Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 22, 2022 | Jun. 30, 2021 | |
Document Information Line Items | |||
Entity Registrant Name | TFF Pharmaceuticals, Inc. | ||
Trading Symbol | TFFP | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 25,371,781 | ||
Entity Public Float | $ 229,001,120 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001733413 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Shell Company | false | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-39102 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 82-4344737 | ||
Entity Address, Address Line One | 1751 River Run | ||
Entity Address, Address Line Two | Suite 400 | ||
Entity Address, City or Town | Fort Worth | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 76107 | ||
City Area Code | (817) | ||
Local Phone Number | 438-6168 | ||
Title of 12(b) Security | Common stock: Par value $0.001 | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes | ||
Auditor Firm ID | 688 | ||
Auditor Name | Marcum LLP | ||
Auditor Location | New York, NY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 33,794,672 | $ 35,300,805 |
Receivable due from collaboration agreement | 1,628,703 | |
Research and development tax incentive receivable | 966,646 | |
Prepaid assets and other current assets | 2,447,930 | 2,258,229 |
Total current assets | 38,837,951 | 37,559,034 |
Property and equipment, net | 1,859,860 | 1,102,808 |
Total assets | 40,697,811 | 38,661,842 |
Current liabilities: | ||
Accounts payable | 1,493,842 | 1,297,725 |
Accrued compensation | 416,910 | |
Deferred research grant revenue | 50,000 | 24,315 |
Total liabilities | 1,960,752 | 1,322,040 |
Commitments and contingencies (see Note 4) | ||
Stockholders’ equity: | ||
Common stock; $0.001 par value, 45,000,000 shares authorized; 25,371,781 and 22,534,874 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 25,372 | 22,535 |
Additional paid-in capital | 104,078,968 | 71,648,453 |
Accumulated other comprehensive loss | (48,921) | (51,538) |
Accumulated deficit | (65,318,360) | (34,279,648) |
Total stockholders’ equity | 38,737,059 | 37,339,802 |
Total liabilities and stockholders’ equity | $ 40,697,811 | $ 38,661,842 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 45,000,000 | 45,000,000 |
Common stock, shares issued | 25,371,781 | 22,534,874 |
Common stock, shares outstanding | 25,371,781 | 22,534,874 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Grant revenue | $ 88,161 | |
Operating expenses: | ||
Research and development | 21,300,865 | 10,681,565 |
General and administrative | 10,573,954 | 8,012,085 |
Total operating expenses | 31,874,819 | 18,693,650 |
Loss from operations | (31,786,658) | (18,693,650) |
Other income: | ||
Other income | 696,714 | |
Interest income | 51,232 | 126,416 |
Total other income | 747,946 | 126,416 |
Net loss | $ (31,038,712) | $ (18,567,234) |
Net loss per share, basic and diluted (in Dollars per share) | $ (1.25) | $ (0.91) |
Weighted average common shares outstanding, basic and diluted (in Shares) | 24,820,971 | 20,425,162 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (31,038,712) | $ (18,567,234) |
Other comprehensive loss: | ||
Foreign currency translation adjustments | 2,617 | (51,538) |
Comprehensive loss | $ (31,036,095) | $ (18,618,772) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 18,451 | $ 43,338,710 | $ (15,712,414) | $ 27,644,747 | |
Balance (in Shares) at Dec. 31, 2019 | 18,450,992 | ||||
Sale of common stock, net of offering costs | $ 3,048 | 24,277,235 | 24,280,283 | ||
Sale of common stock, net of offering costs (in Shares) | 3,048,654 | ||||
Issuance of common stock for accrued research and development expense | $ 221 | 1,131,792 | 1,132,013 | ||
Issuance of common stock for accrued research and development expense (in Shares) | 220,666 | ||||
Issuance of common stock for stock option exercises | $ 285 | 714,097 | 714,382 | ||
Issuance of common stock for stock option exercises (in Shares) | 285,003 | ||||
Issuance of common stock in connection with cashless warrant exercises | $ 530 | (530) | |||
Issuance of common stock in connection with cashless warrant exercises (in Shares) | 529,559 | ||||
Stock-based compensation | 2,187,149 | 2,187,149 | |||
Foreign currency translation adjustment | (51,538) | (51,538) | |||
Net loss | (18,567,234) | (18,567,234) | |||
Balance at Dec. 31, 2020 | $ 22,535 | 71,648,453 | (51,538) | (34,279,648) | 37,339,802 |
Balance (in Shares) at Dec. 31, 2020 | 22,534,874 | ||||
Sale of common stock, net of offering costs | $ 2,140 | 28,012,879 | 28,015,019 | ||
Sale of common stock, net of offering costs (in Shares) | 2,140,000 | ||||
Issuance of common stock for stock option exercises | $ 252 | 689,500 | 689,752 | ||
Issuance of common stock for stock option exercises (in Shares) | 252,156 | ||||
Issuance of common stock for warrant exercises | $ 445 | 179,768 | 180,213 | ||
Issuance of common stock for warrant exercises (in Shares) | 444,751 | ||||
Stock-based compensation | 3,548,368 | 3,548,368 | |||
Foreign currency translation adjustment | 2,617 | 2,617 | |||
Net loss | (31,038,712) | (31,038,712) | |||
Balance at Dec. 31, 2021 | $ 25,372 | $ 104,078,968 | $ (48,921) | $ (65,318,360) | $ 38,737,059 |
Balance (in Shares) at Dec. 31, 2021 | 25,371,781 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (31,038,712) | $ (18,567,234) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Stock based compensation | 3,548,368 | 2,187,149 |
Depreciation and amortization | 111,453 | |
Changes in operating assets and liabilities: | ||
Receivable due from collaboration agreement | (1,628,703) | |
Research and development tax incentive receivable | (997,802) | |
Prepaid assets and other current assets | (203,363) | (1,122,495) |
Accounts payable | 209,193 | 862,676 |
Accrued compensation | 416,910 | |
Deferred revenue | 25,685 | 24,315 |
Net cash used in operating activities | (29,556,971) | (16,615,589) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (868,505) | (1,102,808) |
Net cash used in investing activities | (868,505) | (1,102,808) |
Cash flows from financing activities: | ||
Net proceeds from issuance of common stock | 28,015,019 | 24,280,283 |
Proceeds from issuance of common stock for stock option exercises | 689,752 | 714,382 |
Proceeds from issuance of common stock for warrant exercises | 180,213 | |
Net cash provided by financing activities | 28,884,984 | 24,994,665 |
Effect of exchange rate changes on cash and cash equivalents | 34,359 | (70,399) |
Net change in cash and cash equivalents | (1,506,133) | 7,205,869 |
Cash and cash equivalents at beginning of year | 35,300,805 | 28,094,936 |
Cash and cash equivalents at end of year | 33,794,672 | 35,300,805 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Cashless exercise of warrants | 416 | 530 |
Issuance of common stock for accrued research and development expense | $ 1,132,013 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS TFF Pharmaceuticals, Inc. (the “Company”) was incorporated in the State of Delaware on January 24, 2018 by Lung Therapeutics, Inc. (“LTI”), at which time the Company and LTI entered into a Contribution and Subscription Agreement (“Contribution Agreement”) pursuant to which LTI agreed to transfer to the Company certain of LTI’s non-core intellectual property rights and other assets, including LTI’s rights under a patent license agreement with the University of Texas at Austin (see Note 5), in exchange for 4,000,000 shares of the Company’s common stock. The transactions under the Contribution Agreement closed in March 2018. LTI’s basis in such assets were minimal. LTI is an early-stage biotechnology company focused on the development of certain technologies in the pulmonary field. The Company’s initial focus is on the development of inhaled dry powder drugs to enhance the treatment of pulmonary diseases and conditions. In December 2019, the Company established a wholly-owned Australian subsidiary, TFF Pharmaceuticals Australia Pty Ltd (“TFF Australia”), in order to conduct clinical research. TFF Pharmaceuticals, Inc., along with TFF Australia, are collectively referred to as the “Company”. The Company is in the development stage and is devoting substantially all of its efforts toward technology research and development and the human clinical trials of its initial product candidates. August 2020 Private Placement On August 13, 2020, the Company conducted a private placement of 3,048,654 shares of its common stock, at a purchase price per share of $8.50, for aggregate gross proceeds to the Company of approximately $25,914,000, before deducting selling commissions and other offering expenses payable by the Company. After deducting the placement agent commissions and offering expenses, the Company received net proceeds of approximately $24,280,000. See Note 6 for additional details of the private placement. March 2021 Public Offering On March 30, 2021, the Company completed a public offering (“March 2021 Offering”), selling 2,140,000 shares of common stock at an offering price of $14.00 per share. The Company received gross proceeds of approximately $30,000,000. The Company received net proceeds of approximately $28,015,000, after deducting underwriting discounts and offering-related expenses. COVID-19 As of the date of this report, the COVID-19 pandemic has had a limited impact on our operations. During 2020, we experienced a temporary suspension of dosing in the Phase I clinical trial for our TFF Tac-Lac due to the COVID-19 pandemic, and the pandemic has otherwise caused minor slowing in the timing of certain non-clinical and clinical activities by us and our collaborators and service providers during 2020 and the first nine months of 2021. However, the COVID-19 pandemic has not caused us to forego, abandon or substantially delay any proposed activities. While we believe we have been able to effectively manage the disruption caused by the COVID-19 pandemic to date, there can be no assurance that our operations, including the development of our drug candidates, will not be disrupted or materially adversely affected in the future by the COVID-19 pandemic or an epidemic or outbreak of an infectious disease like the outbreak of COVID-19. |
Liquidity and Management_s Plan
Liquidity and Management’s Plans | 12 Months Ended |
Dec. 31, 2021 | |
Liquidity and Managements Plans [Abstract] | |
