Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 09, 2023 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2023 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 000-50626 | |
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 91-1707622 | |
Entity Address, Address Line One | 200 Connell Drive | |
Entity Address, Address Line Two | Suite 1500 | |
Entity Address, City or Town | Berkeley Heights | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07922 | |
City Area Code | 908 | |
Local Phone Number | 517-7330 | |
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 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001130166 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 12,642,822 | |
Common Stock | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | CYCC | |
Security Exchange Name | NASDAQ | |
Preferred Stock | ||
Title of 12(b) Security | Preferred Stock, $0.001 par value | |
Trading Symbol | CYCCP | |
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 5,944 | $ 18,345 |
Prepaid expenses and other current assets | 5,169 | 6,066 |
Total current assets | 11,113 | 24,411 |
Property and equipment, net | 16 | 32 |
Right-of-use lease asset | 109 | 142 |
Non-current deposits | 1,259 | 3,465 |
Total assets | 12,497 | 28,050 |
Current liabilities: | ||
Accounts payable | 1,571 | 2,561 |
Accrued and other current liabilities | 6,577 | 4,950 |
Total current liabilities | 8,148 | 7,511 |
Lease liability | 52 | 106 |
Total liabilities | 8,200 | 7,617 |
Redeemable common stock, $0.001 par value; 0 shares issued and outstanding at September 30, 2023 and 3,117,100 shares issued and outstanding at December 31, 2022 (Note 10) | 0 | 4,494 |
Stockholders' equity: | ||
Preferred stock, value | 0 | 0 |
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2023 and December 31, 2022; 12,642,822 shares issued and outstanding at September 30, 2023 and 12,539,189 shares issued and outstanding at December 31, 2022 | 12 | 9 |
Additional paid-in capital | 428,464 | 422,973 |
Accumulated other comprehensive loss | (1,168) | (1,316) |
Accumulated deficit | (423,011) | (405,727) |
Total stockholders' equity | 4,297 | 15,939 |
Total liabilities and stockholders' equity | 12,497 | 28,050 |
6% convertible exchangeable preferred stock | ||
Stockholders' equity: | ||
Preferred stock, value | 0 | 0 |
Series A Convertible Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock, value | 0 | 0 |
Series B Convertible Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock, value | $ 0 | $ 0 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Redeemable common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Redeemable common stock, shares issued | 0 | 3,117,100 |
Redeemable common stock, shares outstanding | 3,117,100 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 12,642,822 | 9,422,089 |
Common stock, shares outstanding | 12,642,822 | 9,422,089 |
6% convertible exchangeable preferred stock | ||
Preferred stock, shares issued | 335,273 | 335,273 |
Preferred stock, shares outstanding | 335,273 | 335,273 |
Dividend rate on convertible exchangeable preferred stock (in percent) | 6% | 6% |
Preferred stock, liquidation preference value (in dollars) | $ 4,006,512 | $ 4,006,512 |
Series A Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares issued | 264 | 264 |
Preferred stock, shares outstanding | 264 | 264 |
Series B Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares issued | 237,745 | 237,745 |
Preferred stock, shares outstanding | 237,745 | 237,745 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Revenues | $ 16,000 | $ 0 | $ 389,000 | $ 0 |
Operating expenses: | ||||
Research and development | 5,236,000 | 4,413,000 | 15,637,000 | 13,572,000 |
General and administrative | 1,625,000 | 2,054,000 | 4,845,000 | 5,239,000 |
Total operating expenses | 6,861,000 | 6,467,000 | 20,482,000 | 18,811,000 |
Operating loss | (6,845,000) | (6,467,000) | (20,093,000) | (18,811,000) |
Other income (expense): | ||||
Foreign exchange gains (losses) | 104,000 | 276,000 | (58,000) | 514,000 |
Interest income | 50,000 | 67,000 | 243,000 | 88,000 |
Other income (expense), net | (9,000) | 14,000 | 50,000 | 1,294,000 |
Total other income (expense), net | 145,000 | 357,000 | 235,000 | 1,896,000 |
Loss before taxes | (6,700,000) | (6,110,000) | (19,858,000) | (16,915,000) |
Income tax benefit | 668,000 | 1,014,000 | 2,574,000 | 3,136,000 |
Net loss | (6,032,000) | (5,096,000) | (17,284,000) | (13,779,000) |
Dividend on convertible exchangeable preferred shares | (50,000) | (50,000) | (151,000) | (151,000) |
Net loss applicable to common shareholders | $ (6,082,000) | $ (5,146,000) | $ (17,435,000) | $ (13,930,000) |
Redeemable common shareholders | ||||
Basic and diluted earnings per common share: | ||||
Net loss per share - basic | $ (0.48) | $ (0.38) | $ (1.39) | $ (1.10) |
Net loss per share - diluted | $ (0.48) | $ (0.38) | $ (1.39) | $ (1.10) |
Weighted average common shares outstanding basic | 740,379 | 2,376,721 | 2,307,279 | 809,821 |
Weighted average common shares outstanding diluted | 740,379 | 10,013,317 | 2,307,279 | 809,821 |
Common Stock | ||||
Basic and diluted earnings per common share: | ||||
Net loss per share - basic | $ (0.48) | $ (0.43) | $ (1.39) | $ (1.30) |
Net loss per share - diluted | $ (0.48) | $ (0.43) | $ (1.39) | $ (1.30) |
Weighted average common shares outstanding basic | 11,902,443 | 9,937,958 | 10,271,036 | 10,013,317 |
Weighted average common shares outstanding diluted | 11,902,443 | 9,937,958 | 10,271,036 | 2,376,721 |
Clinical trial supply | ||||
Revenues: | ||||
Revenues | $ 16,000 | $ 389,000 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (6,032) | $ (5,096) | $ (17,284) | $ (13,779) |
Translation adjustment | 8,571 | 17,874 | (2,050) | 39,392 |
Unrealized foreign exchange gain (loss) on intercompany loans | (8,642) | (18,344) | 2,198 | (40,390) |
Comprehensive loss | $ (6,103) | $ (5,566) | $ (17,136) | $ (14,777) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Preferred Stock | Common Stock As previously reported | Common Stock Adjustments | Common Stock | Additional Paid-in Capital As previously reported | Additional Paid-in Capital Adjustments | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit As previously reported | Accumulated Deficit Adjustments | Accumulated Deficit | As previously reported | Adjustments | Total |
Balance at Dec. 31, 2021 | $ 10 | $ 422,960 | $ (748) | $ (384,529) | $ 37,693 | |||||||||
Balance (in shares) at Dec. 31, 2021 | 573,282 | 9,993,135 | ||||||||||||
Stock-based compensation | 380 | 380 | ||||||||||||
Preferred stock dividends | (50) | (50) | ||||||||||||
Unrealized foreign exchange on intercompany loans | (5,878) | (5,878) | ||||||||||||
Translation adjustment | 5,803 | 5,803 | ||||||||||||
Loss for the period | (4,108) | (4,108) | ||||||||||||
Balance at Mar. 31, 2022 | $ 10 | 423,290 | (823) | (388,637) | 33,840 | |||||||||
Balance (in shares) at Mar. 31, 2022 | 573,282 | 9,993,135 | ||||||||||||
Balance at Dec. 31, 2021 | $ 10 | 422,960 | (748) | (384,529) | 37,693 | |||||||||
Balance (in shares) at Dec. 31, 2021 | 573,282 | 9,993,135 | ||||||||||||
Unrealized foreign exchange on intercompany loans | (40,390) | |||||||||||||
Translation adjustment | 39,392 | |||||||||||||
Loss for the period | (13,779) | |||||||||||||
Balance at Sep. 30, 2022 | $ 9 | 422,542 | (1,746) | (398,308) | 22,497 | |||||||||
Balance (in shares) at Sep. 30, 2022 | 573,282 | 9,422,089 | ||||||||||||
Balance at Mar. 31, 2022 | $ 10 | 423,290 | (823) | (388,637) | 33,840 | |||||||||
Balance (in shares) at Mar. 31, 2022 | 573,282 | 9,993,135 | ||||||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | 453 | 453 | ||||||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses (in shares) | 541,542 | |||||||||||||
Deemed dividend on redeemable common stock | (33) | (33) | ||||||||||||
Stock-based compensation | 350 | 350 | ||||||||||||
Stock-based compensation (in shares) | 17,412 | |||||||||||||
Preferred stock dividends | (50) | (50) | ||||||||||||
Unrealized foreign exchange on intercompany loans | (16,168) | (16,168) | ||||||||||||
Translation adjustment | 15,715 | 15,715 | ||||||||||||
Loss for the period | (4,575) | (4,575) | ||||||||||||
Balance at Jun. 30, 2022 | $ 10 | $ 423,633 | 424,010 | (1,276) | $ (417,409) | (393,212) | 29,532 | |||||||
Balance (in shares) at Jun. 30, 2022 | 573,282 | 10,552,089 | ||||||||||||
Reclassification of redeemable common stock | $ (1) | (1,704) | (1,705) | |||||||||||
Reclassification of redeemable common stock (in shares) | (1,130,000) | |||||||||||||
Deemed dividend on redeemable common stock | (102) | (102) | ||||||||||||
Stock-based compensation | 388 | 388 | ||||||||||||
