Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 09, 2022 | |
Document Information Line Items | ||
Entity Registrant Name | TFF PHARMACEUTICALS, Inc. | |
Trading Symbol | TFFP | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 25,373,818 | |
Amendment Flag | false | |
Entity Central Index Key | 0001733413 | |
Entity Current Reporting Status | No | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Ex Transition Period | false | |
Document Quarterly 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 $0.001 | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 26,414,170 | $ 33,794,672 |
Receivable due from collaboration agreement | 1,776,583 | 1,628,703 |
Research and development tax incentive receivable | 1,168,830 | 966,646 |
Prepaid assets and other current assets | 2,164,451 | 2,447,930 |
Total current assets | 31,524,034 | 38,837,951 |
Property and equipment, net | 2,258,738 | 1,859,860 |
Total assets | 33,782,772 | 40,697,811 |
Current liabilities: | ||
Accounts payable | 2,028,779 | 1,493,842 |
Accrued compensation | 416,910 | |
Deferred research grant revenue | 168,000 | 50,000 |
Total liabilities | 2,196,779 | 1,960,752 |
Commitments and contingencies (see Note 4) | ||
Stockholders’ equity: | ||
Common stock; $0.001 par value, 45,000,000 shares authorized; 25,371,781 shares issued and outstanding | 25,372 | 25,372 |
Additional paid-in capital | 105,256,670 | 104,078,968 |
Accumulated other comprehensive loss | (1,687) | (48,921) |
Accumulated deficit | (73,694,362) | (65,318,360) |
Total stockholders’ equity | 31,585,993 | 38,737,059 |
Total liabilities and stockholders’ equity | $ 33,782,772 | $ 40,697,811 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 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 | 25,371,781 | 25,371,781 |
Common stock, shares outstanding | 25,371,781 | 25,371,781 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Grant revenue | $ 67,435 | $ 24,315 |
Operating expenses: | ||
Research and development | 5,261,604 | 5,278,252 |
General and administrative | 3,246,195 | 2,647,415 |
Total operating expenses | 8,507,799 | 7,925,667 |
Loss from operations | (8,440,364) | (7,901,352) |
Other income: | ||
Other income | 57,177 | 231,278 |
Interest income | 7,185 | 15,499 |
Total other income | 64,362 | 246,777 |
Net loss | $ (8,376,002) | $ (7,654,575) |
Net loss per share, basic and diluted (in Dollars per share) | $ (0.33) | $ (0.33) |
Weighted average common shares outstanding, basic and diluted (in Shares) | 25,371,781 | 23,140,607 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (8,376,002) | $ (7,654,575) |
Other comprehensive loss: | ||
Foreign currency translation adjustments | 47,234 | (37,958) |
Comprehensive loss | $ (8,328,768) | $ (7,692,533) |
Unaudited Condensed Consolida_2
Unaudited Condensed 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 | 28,021,424 | 28,023,564 | ||
Sale of common stock, net of offering costs (in Shares) | 2,140,000 | ||||
Issuance of common stock for stock option exercises | $ 245 | 655,008 | 655,253 | ||
Issuance of common stock for stock option exercises (in Shares) | 244,656 | ||||
Issuance of common stock for warrant exercises | $ 444 | 179,768 | 180,212 | ||
Issuance of common stock for warrant exercises (in Shares) | 444,751 | ||||
Stock-based compensation | 1,030,415 | 1,030,415 | |||
Foreign currency translation adjustment | (37,958) | (37,958) | |||
Net loss | (7,654,575) | (7,654,575) | |||
Balance at Mar. 31, 2021 | $ 25,364 | 101,535,068 | (89,496) | (41,934,223) | 59,536,713 |
Balance (in Shares) at Mar. 31, 2021 | 25,364,281 | ||||
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 | ||||
Stock-based compensation | 1,177,702 | 1,177,702 | |||
Foreign currency translation adjustment | 47,234 | 47,234 | |||
Net loss | (8,376,002) | (8,376,002) | |||
Balance at Mar. 31, 2022 | $ 25,372 | $ 105,256,670 | $ (1,687) | $ (73,694,362) | $ 31,585,993 |
Balance (in Shares) at Mar. 31, 2022 | 25,371,781 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (8,376,002) | $ (7,654,575) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Stock based compensation | 1,177,702 | 1,030,415 |
Depreciation and amortization | 77,028 | 1,495 |
Changes in operating assets and liabilities: | ||
Receivable due from collaboration agreement | (147,880) | |
Research and development tax incentive receivable | (108,097) | |
Prepaid assets and other current assets | 237,646 | 534,612 |
Accounts payable | 192,211 | 521,114 |
Accrued compensation | (416,910) | |
Deferred revenue | 118,000 | (24,315) |
Net cash used in operating activities | (7,246,302) | (5,591,254) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (137,231) | (476,128) |
Net cash used in investing activities | (137,231) | (476,128) |
Cash flows from financing activities: | ||
Net proceeds from issuance of common stock | 28,023,564 | |
Proceeds from issuance of common stock for stock option exercises | 655,253 | |
Proceeds from issuance of common stock for warrant exercises | 180,212 | |
Net cash provided by financing activities | 28,859,029 | |
Effect of exchange rate changes on cash and cash equivalents | 3,031 | (37,330) |
Net change in cash and cash equivalents | (7,380,502) | 22,754,317 |