LIQUIDITY AND MANAGEMENT’S PLANS | NOTE 2 – LIQUIDITY AND MANAGEMENT’S PLANS As of December 31, 2021, the Company had cash and cash equivalents of approximately $33,795,000 and a working capital surplus of approximately $36,877,000. The Company has not generated commercial revenues since inception and has incurred recurring operating losses. The Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue its product development. The Company expects to further increase its research and development activities, which will increase the amount of cash utilized subsequent to December 31, 2021. Specifically, the Company expects increased spending on research and development activities and higher payroll expenses as it increases its professional and scientific staff and continues to prepare for anticipated manufacturing activities. If the Company encounters unforeseen delays or expenses, it has the ability to curtail its presently planned level of operations. The Company currently believes its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of these consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The Company’s consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) and reflect the financial position, results of operations and cash flows for all periods presented. Principles of Consolidation The consolidated financial statements include the accounts of TFF Pharmaceuticals, Inc. and its wholly-owned subsidiary, TFF Australia. All material intercompany accounts and transactions have been eliminated in consolidation. Foreign Currency The currency of TFF Australia, the Company’s international subsidiary, is in Australian dollars. Foreign currency denominated assets and liabilities are translated into U.S. dollars using the exchange rates in effect at each balance sheet date. Results of operations and cash flows are translated using the average exchange rates throughout the period. The effect of exchange rate fluctuations on translation of assets and liabilities is included as a separate component of stockholders’ equity in accumulated other comprehensive income (loss). Geographic Concentrations The Company conducts business in the U.S. and Australia. As of December 31, 2021 and 2020, the Company maintained 100% of its net property and equipment in the U.S. Cash and Cash Equivalents The Company maintains its operating accounts in financial institutions in the U.S. and in Australia. The balances are insured up to specified limits. The Company’s cash is maintained in checking accounts and money market funds with maturities of less than three months when purchased, which are readily convertible to known amounts of cash, and which in the opinion of management are subject to insignificant risk of loss in value. As of December 31, 2021 and 2020, the Company had cash in Australia of AUD$831,984 (US$604,944) and AUD$214,240 (US$165,092), respectively. Property and Equipment, net Property and equipment are stated at cost less accumulated depreciation and amortization. The Company calculates depreciation using the straight-line method over the estimated useful lives of the assets, which range from two to five years for furniture, fixtures, lab and computer equipment and software. Assets held within construction in progress are not depreciated. Construction in progress is related to the construction or development of property and equipment that have not yet been placed in service for its intended use. As of December 31, 2021 and 2020, approximately $431,000 and $1,103,000, respectively, of the Company’s property and equipment consisted of lab equipment that are considered construction in progress. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Fair Value of Financial Instruments Authoritative guidance requires disclosure of the fair value of financial instruments. The Company’s financial instruments consist of cash and cash equivalents and accounts payable, the carrying amounts of which approximate their estimated fair values primarily due to the short-term nature of the instruments or based on information obtained from market sources and management estimates. The Company measures the fair value of certain of its financial assets and liabilities on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value which is not equivalent to cost will be classified and disclosed in one of the following three categories: Level 1 — Quoted prices (unadjusted) in active markets for identical assets and liabilities. Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Income Taxes In accordance with authoritative guidance, deferred tax assets and liabilities are recorded for temporary differences between the financial reporting and tax bases of assets and liabilities using the current enacted tax rate expected to be in effect when the differences are expected to reverse. A valuation allowance is recorded on deferred tax assets unless realization is considered more likely than not. The Company evaluates its tax positions taken or expected to be taken in the course of preparing the Company’s tax returns to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet the “more-likely-than-not” threshold are not recorded as a tax benefit or expense in the current year. The Company recognizes interest and penalties, if any, related to uncertain tax positions in interest expense. No interest and penalties related to uncertain tax positions were accrued at either December 31, 2021 or 2020. The Company follows authoritative guidance which requires the evaluation of existing tax positions. The Company files in the federal and various state jurisdictions. Management has analyzed all open tax years, as defined by the statute of limitations, for all major jurisdictions. Open tax years are those that are open for examination by taxing authorities. The Company’s tax years since its incorporation in 2018 and forward are subject to examination by tax authorities due to the carryforward of unutilized net operating losses and research and development credits. Revenue Recognition The Company has entered into feasibility and material transfer agreements (“Feasibility Agreements”) with third parties that provide the Company with funds in return for certain research and development activities. Revenue from the Feasibility Agreements is recognized in the period during which the related qualifying services are rendered and costs are incurred, provided that the applicable conditions under the Feasibility Agreements have been met. The Feasibility Agreements are on a best-effort basis and do not require scientific achievement as a performance obligation. All fees received under the Feasibility Agreements are non-refundable. The costs associated with the Feasibility Agreements are expensed as incurred and are reflected as a component of research and development expense in the accompanying condensed consolidated statements of operations. Funds received from the Feasibility Agreements are recorded as revenue as the Company is the principal participant in the arrangement because the activities under the Feasibility Agreements are part of the Company’s development programs. In those instances where the Company first receives consideration in advance of providing underlying services, the Company classifies such consideration as deferred revenue until (or as) the Company provides the underlying services. In those instances where the Company first provides the underlying services prior to its receipt of consideration, the Company records a grant receivable. During the years ended December 31, 2021 and 2020, the Company rendered the related services and recognized revenue and research and development expenses of $88,161 and $0, respectively. As of December 31, 2021 and 2020, the Company had receivables due related to Feasibility Agreements of $11,996 and $0, respectively, which is included in prepaid assets and other current assets in the accompanying consolidated balance sheets, and deferred grant revenue of $50,000 and $24,315, respectively. Collaborative Arrangements The Company considers the nature and contractual terms of arrangements and assesses whether an arrangement involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity. If the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity, the Company accounts for such arrangement as a collaborative arrangement under Accounting Standards Codification (“ASC”) 808, Collaborative Arrangements For arrangements determined to be within the scope of ASC 808 where a collaborative partner is not a customer for certain research and development activities, the Company accounts for payments received for the reimbursement of research and development costs as a contra-expense in the period such expenses are incurred. This reflects the joint risk sharing nature of these activities within a collaborative arrangement. The Company classifies payments owed or receivables recorded as other current liabilities or prepaid expenses and other current assets, respectively, in the Company’s consolidated balance sheets. Please refer to Note 5, “Joint Development Agreement” for additional details regarding the Company’s joint development agreement (“JDA”) with Augmenta Bioworks, Inc. (“Augmenta”). If payments from the collaborative partner to the Company represent consideration from a customer in exchange for distinct goods and services provided, then the Company accounts for those payments within the scope of ASC 606, Revenue from Contracts with Customers Research and Development Expenses In accordance with authoritative guidance, the Company charges research and development costs to operations as incurred. Research and development expenses consist of personnel costs for the design, development, testing and enhancement of the Company’s technology, and certain other allocated costs, such as depreciation and other facilities related expenditures. Research and Development Tax Incentive The Company is eligible to obtain a cash refund from the Australian Taxation Office for eligible research and development expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”). The Company recognizes the Australian Tax Incentive when there is reasonable assurance that the cash refund will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. During the year ended December 31, 2021, the Company received its first cash refund under the Australian Tax Incentive, which was for expenditures incurred during 2020. Therefore, the Company recorded amounts received, or that it expects to receive, for expenditures incurred during 2020 as other income in the consolidated statements of operations. As the Company has determined that it has reasonable assurance that it will receive the cash refund for eligible research and development expenditures, beginning with expenditures incurred during the year ended December 31, 2021, the Company records the Australian Tax Incentive as a reduction to research and development expenses as the Australian Tax Incentive is not dependent on the Company generating future taxable income, the Company’s ongoing tax status, or tax position. