Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
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 | 36 Crosby Drive | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Bedford | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01730 | |
City Area Code | (781) | |
Local Phone Number | 357-2333 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | PULM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 3,652,285 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 21,336 | $ 35,628 |
Restricted cash | 153 | 153 |
Accounts receivable | 841 | 1,298 |
Prepaid expenses and other current assets | 899 | 1,068 |
Total current assets | 23,229 | 38,147 |
Property and equipment, net | 1,166 | 235 |
Operating lease right-of-use asset | 10,686 | 710 |
Long-term restricted cash | 1,472 | 1,472 |
Other long-term assets | 217 | 389 |
Total assets | 36,770 | 40,953 |
Current liabilities: | ||
Accounts payable | 707 | 1,188 |
Accrued expenses and other current liabilities | 2,535 | 1,638 |
Operating lease liability | 199 | 857 |
Deferred revenue | 988 | 1,339 |
Total current liabilities | 4,429 | 5,022 |
Deferred revenue, net of current portion | 4,038 | 4,822 |
Operating lease liability, net of current portion | 8,422 | |
Total liabilities | 16,889 | 9,844 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at September 30, 2023 and December 31, 2022 | ||
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 and 3,639,185 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | ||
Additional paid-in capital | 305,395 | 304,585 |
Accumulated deficit | (285,514) | (273,476) |
Total stockholders’ equity | 19,881 | 31,109 |
Total liabilities and stockholders’ equity | $ 36,770 | $ 40,953 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 500,000 | 500,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 3,652,285 | 3,639,185 |
Common stock, shares outstanding | 3,652,285 | 3,639,185 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, shares authorized | 6,746 | 6,746 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenues | $ 1,753 | $ 1,872 | $ 5,096 | $ 4,363 |
Operating expenses | ||||
Research and development | 3,963 | 5,287 | 12,002 | 13,773 |
General and administrative | 1,729 | 1,685 | 5,609 | 5,212 |
Total operating expenses | 5,692 | 6,972 | 17,611 | 18,985 |
Loss from operations | (3,939) | (5,100) | (12,515) | (14,622) |
Other income (expense) | ||||
Interest income | 217 | 102 | 675 | 118 |
Other expense, net | (52) | (54) | (198) | (116) |
Total other income, net | 165 | 48 | 477 | 2 |
Net loss | $ (3,774) | $ (5,052) | $ (12,038) | $ (14,620) |
Net loss per share attributable to common stockholders basic | $ (1.03) | $ (1.45) | $ (3.30) | $ (4.32) |
Net loss per share attributable to common stockholders diluted | $ (1.03) | $ (1.45) | $ (3.30) | $ (4.32) |
Weighted average common shares outstanding basic | 3,652,285 | 3,478,157 | 3,651,785 | 3,383,171 |
Weighted average common shares outstanding diluted | 3,652,285 | 3,478,157 | 3,651,785 | 3,383,171 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2021 | $ 1,081 | $ 301,008 | $ (254,640) | $ 47,449 | |
Balance, shares at Dec. 31, 2021 | 1,830 | 3,222,037 | |||
Stock-based compensation | 281 | 281 | |||
Net loss | (4,973) | (4,973) | |||
Conversion of preferred stock to common stock | $ (541) | 541 | |||
Conversion of preferred stock to common stock, shares | (915) | 76,250 | |||
Adjustment due to reverse stock split | |||||
Adjustment due to reverse stock split, shares | 12,635 | ||||
Balance at Mar. 31, 2022 | $ 540 | 301,830 | (259,613) | 42,757 | |
Balance, shares at Mar. 31, 2022 | 915 | 3,310,922 | |||
Balance at Dec. 31, 2021 | $ 1,081 | 301,008 | (254,640) | 47,449 | |
Balance, shares at Dec. 31, 2021 | 1,830 | 3,222,037 | |||
Net loss | (14,620) | ||||
Balance at Sep. 30, 2022 | 304,306 | (269,260) | 35,046 | ||
Balance, shares at Sep. 30, 2022 | 3,639,185 | ||||
Balance at Mar. 31, 2022 | $ 540 | 301,830 | (259,613) | 42,757 | |
Balance, shares at Mar. 31, 2022 | 915 | 3,310,922 | |||
Stock-based compensation | 277 | 277 | |||
Net loss | (4,595) | (4,595) | |||
Conversion of preferred stock to common stock | $ (540) | 540 | |||
Conversion of preferred stock to common stock, shares | (915) | 76,250 | |||
Balance at Jun. 30, 2022 | 302,647 | (264,208) | 38,439 | ||
Balance, shares at Jun. 30, 2022 | 3,387,172 | ||||
Issuance of common stock, net of issuance costs | 1,382 | 1,382 | |||
Issuance of common stock, net of issuance costs, shares | 252,013 | ||||
Stock-based compensation | 277 | 277 | |||
Net loss | (5,052) | (5,052) | |||
Balance at Sep. 30, 2022 | 304,306 | (269,260) | 35,046 | ||
Balance, shares at Sep. 30, 2022 | 3,639,185 | ||||
Balance at Dec. 31, 2022 | 304,585 | (273,476) | 31,109 | ||
Balance, shares at Dec. 31, 2022 | 3,639,185 | ||||
Issuance of common stock, net of issuance costs | 53 | 53 | |||
Issuance of common stock, net of issuance costs, shares | 13,100 | ||||
Stock-based compensation | 296 | 296 | |||
Net loss | (4,448) | (4,448) | |||
Balance at Mar. 31, 2023 | 304,934 | (277,924) | 27,010 | ||
Balance, shares at Mar. 31, 2023 | 3,652,285 | ||||
Balance at Dec. 31, 2022 | 304,585 | (273,476) | 31,109 | ||
Balance, shares at Dec. 31, 2022 | 3,639,185 | ||||
Net loss | (12,038) | ||||
Balance at Sep. 30, 2023 | 305,395 | (285,514) | 19,881 | ||
Balance, shares at Sep. 30, 2023 | 3,652,285 | ||||
Balance at Mar. 31, 2023 | 304,934 | (277,924) | 27,010 | ||
Balance, shares at Mar. 31, 2023 | 3,652,285 | ||||
Stock-based compensation | 255 | 255 | |||
Net loss | (3,816) | (3,816) | |||
Balance at Jun. 30, 2023 | 305,189 | (281,740) | 23,449 | ||
Balance, shares at Jun. 30, 2023 | 3,652,285 | ||||
Stock-based compensation | 206 | 206 | |||
Net loss | (3,774) | (3,774) | |||
Balance at Sep. 30, 2023 | $ 305,395 | $ (285,514) | $ 19,881 | ||
