Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 09, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-36199 | |
Entity Registrant Name | PULMATRIX, INC. | |
Entity Central Index Key | 0001574235 | |
Entity Tax Identification Number | 46-1821392 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 99 Hayden Avenue | |
Entity Address, Address Line Two | Suite 390 | |
Entity Address, City or Town | Lexington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02421 | |
City Area Code | (781) | |
Local Phone Number | 357-2333 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | PULM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 56,249,062 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 53,491 | $ 31,657 |
Accounts receivable | 9 | 84 |
Prepaid expenses and other current assets | 938 | 797 |
Total current assets | 54,438 | 32,538 |
Property and equipment, net | 345 | 361 |
Operating lease right-of-use asset | 761 | 1,489 |
Long-term restricted cash | 204 | 204 |
Goodwill | 3,577 | |
Total assets | 55,748 | 38,169 |
Current liabilities: | ||
Accounts payable | 875 | 925 |
Accrued expenses | 1,385 | 2,028 |
Operating lease liability | 898 | 1,135 |
Deferred revenue | 1,974 | 4,166 |
Total current liabilities | 5,132 | 8,254 |
Deferred revenue, net of current portion | 5,423 | 6,168 |
Operating lease liability, net of current portion | 608 | |
Total liabilities | 10,555 | 15,030 |
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value — 500,000 authorized and 0 issued and outstanding at September 30, 2021 and December 31, 2020 | ||
Common stock, $0.0001 par value — 200,000,000 shares authorized; 56,249,062 and 36,105,097 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively. | 6 | 4 |
Additional paid-in capital | 295,796 | 257,604 |
Accumulated deficit | (250,609) | (234,469) |
Total stockholders’ equity | 45,193 | 23,139 |
Total liabilities and stockholders’ equity | $ 55,748 | $ 38,169 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 500,000 | 500,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 56,249,062 | 36,105,097 |
Common stock, shares outstanding | 56,249,062 | 36,105,097 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenues | $ 1,069 | $ 4,372 | $ 4,713 | $ 10,634 |
Operating expenses: | ||||
Research and development | 4,026 | 3,873 | 12,423 | 12,344 |
General and administrative | 1,656 | 1,776 | 4,837 | 5,478 |
Goodwill impairment | 3,577 | 3,577 | ||
Total operating expenses | 9,259 | 5,649 | 20,837 | 17,822 |
Loss from operations | (8,190) | (1,277) | (16,124) | (7,188) |
Other income (expense): | ||||
Interest income | 1 | 13 | 6 | 78 |
Warrant inducement expense | (9,289) | (9,289) | ||
Other income (expense), net | 5 | (22) | (10) | |
Net loss | $ (8,184) | $ (10,553) | $ (16,140) | $ (16,409) |
Net loss per share attributable to common stockholders-basic and diluted | $ (0.15) | $ (0.31) | $ (0.30) | $ (0.62) |
Weighted average shares of common stock used to compute basic and diluted net loss per share | 56,249,062 | 33,924,499 | 53,081,963 | 26,284,826 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2019 | $ 2 | $ 226,178 | $ (215,161) | $ 11,019 |
Beginning balance, shares at Dec. 31, 2019 | 19,994,560 | |||
Exercise of warrants, net of issuance costs | 239 | 239 | ||
Exercise of warrants, net of issuance costs, shares | 206,747 | |||
Share-based compensation | 343 | 343 | ||
Exercise of pre-funded warrants | ||||
Exercise of pre-funded warrants, shares | 300,000 | |||
Exercise of common stock options | 21 | 21 | ||
Exercise of common stock options, shares | 19,997 | |||
Net loss | (4,686) | (4,686) | ||
Balance at Mar. 31, 2020 | $ 2 | 226,781 | (219,847) | 6,936 |
Shares, Outstanding, Ending Balance at Mar. 31, 2020 | 20,521,304 | |||
Balance at Dec. 31, 2019 | $ 2 | 226,178 | (215,161) | 11,019 |
Beginning balance, shares at Dec. 31, 2019 | 19,994,560 | |||
Warrant inducement expense | 9,289 | |||
Net loss | (16,409) | |||
Balance at Sep. 30, 2020 | $ 3 | 255,067 | (231,570) | 23,500 |
Shares, Outstanding, Ending Balance at Sep. 30, 2020 | 34,407,483 | |||
Balance at Mar. 31, 2020 | $ 2 | 226,781 | (219,847) | 6,936 |
Beginning balance, shares at Mar. 31, 2020 | 20,521,304 | |||
Issuance of common stock, net of issuance costs | $ 1 | 7,313 | 7,314 | |
Issuance of common stock, net of issuance costs, shares | 4,787,553 | |||
Exercise of warrants, net of issuance costs | 536 | 536 | ||
Exercise of warrants, net of issuance costs, shares | 437,999 | |||
Share-based compensation | 266 | 266 | ||
Exercise of common stock options | 3 | 3 | ||
Exercise of common stock options, shares | 2,500 | |||
Net loss | (1,170) | (1,170) | ||
Balance at Jun. 30, 2020 | $ 3 | 234,899 | (221,017) | 13,885 |
Shares, Outstanding, Ending Balance at Jun. 30, 2020 | 25,749,356 | |||
Exercise of warrants, net of issuance costs | 10,576 | 10,576 | ||
Exercise of warrants, net of issuance costs, shares | 8,658,127 | |||
Share-based compensation | 303 | 303 | ||
Warrant inducement expense | 9,289 | 9,289 | ||
Net loss | (10,553) | (10,553) | ||
Balance at Sep. 30, 2020 | $ 3 | 255,067 | (231,570) | 23,500 |
Shares, Outstanding, Ending Balance at Sep. 30, 2020 | 34,407,483 | |||
Balance at Dec. 31, 2020 | $ 4 | 257,604 | (234,469) | 23,139 |
Beginning balance, shares at Dec. 31, 2020 | 36,105,097 | |||
Issuance of common stock, net of issuance costs | $ 2 | 37,077 | 37,079 | |
Issuance of common stock, net of issuance costs, shares | 20,000,000 | |||
Exercise of warrants, net of issuance costs | 204 | 204 | ||
Exercise of warrants, net of issuance costs, shares | 143,965 | |||
Share-based compensation | 328 | 328 | ||
Exercise of pre-funded warrants | ||||
Exercise of pre-funded warrants, shares | ||||
Exercise of common stock options | ||||
Exercise of common stock options, shares | ||||
Warrant inducement expense | ||||
Net loss | (4,104) | (4,104) | ||
Balance at Mar. 31, 2021 | $ 6 | 295,213 | (238,573) | 56,646 |
Shares, Outstanding, Ending Balance at Mar. 31, 2021 | 56,249,062 | |||
Balance at Dec. 31, 2020 | $ 4 | 257,604 | (234,469) | 23,139 |
Beginning balance, shares at Dec. 31, 2020 | 36,105,097 | |||
Warrant inducement expense | ||||
Net loss | (16,140) | |||
Balance at Sep. 30, 2021 | $ 6 | 295,796 | (250,609) | 45,193 |
Shares, Outstanding, Ending Balance at Sep. 30, 2021 | 56,249,062 | |||
Balance at Mar. 31, 2021 | $ 6 | 295,213 | (238,573) | 56,646 |
Beginning balance, shares at Mar. 31, 2021 | 56,249,062 | |||
Share-based compensation | 299 | 299 | ||
Net loss | (3,852) | (3,852) | ||
Balance at Jun. 30, 2021 | 6 | 295,512 | (242,425) | 53,093 |
Share-based compensation | 284 | 284 | ||
Warrant inducement expense | ||||
Net loss | (8,184) | (8,184) | ||
Balance at Sep. 30, 2021 | $ 6 | $ 295,796 | $ (250,609) | $ 45,193 |
Shares, Outstanding, Ending Balance at Sep. 30, 2021 | 56,249,062 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (16,140) | $ (16,409) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 134 | 157 |
Amortization of operating lease right-of-use asset | 728 | 593 |
Share-based compensation | 911 | 912 |
Impairment of goodwill | 3,577 | |
Warrant inducement expense | 9,289 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 75 | 5,983 |
Prepaid expenses and other current assets | (141) | (617) |
Accounts payable | (50) | 9 |
Accrued expenses | (643) | (125) |
Operating lease liability | (845) | (467) |
Deferred revenue | (2,937) | (9,040) |
Net cash (used in)/provided by operating activities | (15,331) | (9,715) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (118) | (198) |
Net cash used in investing activities | (118) | (198) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 37,079 | 7,314 |
Proceeds from exercise of common stock options | 24 | |
Proceeds from exercise of common stock warrants, net of issuance costs | 204 | 11,351 |
Proceeds from exercise of common stock warrants, shares to be issued | 2,292 | |
Proceeds from Paycheck Protection Program loan | 617 | |
Repayment of Paycheck Protection Program loan | (617) | |
Net cash provided by financing activities | 37,283 | 20,981 |
Net increase in cash, cash equivalents and restricted cash | 21,834 | 11,068 |
Cash, cash equivalents and restricted cash — beginning of period | 31,861 | 23,644 |
Cash, cash equivalents and restricted cash — end of period | 53,695 | 34,712 |
Supplemental disclosures of non-cash investing and financing information: | ||