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. This percentage of eligible research and development expenses reimbursable under the Australian Tax Incentive is 43.5% for the years ended December 31, 2021 and 2020. The research and development incentive receivable represents an amount due in connection with the Australian Tax Incentive. The Company has recorded a research and development tax incentive receivable of $966,646 and $0 as of December 31, 2021 and 2020, respectively, in the consolidated balance sheets. The Company has recorded other income of $652,877 and $0, in the consolidated statements of operations for the years ended December 31, 2021 and 2020, respectively, related to refundable Australian research and development incentive program payments for expenditures incurred during 2020. The Company recorded a reduction to research and development expenses of $997,801 and $0 during the years ended December 31, 2021 and 2020, respectively, for expenditures incurred during 2021. In addition, the Company also received $43,837 and $0 during the years ended December 31, 2021 and 2020, respectively, from the United States Internal Revenue Service related to research and development tax credits for expenditures incurred during 2020, which has been included in other income in the consolidated statements of operations. Basic and Diluted Earnings per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive share equivalents outstanding for the period, determined using the treasury-stock and if-converted methods. Since the Company has had net losses for all periods presented, all potentially dilutive securities are anti-dilutive. Basic weighted average shares outstanding for the years ended December 31, 2021 and 2020 include 400,000 shares underlying a warrant to purchase common shares that was exercisable for little consideration (an aggregate exercise price of $0.01 per share) and was deemed issued for the purposes of basic earnings per share. The warrant was exercised during the year ended December 31, 2021. For the years ended December 31, 2021 and 2020, the Company had the following potential common stock equivalents outstanding which were not included in the calculation of diluted net loss per common share because inclusion thereof would be anti-dilutive: Year Ended Year Ended Stock Options 2,893,839 2,610,495 Warrants 389,233 417,355 3,283,072 3,027,850 Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include the fair value of stock-based compensation, valuation allowance against deferred tax assets and related disclosures. Actual results could differ from those estimates. Common Stock Warrants The Company classifies as equity any warrants that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control), (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement) or (iii) that contain reset provisions that do not qualify for the scope exception. The Company assesses classification of its common stock warrants and other freestanding derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required. The Company’s freestanding derivatives consist of warrants to purchase common stock that were issued in connection with services provided to the Company. The Company evaluated these warrants to assess their proper classification and determined that the common stock warrants meet the criteria for equity classification in the consolidated balance sheet. Such warrants are measured at fair value, which the Company determines using the Black-Scholes-Merton option-pricing model. Stock-Based Compensation The Company computes stock-based compensation in accordance with authoritative guidance. The Company uses the Black-Scholes-Merton option-pricing model to determine the fair value of its stock options. The Black-Scholes-Merton option-pricing model includes various assumptions, including the fair market value of the common stock of the Company, expected life of stock options, the expected volatility and the expected risk-free interest rate, among others. These assumptions reflect the Company’s best estimates, but they involve inherent uncertainties based on market conditions generally outside the control of the Company. As a result, if other assumptions had been used, stock-based compensation cost, as determined in accordance with authoritative guidance, could have been materially impacted. Furthermore, if the Company uses different assumptions on future grants, stock-based compensation cost could be materially affected in future periods. Recent Accounting Standards In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, In January 2020, the FASB issued ASU 2020-01, Investments – Equity Securities, Investments – Equity Method and Joint Ventures, and Derivatives and Hedging – Clarifying the Interactions Between Topic 321, Topic 323, and Topic 815 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 4 – COMMITMENTS AND CONTINGENCIES Operating Leases In October 2018, the Company entered into a lease agreement for office space in Doylestown, Pennsylvania. The lease commenced on October 15, 2018 and expires on October 31, 2022, as amended. The lease has an additional one-year option for renewal, and the base rent is $36,000 per year. The Company has determined that the lease agreement is considered a short-term lease under ASC 842 and has not recorded a right-of-use asset or liability. The Company rents another office space on a month-to-month basis with no long-term commitment, which is considered a short-term lease as well. Short-term lease expense for the years ended December 31, 2021 and 2020 was approximately $78,000 and $59,000, respectively. Approximate future minimum lease payments required under the operating leases are as follows: Amount Year Ending December 31, 2022 $ 30,000 Legal The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes and are not predictable with assurance. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which the Company is or could become involved in litigation may have a material adverse effect on its business and financial condition. To the Company’s knowledge, neither the Company nor any of its properties are subject to any pending legal proceedings. |
License and Agreements
License and Agreements | 12 Months Ended |
Dec. 31, 2021 | |
License And Agreement Disclosure [Abstract] | |
LICENSE AND AGREEMENTS | NOTE 5 – LICENSE AND AGREEMENTS In July 2015, the University of Texas at Austin (“UT”) granted to the Company’s former parent, LTI, an exclusive worldwide, royalty bearing license to the patent rights for the TFF platform in all fields of use, other than vaccines for which LTI received a non-exclusive worldwide, royalty bearing license to the patent rights for the TFF platform. In March 2018, LTI completed an assignment to the Company all of its interest to the TFF platform, including the patent license agreement with UT, at which time the Company paid UT an assignment fee of $100,000 in accordance with the patent license agreement. In November 2018, the Company and UT entered into an amendment to the patent license agreement pursuant to which, among other things, the Company’s exclusive patent rights to the TFF platform were expanded to all fields of use. The patent license agreement requires the Company to pay royalties and milestone payments and conform to a variety of covenants and agreements, and in the event of the Company’s breach of agreement, UT may elect to terminate the agreement. For the period ended December 31, 2018, the Company did not achieve any of the milestones and, as such, was not required to make any milestone payments. During the ended December 31, 2019, the Company achieved one milestone by gaining IND approval on first indication of a licensed product on November 24, 2019. The milestone fee associated with this achievement was $50,000 and the Company’s issuance of common shares to UT equal to 1% of the Company’s outstanding shares of common stock, on a fully diluted basis, as of 30 days after IND approval, which was December 24, 2019. The Company paid the $50,000 and issued the shares in January 2020. As of the date of these consolidated financial statements, the Company is in compliance with the patent license agreement as all required amounts have been paid in accordance with the agreement. In May 2018, the Company entered into a master services agreement and associated individual study contracts with ITR Canada, Inc. (“ITR”) to provide initial contract pre-clinical research and development services for the Company’s drug product candidates. In January 2019, the Company cancelled all of the individual study contracts with ITR and entered into contracts with 11036114 Canada Inc. (initially dba VJO Non-Clinical Development and now dba Strategy Point Innovations (“SPI”)) and 11035835 Canada Inc., (dba Periscope Research) to complete additional pre-clinical research and development services in order to take advantage of eligible Canadian Tax Credits. The services related to the contract with SPI were sub-contracted to ITR and others under substantially the same terms as the initial contract with ITR. Desire Ventures, LLC facilitates the invoicing for the various affiliates. The accounts payable due in connection with this agreement as of December 31, 2021 and 2020 was $0 and $56,000, respectively. During the years ended December 31, 2021 and 2020, the Company recorded research and development costs of approximately $4,789,000 and $3,001,000, respectively. In April 2019, the Company entered into a master services agreement with Irisys, LLC to provide contract manufacturing services for one of the Company’s drug product candidates, Voriconazole. The accounts payable due in connection with this agreement was approximately $21,000 and $59,000 as of December 31, 2021 and 2020, respectively. During the years ended December 31, 2021 and 2020, the Company recorded research and development costs of approximately $1,940,000 and $1,837,000, respectively. In January 2020, TFF Australia entered into a master consultancy agreement with Novotech (Australia) Pty Ltd. (formally known as Clinical Network Services Pty Ltd.) to provide initial contract clinical research and development services for the Company’s drug product candidates. The accounts payable due in connection with this agreement was approximately AUD$138,000 (US$100,000) and AUD$170,000 (US$131,000) as of December 31, 2021 and 2020, respectively. During the years ended December 31, 2021 and 2020, the Company recorded research and development costs of approximately AUD$2,080,000 (US$1,561,000) and AUD$590,000 (US$407,000), respectively, pertaining to this agreement. In May 2020, TFF Australia entered into an amended clinical trial research agreement with Nucleus Network Pty Ltd. to provide a Phase I study of one of the Company’s drug candidates, Tacrolimus. The accounts payable due in connection with this agreement was approximately AUD$161,000 (US$117,000) and AUD$51,000 (US$40,000) as of December 31, 2021 and 2020, respectively. During the years ended December 31, 2021 and 2020, the Company recorded research and development costs of approximately AUD$714,000 (US$536,000) and