Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 09, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Period Focus | Q2 | |
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 | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 56,903 | $ 31,657 |
Restricted cash | 204 | |
Accounts receivable | 1,766 | 84 |
Prepaid expenses and other current assets | 1,596 | 797 |
Total current assets | 60,469 | 32,538 |
Property and equipment, net | 379 | 361 |
Operating lease right-of-use asset | 1,008 | 1,489 |
Long-term restricted cash | 204 | |
Goodwill | 3,577 | 3,577 |
Total assets | 65,433 | 38,169 |
Current liabilities: | ||
Accounts payable | 1,508 | 925 |
Accrued expenses | 1,191 | 2,028 |
Operating lease liability | 1,184 | 1,135 |
Deferred revenue | 3,034 | 4,166 |
Total current liabilities | 6,917 | 8,254 |
Deferred revenue, net of current portion | 5,423 | 6,168 |
Operating lease liability, net of current portion | 608 | |
Total liabilities | 12,340 | 15,030 |
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value — 500,000 authorized and 0 issued and outstanding at June 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 June 30, 2021 and December 31, 2020, respectively. | 6 | 4 |
Additional paid-in capital | 295,512 | 257,604 |
Accumulated deficit | (242,425) | (234,469) |
Total stockholders’ equity | 53,093 | 23,139 |
Total liabilities and stockholders’ equity | $ 65,433 | $ 38,169 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 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 | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenues | $ 2,254 | $ 3,500 | $ 3,644 | $ 6,262 |
Operating expenses: | ||||
Research and development | 4,541 | 3,184 | 8,397 | 8,471 |
General and administrative | 1,562 | 1,490 | 3,181 | 3,702 |
Total operating expenses | 6,103 | 4,674 | 11,578 | 12,173 |
Loss from operations | (3,849) | (1,174) | (7,934) | (5,911) |
Other income (expense): | ||||
Interest income | 2 | 13 | 5 | 65 |
Other expense, net | (5) | (9) | (27) | (10) |
Net loss | $ (3,852) | $ (1,170) | $ (7,956) | $ (5,856) |
Net loss per share attributable to common stockholders-basic and diluted | $ (0.07) | $ (0.05) | $ (0.16) | $ (0.26) |
Weighted average shares of common stock used to compute basic and diluted net loss per share | 56,249,062 | 24,376,571 | 51,319,680 | 22,423,014 |
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 |
Beginning balance, value at Dec. 31, 2019 | $ 2 | $ 226,178 | $ (215,161) | $ 11,019 |
Beginning balance, shares at Dec. 31, 2019 | 19,994,560 | |||
Exercise of warrants | 239 | 239 | ||
Exercise of warrants, 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) | ||
Ending balance, value at Mar. 31, 2020 | $ 2 | 226,781 | (219,847) | 6,936 |
Ending balance, shares at Mar. 31, 2020 | 20,521,304 | |||
Beginning balance, value at Dec. 31, 2019 | $ 2 | 226,178 | (215,161) | 11,019 |
Beginning balance, shares at Dec. 31, 2019 | 19,994,560 | |||
Net loss | (5,856) | |||
Ending balance, value at Jun. 30, 2020 | $ 3 | 234,899 | (221,017) | 13,885 |
Ending balance, shares at Jun. 30, 2020 | 25,749,356 | |||
Beginning balance, value 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 | 536 | 536 | ||
Exercise of warrants, 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) | ||
Ending balance, value at Jun. 30, 2020 | $ 3 | 234,899 | (221,017) | 13,885 |
Ending balance, shares at Jun. 30, 2020 | 25,749,356 | |||
Beginning balance, value 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 | 204 | 204 | ||
Exercise of warrants, shares | 143,965 | |||
Share-based compensation | 328 | 328 | ||
Net loss | (4,104) | (4,104) | ||
Ending balance, value at Mar. 31, 2021 | $ 6 | 295,213 | (238,573) | 56,646 |
Ending balance, shares at Mar. 31, 2021 | 56,249,062 | |||
Beginning balance, value at Dec. 31, 2020 | $ 4 | 257,604 | (234,469) | 23,139 |
Beginning balance, shares at Dec. 31, 2020 | 36,105,097 | |||
Net loss | (7,956) | |||
Ending balance, value at Jun. 30, 2021 | $ 6 | 295,512 | (242,425) | 53,093 |
Ending balance, shares at Jun. 30, 2021 | 56,249,062 | |||
Beginning balance, value 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) | ||
Ending balance, value at Jun. 30, 2021 | $ 6 | $ 295,512 | $ (242,425) | $ 53,093 |
Ending balance, shares at Jun. 30, 2021 | 56,249,062 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (7,956) | $ (5,856) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 88 | 103 |
Amortization of operating lease right-of-use asset | 481 | 359 |
Share-based compensation | 627 | 609 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,682) | 6,847 |
Prepaid expenses and other current assets | (799) | (671) |
Accounts payable | 495 | (321) |
Accrued expenses | (837) | 931 |
Operating lease liability | (559) | (317) |
Deferred revenue | (1,877) | (5,884) |
