proforma disclosure for Panoptes acquisition | The following table includes the pro forma results for Bayon the year ended December 31, 2021 of the combined companies as though the Bayon Acquisition had been completed as of the beginning of the period presented. Year Ended Year Ended December 31, 2021 December 31, 2020 (unaudited) (unaudited) Operating Expenses $ 16,964,040 $ 8,426,655 Net Loss $ (16,416,499) $ (8,103,868) The following table includes the pro forma results for Panoptes the year ended December 31, 2020 of the combined companies as though the Panoptes Acquisition had been completed as of the beginning of the period presented. Year Ended December 31, 2020 (unaudited) Revenues $ 558,063 Operating Expenses 9,842,685 Net Loss $ (9,172,201) |
Organization, Business (Details
Organization, Business (Details) - USD ($) | Aug. 11, 2021 | Jan. 06, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | May 13, 2019 |
Subsidiary, Sale of Stock [Line Items] | |||||
Cash and Cash Equivalents, at Carrying Value | $ 7,854,690 | $ 1,185,677 | |||
Retained Earnings (Accumulated Deficit) | $ (124,733,753) | $ (108,338,834) | |||
Proceeds from Issuance of Private Placement | $ 8,000,000 | ||||
Capital Units, Authorized | 50,000,000 | ||||
Registered direct offering | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from Issuance of Private Placement | $ 9,800,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Net Loss per Share - Basic and Diluted (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Common Stock Issuable | 7,275,191 | 3,839,093 |
Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Common Stock Issuable | 6,757,180 | 2,726,700 |
Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Common Stock Issuable | 2,089 | 865,500 |
Employee Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Common Stock Issuable | 515,922 | 246,893 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) | Aug. 11, 2021$ / sharesshares | Jan. 06, 2021USD ($)$ / sharesshares | Jan. 03, 2020shares | Dec. 31, 2021USD ($)item | Dec. 31, 2020USD ($)item |
Restricted cash | $ 45,000 | $ 45,000 | |||
Goodwill | 0 | 3,484,607 | |||
Impairment loss | 4,498,234 | 0 | |||
In-process R&D | 8,696,000 | 9,730,000 | |||
Impairment loss of in-process R&D | 1,770,314 | 0 | |||
Deferred Tax Liabilities, Net | 614,436 | 728,926 | |||
Unrecognized uncertain income tax | 0 | 0 | |||
Money Market Funds Fair Value | 6,519,000 | 5,343,000 | |||
Fair value of contingent consideration | 0 | 0 | |||
Other assets or liabilities that are subject to fair value methodology and estimation | $ 0 | $ 0 | |||
Number of vendors with whom the company has entered into related party transactions | item | 1 | 2 | |||
Number of consultants with whom the company has entered into related party transactions | item | 6 | 7 | |||
Shares issued | shares | 4,668,844 | 1,531,101 | 500,000 | ||
Warrants to purchase common stock | shares | 233,442 | ||||
Accumulated Deficit | $ (124,733,753) | $ (108,338,834) | |||
Purchase price | $ / shares | $ 2.3025 | ||||
Net proceeds from the private placement | $ 8,000,000 | ||||
Related party transactions payments related to services provided | 502,000 | ||||
Contingent consideration liability | 29,719 | 0 | |||
Common Stock | Private Placement | |||||
Shares issued | shares | 1,531,101 | ||||
Warrants to purchase common stock | shares | 1,531,101 | ||||
Purchase price | $ / shares | $ 5.225 | ||||
Net proceeds from the private placement | $ 8,000,000 | ||||
Maximum [Member] | |||||
Estimated useful life (in years) | 5 years | ||||
Minimum [Member] | |||||
Estimated useful life (in years) | 2 years | ||||
Panoptes acquisition | |||||
Contingent consideration liability | $ 212,000 | ||||
Contingent consideration | $ 3,633,000 | ||||
Bayon acquisition | |||||
Contingent consideration | $ 1,388,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 187,131 | $ 123,540 |
Less: Accumulated Depreciation | 113,132 | 92,974 |
Total Property and Equipment, Net | 73,999 | 30,566 |
Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 88,399 | 82,653 |
Property, Plant and Equipment, Useful Life | 3 years | |