AUD$489,000 (US$337,000), respectively, pertaining to this agreement. On August 12, 2020, the Company entered into a licensing and collaboration agreement with UNION therapeutics A/S in which UNION acquired an option to obtain a worldwide exclusive license for the TFF technology in combination with niclosamide. Pursuant to the terms of the license agreement, UNION can exercise its option to obtain the license within 45 days after the complete data has been received by UNION from investigator-initiated trials. Upon exercise of the option, UNION shall be responsible to pay all expenses incurred in the development of any licensed product. The Company will be eligible to receive milestone payments upon the achievement of certain milestones in the development the licensed products, based on completion of clinical trials, pre-marketing approvals and/or the receipt of at least $25,000,000 of grant funding. The Company will receive a single-digit tiered royalty on net sales. The Company will also be entitled to receive sales-related milestone payments based on the commercial success of the licensed products. In January 2021, the Company entered into a master services agreement with Experic to provide contract manufacturing services for one of the Company’s drug product candidates, Voriconazole. The accounts payable due in connection with this agreement was approximately $313,000 as of December 31, 2021. During the year ended December 31, 2021, the Company recorded research and development costs of approximately $1,823,000 pertaining to this agreement. Joint Development Agreement On November 2, 2020, the Company and Augmenta entered into the JDA pursuant to which the Company and Augmenta (collectively the “Parties”) agreed to work jointly to develop one or more novel commercial products incorporating Augmenta’s human derived monoclonal antibody for the treatment of patients with COVID-19 and the Company’s patented Thin Film Freezing technology platform. Each party retains full ownership over its existing assets. The Parties will share development costs with each party funding its fifty-percent-share at specified times. In the event that one of the Parties fails to make its pro rata share payment, the other party may terminate the JDA. In lieu of terminating the JDA, the non-defaulting party may elect to continue the JDA by paying the delinquent amount and each party’s pro rata share of the JDA will automatically adjust by the amount paid. In addition, in the event Augmenta experiences a default on its required payment, Augmenta will have the one-time right to elect to require the Company to purchase Augmenta’s interest in the JDA (“Put Right”) for a one-time fee of $500,000. Upon exercise of the Put Right and payment by the Company, Augmenta will grant the Company an exclusive, worldwide, royalty-free, transferable, sublicensable license to the Augmenta antibody and Augmenta’s rights to the property developed under the JDA. The Company has determined that the likelihood of the Put Right being exercised to be remote. The JDA is within the scope of ASC 808 as the Company and Augmenta are both active participants in the research and development activities and are exposed to significant risks and rewards that are dependent on commercial success of the activities of the arrangement. The research and development activities are a unit of account under the scope of ASC 808 and are not promises to a customer under the scope of ASC 606. The Company records its portion of the research and development expenses as the related expenses are incurred. All payments received or amounts due from Augmenta for reimbursement of shared costs are accounted for as an offset to research and development expense. During the year ended December 31, 2021, the Company recorded research and development expenses of $1,626,153 and has recorded a receivable of $1,628,703 for reimbursement due from Augmenta as of December 31, 2021. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 6 – STOCKHOLDERS’ EQUITY Common Stock UT Agreement In November 2019, the Company achieved a milestone in connection with the UT agreement (see Note 5). As a result of the milestone, the Company owed UT 220,666 shares of common stock, which had a fair value of approximately $1,132,000, which was accrued in accrued research and development expense as of December 31, 2019. In January 2020, the Company issued the 220,666 shares of common stock to UT. August 2020 Private Placement On August 10, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) and a Registration Rights Agreement (the “Registration Rights Agreement”) with certain institutional and other accredited investors pursuant to which the Company issued and sold to the investors 3,048,654 shares of the Company’s common stock at a price of $8.50 per share for gross proceeds of approximately $25.91 million, before deducting placement agent commissions and other offering expenses. After deducting the placement agent commissions and other offering expenses, the Company received net proceeds of approximately $24.28 million. The Purchase Agreement included customary representations, warranties, and covenants by the investors and the Company, and an indemnity from the Company in favor of the investors. Jefferies LLC acted as placement agent for the private placement and the private placement closed on August 13, 2020. Pursuant to the terms of the Registration Rights Agreement, the Company filed a resale registration statement on Form S-1 with the SEC that was declared effective on September 15, 2020. March 2021 Offering On March 30, 2021, the Company completed the March 2021 Offering, selling 2,140,000 shares of common stock at an offering price of $14.00 per share. The Company received gross proceeds of approximately $30,000,000. The Company received net proceeds of approximately $28,015,000, after deducting underwriting discounts and offering-related expenses. Stock Option Exercises During November and December 2020, 285,003 shares of common stock were issued in connection with the exercise of stock options for total proceeds of $714,382. During the year ended December 31, 2021, 252,156 shares of common stock were issued in connection with the exercise of stock options for total proceeds of $689,752. Warrant Exercises During August through December 2020, 529,559 shares of common stock were issued in connection with the cashless exercise of 659,108 common stock warrants. During the year ended December 31, 2021, 415,917 shares of common stock were issued in connection with the cashless exercise of 424,288 common stock warrants. During the year ended December 31, 2021, 28,834 shares of common stock were issued in connection with the exercise of common stock warrants for total proceeds of $180,213. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2021 | |
Warrants [Abstract] | |
WARRANTS | NOTE 7 – WARRANTS On February 1, 2021, the Company issued a five-year warrant to purchase 25,000 shares of common stock at $15.90 per share to a consultant. The fair value of the warrant on the grant date was estimated using the Black-Scholes-Merton option pricing model with a common stock value of $16.13 per share, a contractual life of 5.0 years, a dividend yield of 0%, volatility of 97.09% and an assumed risk-free interest rate of 0.42%. The warrant is immediately exercisable. The fair value of the warrant was determined to be approximately $293,000 and was recorded in general and administrative expenses in the consolidated statement of operations during the year ended December 31, 2021. In determining the fair value for warrants, the expected life of the Company’s warrants was determined using the contractual life. The methodology in determining all other inputs to calculate the fair value utilizing the Black-Scholes-Merton option pricing model is the same as the stock option methodology described in Note 8 for stock options. A summary of warrant activity for the years ended December 31, 2021 and 2020 is as follows: Number of Range of Weighted-Average Weighted-Average Outstanding at January 1, 2020 1,476,463 $ 0.01 – $6.25 $ 2.71 4.1 Exercised (659,108 ) 2.50 – 6.25 2.75 — Outstanding at December 31, 2020 817,355 0.01 – 6.25 2.68 3.7 Issued 25,000 15.90 15.90 — Exercised (453,122 ) 0.01 – 6.25 0.74 — Outstanding at December 31, 2021 389,233 $ 2.50 – $15.90 $ 5.79 4.4 The warrants outstanding at December 31, 2021 had an aggregate intrinsic value of approximately $1,432,000. |
Stock Based Compensation
Stock Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK BASED COMPENSATION | NOTE 8 – STOCK BASED COMPENSATION In January 2018, the Company’s board of directors approved its 2018 Stock Incentive Plan (“2018 Plan”). The 2018 Plan provides for the grant of non-qualified stock options and incentive stock options to purchase shares of the Company’s common stock, the grant of restricted and unrestricted share awards and grant of restricted stock units. The Company initially reserved 1,630,000 shares of its common stock under the 2018 Plan; however, upon completion of the Company’s IPO the number of shares reserved for issuance under the 2018 Plan increased to 3,284,480, representing 15% of the Company’s outstanding shares of common stock calculated on a fully diluted basis upon the close of the IPO. All of the Company’s employees and any subsidiary employees (including officers and directors who are also employees), as well as all of the Company’s nonemployee directors and other consultants, advisors and other persons who provide services to the Company will be eligible to receive incentive awards under the 2018 Plan. In September 2021, the Company’s board of directors approved its 2021 Stock Incentive Plan (“2021 Plan”), which was also approved by the stockholders of the Company at the Company’s annual meeting of stockholders held on November 4, 2021. The 2021 Plan provides for the grant of non-qualified stock options and incentive stock options to purchase shares of the Company’s common stock, the grant of restricted and unrestricted share awards and grant of restricted stock units. The Company has 4,200,000 shares of its common stock reserved under the 2021 Plan. All of the Company’s employees and any subsidiary employees (including officers and directors who are also employees), as well as all of the Company’s nonemployee directors and other consultants, advisors and other persons who provide services to the Company will be eligible to receive incentive awards under the 2021 Plan. The following table summarizes the stock-based compensation expense recorded in the Company’s results of operations during the years ended December 31, 2021 and 2020 for stock options and warrants: Year Ended Year Ended Research and development $ 459,492 $ 140,278 General and administrative 3,088,876 2,046,871 $ 3,548,368 $ 2,187,149 As of December 31, 