Fixed asset purchases in accounts payable | $ 21 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Organization | 1. Organization Pulmatrix, Inc. (the “Company”) was incorporated in 2013 as a Delaware corporation. The Company is a clinical stage biotechnology company focused on the discovery and development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery platform, iSPERSE™ (inhaled Small Particles Easily Respirable and Emitted), is engineered to deliver small, dense particles with highly efficient dispersibility and delivery to the airways, which can be used with an array of dry powder inhaler technologies and can be formulated with a variety of drug substances. The Company is developing a pipeline of iSPERSE ™ |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Standard | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Recent Accounting Standard | 2. Summary of Significant Accounting Policies and Recent Accounting Standard Basis of Presentation Principles of Consolidation The condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 23, 2021, and amended on March 26, 2021 and May 14, 2021 (the “Annual Report”). In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2021, are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2021. For further information, refer to the financial statements and footnotes included in the Company’s annual financial statements for the fiscal year ended December 31, 2020, which are included in the Annual Report. Use of Estimates In preparing condensed consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include valuing equity securities in share-based payments, valuing future expected costs in order to derive and recognize revenue, estimating the useful lives of depreciable and amortizable assets, interest borrowing rate, valuation allowance against deferred tax assets, goodwill impairment, and estimating the fair value of long-lived assets to assess whether impairment charges may apply. Concentrations of Credit Risk and Off-Balance Sheet Arrangements Cash is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially all of the Company’s cash was deposited in an account at a single financial institution that management believes is creditworthy. The Company is exposed to credit risk in the event of default by these financial institutions for amounts in excess of the Federal Deposit Insurance Corporation insured limits. The Company has not incurred any losses to date. We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash, checking accounts and money market accounts. Restricted cash consists of two security deposits with a financial institution. The following table provides a reconciliation of cash, cash equivalents and restricted cash as reported in the condensed consolidated balance sheets that sum to the total of the same amounts in the statement of cash flows. Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash 2021 2020 Nine months ended September 30, 2021 2021 2020 Cash and cash equivalents $ 53,491 $ 34,508 Restricted cash 204 204 Total cash, cash equivalents and restricted cash $ 53,695 $ 34,712 Revenue Recognition The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Our principal sources of revenue during the reporting period were income that resulted through our collaborative arrangements and license agreements that related to the development and commercialization of Pulmazole and PUR1800, and from reimbursement of clinical study costs. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, and collectability of the resulting receivable is reasonably assured. During the three months ended September 30, 2021, our principal source of revenue was income that resulted from the JJEI License Agreement, and immaterial royalties from the Sensory Cloud Agreement. During the nine months ended September 30, 2021, our principal source of revenue was income that resulted from the JJEI License Agreement and the Cipla Agreement described in Note 6, and immaterial royalties from the Sensory Cloud Agreement. Milestone Payments At the inception of each arrangement that includes research or development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments upon first commercial sales and milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has recognized immaterial royalty revenue that resulted from the Sensory Cloud licensing arrangement. Research and Development Costs Research and development costs are expensed as incurred and include: salaries, benefits, bonus, share-based compensation, license fees, milestone payments due under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, develop drug materials and delivery devices, and associated overhead and facilities costs. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contract research organizations (“CROs”) to carry out our clinical development activities and third-party contract manufacturing organizations (“CMOs”) to carry out our clinical manufacturing activities. Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of fees and costs associated with the contract that were rendered during the period and they are expensed as incurred. Research and development costs that are paid in advance of performance are capitalized as prepaid expenses and amortized over the service period as the services are provided. Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired, and liabilities assumed under the acquisition method of accounting for push-down accounting. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis during the fourth quarter, or more frequently if an event occurs or circumstances change that would more likely than not reduce the fair value of the Company’s reporting unit below its carrying amount. When performing the impairment assessment, the accounting standard for testing goodwill for impairment permits a company to first assess the qualitative factors to determine whether the existence of events and circumstances indicates that it is more likely than not that the goodwill is impaired. If the Company believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of goodwill is impaired, the Company then must perform a quantitative analysis to determine if the carrying value of the reporting entity exceeds its fair value. The impact of the novel coronavirus (“COVID-19”) pandemic was considered in the Company’s qualitative assessment. Given the Company’s common stock value decline during the nine months ended September 30, 2021, and based on the quantitative assessment, the Company determined that goodwill was impaired as of September 30, 2021, and a full impairment charge of $3,577 Recently Issued Accounting Pronouncements There have been no new, or existing recently issued, accounting pronouncements that are of significance, or potential significance, that impact the Company’s condensed consolidated financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2021 | |
Prepaid Expenses And Other Current Assets | |
Prepaid Expenses and Other Current Assets | 3. Prepaid Expenses and Other Current Assets Prepaid expenses consisted of the following: Schedule of Prepaid Expenses and Other Current Assets 2021 2020 At At September 30, 2021 December 31, 2020 Prepaid Insurance $ 474 $ 276 Prepaid Clinical Trials 43 317 Prepaid Other 283 130 Deferred Operating Costs - 74 Deferred Offering Costs 138 - Total prepaid and other current assets $ 938 $ 797 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 4. Property and Equipment, Net Property and equipment consisted of the following: Summary of Property and Equipment At At September 30, 2021 December 31, 2020 Laboratory equipment $ 1,828 $ 1,702 Computer equipment 304 302 Office furniture and equipment 217 217 Leasehold improvements 602 596 Capital in progress - 25 Total property and equipment 2,951 2,842 Less accumulated depreciation and amortization (2,606 ) (2,481 ) Property and equipment, net $ 345 $ 361 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses consisted of the following: Schedule of Accrued Expenses 2021 2020 At At September 30, 2021 December 31, 2020 Accrued vacation $ 103 $ 56 Accrued wages and incentive 692 813 Accrued clinical & consulting 435 1,010 Accrued legal & patent 114 129 Accrued other expenses 41 20 Total accrued expenses $ 1,385 $ 2,028 |
Significant Agreements