Balance, shares at Sep. 30, 2023 | 3,652,285 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (12,038) | $ (14,620) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 96 | 123 |
Amortization of operating lease right-of-use asset | 1,171 | 1,033 |
Stock-based compensation | 757 | 835 |
Loss on disposal of property and equipment | 8 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 457 | (409) |
Prepaid expenses and other current assets | 169 | (1,042) |
Other long-term assets | 172 | (428) |
Accounts payable | (481) | 478 |
Accrued expenses and other current liabilities | 233 | 1,515 |
Operating lease liability | (3,383) | (1,007) |
Deferred revenue | (1,135) | (788) |
Net cash used in operating activities | (13,974) | (14,310) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (371) | (77) |
Net cash used in investing activities | (371) | (77) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 53 | 1,382 |
Preferred stock issuance costs | (152) | |
Net cash provided by financing activities | 53 | 1,230 |
Net decrease in cash, cash equivalents and restricted cash | (14,292) | (13,157) |
Cash, cash equivalents and restricted cash — beginning of period | 37,253 | 55,465 |
Total cash, cash equivalents and restricted cash | 22,961 | 42,308 |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | ||
Cash and cash equivalents | 21,336 | 40,683 |
Restricted cash | 153 | 153 |
Long-term restricted cash | 1,472 | 1,472 |
Supplemental disclosures of non-cash investing and financing information: | ||
Operating lease right-of-use asset obtained in exchange for operating lease liability | 9,323 | |
Purchases of property and equipment not yet paid | 664 | |
Conversion of preferred stock to common stock | $ 1,081 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Pulmatrix, Inc. (the “Company”) was incorporated in 2013 as a Delaware corporation. The Company is a clinical-stage biopharmaceutical company focused on the development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery platform, iSPERSE ™ ™ |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Standards | 9 Months Ended |
Sep. 30, 2023 | |
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 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 (“U.S. 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 consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “Annual Report”). The financial information as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, is unaudited. 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. The balance sheet data as of December 31, 2022 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. Use of Estimates In preparing the condensed consolidated financial statements in conformity with U.S. 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 condensed consolidated 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. The most significant estimates and assumptions in the Company’s condensed consolidated financial statements include, but are not limited to, estimates of future expected costs in order to derive and recognize revenue, estimates related to clinical trial accruals and upfront deposits, incremental borrowing rate, and accounting for income taxes and the related valuation allowance. Concentrations of Credit Risk 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 accounts at a single financial institution that management believes is creditworthy, and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits. For the three and nine months ended September 30, 2023, revenue from one customer accounted for 100 99 100 Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Except as set forth below, the Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its condensed consolidated financial statements. In June 2016, the FASB issued Accounting Standards Update (“ASU”) ASU 2016-13, Financial Instruments—Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments January 1, 2023 As of September 30, 2023, there are no new, or existing recently issued, accounting pronouncements that are of significance, or potential significance, that impact the Company’s condensed consolidated financial statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments As of September 30, 2023 and December 31, 2022, the Company did not hold any financial assets or liabilities that were measured at fair value on a recurring or nonrecurring basis. During the nine months ended September 30, 2023, there were no transfers between Level 1, Level 2 and Level 3. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses And Other Current Assets | |
Prepaid Expenses and Other Current Assets | 4. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: Schedule of Prepaid Expenses and Other Current Assets September 30, 2023 December 31, 2022 Insurance $ 361 $ 286 Software and hosting costs 83 99 Clinical and consulting 50 517 Other 405 166 Total prepaid expenses and other current assets $ 899 $ 1,068 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consisted of the following: Schedule of Property and Equipment September 30, 2023 December 31, 2022 Laboratory equipment $ 1,639 $ 1,827 Capital in progress 600 - Office furniture and equipment 387 217 Computer equipment 237 275 Leasehold improvements - 664 Total property and equipment 2,863 2,983 Less accumulated depreciation and amortization (1,697 ) (2,748 ) Property and equipment, net $ 1,166 $ 235 Depreciation and amortization expense for the nine months ended September 30, 2023 and 2022 was $ 96 123 8 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: Schedule of Accrued Expenses and Other Current Liabilities September 30, 2023 December 31, 2022 Wages and incentives $ 904 $ 1,130 Clinical and consulting 704 475 Accrued purchases of property and equipment 664 - Legal and patents 49 - Other 214 33 Total accrued expenses and other current liabilities $ 2,535 $ 1,638 |
