Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 21, 2023 | Jun. 30, 2022 | |
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 | 36,193,085 | ||
Entity Public Float | $ 139,121,520 | ||
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, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
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, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 16,612,315 | $ 33,794,672 |
Receivable due from collaboration agreement | 1,628,703 | |
Research and development tax incentive receivable | 186,507 | 966,646 |
Prepaid assets and other current assets | 2,226,344 | 2,447,930 |
Total current assets | 19,025,166 | 38,837,951 |
Operating lease right-of use asset, net | 196,044 | |
Property and equipment, net | 3,078,342 | 1,859,860 |
Other assets | 7,688 | |
Note receivable - Augmenta | 1,812,975 | |
Total assets | 24,120,215 | 40,697,811 |
Current liabilities: | ||
Accounts payable | 919,607 | 1,493,842 |
Accrued compensation | 4,430 | 416,910 |
Deferred research grant revenue | 126,000 | 50,000 |
Current portion of operating lease liability | 80,625 | |
Total current liabilities | 1,130,662 | 1,960,752 |
Operating lease liability, net of current portion | 110,094 | |
Total liabilities | 1,240,756 | 1,960,752 |
Commitments and contingencies (see Note 4) | ||
Stockholders’ equity: | ||
Common stock; $0.001 par value, 45,000,000 shares authorized; 36,193,085 and 25,371,781 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 36,193 | 25,372 |
Additional paid-in capital | 120,070,983 | 104,078,968 |
Accumulated other comprehensive loss | (139,295) | (48,921) |
Accumulated deficit | (97,088,422) | (65,318,360) |
Total stockholders’ equity | 22,879,459 | 38,737,059 |
Total liabilities and stockholders’ equity | $ 24,120,215 | $ 40,697,811 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 36,193,085 | 25,371,781 |
Common stock, shares outstanding | 36,193,085 | 25,371,781 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Grant revenue | $ 495,805 | $ 88,161 |
Operating expenses: | ||
Research and development | 18,496,340 | 21,300,865 |
General and administrative | 13,796,255 | 10,573,954 |
Total operating expenses | 32,292,595 | 31,874,819 |
Loss from operations | (31,796,790) | (31,786,658) |
Other income: | ||
Other income | 696,714 | |
Interest income | 26,728 | 51,232 |
Total other income | 26,728 | 747,946 |
Net loss | $ (31,770,062) | $ (31,038,712) |
Net loss per share, basic and diluted (in Dollars per share) | $ (1.06) | $ (1.25) |
Weighted average common shares outstanding, basic and diluted (in Shares) | 29,979,776 | 24,820,971 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (31,770,062) | $ (31,038,712) |
Other comprehensive loss: | ||
Foreign currency translation adjustments | (90,374) | 2,617 |
Comprehensive loss | $ (31,860,436) | $ (31,036,095) |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parentheticals) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Net loss per share, basic and diluted | $ (1.06) | $ (1.25) |
Weighted average common shares outstanding, basic and diluted | 29,979,776 | 24,820,971 |
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, 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 | ||||
Sales of common stock through the at-the-market offering, net of offering costs | $ 104 | 404,451 | 404,555 | ||
Sales of common stock through the at-the-market offering, net of offering costs (in Shares) | 104,011 | ||||
Sales of common stock and warrants through public offering, net of offering costs | $ 10,675 | 11,224,951 | 11,235,626 | ||
Sales of common stock and warrants through public offering, net of offering costs (in Shares) | 10,675,001 | ||||
Issuance of common stock for stock option exercises | $ 42 | 110,780 | 110,822 | ||
Issuance of common stock for stock option exercises (in Shares) | 42,292 | ||||
Stock-based compensation | 4,251,833 | 4,251,833 | |||
Foreign currency translation adjustment | (90,374) | (90,374) | |||
Net loss | (31,770,062) | (31,770,062) | |||
Balance at Dec. 31, 2022 | $ 36,193 | $ 120,070,983 | $ (139,295) | $ (97,088,422) | $ 22,879,459 |
Balance (in Shares) at Dec. 31, 2022 | 36,193,085 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (31,770,062) | $ (31,038,712) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 4,251,833 | 3,548,368 |
Depreciation and amortization | 388,221 | 111,453 |
Changes in operating assets and liabilities: | ||
Receivable due from collaboration agreement | (184,272) | (1,628,703) |
Research and development tax incentive receivable | 751,403 | (997,802) |
Prepaid assets and other current assets | 181,604 | (203,363) |
Accounts payable | (577,105) | 209,193 |
Accrued compensation | (412,480) | 416,910 |
Deferred revenue | 76,000 | 25,685 |
Operating lease obligation | (47,302) | |
Net cash used in operating activities | (27,342,160) | (29,556,971) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,551,326) | (868,505) |
Net cash used in investing activities | (1,551,326) | (868,505) |
Cash flows from financing activities: | ||
Net proceeds from issuances of common stock | 404,555 | 28,015,019 |
Net proceeds from issuances of common stock and warrants | 11,235,626 | |
Proceeds from issuance of common stock for stock option exercises | 110,822 | 689,752 |
Proceeds from issuance of common stock for warrant exercises | 180,213 | |
Net cash provided by financing activities | 11,751,003 | 28,884,984 |
Effect of exchange rate changes on cash and cash equivalents | (39,874) | 34,359 |
Net change in cash and cash equivalents | (17,182,357) | (1,506,133) |
Cash and cash equivalents at beginning of year | 33,794,672 | 35,300,805 |
Cash and cash equivalents at end of year | 16,612,315 | 33,794,672 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Cashless exercise of warrants | 416 | |
ROU asset obtained for new operating lease | 238,021 | |
Conversion of collaboration receivable to note receivable | 1,812,975 | |
Purchases of equipment included in accounts payable | $ 13,400 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [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. 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. 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. ATM Offering On June 10, 2022, the Company entered into an Open Market Sale Agreement with Jefferies LLC, as agent, under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $35.0 million in an “at-the-market” (“ATM”) offering, to or through the agent. From July 2022 through September 30, 2022, the Company sold 104,011 shares of its common stock at average price of $5.96 per share resulting in net proceeds of approximately $405,000, after deducting sales agent commissions and offering expenses. November 2022 Public Offering In November 2022, the Company completed a public offering (“November 2022 Offering”), selling 9,282,609 shares of common stock and warrants to purchase up to 4,641,305 shares of common stock at an offering price of $1.15 per share. The Company received gross proceeds of approximately $10,675,000. In addition, the Company granted the underwriter a 45-day option to purchase an additional 15% of the number of shares of common stock and warrants at the public offering price, less underwriting discounts and commissions. The option was exercised in November 2022 and the underwriter purchased an additional 1,392,392 shares of common stock and warrants to purchase up to 696,196 shares of common stock and the Company received additional gross proceeds of approximately $1,601,251. The Company received net proceeds of $11,235,626, after deducting underwriting discounts and offering-related expenses. |