Office Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 3,614 | 3,888 |
Property, Plant and Equipment, Useful Life | 3 years | |
Office Furniture | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 72,549 | 14,430 |
Property, Plant and Equipment, Useful Life | 5 years | |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 22,569 | $ 22,569 |
Property, Plant and Equipment, Useful Life | 2 years |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property and Equipment | ||
Depreciation | $ 20,296 | $ 8,399 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses | ||
Payroll and Benefits | $ 937,970 | $ 629,465 |
Professional Fees | 194,425 | 328,420 |
Clinical Trials | 168,785 | 203,646 |
Other | 28,961 | 127,730 |
Total Accrued Expenses | $ 1,330,141 | $ 1,289,261 |
Debt (Details)
Debt (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
May 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Debt | |||
Proceeds from Paycheck Protection Program Loan | $ 278,000 | $ 0 | $ 278,190 |
Intangible Assets and In-Proc_3
Intangible Assets and In-Process R&D (Details) - Trade Secrets - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Trade Secrets | $ 250,000 | $ 250,000 |
Less: Accumulated Amortization | (81,250) | (56,250) |
Intangible Assets, Net | 168,750 | 193,750 |
In-Process R&D | 10,297,414 | 9,536,414 |
Impairment Loss | (1,770,314) | |
In-Process R&D, Net | 8,527,100 | 9,536,414 |
Total Intangible Assets and In-Process R&D, Net | $ 8,695,850 | $ 9,730,164 |
Estimated Useful Life (Years) | 10 years |
Intangible Assets and In-Proc_4
Intangible Assets and In-Process R&D - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Sep. 26, 2018 | |
Intangible Assets and In-Process R&D, Net | $ 8,695,850 | $ 9,730,164 | |
Amortization of Intangible Assets, Total | 25,000 | $ 25,000 | |
SentrX Animal Care Inc | |||
Intangible Assets and In-Process R&D, Net | 250,000 | ||
Intangible Assets Expected Milestone Payable | $ 4,750,000 | $ 4,750,000 |
Capital Stock (Details)
Capital Stock (Details) - USD ($) | Sep. 17, 2021 | Aug. 11, 2021 | Jul. 27, 2021 | Jan. 06, 2021 | Dec. 18, 2020 | Jan. 03, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 25, 2020 |
Class of Stock [Line Items] | |||||||||
Shares issued | 4,668,844 | 1,531,101 | 500,000 | ||||||
Share Price | $ 10 | ||||||||
Warrant Term | 5 years | ||||||||
Common Stock, Shares Authorized | 50,000,000 | 50,000,000 | 120,000,000 | ||||||
Class Of Warrant Or Right Number Of Warrant Issued | 1,531,101 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 233,442 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.8781 | ||||||||
Share Purchase Price Of Common Stock And Warrant | $ 5.225 | ||||||||
Warrants, exercise price, per share, subject to adjustments | $ 5.225 | ||||||||
Proceeds from Issuance of Private Placement | $ 8,000,000 | ||||||||
Total net proceeds from offerings | $ 9,800,000 | $ 4,500,000 | $ 18,750,016 | $ 5,000,000 | |||||
Purchase price | $ 2.3025 | ||||||||
Number of warrants issued to purchase the shares | 233,442 | ||||||||
Exercise price | $ 2.8781 | ||||||||
Expiry term | 5 years | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | |||||||
Issuance of Common Stock in Offerings, Net of Offering Costs | $ 10,911 | $ 4,501,313 | |||||||
Warrant | |||||||||
Class of Stock [Line Items] | |||||||||
Warrant Term | 6 months | ||||||||
Private Placement Warrants | |||||||||
Class of Stock [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,334,422 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.24 | ||||||||
Number of warrants issued to purchase the shares | 2,334,422 | ||||||||
Exercise price | $ 2.24 | ||||||||
Expiry term | 5 years | ||||||||
Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Conversion of Series C Preferred Stock into Common Stock (in shares) | 852,500 | ||||||||
Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Conversion of Series C Preferred Stock into Common Stock (in shares) | 4,092 | ||||||||
SeriesD Convertible Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 20,000 | ||||||||