Significant Agreements
Significant Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Significant Agreements | 7. Significant Agreements Development and Commercialization Agreement with Cipla Technologies LLC (“Cipla”) On April 15, 2019, the Company entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla for the co-development and commercialization, on a worldwide exclusive basis, of PUR1900, the Company’s inhaled iSPERSE ™ The Company received a non-refundable upfront payment of $ 22.0 ™ Pursuant to the Amendment, the Company and Cipla will each initially 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”). Upon the achievement of each development milestone set forth in the table below, Cipla will reimburse the Company an amount equal to 10% of the cumulative aggregate Direct Costs incurred (each reimbursement referred to as a “Holdback Payment”), potentially bringing the sharing of Direct Costs to a 50/50 basis. If a development milestone is not achieved, the respective Holdback Payment will continue to aggregate and be reimbursed by Cipla to the Company if the Company achieves the subsequent development milestone for that trial set forth in the table below. The Company will share all other development costs with Cipla 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 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 FEV 1 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 The Prescription Drug User Fee Act To be proposed by JSC As of November 6, 2023, the Company has dosed 25% of patients by the date of this report but this first Phase 2b development milestone was not achieved by June 30, 2023. Delayed regulatory approval in certain foreign jurisdictions and slower than expected enrollment contributed to missing this milestone. The associated cumulative aggregated Holdback Payment (as defined herein) could still have been reimbursed by Cipla to the Company if the Company achieved the subsequent development milestone of delivering topline data by June 30, 2024. However, as the Company is currently anticipating topline results in the second half of 2024, after the related June 30, 2024 milestone date has passed, the Company currently expects that it will therefore not be reimbursed the aggregated Holdback Payment. All such previously referred to regulatory approvals in this paragraph have since been obtained and enrollment is ongoing. Accounting Treatment The Company concluded that because both it and Cipla are active participants in the arrangement and are exposed to the significant risks and rewards of the collaboration, the Company’s collaboration with Cipla is within the scope of Accounting Standards Codification (“ASC”) 808, Collaborative Arrangements Revenue from Contracts with Customers The Company initially determined the total transaction price to be $ 22.0 12.0 10.0 The Company concluded that the Amendment represented a contract modification that is treated for accounting purposes as the termination of the Cipla Agreement and a creation of a new contract (the “Amended Cipla Agreement”). Accordingly, the modification is accounted for on a prospective basis. The total transaction price for the Amended Cipla Agreement includes variable consideration from the Amendment as well as $ 7.4 Revenue is recognized for the Amended Cipla Agreement 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 Company’s obligations. In management’s judgment, this input method is the best measure of the transfer of control of the combined performance obligation. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated balance sheets, with amounts expected to be recognized in the next 12 months recorded as current. During the three and nine months ended September 30, 2023, the Company recognized $ 1.8 5.1 0.2 0.8 5.0 1.0 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Common Stock | 8. Common Stock In May 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 $ 20.0 3.0 During the nine months ended September 30, 2023, the Company sold 13,100 4.25 53 |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Warrants | |
Warrants | 9. Warrants There were no 123,310 149.99 Schedule of Warrants Outstanding Adjusted Number of Shares Issue Date Exercise Price Expiration Date Outstanding Exercisable December 17, 2021 $ 14.99 December 15, 2026 36,538 36,538 December 17, 2021 $ 13.99 December 17, 2026 281,047 281,047 February 16, 2021 $ 49.99 February 11, 2026 65,003 65,003 August 7, 2020 $ 35.99 July 14, 2025 90,743 90,743 August 7, 2020 $ 44.99 July 14, 2025 10,939 10,939 July 23, 2020 $ 35.99 July 14, 2025 77,502 77,502 July 13, 2020 $ 44.99 July 14, 2025 21,846 21,846 July 13, 2020 $ 35.99 July 14, 2025 334,800 334,800 April 8, 2019 $ 26.99 April 8, 2024 65,907 65,907 April 8, 2019 $ 33.74 April 3, 2024 39,871 39,871 February 12, 2019 $ 36.62 February 7, 2024 5,548 5,548 February 12, 2019 $ 26.79 August 12, 2024 66,675 66,675 February 4, 2019 $ 42.49 January 30, 2024 1,732 1,732 January 31, 2019 $ 42.49 January 26, 2024 511 511 December 3, 2018 $ 77.99 June 3, 2024 46,876 46,876 June 15, 2015 $ 1,509.99 Five years after milestone achievement 15,955 - Total 1,161,493 1,145,538 |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | 10. Stock-based Compensation The Company sponsors the Pulmatrix, Inc. Amended and Restated 2013 Employee, Director and Consultant Equity Incentive Plan (the “Incentive Plan”). As of September 30, 2023, the Incentive Plan provided for the grant of up to 636,322 267,541 32 The following table summarizes stock option activity for the nine months ended September 30, 2023: Summary of Stock Option Activity Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding — January 1, 2023 304,823 $ 28.66 7.98 $ - Granted 118,472 $ 3.98 Forfeited or