Preferred stock dividends | (50) | (50) | ||||||||||||
Unrealized foreign exchange on intercompany loans | (18,344) | (18,344) | ||||||||||||
Translation adjustment | 17,874 | 17,874 | ||||||||||||
Loss for the period | (5,096) | (5,096) | ||||||||||||
Balance at Sep. 30, 2022 | $ 9 | 422,542 | (1,746) | (398,308) | 22,497 | |||||||||
Balance (in shares) at Sep. 30, 2022 | 573,282 | 9,422,089 | ||||||||||||
Balance at Dec. 31, 2022 | $ 9 | 422,973 | (1,316) | (406,157) | $ 430 | (405,727) | 15,939 | |||||||
Balance (in shares) at Dec. 31, 2022 | 573,282 | 9,422,089 | ||||||||||||
Stock-based compensation | 401 | 401 | ||||||||||||
Preferred stock dividends | (50) | (50) | ||||||||||||
Unrealized foreign exchange on intercompany loans | 5,263 | 5,263 | ||||||||||||
Translation adjustment | (5,171) | (5,171) | ||||||||||||
Loss for the period | (5,804) | (5,804) | ||||||||||||
Balance at Mar. 31, 2023 | $ 9 | 423,324 | (1,224) | (411,961) | 430 | (411,531) | $ 10,148 | $ 430 | 10,578 | |||||
Balance (in shares) at Mar. 31, 2023 | 573,282 | 9,422,089 | ||||||||||||
Balance at Dec. 31, 2022 | $ 9 | 422,973 | (1,316) | (406,157) | 430 | (405,727) | 15,939 | |||||||
Balance (in shares) at Dec. 31, 2022 | 573,282 | 9,422,089 | ||||||||||||
Loss for the period | (11,252) | |||||||||||||
Balance at Jun. 30, 2023 | $ 9 | $ 1 | $ 10 | $ 1,104 | 424,737 | (1,097) | 430 | (416,979) | 5,136 | 1,535 | 6,671 | |||
Balance (in shares) at Jun. 30, 2023 | 573,282 | 10,220,289 | ||||||||||||
Balance at Dec. 31, 2022 | $ 9 | 422,973 | (1,316) | (406,157) | 430 | (405,727) | 15,939 | |||||||
Balance (in shares) at Dec. 31, 2022 | 573,282 | 9,422,089 | ||||||||||||
Unrealized foreign exchange on intercompany loans | 2,198 | |||||||||||||
Translation adjustment | (2,050) | |||||||||||||
Loss for the period | (17,284) | |||||||||||||
Balance at Sep. 30, 2023 | $ 12 | 428,464 | (1,168) | (423,011) | 4,297 | |||||||||
Balance (in shares) at Sep. 30, 2023 | 573,282 | 12,642,822 | ||||||||||||
Balance at Mar. 31, 2023 | $ 9 | 423,324 | (1,224) | $ (411,961) | 430 | (411,531) | 10,148 | 430 | 10,578 | |||||
Balance (in shares) at Mar. 31, 2023 | 573,282 | 9,422,089 | ||||||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | 1 | $ 1 | 1,104 | 1,104 | ||||||||||
Reclassification of redeemable common stock | $ 1 | 1,104 | 1,105 | |||||||||||
Reclassification of redeemable common stock (in shares) | 798,200 | |||||||||||||
Stock-based compensation | 359 | 359 | ||||||||||||
Preferred stock dividends | (50) | (50) | ||||||||||||
Unrealized foreign exchange on intercompany loans | 5,577 | 5,577 | ||||||||||||
Translation adjustment | (5,450) | (5,450) | ||||||||||||
Loss for the period | (5,448) | (5,448) | ||||||||||||
Balance at Jun. 30, 2023 | $ 9 | $ 1 | $ 10 | $ 1,104 | 424,737 | (1,097) | $ 430 | (416,979) | $ 5,136 | $ 1,535 | 6,671 | |||
Balance (in shares) at Jun. 30, 2023 | 573,282 | 10,220,289 | ||||||||||||
Reclassification of redeemable common stock | $ 2 | 3,387 | 3,389 | |||||||||||
Reclassification of redeemable common stock (in shares) | 2,318,900 | |||||||||||||
Stock-based compensation | 390 | 390 | ||||||||||||
Stock-based compensation (in shares) | 103,633 | |||||||||||||
Preferred stock dividends | (50) | (50) | ||||||||||||
Unrealized foreign exchange on intercompany loans | (8,642) | (8,642) | ||||||||||||
Translation adjustment | 8,571 | 8,571 | ||||||||||||
Loss for the period | (6,032) | (6,032) | ||||||||||||
Balance at Sep. 30, 2023 | $ 12 | $ 428,464 | $ (1,168) | $ (423,011) | $ 4,297 | |||||||||
Balance (in shares) at Sep. 30, 2023 | 573,282 | 12,642,822 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities: | ||
Net loss | $ (17,284) | $ (13,779) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 23 | 24 |
Stock-based compensation | 1,151 | 1,119 |
Changes in lease liability | (55) | 29 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 3,364 | (2,816) |
Accounts payable, accrued and other current liabilities | 599 | (235) |
Net cash used in operating activities | (12,202) | (15,658) |
Investing activities: | ||
Purchase of property, plant and equipment | (6) | (7) |
Net cash used in investing activities | (6) | (7) |
Financing activities: | ||
Proceeds, net of issuance costs, from issuing common stock and warrants | 0 | 3,107 |
Payment of preferred stock dividend | (151) | (151) |
Net cash (used in) provided by financing activities | (151) | 2,956 |
Effect of exchange rate changes on cash and cash equivalents | (42) | (144) |
Net (decrease) increase in cash and cash equivalents | (12,401) | (12,853) |
Cash and cash equivalents, beginning of period | 18,345 | 36,559 |
Cash and cash equivalents, end of period | 5,944 | 23,706 |
Cash received during the period for: | ||
Interest | 243 | 89 |
Research & Development Tax Credits | 4,846 | 3,050 |
Cash paid during the period for: | ||
Taxes | 2 | 2 |
Non cash financing activities: | ||
Accrual of preferred stock dividends | 50 | 50 |
Deemed Dividend On Redeemable Common Stock | $ 0 | $ 135 |
Restatement of Prior Financial
Restatement of Prior Financial Information | 9 Months Ended |
Sep. 30, 2023 | |
Restatement of Prior Financial Information | |
Restatement of Prior Financial Information | CYCLACEL PHARMACEUTICALS, INC. NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS 1. Restatement of Prior Financial Information As previously summarized in our Current Report on Form 8-K filed with the SEC on November 15, 2023, during recent contract renegotiations with a contract counterparty related to the Company’s 065-102 study and the related return to the Company of the original contract deposit of $1.0 million and the subsequent preparation of the Company’s financial statements for the period ended September 30, 2023, the Company identified an error in the accounting treatment of contract deposit-related invoices during the period September 2021 to November 2021. Vendor invoices totaling $549,295 related to contractually required deposits received during September 2021 and November 2021 were incorrectly expensed to the income statement instead of being capitalized on the balance sheet as non-current deposits. The amounts were contractually required to remain on deposit until the end of the related contract. This resulted in an overstatement of operating loss of $293,845 for the quarter ended September 30, 2021 and $255,450 for the quarter ended December 31, 2021 and a corresponding understatement of non-current deposits in the same periods. In addition, the Company’s UK research and development tax credits were consequentially overstated by $64,000 for the quarter ended September 30, 2021 and $55,000 for the quarter ended December 31, 2021. On August 12, 2022, we became aware that our shelf registration statement on Form S-3 had expired on June 21, 2022. Prior to becoming aware of the expiration, but following the expiration, we sold an aggregate of 1,987,100 shares of our common stock at market prices for aggregate proceeds of approximately $2,721,187. The sale of these shares were subject to potential rescission rights by certain stockholders. As a result of these rescission rights, we classified 3,117,100 shares (including 1,130,000 previously issued and outstanding shares sold for which the Company did not receive proceeds and which were reclassified to temporary equity as of September 30, 2022), with an aggregate redemption value of $4,494,496 of our common stock as stock outside stockholders equity. In connection with the third quarter financial statement close process, the Company determined that it should have recorded 798,200 shares subject to potential rescission rights as temporary equity as of June 30, 2022 and these should have been reclassified out of temporary equity as of June 30, 2023 upon expiration of the rescission rights. The Company had recorded reclassification of these 798,200 shares sold in the second quarter of 2022, which had a redemption value of $1,105,507 to temporary equity as of September 30, 2022. Moreover, the Company has determined that it did not properly account for the $135,000 of aggregate fees paid in connection with the sale of those shares as a dividend to those stockholders. The $135,000 of fees should be accounted for as accretion to the maximum redemption amount of the shares subject to potential rescission in the computation of loss per share as of June 30, 2022 and September 30, 2022 and the year ended December 31, 2022, as well as of March 31, 2023 and June 30, 2023, as is required by ASC 480-10-S99-3A(20). The effect of the error corrections affecting the unaudited consolidated financial statements included in