Convertible Preferred Stock, Conversion Price | $ 3.5321 | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | ||||||||
Issuance of Common Stock in Offerings, Net of Offering Costs | $ 39 |
Warrants (Details)
Warrants (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year | 77,262 | ||
Outstanding at end of year | 41,216 | 77,262 | |
Weighted Average Remaining Term in Years, Outstanding | 1 year 5 months 26 days | ||
Warrant | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year | 2,726,700 | 2,875,006 | |
Issued | 4,098,965 | 25,000 | |
Exercised | (10,417) | (45,417) | |
Expired | (58,068) | ||
Expired | (127,889) | ||
Outstanding at end of year | 6,757,180 | 2,726,700 | 2,875,006 |
Weighted Average Exercise Price, Outstanding at beginning of year | $ 8.41 | $ 14.14 | |
Weighted Average Exercise Price, Issued | 3.39 | 12.50 | |
Weighted Average Exercise Price, Exercised | 4.80 | 4.80 | |
Weighted Average Exercise Price, Expired | 52.50 | 139.28 | |
Weighted Average Exercise Price, Outstanding at end of year | $ 4.99 | $ 8.41 | $ 14.14 |
Weighted Average Remaining Term in Years, Outstanding | 3 years 5 months 1 day | 2 years 5 months 12 days | 3 years 4 months 13 days |
Weighted Average Remaining Term in Years, Issued | 4 years 8 months 4 days | 4 years 3 days | |
Weighted Average Remaining Term in Years, Exercised | 1 year 3 months 14 days | 2 years 3 months 14 days | |
Weighted Average Remaining Term in Years, Expired | 0 years | 0 years |
Warrants - Additional Informati
Warrants - Additional Information (Details) - shares | Aug. 11, 2021 | Jan. 06, 2021 | Jan. 03, 2020 |
Warrants | |||
Class Of Warrant Or Right Number Of Warrant Issued | 1,531,101 | ||
Stock Issued During Period, Shares, New Issues | 4,668,844 | 1,531,101 | 500,000 |
Equity Incentive Plan (Details)
Equity Incentive Plan (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Equity Incentive Plan | |||
Number of Options, Outstanding at beginning of year | 246,893 | 174,175 | |
Number of Options, Granted | 345,865 | 93,165 | |
Number of Options, Expired | (32,544) | (17,114) | |
Number of Options, Forfeited | (44,292) | (3,333) | |
Number of Options, Outstanding at end of year | 515,922 | 246,893 | 174,175 |
Number of Options, Exercisable at end of year | 201,653 | 142,061 | |
Number of Options, Vested and expected to vest at end of year | 515,922 | 246,893 | |
Weighted- Average Exercise Price, Outstanding at beginning of year | $ 20.90 | $ 27.42 | |
Weighted- Average Exercise Price, Granted | 4.11 | 6.31 | |
Weighted- Average Exercise Price, Expired | 25.86 | 10.59 | |
Weighted- Average Exercise Price, Forfeited | 6.49 | 7.20 | |
Weighted- Average Exercise Price, Outstanding at end of year | 10.43 | 20.90 | $ 27.42 |
Weighted- Average Exercise Price, Exercisable at end of year | 22 | 31.58 | |
Weighted- Average Exercise Price, Vested and expected to vest at end of year | $ 10.43 | $ 20.90 | |
Weighted-Average Remaining Contractual Life (In Years), Outstanding | 8 years 3 months 18 days | 7 years 2 months 12 days | 6 years 2 months 19 days |
Weighted-Average Remaining Contractual Life (In Years), Exercisable at end of year | 6 years 4 months 13 days | 5 years 10 months 6 days | |
Weighted-Average Remaining Contractual Life (In Years), Vested and expected to vest at end of year | 8 years 3 months 18 days | 7 years 2 months 12 days |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Risk-Free Interest Rate | 1.82% | 1.82% |
Expected Life | 10 years | 10 years |
Expected Average Volatility | 140.00% | 153.00% |
Expected Dividend Yield | 0.00% | 0.00% |
Equity Incentive Plan - Restric
Equity Incentive Plan - Restricted Stock Activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Outstanding at beginning of year | 77,262 | ||
Outstanding at end of year | 41,216 | 77,262 | |
Weighted- Average Remaining Recognition Period Nonvested Outstanding | 1 year 5 months 26 days | ||
Restricted Stock | |||
Outstanding at beginning of year | 67,420 | 50,187 | |
Number of Shares Awarded | 0 | 49,000 | |
Number of Shares Vested | (46,437) | (31,767) | |
Number of Shares Forfeited | (5,971) | ||
Outstanding at end of year | 15,012 | 67,420 | 50,187 |