Cash and cash equivalents at beginning of period | 33,794,672 | 35,300,805 |
Cash and cash equivalents at end of period | 26,414,170 | 58,055,122 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Purchases of equipment included in accounts payable | 338,674 | |
Cashless exercise of warrants | $ 416 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS TFF Pharmaceuticals, Inc. (the “Company”) was incorporated in the State of Delaware on January 24, 2018. 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. COVID-19 As of the date of this report, the COVID-19 pandemic has had a relatively insignificant impact on the Company’s operations and has not caused the Company to forego, abandon or materially delay any proposed activities. While the Company believes it has been able to effectively manage the disruption caused by the COVID-19 pandemic to date, 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. |
Liquidity and Management_s Plan
Liquidity and Management’s Plans | 3 Months Ended |
Mar. 31, 2022 | |
Liquidity and Managements Plans [Abstract] | |
LIQUIDITY AND MANAGEMENT’S PLANS | NOTE 2 - LIQUIDITY AND MANAGEMENT’S PLANS As of March 31, 2022, the Company had cash and cash equivalents of approximately $26,414,000 and a working capital of approximately $29,327,000. The Company has not generated revenues from commercial operations since inception and has incurred recurring operating losses. The Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to continue the pursuit of its product development. The Company expects to further increase its research and development activities, which will increase the amount of cash utilized subsequent to March 31, 2022. Specifically, the Company expects increased spending on research and development activities and higher payroll expenses as it increases its professional and scientific staff and continues to prepare for anticipated manufacturing activities. If the Company encounters unforeseen delays or expenses, it has the ability to curtail our presently planned level of operations. The Company currently believes its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial statements and with Form 10-Q and Article 10 of Regulation S-X of the United States Securities and Exchange Commission (“SEC”). Accordingly, they do not contain all information and footnotes required by GAAP for annual financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all the adjustments necessary (consisting only of normal recurring accruals) to present the financial position of the Company as of March 31, 2022 and the results of operations, changes in stockholders’ equity and cash flows for the periods presented. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the operating results for the full fiscal year or any future period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. 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 loss. 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 March 31, 2022 and December 31, 2021, the Company had cash in Australia of AUD$308,824 (US$231,447) and AUD$831,984 (US$604,944), respectively. Revenue Recognition The Company has entered into feasibility and material transfer agreements (“Feasibility Agreements”) with third parties that provide the Company with funds in return for certain research and development activities. Revenue from the Feasibility Agreements is recognized in the period during which the related qualifying services are rendered and costs are incurred, provided that the applicable conditions under the Feasibility Agreements have been met. The Feasibility Agreements are on a best-effort basis and do not require scientific achievement as a performance obligation. All fees received under the Feasibility Agreements are non-refundable. The costs associated with the Feasibility Agreements are expensed as incurred and are reflected as a component of research and development expense in the accompanying condensed consolidated statements of operations. Funds received from the Feasibility Agreements are recorded as revenue as the Company is the principal participant in the arrangement because the activities under the Feasibility Agreements are part of the Company’s development programs. In those instances where the Company first receives consideration in advance of providing underlying services, the Company classifies such consideration as deferred revenue until (or as) the Company provides the underlying services. In those instances where the Company first provides the underlying services prior to its receipt of consideration, the Company records a grant receivable. During the three months ended March 31, 2022 and 2021, the Company rendered the related services and recognized revenue and research and development expenses of $67,435 and $24,315, respectively. As of March 31, 2022 and December 31, 2021, the Company had receivables due related to Feasibility Agreements of $55,435 and $11,996, respectively, which is included in prepaid assets and other current assets in the accompanying condensed consolidated balance sheets, and deferred grant revenue of approximately $168,000 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 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 condensed consolidated statements of operations during the period ended March 31, 2021. 