the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023 and June 30, 2023 are as follows (in thousands, except per share amounts): (Unaudited) March 31, 2023 March 31, 2023 CONSOLIDATED BALANCE SHEETS As previously reported Adjustments As Restated ASSETS Non-current deposits $ 2,916 $ 549 $ 3,465 Total assets $ 22,060 $ 549 $ 22,609 LIABILITIES AND STOCKHOLDERS’ EQUITY Accrued and other current liabilities $ 4,829 $ 119 $ 4,948 Total current liabilities 7,338 119 7,457 Total liabilities 7,418 119 7,537 Accumulated deficit (411,961) 430 (411,531) Total stockholders’ equity $ 10,148 $ 430 $ 10,578 Total liabilities and stockholders’ equity $ 22,060 $ 549 $ 22,609 (Unaudited) Three Months Ended March 31, 2023 2023 CONSOLIDATED STATEMENTS OF INCOME As previously reported Adjustments As Restated Net loss applicable to common shareholders $ (5,854) $ — $ (5,854) Basic and diluted earnings per common share: Net Loss per share - basic and diluted (common shareholders) $ (0.47) $ — $ (0.47) Net Loss per share - basic and diluted (redeemable common shareholders) $ — $ (0.47) $ (0.47) (Unaudited) March 31, 2023 March 31, 2023 CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY As previously reported Adjustments As Restated Accumulated Deficit (Balances at December 31, 2022) $ (406,157) $ 430 $ (405,727) Accumulated Deficit (Balances at March 31, 2023) $ (411,961) $ 430 $ (411,531) Total Stockholders' Equity (Balances at March 31, 2023) $ 10,148 $ 430 $ 10,578 (Unaudited) June 30, 2023 June 30, 2023 As previously CONSOLIDATED BALANCE SHEETS reported Adjustments As Restated ASSETS Non-current deposits $ 1,000 $ 549 $ 1,549 Total assets $ 16,442 $ 549 $ 16,991 LIABILITIES AND STOCKHOLDERS’ EQUITY Accrued and other current liabilities $ 4,577 $ 119 $ 4,696 Total current liabilities 6,746 119 6,865 Total liabilities 6,812 119 6,931 Temporary equity $ 4,494 $ (1,105) $ 3,389 Common Stock 9 1 10 Additional Paid-In Capital 423,633 1,104 424,737 Accumulated deficit (417,409) 430 (416,979) Total stockholders’ equity 5,136 1,535 6,671 Total liabilities and stockholders’ equity $ 16,442 $ 549 $ 16,991 (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2023 2023 2023 CONSOLIDATED STATEMENTS OF INCOME As previously reported Adjustments As Restated As previously reported Adjustments As Restated Net loss applicable to common shareholders $ (5,498) $ — $ (5,498) $ (11,353) $ — $ (11,353) Basic and diluted earnings per common share: Net Loss per share - basic and diluted (common shareholders) $ (0.44) $ — $ (0.44) $ (0.91) $ — $ (0.90) Net Loss per share - basic and diluted (redeemable common shareholders) $ — $ (0.44) $ (0.44) $ — $ (0.90) $ (0.90) (Unaudited) June 30, 2023 June 30, 2023 CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY As previously reported Adjustments As Restated Accumulated Deficit (Balances at December 31, 2022) $ (406,157) $ 430 $ (405,727) Accumulated Deficit (Balances at March 31, 2023) $ (411,961) $ 430 $ (411,531) Total Stockholders' Equity (Balances at March 31, 2023) $ 10,148 $ 430 $ 10,578 Common Stock - Issue of common stock on At Market, net of expenses $ — $ 1 $ 1 Common Stock (Balances at June 30, 2023) $ 9 $ 1 $ 10 Additional Paid-In Capital - Issue of common stock on At Market, net of expenses $ — $ 1,104 $ 1,104 Additional Paid-In Capital (Balances at June 30, 2023) $ 423,633 $ 1,104 $ 424,737 Accumulated Deficit (Balances at June 30, 2023) $ (417,409) $ 430 $ (416,979) Total Stockholders' Equity (Balances at June 30, 2023) $ 5,136 $ 1,535 $ 6,671 Common Stock No. Shares (Reclassification of redeemable common stock) — 798,200 798,200 Common Stock No. Shares (Balance at June 30, 2023) 9,422,089 798,200 10,220,289 The correction of the errors did not change the reported net loss in 2023 or the 2022 comparative periods. |
Company Overview
Company Overview | 9 Months Ended |
Sep. 30, 2023 | |
Company Overview | |
Company Overview | 2. Company Overview Nature of Operations Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or the “Company”) company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis control biology. Through September 30, 2023, substantially all efforts of the Company to date have been devoted to performing research and development, conducting clinical trials, developing and acquiring intellectual property, raising capital and recruiting and training personnel. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The consolidated balance sheet as of September 30, 2023, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and the consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2022 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2023. The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by GAAP for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2023, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2023, and cash flows for the nine months ended September 30, 2023, have been made. The interim results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2022 that are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2023. Going Concern Pursuant to the requirements of Accounting Standard Codification (“ASC”) 205-40, Presentation of Financial Statements-Going Concern Based on the Company’s current operating plan, it is anticipated that cash and cash equivalents of $5.9 million as of September 30, 2023, will allow it to meet liquidity requirements through the end of 2023. However, the current operating plan includes discretionary expenditures, which if not incurred and taken together with the anticipated receipt of research & development tax credits of approximately $3.1 million in the first quarter of 2024 could extend liquidity requirements into the second quarter of 2024. The Company’s history of losses, negative cash flows from operations, liquidity resources currently on hand, and its dependence on the ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in the assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the issuance date of these financial statements. While the Company has plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of public or private equity or debt financings or by entering into partnership agreements for further development of our drug candidates, there is no guarantee that it will be successful in these mitigation efforts. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. Accounting Standards Adopted in the Period In November 2021 , the issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance . This requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model under ASC 958-605 or based on International Accounting Standard No. 20 . ASU 2021-10 became effective on January 1, 2022. The adoption of this guidance had no material effect on the Company’s Consolidated Financial Statements. In May 2021, the FASB issued Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) . The new ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment became effective on January 1, 2022. The adoption of this new guidance did not have a material impact on our financial statements for any past transactions, but it could change the way that the Company accounts for subsequent amendments to its outstanding warrants, if any. Recently Issued Accounting Pronouncements The FASB has issued ASU 2020-04, “Reference Rate Reform (Topic 848)”. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform initiatives that would replace interbank offered rates, including the London Interbank Offered Rate (“LIBOR”). For example, modifications of lease contracts within the scope of ASC 842 solely for changes in reference rates would be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate. Following the issuance of ASU 2022-06, “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848”, the relief remains effective for all entities as of March 12, 2020 through December 31, 2024. The Company does not currently have any contracts affected by this guidance. Fair Value of Financial Instruments Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income (loss). There were no reclassifications out of other comprehensive income (loss) during the nine months ended September 30, 2023 and 2022. Revenue Recognition When the Company enters into contracts with customers, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the Company satisfies a performance obligation. The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers: ● Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies; ● Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time; ● Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and ● The complexity and inherent uncertainty underlying the achievement of the