Net cash used in operating activities | (12,019) | (4,200) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (18) | (98) |
Net cash used in investing activities | (18) | (98) |
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 warrants | 204 | 775 |
Proceeds from Paycheck Protection Program loan | 617 | |
Repayment of Paycheck Protection Program loan | (617) | |
Net cash provided by financing activities | 37,283 | 8,113 |
Net increase in cash, cash equivalents and restricted cash | 25,246 | 3,815 |
Cash, cash equivalents and restricted cash — beginning of period | 31,861 | 23,644 |
Cash, cash equivalents and restricted cash — end of period | 57,107 | 27,459 |
Supplemental disclosures of non-cash investing and financing information: | ||
Fixed asset purchases in accounts payable | $ 88 | $ 12 |
Organization
Organization | 6 Months Ended |
Jun. 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 Standards | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Recent Accounting Standards | 2. Summary of Significant Accounting Policies and Recent Accounting Standards 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 six months ended June 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 Six months ended June 30 2021 2020 Cash and cash equivalents $ 56,903 $ 27,255 Restricted cash 204 204 Total cash, cash equivalents and restricted cash $ 57,107 $ 27,459 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 and six months ended June 30, 2021, our principal source of revenue was income that resulted from the Cipla Agreement and the JJEI License 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. Currently, there has not been a significant impact on the carrying value of the Company, but this factor will continue to be evaluated. 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 | 6 Months Ended |
Jun. 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 June 30, 2021 December 31, 2020 At At June 30, 2021 December 31, 2020 Prepaid insurance $ 632 $ 276 Prepaid clinical trials 531 317 Deferred operating costs 283 74 Prepaid other 150 130 Total prepaid and other current assets $ 1,596 $ 797 |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Jun. 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 June 30, 2021 December 31, 2020 Laboratory equipment $ 1,741 $ 1,702 Computer equipment 304 302 Office furniture and equipment 216 217 Leasehold improvements 600 596 Capital in progress 87 25 Total property and equipment 2,948 2,842 Less accumulated depreciation and amortization (2,569 ) (2,481 ) Property and equipment, net $ 379 $ 361 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 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 June 30, 2021 December 31, 2020 At At June 30, 2021 December 31, 2020 Accrued vacation $ 117 $ 56 Accrued wages and incentive 409 813 Accrued clinical & consulting 449 1,010 Accrued legal & patent 164 129 Accrued other expenses 52 20 Total accrued expenses $ 1,191 $ 2,028 |
Significant Agreements
Significant Agreements | 6 Months Ended |
Jun. 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 six months ending June 30, 2021, the Company recognized $ 2,688 647 413 Collaborations - Development and Commercialization Agreement with Cipla Technologies LLC (“Cipla”) The Company received a non-refundable upfront payment of $ 22,000 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, 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 any event, either the Company or Cipla 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, now plan to commence the Phase 2b clinical study when the risks of study conduct presented by the ongoing COVID-19 pandemic is 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 planned 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. Cipla has refused to approve the development plan and budget for the Phase 2b clinical study unless the Company accepts Cipla’s demands that the Company absorb a disproportionate amount of the costs and financial risks of the development plan. In the letter, the Company stated that Cipla had 30 days from the date of the letter to reaffirm that it will perform the Cipla Agreement in accordance with its terms. Since the date of the Company’s letter to Cipla, the Company has received several correspondences from Cipla disputing that Cipla is in material breach of the Cipla Agreement and that the Company is entitled to terminate the Agreement. Accordingly, Cipla and the Company have initiated certain mandatory dispute resolution procedures under the Cipla Agreement, which remain ongoing. As of the date of this report, the Company has not terminated the Agreement and the Agreement remains in full force and effect. However, the Company intends to continue to seek Cipla’s reaffirmation of all of its obligations under the Cipla Agreement and, in the absence of such reaffirmation, to pursue all available remedies. 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. During the six months ended June 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. The aggregate amount of the transaction price related to the Company’s unsatisfied performance obligations and at June 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 | 6 Months Ended |