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 three months ended March 31, 2022 and 2021. In addition, the Company is also eligible to receive amounts from the United States Internal Revenue Service (“IRS”) related to research and development tax credits for expenditures. The research and development incentive receivable represents amounts due in connection with the Australian Tax Incentive and from the IRS. The Company has recorded a research and development tax incentive receivable of $1,168,830 and $966,646 as of March 31, 2022 and December 31, 2021, respectively, in the condensed consolidated balance sheets. The Company has recorded other income of $57,177 and $231,278, in the condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021, respectively, related to refundable IRS and Australian research and development incentive program payments for expenditures incurred during 2020. The Company recorded a reduction to research and development expenses of $108,098 during the three months ended March 31, 2022 for expenditures incurred during 2022 and $0 during the three months ended March 31, 2021 for expenditures incurred during 2021. 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 three months ended March 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: Three Months Ended Three Months Ended March 31, March 31, Stock Options 2,976,090 2,375,839 Warrants 389,233 389,233 3,365,323 2,765,072 * On an as-converted basis Use of Estimates The preparation of condensed 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 and warrants and the valuation allowance against deferred tax assets and related disclosures. Actual results could differ from those estimates. Recent Accounting Standards There have been no recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the three months ended March 31, 2022 that are of significance or potential significance to the Company. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 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, 2022, as amended. The lease has an additional one-year option for renewal, and the base rent is $36,000 per year. The Company has determined that the lease agreement is considered a short-term lease under ASC 842 and has not recorded a right-of-use asset or liability. The Company rents another office space on a month-to-month basis with no long-term commitment, which is considered a short-term lease as well. Short-term lease expense for the three months ended March 31, 2022 and 2021 was approximately $21,000 and $15,000, respectively. Approximate future minimum lease payments required under the operating leases are as follows: Amount Year Ending December 31, 2022 $ 21,000 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 | 3 Months Ended |
Mar. 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. 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 condensed consolidated financial statements, the Company is in compliance with the patent license agreement as all required amounts have been paid in accordance with the agreement. In May 2018, the Company entered into a master services agreement and associated individual study contracts with ITR Canada, Inc. (“ITR”) to provide initial contract pre-clinical research and development services for the Company’s drug product candidates. In January 2019, the Company cancelled all of the individual study contracts with ITR and entered into contracts with 11036114 Canada Inc. (initially dba VJO Non-Clinical Development and now dba Strategy Point Innovations (“SPI”)) and 11035835 Canada Inc., (dba Periscope Research) to complete additional pre-clinical research and development services in order to take advantage of eligible Canadian Tax Credits. The services related to the contract with SPI were sub-contracted to ITR and others under substantially the same terms as the initial contract with ITR. Desire Ventures, LLC facilitates the invoicing for the various affiliates. The accounts payable due in connection with this agreement was approximately $472,000 and $0 as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately $1,585,000 and $1,812,000, respectively, pertaining to this agreement. In April 2019, the Company entered into a master services agreement with Irisys, LLC to provide contract manufacturing services for one of the Company’s drug product candidates, Voriconazole. The accounts payable due in connection with this agreement was approximately $35,000 and $21,000 as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately $446,000 and $494,000, respectively, pertaining to this agreement. 