Significant Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Significant Agreements | 6. Significant Agreements License, Development and Commercialization Agreement with Johnson & Johnson Enterprise Innovation, Inc. (“JJEI”) On December 26, 2019, the Company entered into a License, Development and Commercialization Agreement (the “JJEI License Agreement”) with Johnson & Johnson Enterprise Innovation, Inc. Under the terms of the JJEI License Agreement, the Company has granted JJEI an option to acquire (1) the Company’s rights to an intellectual property portfolio of materials and technology related to narrow spectrum kinase inhibitor compounds (the “Licensed Product”) and (2) an exclusive, worldwide, royalty bearing license to PUR1800, the Company’s inhaled iSPERSE drug delivery system as formulated with one of the kinase inhibitor compounds. The Company is currently conducting a clinical and chronic toxicology program focused on chronic obstructive pulmonary diseases (“COPD”) and lung cancer interception. JJEI exercised its option to terminate the Company’s license, development, and commercialization agreement in April 2021. All rights to the kinase inhibitor portfolio, including PUR1800 and PUR5700, reverted to Pulmatrix when the termination of the contract became effective on July 6, 2021. The Company intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbation of chronic obstructive pulmonary disease (“AECOPD”) and other chronic airway diseases. Accounting Treatment Revenue associated with the combined research and development services for the Licensed Product and the irrevocable license to the Assigned Assets (as defined below) is recognized as revenue as the research and development services are provided using an input method, according to the ratio of costs incurred to the total costs expected to be incurred in the future to satisfy the performance obligation. In management’s judgment, this input method is the best measure of the transfer of control of the performance obligation. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s condensed consolidated balance sheet. During the three months ended September 30, 2021, the Company recognized $ 647 in revenue related to the license agreement and $ 413 in revenue related to reimbursed expenses in the Company’s condensed consolidated statement of operations. During the nine months ended September 30, 2021, the Company recognized $1,993 in revenue related to the license agreement and $1,755 in revenue related to reimbursed expenses in the Company’s condensed consolidated statement of operations. On July 6, 2021, all deferred revenue associated with the JJEI License Agreement was recognized. Collaborations - Development and Commercialization Agreement with Cipla Technologies LLC (“Cipla”) On April 15, 2019, we entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla Technologies LLC (“Cipla”) for the co-development and commercialization, on a worldwide exclusive basis, of Pulmazole, our inhaled iSPERSE drug delivery system enabled formulation of the antifungal drug, itraconazole, for the treatment of all pulmonary indications, including ABPA in patients with asthma. The Company received a non-refundable upfront payment of $22,000 (the “Upfront Payment”) under the Cipla Agreement. Upon receipt of the Upfront Payment, the Company irrevocably assigned to Cipla the following assets, solely to the extent that each covers the Product in connection with any treatment, prevention, and/or diagnosis of diseases of the pulmonary system (“Pulmonary Indications”): all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets directly related to the Product, specifically in relation to Pulmonary Indications (collectively, the “Assigned Assets”), excluding most specifically the Company’s iSPERSE technology. The Cipla Agreement will remain in effect in perpetuity, unless otherwise earlier terminated in accordance with its terms. In the event of circumstances affecting the continuity of development of the Product in line with the Cipla Agreement or certain development milestones are not achieved within a specified timeframe discussed in greater detail below, the joint steering committee (“JSC”) will evaluate the cause and effect and make a recommendation as to the most optimal option available to Cipla and the Company. In such events, the parties are not obligated to follow the recommendation of the JSC and, either party may elect to terminate (a “Terminating Party”) its obligation to fund additional costs and expenses for the development and/or commercialization of the Product. If the non-Terminating Party wishes to continue the development of the Product, it will have the right to purchase the rights of the Terminating Party in the Product at its fair market value. If both the Company and Cipla abandon the development program, the Company and Cipla shall make commercially reasonable efforts to monetize the Product and development program in connection with the Pulmonary Indications. The Company and Cipla will equally share the proceeds. The Company conducted a Type C meeting with the U.S. Food and Drug Administration (the “FDA”) on January 27, 2021, and, leveraging the insights gained from this meeting, had planned to commence the Phase 2b clinical study when the risks of study conduct presented by the ongoing COVID-19 pandemic were reduced to an acceptable level. The Phase 2b clinical study design includes a 16-week dosing regimen as well as an exploration of potential efficacy endpoints, whereas the terminated Phase 2 study comprised only a 4 week dosing regimen with safety and tolerability as its primary endpoint. The longer dosing regimen of the new Phase 2b clinical study is supported by the 6-month inhalation toxicology study in dogs completed in April 2020. On May 10, 2021, the Company sent a letter to Cipla notifying Cipla that it is in material breach of the Cipla Agreement due to Cipla’s anticipatory breach of its obligation under the Agreement to fund 50% of the development costs for Pulmazole in accordance with the terms of the Cipla Agreement. Due to the ongoing dispute with Cipla, development activities related to the Pulmazole program have been paused. (i) all development and commercialization activities with respect to the Product in India, South Africa, Sri Lanka, Nepal, Iran, Yemen, Myanmar and Algeria (such countries, the “Cipla Territory”) will be conducted exclusively by Cipla at Cipla’s sole cost and expense, (ii) Cipla shall be entitled to all profits from the sale of the Product in the Cipla Territory, except that if Cipla successfully transfers manufacturing of the Product for the Cipla Territory to a manufacturing site determined by Cipla, the Company will become entitled to a royalty equal to 2% of net sales in the Cipla Territory, and (iii) following the depletion of development funding initially set aside for the development of the Product by the Company, the Company and Cipla will each be responsible for 60% and 40%, respectively, of the Company’s overhead costs and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”), provided, that Cipla will reimburse the Company an amount equal to 10% of aggregate Direct Costs upon the achievement of certain development milestones set forth in the table below. Cipla and the Company will continue to share all other development costs that are not Direct Costs, such as the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis. The Phase 2b study is expected to start in Q1 2023 with top-line data expected in mid 2024. In addition, if any development milestone is not met by the date that is 9 months after the applicable deadline for achieving such development milestone, either party may elect to terminate its obligation to fund additional development costs, in which case either (i) the non-Terminating Party can acquire the rights of the Terminating Party for fair market value or (ii) the parties will monetize the Product. The table below sets forth the development milestones. Phase 2b Development Plan – Development Milestones Development Milestone Milestone Date 25% of patients enrolled in Phase 2b Clinical Study are dosed June 30, 2023 Company delivers summary of key efficacy and safety data to include FEV1, IgE, ACQ-6, number of subjects withdrawn, any severe adverse events related to the medication and an overall summary table of adverse events (“Topline Results”) to JSC June 30, 2024 Phase 3 Development Plan – Development Milestones Development Milestone Milestone Date 25% of patients enrolled in Phase 3 Clinical Study dosed To be proposed by JSC Company delivers Topline Results to the JSC To be proposed by JSC PDUFA To be proposed by JSC The Amendment also contains a mutual release of alleged breaches of the Cipla Agreement that may have occurred prior to the date of the Amendment. Accounting Treatment The Company determined the total transaction price to be $22,000 $12,000 $10,000 Revenue associated with the combined research and development services for the Product and the irrevocable license to the Assigned Assets is recognized as revenue as the research and development services are provided using an input method, according to the ratio of costs incurred to the total costs expected to be incurred in the future to satisfy the performance obligation. In management’s judgment, this input method is the best measure of the transfer of control of the performance obligation. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s condensed consolidated balance sheet. The Company received the $22,000 upfront payment in May 2019. No revenue was recognized during the three months ended September 30, 2021. During the nine months ended September 30, 2021, the Company recognized $755 in revenue related to the research and development services and $189 in revenue for the irrevocable license to the Assigned Assets in the Company’s condensed consolidated statements of operations. Due to the ongoing dispute with Cipla, activities related to the Pulmazole program were paused and no deferred revenue has been recognized as revenue during the three months ended September 30, 2021. The aggregate amount of the transaction price related to the Company’s unsatisfied performance obligations, and on September 30, 2021, the Company recorded $7,397 in deferred revenue, $1,974 of which is current. The Company expects to recognize the deferred revenue according to costs incurred over the remaining research term. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Common Stock | 7. Common Stock 2021 At-the-Market Offering On May 26, 2021, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with H.C. Wainwright and Co., LLC (“HCW”) to act as the Company’s sales agent with respect to the issuance and sale of up to $20,000 3.0% There have been no On February 16, 2021, the Company closed on a registered direct offering with certain healthcare-focused institutional investors for the sale of 20,000,000 $40,000 1,300,000 five $2.50 $1.57 $2,921 $37,079 2020 In April 20, 2020, the Company sold 4,787,553 $1.671 $8,000 $686 4,787,553 $1.55 April 20, 2022 311,191 $2.0888 April 20, 2022 $0.64 $0.54 Exercise of Warrants 2021 During the three months ended September 30, 2021, no During the nine months ended September 30, 2021, warrants to purchase 25,000 100,000 18,965 $204 2020 During the three months ended September 30, 2020, the Company issued 8,658,127 shares of common stock upon the exercise of 10,355,741 common stock warrants. The Company collected net proceeds of $12,868 which includes proceeds of $2,292 related to 1,697,614 shares of common stock held in abeyance and recorded as a common stock payable in the accompanying condensed consolidated balance sheet as of September 30, 2020. During the nine months ended September 30, 2020 the Company issued 9,302,873 and 300,000 shares of common stock upon exercise of 11,202,925 warrants and 300,000 pre-funded warrants respectively. The Company collected net proceeds of $13,643 which includes proceeds of $2,292 related to 1,697,614 shares of common stock held in abeyance and recorded as a common stock payable in the accompanying condensed consolidated balance sheet as of September 30, 2020. Exercise of Stock Options During the three and nine months ended September 30, 2021, no During the three months ended September 30, 2020, no During the nine months ended September 30, 2020, stock options to buy 22,497 $24 |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2021 | |
Warrants | |
Warrants | 8. Warrants A rollforward of the common stock warrants outstanding at September 30, 2021 is as follows. Schedule of Rollforward of Common Stock Warrants Outstanding Number of Warrants Weighted Average Weighted Average Aggregate Outstanding January 1, 2021 23,284,813 $ 3.41 3.3 $ - Warrants exercised (143,965 ) $ 1.42 Warrants issued 1,300,000 $ 2.50 Outstanding September 30, 2021 24,440,848 $ 3.37 2.7 $ - There were no warrants issued during the three months ended September 30, 2021. The estimated fair values of warrants granted during the nine months ended September 30, 2021, and the three and nine months ended September 30, 2020, were determined on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Schedule of Warrants Assumptions For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Contractual term (years) - 5 5 4 Risk-free interest rate - 0.28 % 0.57 % 0.26 % Expected volatility - 99.0 % 105.8 % 98.8 % Expected dividend yield - 0 % 0 % 0 % 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 weighted average of the historical volatility for industry peers and our own volatility. The dividend yield considers that the Company has not historically paid dividends and does not expect to pay dividends in the foreseeable future. The following represents a summary of the warrants outstanding at each of the dates identified: Schedule of Warrants Outstanding Number of Shares Underlying Warrants For the Period Ended September 30 Issue Date Classification Exercise Price Expiration Date 2021 2020 February 16, 2021 Equity $ 2.50 February 11, 2026 1,300,000 — August 07, 2020 Equity $ 1.80 July 14, 2025 1,814,815 1,814,815 August 07, 2020 Equity $ 2.25 July 14, 2025 218,713 218,713 July 23, 2020 Equity $ 1.80 July 14, 2025 1,550,000 1,550,000 July 13, 2020 Equity $ 2.25 July 14, 2025 436,860 436,860 July 13, 2020 Equity $ 1.80 July 14, 2025 6,695,926 6,720,926 April 20, 2020 Equity $ 1.55 April 20, 2022 4,787,553 4,787,553 April 20, 2020 Equity $ 2.0888 April 20, 2022 311,191 311,191 April 8, 2019 Equity $ 1.35 April 8, 2024 1,317,812 1,336,777 April 8, 2019 Equity $ 1.6875 April 3, 2024 797,334 797,334 February 12, 2019 Equity $ 1.8313 February 7, 2024 110,922 110,922 February 12, 2019 Equity $ 1.34 August 12, 2024 1,333,447 1,433,447 February 04, 2019 Equity $ 2.125 January 30, 2024 34,605 34,605 January 31, 2019 Equity $ 2.125 January 26, 2024 10,151 10,151 December 3, 2018 Equity $ 3.90 June 3, 2024 937,500 937,500 April 3, 2018 Equity $ 7.50 April 3, 2023 2,350,011 2,350,011 April 4, 2018 Equity $ 7.50 April 4, 2023 115,000 115,000 June 15, 2015 Equity $ 75.50 Five years after milestone achievement 319,008 319,008 Total Outstanding 24,440,848 23,284,813 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | 9. Share-Based Compensation The Company sponsors the Pulmatrix, Inc. 2013 Employee, Director and Consultant Equity Incentive Plan (the “2013 Plan). As of September 30, 2021, the 2013 Plan provides for the grant of up to 5,865,254 1,901,869 In addition, the Company has two legacy plans: The Pulmatrix Operating’s 2013 Employee, Director and Consultant Equity Incentive Plan (the “Original 2013 Plan”) and Pulmatrix Operating’s 2003 Employee, Director, and Consultant Stock Plan (the “2003 Plan”). As of September 30, 2021, a total of 1,304 Stock Options During the three months ended September 30, 2021, the Company granted 70,500 $51 1,128,087 $1,278 During the three months ended September 30, 2020, the Company granted 16,400 $20 2,265,504 $2,634 four years ten years The following table summarizes stock option activity for the nine months ended September 30, 2021: Summary of Stock Option Activity Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding January 1, 2021 2,899,837 $ 3.22 8.75 $ 60 Granted 1,128,087 $ 1.41 Forfeited or expired (140,049 ) $ 4.22 Outstanding - September 30, 2021 3,887,875 $ 2.66 8.36 $ - Exercisable - September 30, 2021 1,675,671 $ 4.26 7.91 $ - The estimated fair values of employee stock options granted during the three and nine months ended September 30, 2021, and September 30, 2020, were determined on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Schedule of Calculation of Fair Value Assumptions For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Expected option life (years) 6.07 6.03 5.98 5.92 Risk-free interest rate 0.94 % 0.40 % 0.62 % 1.61 % Expected volatility 106.04 % 94.41 % 104.96 % 93.91 % Expected dividend yield 0 % 0 % 0 % 0 % 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 weighted average of the historical volatility for industry peers and our own volatility. 