Jun. 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 of the Company’s shares of common stock, from time to time in an at-the-market public offering (the “Offering”). Sales of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed with the SEC on May 26, 2021, and subsequently declared effective on June 9, 2021 (File No. 333-256502), and a related prospectus. HCW acts as the Company’s sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of The NASDAQ Capital Market. If expressly authorized by the Company, HCW may also sell the Company’s common stock in privately negotiated transactions. There is no specific date on which the Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds of this offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0 % of the gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement. 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 June 30, 2021, no During the six months ended June 30, 2021, warrants to purchase 25,000 100,000 18,965 204 2020 During the three months ended June 30, 2020, the Company issued 437,999 524,353 536 During the six months ended June 30, 2020, the Company issued 944,746 1,147,184 775 Exercise of Stock Options During the three and six months ended June 30, 2021, no During the three months ended June 30, 2020, stock options to buy 2,500 3 During the six months ended June 30, 2020, stock options to buy 22,497 shares were exercised, and the Company collected proceeds of $ 24 . |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2021 | |
Warrants | |
Warrants | 8. Warrants A rollforward of the common stock warrants outstanding at June 30, 2021 is as follows. Schedule of Rollforward of Common Stock Warrants Outstanding Number of Warrants Weighted Average Weighted Average Aggregate Intrinsic 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 June 30, 2021 24,440,848 $ 3.37 2.9 $ - There were no warrants issued during the three months ended June 30, 2021. The estimated fair values of warrants granted during the six months ended June 30, 2021, and the three and six months ended June 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 Six Months Ended June 30, June 30, 2021 2020 2021 2020 Expected life (years) - 2 5 2 Risk-free interest rate - 0.20 % 0.57 % 0.20 % Expected volatility - 98.51 % 105.77 % 98.51 % 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 June 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 — August 07, 2020 Equity $ 2.25 July 14, 2025 218,713 — July 23, 2020 Equity $ 1.80 July 14, 2025 1,550,000 — July 13, 2020 Equity $ 2.25 July 14, 2025 436,860 — July 13, 2020 Equity $ 1.80 July 14, 2025 6,695,926 — 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 11,692,518 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 August 31, 2015 Equity $ 118.00 August 31, 2020 — 3,000 June 15, 2015 Equity $ 75.50 Five years after milestone achievement 319,008 319,008 Total Outstanding 24,440,848 22,902,240 |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 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 June 30, 2021, the 2013 Plan provides for the grant of up to 5,865,254 1,859,348 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 June 30, 2021, a total of 6,048 Stock Options During the three months ended June 30, 2021, the Company granted 64,000 53 1,057,587 1,228 During the three months ended June 30, 2020, the Company granted 105,000 options to employees, directors, or consultants and the fair value of the awards on the date of grant was $ 117 . During the six months ended June 30, 2020, the Company granted 2,249,104 options to employees, directors and consultants and the fair value of the awards on the date of grant was $ 2,615 . The options vest over four years and expire ten years The following table summarizes stock option activity for the six months ended June 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 1,057,587 $ 1.44 Forfeited or expired (22,284 ) $ 2.39 Outstanding - June 30, 2021 3,935,140 $ 2.75 8.58 $ 1 Exercisable - June 30, 2021 1,488,568 $ 4.87 8.02 $ - The estimated fair values of employee stock options granted during the three and six months ended June 30, 2021, and June 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 Six Months Ended June 30, June 30, 2021 2020 2021 2020 Contractual term 6.06 6.03 5.97 5.92 Risk-free interest rate 0.97 % 0.45 % 0.60 % 1.62 % Expected volatility 106.11 % 94.40 % 104.89 % 93.90 % 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 June 30, 2021, there