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$179,000 (US$134,000) and AUD$138,000 (US$100,000) as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately AUD$347,000 (US$251,000) and AUD$705,000 (US$545,000), respectively, pertaining to this agreement. In May 2020, TFF Australia entered into an amended clinical trial research agreement with Nucleus Network Pty Ltd. to provide a Phase I study of one of the Company’s drug candidates, Tacrolimus. The accounts payable due in connection with this agreement was approximately $0 and AUD$161,000 (US$117,000) as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately $0 and AUD$244,000 (US$188,000), respectively, pertaining to this agreement. On August 12, 2020, the Company entered into a licensing and collaboration agreement with UNION therapeutics A/S in which UNION acquired an option to obtain a worldwide exclusive license for the TFF technology in combination with niclosamide. Pursuant to the terms of the license agreement, UNION can exercise its option to obtain the license within 45 days after the complete data has been received by UNION from investigator-initiated trials. Upon exercise of the option, UNION shall be responsible to pay all expenses incurred in the development of any licensed product. The Company will be eligible to receive milestone payments upon the achievement of certain milestones in the development the licensed products, based on completion of clinical trials, pre-marketing approvals and/or the receipt of at least $25,000,000 of grant funding. The Company will receive a single-digit tiered royalty on net sales. The Company will also be entitled to receive sales-related milestone payments based on the commercial success of the licensed products. In January 2021, the Company entered into a master services agreement with Experic to provide contract manufacturing services for one of the Company’s drug product candidates, Voriconazole. The accounts payable due in connection with this agreement was approximately $87,000 and $313,000 as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately $318,000 and $196,000, 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 while negotiating a Master Services Agreement for one of the Company’s drug product candidates, Voriconazole. The accounts payable due in connection with this agreement was approximately $14,000 as of March 31, 2022. During the three months ended March 31, 2022, the Company recorded research and development costs of approximately $226,000 pertaining to this agreement. Joint Development Agreement On November 2, 2020, the Company and Augmenta entered into the JDA pursuant to which the Company and Augmenta (collectively the “Parties”) agreed to work jointly to develop one or more novel commercial products incorporating Augmenta’s human derived monoclonal antibody for the treatment of patients with COVID-19 and the Company’s patented Thin Film Freezing technology platform. Each party retains full ownership over its existing assets. The Parties will share development costs with each party funding its fifty-percent-share at specified times. In the event that one of the Parties fails to make its pro rata share payment, the other party may terminate the JDA. In lieu of terminating the JDA, the non-defaulting party may elect to continue the JDA by paying the delinquent amount and each party’s pro rata share of the JDA will automatically adjust by the amount paid. In addition, in the event Augmenta experiences a default on its required payment, Augmenta will have the one-time right to elect to require the Company to purchase Augmenta’s interest in the JDA (“Put Right”) for a one-time fee of $500,000. Upon exercise of the Put Right and payment by the Company, Augmenta will grant the Company an exclusive, worldwide, royalty-free, transferable, sublicensable license to the Augmenta antibody and Augmenta’s rights to the property developed under the JDA. The Company has determined that the likelihood of the Put Right being exercised to be remote. The JDA is within the scope of ASC 808 as the Company and Augmenta are both active participants in the research and development activities and are exposed to significant risks and rewards that are dependent on commercial success of the activities of the arrangement. The research and development activities are a unit of account under the scope of ASC 808 and are not promises to a customer under the scope of ASC 606. The Company records its portion of the research and development expenses as the related expenses are incurred. All payments received or amounts due from Augmenta for reimbursement of shared costs are accounted for as an offset to research and development expense. During the three months ended March 31, 2022 and 2021, the Company recorded research and development expenses of $147,880 and $76,200, respectively, and has recorded a receivable of $1,776,583 and $1,628,703 for reimbursement due from Augmenta as of March 31, 2022 and December 31, 2021, respectively. |
Stock Based Compensation