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. The dividend yield considers that the Company has not historically paid dividends and does not expect to pay dividends in the foreseeable future. As of September 30, 2021, there was $2,414 2.58 Schedule of Stock-Based Compensation Expense For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development $ 53 $ 46 $ 164 $ 142 General and administrative 231 257 747 770 Total share-based compensation expense $ 284 $ 303 $ 911 $ 912 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Research and Development Activities The Company contracts with various other organizations to conduct research and development activities. As of September 30, 2021, the Company had aggregate commitments to pay approximately $256 remaining on these contracts. The scope of the services under contracts for research and development activities may be modified and the contracts, subject to certain conditions, may generally be cancelled by the Company upon written notice. In some instances, the contracts, subject to certain conditions, may be cancelled by the third party. Operating Leases The Company has limited leasing activities as a lessee and are primarily related to its corporate headquarters located at 99 Hayden Avenue, Suite 390, Lexington, Massachusetts. The Company currently leases approximately 22,000 June 30, 2022 The components of lease expense for the Company as of September 30, 2021, are as follows: Schedule of Components of Lease Expense 2021 2020 2021 2020 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Lease Cost: Fixed lease cost $ 259 $ 259 $ 777 $ 650 Variable lease cost 97 99 319 317 Total lease cost $ 356 $ 358 $ 1,096 $ 967 Maturities of lease liabilities due under these lease agreements as of September 30, 2021 are as follows: Schedule of Maturities of Lease Liabilities 2021 Operating Leases Maturity of lease liabilities: 2021 (excluding the nine months ended September 30, 2021) $ 299 2022 (half year) 615 Total lease payments 914 Less: interest (16 ) Total lease liabilities $ 898 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. Net Loss Per Share The Company computes basic and diluted net loss per share using a methodology that gives effect to the impact of outstanding participating securities (the “two-class method”). As the three and nine months ended September 30, 2021 and 2020, respectively, resulted in net losses attributable to common stockholders, there is no income allocation required under the two-class method or dilution attributed to weighted average shares outstanding in the calculation of diluted net loss per share. The following potentially dilutive securities outstanding prior to the use of the treasury stock method have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding As of September 30, 2021 2020 Options to purchase common stock 3,887,875 2,879,231 Warrants to purchase common stock 24,440,848 23,284,813 Total 28,328,723 26,164,044 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events On November 8, 2021, the Company entered into an amendment to the Cipla Agreement which modifies certain provisions of the Cipla Agreement and resolves the current dispute between the Company and Cipla as further discussed in Note 6. On October 14, 2021, the Company granted 32,800 On October 5 th $1,725 June 30, 2023 The Company has evaluated its events subsequent to September 30, 2021 to the date these condensed consolidated financial statements were issued, and has determined that, other than what was disclosed above, it does not have any subsequent events to disclose in these condensed consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recent Accounting Standard (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 23, 2021, and amended on March 26, 2021 and May 14, 2021 (the “Annual Report”). In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2021, are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2021. For further information, refer to the financial statements and footnotes included in the Company’s annual financial statements for the fiscal year ended December 31, 2020, which are included in the Annual Report. |
Use of Estimates | Use of Estimates In preparing condensed consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include valuing equity securities in share-based payments, valuing future expected costs in order to derive and recognize revenue, estimating the useful lives of depreciable and amortizable assets, interest borrowing rate, valuation allowance against deferred tax assets, goodwill impairment, and estimating the fair value of long-lived assets to assess whether impairment charges may apply. |
Concentrations of Credit Risk and Off-Balance Sheet Arrangements | Concentrations of Credit Risk and Off-Balance Sheet Arrangements Cash is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially all of the Company’s cash was deposited in an account at a single financial institution that management believes is creditworthy. The Company is exposed to credit risk in the event of default by these financial institutions for amounts in excess of the Federal Deposit Insurance Corporation insured limits. The Company has not incurred any losses to date. We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of cash, checking accounts and money market accounts. Restricted cash consists of two security deposits with a financial institution. The following table provides a reconciliation of cash, cash equivalents and restricted cash as reported in the condensed consolidated balance sheets that sum to the total of the same amounts in the statement of cash flows. Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash 2021 2020 Nine months ended September 30, 2021 2021 2020 Cash and cash equivalents $ 53,491 $ 34,508 Restricted cash 204 204 Total cash, cash equivalents and restricted cash $ 53,695 $ 34,712 |
Revenue Recognition | Revenue Recognition The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Our principal sources of revenue during the reporting period were income that resulted through our collaborative arrangements and license agreements that related to the development and commercialization of Pulmazole and PUR1800, and from reimbursement of clinical study costs. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, and collectability of the resulting receivable is reasonably assured. During the three months ended September 30, 2021, our principal source of revenue was income that resulted from the JJEI License Agreement, and immaterial royalties from the Sensory Cloud Agreement. During the nine months ended September 30, 2021, our principal source of revenue was income that resulted from the JJEI License Agreement and the Cipla Agreement described in Note 6, and immaterial royalties from the Sensory Cloud Agreement. Milestone Payments At the inception of each arrangement that includes research or development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments upon first commercial sales and milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has recognized immaterial royalty revenue that resulted from the Sensory Cloud licensing arrangement. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred and include: salaries, benefits, bonus, share-based compensation, license fees, milestone payments due under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, develop drug materials and delivery devices, and associated overhead and facilities costs. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contract research organizations (“CROs”) to carry out our clinical development activities and third-party contract manufacturing organizations (“CMOs”) to carry out our clinical manufacturing activities. Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of fees and costs associated with the contract that were rendered during the period and they are expensed as incurred. Research and development costs that are paid in advance of performance are capitalized as prepaid expenses and amortized over the service period as the services are provided. |
Goodwill | Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired, and liabilities assumed under the acquisition method of accounting for push-down accounting. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis during the fourth quarter, or more frequently if an event occurs or circumstances change that would more likely than not reduce the fair value of the Company’s reporting unit below its carrying amount. When performing the impairment assessment, the accounting standard for testing goodwill for impairment permits a company to first assess the qualitative factors to determine whether the existence of events and circumstances indicates that it is more likely than not that the goodwill is impaired. If the Company believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of goodwill is impaired, the Company then must perform a quantitative analysis to determine if the carrying value of the reporting entity exceeds its fair value. The impact of the novel coronavirus (“COVID-19”) pandemic was considered in the Company’s qualitative assessment. Given the Company’s common stock value decline during the nine months ended September 30, 2021, and based on the quantitative assessment, the Company determined that goodwill was impaired as of September 30, 2021, and a full impairment charge of $3,577 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements There have been no new, or existing recently issued, accounting pronouncements that are of significance, or potential significance, that impact the Company’s condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recent Accounting Standard (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash as reported in the condensed consolidated balance sheets that sum to the total of the same amounts in the statement of cash flows. Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash 2021 2020 Nine months ended September 30, 2021 2021 2020 Cash and cash equivalents $ 53,491 $ 34,508 Restricted cash 204 204 Total cash, cash equivalents and restricted cash $ 53,695 $ 34,712 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Prepaid Expenses And Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses consisted of the following: Schedule of Prepaid Expenses and Other Current Assets 2021 2020 At At September 30, 2021 December 31, 2020 Prepaid Insurance $ 474 $ 276 Prepaid Clinical Trials 43 317 Prepaid Other 283 130 Deferred Operating Costs - 74 Deferred Offering Costs 138 - Total prepaid and other current assets $ 938 $ 797 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consisted of the following: Summary of Property and Equipment At At September 30, 2021 December 31, 2020 Laboratory equipment $ 1,828 $ 1,702 Computer equipment 304 302 Office furniture and equipment 217 217 Leasehold improvements 602 596 Capital in progress - 25 Total property and equipment 2,951 2,842 Less accumulated depreciation and amortization (2,606 ) (2,481 ) Property and equipment, net $ 345 $ 361 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: Schedule of Accrued Expenses 2021 2020 At At September 30, 2021 December 31, 2020 Accrued vacation $ 103 $ 56 Accrued wages and incentive 692 813 Accrued clinical & consulting 435 1,010 Accrued legal & patent 114 129 Accrued other expenses 41 20 Total accrued expenses $ 1,385 $ 2,028 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Warrants | |
Schedule of Rollforward of Common Stock Warrants Outstanding | A rollforward of the common stock warrants outstanding at September 30, 2021 is as follows. Schedule of Rollforward of Common Stock Warrants Outstanding Number of Warrants Weighted Average Weighted Average Aggregate Outstanding January 1, 2021 23,284,813 $ 3.41 3.3 $ - Warrants exercised (143,965 ) $ 1.42 Warrants issued 1,300,000 $ 2.50 Outstanding September 30, 2021 24,440,848 $ 3.37 2.7 $ - |
Schedule of Warrants Assumptions | Schedule of Warrants Assumptions For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Contractual term (years) - 5 5 4 Risk-free interest rate - 0.28 % 0.57 % 0.26 % Expected volatility - 99.0 % 105.8 % 98.8 % Expected dividend yield - 0 % 0 % 0 % |
Schedule of Warrants Outstanding | The following represents a summary of the warrants outstanding at each of the dates identified: Schedule of Warrants Outstanding Number of Shares Underlying Warrants For the Period Ended September 30 Issue Date Classification Exercise Price Expiration Date 2021 2020 February 16, 2021 Equity $ 2.50 February 11, 2026 1,300,000 — August 07, 2020 Equity $ 1.80 July 14, 2025 1,814,815 1,814,815 August 07, 2020 Equity $ 2.25 July 14, 2025 218,713 218,713 July 23, 2020 Equity $ 1.80 July 14, 2025 1,550,000 1,550,000 July 13, 2020 Equity $ 2.25 July 14, 2025 436,860 436,860 July 13, 2020 Equity $ 1.80 July 14, 2025 6,695,926 6,720,926 April 20, 2020 Equity $ 1.55 April 20, 2022 4,787,553 4,787,553 April 20, 2020 Equity $ 2.0888 April 20, 2022 311,191 311,191 April 8, 2019 Equity $ 1.35 April 8, 2024 1,317,812 1,336,777 April 8, 2019 Equity $ 1.6875 April 3, 2024 797,334 797,334 February 12, 2019 Equity $ 1.8313 February 7, 2024 110,922 110,922 February 12, 2019 Equity $ 1.34 August 12, 2024 1,333,447 1,433,447 February 04, 2019 Equity $ 2.125 January 30, 2024 34,605 34,605 January 31, 2019 Equity $ 2.125 January 26, 2024 10,151 10,151 December 3, 2018 Equity $ 3.90 June 3, 2024 937,500 937,500 April 3, 2018 Equity $ 7.50 April 3, 2023 2,350,011 2,350,011 April 4, 2018 Equity $ 7.50 April 4, 2023 115,000 115,000 June 15, 2015 Equity $ 75.50 Five years after milestone achievement 319,008 319,008 Total Outstanding 24,440,848 23,284,813 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the nine months ended September 30, 2021: Summary of Stock Option Activity Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding January 1, 2021 2,899,837 $ 3.22 8.75 $ 60 Granted 1,128,087 $ 1.41 Forfeited or expired (140,049 ) $ 4.22 Outstanding - September 30, 2021 3,887,875 $ 2.66 8.36 $ - Exercisable - September 30, 2021 1,675,671 $ 4.26 7.91 $ - |
Schedule of Calculation of Fair Value Assumptions | The estimated fair values of employee stock options granted during the three and nine months ended September 30, 2021, and September 30, 2020, were determined on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Schedule of Calculation of Fair Value Assumptions For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Expected option life (years) 6.07 6.03 5.98 5.92 Risk-free interest rate 0.94 % 0.40 % 0.62 % 1.61 % Expected volatility 106.04 % 94.41 % 104.96 % 93.91 % Expected dividend yield 0 % 0 % 0 % 0 % |
Schedule of Stock-Based Compensation Expense | Schedule of Stock-Based Compensation Expense For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development $ 53 $ 46 $ 164 $ 142 General and administrative 231 257 747 770 Total share-based compensation expense $ 284 $ 303 $ 911 $ 912 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense for the Company as of September 30, 2021, are as follows: Schedule of Components of Lease Expense 2021 2020 2021 2020 For the Three Months Ended For the Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Lease Cost: Fixed lease cost $ 259 $ 259 $ 777 $ 650 Variable lease cost 97 99 319 317 Total lease cost $ 356 $ 358 $ 1,096 $ 967 |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities due under these lease agreements as of September 30, 2021 are as follows: Schedule of Maturities of Lease Liabilities 2021 Operating Leases Maturity of lease liabilities: 2021 (excluding the nine months ended September 30, 2021) $ 299 2022 (half year) 615 Total lease payments 914 Less: interest (16 ) Total lease liabilities $ 898 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding | Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding As of September 30, 2021 2020 Options to purchase common stock 3,887,875 2,879,231 Warrants to purchase common stock 24,440,848 23,284,813 Total 28,328,723 26,164,044 |
Schedule of Reconciliation of C
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 53,491 | $ 31,657 | $ 34,508 |
Restricted cash | 204 | 204 | |
Total cash, cash equivalents and restricted cash | $ 53,695 | $ 34,712 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Recent Accounting Standard (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Accounting Policies [Abstract] | ||||
Impairment goodwill charge | $ 3,577 | $ 3,577 |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Prepaid Expenses And Other Current Assets | ||
Prepaid Insurance | $ 474 | $ 276 |
Prepaid Clinical Trials | 43 | 317 |
Prepaid Other | 283 | 130 |
Deferred Operating Costs | 74 | |
Deferred Offering Costs | 138 | |
Total prepaid and other current assets | $ 938 | $ 797 |
Summary of Property and Equipme
Summary of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 2,951 | $ 2,842 |
Less accumulated depreciation and amortization | (2,606) | (2,481) |
Property and equipment, net | 345 | 361 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,828 | 1,702 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 304 | 302 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 217 | 217 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 602 | 596 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 25 |
Schedule of Accrued Expenses (D
Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued vacation | $ 103 | $ 56 |
Accrued wages and incentive | 692 | 813 |
Accrued clinical & consulting | 435 | 1,010 |
Accrued legal & patent | 114 | 129 |
Accrued other expenses | 41 | 20 |
Total accrued expenses | $ 1,385 | $ 2,028 |
Significant Agreements (Details
Significant Agreements (Details Narrative) - USD ($) $ in Thousands | Nov. 08, 2021 | May 10, 2021 | May 31, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 |
Loss Contingencies [Line Items] | ||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 1,069 | $ 4,372 | $ 4,713 | $ 10,634 | ||||
Deferred Revenue | 1,755 | 1,755 | ||||||
Transaction price | 22,000 | |||||||
Deferred Revenue, Current | 1,974 | 1,974 | $ 4,166 | |||||
Reimbursed Expenses [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 413 | |||||||