2021, there was approximately $9,474,000 of total unrecognized compensation expense related to non-vested share-based compensation arrangements that are expected to vest. This cost is expected to be recognized over a weighted-average period of 2.5 years. The Company records compensation expense for employee and nonemployee awards with graded vesting using the straight-line method. The Company recognizes compensation expense over the requisite service period applicable to each individual award, which generally equals the vesting term. The Company estimates the fair value of each option award using the Black-Scholes-Merton option pricing model. Forfeitures are recognized when realized. The Company estimated the fair value of employee and nonemployee stock options using the Black-Scholes option pricing model. The fair value of stock options issued was estimated using the following assumptions: Ended Year Ended Weighted average exercise price $ 8.86 $ 10.42 Weighted average grant date fair value $ 6.83 $ 9.25 Assumptions Expected volatility 89-97 % 87-91 % Expected term (in years) 6.0-10.0 6.3-10 Risk-free interest rate 0.81-1.55 % 0.36-1.47 % Expected dividend yield 0.00 % 0.00 % The risk-free interest rate was obtained from U.S. Treasury rates for the applicable periods. The Company’s expected volatility was based upon the historical volatility for industry peers and used an average of those volatilities. The expected life of the Company’s options was determined using the simplified method as a result of limited historical data regarding the Company’s activity for employee awards and the contractual term for nonemployee awards. The dividend yield considers that the Company has not historically paid dividends, and does not expect to pay dividends in the foreseeable future. The Company uses the closing stock price on the date of grant as the fair value of the common stock. The following table summarizes stock option activity during the years ended December 31, 2021 and 2020: Number of Shares Weighted-Average Weighted-Average Remaining Contractual Term (In Years) Intrinsic Value Outstanding at January 1, 2020 2,139,078 $ 3.46 9.17 $ 4,052,512 Granted 782,045 10.42 — — Exercised (285,003 ) 2.74 — — Cancelled (25,625 ) 4.86 — — Outstanding at December 31, 2020 2,610,495 $ 5.63 8.60 $ 22,789,233 Granted 535,500 8.86 — — Exercised (252,156 ) 2.74 — — Outstanding at December 31, 2021 2,893,839 $ 6.48 8.05 $ 9,932,413 Exercisable at December 31, 2021 1,219,841 $ 4.91 7.46 $ 5,730,660 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 9 – INCOME TAXES The Company had no income tax expense due to operating losses incurred for the years ended December 31, 2021 and 2020. The Company accounts for income taxes in accordance with ASC 740, which requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Because of the Company’s recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a full valuation allowance. The Company’s income tax expense for the years ended December 31, 2021 and 2020 are summarized below: December 31, December 31, Current: Federal $ - $ - State - - Foreign - - Total current $ - $ - Deferred: Federal $ (6,076,003 ) $ (4,502,016 ) State - - Foreign (240,902 ) (480,666 ) Change in valuation allowance 6,316,905 4,982,682 Total deferred - - Income tax provision (benefit) $ - $ - The Company’s deferred tax assets are as follows: December 31, December 31, Deferred tax assets: Net operating loss carryforwards $ 13,087,758 $ 6,807,300 Research and development tax credit 785,761 1,092,345 Intangibles 143,854 136,226 Stock compensation 1,054,242 761,741 Total deferred tax assets 15,071,615 8,797,612 Valuation allowances (15,071,615 ) (8,797,612 ) Net deferred tax assets $ - $ - The effective tax rate of the Company’s provision (benefit) for income taxes differs from the federal statutory rate as follows: December 31, December 31, Statutory rate 21.00 % 21.00 % State rate 0.00 % 0.00 % Foreign (0.54 )% (1.81 )% Permanent book/tax differences (1.95 )% (0.26 )% Research and development credit 1.07 % 5.09 % Changes in valuation allowance (19.58 )% (24.02 )% Total - - As of December 31, 2021 and 2020, the Company had gross federal income tax net operating loss (“NOL”) carryforwards of $59,111,972 and $30,126,830, respectively, and federal research tax credits of $1,047,681 and $1,486,704, respectively. Additionally, the Company had gross foreign income tax net operating loss carryforwards of $2,247,481 and $1,602,220 as of December 31, 2021 and 2020, respectively. The federal and foreign NOL have an indefinite life while the federal research tax credits will expire by 2041. Utilization of U.S. net operating losses and tax credit carryforwards may be limited by “ownership change” rules, as defined in Sections 382 and 383 of the Code. Similar rules may apply under state tax laws. The Company has not conducted a study to-date to assess whether a limitation would apply under Sections 382 and 383 of the Code as and when it starts utilizing its net operating losses and tax credits. The Company will continue to monitor activities in the future. In the event the Company previously experienced an ownership change, or should experience an ownership change in the future, the amount of net operating losses and research and development credit carryovers available in any taxable year could be limited and may expire unutilized. The CARES Act was signed into law on March 27, 2020 as a response to the economic challenges facing U.S. businesses caused by the COVID-19 global pandemic. The CARES Act allowed net operating loss incurred in 2018-2020 to be carried back five years or carried forward indefinitely, and to be fully utilized without being subjected to the 80% taxable income limitation. Net operating losses incurred after December 31, 2020 will be subjected to the 80% taxable income limitation. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion, or all, of the deferred tax asset will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during periods in which those temporary differences become deductible. Due to the uncertainty surrounding the realization of the benefits of its deferred assets, including NOL carryforwards, the Company has provided a 100% valuation allowance on its deferred tax assets at December 31, 2021. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740, Income Taxes A reconciliation of the change in the unrecognized tax positions for the year ended December 31, 2021 is as follows: Federal and State Balance at December 31, 2020 $ 394,358 Additions for tax positions related to current year 110,827 Decreases for tax positions related to prior years (243,265 ) Balance at December 31, 2021 $ 261,920 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10 – SUBSEQUENT EVENTS The Company has performed an evaluation of events occurring subsequent to December 31, 2021 through the filing date of this Annual Report. Based on its evaluation, nothing other than the events described below need to be disclosed. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) and reflect the financial position, results of operations and cash flows for all periods presented. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of TFF Pharmaceuticals, Inc. and its wholly-owned subsidiary, TFF Australia. All material intercompany accounts and transactions have been eliminated in consolidation. |
Foreign Currency | Foreign Currency The currency of TFF Australia, the Company’s international subsidiary, is in Australian dollars. Foreign currency denominated assets and liabilities are translated into U.S. dollars using the exchange rates in effect at each balance sheet date. Results of operations and cash flows are translated using the average exchange rates throughout the period. The effect of exchange rate fluctuations on translation of assets and liabilities is included as a separate component of stockholders’ equity in accumulated other comprehensive income (loss). |
Geographic Concentrations | Geographic Concentrations The Company conducts business in the U.S. and Australia. As of December 31, 2021 and 2020, the Company maintained 100% of its net property and equipment in the U.S. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company maintains its operating accounts in financial institutions in the U.S. and in Australia. The balances are insured up to specified limits. The Company’s cash is maintained in checking accounts and money market funds with maturities of less than three months when purchased, which are readily convertible to known amounts of cash, and which in the opinion of management are subject to insignificant risk of loss in value. As of December 31, 2021 and 2020, the Company had cash in Australia of AUD$831,984 (US$604,944) and AUD$214,240 (US$165,092), respectively. |
Property and Equipment, net | Property and Equipment, net Property and equipment are stated at cost less accumulated depreciation and amortization. The Company calculates depreciation using the straight-line method over the estimated useful lives of the assets, which range from two to five years for furniture, fixtures, lab and computer equipment and software. Assets held within construction in progress are not depreciated. Construction in progress is related to the construction or development of property and equipment that have not yet been placed in service for its intended use. As of December 31, 2021 and 2020, approximately $431,000 and $1,103,000, respectively, of the Company’s property and equipment consisted of lab equipment that are considered construction in progress. Expenditures for repairs and maintenance of assets are charged to expense as incurred. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Authoritative guidance requires disclosure of the fair value of financial instruments. The Company’s financial instruments consist of cash and cash equivalents and accounts payable, the carrying amounts of which approximate their estimated fair values primarily due to the short-term nature of the instruments or based on information obtained from market sources and management estimates. The Company measures the fair value of certain of its financial assets and liabilities on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value which is not equivalent to cost will be classified and disclosed in one of the following three categories: Level 1 — Quoted prices (unadjusted) in active markets for identical assets and liabilities. Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Income Taxes | Income Taxes In accordance with authoritative guidance, deferred tax assets and liabilities are recorded for temporary differences between the financial reporting and tax bases of assets and liabilities using the current enacted tax rate expected to be in effect when the differences are expected to reverse. A valuation allowance is recorded on deferred tax assets unless realization is considered more likely than not. The Company evaluates its tax positions taken or expected to be taken in the course of preparing the Company’s tax returns to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet the “more-likely-than-not” threshold are not recorded as a tax benefit or expense in the current year. The Company recognizes interest and penalties, if any, related to uncertain tax positions in interest expense. No interest and penalties related to uncertain tax positions were accrued at either December 31, 2021 or 2020. The Company follows authoritative guidance which requires the evaluation of existing tax positions. The Company files in the federal and various state jurisdictions. Management has analyzed all open tax years, as defined by the statute of limitations, for all major jurisdictions. Open tax years are those that are open for examination by taxing authorities. The Company’s tax years since its incorporation in 2018 and forward are subject to examination by tax authorities due to the carryforward of unutilized net operating losses and research and development credits. |