Stock Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK BASED COMPENSATION | NOTE 6 – 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 three months ended March 31, 2022 and 2021 for stock options and warrants: Three Three March 31, March 31, Research and development $ 205,809 $ 67,279 General and administrative 971,893 963,136 $ 1,177,702 $ 1,030,415 As of March 31, 2022, there was approximately $8,135,000 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 2.4 years. The Company records compensation expense for 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 stock options using the Black-Scholes option pricing model. The fair value of stock options is being amortized on a straight-line basis over the requisite service periods of the respective awards. The fair value of stock options issued was estimated using the following: Three Months Weighted average exercise price $ 6.90 Weighted average grant date fair value $ 5.20 Assumptions Expected volatility 96%-97 % Expected term (in years) 6.3 Risk-free interest rate 1.79%-2.41 % Expected dividend yield 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 three months ended March 31, 2022: Number of Weighted- Weighted- Intrinsic Outstanding at January 1, 2022 2,893,839 $ 6.48 8.05 $ 9,932,413 Granted 100,000 6.90 — — Cancelled (17,749 ) 11.09 — — Outstanding at March 31, 2022 2,976,090 $ 6.47 7.87 $ 4,435,685 Exercisable at March 31, 2022 1,411,441 $ 5.00 7.24 $ 3,196,095 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had strike prices lower than the fair value of the Company’s common stock. Option Modification 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 three months ended March 31, 2022, in accordance with ASC Topic 718, Compensation—Stock Compensation, |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 7 – SUBSEQUENT EVENTS The Company has performed an evaluation of events occurring subsequent to March 31, 2022 through the filing date of this Quarterly Report. Based on its evaluation, there are no events that need to be disclosed. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial statements and with Form 10-Q and Article 10 of Regulation S-X of the United States Securities and Exchange Commission (“SEC”). Accordingly, they do not contain all information and footnotes required by GAAP for annual financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all the adjustments necessary (consisting only of normal recurring accruals) to present the financial position of the Company as of March 31, 2022 and the results of operations, changes in stockholders’ equity and cash flows for the periods presented. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the operating results for the full fiscal year or any future period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. |
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 loss. |
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 March 31, 2022 and December 31, 2021, the Company had cash in Australia of AUD$308,824 (US$231,447) and AUD$831,984 (US$604,944), respectively. |
Revenue Recognition | Revenue Recognition The Company has entered into feasibility and material transfer agreements (“Feasibility Agreements”) with third parties that provide the Company with funds in return for certain research and development activities. Revenue from the Feasibility Agreements is recognized in the period during which the related qualifying services are rendered and costs are incurred, provided that the applicable conditions under the Feasibility Agreements have been met. The Feasibility Agreements are on a best-effort basis and do not require scientific achievement as a performance obligation. All fees received under the Feasibility Agreements are non-refundable. The costs associated with the Feasibility Agreements are expensed as incurred and are reflected as a component of research and development expense in the accompanying condensed consolidated statements of operations. Funds received from the Feasibility Agreements are recorded as revenue as the Company is the principal participant in the arrangement because the activities under the Feasibility Agreements are part of the Company’s development programs. In those instances where the Company first receives consideration in advance of providing underlying services, the Company classifies such consideration as deferred revenue until (or as) the Company provides the underlying services. In those instances where the Company first provides the underlying services prior to its receipt of consideration, the Company records a grant receivable. During the three months ended March 31, 2022 and 2021, the Company rendered the related services and recognized revenue and research and development expenses of $67,435 and $24,315, respectively. As of March 31, 2022 and December 31, 2021, the Company had receivables due related to Feasibility Agreements of $55,435 and $11,996, respectively, which is included in prepaid assets and other current assets in the accompanying condensed consolidated balance sheets, and deferred grant revenue of approximately $168,000 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 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 condensed consolidated statements of operations during the period ended March 31, 2021. 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 three months ended March 31, 2022 and 2021. In addition, the Company is also eligible to receive amounts from the United States Internal Revenue Service (“IRS”) related to research and development tax credits for expenditures. The research and development incentive receivable represents amounts due in connection with the Australian Tax Incentive and from the IRS. The Company has recorded a research and development tax incentive receivable of $1,168,830 and $966,646 as of March 31, 2022 and December 31, 2021, respectively, in the condensed consolidated balance sheets. The Company has recorded other income of $57,177 and $231,278, in the condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021, respectively, related to refundable IRS and Australian research and development incentive program payments for expenditures incurred during 2020. The Company recorded a reduction to research and development expenses of $108,098 during the three months ended March 31, 2022 for expenditures incurred during 2022 and $0 during the three months ended March 31, 2021 for expenditures incurred during 2021. |