Going Concern and Management_s
Going Concern and Management’s Plans | 12 Months Ended |
Dec. 31, 2022 | |
Liquidity and Managements Plans [Abstract] | |
GOING CONCERN AND MANAGEMENT’S PLANS | NOTE 2 – GOING CONCERN AND MANAGEMENT’S PLANS The accompanying consolidated financial statements have been prepared under the assumption the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. For the years ended December 31, 2022 and 2021, the Company reported a net loss of $31.8 million and $31.0 million, respectively, and negative cash from operations of $27.3 million and $29.6 million, respectively. As of December 31, 2022, the Company had cash and cash equivalents of approximately $16.6 million, a working capital surplus of approximately $17.9 million and an accumulated deficit of $97.1 million. The Company has not generated revenues from commercial operations since inception and expects to continue incurring losses for the foreseeable future and needs to raise additional capital to continue the pursuit of its product development. As discussed in Note 1, during 2022, the Company sold shares of its common stock under the ATM offering resulting in net proceeds of approximately $405,000 and sold shares of its common stock and warrants to purchase shares of common stock in the November 2022 Offering for net proceeds of $11.2 million. Management believes that the Company the the next months from the date of filing |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 and 2021, 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, 2022 and 2021, the Company had cash in Australia of AUD$1,028,616 (US$699,977) and AUD$831,984 (US$604,944), 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, 2022 and 2021, approximately $1,493,000 and $431,000, 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. Leases At the inception of an arrangement, the Company determines whether an arrangement is or contains a lease based on the facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases with a term greater than one year are recognized on the consolidated balance sheets as operating lease right-of-use assets and current and long-term operating lease liabilities, as applicable. The Company has elected not to recognize on the consolidated balance sheets leases with terms of 12 months or less. The Company typically only includes the initial lease term in its assessment of a lease arrangement. Options to extend a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued rent. The interest rate implicit in the Company’s leases is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. 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, 2022 or 2021. 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 2019 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 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, 2022 and 2021, the Company rendered the related services and recognized revenue and research and development expenses of $495,805 and $88,161, respectively. As of December 31, 2022 and 2021, the Company had receivables due related to Feasibility Agreements of $92,781 and $11,996, respectively, which is included in prepaid assets and other current assets in the accompanying consolidated balance sheets, and deferred grant revenue of $126,000 and $50,000, 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, 2022 and 2021. In addition, the Company is also eligible to receive amounts from the IRS related to research and development tax credits for expenditures. The research and development incentive receivable represents an amount due in connection with the Australian Tax Incentive and from the IRS. The Company has recorded a research and development tax incentive receivable of $186,507 and $966,646 as of December 31, 2022 and 2021, respectively, in the consolidated balance sheets. The Company has recorded other income of $0 and $696,714, in the consolidated statements of operations for the years ended December 31, 2022 and 2021, respectively, related to refundable research and development incentive program payments for expenditures incurred during 2020. The Company recorded a reduction to research and development expenses of $274,863 and $997,801 during the years ended December 31, 2022 and 2021, respectively, for expenditures incurred during those respective years. 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. For the years ended December 31, 2022 and 2021, 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: Years Ended 2022 2021 Stock Options 2,909,057 2,893,839 Warrants 5,751,734 389,233 8,660,791 3,283,072 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 and the November 2022 Offering. 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. The warrants issued for services provided to the Company 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. Risks and Uncertainties In December 2019, COVID-19, a novel strain of coronavirus, was first identified in China. In March 2020, the World Health Organization categorized COVID-19 as a pandemic, and the virus has spread to over 100 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Potential impacts to the Company’s business include, but are not limited to, temporary closures of facilities of its vendors, disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing laboratory experiments, preclinical studies, clinical trials, third-party manufacturing supply and other operations, the supply of comparator products, the potential diversion of healthcare resources and staff away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the U.S. Food and Drug Administration or other regulatory authorities, and the Company’s ability to raise capital and conduct business development activities. The Company has experienced COVID-19 related delays in its Phase 2 clinical trials for TFF Voriconazole Inhalation Powder (“TFF VORI”) and TFF Tacrolimus Inhalation Powder (“TFF TAC”). While the Company believes it will be able to effectively manage the delays, there can be no assurance that its operations, including the development of its 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. Recent Accounting Standards In August 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging -Contracts in Entity’ Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’ Own Equity The Company’s management does not believe that any other recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the consolidated financial statements. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