License Agreement [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 647 | 1,993 | ||||||
Cipla Agreement [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Breach of contract percentage | 50.00% | |||||||
Cipla Agreement [Member] | Subsequent Event [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
[custom:AgreementDescription] | (i) all development and commercialization activities with respect to the Product in India, South Africa, Sri Lanka, Nepal, Iran, Yemen, Myanmar and Algeria (such countries, the “Cipla Territory”) will be conducted exclusively by Cipla at Cipla’s sole cost and expense, (ii) Cipla shall be entitled to all profits from the sale of the Product in the Cipla Territory, except that if Cipla successfully transfers manufacturing of the Product for the Cipla Territory to a manufacturing site determined by Cipla, the Company will become entitled to a royalty equal to 2% of net sales in the Cipla Territory, and (iii) following the depletion of development funding initially set aside for the development of the Product by the Company, the Company and Cipla will each be responsible for 60% and 40%, respectively, of the Company’s overhead costs and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”), provided, that Cipla will reimburse the Company an amount equal to 10% of aggregate Direct Costs upon the achievement of certain development milestones set forth in the table below. Cipla and the Company will continue to share all other development costs that are not Direct Costs, such as the cost of clinical research organizations, manufacturing costs and other third-party costs, on a 50/50 basis. | |||||||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Deferred Revenue | 7,397 | 7,397 | ||||||
Transaction price | 22,000 | |||||||
Proceeds From UpFront Fee | $ 22,000 | |||||||
Deferred Revenue, Current | $ 1,974 | 1,974 | ||||||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Research and Development Service [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 755 | |||||||
Transaction price | 12,000 | |||||||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Irrevocable License [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 189 | |||||||
Transaction price | $ 10,000 |
Common Stock (Details Narrative
Common Stock (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | May 26, 2021 | Feb. 16, 2021 | Apr. 20, 2020 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Jul. 31, 2020 | Apr. 30, 2019 | Feb. 28, 2019 |
CommonStockLineItem [Line Items] | ||||||||||||
Gross proceeds from sale of common stock | $ 37,079 | $ 7,314 | ||||||||||
Warrants exercise, shares | 0 | |||||||||||
Proceeds from warrants exercise | $ 2,292 | |||||||||||
Share-based Payment Arrangement, Option [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Number of stock options shares exercised | 0 | 0 | 0 | 0 | ||||||||
Employee Stock Option One [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Proceeds from warrants exercise | $ 24 | |||||||||||
Number of stock options shares exercised | 22,497 | |||||||||||
Warrant [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Warrants to purchase shares of common stock | 24,440,848 | 23,284,813 | 24,440,848 | 23,284,813 | 25,000 | 18,965 | 100,000 | |||||
Proceeds from warrants exercise | $ 204 | |||||||||||
Warrants [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Sale of common stock | 8,658,127 | |||||||||||
Warrants to purchase shares of common stock | 10,355,741 | 10,355,741 | ||||||||||
Proceeds from warrants exercise | $ 12,868 | |||||||||||
Common Stock One [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Warrants to purchase shares of common stock | 1,697,614 | 1,697,614 | ||||||||||
Proceeds from warrants exercise | $ 2,292 | |||||||||||
Warrants Two [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Sale of common stock | 9,302,873 | |||||||||||
Warrants to purchase shares of common stock | 11,202,925 | 11,202,925 | ||||||||||
Proceeds from warrants exercise | $ 13,643 | |||||||||||
Common Stock Two [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Sale of common stock | 300,000 | |||||||||||
Warrants to purchase shares of common stock | 1,697,614 | 1,697,614 | ||||||||||
Proceeds from warrants exercise | $ 2,292 | |||||||||||
Warrant Two [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Warrant exercise price per share | $ 1.80 | $ 1.80 | ||||||||||
Warrants to purchase shares of common stock | 1,814,815 | 1,814,815 | 1,814,815 | 1,814,815 | ||||||||
Warrants maturity date | Jul. 14, 2025 | Jul. 14, 2025 | ||||||||||
Exercise of pre-funded warrants, shares | 300,000 | |||||||||||
Direct Offering [Member] | Institutional Investors [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Sale of common stock | 20,000,000 | |||||||||||
Gross proceeds from sale of common stock | $ 40,000 | |||||||||||
Private Placement [Member] | Institutional Investors [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Warrant issued | 1,300,000 | |||||||||||
Warrants and rights, term | 5 years | |||||||||||
Warrant exercise price per share | $ 2.50 | |||||||||||
Securities Purchase Agreement [Member] | Institutional Investor [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Sales of common stock, value | $ 8,000 | |||||||||||
Sales of common stock, shares | 4,787,553 | |||||||||||
Warrant fair value price per share | $ 1.57 | $ 0.64 | ||||||||||
Fees and expenses | $ 2,921 | $ 686 | ||||||||||
Proceeds from fees and expenses | $ 37,079 | |||||||||||
Sale of stock price per share | $ 1.671 | |||||||||||
Securities Purchase Agreement [Member] | Placement Agents [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Warrant exercise price per share | 2.0888 | |||||||||||
Warrant fair value price per share | $ 0.54 | |||||||||||
Warrants to purchase shares of common stock | 311,191 | |||||||||||
Warrants maturity date | Apr. 20, 2022 | |||||||||||
Securities Purchase Agreement [Member] | Private Placement [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Warrant exercise price per share | $ 1.55 | |||||||||||
Warrants to purchase shares of common stock | 4,787,553 | |||||||||||
Warrants maturity date | Apr. 20, 2022 | |||||||||||
H.C.Wainwright and Co., LLC [Member] | Sale Agreement [Member] | ||||||||||||
CommonStockLineItem [Line Items] | ||||||||||||
Sales of common stock, value | $ 20,000 | |||||||||||
Commission percentage | 3.00% | |||||||||||
Sales of common stock, shares | 0 |
Schedule of Rollforward of Comm
Schedule of Rollforward of Common Stock Warrants Outstanding (Details) - Warrant [Member] shares in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | |
Number of Common Warrants, Outstanding, Beginning Balance | shares | 23,284,813 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | $ 3.41 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Beginning Balance | 3 years 3 months 18 days |
Aggregate Intrinsic Value, Outstanding, Beginning balance | $ | |
Number of Common Warrants, Warrants exercised | shares | (143,965) |
Weighted Average Exercise Price, Warrants exercised | $ / shares | $ 1.42 |
Number of Common Warrants, Warrants issued | shares | 1,300,000 |
Weighted Average Exercise Price, Warrants issued | $ / shares | $ 2.50 |
Number of Common Warrants, Outstanding, Ending Balance | shares | 24,440,848 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | $ 3.37 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Ending balance | 2 years 8 months 12 days |
Aggregate Intrinsic Value, Outstanding, Ending balance | $ |
Schedule of Warrants Assumption
Schedule of Warrants Assumptions (Details) - Warrant [Member] | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Contratual term (years) | 0 years | 5 years | 5 years | 4 years |
Risk-free interest rate | 0.28% | 0.57% | 0.26% | |
Expected volatility | 99.00% | 105.80% | 98.80% | |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - $ / shares | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Jul. 31, 2020 | Apr. 30, 2019 | Feb. 28, 2019 | |
Warrant One [Member] | |||||
Warrants, Issue Date | Feb. 16, 2021 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 2.50 | ||||
Warrants, Expiration Date | Feb. 11, 2026 | ||||
Number of Shares Underlying Warrants | 1,300,000 | ||||
Warrant Two [Member] | |||||
Warrants, Issue Date | Aug. 7, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.80 | ||||
Warrants, Expiration Date | Jul. 14, 2025 | ||||
Number of Shares Underlying Warrants | 1,814,815 | 1,814,815 | |||
Warrant Three [Member] | |||||
Warrants, Issue Date | Aug. 7, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 2.25 | ||||
Warrants, Expiration Date | Jul. 14, 2025 | ||||