was $ 2,687 of unrecognized stock-based compensation expense related to unvested stock options granted under the Company’s stock award plans. This expense is expected to be recognized over a weighted-average period of approximately 2.8 years. The following table presents total share-based compensation expense for the three and six months ended June 30, 2021 and 2020: Schedule of Stock-Based Compensation Expense For the Three Months Ended For the Six Months Ended June 30, June 30, 2021 2020 2021 2020 Research and development $ 55 $ 49 $ 111 $ 96 General and administrative 244 217 516 513 Total share-based compensation expense $ 299 $ 266 $ 627 $ 609 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 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 June 30, 2021, we had aggregate commitments to pay approximately $ 933 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 June 30, 2021, are as follows: Schedule of Components of Lease Expense 2021 2020 2021 2020 For the Three Months Ended For the Six Months Ended June 30, June 30, 2021 2020 2021 2020 Lease Cost: Fixed lease cost $ 259 $ 228 $ 518 $ 391 Variable lease cost 96 99 222 218 Total lease cost $ 355 $ 327 $ 740 $ 609 Maturities of lease liabilities due under these lease agreements as of June 30, 2021 are as follows: Schedule of Maturities of Lease Liabilities Operating Leases Maturity of lease liabilities: 2021 $ 597 2022 (half year) 615 Total lease payments 1,212 Less: interest (28 ) Total lease liabilities $ 1,184 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 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 six months ended June 30, 2021 and 2020, respectively, resulted in net losses attributable to common shareholders, 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 2021 2020 Options to purchase common stock 3,935,140 2,980,432 Warrants to purchase common stock 22,440,848 22,902,240 Total 26,375,988 25,882,672 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events During July, 2021, the Company granted 34,900 30,000 The Company has evaluated its events subsequent to June 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 Standards (Policies) | 6 Months Ended |
Jun. 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 six months ended June 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 Six months ended June 30 2021 2020 Cash and cash equivalents $ 56,903 $ 27,255 Restricted cash 204 204 Total cash, cash equivalents and restricted cash $ 57,107 $ 27,459 |
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 and six months ended June 30, 2021, our principal source of revenue was income that resulted from the Cipla Agreement and the JJEI License 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. Currently, there has not been a significant impact on the carrying value of the Company, but this factor will continue to be evaluated. |
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 Standards (Tables) | 6 Months Ended |
Jun. 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 Six months ended June 30 2021 2020 Cash and cash equivalents $ 56,903 $ 27,255 Restricted cash 204 204 Total cash, cash equivalents and restricted cash $ 57,107 $ 27,459 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 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 June 30, 2021 December 31, 2020 At At June 30, 2021 December 31, 2020 Prepaid insurance $ 632 $ 276 Prepaid clinical trials 531 317 Deferred operating costs 283 74 Prepaid other 150 130 Total prepaid and other current assets $ 1,596 $ 797 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Jun. 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 June 30, 2021 December 31, 2020 Laboratory equipment $ 1,741 $ 1,702 Computer equipment 304 302 Office furniture and equipment 216 217 Leasehold improvements 600 596 Capital in progress 87 25 Total property and equipment 2,948 2,842 Less accumulated depreciation and amortization (2,569 ) (2,481 ) Property and equipment, net $ 379 $ 361 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: Schedule of Accrued Expenses June 30, 2021 December 31, 2020 At At June 30, 2021 December 31, 2020 Accrued vacation $ 117 $ 56 Accrued wages and incentive 409 813 Accrued clinical & consulting 449 1,010 Accrued legal & patent 164 129 Accrued other expenses 52 20 Total accrued expenses $ 1,191 $ 2,028 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Warrants | |
Schedule of Rollforward of Common Stock Warrants Outstanding | A rollforward of the common stock warrants outstanding at June 30, 2021 is as follows. Schedule of Rollforward of Common Stock Warrants Outstanding Number of Warrants Weighted Average Weighted Average Aggregate Intrinsic 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 June 30, 2021 24,440,848 $ 3.37 2.9 $ - |