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 three months ended March 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: Three Months Ended Three Months Ended March 31, March 31, Stock Options 2,976,090 2,375,839 Warrants 389,233 389,233 3,365,323 2,765,072 * On an as-converted basis |
Use of Estimates | Use of Estimates The preparation of condensed 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 and warrants and the valuation allowance against deferred tax assets and related disclosures. Actual results could differ from those estimates. |
Recent Accounting Standards | Recent Accounting Standards There have been no recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the three months ended March 31, 2022 that are of significance or potential significance to the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of potential common stock equivalents outstanding | Three Months Ended Three Months Ended March 31, March 31, Stock Options 2,976,090 2,375,839 Warrants 389,233 389,233 3,365,323 2,765,072 * On an as-converted basis |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments | Amount Year Ending December 31, 2022 $ 21,000 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense stock options and warrants | Three Three March 31, March 31, Research and development $ 205,809 $ 67,279 General and administrative 971,893 963,136 $ 1,177,702 $ 1,030,415 |
Schedule of fair value of employee stock options | Three Months Weighted average exercise price $ 6.90 Weighted average grant date fair value $ 5.20 Assumptions Expected volatility 96%-97 % Expected term (in years) 6.3 Risk-free interest rate 1.79%-2.41 % Expected dividend yield 0.00 % |
Schedule of stock option activity | Number of Weighted- Weighted- Intrinsic Outstanding at January 1, 2022 2,893,839 $ 6.48 8.05 $ 9,932,413 Granted 100,000 6.90 — — Cancelled (17,749 ) 11.09 — — Outstanding at March 31, 2022 2,976,090 $ 6.47 7.87 $ 4,435,685 Exercisable at March 31, 2022 1,411,441 $ 5.00 7.24 $ 3,196,095 |
Liquidity and Management_s Pl_2
Liquidity and Management’s Plans (Details) | Mar. 31, 2022USD ($) |
Liquidity And Managements Plans [Abstract] | |
Cash and cash equivalents | $ 26,414,000 |
Working capital surplus | $ 29,327,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 3 Months Ended | ||||
Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2022AUD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2021AUD ($) | |
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Cash | $ 231,447 | $ 308,824 | $ 604,944 | $ 831,984 | |
Research and development expenses | 67,435 | $ 24,315 | |||
Prepaid assets and other current assets | 55,435 | 11,996 | |||
Deferred grant revenue | $ 168,000 | 50,000 | |||
Research and development tax percentage | 43.50% | 43.50% | |||
Other income (expense) | $ 57,177 | $ 231,278 | |||
Research and Development [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Research and development tax incentive | 1,168,830 | $ 966,646 | |||
Other income (expense) | 57,177 | 231,278 | |||
Research and development additional received | $ 108,098 | $ 0 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 3,365,323 | 2,765,072 |
Warrants [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 389,233 | 389,233 |
Stock Options [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of potential common stock equivalents outstanding [Line Items] | ||
Potential common stock equivalents outstanding | 2,976,090 | 2,375,839 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Oct. 31, 2018 | Mar. 31, 2022 | Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Rent expenses | $ 36,000 | ||
Short-term lease expense | $ 21,000 | $ 15,000 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of future minimum lease payments | Mar. 31, 2022USD ($) |
Schedule of future minimum lease payments [Abstract] | |
Year Ending December 31, 2022 | $ 21,000 |
License and Agreements (Details
License and Agreements (Details) - USD ($) | Aug. 12, 2020 | May 31, 2020 | Jan. 31, 2020 | Jan. 31, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Nov. 24, 2019 | Mar. 31, 2018 |
License and Agreements (Details) [Line Items] | |||||||||
Assignment fee | $ 100,000 | ||||||||
Milestone fee | $ 50,000 | ||||||||
Accounts payable due | $ 35,000 | $ 21,000 | |||||||
Research and development cost expenses | 1,585,000 | $ 1,812,000 | |||||||
Pre-marketing approvals | $ 25,000,000 | ||||||||
Recorded research and development costs | 5,261,604 | 5,278,252 | |||||||
Interest fee | 500,000 | ||||||||
Other receivable | 1,776,583 | 1,628,703 | |||||||