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, 2023, as amended. The lease has an additional one-year option for renewal, and the base rent is $36,000 per year through October 31, 2022 and increases to $37,080 per year through October 31, 2023. 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. In May 2022, the Company entered into a lease agreement for lab space in Austin, Texas. The lease commenced on June 1, 2022 and expires on May 31, 2025. The lease has an additional three-year option for renewal, which the Company has determined it is not reasonably certain to exercise. Supplemental balance sheet information related to leases was as follows: December 31, Operating leases: Operating lease right-of-use assets $ 196,044 Operating lease liability - current portion $ 80,625 Operating lease liability - long-term portion 110,094 Total operating lease liabilities $ 190,719 Supplemental lease expense related to leases was as follows: For The Years Ended December 31, Lease Statement of Operations Classification 2022 2021 Operating lease cost Research and development $ 51,975 $ - Short-term lease cost Research and development 20,815 42,000 Short-term lease cost General and administrative 83,870 36,000 Total lease expense $ 156,660 $ 78,000 Other information related to operating leases: December 31, Weighted-average remaining lease term 2.4 years Weighted-average discount rate 8 % Supplemental cash flow information related to operating leases was as follows: For The Years Ended 2022 2021 Cash paid for operating lease liabilities $ 57,300 $ - Approximate future minimum lease payments under non-cancellable leases (including short-term leases) are as follows: Fiscal Year Ending December 31, 2023 $ 112,000 2024 91,000 2025 38,000 Total minimum lease payments 241,000 Less: Imputed interest (19,000 ) Total $ 222,000 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, 2022 | |
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, and in March 2022 the Company and UT entered into an amended and restated patent license agreement for purposes of further strengthening the Company’s license rights, including the Company’s exclusive right to license all future UT patents relating to the TFF technology and all know-how held by UT relating to the TFF technology . 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 and the Company satisfied the milestone payment of $50,000 and issuance of shares in accordance with the agreement. 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. There was no accounts payable due in connection with this agreement as of December 31, 2022 and 2021. During the years ended December 31, 2022 and 2021, the Company recorded research and development costs of approximately $2,419,000 and $4,789,000, respectively. In April 2019, the Company entered into a master services agreement with Societal CDMO (formally known as Irisys, LLC) to provide contract manufacturing services for one of the Company’s drug product candidates, TFF VORI. The Company had a credit due in connection with this agreement of approximately $25,000 as of December 31, 2022 and accounts payable due in connection with this agreement was approximately $21,000 as of December 31, 2021. During the years ended December 31, 2022 and 2021, the Company recorded research and development costs of approximately $974,000 and $1,940,000, 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$22,000 (US$15,000) and AUD$138,000 (US$100,000) as of December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021, the Company recorded research and development costs of approximately AUD$761,000 (US$527,000) and AUD$2,080,000 (US$1,561,000), 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, TFF TAC. The accounts payable due in connection with this agreement was approximately $0 and AUD$161,000 (US$117,000) as of December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021, the Company recorded research and development costs of approximately $0 and AUD$714,000 (US$536,000), 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, TFF . The accounts payable due in connection with this agreement was approximately $176,000 and $313,000, respectively, as of December 31, 2022 and 2021. During the years ended December 31, 2022 and 2021, the Company recorded research and development costs of approximately $1,935,000 and $1,823,000, respectively, pertaining to this agreement. In January 2022, the Company entered into a Letter of Intent with Synteract, Inc. to provide contract research and development services, which was replaced by a Master Services Agreement entered into in May 2022, for one of the Company’s drug product candidates, TFF . The accounts payable due in connection with this agreement was approximately $191,000 as of December 31, 2022. During the year ended December 31, 2022, the Company recorded research and development costs of approximately $2,743,000 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 experienced a default on its required payment, Augmenta had 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 would 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 determined that the likelihood of the Put Right being exercised to be remote. The Put Right was eliminated in connection with a convertible note purchase agreement (see below and Note 10). 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 years ended December 31, 2022 and 2021, the Company recorded research and development expenses of $341,840 and $1,626,153, respectively, and has recorded a receivable of $1,812,975 and $1,628,703 for reimbursement due from Augmenta as of December 31, 2022 and 2021, respectively. Effective January 1, 2023, the Company and Augmenta entered into a convertible note purchase agreement (“Augmenta Note”) in which the receivable due from Augmenta was converted into a convertible note receivable (see Note 10). The Augmenta Note satisfies Augmenta’s requirement to fund its fifty-percent-share of the development costs under the JDA. In addition, the Company and Augmenta agreed to suspend the development work under the JDA. The Augmenta Note has a maturity date of January 1, 2026; therefore, the Company has reflected the amount due under the Augmenta Note as a long-term note receivable as of December 31, 2022. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 6 – STOCKHOLDERS’ EQUITY Common Stock 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. ATM Offering From July 2022 through September 30, 2022, the Company sold 104,011 shares of its common stock through the ATM offering at average price of $5.96 per share resulting in net proceeds of approximately $405,000, after deducting sales agent commissions and offering expenses. November 2022 Public Offering In November 2022, the Company completed the November 2022 Offering, selling 9,282,609 shares of common stock and warrants to purchase up to 4,641,305 shares of common stock at an offering price of $1.15 per share. The Company received gross proceeds of approximately $10,675,000. In addition, the Company granted the underwriter a 45-day option to purchase an additional 15% of the number of shares of common stock and warrants at the public offering price, less underwriting discounts and commissions. The option was exercised in November 2022 and the underwriter purchased an additional 1,392,392 shares of common stock and warrants to purchase up to 696,196 shares of common stock and the Company received additional gross proceeds of approximately $1,601,251. The Company received net proceeds of $11,235,626, after deducting underwriting discounts and offering-related expenses. Stock Option Exercises 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. During the year ended December 31, 2022, 42,292 shares of common stock were issued in connection with the exercise of stock options for total proceeds of $110,822. Warrant Exercises 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, 2022 | |