Schedule of Warrants Assumptions | Schedule of Warrants Assumptions For the Three Months Ended For the Six Months Ended June 30, June 30, 2021 2020 2021 2020 Expected life (years) - 2 5 2 Risk-free interest rate - 0.20 % 0.57 % 0.20 % Expected volatility - 98.51 % 105.77 % 98.51 % 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 June 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 — August 07, 2020 Equity $ 2.25 July 14, 2025 218,713 — July 23, 2020 Equity $ 1.80 July 14, 2025 1,550,000 — July 13, 2020 Equity $ 2.25 July 14, 2025 436,860 — July 13, 2020 Equity $ 1.80 July 14, 2025 6,695,926 — 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 11,692,518 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 August 31, 2015 Equity $ 118.00 August 31, 2020 — 3,000 June 15, 2015 Equity $ 75.50 Five years after milestone achievement 319,008 319,008 Total Outstanding 24,440,848 22,902,240 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the six months ended June 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 1,057,587 $ 1.44 Forfeited or expired (22,284 ) $ 2.39 Outstanding - June 30, 2021 3,935,140 $ 2.75 8.58 $ 1 Exercisable - June 30, 2021 1,488,568 $ 4.87 8.02 $ - |
Schedule of Calculation of Fair Value Assumptions | The estimated fair values of employee stock options granted during the three and six months ended June 30, 2021, and June 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 Six Months Ended June 30, June 30, 2021 2020 2021 2020 Contractual term 6.06 6.03 5.97 5.92 Risk-free interest rate 0.97 % 0.45 % 0.60 % 1.62 % Expected volatility 106.11 % 94.40 % 104.89 % 93.90 % 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 Six Months Ended June 30, June 30, 2021 2020 2021 2020 Research and development $ 55 $ 49 $ 111 $ 96 General and administrative 244 217 516 513 Total share-based compensation expense $ 299 $ 266 $ 627 $ 609 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense for the Company as of June 30, 2021, are as follows: Schedule of Components of Lease Expense 2021 2020 2021 2020 For the Three Months Ended For the Six Months Ended June 30, June 30, 2021 2020 2021 2020 Lease Cost: Fixed lease cost $ 259 $ 228 $ 518 $ 391 Variable lease cost 96 99 222 218 Total lease cost $ 355 $ 327 $ 740 $ 609 |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities due under these lease agreements as of June 30, 2021 are as follows: Schedule of Maturities of Lease Liabilities Operating Leases Maturity of lease liabilities: 2021 $ 597 2022 (half year) 615 Total lease payments 1,212 Less: interest (28 ) Total lease liabilities $ 1,184 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 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 2021 2020 Options to purchase common stock 3,935,140 2,980,432 Warrants to purchase common stock 22,440,848 22,902,240 Total 26,375,988 25,882,672 |
Schedule of Reconciliation of C
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 56,903 | $ 31,657 | $ 27,255 |
Restricted cash | 204 | 204 | |
Total cash, cash equivalents and restricted cash | $ 57,107 | $ 27,459 |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Prepaid Expenses And Other Current Assets | ||
Prepaid insurance | $ 632 | $ 276 |
Prepaid clinical trials | 531 | 317 |
Deferred operating costs | 283 | 74 |
Prepaid other | 150 | 130 |
Total prepaid and other current assets | $ 1,596 | $ 797 |
Summary of Property and Equipme
Summary of Property and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 2,948 | $ 2,842 |
Less accumulated depreciation and amortization | (2,569) | (2,481) |
Property and equipment, net | 379 | 361 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,741 | 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 | 216 | 217 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 600 | 596 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 87 | $ 25 |
Schedule of Accrued Expenses (D
Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued vacation | $ 117 | $ 56 |
Accrued wages and incentive | 409 | 813 |
Accrued clinical & consulting | 449 | 1,010 |
Accrued legal & patent | 164 | 129 |
Accrued other expenses | 52 | 20 |
Total accrued expenses | $ 1,191 | $ 2,028 |
Significant Agreements (Details
Significant Agreements (Details Narrative) - USD ($) $ in Thousands | May 10, 2021 | May 31, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 |
Product Liability Contingency [Line Items] | |||||||
Revenue recognized | $ 2,254 | $ 3,500 | $ 3,644 | $ 6,262 | |||
Deferred revenue | 413 | 413 | |||||
Transaction price | 22,000 | ||||||
Deferred Revenue, Current | 3,034 | 3,034 | $ 4,166 | ||||
License Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Revenue recognized | 2,688 | ||||||
Deferred revenue | 647 | 647 | |||||
Cipla Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
[custom:BreachOfContractPercentage] | 50.00% | ||||||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | |||||||