Weighted- Average Grant Date Fair Value Outstanding at beginning of year | $ 7.10 | $ 8.64 | |
Weighted- Average Grant Date Fair Value Awarded | 7.33 | 6.55 | |
Weighted- Average Grant Date Fair Value Vested | 8.69 | ||
Weighted- Average Grant Date Fair Value Forfeited | 6.66 | ||
Weighted- Average Grant Date Fair Value Outstanding at end of year | $ 6.55 | $ 7.10 | $ 8.64 |
Weighted- Average Remaining Recognition Period Nonvested Outstanding | 1 year 1 month 2 days | 1 year 7 months 28 days |
Equity Incentive Plan - Stock-b
Equity Incentive Plan - Stock-based Compensation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total Stock-Based Compensation Expense | $ 842,475 | $ 723,856 |
Research and Development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total Stock-Based Compensation Expense | 246,386 | 197,806 |
General and Administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total Stock-Based Compensation Expense | $ 596,089 | $ 526,050 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2010 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 1,001,000 | $ 780,000 | |||
Fair value of options granted | $ 1,233,000 | $ 580,000 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 3 months 7 days | 1 year 11 months 12 days | |||
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding And Exercisable Intrinsic Value | $ 0 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 345,865 | 93,165 | |||
Excess Stock, Shares Authorized | 59,414 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 4.91 | $ 6.26 | |||
Number of Options, Granted | 345,865 | 93,165 | |||
One-year anniversary [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | ||||
24-month period [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 0.67% | ||||
Holders Owing More Than Ten Percentage Voting Rights [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 5 years | ||||
Holders Owing More Than Ten Percentage Voting Rights [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Percentage of Exercise Price | 110.00% | ||||
Holders Owing More Than Ten Percentage Voting Rights [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 10 years | ||||
ESPP [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 7,806 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 11,371 | ||||
2014 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 110,874 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 806,005 | 806,005 | |||
Excess Stock, Shares Authorized | 200,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 23,333 | ||||
Restricted Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period | 5,971 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 0 | 49,000 | |||
Restricted Stock | One-year anniversary [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | ||||
Restricted Stock | 24-month period [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 0.67% |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Domestic | $ 13,376,230 | $ 7,996,327 |
Foreign | 3,323,470 | 83,558 |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total | $ (16,699,700) | $ (8,079,885) |
Income Taxes - Components of in
Income Taxes - Components of income tax expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Deferred Taxes | ||
Federal | $ (190,937) | $ (529) |
State | (113,843) | 12,584 |
Total Deferred Taxes | (304,780) | 12,055 |
Income Tax Benefit | $ (304,780) | $ 12,055 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of effective tax rate (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
United States Federal Income Tax Rate | 21.00% | 21.00% |
State Taxes, Net of Federal Benefit | 3.22% | (1.59%) |
Permanent Differences | (5.69%) | (15.00%) |
Change in Valuation Allowance | (19.81%) | 17.53% |
Research and Development Credits | 0.91% | 1.65% |
Tax Rate Differential | 0.83% | (2.12%) |
Stock-Based Compensation | (1.32%) | |
Gain on Dissolution of Foreign Subsidiary | (15.81%) | |
Other | 1.36% | (4.49%) |
Effective Tax Rate (Expense) Benefit | 1.82% | (0.15%) |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Net Deferred Tax Liability | ||