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. In connection with the November 2022 Offering, the Company issued warrants to purchase 5,337,501 shares of common stock. Each warrant is immediately exercisable on the date of issuance at an exercise price of $1.29 per share and expires five years from the date of issuance. The Company evaluated these warrants to assess their proper classification and determined that the warrants meet the criteria for equity classification in the consolidated balance sheet. A summary of warrant activity for the years ended December 31, 2022 and 2021 is as follows: Number of Range of Weighted- Weighted- Outstanding at January 1, 2021 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 Issued 5,362,501 1.29-5.70 1.31 — Exercised — — — — Outstanding at December 31, 2022 5,751,734 $1.29 – $15.90 $ 1.61 4.8 The warrants outstanding at December 31, 2022 had an aggregate intrinsic value of approximately $0. |
Stock Based Compensation
Stock Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 and 2021 for stock options and warrants: Years Ended December 31, 2022 2021 Research and development $ 908,712 $ 459,492 General and administrative 3,343,121 3,088,876 $ 4,251,833 $ 3,548,368 As of December 31, 2022, there was approximately $5,220,000 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 2.1 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: Years Ended December 31, 2022 2021 Weighted average exercise price $ 3.71 $ 8.86 Weighted average grant date fair value $ 2.84 $ 6.83 Assumptions Expected volatility 90-97 % 89-97 % Expected term (in years) 5.3-10.0 6.0-10.0 Risk-free interest rate 2.41-4.20 % 0.81-1.55 % 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, 2022 and 2021: Number of Shares Weighted- Weighted- Intrinsic Value Outstanding at January 1, 2021 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 Granted 456,393 3.71 — — Exercised (42,292 ) 2.62 — — Exercised (398,883 ) 7.53 — — Outstanding at December 31, 2022 2,909,057 $ 5.96 7.46 $ 24,279 Exercisable at December 31, 2022 1,189,267 $ 5.50 6.69 $ — Option Modifications Effective March 21, 2022, one of the members of the Company’s board of directors, Dr. Brian Windsor, resigned. As part of his resignation from the board of directors, modifications were made to Dr. Windsor’s vested and non-vested stock option awards including acceleration of certain non-vested option awards and the extension of the post-termination exercise period of certain stock option awards. During the year ended December 31, 2022, in accordance with ASC Topic 718, Compensation-Stock Compensation Effective December 4, 2022, the Company’s CEO, Glenn Mattes, resigned. As part of his resignation, modifications were made to certain of Mr. Mattes’ vested stock option awards to extend the post-termination exercise period of these stock option awards. During the year ended December 31, 2022, in accordance with ASC 718, the Company recorded a one-time, non-cash incremental compensation expense in the amount of approximately $160,000, which is included in general and administrative expense in the accompanying consolidated statements of operations. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 and 2021. 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, 2022 and 2021 are summarized below: December 31, 2022 2021 Current: Federal $ - $ - State - - Foreign - - Total current $ - $ - Deferred: Federal $ (7,871,979 ) $ (6,076,003 ) State - - Foreign 453,410 (240,902 ) Change in valuation allowance 7,418,569 6,316,905 Total deferred - - Income tax provision (benefit) $ - $ - The Company’s deferred tax assets are as follows: December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 15,321,270 $ 13,087,758 Research and development tax credit 2,384,554 785,761 Section 174 amortization 3,437,763 - Intangibles 175,334 143,854 Stock compensation 1,029,447 1,054,242 Accruals and other (173 ) - Total deferred tax assets 22,348,195 15,071,615 Valuation allowances (22,348,195 ) (15,071,615 ) 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, 2022 2021 Statutory rate 21.00 % 21.00 % State rate 0.00 % 0.00 % Foreign (0.31 )% (0.54 )% Permanent book/tax differences (0.94 )% (1.95 )% Research and development credit 5.03 % 1.07 % Changes in valuation allowance (24.78 )% (19.58 )% Total - - As of December 31, 2022 and 2021, the Company had gross federal income tax net operating loss (“NOL”) carryforwards of $ and $59,111,972, respectively, and federal research tax credits of $3,179,405 and $1,047,681, respectively. Additionally, the Company had gross foreign income tax net operating loss carryforwards of $ and $2,247,481 as of December 31, 2022 and 2021, respectively. The federal and foreign NOL have an indefinite life while the federal research tax credits will expire by 2042. 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. The Inflation Reduction Act (“IRA”) was enacted on August 16, 2022. The IRA introduced new provisions including a 15% corporate alternative minimum tax for certain large corporations that have at least an average of $1 billion adjusted financial statement income over a consecutive three-tax-year period and a 1% excise tax surcharge on stock repurchases. The IRA is applicable for tax years beginning after December 31, 2022 and had no benefit to the consolidated financial statements for any of the periods presented, and the Company does not expect it to have a direct material impact on its future results of operations, financial condition, or cash flows. 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, 2022. 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, 2022 is as follows: Federal and State Balance at December 31, 2021 $ 261,920 Additions for tax positions related to current year 532,931 Decreases for tax positions related to prior years - Balance at December 31, 2022 $ 794,851 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10 – SUBSEQUENT EVENTS The Company has performed an evaluation of events occurring subsequent to December 31, 2022 through the filing date of this Annual Report. Based on its evaluation, nothing other than the events described below need to be disclosed. Effective January 1, 2023, the Company and Augmenta entered into the Augmenta Note in which a receivable due from Augmenta in connection with the JDA was converted into a convertible note receivable (see Note 5). Under the terms of the Augmenta Note, Augmenta agreed to pay the principal amount of $1,812,975 to the Company. The Augmenta Note accrues interest at a rate of 6% per annum and has a maturity date of the earlier of (i) January 1, 2026 (“Maturity Date”), or (ii) upon the occurrence and during the continuance of an event of default. Accrued interest shall be payable at maturity. The Company has the following optional conversion rights under the Augmenta Note: ● The Company may convert, at any time and at its option, all outstanding principal and accrued and unpaid interest into shares of Augmenta common stock at a price per share equal to an amount obtained by