Product Liability Contingency [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] | |||||||
Product Liability Contingency [Line Items] | |||||||
Revenue recognized | 755 | ||||||
Transaction price | 12,000 | ||||||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Irrevocable License [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Revenue recognized | 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 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jul. 31, 2020 | Apr. 30, 2019 | Feb. 28, 2019 |
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Proceeds from sale of common stock | $ 37,079 | $ 7,314 | ||||||||
Warrants exercise, shares | 0 | |||||||||
Share-based Payment Arrangement, Option [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Proceeds from warrants exercise | $ 3 | $ 24 | ||||||||
Number of stock options shares exercised | 0 | 2,500 | 0 | 22,497 | ||||||
Warrant [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants to purchase shares of common stock | 24,440,848 | 22,902,240 | 24,440,848 | 22,902,240 | 25,000 | 18,965 | 100,000 | |||
Proceeds from warrants exercise | $ 204 | |||||||||
Warrants [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants to purchase shares of common stock | 524,353 | 524,353 | ||||||||
Proceeds from warrants exercise | $ 536 | |||||||||
Number of common stock shares issued | 437,999 | |||||||||
Warrants Two [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants to purchase shares of common stock | 1,147,184 | 1,147,184 | ||||||||
Proceeds from warrants exercise | $ 775 | |||||||||
Number of common stock shares issued | 944,746 | |||||||||
Institutiona Investors [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Sales of common stock, value | $ 40,000 | |||||||||
Sales of common stock, shares | 20,000,000 | |||||||||
Fees and expenses related to sale | $ 2,921 | |||||||||
Proceeds from sale of common stock | $ 37,079 | |||||||||
Placement Agents [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants to purchase shares of common stock | 1,300,000 | |||||||||
Warrants expiry term | 5 years | |||||||||
Warrant exercise price per share | $ 2.50 | |||||||||
Warrant fair value price per share | $ 1.57 | |||||||||
Securities Purchase Agreement [Member] | Private Placement [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants to purchase shares of common stock | 4,787,553 | |||||||||
Warrant exercise price per share | $ 1.55 | |||||||||
Warrants maturity date | Apr. 20, 2022 | |||||||||
Securities Purchase Agreement [Member] | Institutiona Investors [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Sales of common stock, value | $ 8,000 | |||||||||
Sales of common stock, shares | 4,787,553 | |||||||||
Warrant fair value price per share | $ 0.64 | |||||||||
Sale of stock price per share | $ 1.671 | |||||||||
Fees and expenses | $ 686 | |||||||||
Securities Purchase Agreement [Member] | Placement Agents [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants to purchase shares of common stock | 311,191 | |||||||||
Warrant exercise price per share | $ 2.0888 | |||||||||
Warrant fair value price per share | $ 0.54 | |||||||||
Warrants maturity date | Apr. 20, 2022 | |||||||||
H.C.Wainwright and Co., LLC [Member] | Sale Agreement [Member] | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Sales of common stock, value | $ 20,000 | |||||||||
[custom:CommissionPercentage] | 3.00% | |||||||||
Sales of common stock, shares | 0 |
Schedule of Rollforward of Comm
Schedule of Rollforward of Common Stock Warrants Outstanding (Details) - Warrant [Member] | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
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 10 months 24 days |
Aggregate Intrinsic Value, Outstanding, Ending balance | $ |
Schedule of Warrants Assumption
Schedule of Warrants Assumptions (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Measurement Input, Expected Term [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Warrants, measurement input, term | 2 years | 5 years | 2 years | |
Measurement Input, Risk Free Interest Rate [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Warrants, measurement input, percentage | 0.20% | 0.57% | 0.20% | |
Measurement Input, Price Volatility [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Warrants, measurement input, percentage | 98.51% | 105.77% | 98.51% | |
Measurement Input, Expected Dividend Rate [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Warrants, measurement input, percentage | 0.00% | 0.00% | 0.00% |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) - $ / shares | 6 Months Ended | ||||
Jun. 30, 2021 | Jul. 31, 2020 | Jun. 30, 2020 | Apr. 30, 2019 | Feb. 28, 2019 | |
Warrant One [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 | ||||