milestone. The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives. The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation. The Company recognizes a contract asset, when the value of satisfied (or partially satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or partially satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable. Grant revenue received from organizations that are not the Company’s customers, such as charitable foundations or government agencies, is presented as a reduction against the related research and development expenses. Leases The Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2023, the Company’s outstanding leases are classified as operating leases. The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates that are the same tenure as the lease term, adjusted for various factors, including the effects of assumed collateral, the nature of how the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk. The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as: ● The lease payments due in any optional period; ● Penalties for failure to exercise (or not exercise) the option; ● Market factors, such as the availability of similar assets and current rental rates for such assets; ● The nature of the underlying leased asset and its importance to the Company’s operations; and ● The remaining useful lives of any related leasehold improvements. Lease expense for operating leases is recognized on a straight-line basis over the lease term. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset. The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue [Abstract] | |
Revenue | 4. Revenue The Company recognized $16,000 of revenue for the three months ended September 30, 2023, and $389,000 of revenue for the nine months ended September 30, 2023. This revenue relates to recovery of clinical manufacturing costs associated with an investigator sponsored study managed by Cedars-Sinai Medical Center. There were no revenues recognized for the comparative periods in 2022. |
Net Loss per Common Share
Net Loss per Common Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Common Share | |
Net Loss Per Share | 5. Net Loss per Common Share The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. During 2022 and 2023, the Company calculated loss per share using the two-class method. The two-class method is an allocation formula that determines loss per share for each share of common stock and redeemable common stock , a participating security, according to dividends declared and participation rights in undistributed earnings. Three Months Ended March 31, 2023 As restated (see Note 1) Numerator: Net loss $ (5,804) Dividend on convertible exchangeable preferred shares (50) Net loss attributable to common shareholders $ (5,854) Deemed dividend on accretion of redeemable common stock — Remaining undistributed loss (5,854) Three Months Ended March 31, 2023 Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (4,399) $ (1,455) Deemed dividend on accretion of redeemable common stock — Net loss attributable to common shareholders (4,399) (1,455) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 9,422,089 3,117,100 Loss per share - basic and diluted $ (0.47) $ (0.47) Distributed earnings — — Undistributed loss (0.47) (0.47) Net loss per share $ (0.47) $ (0.47) Three And Six Months Ended June 30, 2023 Three Months Six Months As restated (see Note 1) As restated (see Note 1) Numerator: Net loss $ (5,448) $ (11,252) Dividend on convertible exchangeable preferred shares (50) (101) Net loss attributable to common shareholders $ (5,498) $ (11,353) Deemed dividend on accretion of redeemable common stock — — Remaining undistributed loss (5,498) (11,353) Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 Common Shareholders Redeemable Common Shareholders Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (4,144) $ (1,354) $ (8,544) $ (2,809) Deemed dividend on accretion of redeemable common stock — — Net loss attributable to common shareholders (4,144) (1,354) (8,544) (2,809) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 9,461,317 3,090,477 9,441,811 3,107,715 Loss per share - basic and diluted $ (0.44) $ (0.44) $ (0.90) $ (0.90) Distributed earnings — — — — Undistributed loss (0.44) (0.44) (0.90) (0.90) Net loss per share $ (0.44) $ (0.44) $ (0.90) $ (0.90) Three And Nine Months Ended September 30, 2023 Three Months Nine Months Numerator: Net loss $ (6,032) $ (17,284) Dividend on convertible exchangeable preferred shares (50) (151) Net loss attributable to common shareholders $ (6,082) $ (17,435) Deemed dividend on accretion of redeemable common stock — — Remaining undistributed loss (6,082) (17,435) Three Months Ended September 30, 2023 Nine Months Ended September 30, 2023 Common Shareholders Redeemable Common Shareholders Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (5,726) $ (356) $ (14,237) $ (3,198) Deemed dividend on accretion of redeemable common stock — — Net loss attributable to common shareholders (5,726) (356) (14,237) (3,198) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 11,902,443 740,379 10,271,036 2,307,279 Loss per share - basic and diluted $ (0.48) $ (0.48) $ (1.39) $ (1.39) Distributed earnings — — — — Undistributed loss (0.48) (0.48) (1.39) (1.39) Net loss per share $ (0.48) $ (0.48) $ (1.39) $ (1.39) Three And Nine Months Ended September 30, 2022 Three Months Nine Months Numerator: Net loss $ (5,096) $ (13,779) Dividend on convertible exchangeable preferred shares (50) (151) Net loss attributable to common shareholders $ (5,146) $ (13,930) Deemed dividend on accretion of redeemable common stock (102) (135) Remaining undistributed loss (5,248) (14,065) Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 Common Shareholders Redeemable Common Shareholders Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (4,235) $ (1,013) $ (13,040) $ (1,025) Deemed dividend on accretion of redeemable common stock 102 — 135 Net loss attributable to common shareholders (4,235) (911) (13,040) (890) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 9,937,958 2,376,721 10,013,317 809,821 Loss per share - basic and diluted $ (0.43) $ (0.38) $ (1.30) $ (1.10) Distributed earnings — 0.04 — 0.17 Undistributed loss (0.43) (0.42) (1.30) (1.27) Net loss per share $ (0.43) $ (0.38) $ (1.30) $ (1.10) The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three months ended September 30, 2023 and 2022, as the result would be anti-dilutive: September 30, September 30, 2023 2022 Stock options 2,181,689 1,618,089 Restricted Stock Units 521,971 137,657 6% convertible exchangeable preferred stock 85 85 Series A preferred stock 6,600 6,600 Series B preferred stock 1,188,725 1,188,725 Common stock warrants 3,234,379 3,234,379 Total shares excluded from calculation 7,133,449 6,185,535 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses And Other Current Assets [Abstract] | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in $000s): September 30, December 31, 2023 2022 Research and development tax credit receivable $ 2,527 $ 4,664 Prepayments and VAT receivable 692 976 Other current assets 1,950 426 $ 5,169 $ 6,066 Other current assets as of September 30, 2023 include reclassification of approximately $1.6 million of clinical trial deposits previously recognized as long term but now expected to be consumed within one year as of September 30, 2023. |
Non-Current Assets
Non-Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Non-Current Assets [Abstract] | |
Non-Current Assets | 7. Non-Current Assets As of September 30, 2023, the Company had non-current assets of $1.3 million, which is primarily comprised of clinical trial deposits held by a contract research organization in relation to the Company’s Phase 1/2 clinical trials. |
Accrued and Other Liabilities
Accrued and Other Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Accrued and Other Current Liabilities [Abstract] | |
Accrued and Other Liabilities | 8. Accrued and Other Liabilities Accrued and other current liabilities consisted of the following (in $000s): September 30, December 31, 2023 2022 Accrued research and development $ 5,866 $ 3,611 Accrued legal and professional fees 355 333 Other current liabilities 356 1,006 $ 6,577 $ 4,950 Other current liabilities for the year ended December 31, 2022 were largely attributed to accrued payroll costs. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 9. Leases The Company currently has an operating lease liability relating to its facilities in Berkeley Heights, New Jersey. For the nine months ended September 30, 2023 and 2022, the Company recognized operating lease expenses of $55,982 and $46,699 respectively, including $7,902 in 2023 relating to a short term lease for offices in Dundee, Scotland. Cash payments made during the nine months ended September 30, 2023 and 2022 totaled $55,245 and $46,489, respectively, and were presented within cash outflows from operating activities. The remaining lease term as of September 30, 2023 is approximately 1.8 years for the Berkeley Heights facility. The discount rate used by the Company in determining the lease liability was 12%. Remaining lease payments for both facilities are as follows (in $000s): 2023 $ 19 2024 66 2025 38 Thereafter — $ 123 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Stock Based Compensation [Abstract] | |