dividing $15,000,000 by the number of outstanding shares of Augment common stock on a fully diluted basis (“Conversion Price”). ● If Augmenta completes a private placement sale of its preferred stock in the amount less than $15,000,000, the Company may convert, at its option, all outstanding principal and accrued and unpaid interest into shares of the same security in such financing at a per share price equal to the lower of the Conversion Price or the price per share sold in the financing. In addition, the outstanding principal and accrued and unpaid interest under the Augmenta Note will automatically convert in the following scenarios: ● If Augmenta completes a financing with gross proceeds of at least $15,000,000 (“Qualified Financing”) on or before the Maturity Date, then the outstanding principal and accrued and unpaid interest shall automatically convert into the same security at a price per share equal to the lower of the Conversion Price or the price per share sold in the Qualified Financing. ● If Augmenta completes an underwritten public offering with gross proceeds of at least $35,000,000 (“Qualified IPO”) on or before the Maturity Date, then the outstanding principal and accrued and unpaid interest shall automatically convert into the same security at a price per share equal to the lower of the Conversion Price or the price per share sold in the Qualified IPO. ● If a change of control occurs prior to the payment in full of the principal amount of the Augmenta Note, then the Company will be paid all outstanding principal and accrued and unpaid interest, plus a premium of 100% of the outstanding principal. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 and 2021, 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, 2022 and 2021, the Company had cash in Australia of AUD$1,028,616 (US$699,977) and AUD$831,984 (US$604,944), 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, 2022 and 2021, approximately $1,493,000 and $431,000, 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. |
Leases | Leases At the inception of an arrangement, the Company determines whether an arrangement is or contains a lease based on the facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Leases with a term greater than one year are recognized on the consolidated balance sheets as operating lease right-of-use assets and current and long-term operating lease liabilities, as applicable. The Company has elected not to recognize on the consolidated balance sheets leases with terms of 12 months or less. The Company typically only includes the initial lease term in its assessment of a lease arrangement. Options to extend a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued rent. The interest rate implicit in the Company’s leases is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. |
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, 2022 or 2021. 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 2019 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 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, 2022 and 2021, the Company rendered the related services and recognized revenue and research and development expenses of $495,805 and $88,161, respectively. As of December 31, 2022 and 2021, the Company had receivables due related to Feasibility Agreements of $92,781 and $11,996, respectively, which is included in prepaid assets and other current assets in the accompanying consolidated balance sheets, and deferred grant revenue of $126,000 and $50,000, 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, 2022 and 2021. In addition, the Company is also eligible to receive amounts from the IRS related to research and development tax credits for expenditures. The research and development incentive receivable represents an amount due in connection with the Australian Tax Incentive and from the IRS. The Company has recorded a research and development tax incentive receivable of $186,507 and $966,646 as of December 31, 2022 and 2021, respectively, in the consolidated balance sheets. The Company has recorded other income of $0 and $696,714, in the consolidated statements of operations for the years ended December 31, 2022 and 2021, respectively, related to refundable research and development incentive program payments for expenditures incurred during 2020. The Company recorded a reduction to research and development expenses of $274,863 and $997,801 during the years ended December 31, 2022 and 2021, respectively, for expenditures incurred during those respective years. |
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. For the years ended December 31, 2022 and 2021, 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: Years Ended 2022 2021 Stock Options 2,909,057 2,893,839 Warrants 5,751,734 389,233 8,660,791 3,283,072 |
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 and the November 2022 Offering. 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. The warrants issued for services provided to the Company 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. |
Risks and Uncertainties | Risks and Uncertainties In December 2019, COVID-19, a novel strain of coronavirus, was first identified in China. In March 2020, the World Health Organization categorized COVID-19 as a pandemic, and the virus has spread to over 100 countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Potential impacts to the Company’s business include, but are not limited to, temporary closures of facilities of its vendors, disruptions or restrictions on its employees’ ability to travel, disruptions to or delays in ongoing laboratory experiments, preclinical studies, clinical trials, third-party manufacturing supply and other operations, the supply of comparator products, the potential diversion of healthcare resources and staff away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the U.S. Food and Drug Administration or other regulatory authorities, and the Company’s ability to raise capital and conduct business development activities. The Company has experienced COVID-19 related delays in its Phase 2 clinical trials for TFF Voriconazole Inhalation Powder (“TFF VORI”) and TFF Tacrolimus Inhalation Powder (“TFF TAC”). While the Company believes it will be able to effectively manage the delays, there can be no assurance that its operations, including the development of its 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. |
Recent Accounting Standards | Recent Accounting Standards In August 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging -Contracts in Entity’ Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’ Own Equity The Company’s management does not believe that any other recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of potential common stock equivalents outstanding | Years Ended 2022 2021 Stock Options 2,909,057 2,893,839 Warrants 5,751,734 389,233 8,660,791 3,283,072 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of supplemental balance sheet information related to leases | December 31, Operating leases: Operating lease right-of-use assets $ 196,044 Operating lease liability - current portion $ 80,625 Operating lease liability - long-term portion 110,094 Total operating lease liabilities $ 190,719 |