Warrant Three [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 | ||||
Warrant Four [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 | ||||
Warrant Five [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 | ||||
Warrant Six [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 | ||||
Warrant Seven [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 | 11,692,518 | |||
Warrant Ten [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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 Eighteen [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Warrants, Issue Date | Aug. 31, 2015 | ||||
Warrants, Classification | Equity | ||||
Warrants, Exercise Price | $ 118 | ||||
Warrants, Expiration Date | Aug. 31, 2020 | ||||
Number of Shares Underlying Warrants | 3,000 | ||||
Warrant Nineteen [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
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] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Number of Shares Underlying Warrants | 24,440,848 | 25,000 | 22,902,240 | 18,965 | 100,000 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) - Equity Option [Member] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Investment Holdings [Line Items] | |
Number of Options, Outstanding, Beginning Balance | 2,899,837 |
Weighted Average Exercise Price, Outstanding, Beginning Balance | $ 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 | 1,057,587 |
Weighted Average Exercise Price, Granted | $ 1.44 |
Number of Options, Forfeited or expired | (22,284) |
Weighted Average Exercise Price, Forfeited or Expired | $ 2.39 |
Number of Options, Outstanding, Ending Balance | 3,935,140 |
Weighted Average Exercise Price, Outstanding, Ending Balance | $ 2.75 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Ending balance | 8 years 6 months 29 days |
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ 1 |
Number of Options, Outstanding, Exercisable | 1,488,568 |
Weighted Average Exercise Price, Outstanding, Exercisable | $ 4.87 |
Weighted Average Remaining Contractual Term (Years), Outstanding, Exercisable | 8 years 7 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 | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected option life (years) | 6 years 21 days | 6 years 10 days | 5 years 11 months 19 days | 5 years 11 months 1 day |
Risk-free interest rate | 0.97% | 0.45% | 0.60% | 1.62% |
Expected volatility | 106.11% | 94.40% | 104.89% | 93.90% |
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 | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 299 | $ 266 | $ 627 | $ 609 |
Research and Development Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 55 | 49 | 111 | 96 |
General and Administrative Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 244 | $ 217 | $ 516 | $ 513 |
Share-Based Compensation (Detai
Share-Based Compensation (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement, Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award 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 | 64,000 | 1,057,587 | ||
Fair value of the awards | $ 53 | $ 1,228 | ||
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 | 105,000 | 2,249,104 | ||
Fair value of the awards | $ 117 | $ 2,615 | ||
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 | 1,859,348 | 1,859,348 | ||
Legacy Share Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares outstanding | 6,048 | 6,048 | ||
Stock Award Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 2,687 | $ 2,687 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 9 months 18 days |
Schedule of Components of Lease
Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Fixed lease cost | $ 259 | $ 228 | $ 518 | $ 391 |
Variable lease cost | 96 | 99 | 222 | 218 |
Total lease cost | $ 355 | $ 327 | $ 740 | $ 609 |
Schedule of Maturities of Lease
Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ 597 |
2022 (half year) | 615 |
Total lease payments | 1,212 |
Less: interest | (28) |
Total lease liabilities | $ 1,184 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) $ in Thousands | Apr. 23, 2020 | Jun. 30, 2021USD ($)ft² |
Entity Listings [Line Items] | ||
Payments for commitments | $ | $ 933 | |
Area of lease | ft² | 22,000 | |
Hayden LLC [Member] | ||
Entity Listings [Line Items] | ||
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 | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 26,375,988 | 25,882,672 |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,935,140 | 2,980,432 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 22,440,848 | 22,902,240 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - Subsequent Event [Member] | 1 Months Ended |
Jul. 31, 2021shares | |
Employees [Member] | |
Subsequent Event [Line Items] | |
Stock option granted | 34,900 |
Director [Member] | |
Subsequent Event [Line Items] | |
Stock option granted | 30,000 |