Revenue Recognition | Revenue Recognition The Company has entered into feasibility and material transfer agreements (“Feasibility Agreements”) with third parties that provide the Company with funds in return for certain research and development activities. Revenue from the Feasibility Agreements is recognized in the period during which the related qualifying services are rendered and costs are incurred, provided that the applicable conditions under the Feasibility Agreements have been met. The Feasibility Agreements are on a best-effort basis and do not require scientific achievement as a performance obligation. All fees received under the Feasibility Agreements are non-refundable. The costs associated with the Feasibility Agreements are expensed as incurred and are reflected as a component of research and development expense in the accompanying condensed consolidated statements of operations. Funds received from the Feasibility Agreements are recorded as revenue as the Company is the principal participant in the arrangement because the activities under the Feasibility Agreements are part of the Company’s development programs. In those instances where the Company first receives consideration in advance of providing underlying services, the Company classifies such consideration as deferred revenue until (or as) the Company provides the underlying services. In those instances where the Company first provides the underlying services prior to its receipt of consideration, the Company records a grant receivable. During the years ended December 31, 2021 and 2020, the Company rendered the related services and recognized revenue and research and development expenses of $88,161 and $0, respectively. As of December 31, 2021 and 2020, the Company had receivables due related to Feasibility Agreements of $11,996 and $0, respectively, which is included in prepaid assets and other current assets in the accompanying consolidated balance sheets, and deferred grant revenue of $50,000 and $24,315, respectively. |
Collaborative Arrangements | Collaborative Arrangements The Company considers the nature and contractual terms of arrangements and assesses whether an arrangement involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity. If the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity, the Company accounts for such arrangement as a collaborative arrangement under Accounting Standards Codification (“ASC”) 808, Collaborative Arrangements For arrangements determined to be within the scope of ASC 808 where a collaborative partner is not a customer for certain research and development activities, the Company accounts for payments received for the reimbursement of research and development costs as a contra-expense in the period such expenses are incurred. This reflects the joint risk sharing nature of these activities within a collaborative arrangement. The Company classifies payments owed or receivables recorded as other current liabilities or prepaid expenses and other current assets, respectively, in the Company’s consolidated balance sheets. Please refer to Note 5, “Joint Development Agreement” for additional details regarding the Company’s joint development agreement (“JDA”) with Augmenta Bioworks, Inc. (“Augmenta”). If payments from the collaborative partner to the Company represent consideration from a customer in exchange for distinct goods and services provided, then the Company accounts for those payments within the scope of ASC 606, Revenue from Contracts with Customers |
Research and Development Expenses | Research and Development Expenses In accordance with authoritative guidance, the Company charges research and development costs to operations as incurred. Research and development expenses consist of personnel costs for the design, development, testing and enhancement of the Company’s technology, and certain other allocated costs, such as depreciation and other facilities related expenditures. |
Research and Development Tax Incentive | Research and Development Tax Incentive The Company is eligible to obtain a cash refund from the Australian Taxation Office for eligible research and development expenditures under the Australian R&D Tax Incentive Program (the “Australian Tax Incentive”). The Company recognizes the Australian Tax Incentive when there is reasonable assurance that the cash refund will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. During the year ended December 31, 2021, the Company received its first cash refund under the Australian Tax Incentive, which was for expenditures incurred during 2020. Therefore, the Company recorded amounts received, or that it expects to receive, for expenditures incurred during 2020 as other income in the consolidated statements of operations. As the Company has determined that it has reasonable assurance that it will receive the cash refund for eligible research and development expenditures, beginning with expenditures incurred during the year ended December 31, 2021, the Company records the Australian Tax Incentive as a reduction to research and development expenses as the Australian Tax Incentive is not dependent on the Company generating future taxable income, the Company’s ongoing tax status, or tax position. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. This percentage of eligible research and development expenses reimbursable under the Australian Tax Incentive is 43.5% for the years ended December 31, 2021 and 2020. The research and development incentive receivable represents an amount due in connection with the Australian Tax Incentive. The Company has recorded a research and development tax incentive receivable of $966,646 and $0 as of December 31, 2021 and 2020, respectively, in the consolidated balance sheets. The Company has recorded other income of $652,877 and $0, in the consolidated statements of operations for the years ended December 31, 2021 and 2020, respectively, related to refundable Australian research and development incentive program payments for expenditures incurred during 2020. The Company recorded a reduction to research and development expenses of $997,801 and $0 during the years ended December 31, 2021 and 2020, respectively, for expenditures incurred during 2021. In addition, the Company also received $43,837 and $0 during the years ended December 31, 2021 and 2020, respectively, from the United States Internal Revenue Service related to research and development tax credits for expenditures incurred during 2020, which has been included in other income in the consolidated statements of operations. |
Basic and Diluted Earnings per Common Share | Basic and Diluted Earnings per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive share equivalents outstanding for the period, determined using the treasury-stock and if-converted methods. Since the Company has had net losses for all periods presented, all potentially dilutive securities are anti-dilutive. Basic weighted average shares outstanding for the years ended December 31, 2021 and 2020 include 400,000 shares underlying a warrant to purchase common shares that was exercisable for little consideration (an aggregate exercise price of $0.01 per share) and was deemed issued for the purposes of basic earnings per share. The warrant was exercised during the year ended December 31, 2021. For the years ended December 31, 2021 and 2020, the Company had the following potential common stock equivalents outstanding which were not included in the calculation of diluted net loss per common share because inclusion thereof would be anti-dilutive: Year Ended Year Ended Stock Options 2,893,839 2,610,495 Warrants 389,233 417,355 3,283,072 3,027,850 |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include the fair value of stock-based compensation, valuation allowance against deferred tax assets and related disclosures. Actual results could differ from those estimates. |
Common Stock Warrants | Common Stock Warrants The Company classifies as equity any warrants that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control), (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement) or (iii) that contain reset provisions that do not qualify for the scope exception. The Company assesses classification of its common stock warrants and other freestanding derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required. The Company’s freestanding derivatives consist of warrants to purchase common stock that were issued in connection with services provided to the Company. The Company evaluated these warrants to assess their proper classification and determined that the common stock warrants meet the criteria for equity classification in the consolidated balance sheet. Such warrants are measured at fair value, which the Company determines using the Black-Scholes-Merton option-pricing model. |
Stock-Based Compensation | Stock-Based Compensation The Company computes stock-based compensation in accordance with authoritative guidance. The Company uses the Black-Scholes-Merton option-pricing model to determine the fair value of its stock options. The Black-Scholes-Merton option-pricing model includes various assumptions, including the fair market value of the common stock of the Company, expected life of stock options, the expected volatility and the expected risk-free interest rate, among others. These assumptions reflect the Company’s best estimates, but they involve inherent uncertainties based on market conditions generally outside the control of the Company. As a result, if other assumptions had been used, stock-based compensation cost, as determined in accordance with authoritative guidance, could have been materially impacted. Furthermore, if the Company uses different assumptions on future grants, stock-based compensation cost could be materially affected in future periods. |