Schedule of supplemental lease expense related to leases | For The Years Ended December 31, Lease Statement of Operations Classification 2022 2021 Operating lease cost Research and development $ 51,975 $ - Short-term lease cost Research and development 20,815 42,000 Short-term lease cost General and administrative 83,870 36,000 Total lease expense $ 156,660 $ 78,000 |
Schedule of other information related to operating leases | December 31, Weighted-average remaining lease term 2.4 years Weighted-average discount rate 8 % |
Schedule of supplemental cash flow information related to operating leases | For The Years Ended 2022 2021 Cash paid for operating lease liabilities $ 57,300 $ - |
Schedule of future minimum lease payments under non-cancellable leases | Fiscal Year Ending December 31, 2023 $ 112,000 2024 91,000 2025 38,000 Total minimum lease payments 241,000 Less: Imputed interest (19,000 ) Total $ 222,000 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Warrants [Abstract] | |
Schedule of warrant activity | Number of Range of Weighted- Weighted- Outstanding at January 1, 2021 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 Issued 5,362,501 1.29-5.70 1.31 — Exercised — — — — Outstanding at December 31, 2022 5,751,734 $1.29 – $15.90 $ 1.61 4.8 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense | Years Ended December 31, 2022 2021 Research and development $ 908,712 $ 459,492 General and administrative 3,343,121 3,088,876 $ 4,251,833 $ 3,548,368 |
Schedule of fair value of employee stock options | Years Ended December 31, 2022 2021 Weighted average exercise price $ 3.71 $ 8.86 Weighted average grant date fair value $ 2.84 $ 6.83 Assumptions Expected volatility 90-97 % 89-97 % Expected term (in years) 5.3-10.0 6.0-10.0 Risk-free interest rate 2.41-4.20 % 0.81-1.55 % Expected dividend yield 0.00 % 0.00 % |
Schedule of stock option activity | Number of Shares Weighted- Weighted- Intrinsic Value Outstanding at January 1, 2021 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 Granted 456,393 3.71 — — Exercised (42,292 ) 2.62 — — Exercised (398,883 ) 7.53 — — Outstanding at December 31, 2022 2,909,057 $ 5.96 7.46 $ 24,279 Exercisable at December 31, 2022 1,189,267 $ 5.50 6.69 $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax expense | December 31, 2022 2021 Current: Federal $ - $ - State - - Foreign - - Total current $ - $ - Deferred: Federal $ (7,871,979 ) $ (6,076,003 ) State - - Foreign 453,410 (240,902 ) Change in valuation allowance 7,418,569 6,316,905 Total deferred - - Income tax provision (benefit) $ - $ - |
Schedule of deferred tax assets | December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 15,321,270 $ 13,087,758 Research and development tax credit 2,384,554 785,761 Section 174 amortization 3,437,763 - Intangibles 175,334 143,854 Stock compensation 1,029,447 1,054,242 Accruals and other (173 ) - Total deferred tax assets 22,348,195 15,071,615 Valuation allowances (22,348,195 ) (15,071,615 ) Net deferred tax assets $ - $ - |
Schedule of provision federal statutory rate | December 31, 2022 2021 Statutory rate 21.00 % 21.00 % State rate 0.00 % 0.00 % Foreign (0.31 )% (0.54 )% Permanent book/tax differences (0.94 )% (1.95 )% Research and development credit 5.03 % 1.07 % Changes in valuation allowance (24.78 )% (19.58 )% Total - - |
Schedule of unrecognized tax positions | Federal and State Balance at December 31, 2021 $ 261,920 Additions for tax positions related to current year 532,931 Decreases for tax positions related to prior years - Balance at December 31, 2022 $ 794,851 |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) | 1 Months Ended | ||
Jun. 10, 2022 | Nov. 30, 2022 | Mar. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Stock issued (in Shares) | 2,140,000 | ||
Share price (in Dollars per share) | $ 14 | ||
Stock issued, value | $ 30,000,000 | ||
Received net proceeds | $ 28,015,000 | ||
Aggregate offering price | $ 35,000,000 | ||
Shares of common stock (in Shares) | 9,282,609 | ||
Shares of warrant to purchase (in Shares) | 4,641,305 | ||
Offering price per share (in Dollars per share) | $ 1.15 | ||
Company received gross proceeds | $ 10,675,000 | ||
Common stock shares, description | From July 2022 through September 30, 2022, the Company sold 104,011 shares of its common stock at average price of $5.96 per share resulting in net proceeds of approximately $405,000, after deducting sales agent commissions and offering expenses. | the Company granted the underwriter a 45-day option to purchase an additional 15% of the number of shares of common stock and warrants at the public offering price, less underwriting discounts and commissions. The option was exercised in November 2022 and the underwriter purchased an additional 1,392,392 shares of common stock and warrants to purchase up to 696,196 shares of common stock and the Company received additional gross proceeds of approximately $1,601,251. The Company received net proceeds of $11,235,626, after deducting underwriting discounts and offering-related expenses. |
Going Concern and Management__2
Going Concern and Management’s Plans (Details) - USD ($) | 12 Months Ended | ||
Nov. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Going Concern And Managements Plans Abstract | |||
Net loss | $ 31,800,000 | $ 31,000,000 | |
Negative cash from operations | 27,300,000 | $ 29,600,000 | |
Cash and cash equivalents | 16,600,000 | ||
Working capital surplus | 17,900,000 | ||
Accumulated deficit | 97,100,000 | ||
Net proceeds | $ 11,200,000 | $ 405,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 1 Months Ended | 12 Months Ended | |||
Aug. 16, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2022 AUD ($) | Dec. 31, 2021 AUD ($) | |
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Percentage of net property and equipment | 100% | 100% | 100% | 100% | |
Cash | $ 699,977 | $ 1,028,616 | |||
Due from related parties | $ 604,944 | $ 831,984 | |||
Property and equipment | $ 1,493,000 | 431,000 | |||
Lease term | 1 year | ||||
Research and development expense | $ 495,805 | 88,161 | |||
Prepaid assets and other current assets | 92,781 | 11,996 | |||
Deferred research grant revenue | $ 126,000 | $ 50,000 | |||
Research and development tax percentage | 43.50% | 43.50% | |||
Research and development tax incentive | $ 2,384,554 | $ 785,761 | |||
Other income (expense) | $ 1,000,000,000 | 696,714 | |||
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 [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Research and development tax incentive | $ 186,507 | 966,646 | |||
Other income (expense) | 0 | 696,714 | |||
Research and Development Expense [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Research and development expense | $ 274,863 | $ 997,801 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 8,660,791 | 3,283,072 |
Stock Options [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 2,909,057 | 2,893,839 |
Warrants [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 5,751,734 | 389,233 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | |
Oct. 31, 2023 | Oct. 31, 2022 | |
Commitments and Contingencies (Details) [Line Items] | ||
Rent expenses | $ 36,000 | |
Forecast [Member] | ||
Commitments and Contingencies (Details) [Line Items] | ||