expired (58,320 ) $ 19.96 Outstanding — September 30, 2023 364,975 $ 22.04 7.74 $ - Exercisable — September 30, 2023 208,835 $ 32.51 7.02 $ - The Company records stock-based compensation expense related to stock options based on their grant-date fair value. During the nine months ended September 30, 2023 and 2022, the Company used the Black-Scholes option-pricing model to estimate the fair value of stock option grants and to determine the related compensation expense. The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates. The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2023 was $ 3.27 Schedule of Calculation of Fair Value Assumptions Nine Months Ended September 30, 2023 2022 Expected option life (years) 6.0 6.0 Risk-free interest rate 3.53 % 2.03 % Expected volatility 104.24 % 113.28 % Expected dividend yield - % - % 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 risk-free interest rate was obtained from U.S. Treasury rates for the expected life of the stock options. The Company’s expected volatility was based upon the historical volatility of the Company’s common stock. 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, 2023, there was $ 1.0 2.0 The following table presents total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022: Schedule of Stock-based Compensation Expenses 2023 2022 2023 2022 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 57 $ 65 $ 188 $ 189 General and administrative 149 212 569 646 Total stock-based compensation expense $ 206 $ 277 $ 757 $ 835 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Research and Development Activities The Company contracts with various other organizations to conduct research and development activities, including clinical trials. As of September 30, 2023, the Company had aggregate commitments to pay approximately $ 4.0 2.0 4.0 3.8 Legal Proceedings In the ordinary course of its business, the Company may be involved in various legal proceedings involving contractual and employment relationships, patent or other intellectual property rights, and a variety of other matters. The Company is not aware of any pending legal proceedings that would reasonably be expected to have a material impact on the Company’s financial position or results of operations. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Leases | 12. Leases New Corporate Headquarters The Company has limited leasing activities as a lessee which are primarily related to its corporate headquarters, which were relocated during the nine months ended September 30, 2023. On January 7, 2022, the Company executed a lease agreement with Cobalt Propco 2020, LLC for its new corporate headquarters at 36 Crosby Drive, Bedford, Massachusetts. The leased premises comprise approximately 20,000 lease provides for base rent of $ 0.1 The lease commenced on August 1, 2023, following substantial completion of construction to prepare the premises for the Company’s use, and the Company has included the lease as a component of its operating lease right-of-use asset and operating lease liabilities upon commencement. The improvements to prepare the leased premises for the Company’s intended use have been funded by (i) the landlord, through a tenant allowance of $ 3.9 0.5 2.4 Other Leasing Activities During the first quarter of 2023, the Company executed a two-month lease extension for its previous corporate headquarters in Lexington, Massachusetts, through August 31, 2023. The Company terminated that lease extension, as planned, during the third quarter of 2023. The Company also leases small office equipment which is primarily short-term or immaterial in nature. Therefore, no right-of-use assets and lease liabilities are recognized for these leases. The components of lease expense for the Company for the three and nine months ended September 30, 2023 and 2022 were as follows: Schedule of Components of Lease Expenses 2023 2022 2023 2022 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Lease cost Fixed lease cost $ 553 $ 357 $ 1,349 $ 1,072 Variable lease cost 203 206 484 556 Total lease cost $ 756 $ 563 $ 1,833 $ 1,628 Other information Cash paid for amounts included in the measurement of lease liabilities $ 2,699 $ 431 $ 3,562 $ 1,046 Weighted-average remaining lease term — operating leases 10.2 Weighted-average discount rate — operating leases 11.00 % Maturities of lease liabilities due under these lease agreements as of September 30, 2023 are as follows: Schedule of Maturities of Lease Liabilities Operating Leases Maturity of lease liabilities 2023 (three months) $ 171 2024 1,289 2025 1,326 2026 1,364 2027 1,402 2028 and thereafter 9,154 Total lease payments 14,706 Less: interest (6,085 ) Total lease liabilities $ 8,621 Reported as of September 30, 2023 Lease liabilities — short term $ 199 Lease liabilities — long term 8,422 Total lease liabilities $ 8,621 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes The Company had no Management of the Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and determined that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. As a result, a full valuation allowance was recorded as of September 30, 2023 and December 31, 2022. The Company applies ASC 740, Income Taxes |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 14. Net Loss Per Share Basic and diluted earnings (loss) per share are computed using the two-class method, which is an earnings allocation method that determines earnings (loss) per share for common shares and participating securities. The participating securities consist of the Company’s Series A Preferred Stock. The undistributed earnings are allocated between common shares and participating securities as if all earnings had been distributed during the period. In periods of loss, no allocation is made to the Series A Preferred Stock and diluted net loss per share is the same as basic net loss per share because common stock equivalents are excluded as their inclusion would be antidilutive. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact: Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding Three and Nine Months Ended 2023 2022 Options to purchase common stock 364,975 307,918 Warrants to purchase common stock 1,161,493 1,284,803 Total potentially dilutive securities excluded 1,526,468 1,592,721 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events The Company has completed an evaluation of all subsequent events after the balance sheet date of September 30, 2023 through the date the condensed consolidated financial statements were issued to ensure that the condensed consolidated financial statements include appropriate disclosure of events both recognized in the condensed consolidated financial statements as of September 30, 2023, and events which occurred subsequently but were not recognized in the condensed consolidated financial statements. The Company has concluded that no subsequent events have occurred that require disclosure, except as disclosed within the condensed consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recent Accounting Standards (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation 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 (“U.S. 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 consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 30, 2023 (the “Annual Report”). The financial information as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, is unaudited. 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. The balance sheet data as of December 31, 2022 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. |
Use of Estimates | Use of Estimates In preparing the condensed consolidated financial statements in conformity with U.S. 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 condensed consolidated 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. The most significant estimates and assumptions in the Company’s condensed consolidated financial statements include, but are not limited to, estimates of future expected costs in order to derive and recognize revenue, estimates related to clinical trial accruals and upfront deposits, incremental borrowing rate, and accounting for income taxes and the related valuation allowance. |
Concentrations of Credit Risk | Concentrations of Credit Risk 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 accounts at a single financial institution that management believes is creditworthy, and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits. For the three and nine months ended September 30, 2023, revenue from one customer accounted for 100 99 100 |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Except as set forth below, the Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its condensed consolidated financial statements. In June 2016, the FASB issued Accounting Standards Update (“ASU”) ASU 2016-13, Financial Instruments—Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments January 1, 2023 As of September 30, 2023, there are 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 Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses And Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: Schedule of Prepaid Expenses and Other Current Assets September 30, 2023 December 31, 2022 Insurance $ 361 $ 286 Software and hosting costs 83 99 Clinical and consulting 50 517 Other 405 166 Total prepaid expenses and other current assets $ 899 $ 1,068 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consisted of the following: Schedule of Property and Equipment September 30, 2023 December 31, 2022 Laboratory equipment $ 1,639 $ 1,827 Capital in progress 600 - Office furniture and equipment 387 217 Computer equipment 237 275 Leasehold improvements - 664 Total property and equipment 2,863 2,983 Less accumulated depreciation and amortization (1,697 ) (2,748 ) Property and equipment, net $ 1,166 $ 235 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: Schedule of Accrued Expenses and Other Current Liabilities September 30, 2023 December 31, 2022 Wages and incentives $ 904 $ 1,130 Clinical and consulting 704 475 Accrued purchases of property and equipment 664 - Legal and patents 49 - Other 214 33 Total accrued expenses and other current liabilities $ 2,535 $ 1,638 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Warrants | |
Schedule of Warrants Outstanding | Schedule of Warrants Outstanding Adjusted Number of Shares Issue Date Exercise Price Expiration Date Outstanding Exercisable December 17, 2021 $ 14.99 December 15, 2026 36,538 36,538 December 17, 2021 $ 13.99 December 17, 2026 281,047 281,047 February 16, 2021 $ 49.99 February 11, 2026 65,003 65,003 August 7, 2020 $ 35.99 July 14, 2025 90,743 90,743 August 7, 2020 $ 44.99 July 14, 2025 10,939 10,939 July 23, 2020 $ 35.99 July 14, 2025 77,502 77,502 July 13, 2020 $ 44.99 July 14, 2025 21,846 21,846 July 13, 2020 $ 35.99 July 14, 2025 334,800 334,800 April 8, 2019 $ 26.99 April 8, 2024 65,907 65,907 April 8, 2019 $ 33.74 April 3, 2024 39,871 39,871 February 12, 2019 $ 36.62 February 7, 2024 5,548 5,548 February 12, 2019 $ 26.79 August 12, 2024 66,675 66,675 February 4, 2019 $ 42.49 January 30, 2024 1,732 1,732 January 31, 2019 $ 42.49 January 26, 2024 511 511 December 3, 2018 $ 77.99 June 3, 2024 46,876 46,876 June 15, 2015 $ 1,509.99 Five years after milestone achievement 15,955 - Total 1,161,493 1,145,538 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the nine months ended September 30, 2023: Summary of Stock Option Activity Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding — January 1, 2023 304,823 $ 28.66 7.98 $ - Granted 118,472 $ 3.98 Forfeited or expired (58,320 ) $ 19.96 Outstanding — September 30, 2023 364,975 $ 22.04 7.74 $ - Exercisable — September 30, 2023 208,835 $ 32.51 7.02 $ - |