Number of Shares Underlying Warrants | 218,713 | 218,713 | |||
Warrant Four [Member] | |||||
Warrants, Issue Date | Jul. 23, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.80 | ||||
Warrants, Expiration Date | Jul. 14, 2025 | ||||
Number of Shares Underlying Warrants | 1,550,000 | 1,550,000 | |||
Warrant Five [Member] | |||||
Warrants, Issue Date | Jul. 13, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 2.25 | ||||
Warrants, Expiration Date | Jul. 14, 2025 | ||||
Number of Shares Underlying Warrants | 436,860 | 436,860 | |||
Warrant Six [Member] | |||||
Warrants, Issue Date | Jul. 13, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.80 | ||||
Warrants, Expiration Date | Jul. 14, 2025 | ||||
Number of Shares Underlying Warrants | 6,695,926 | 6,720,926 | |||
Warrant Seven [Member] | |||||
Warrants, Issue Date | Apr. 20, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.55 | ||||
Warrants, Expiration Date | Apr. 20, 2022 | ||||
Number of Shares Underlying Warrants | 4,787,553 | 4,787,553 | |||
Warrant Eight [Member] | |||||
Warrants, Issue Date | Apr. 20, 2020 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 2.0888 | ||||
Warrants, Expiration Date | Apr. 20, 2022 | ||||
Number of Shares Underlying Warrants | 311,191 | 311,191 | |||
Warrant Nine [Member] | |||||
Warrants, Issue Date | Apr. 8, 2019 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.35 | ||||
Warrants, Expiration Date | Apr. 8, 2024 | ||||
Number of Shares Underlying Warrants | 1,317,812 | 1,336,777 | |||
Warrant Ten [Member] | |||||
Warrants, Issue Date | Apr. 8, 2019 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.6875 | ||||
Warrants, Expiration Date | Apr. 3, 2024 | ||||
Number of Shares Underlying Warrants | 797,334 | 797,334 | |||
Warrant Eleven [Member] | |||||
Warrants, Issue Date | Feb. 12, 2019 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.8313 | ||||
Warrants, Expiration Date | Feb. 7, 2024 | ||||
Number of Shares Underlying Warrants | 110,922 | 110,922 | |||
Warrant Twelve [Member] | |||||
Warrants, Issue Date | Feb. 12, 2019 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 1.34 | ||||
Warrants, Expiration Date | Aug. 12, 2024 | ||||
Number of Shares Underlying Warrants | 1,333,447 | 1,433,447 | |||
Warrant Thirteen [Member] | |||||
Warrants, Issue Date | Feb. 4, 2019 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 2.125 | ||||
Warrants, Expiration Date | Jan. 30, 2024 | ||||
Number of Shares Underlying Warrants | 34,605 | 34,605 | |||
Warrant Fourteen [Member] | |||||
Warrants, Issue Date | Jan. 31, 2019 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 2.125 | ||||
Warrants, Expiration Date | Jan. 26, 2024 | ||||
Number of Shares Underlying Warrants | 10,151 | 10,151 | |||
Warrant Fifteen [Member] | |||||
Warrants, Issue Date | Dec. 3, 2018 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 3.90 | ||||
Warrants, Expiration Date | Jun. 3, 2024 | ||||
Number of Shares Underlying Warrants | 937,500 | 937,500 | |||
Warrant Sixteen [Member] | |||||
Warrants, Issue Date | Apr. 3, 2018 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 7.50 | ||||
Warrants, Expiration Date | Apr. 3, 2023 | ||||
Number of Shares Underlying Warrants | 2,350,011 | 2,350,011 | |||
Warrant Seventeen [Member] | |||||
Warrants, Issue Date | Apr. 4, 2018 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 7.50 | ||||
Warrants, Expiration Date | Apr. 4, 2023 | ||||
Number of Shares Underlying Warrants | 115,000 | 115,000 | |||
Warrant Nineteen [Member] | |||||
Warrants, Issue Date | Jun. 15, 2015 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 75.50 | ||||
Number of Shares Underlying Warrants | 319,008 | 319,008 | |||
Warrants, Expiration Date, Description | Five years after milestone achievement | ||||
Warrant [Member] | |||||
Number of Shares Underlying Warrants | 24,440,848 | 23,284,813 | 25,000 | 18,965 | 100,000 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) - Equity Option [Member] $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($)$ / sharesshares | |
Offsetting Assets [Line Items] | |
Number of Options, Outstanding, Beginning Balance | shares | 2,899,837 |
Weighted Average Exercise Price, Outstanding, Beginning Balance | $ / shares | $ 3.22 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Beginning Balance | 8 years 9 months |
Aggregate Intrinsic Value, Outstanding, Beginning Balance | $ | $ 60 |
Number of Options, Granted | shares | 1,128,087 |
Weighted Average Exercise Price, Granted | $ / shares | $ 1.41 |
Number of Options, Forfeited or expired | shares | (140,049) |
Weighted Average Exercise Price, Forfeited or Expired | $ / shares | $ 4.22 |
Number of Options, Outstanding, Ending Balance | shares | 3,887,875 |
Weighted Average Exercise Price, Outstanding, Ending Balance | $ / shares | $ 2.66 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Ending balance | 8 years 4 months 9 days |
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ | |
Number of Options, Outstanding, Exercisable | shares | 1,675,671 |
Weighted Average Exercise Price, Outstanding, Exercisable | $ / shares | $ 4.26 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Exercisable | 7 years 10 months 28 days |
Aggregate Intrinsic Value, Outstanding, Exercisable | $ |
Schedule of Calculation of Fair
Schedule of Calculation of Fair Value Assumptions (Details) - Share-based Payment Arrangement, Option [Member] | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected option life (years) | 6 years 25 days | 6 years 10 days | 5 years 11 months 23 days | 5 years 11 months 1 day |
Risk-free interest rate | 0.94% | 0.40% | 0.62% | 1.61% |
Expected volatility | 106.04% | 94.41% | 104.96% | 93.91% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Schedule of Stock-Based Compens
Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 284 | $ 303 | $ 911 | $ 912 |
Research and Development Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 53 | 46 | 164 | 142 |
General and Administrative Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 231 | $ 257 | $ 747 | $ 770 |
Share-Based Compensation (Detai
Share-Based Compensation (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement, Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation vesting period | 4 years | |||
Stock options expire date | 10 years | |||
Share-based Payment Arrangement, Option [Member] | Employees and Directors [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares provides for grant | 70,500 | 1,128,087 | ||
Fair value of the awards | $ 51 | $ 1,278 | ||
Share-based Payment Arrangement, Option [Member] | Employees Directors and Consultant [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares provides for grant | 16,400 | 2,265,504 | ||
Fair value of the awards | $ 20 | $ 2,634 | ||
2013 Employee, Director and Consultant Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares authorized to grant | 5,865,254 | 5,865,254 | ||
Shares remain available for future grant | 1,901,869 | 1,901,869 | ||
Legacy Share Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares outstanding | 1,304 | 1,304 | ||
Stock Award Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized stock-based compensation expenses | $ 2,414 | $ 2,414 | ||
Weighted-average period of unrecognized stock-based compensation expense | 2 years 6 months 29 days |
Schedule of Components of Lease
Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Fixed lease cost | $ 259 | $ 259 | $ 777 | $ 650 |
Variable lease cost | 97 | 99 | 319 | 317 |
Total lease cost | $ 356 | $ 358 | $ 1,096 | $ 967 |
Schedule of Maturities of Lease
Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 (excluding the nine months ended September 30, 2021) | $ 299 |
2022 (half year) | 615 |
Total lease payments | 914 |
Less: interest | (16) |
Total lease liabilities | $ 898 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($)ft² | |
Other Commitment | $ | $ 256 |
Area of lease | ft² | 22,000 |
Hayden L L C [Member] | |
Operating lease expiration date | Jun. 30, 2022 |
Schedule of Computation of Anti
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding (Details) - shares | 3 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 28,328,723 | 26,164,044 |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,887,875 | 2,879,231 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 24,440,848 | 23,284,813 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - Subsequent Event [Member] - USD ($) | Oct. 14, 2021 | Oct. 05, 2021 |
Subsequent Event [Line Items] | ||
Payments for rent | $ 1,725 | |
Lease Expiration Date | Jun. 30, 2023 | |
Employees [Member] | ||
Subsequent Event [Line Items] | ||
Stock option granted | 32,800 |