Recent Accounting Standards | Recent Accounting Standards In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, In January 2020, the FASB issued ASU 2020-01, Investments – Equity Securities, Investments – Equity Method and Joint Ventures, and Derivatives and Hedging – Clarifying the Interactions Between Topic 321, Topic 323, and Topic 815 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of potential common stock equivalents outstanding | Year Ended Year Ended Stock Options 2,893,839 2,610,495 Warrants 389,233 417,355 3,283,072 3,027,850 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments | Amount Year Ending December 31, 2022 $ 30,000 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Warrants [Abstract] | |
Schedule of warrant activity | Number of Range of Weighted-Average Weighted-Average Outstanding at January 1, 2020 1,476,463 $ 0.01 – $6.25 $ 2.71 4.1 Exercised (659,108 ) 2.50 – 6.25 2.75 — Outstanding at December 31, 2020 817,355 0.01 – 6.25 2.68 3.7 Issued 25,000 15.90 15.90 — Exercised (453,122 ) 0.01 – 6.25 0.74 — Outstanding at December 31, 2021 389,233 $ 2.50 – $15.90 $ 5.79 4.4 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense stock options and warrants | Year Ended Year Ended Research and development $ 459,492 $ 140,278 General and administrative 3,088,876 2,046,871 $ 3,548,368 $ 2,187,149 |
Schedule of fair value of employee stock options | Ended Year Ended Weighted average exercise price $ 8.86 $ 10.42 Weighted average grant date fair value $ 6.83 $ 9.25 Assumptions Expected volatility 89-97 % 87-91 % Expected term (in years) 6.0-10.0 6.3-10 Risk-free interest rate 0.81-1.55 % 0.36-1.47 % Expected dividend yield 0.00 % 0.00 % |
Schedule of stock option activity | Number of Shares Weighted-Average Weighted-Average Remaining Contractual Term (In Years) Intrinsic Value Outstanding at January 1, 2020 2,139,078 $ 3.46 9.17 $ 4,052,512 Granted 782,045 10.42 — — Exercised (285,003 ) 2.74 — — Cancelled (25,625 ) 4.86 — — Outstanding at December 31, 2020 2,610,495 $ 5.63 8.60 $ 22,789,233 Granted 535,500 8.86 — — Exercised (252,156 ) 2.74 — — Outstanding at December 31, 2021 2,893,839 $ 6.48 8.05 $ 9,932,413 Exercisable at December 31, 2021 1,219,841 $ 4.91 7.46 $ 5,730,660 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax expense | December 31, December 31, Current: Federal $ - $ - State - - Foreign - - Total current $ - $ - Deferred: Federal $ (6,076,003 ) $ (4,502,016 ) State - - Foreign (240,902 ) (480,666 ) Change in valuation allowance 6,316,905 4,982,682 Total deferred - - Income tax provision (benefit) $ - $ - |
Schedule of deferred tax assets | December 31, December 31, Deferred tax assets: Net operating loss carryforwards $ 13,087,758 $ 6,807,300 Research and development tax credit 785,761 1,092,345 Intangibles 143,854 136,226 Stock compensation 1,054,242 761,741 Total deferred tax assets 15,071,615 8,797,612 Valuation allowances (15,071,615 ) (8,797,612 ) Net deferred tax assets $ - $ - |
Schedule of provision federal statutory rate | December 31, December 31, Statutory rate 21.00 % 21.00 % State rate 0.00 % 0.00 % Foreign (0.54 )% (1.81 )% Permanent book/tax differences (1.95 )% (0.26 )% Research and development credit 1.07 % 5.09 % Changes in valuation allowance (19.58 )% (24.02 )% Total - - |
Schedule of unrecognized tax positions | Federal and State Balance at December 31, 2020 $ 394,358 Additions for tax positions related to current year 110,827 Decreases for tax positions related to prior years (243,265 ) Balance at December 31, 2021 $ 261,920 |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) | Aug. 13, 2020 | Mar. 30, 2021 | Jan. 24, 2018 |
Accounting Policies [Abstract] | |||
Exchange of common stock (in Shares) | 4,000,000 | ||
Stock issued (in Shares) | 3,048,654 | 2,140,000 | |
Share price (in Dollars per share) | $ 8.5 | $ 14 | |
Stock issued, value | $ 25,914,000 | $ 30,000,000 | |
Received net proceeds | $ 24,280,000 | $ 28,015,000 |
Liquidity and Management_s Pl_2
Liquidity and Management’s Plans (Details) | Dec. 31, 2021USD ($) |
Liquidity And Managements Plans [Abstract] | |
Cash and cash equivalents | $ 33,795,000 |
Working capital surplus | $ 36,877,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 12 Months Ended | ||||
Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($) | Dec. 31, 2021AUD ($) | Dec. 31, 2020AUD ($) | |
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Percentage of net property and equipment | 100.00% | 100.00% | |||
Due from related parties | $ 604,944 | $ 831,984 | |||
Cash | $ 165,092 | $ 214,240 | |||
Property and equipment | 431,000 | 1,103,000 | |||
Research and development expense | 88,161 | 0 | |||
Prepaid assets and other current assets | 11,996 | 0 | |||
Deferred research grant revenue | $ 50,000 | $ 24,315 | |||
Research and development tax percentage | 43.50% | 43.50% | |||
Research and development tax incentive | $ 785,761 | $ 1,092,345 | |||
Other income (expense) | $ 696,714 | ||||
Research and development additional received | $ 1,132,000 | ||||
Warrant purchase common shares (in Shares) | shares | 400,000 | 400,000 | |||
Aggregate exercise price (in Dollars per share) | $ / shares | $ 0.01 | ||||
Research and Development [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Research and development tax incentive | $ 966,646 | $ 0 | |||
Other income (expense) | 652,877 | 0 | |||
Research and development additional received | $ 43,837 | 0 | |||
Minimum [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Estimated useful lives | two | ||||
Maximum [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Estimated useful lives | five | ||||
Research and Development Expense [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Research and development expense | $ 997,801 | $ 0 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 3,283,072 | 3,027,850 |
Stock Options [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 2,893,839 | 2,610,495 |
Warrants [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 389,233 | 417,355 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Commitments and contingencies, description | the Company entered into a lease agreement for office space in Doylestown, Pennsylvania. The lease commenced on October 15, 2018 and expires on October 31, 2022, as amended. The lease has an additional one-year option for renewal, and the base rent is $36,000 per year. The Company has determined that the lease agreement is considered a short-term lease under ASC 842 and has not recorded a right-of-use asset or liability. The Company rents another office space on a month-to-month basis with no long-term commitment, which is considered a short-term lease as well. | ||
Rent expenses | $ 36,000 | ||
Short-term lease expense | $ 78,000 | $ 59,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of future minimum lease payments | Dec. 31, 2021USD ($) |
Schedule of future minimum lease payments [Abstract] | |
Year Ending December 31, 2022 | $ 30,000 |
License and Agreements (Details
License and Agreements (Details) | Aug. 12, 2020USD ($) | May 31, 2020 | Jan. 31, 2020USD ($) | Dec. 24, 2019USD ($) | Jan. 31, 2019 | Dec. 31, 2021USD ($) | Dec. 31, 2021AUD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020AUD ($) | Mar. 31, 2018USD ($) |
License and Agreements (Details) [Line Items] | ||||||||||
Assignment fee | $ 100,000 | |||||||||
Milestone fee | $ 50,000 | |||||||||
Common stock outstanding, percentage | 1.00% | |||||||||
Payments of shares | $ 50,000 | |||||||||
Accounts payable due | $ 21,000 | $ 59,000 | ||||||||
Research and development expense | 1,940,000 | 1,837,000 | ||||||||
Pre-marketing approvals | $ 25,000,000 | |||||||||
Recorded research and development costs | 21,300,865 | 10,681,565 | ||||||||
Interest fee | 500,000 | |||||||||
Recorded receivable | 1,628,703 | |||||||||
Master Services Agreement [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Agreement term, description | In January 2019, the Company cancelled all of the individual study contracts with ITR and entered into contracts with 11036114 Canada Inc. (initially dba VJO Non-Clinical Development and now dba Strategy Point Innovations (“SPI”)) and 11035835 Canada Inc., (dba Periscope Research) to complete additional pre-clinical research and development services in order to take advantage of eligible Canadian Tax Credits. | |||||||||
Accounts payable due | 0 | 56,000 | ||||||||
Research and development expense | 4,789,000 | 3,001,000 | ||||||||
Master Services Agreement [Member] | Contract manufacturing services [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Accounts payable due | 313,000 | |||||||||
Recorded research and development costs | 1,823,000 | |||||||||
Master Consultancy Agreement [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Research and development expense | 1,561,000 | $ 2,080,000 | ||||||||
Agreement description | to provide initial contract clinical research and development services for the Company’s drug product candidates. The accounts payable due in connection with this agreement was approximately AUD$138,000 (US$100,000) and AUD$170,000 (US$131,000) as of December 31, 2021 and 2020, respectively. | |||||||||
Clinical trial research agreement with Nucleus Network Pty Ltd. [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Agreement description | to provide a Phase I study of one of the Company’s drug candidates, Tacrolimus. The accounts payable due in connection with this agreement was approximately AUD$161,000 (US$117,000) and AUD$51,000 (US$40,000) as of December 31, 2021 and 2020, respectively. | |||||||||
Trial research agreement [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Research and development expense | 536,000 | $ 714,000 | 337,000 | $ 489,000 | ||||||
Clinical Network Services Pty Ltd. [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Research and development expense | $ 407,000 | $ 590,000 | ||||||||
Research and Development Expense [Member] | ||||||||||
License and Agreements (Details) [Line Items] | ||||||||||
Research and development expense | $ 1,626,153 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Aug. 10, 2020 | Mar. 30, 2021 | Dec. 31, 2020 | Nov. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2020 |
Stockholders' Equity (Details) [Line Items] | ||||||||
Research and development expense (in Dollars) | $ 1,132,000 | |||||||
Common stock issued | 22,534,874 | 25,371,781 | 22,534,874 | 220,666 | ||||
Sale of stock, price per share (in Dollars per share) | $ 14 | |||||||
Net proceeds (in Dollars) | $ 28,015,000 | |||||||
Shares of common stock | 2,140,000 | |||||||
Gross proceeds (in Dollars) | $ 30,000,000 | |||||||
Issuance of common stock for stock option exercises | 285,003 | 285,003 | 252,156 | |||||