Stock-Based Compensation | 10. Stock Based Compensation ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period which, for the Company, is the period between the grant date and the date the award vests or becomes exercisable. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures are recognized in the periods when they occur. Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and nine months ended September 30, 2023 and 2022 as shown in the following table (in $000s): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 General and administrative $ 279 $ 255 $ 801 $ 724 Research and development 111 $ 134 $ 350 $ 396 Stock-based compensation costs before income taxes $ 390 $ 389 $ 1,151 $ 1,119 2018 Plan In May 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The 2018 Plan replaced the 2015 Equity Incentive Plan (the “2015 Plan”). The 2018 Plan allows for various types of award grants, including stock options and restricted stock units. On June 14, 2022, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares of common stock available for grant under the 2018 Plan by 500,000 shares. On June 13, 2023, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares of common stock available for grant under the 2018 Plan by an additional 900,000 shares. As of September 30, 2023, the Company has reserved 336,984 shares of the Company’s common stock under the 2018 Plan for future issuances. Stock option awards granted under the Company’s equity incentive plans have a maximum life of 10 years and generally vest over a one 2020 Inducement Equity Incentive Plan In October 2020, the Inducement Equity Incentive Plan (the “Inducement Plan”), became effective. Under the Inducement Plan, Cyclacel may make equity incentive grants to new senior level employees (persons to whom the Company may issue securities without stockholder approval). The Inducement Plan allows for the issuance of up to 200,000 shares of the Company’s common stock (or the equivalent of such number). As of September 30, 2023, 120,000 shares under the Inducement Plan have been issued, leaving 80,000 shares in reserve. Option Grants and Exercises There were 650,128 options granted during the nine months ended September 30, 2023. These options had a grant date fair value ranging between $0.42-$0.73 per option. There were 522,337 options granted during the nine months ended September 30, 2022. These options had a grant date fair value ranging between $0.83-$2.90 per option. Of the options granted during the nine months ended September 30, 2023, 384,500 shall vest on the third anniversary of their date of grant, or earlier if either of the certain performance conditions are met relating to enrollment goals for various clinical studies. For purposes of the below calculations, the Company has assumed that these awards will vest after three years as satisfaction of the performance conditions is not probable at this time. The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions: Nine months ended Nine months ended September 30, 2023 September 30, 2022 Expected term (years) 5-6 5-6 Risk free interest rate 3.660% – 4.050% 1.370% – 3.605% Volatility 89% – 92% 86% – 93% Expected dividend yield over expected term 0.00% 0.00% There were no stock options exercised during each of the nine months ended September 30, 2023 and 2022, respectively. The Company does not expect to be able to benefit from the deduction for stock option exercises that may occur because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income. Outstanding Options A summary of the share option activity and related information is as follows: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Contractual Intrinsic Outstanding Price Per Share Term (Years) Value ($000) Options outstanding at December 31, 2022 1,610,590 $ 5.85 8.34 $ — Granted 650,128 $ 0.59 — — Cancelled/forfeited (79,030) $ 15.47 — — Options outstanding at September 30, 2023 2,181,688 $ 3.93 8.21 $ — Unvested at September 30, 2023 994,421 $ 1.59 9.20 $ — Vested and exercisable at September 30, 2023 1,187,267 $ 5.89 7.38 $ — Restricted Stock Units The Company issued 384,314 restricted stock units during the nine months ended September 30, 2023. The 127,314 restricted stock units issued in June 2023 vest on the first anniversary of the date of grant. Each of these restricted stock units were valued at $0.59 at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date. The 257,000 restricted stock units issued in January 2023 vest on the third anniversary of their date of grant, or earlier if certain defined clinical trial related performance targets are met. A three-year vesting assumption was applied to these restricted stock units as satisfaction of the performance conditions is not probable at this time. Each restricted stock unit was valued at $0.90 at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date. The Company issued 118,665 restricted stock units during the year ended December 31, 2022. These restricted stock units vest over a period of one year for awards granted to directors and three years for grants to employees. Each restricted stock unit was valued at $1.11 based on their fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock. Summarized information for restricted stock units as of September 30, 2023 is as follows: Weighted Weighted Average Average Restricted Grant Date Remaining Stock Units Value Per Share Term Restricted Stock Units outstanding at September 30, 2023 521,971 $ 1.08 9.21 years Unvested at September 30, 2023 400,927 $ 0.82 9.45 years Vested and exercisable at September 30, 2023 121,044 $ 1.95 8.42 years |
Stockholders Equity
Stockholders Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders Equity | 11. Stockholders Equity August 2021 Controlled Equity Offering Sales Agreement On August 12, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor"), pursuant to which the Company could issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $10.0 million through Cantor as the sales agent. Cantor could sell the Company’s common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act. On August 12, 2022, the Company became aware that the shelf registration statement on Form S-3 (file number 333-231923) (the “Registration Statement”) associated with this Sales Agreement had expired on June 21, 2022. Prior to becoming aware of the expiration, the Company sold an aggregate of 1,987,100 shares of its common stock at the market price, following the expiration of the Registration Statement and through August 12, 2022, for aggregate proceeds of approximately $2,721,187. There was no sale of shares after August 12, 2022. The sale of these shares may have been subject to potential rescission rights by certain stockholders. As a result of these potential rescission rights, the Company reclassified 3,117,100 shares (including 1,130,000 shares sold for which the Company did not receive any proceeds) with an aggregate redemption value of $4,494,496, of its common stock as outside stockholders’ equity. These shares have been treated as issued and outstanding for financial reporting purposes. The reclassification period for these shares has now lapsed and the shares have been reclassified back to permanent equity. As of September 30, 2023, there have been no claims or demands to exercise such rights. On August 15, 2022, due to expiry of the Registration Statement, the Sales Agreement was mutually terminated. Since the start of the agreement on August 12, 2021, a total of 3,281,067 shares, for gross proceeds of approximately $7.6 million, had been sold pursuant to the Sales Agreement. Warrants December 2020 Warrants As of September 30, 2023, warrants to purchase 669,854 shares of common stock issued pursuant to a securities purchase agreement in a December 2020 financing transaction remained outstanding. Each warrant shall be exercisable beginning on the 12-month anniversary of the date of issuance for a period of five years after the date of issuance, at an exercise price of $4.13 per warrant share. The exercise price of the warrants will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the warrants. The warrants may be exercised on a “cashless” basis. There were no exercises of these warrants during the nine months ended September 30, 2023 or September 30, 2022. April 2020 Warrants As of September 30, 2023, 2,190,000 warrants issued pursuant to a securities purchase agreement in connection with an April 2020 equity financing remained outstanding, each with an exercise price of $5.00. The common warrants are immediately exercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the Company’s common stock. The common warrants were issued separately from the common stock and were eligible for transfer immediately after issuance. A common warrant to purchase one share of common stock was issued for every share of common stock purchased in this offering. The common warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment in full for the number of shares of the Company’s common stock purchased upon such exercise (except in the case of a cashless exercise). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days prior notice from the holder to the Company, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common warrants up to 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the common warrants. No fractional shares of common stock will be issued in connection with the exercise of a common warrant. In lieu of fractional shares, the Company will round down to the next whole share. There were no exercises of these warrants during the nine months ended September 30, 2023 or September 30, 2022. July 2017 Warrants As of September 30, 2023, 374,525 warrants issued in connection with the July 2017 underwritten public offering remained outstanding, each with an exercise price of $40.00. All such warrants were issued in connection with the July 2017 underwritten public offering and are immediately exercisable. The warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise. The exercise price and the number of shares issuable upon exercise of the warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. The warrant holders must pay the exercise price in cash upon exercise of the warrants, unless such warrant holders are utilizing the cashless exercise provision of the warrants. On the expiration date, unexercised warrants will automatically be exercised via the “cashless” exercise provision. Prior to the exercise of any warrants to purchase common stock, holders of the warrants will not have any of the rights of holders of the common stock purchasable upon exercise, including the right to vote, except as set forth therein. There were no exercises of these warrants during the nine months ended September 30, 2023 or September 30, 2022. Series B Preferred Stock 237,745 shares of the Company’s Series B Preferred Stock were issued in a December 2020 Securities Purchase Agreement. Each share of Series B Preferred Stock shall initially be convertible into five shares of Common Stock, subject to adjustment in accordance with the Certificate of Designation. As of September 30, 2023, 237,745 shares of the Series B Preferred Stock remained issued and outstanding. Holders of Series B Preferred Stock are entitled to receive dividends on shares of Series B Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the Company’s common stock. Except as otherwise required by law, the Series B Preferred Stock does not have voting rights. However, as long as any shares of Series B Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock, (d) increase the number of authorized shares of Series B Preferred Stock, (e) pay certain dividends or (f) enter into any agreement with respect to any of the foregoing. The Series B Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company. The Series B Preferred Stock may be converted into shares of common stock if and solely to the extent that such conversion would not result in the holder beneficially owning in excess of 9.99% of then-outstanding common stock or aggregate voting power of the Company and any portion in excess of such limitation will remain outstanding as Series B Preferred Stock. Series A Preferred Stock 8,872 shares of the Company’s Series A Preferred Stock were issued in the July 2017 underwritten public offering. During the year ended December 31, 2017, 8,608 shares of the Series A Preferred Stock were converted into 215,200 shares of common stock. As of September 30, 2023, 264 shares of the Series A Preferred Stock remained issued and outstanding Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into a number of shares of common stock determined by dividing $1,000 by the initial conversion price of $40.00 per share, subject to a 4.99% blocker provision, or, upon election by a holder prior to the issuance of shares of Series A Preferred Stock, 9.99%, and is subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations. The 264 shares of Series A Preferred Stock issued and outstanding at September 30, 2023 are convertible into 6,600 shares of common stock. In the event of a liquidation, the holders of shares of the Series A Preferred Stock shall be permitted to participate on an as-converted-to-common-stock basis in any distribution of assets of the Company. The Company shall not pay any dividends on shares of common stock (other than dividends in the form of common stock) unless and until such time as dividends on each share of Series A Preferred Stock are paid on an as-converted basis. There is no restriction on the Company’s ability to repurchase shares of Series A Preferred Stock while there is any arrearage in the payment of dividends on such shares, and there are no sinking fund provisions applicable to the Series A Preferred Stock. Subject to certain conditions, at any time following the issuance of the Series A Preferred Stock, the Company has the right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock in the event that (i) the volume weighted average price of our common stock for 30 The Series A Preferred Stock has no maturity date, will carry the same dividend rights as the common stock, and with certain exceptions, contains no voting rights. In the event of any liquidation or dissolution of the Company, the Series A Preferred Stock ranks senior to the common stock in the distribution of assets, to the extent legally available for distribution. 6% Convertible Exchangeable Preferred Stock As of September 30, 2023, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (the “6% Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the 6% Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the 6% Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s board of directors and must come from funds that are legally available for dividend payments. The 6% Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. As of September 30, 2023, accrued and unpaid dividends amounted to $50,291. The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $59,220, which is 150% of the conversion price of the 6% Preferred Stock, for at least 20 trading days during any 30 day trading period, ending within five trading days prior to notice of automatic conversion. The 6% Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances. The Company may, at its option, redeem the 6% Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share. The 6% Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (the “Debentures”) at the rate of $10.00 principal amount of Debentures for each share of 6% Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have substantially similar terms to those of the 6% Preferred Stock. No such exchanges have taken place to date. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Events Dividends on 6% Preferred Stock On September 6, 2023, the board of directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Preferred Stock. The cash dividend was paid |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated balance sheet as of September 30, 2023, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2023 and 2022 and the consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2022 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2023. The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by GAAP for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2023, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2023, and cash flows for the nine months ended September 30, 2023, have been made. The interim results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2022 that are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2023. |