Net Operating Loss Carryforwards | $ 20,689,134 | $ 17,042,422 |
Research and Development Credit Carryforwards | 2,853,598 | 2,695,773 |
Capitalized Research and Development | 5,640,428 | 6,251,945 |
Stock-Based Compensation | 835,432 | 781,252 |
Cash Versus Accrual Adjustments | 128,188 | 223,674 |
Total Deferred Tax Assets | 30,146,780 | 26,995,066 |
Valuation Allowance | (28,628,836) | (25,320,159) |
Net Deferred Tax Asset | 1,517,944 | 1,674,907 |
Depreciation and Amortization | (955) | (1,083) |
In-Process Research and Development | (2,131,425) | (2,402,750) |
Net Deferred Tax Liability | $ (614,436) | $ (728,926) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes | ||||
Operating Loss Carryforwards, Expiration Period | 2041 | |||
Operating Loss Carryforwards | $ 72,370,000 | $ 51,930,000 | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 3,309,000 | $ (958,000) | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | ||
Unrecognized uncertain income tax | $ 0 | $ 0 | ||
Domestic Tax Authority [Member] | ||||
Income Taxes | ||||
Operating Loss Carryforwards | 639,000 | $ 46,054,000 | ||
Tax Credit Carryforward, Amount | $ 26,316,000 | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 80.00% | |||
Foreign Tax Authority [Member] | ||||
Income Taxes | ||||
Operating Loss Carryforwards | 9,405,000 | |||
State and Local Jurisdiction [Member] | ||||
Income Taxes | ||||
Operating Loss Carryforwards | 49,894,000 | $ 2,037,000 | ||
Tax Credit Carryforward, Amount | $ 503,000 | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 80.00% | |||
Research Tax Credit Carryforward [Member] | ||||
Income Taxes | ||||
Operating Loss Carryforwards, Expiration Period | 2041 | |||
Research Tax Credit Carryforward [Member] | Domestic Tax Authority [Member] | ||||
Income Taxes | ||||
Tax Credit Carryforward, Amount | $ 2,456,000 |
Commitments and Contingencies -
Commitments and Contingencies - Maturities of Lease Liabilities (Details) | Dec. 31, 2021USD ($) |
Commitments and Contingencies | |
2022 | $ 133,339 |
2023 | 95,086 |
Less: Imputed Interest | (19,014) |
Lease Liabilities | $ 209,411 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | Apr. 23, 2020USD ($) | Sep. 12, 2013USD ($) | Jul. 02, 2013USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Nov. 30, 2023ft² | Oct. 31, 2023ft² | Mar. 31, 2022ft² |
Commitments and Contingencies [Line Items] | ||||||||
Payment of annual fee | $ 5,000 | |||||||
Intangible Assets, Net (Excluding Goodwill) | $ 8,695,850 | $ 9,730,164 | ||||||
Cease Payments Not Yet Paid Based On Prevailing Financial Market Conditions | 10.00% | |||||||
Operating lease expense | $ 215,000 | |||||||
Imputed interest on the lease liability | $ 174,000 | |||||||
For The First 250 Million Net Sales [Member] | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Percentage Of Royalties On Net Sales | 2.00% | |||||||
Between 250 And 500 Million Net Sales [Member] | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Percentage Of Royalties On Net Sales | 1.25% | |||||||
Net Sales Over 500 Million [Member] | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Percentage Of Royalties On Net Sales | 0.50% | |||||||
License [Member] | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Cost of Goods and Services Sold | $ 30,000 | $ 155,000,000 | ||||||
Subsequent Event | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Area of Land | ft² | 3,540 | 1,555 | ||||||
New Valeant Agreement | Subsequent Event | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Area of Land | ft² | 4,516 | |||||||
Licensing Agreements [Member] | License [Member] | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Percentage Of Royalties On Net Sales | 6.00% | 3.25% |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2021 | |
Employee Benefit Plans | ||
Defined Benefit Plan, Plan Assets, Contributions by Employer | $ 25,905 | |
Defined Benefit Plan Contributions by Employer Accrued | $ 20,334 | |
Defined Benefit Plan, Plan Assets, Matching Contributions by Employer | 0.00% |
Acquisition (Details)
Acquisition (Details) - USD ($) | Dec. 18, 2020 | Dec. 31, 2021 | Oct. 21, 2021 | Dec. 31, 2020 |