Schedule of Calculation of Fair Value Assumptions | Schedule of Calculation of Fair Value Assumptions Nine Months Ended September 30, 2023 2022 Expected option life (years) 6.0 6.0 Risk-free interest rate 3.53 % 2.03 % Expected volatility 104.24 % 113.28 % Expected dividend yield - % - % |
Schedule of Stock-based Compensation Expenses | The following table presents total stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022: Schedule of Stock-based Compensation Expenses 2023 2022 2023 2022 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 57 $ 65 $ 188 $ 189 General and administrative 149 212 569 646 Total stock-based compensation expense $ 206 $ 277 $ 757 $ 835 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Schedule of Components of Lease Expenses | The components of lease expense for the Company for the three and nine months ended September 30, 2023 and 2022 were as follows: Schedule of Components of Lease Expenses 2023 2022 2023 2022 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Lease cost Fixed lease cost $ 553 $ 357 $ 1,349 $ 1,072 Variable lease cost 203 206 484 556 Total lease cost $ 756 $ 563 $ 1,833 $ 1,628 Other information Cash paid for amounts included in the measurement of lease liabilities $ 2,699 $ 431 $ 3,562 $ 1,046 Weighted-average remaining lease term — operating leases 10.2 Weighted-average discount rate — operating leases 11.00 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities due under these lease agreements as of September 30, 2023 are as follows: Schedule of Maturities of Lease Liabilities Operating Leases Maturity of lease liabilities 2023 (three months) $ 171 2024 1,289 2025 1,326 2026 1,364 2027 1,402 2028 and thereafter 9,154 Total lease payments 14,706 Less: interest (6,085 ) Total lease liabilities $ 8,621 Reported as of September 30, 2023 Lease liabilities — short term $ 199 Lease liabilities — long term 8,422 Total lease liabilities $ 8,621 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact: Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding Three and Nine Months Ended 2023 2022 Options to purchase common stock 364,975 307,918 Warrants to purchase common stock 1,161,493 1,284,803 Total potentially dilutive securities excluded 1,526,468 1,592,721 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recent Accounting Standards (Details Narrative) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Accounting Standards Update 2016-13 [Member] | |||||
Product Information [Line Items] | |||||
Adoption date | Jan. 01, 2023 | Jan. 01, 2023 | |||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | One Customer [Member] | |||||
Product Information [Line Items] | |||||
Concentration risk percentage | 100% | 99% | 100% | 99% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | One Customer [Member] | |||||
Product Information [Line Items] | |||||
Concentration risk percentage | 100% | 100% |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Insurance | $ 361 | $ 286 |
Software and hosting costs | 83 | 99 |
Clinical and consulting | 50 | 517 |
Other | 405 | 166 |
Total prepaid expenses and other current assets | $ 899 | $ 1,068 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 2,863 | $ 2,983 |
Less accumulated depreciation and amortization | (1,697) | (2,748) |
Property and equipment, net | 1,166 | 235 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,639 | 1,827 |
Capital In Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 600 | |
Office Furniture And Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 387 | 217 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 237 | 275 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 664 |
Property and Equipment, Net (De
Property and Equipment, Net (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Impairment Effects on Earnings Per Share [Line Items] | ||
Depreciation and amortization | $ 96 | $ 123 |
Loss on disposal of property and equipment | 8 | |
Property, Plant and Equipment [Member] | ||
Impairment Effects on Earnings Per Share [Line Items] | ||
Loss on disposal of property and equipment | $ 8 | $ 8 |
Schedule of Accrued Expenses an
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Wages and incentives | $ 904 | $ 1,130 |
Clinical and consulting | 704 | 475 |
Accrued purchases of property and equipment | 664 | |
Legal and patents | 49 | |
Other | 214 | 33 |
Total accrued expenses and other current liabilities | $ 2,535 | $ 1,638 |
Significant Agreements (Details
Significant Agreements (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Product Liability Contingency [Line Items] | |||||
Agreement description | Pursuant to the Amendment, the Company and Cipla will each initially 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”). Upon the achievement of each development milestone set forth in the table below, Cipla will reimburse the Company an amount equal to 10% of the cumulative aggregate Direct Costs incurred (each reimbursement referred to as a “Holdback Payment”), potentially bringing the sharing of Direct Costs to a 50/50 basis. If a development milestone is not achieved, the respective Holdback Payment will continue to aggregate and be reimbursed by Cipla to the Company if the Company achieves the subsequent development milestone for that trial set forth in the table below. The Company will share all other development costs with Cipla 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 | ||||
Transaction cost | $ 22,000 | $ 22,000 | |||
Revenue | 1,753 | $ 1,872 | 5,096 | $ 4,363 | |
Deferred revenue, current | 988 | 988 | $ 1,339 | ||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Proceeds from related party debt | 22,000 | ||||
Transaction price | 7,400 | ||||