Rent expenses | $ 37,080 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of supplemental balance sheet information related to leases | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Operating leases: | |
Operating lease right-of-use assets | $ 196,044 |
Operating lease liability - current portion | 80,625 |
Operating lease liability - long-term portion | 110,094 |
Total operating lease liabilities | $ 190,719 |
Commitments and Contingencies_4
Commitments and Contingencies (Details) - Schedule of supplemental lease expense related to leases - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Segment Reporting Information [Line Items] | ||
Total lease expense | $ 156,660 | $ 78,000 |
Research and development [Member] | ||
Segment Reporting Information [Line Items] | ||
Operating lease cost | 51,975 | |
Short-term lease cost | 20,815 | 42,000 |
General and administrative [Member] | ||
Segment Reporting Information [Line Items] | ||
Short-term lease cost | $ 83,870 | $ 36,000 |
Commitments and Contingencies_5
Commitments and Contingencies (Details) - Schedule of other information related to operating leases | Dec. 31, 2022 |
Schedule of Other Information Related to Operating Leases [Abstract] | |
Weighted-average remaining lease term | 2 years 4 months 24 days |
Weighted-average discount rate | 8% |
Commitments and Contingencies_6
Commitments and Contingencies (Details) - Schedule of supplemental cash flow information related to operating leases - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Supplemental Cash Flow Information Related to Operating Leases [Abstract] | ||
Cash paid for operating lease liabilities | $ 57,300 |
Commitments and Contingencies_7
Commitments and Contingencies (Details) - Schedule of future minimum lease payments under non-cancellable leases | Dec. 31, 2022 USD ($) |
Schedule of Future Minimum Lease Payments under Non Cancellable Leases [Abstract] | |
2023 | $ 112,000 |
2024 | 91,000 |
2025 | 38,000 |
Total minimum lease payments | 241,000 |
Less: Imputed interest | (19,000) |
Total | $ 222,000 |
License and Agreements (Details
License and Agreements (Details) | 1 Months Ended | 12 Months Ended | |||||||
Aug. 12, 2020 USD ($) | Jan. 31, 2020 | Nov. 24, 2019 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 AUD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2021 AUD ($) | Dec. 31, 2021 AUD ($) | Mar. 31, 2018 USD ($) | |
License and Agreements (Details) [Line Items] | |||||||||
Assignment fee | $ 100,000 | ||||||||
Milestone payment | $ 50,000 | ||||||||
Research and development expenses | $ 714,000 | $ 536,000 | |||||||
Milestone fee | $ 25,000 | ||||||||
Accounts payable agreement | 21,000 | ||||||||
Accounts payable due | 0 | 117,000 | $ 161,000 | ||||||
Pre-marketing approvals | $ 25,000,000 | ||||||||
Recorded research and development costs | 18,496,340 | 21,300,865 | |||||||
Interest fee | 500,000 | ||||||||
Other receivable | 1,812,975 | 1,628,703 | |||||||
Clinical Network Services Pty Ltd. [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expenses | $ 527,000 | $ 761,000 | |||||||
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. | 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. | |||||||
Research and development expenses | $ 2,419,000 | 4,789,000 | |||||||
Accounts payable due | 176,000 | 313,000 | |||||||
Master Services Agreement [Member] | Contract manufacturing services [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Accounts payable due | 191,000 | ||||||||
Recorded research and development costs | 2,743,000 | ||||||||
Master Services Agreement with Societal [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expenses | 974,000 | 1,940,000 | |||||||
Master Consultancy Agreement [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expenses | 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$22,000 (US$15,000) and AUD$138,000 (US$100,000) as of December 31, 2022 and 2021, respectively. | ||||||||
Trial research agreement [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expenses | 0 | 0 | |||||||
Master Services Agreement with Experic [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expenses | 1,935,000 | 1,823,000 | |||||||
Research and Development Expense [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expenses | $ 341,840 | $ 1,626,153 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Nov. 30, 2022 | Mar. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity (Details) [Line Items] | |||||
Shares of common stock | 2,140,000 | 28,834 | |||
Price per share (in Dollars per share) | $ 14 | ||||
Gross proceeds (in Dollars) | $ 10,675,000 | $ 30,000,000 | |||
Net proceeds (in Dollars) | 11,235,626 | $ 28,015,000 | |||
Additional gross proceeds (in Dollars) | $ 1,601,251 | ||||
Total proceeds (in Dollars) | $ 180,213 | ||||
Common Stock [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Shares of common stock | 9,282,609 | 42,292 | 252,156 | ||
Price per share (in Dollars per share) | $ 1.15 | ||||
Additional shares of common stock | 1,392,392 | ||||
Total proceeds (in Dollars) | $ 110,822 | $ 689,752 | |||
Warrant [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Shares of common stock | 4,641,305 | 415,917 | |||
Number of shares, percentage | 15% | ||||
Additional shares of common stock | 696,196 | ||||
Common stock warrants | 424,288 | ||||
ATM Offering [Member] | |||||
Stockholders' Equity (Details) [Line Items] | |||||
Shares of common stock | 104,011 | ||||
Price per share (in Dollars per share) | $ 5.96 | ||||
Net proceeds (in Dollars) | $ 405,000 |
Warrants (Details)
Warrants (Details) - USD ($) | Nov. 30, 2022 | Feb. 01, 2021 | Dec. 31, 2022 |
Warrants (Details) [Line Items] | |||
Warrant issued | 5 years | ||
Contractual life | 5 years | ||
Dividend yield percentage | 0% | ||
Volatility percentage | 97.09% | ||
Risk-free interest rate | 0.42% | ||
General and administrative expenses | $ 293,000 | ||
Exercise price per share | $ 1.29 | ||
Expire year | 5 years | ||
Aggregate intrinsic value | $ 0 | ||
Warrant [Member] | |||
Warrants (Details) [Line Items] | |||
Shares of common stock | 5,337,501 | 25,000 | |
Price per share | $ 15.9 | ||
Common Stock [Member] | |||
Warrants (Details) [Line Items] | |||
Price per share | $ 16.13 |
Warrants (Details) - Schedule o
Warrants (Details) - Schedule of warrant activity - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants (Details) - Schedule of warrant activity [Line Items] | ||
Number of Shares, Outstanding beginning balance (in Shares) | 389,233 | 817,355 |
Weighted- Average Exercise Prices, Outstanding beginning balance | $ 5.79 | $ 2.68 |
Weighted- Average Remaining Life, Outstanding beginning balance | 3 years 8 months 12 days | |
Number of Shares, Issued (in Shares) | 5,362,501 | 25,000 |
Range of Exercise Prices, Issued | $ 15.9 | |
Weighted- Average Exercise Prices, Issued | $ 1.31 | $ 15.9 |
Weighted- Average Remaining Life, Issued | ||
Number of Shares, Exercised (in Shares) | (453,122) | |
Range of Exercise Prices, Exercised | ||
Weighted- Average Exercise Prices, Exercised | $ 0.74 | |
Weighted- Average Remaining Life, Exercised | ||
Number of Shares, Outstanding ending balance (in Shares) | 5,751,734 | 389,233 |
Weighted- Average Exercise Prices, Outstanding ending balance | $ 1.61 | $ 5.79 |
Weighted- Average Remaining Life, Outstanding ending balance | 4 years 9 months 18 days | 4 years 4 months 24 days |