Stock option exercises total proceeds (in Dollars) | $ 714,382 | $ 714,382 | $ 689,752 | |||||
Issuance of common stock | 529,559 | |||||||
Issuance of common stock warrant | 659,108 | |||||||
Common stock cashless exercise | 415,917 | |||||||
Common stock warrants | 424,288 | |||||||
Exercise of common stock warrants | 28,834 | |||||||
Total proceeds (in Dollars) | $ 180,213 | |||||||
Private Placement [Member] | ||||||||
Stockholders' Equity (Details) [Line Items] | ||||||||
Common stock issued | 3,048,654 | |||||||
Sale of stock, price per share (in Dollars per share) | $ 8.5 | |||||||
Gross proceeds (in Dollars) | $ 25,910,000 | |||||||
Net proceeds (in Dollars) | $ 24,280,000 |
Warrants (Details)
Warrants (Details) - USD ($) | Feb. 01, 2021 | Dec. 31, 2021 |
Warrants [Abstract] | ||
Warrant to purchase shares | $ 25,000 | |
Common stock per share | $ 15.9 | |
Common stock value, per share | $ 16.13 | |
Warrant issued | 5 years | |
Dividend yield | 0.00% | |
Volatility | 97.09% | |
Risk-free interest rate | 0.42% | |
General and administrative expenses | $ 293,000 | |
Aggregate intrinsic value | $ 1,432,000 | |
Warrant issued | 5 years |
Warrants (Details) - Schedule o
Warrants (Details) - Schedule of warrant activity - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Warrants (Details) - Schedule of warrant activity [Line Items] | ||
Number of Shares, Outstanding, beginning (in Shares) | 817,355 | 1,476,463 |
Weighted-Average Exercise Prices, Outstanding, beginning | $ 2.68 | $ 2.71 |
Weighted-Average Remaining Life, Outstanding, beginning | 4 years 1 month 6 days | |
Number of Shares, Exercised (in Shares) | (453,122) | (659,108) |
Weighted-Average Exercise Prices, Exercised | $ 0.74 | $ 2.75 |
Number of Shares, Outstanding, ending (in Shares) | 389,233 | 817,355 |
Weighted-Average Exercise Prices, Outstanding, ending | $ 5.79 | $ 2.68 |
Weighted-Average Remaining Life, Outstanding, ending | 4 years 4 months 24 days | 3 years 8 months 12 days |
Number of Shares, Issued (in Shares) | 25,000 | |
Range of Exercise Prices, Issued | $ 15.9 | |
Weighted-Average Exercise Prices, Issued | 15.9 | |
Minimum [Member] | ||
Warrants (Details) - Schedule of warrant activity [Line Items] | ||
Range of Exercise Prices, Outstanding, beginning | 0.01 | $ 0.01 |
Range of Exercise Prices, Exercised | 0.01 | 2.5 |
Range of Exercise Prices, Outstanding, ending | 2.5 | 0.01 |
Maximum [Member] | ||
Warrants (Details) - Schedule of warrant activity [Line Items] | ||
Range of Exercise Prices, Outstanding, beginning | 6.25 | 6.25 |
Range of Exercise Prices, Exercised | 6.25 | 6.25 |
Range of Exercise Prices, Outstanding, ending | $ 15.9 | $ 6.25 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Jan. 31, 2018 | Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |||
Stock based compensation, description | the Company’s board of directors approved its 2021 Stock Incentive Plan (“2021 Plan”), which was also approved by the stockholders of the Company at the Company’s annual meeting of stockholders held on November 4, 2021. The 2021 Plan provides for the grant of non-qualified stock options and incentive stock options to purchase shares of the Company’s common stock, the grant of restricted and unrestricted share awards and grant of restricted stock units. The Company has 4,200,000 shares of its common stock reserved under the 2021 Plan. All of the Company’s employees and any subsidiary employees (including officers and directors who are also employees), as well as all of the Company’s nonemployee directors and other consultants, advisors and other persons who provide services to the Company will be eligible to receive incentive awards under the 2021 Plan. | the Company’s board of directors approved its 2018 Stock Incentive Plan (“2018 Plan”). The 2018 Plan provides for the grant of non-qualified stock options and incentive stock options to purchase shares of the Company’s common stock, the grant of restricted and unrestricted share awards and grant of restricted stock units. The Company initially reserved 1,630,000 shares of its common stock under the 2018 Plan; however, upon completion of the Company’s IPO the number of shares reserved for issuance under the 2018 Plan increased to 3,284,480, representing 15% of the Company’s outstanding shares of common stock calculated on a fully diluted basis upon the close of the IPO. All of the Company’s employees and any subsidiary employees (including officers and directors who are also employees), as well as all of the Company’s nonemployee directors and other consultants, advisors and other persons who provide services to the Company will be eligible to receive incentive awards under the 2018 Plan. | |
Unrecognized compensation expense | $ 9,474,000 | ||
Weighted-average period | 2 years 6 months |
Stock Based Compensation (Det_2
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants [Line Items] | ||
Stock based compensation expense | $ 3,548,368 | $ 2,187,149 |
Research and development [Member] | ||
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants [Line Items] | ||
Stock based compensation expense | 459,492 | 140,278 |
General and administrative [Member] | ||
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants [Line Items] | ||
Stock based compensation expense | $ 3,088,876 | $ 2,046,871 |
Stock Based Compensation (Det_3
Stock Based Compensation (Details) - Schedule of fair value of employee stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Based Compensation (Details) - Schedule of fair value of employee stock options [Line Items] | ||
Weighted average exercise price (in Dollars per share) | $ 8.86 | $ 10.42 |
Weighted average grant date fair value (in Dollars per share) | $ 6.83 | $ 9.25 |
Assumptions | ||
Expected term (in years) | ||
Risk-free interest rate | ||
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Stock Based Compensation (Details) - Schedule of fair value of employee stock options [Line Items] | ||
Weighted average exercise price (in Dollars per share) | ||
Weighted average grant date fair value (in Dollars per share) | ||
Assumptions | ||
Expected volatility | 89.00% | 87.00% |
Expected term (in years) | 6 years | 6 years 3 months 18 days |
Risk-free interest rate | 0.81% | 0.36% |
Expected dividend yield | ||
Maximum [Member] | ||
Stock Based Compensation (Details) - Schedule of fair value of employee stock options [Line Items] | ||
Weighted average exercise price (in Dollars per share) | ||
Weighted average grant date fair value (in Dollars per share) | ||
Assumptions | ||
Expected volatility | 97.00% | 91.00% |
Expected term (in years) | 10 years | 10 years |
Risk-free interest rate | 1.55% | 1.47% |
Expected dividend yield |
Stock Based Compensation (Det_4
Stock Based Compensation (Details) - Schedule of stock option activity - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of stock option activity [Abstract] | ||
Number of Shares, Outstanding, beginning balance shares | 2,610,495 | 2,139,078 |
Weighted-Average Exercise Prices, Outstanding, beginning balance | $ 5.63 | $ 3.46 |
Weighted-Average Remaining Contractual Term, Outstanding beginning balance | 9 years 2 months 1 day | |
Intrinsic Value, Outstanding beginning balance | $ 22,789,233 | $ 4,052,512 |
Number of Shares, Outstanding, Granted | 535,500 | 782,045 |
Weighted-Average Exercise Prices, Outstanding, Granted | $ 8.86 | $ 10.42 |
Weighted-Average Remaining Contractual Term, Granted | ||
Intrinsic Value, Granted | ||
Number of Shares, Outstanding, Exercised | (252,156) | (285,003) |
Weighted-Average Exercise Prices, Outstanding, Exercised | $ 2.74 | $ 2.74 |
Weighted-Average Remaining Contractual Term, Exercised | ||
Intrinsic Value, Exercised | ||
Number of Shares, Outstanding, Cancelled | (25,625) | |
Weighted-Average Exercise Prices, Cancelled | $ 4.86 | |
Number of Shares, Outstanding, Outstanding ending balance | 2,893,839 | 2,610,495 |
Weighted-Average Exercise Prices, Outstanding, Outstanding ending balance | $ 6.48 | $ 5.63 |
Weighted-Average Remaining Contractual Term, Outstanding ending balance | 8 years 18 days | 8 years 7 months 6 days |
Intrinsic Value, Outstanding ending balance | $ 9,932,413 | $ 22,789,233 |
Number of Shares, Outstanding, Exercisable | 1,219,841 | |
Weighted-Average Exercise Prices, Outstanding, Exercisable | $ 4.91 | |
Weighted-Average Remaining Contractual Term, Exercisable | 7 years 5 months 15 days | |
Intrinsic Value, Exercisable | $ 5,730,660 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Mar. 27, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes (Details) [Line Items] | |||
Gross federal income tax net operating loss | $ 59,111,972 | $ 30,126,830 | |
Federal research tax credits | 1,047,681 | 1,486,704 | |
Foreign income tax net operating loss | $ 2,247,481 | $ 1,602,220 | |
Carried forward indefinitely years | 5 years | ||
Taxable income for losses | 80.00% | 80.00% | |
Valuation allowance on deferred tax assets | 100.00% | ||
Uncertain Tax Positions | $ 261,920 | ||
Effective Tax [Member] | |||
Income Taxes (Details) [Line Items] | |||
Uncertain Tax Positions | $ 261,920 |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of income tax expense - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | ||
Federal | ||
State | ||
Foreign | ||
Total current | ||
Deferred: | ||
Federal | (6,076,003) | (4,502,016) |
State | ||
Foreign | (240,902) | (480,666) |
Change in valuation allowance | 6,316,905 | 4,982,682 |
Total deferred | ||
Income tax provision (benefit) |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of deferred tax assets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 13,087,758 | $ 6,807,300 |
Research and development tax credit | 785,761 | 1,092,345 |
Intangibles | 143,854 | 136,226 |
Stock compensation | 1,054,242 | 761,741 |
Total deferred tax assets | 15,071,615 | 8,797,612 |
Valuation allowances | (15,071,615) | (8,797,612) |
Net deferred tax assets |
Income Taxes (Details) - Sche_3
Income Taxes (Details) - Schedule of provision federal statutory rate | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of provision federal statutory rate [Abstract] | ||
Statutory rate | 21.00% | 21.00% |
State rate | 0.00% | 0.00% |
Foreign | (0.54%) | (1.81%) |
Permanent book/tax differences | (1.95%) | (0.26%) |
Research and development credit | 1.07% | 5.09% |
Changes in valuation allowance | (19.58%) | (24.02%) |
Total |
Income Taxes (Details) - Sche_4
Income Taxes (Details) - Schedule of unrecognized tax positions - Federal and State [Member] | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Income Taxes (Details) - Schedule of unrecognized tax positions [Line Items] | |
Balance at December 31, 2020 | $ 394,358 |
Additions for tax positions related to current year | 110,827 |
Decreases for tax positions related to prior years | (243,265) |
Balance at December 31, 2021 | $ 261,920 |