Revenue recognized | 200 | 800 | |||
Deferred revenue | 5,000 | 5,000 | |||
Deferred revenue, current | 1,000 | 1,000 | |||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Research and Development Service [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Transaction cost | 12,000 | 12,000 | |||
Revenue | 1,800 | 5,100 | |||
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Irrevocable License [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Transaction cost | $ 10,000 | $ 10,000 |
Common Stock (Details Narrative
Common Stock (Details Narrative) - H.C.Wainwright and Co., LLC [Member] - Sale Agreement [Member] - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended |
May 31, 2021 | Sep. 30, 2023 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Sale of stock, consideration received on transaction | $ 20,000 | |
Commission percentage | 3% | |
Common Stock [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of shares issued in transaction | 13,100 | |
Sale of stock, price per share | $ 4.25 | |
Sale of stock, consideration received per transaction | $ 53 |
Schedule of Warrants Outstandin
Schedule of Warrants Outstanding (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Warrant One [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Dec. 17, 2021 |
Warrants, Exercise Price | $ / shares | $ 14.99 |
Warrants, Expiration Date | Dec. 15, 2026 |
Number of Shares Underlying Warrants, Outstanding Total | 36,538 |
Number of Shares Underlying Warrants, Exercisable Total | 36,538 |
Warrant Two [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Dec. 17, 2021 |
Warrants, Exercise Price | $ / shares | $ 13.99 |
Warrants, Expiration Date | Dec. 17, 2026 |
Number of Shares Underlying Warrants, Outstanding Total | 281,047 |
Number of Shares Underlying Warrants, Exercisable Total | 281,047 |
Warrant Three [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Feb. 16, 2021 |
Warrants, Exercise Price | $ / shares | $ 49.99 |
Warrants, Expiration Date | Feb. 11, 2026 |
Number of Shares Underlying Warrants, Outstanding Total | 65,003 |
Number of Shares Underlying Warrants, Exercisable Total | 65,003 |
Warrant Four [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Aug. 07, 2020 |
Warrants, Exercise Price | $ / shares | $ 35.99 |
Warrants, Expiration Date | Jul. 14, 2025 |
Number of Shares Underlying Warrants, Outstanding Total | 90,743 |
Number of Shares Underlying Warrants, Exercisable Total | 90,743 |
Warrant Five [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Aug. 07, 2020 |
Warrants, Exercise Price | $ / shares | $ 44.99 |
Warrants, Expiration Date | Jul. 14, 2025 |
Number of Shares Underlying Warrants, Outstanding Total | 10,939 |
Number of Shares Underlying Warrants, Exercisable Total | 10,939 |
Warrant Six [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Jul. 23, 2020 |
Warrants, Exercise Price | $ / shares | $ 35.99 |
Warrants, Expiration Date | Jul. 14, 2025 |
Number of Shares Underlying Warrants, Outstanding Total | 77,502 |
Number of Shares Underlying Warrants, Exercisable Total | 77,502 |
Warrant Seven [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Jul. 13, 2020 |
Warrants, Exercise Price | $ / shares | $ 44.99 |
Warrants, Expiration Date | Jul. 14, 2025 |
Number of Shares Underlying Warrants, Outstanding Total | 21,846 |
Number of Shares Underlying Warrants, Exercisable Total | 21,846 |
Warrant Eight [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Jul. 13, 2020 |
Warrants, Exercise Price | $ / shares | $ 35.99 |
Warrants, Expiration Date | Jul. 14, 2025 |
Number of Shares Underlying Warrants, Outstanding Total | 334,800 |
Number of Shares Underlying Warrants, Exercisable Total | 334,800 |
Warrant Nine [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Apr. 08, 2019 |
Warrants, Exercise Price | $ / shares | $ 26.99 |
Warrants, Expiration Date | Apr. 08, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 65,907 |
Number of Shares Underlying Warrants, Exercisable Total | 65,907 |
Warrant Ten [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Apr. 08, 2019 |
Warrants, Exercise Price | $ / shares | $ 33.74 |
Warrants, Expiration Date | Apr. 03, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 39,871 |
Number of Shares Underlying Warrants, Exercisable Total | 39,871 |
Warrant Eleven [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Feb. 12, 2019 |
Warrants, Exercise Price | $ / shares | $ 36.62 |
Warrants, Expiration Date | Feb. 07, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 5,548 |
Number of Shares Underlying Warrants, Exercisable Total | 5,548 |
Warrant Twelve [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Feb. 12, 2019 |
Warrants, Exercise Price | $ / shares | $ 26.79 |
Warrants, Expiration Date | Aug. 12, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 66,675 |
Number of Shares Underlying Warrants, Exercisable Total | 66,675 |
Warrant Thirteen [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Feb. 04, 2019 |
Warrants, Exercise Price | $ / shares | $ 42.49 |
Warrants, Expiration Date | Jan. 30, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 1,732 |
Number of Shares Underlying Warrants, Exercisable Total | 1,732 |
Warrant Fourteen [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Jan. 31, 2019 |
Warrants, Exercise Price | $ / shares | $ 42.49 |
Warrants, Expiration Date | Jan. 26, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 511 |
Number of Shares Underlying Warrants, Exercisable Total | 511 |
Warrant Fifteen [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Dec. 03, 2018 |
Warrants, Exercise Price | $ / shares | $ 77.99 |
Warrants, Expiration Date | Jun. 03, 2024 |
Number of Shares Underlying Warrants, Outstanding Total | 46,876 |
Number of Shares Underlying Warrants, Exercisable Total | 46,876 |