Going Concern | Going Concern Pursuant to the requirements of Accounting Standard Codification (“ASC”) 205-40, Presentation of Financial Statements-Going Concern Based on the Company’s current operating plan, it is anticipated that cash and cash equivalents of $5.9 million as of September 30, 2023, will allow it to meet liquidity requirements through the end of 2023. However, the current operating plan includes discretionary expenditures, which if not incurred and taken together with the anticipated receipt of research & development tax credits of approximately $3.1 million in the first quarter of 2024 could extend liquidity requirements into the second quarter of 2024. The Company’s history of losses, negative cash flows from operations, liquidity resources currently on hand, and its dependence on the ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in the assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the issuance date of these financial statements. While the Company has plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of public or private equity or debt financings or by entering into partnership agreements for further development of our drug candidates, there is no guarantee that it will be successful in these mitigation efforts. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. |
Accounting standards adopted in the period | Accounting Standards Adopted in the Period In November 2021 , the issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance . This requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model under ASC 958-605 or based on International Accounting Standard No. 20 . ASU 2021-10 became effective on January 1, 2022. The adoption of this guidance had no material effect on the Company’s Consolidated Financial Statements. In May 2021, the FASB issued Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) . The new ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment became effective on January 1, 2022. The adoption of this new guidance did not have a material impact on our financial statements for any past transactions, but it could change the way that the Company accounts for subsequent amendments to its outstanding warrants, if any. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements The FASB has issued ASU 2020-04, “Reference Rate Reform (Topic 848)”. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform initiatives that would replace interbank offered rates, including the London Interbank Offered Rate (“LIBOR”). For example, modifications of lease contracts within the scope of ASC 842 solely for changes in reference rates would be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate. Following the issuance of ASU 2022-06, “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848”, the relief remains effective for all entities as of March 12, 2020 through December 31, 2024. The Company does not currently have any contracts affected by this guidance. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income (loss). There were no reclassifications out of other comprehensive income (loss) during the nine months ended September 30, 2023 and 2022. |
Revenue recognition | Revenue Recognition When the Company enters into contracts with customers, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the Company satisfies a performance obligation. The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers: ● Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies; ● Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time; ● Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and ● The complexity and inherent uncertainty underlying the achievement of the milestone. The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives. The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation. The Company recognizes a contract asset, when the value of satisfied (or partially satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or partially satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable. Grant revenue received from organizations that are not the Company’s customers, such as charitable foundations or government agencies, is presented as a reduction against the related research and development expenses. |
Leases | Leases The Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2023, the Company’s outstanding leases are classified as operating leases. The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates that are the same tenure as the lease term, adjusted for various factors, including the effects of assumed collateral, the nature of how the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk. The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as: ● The lease payments due in any optional period; ● Penalties for failure to exercise (or not exercise) the option; ● Market factors, such as the availability of similar assets and current rental rates for such assets; ● The nature of the underlying leased asset and its importance to the Company’s operations; and ● The remaining useful lives of any related leasehold improvements. Lease expense for operating leases is recognized on a straight-line basis over the lease term. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset. The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component. |
Restatement of Prior Financia_2
Restatement of Prior Financial Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Restatement of Prior Financial Information | |
Schedule of error corrections affecting the unaudited consolidated financial statements | (Unaudited) March 31, 2023 March 31, 2023 CONSOLIDATED BALANCE SHEETS As previously reported Adjustments As Restated ASSETS Non-current deposits $ 2,916 $ 549 $ 3,465 Total assets $ 22,060 $ 549 $ 22,609 LIABILITIES AND STOCKHOLDERS’ EQUITY Accrued and other current liabilities $ 4,829 $ 119 $ 4,948 Total current liabilities 7,338 119 7,457 Total liabilities 7,418 119 7,537 Accumulated deficit (411,961) 430 (411,531) Total stockholders’ equity $ 10,148 $ 430 $ 10,578 Total liabilities and stockholders’ equity $ 22,060 $ 549 $ 22,609 (Unaudited) Three Months Ended March 31, 2023 2023 CONSOLIDATED STATEMENTS OF INCOME As previously reported Adjustments As Restated Net loss applicable to common shareholders $ (5,854) $ — $ (5,854) Basic and diluted earnings per common share: Net Loss per share - basic and diluted (common shareholders) $ (0.47) $ — $ (0.47) Net Loss per share - basic and diluted (redeemable common shareholders) $ — $ (0.47) $ (0.47) (Unaudited) March 31, 2023 March 31, 2023 CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY As previously reported Adjustments As Restated Accumulated Deficit (Balances at December 31, 2022) $ (406,157) $ 430 $ (405,727) Accumulated Deficit (Balances at March 31, 2023) $ (411,961) $ 430 $ (411,531) Total Stockholders' Equity (Balances at March 31, 2023) $ 10,148 $ 430 $ 10,578 (Unaudited) June 30, 2023 June 30, 2023 As previously CONSOLIDATED BALANCE SHEETS reported Adjustments As Restated ASSETS Non-current deposits $ 1,000 $ 549 $ 1,549 Total assets $ 16,442 $ 549 $ 16,991 LIABILITIES AND STOCKHOLDERS’ EQUITY Accrued and other current liabilities $ 4,577 $ 119 $ 4,696 Total current liabilities 6,746 119 6,865 Total liabilities 6,812 119 6,931 Temporary equity $ 4,494 $ (1,105) $ 3,389 Common Stock 9 1 10 Additional Paid-In Capital 423,633 1,104 424,737 Accumulated deficit (417,409) 430 (416,979) Total stockholders’ equity 5,136 1,535 6,671 Total liabilities and stockholders’ equity $ 16,442 $ 549 $ 16,991 (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2023 2023 2023 CONSOLIDATED STATEMENTS OF INCOME As previously reported Adjustments As Restated As previously reported Adjustments As Restated Net loss applicable to common shareholders $ (5,498) $ — $ (5,498) $ (11,353) $ — $ (11,353) Basic and diluted earnings per common share: Net Loss per share - basic and diluted (common shareholders) $ (0.44) $ — $ (0.44) $ (0.91) $ — $ (0.90) Net Loss per share - basic and diluted (redeemable common shareholders) $ — $ (0.44) $ (0.44) $ — $ (0.90) $ (0.90) (Unaudited) June 30, 2023 June 30, 2023 CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY As previously reported Adjustments As Restated Accumulated Deficit (Balances at December 31, 2022) $ (406,157) $ 430 $ (405,727) Accumulated Deficit (Balances at March 31, 2023) $ (411,961) $ 430 $ (411,531) Total Stockholders' Equity (Balances at March 31, 2023) $ 10,148 $ 430 $ 10,578 Common Stock - Issue of common stock on At Market, net of expenses $ — $ 1 $ 1 Common Stock (Balances at June 30, 2023) $ 9 $ 1 $ 10 Additional Paid-In Capital - Issue of common stock on At Market, net of expenses $ — $ 1,104 $ 1,104 Additional Paid-In Capital (Balances at June 30, 2023) $ 423,633 $ 1,104 $ 424,737 Accumulated Deficit (Balances at June 30, 2023) $ (417,409) $ 430 $ (416,979) Total Stockholders' Equity (Balances at June 30, 2023) $ 5,136 $ 1,535 $ 6,671 Common Stock No. Shares (Reclassification of redeemable common stock) — 798,200 798,200 Common Stock No. Shares (Balance at June 30, 2023) 9,422,089 798,200 10,220,289 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Common Share | |