Master Services Agreement [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Agreement term, description | the Company cancelled all of the individual study contracts with ITR and entered into contracts with 11036114 Canada Inc. (initially dba VJO Non-Clinical Development and now dba Strategy Point Innovations (“SPI”)) and 11035835 Canada Inc., (dba Periscope Research) to complete additional pre-clinical research and development services in order to take advantage of eligible Canadian Tax Credits. | ||||||||
Accounts payable due | 472,000 | 0 | |||||||
Clinical Network Services Pty Ltd. [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
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$179,000 (US$134,000) and AUD$138,000 (US$100,000) as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately AUD$347,000 (US$251,000) and AUD$705,000 (US$545,000), respectively, pertaining to this agreement. | ||||||||
Clinical trial research agreement with Nucleus Network Pty Ltd. [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Agreement description | to provide a Phase I study of one of the Company’s drug candidates, Tacrolimus. The accounts payable due in connection with this agreement was approximately $0 and AUD$161,000 (US$117,000) as of March 31, 2022 and December 31, 2021, respectively. During the three months ended March 31, 2022 and 2021, the Company recorded research and development costs of approximately $0 and AUD$244,000 (US$188,000), respectively, pertaining to this agreement. | ||||||||
Contract manufacturing services [Member] | Master Services Agreement [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Accounts payable due | 14,000 | ||||||||
Recorded research and development costs | 226,000 | ||||||||
April 2019 [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development cost expenses | 446,000 | 494,000 | |||||||
January 2021 [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development cost expenses | 318,000 | 196,000 | |||||||
January 2021 [Member] | Master Services Agreement [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Accounts payable due | 87,000 | $ 313,000 | |||||||
Research and Development Expense [Member] | |||||||||
License and Agreements (Details) [Line Items] | |||||||||
Research and development expense | $ 147,880 | $ 76,200 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Sep. 30, 2021 | Jan. 31, 2018 | Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |||
Reserved shares | 4,200,000 | 1,630,000 | |
IPO shares | 3,284,480 | ||
Outstanding percentage | 15.00% | ||
Unrecognized compensation expense (in Dollars) | $ 8,135,000 | ||
Weighted-average period | 2 years 4 months 24 days | ||
General and administrative (in Dollars) | $ 339,000 |
Stock Based Compensation (Det_2
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants [Line Items] | ||
Stock based compensation expense | $ 1,177,702 | $ 1,030,415 |
Research and development [Member] | ||
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants [Line Items] | ||
Stock based compensation expense | 205,809 | 67,279 |
General and administrative [Member] | ||
Stock Based Compensation (Details) - Schedule of stock-based compensation expense stock options and warrants [Line Items] | ||
Stock based compensation expense | $ 971,893 | $ 963,136 |
Stock Based Compensation (Det_3
Stock Based Compensation (Details) - Schedule of fair value of employee stock options | 3 Months Ended |
Mar. 31, 2022$ / shares | |
Stock Based Compensation (Details) - Schedule of fair value of employee stock options [Line Items] | |
Weighted average exercise price (in Dollars per share) | $ 6.9 |
Weighted average grant date fair value (in Dollars per share) | $ 5.2 |
Assumptions | |
Expected term (in years) | 6 years 3 months 18 days |
Expected dividend yield | 0.00% |
Minimum [Member] | |
Assumptions | |
Expected volatility | 96.00% |
Risk-free interest rate | 1.79% |
Maximum [Member] | |
Assumptions | |
Expected volatility | 97.00% |
Risk-free interest rate | 2.41% |
Stock Based Compensation (Det_4
Stock Based Compensation (Details) - Schedule of stock option activity | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Schedule of stock option activity [Abstract] | |
Number of Shares, Outstanding, Outstanding ending balance | shares | 2,893,839 |
Weighted-Average Exercise Prices, Outstanding, Outstanding ending balance | $ / shares | $ 6.48 |
Weighted-Average Remaining Contractual Term, Outstanding ending balance | 8 years 18 days |
Intrinsic Value, Outstanding ending balance | $ | $ 9,932,413 |
Number of Shares, Outstanding, Granted | shares | 100,000 |
Weighted-Average Exercise Prices, Outstanding, Granted | $ / shares | $ 6.9 |
Number of Shares, Outstanding, Exercised | shares | (17,749) |
Weighted-Average Exercise Prices, Outstanding, Exercised | $ / shares | $ 11.09 |
Number of Shares, Outstanding, Outstanding ending balance | shares | 2,976,090 |
Weighted-Average Exercise Prices, Outstanding, Outstanding ending balance | $ / shares | $ 6.47 |
Weighted-Average Remaining Contractual Term, Outstanding ending balance | 7 years 10 months 13 days |
Intrinsic Value, Outstanding ending balance | $ | $ 4,435,685 |
Number of Shares, Outstanding, Exercisable | shares | 1,411,441 |
Weighted-Average Exercise Prices, Outstanding, Exercisable | $ / shares | $ 5 |
Weighted-Average Remaining Contractual Term, Exercisable | 7 years 2 months 26 days |
Intrinsic Value, Exercisable | $ | $ 3,196,095 |