Warrant Eighteen [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Warrants, Issue Date | Jun. 15, 2015 |
Warrants, Exercise Price | $ / shares | $ 1,509.99 |
Number of Shares Underlying Warrants, Outstanding Total | 15,955 |
Number of Shares Underlying Warrants, Exercisable Total | |
Warrants, Expiration Date, Description | Five years after milestone achievement |
Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares Underlying Warrants, Outstanding Total | 1,161,493 |
Number of Shares Underlying Warrants, Exercisable Total | 1,145,538 |
Warrants (Details Narrative)
Warrants (Details Narrative) | 9 Months Ended |
Sep. 30, 2023 shares | |
Warrants | |
Warrants issued or exercised | 0 |
Warrants expired shares | 123,310 |
Warrants expired per shares | 149.99 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) - Equity Option [Member] - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Offsetting Assets [Line Items] | ||
Number of Options, Outstanding, Balance | 304,823 | |
Weighted Average Exercise Price, Outstanding, Balance | $ 28.66 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 7 years 8 months 26 days | 7 years 11 months 23 days |
Aggregate Intrinsic Value, Balance | ||
Number of Options, Granted | 118,472 | |
Weighted Average Exercise Price, Granted | $ 3.98 | |
Number of Options, Forfeited or expired | (58,320) | |
Weighted Average Exercise Price, Forfeited or expired | $ 19.96 | |
Number of Options, Outstanding, Balance | 364,975 | 304,823 |
Weighted Average Exercise Price, Outstanding, Balance | $ 22.04 | $ 28.66 |
Aggregate Intrinsic Value, Balance | ||
Number of Options, Exercisable | 208,835 | |
Weighted Average Exercise Price, Outstanding, Exercisable | $ 32.51 | |
Weighted Average Remaining Contractual Term (Years), Exercisable | 7 years 7 days | |
Aggregate Intrinsic Value, Exercisable |
Schedule of Calculation of Fair
Schedule of Calculation of Fair Value Assumptions (Details) - Share-Based Payment Arrangement, Option [Member] | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected option life (years) | 6 years | 6 years |
Risk-free interest rate | 3.53% | 2.03% |
Expected volatility | 104.24% | 113.28% |
Expected dividend yield |
Schedule of Stock-based Compens
Schedule of Stock-based Compensation Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 206 | $ 277 | $ 757 | $ 835 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 57 | 65 | 188 | 189 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 149 | $ 212 | $ 569 | $ 646 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) $ / shares in Units, $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Valuation Technique, Option Pricing Model [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Weighted average grant date fair value of options | $ / shares | $ 3.27 |
Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share based compensation arrangement, number of shares authorized | 636,322 |
Share based compensation arrangement, number of shares available for grant | 267,541 |
Legacy Share Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share based compensation arrangement, award options outstanding number | 32 |
Stock Award Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unrecognized stock-based compensation expenses | $ | $ 1 |
Weighted-average period of unrecognized stock-based compensation expense | 2 years |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Payments for research and development | $ 4 |
Expects to be reimbursed | 2 |
Commitments | 4 |
Commitment, due in twelve months | $ 3.8 |
Schedule of Components of Lease
Schedule of Components of Lease Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lease cost | ||||
Fixed lease cost | $ 553 | $ 357 | $ 1,349 | $ 1,072 |
Variable lease cost | 203 | 206 | 484 | 556 |
Total lease cost | 756 | 563 | 1,833 | 1,628 |
Other information | ||||
Cash paid for amounts included in the measurement of lease liabilities | $ 2,699 | $ 431 | $ 3,562 | $ 1,046 |
Weighted-average discount rate - operating leases | 10 years 2 months 12 days | 10 years 2 months 12 days | ||
Weighted-average discount rate - operating leases | 11% | 11% |
Schedule of Maturities of Lease
Schedule of Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases | ||
2023 (three months) | $ 171 | |
2024 | 1,289 | |
2025 | 1,326 | |
2026 | 1,364 | |
2027 | 1,402 | |
2028 and thereafter | 9,154 | |
Total lease payments | 14,706 | |
Less: interest | (6,085) | |
Total lease liabilities | 8,621 | |
Lease liabilities — short term | 199 | $ 857 |
Lease liabilities — long term | 8,422 | |
Total lease liabilities | $ 8,621 |
Leases (Details Narrative)
Leases (Details Narrative) - Lease Agreement [Member] - Cobalt Propco [Member] $ in Millions | Jan. 07, 2022 USD ($) ft² |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Area of land | ft² | 20,000 |
Lessee, operating lease, description | lease provides for base rent of $0.1 million per month, expected to begin in December 2023, which will increase 3% each year over the ten-year noncancellable term. The Company has the option to extend the lease for one additional five-year term and is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises |
Payments for rent | $ 0.1 |
Payments for tenant improvements | 3.9 |
Tenat improvements | 0.5 |
Proceeds from affiliates | $ 2.4 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 0 | $ 0 |
Schedule of Computation of Anti
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average shares outstanding | 1,526,468 | 1,592,721 | 1,526,468 | 1,592,721 |
Options to Purchase Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average shares outstanding | 364,975 | 307,918 | 364,975 | 307,918 |
Warrants to Purchase Common Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average shares outstanding | 1,161,493 | 1,284,803 | 1,161,493 | 1,284,803 |