Minimum [Member] | ||
Warrants (Details) - Schedule of warrant activity [Line Items] | ||
Range of Exercise Prices, Outstanding beginning balance | $ 2.5 | $ 0.01 |
Range of Exercise Prices, Issued | 1.29 | |
Range of Exercise Prices, Exercised | 0.01 | |
Range of Exercise Prices, Outstanding ending balance | 1.29 | 2.5 |
Maximum [Member] | ||
Warrants (Details) - Schedule of warrant activity [Line Items] | ||
Range of Exercise Prices, Outstanding beginning balance | 15.9 | 6.25 |
Range of Exercise Prices, Issued | 5.7 | |
Range of Exercise Prices, Exercised | 6.25 | |
Range of Exercise Prices, Outstanding ending balance | $ 15.9 | $ 15.9 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Jan. 31, 2018 | Dec. 31, 2022 | 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 | $ 5,220,000 | |||
Weighted-average period | 2 years 1 month 6 days | |||
Compensation attributed to non-vested shares | 339,000 | |||
Compensation expense | $ 160,000 |
Stock Based Compensation (Det_2
Stock Based Compensation (Details) - Schedule of stock-based compensation expense - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items] | ||
Stock based compensation expense | $ 4,251,833 | $ 3,548,368 |
Research and development [Member] | ||
Stock Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items] | ||
Stock based compensation expense | 908,712 | 459,492 |
General and administrative [Member] | ||
Stock Based Compensation (Details) - Schedule of stock-based compensation expense [Line Items] | ||
Stock based compensation expense | $ 3,343,121 | $ 3,088,876 |
Stock Based Compensation (Det_3
Stock Based Compensation (Details) - Schedule of fair value of employee stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Based Compensation (Details) - Schedule of fair value of employee stock options [Line Items] | ||
Weighted average exercise price (in Dollars per share) | $ 3.71 | $ 8.86 |
Weighted average grant date fair value (in Dollars per share) | $ 2.84 | $ 6.83 |
Assumptions | ||
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Assumptions | ||
Expected volatility | 90% | 89% |
Expected term (in years) | 5 years 3 months 18 days | 6 years |
Risk-free interest rate | 2.41% | 0.81% |
Maximum [Member] | ||
Assumptions | ||
Expected volatility | 97% | 97% |
Expected term (in years) | 10 years | 10 years |
Risk-free interest rate | 4.20% | 1.55% |
Stock Based Compensation (Det_4
Stock Based Compensation (Details) - Schedule of stock option activity - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Stock Option Activity [Abstract] | ||
Number of Shares, Outstanding, beginning balance shares | 2,893,839 | 2,610,495 |
Weighted-Average Exercise Prices, Outstanding, beginning balance | $ 6.48 | $ 5.63 |
Weighted-Average Remaining Contractual Term, Outstanding beginning balance | 8 years 7 months 6 days | |
Intrinsic Value, Outstanding beginning balance | $ 9,932,413 | $ 22,789,233 |
Number of Shares, Outstanding, Granted | 456,393 | 535,500 |
Weighted-Average Exercise Prices, Outstanding, Granted | $ 3.71 | $ 8.86 |
Weighted-Average Remaining Contractual Term, Granted | ||
Intrinsic Value, Granted | ||
Number of Shares, Outstanding, Exercised | (42,292) | (252,156) |
Weighted-Average Exercise Prices, Outstanding, Exercised | $ 2.62 | $ 2.74 |
Weighted-Average Remaining Contractual Term, Exercised | ||
Intrinsic Value, Exercised | ||
Number of Shares, Outstanding, Exercised | (398,883) | |
Weighted-Average Exercise Prices, Outstanding, Exercised | $ 7.53 | |
Number of Shares, Outstanding, Outstanding ending balance | 2,909,057 | 2,893,839 |
Weighted-Average Exercise Prices, Outstanding, Outstanding ending balance | $ 5.96 | $ 6.48 |
Weighted-Average Remaining Contractual Term, Outstanding ending balance | 7 years 5 months 15 days | 8 years 18 days |
Intrinsic Value, Outstanding ending balance | $ 24,279 | $ 9,932,413 |
Number of Shares, Outstanding, Exercisable | 1,189,267 | |
Weighted-Average Exercise Prices, Outstanding, Exercisable | $ 5.5 | |
Weighted-Average Remaining Contractual Term, Exercisable | 6 years 8 months 8 days | |
Intrinsic Value, Exercisable |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Aug. 16, 2022 | Mar. 27, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes (Details) [Line Items] | |||||
Gross federal income tax net operating loss | $ 71,906,839 | $ 59,111,972 | |||
Federal research tax credits | 3,179,405 | 1,047,681 | |||
Foreign income tax net operating loss | $ 736,112 | 2,247,481 | |||
Carried forward indefinitely years | 5 years | ||||
Taxable income for losses | 80% | 80% | |||
Corporate rate, percentage | 15% | ||||
Average income | $ 1,000,000,000 | $ 696,714 | |||
Excise tax surcharge, percentage | 1% | ||||
Valuation allowance on deferred tax assets | 100% | ||||
Uncertain Tax Positions | $ 794,851 | ||||
Effective Tax [Member] | |||||
Income Taxes (Details) [Line Items] | |||||
Uncertain Tax Positions | $ 794,851 |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of income tax expense - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
Federal | ||
State | ||
Foreign | ||
Total current | ||
Deferred: | ||
Federal | (7,871,979) | (6,076,003) |
State | ||
Foreign | 453,410 | (240,902) |
Change in valuation allowance | 7,418,569 | 6,316,905 |
Total deferred | ||
Income tax provision (benefit) |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of deferred tax assets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Deferred Tax Assets Abstract | ||
Net operating loss carryforwards | $ 15,321,270 | $ 13,087,758 |
Research and development tax credit | 2,384,554 | 785,761 |
Section 174 amortization | 3,437,763 | |
Intangibles | 175,334 | 143,854 |
Stock compensation | 1,029,447 | 1,054,242 |
Accruals and other | (173) | |
Total deferred tax assets | 22,348,195 | 15,071,615 |
Valuation allowances | (22,348,195) | (15,071,615) |
Net deferred tax assets |
Income Taxes (Details) - Sche_3
Income Taxes (Details) - Schedule of provision federal statutory rate | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Provision Federal Statutory Rate [Abstract] | ||
Statutory rate | 21% | 21% |
State rate | 0% | 0% |
Foreign | (0.31%) | (0.54%) |
Permanent book/tax differences | (0.94%) | (1.95%) |
Research and development credit | 5.03% | 1.07% |
Changes in valuation allowance | (24.78%) | (19.58%) |
Total |
Income Taxes (Details) - Sche_4
Income Taxes (Details) - Schedule of unrecognized tax positions - Federal and State [Member] | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Income Taxes (Details) - Schedule of unrecognized tax positions [Line Items] | |
Balance at December 31, 2021 | $ 261,920 |
Additions for tax positions related to current year | 532,931 |
Decreases for tax positions related to prior years | |
Balance at December 31, 2022 | $ 794,851 |
Subsequent Events (Details)
Subsequent Events (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Subsequent Events (Details) [Line Items] | |
Principal amount | $ 1,812,975 |
Interest rate | 6% |
Maturity date | Jan. 01, 2026 |
Dividing amount | $ 15,000,000 |
Outstanding principal amount | 15,000,000 |
Gross proceeds | $ 15,000,000 |
Outstanding principal amount percentage | 100% |
IPO [Member] | |
Subsequent Events (Details) [Line Items] | |
Gross proceeds | $ 35,000,000 |