Business Acquisition [Line Items] | ||||
Fair value of contingent consideration | $ 0 | $ 0 | ||
Panoptes | ||||
Business Acquisition [Line Items] | ||||
Percentage of equity interests acquired | 100.00% | |||
Cash consideration paid | $ 445,000 | |||
Fair value of contingent consideration | 3,632,950 | |||
Fair value of shares issued | $ 3,169,000 | |||
Threshold period of volume weighted average price | 30 days | |||
Volume weighted average price | $ 3.5321 | |||
Panoptes | Due to creditor | ||||
Business Acquisition [Line Items] | ||||
Fair Value at the acquisition date | $ 212,000 | |||
Panoptes | Earn-out provisions | ||||
Business Acquisition [Line Items] | ||||
Fair value of contingent consideration | 2,067,000 | |||
Additional milestone payment | $ 4,750,000 | |||
Panoptes | 18-month Period subject to post-closing adjustments | ||||
Business Acquisition [Line Items] | ||||
Shares issued as consideration | 1,500 | |||
Number of shares convertible | 424,685 | |||
Fair value of contingent consideration | $ 1,353,000 | |||
Bayon | ||||
Business Acquisition [Line Items] | ||||
Percentage of equity interests acquired | 100.00% | |||
Cash consideration paid | $ 97,000 | |||
Shares issued as consideration | 33,798 | |||
Fair value of contingent consideration | $ 1,388,101 | |||
Fair value of shares issued | $ 68,000 | |||
Volume weighted average price | $ 2.01 | |||
Bayon | Due to creditor | ||||
Business Acquisition [Line Items] | ||||
Fair Value at the acquisition date | $ 1,388,000 | |||
Bayon | Earn-out provisions | ||||
Business Acquisition [Line Items] | ||||
Earnout consideration | $ 7,100,000 | |||
Common Stock | Panoptes | ||||
Business Acquisition [Line Items] | ||||
Shares issued as consideration | 884,222 | |||
Series D Convertible Preferred Stock | Panoptes | ||||
Business Acquisition [Line Items] | ||||
Shares issued as consideration | 45.893 | |||
Number of shares convertible | 13,000 |
Acquisition - Purchase price al
Acquisition - Purchase price allocation (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Oct. 21, 2021 | Dec. 18, 2020 | |
Business Acquisition [Line Items] | ||||
Contingent Consideration | $ 0 | $ 0 | ||
Panoptes | ||||
Business Acquisition [Line Items] | ||||
Current Assets | $ 410,863 | |||
In-Process R&D | 5,624,100 | |||
Goodwill | 1,958,711 | |||
Property, Plant and Equipment | 2,042 | |||
Accounts Payable and Other Liabilities | (87,777) | |||
Deferred Tax Liability | (351,507) | |||
Contingent Consideration | (3,632,950) | |||
Assumed Liabilities | (312,852) | |||
Total Purchase Price | 3,610,630 | |||
Cash | 333,860 | |||
Receivables | 73,368 | |||
Prepaid expenses | $ 3,635 | |||
Net losses of acquiree from the acquisition date | 34,000 | |||
Acquisition-related costs | 50,000 | $ 414,000 | ||
Bayon | ||||
Business Acquisition [Line Items] | ||||
Current Assets | $ 5,290 | |||
In-Process R&D | 761,000 | |||
Goodwill | 1,013,627 | |||
Accounts Payable and Other Liabilities | (36,525) | |||
Deferred Tax Liability | (190,291) | |||
Contingent Consideration | (1,388,101) | |||
Total Purchase Price | $ 165,000 | |||
Cash | 3,910 | |||
Receivables | 1,380 | |||
Net losses of acquiree from the acquisition date | 128,000 | |||
Acquisition-related costs | $ 90,000 |
Acquisition - Proforma disclosu
Acquisition - Proforma disclosure (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Panoptes | ||
Business Acquisition [Line Items] | ||
Revenues | $ 558,063 | |
Operating Expenses | 9,842,685 | |
Net Loss | (9,172,201) | |
Bayon | ||
Business Acquisition [Line Items] | ||
Operating Expenses | $ 16,964,040 | 8,426,655 |
Net Loss | $ (16,416,499) | $ (8,103,868) |
Subsequent Events (Details)
Subsequent Events (Details) - $ / shares | Aug. 11, 2021 | Jan. 06, 2021 | Jan. 03, 2020 | Dec. 31, 2021 |
Subsequent Event [Line Items] | ||||
Shares issued | 4,668,844 | 1,531,101 | 500,000 | |
Warrants to purchase common stock | 233,442 | |||
Share Price | $ 10 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.8781 | |||
Expiry term | 5 years | |||
Bayon | ||||
Subsequent Event [Line Items] | ||||
Consideration (in shares) | 33,798 |