Schedule of Basic and Diluted Net Loss Per Share | Three Months Ended March 31, 2023 As restated (see Note 1) Numerator: Net loss $ (5,804) Dividend on convertible exchangeable preferred shares (50) Net loss attributable to common shareholders $ (5,854) Deemed dividend on accretion of redeemable common stock — Remaining undistributed loss (5,854) Three Months Ended March 31, 2023 Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (4,399) $ (1,455) Deemed dividend on accretion of redeemable common stock — Net loss attributable to common shareholders (4,399) (1,455) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 9,422,089 3,117,100 Loss per share - basic and diluted $ (0.47) $ (0.47) Distributed earnings — — Undistributed loss (0.47) (0.47) Net loss per share $ (0.47) $ (0.47) Three And Six Months Ended June 30, 2023 Three Months Six Months As restated (see Note 1) As restated (see Note 1) Numerator: Net loss $ (5,448) $ (11,252) Dividend on convertible exchangeable preferred shares (50) (101) Net loss attributable to common shareholders $ (5,498) $ (11,353) Deemed dividend on accretion of redeemable common stock — — Remaining undistributed loss (5,498) (11,353) Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 Common Shareholders Redeemable Common Shareholders Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (4,144) $ (1,354) $ (8,544) $ (2,809) Deemed dividend on accretion of redeemable common stock — — Net loss attributable to common shareholders (4,144) (1,354) (8,544) (2,809) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 9,461,317 3,090,477 9,441,811 3,107,715 Loss per share - basic and diluted $ (0.44) $ (0.44) $ (0.90) $ (0.90) Distributed earnings — — — — Undistributed loss (0.44) (0.44) (0.90) (0.90) Net loss per share $ (0.44) $ (0.44) $ (0.90) $ (0.90) Three And Nine Months Ended September 30, 2023 Three Months Nine Months Numerator: Net loss $ (6,032) $ (17,284) Dividend on convertible exchangeable preferred shares (50) (151) Net loss attributable to common shareholders $ (6,082) $ (17,435) Deemed dividend on accretion of redeemable common stock — — Remaining undistributed loss (6,082) (17,435) Three Months Ended September 30, 2023 Nine Months Ended September 30, 2023 Common Shareholders Redeemable Common Shareholders Common Shareholders Redeemable Common Shareholders Allocation of undistributed loss $ (5,726) $ (356) $ (14,237) $ (3,198) Deemed dividend on accretion of redeemable common stock — — Net loss attributable to common shareholders (5,726) (356) (14,237) (3,198) Denominator: Weighted-average number of common shares used in loss per share – basic and diluted 11,902,443 740,379 10,271,036 2,307,279 Loss per share - basic and diluted $ (0.48) $ (0.48) $ (1.39) $ (1.39) Distributed earnings — — — — Undistributed loss (0.48) (0.48) (1.39) (1.39) Net loss per share $ (0.48) $ (0.48) $ (1.39) $ (1.39) |
Schedule of antidilutive shares excluded from computation of diluted net loss per share | September 30, September 30, 2023 2022 Stock options 2,181,689 1,618,089 Restricted Stock Units 521,971 137,657 6% convertible exchangeable preferred stock 85 85 Series A preferred stock 6,600 6,600 Series B preferred stock 1,188,725 1,188,725 Common stock warrants 3,234,379 3,234,379 Total shares excluded from calculation 7,133,449 6,185,535 |
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 [Abstract] | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following (in $000s): September 30, December 31, 2023 2022 Research and development tax credit receivable $ 2,527 $ 4,664 Prepayments and VAT receivable 692 976 Other current assets 1,950 426 $ 5,169 $ 6,066 |
Accrued and Other Liabilities (
Accrued and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued and Other Current Liabilities [Abstract] | |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consisted of the following (in $000s): September 30, December 31, 2023 2022 Accrued research and development $ 5,866 $ 3,611 Accrued legal and professional fees 355 333 Other current liabilities 356 1,006 $ 6,577 $ 4,950 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of the Company's Contractual Obligations and Commitments Relating to its Facilities Leases | Remaining lease payments for both facilities are as follows (in $000s): 2023 $ 19 2024 66 2025 38 Thereafter — $ 123 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock Based Compensation [Abstract] | |
Schedule of Stock Based Compensation Expense | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 General and administrative $ 279 $ 255 $ 801 $ 724 Research and development 111 $ 134 $ 350 $ 396 Stock-based compensation costs before income taxes $ 390 $ 389 $ 1,151 $ 1,119 |
Schedule of Fair Value of the Stock Options Granted | Nine months ended Nine months ended September 30, 2023 September 30, 2022 Expected term (years) 5-6 5-6 Risk free interest rate 3.660% – 4.050% 1.370% – 3.605% Volatility 89% – 92% 86% – 93% Expected dividend yield over expected term 0.00% 0.00% |
Schedule of Share Option Activity | A summary of the share option activity and related information is as follows: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Contractual Intrinsic Outstanding Price Per Share Term (Years) Value ($000) Options outstanding at December 31, 2022 1,610,590 $ 5.85 8.34 $ — Granted 650,128 $ 0.59 — — Cancelled/forfeited (79,030) $ 15.47 — — Options outstanding at September 30, 2023 2,181,688 $ 3.93 8.21 $ — Unvested at September 30, 2023 994,421 $ 1.59 9.20 $ — Vested and exercisable at September 30, 2023 1,187,267 $ 5.89 7.38 $ — |
Schedule of Restricted Stock Units Activity | Weighted Weighted Average Average Restricted Grant Date Remaining Stock Units Value Per Share Term Restricted Stock Units outstanding at September 30, 2023 521,971 $ 1.08 9.21 years Unvested at September 30, 2023 400,927 $ 0.82 9.45 years Vested and exercisable at September 30, 2023 121,044 $ 1.95 8.42 years |
Restatement of Prior Financia_3
Restatement of Prior Financial Information - (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | |
Restatement of Prior Financial Information | |||
Reclassification of redeemable common stock | $ (3,389) | $ (1,105) | $ 1,705 |
Restatement of Prior Financia_4
Restatement of Prior Financial Information - CONSOLIDATED BALANCE SHEETS (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
ASSETS | ||||||||
Non-current deposits | $ 1,259 | $ 1,549 | $ 3,465 | $ 3,465 | ||||
Total Assets | 12,497 | 16,991 | 22,609 | 28,050 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Accrued and other current liabilities | 6,577 | 4,696 | 4,948 | 4,950 | ||||
Total current liabilities | 8,148 | 6,865 | 7,457 | 7,511 | ||||
Total liabilities | 8,200 | 6,931 | 7,537 | 7,617 | ||||
Additional Paid-In Capital | 428,464 | 424,737 | 422,973 | |||||
Accumulated deficit | (423,011) | (416,979) | (411,531) | (405,727) | ||||
Temporary equity | 0 | 3,389 | 4,494 | |||||
Total stockholders' equity | 4,297 | 6,671 | 10,578 | 15,939 | $ 22,497 | $ 29,532 | $ 33,840 | $ 37,693 |
Total liabilities and stockholders' equity | $ 12,497 | 16,991 | 22,609 | $ 28,050 | ||||
As previously reported | ||||||||
ASSETS | ||||||||
Non-current deposits | 1,000 | 2,916 | ||||||
Total Assets | 16,442 | 22,060 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Accrued and other current liabilities | 4,577 | 4,829 | ||||||
Total current liabilities | 6,746 | 7,338 | ||||||
Total liabilities | 6,812 | 7,418 | ||||||
Additional Paid-In Capital | 423,633 | |||||||
Accumulated deficit | (417,409) | (411,961) | ||||||
Temporary equity | 4,494 | |||||||
Total stockholders' equity | 5,136 | 10,148 | ||||||
Total liabilities and stockholders' equity | 16,442 | 22,060 | ||||||
Adjustments | ||||||||
ASSETS | ||||||||
Non-current deposits | 549 | 549 | ||||||
Total Assets | 549 | 549 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Accrued and other current liabilities | 119 | 119 | ||||||
Total current liabilities | 119 | 119 | ||||||
Total liabilities | 119 | 119 | ||||||
Additional Paid-In Capital | 1,104 | |||||||
Accumulated deficit | 430 | 430 | ||||||
Temporary equity | (1,105) | |||||||
Total stockholders' equity | 1,535 | 430 | ||||||
Total liabilities and stockholders' equity | $ 549 | $ 549 |
Restatement of Prior Financia_5
Restatement of Prior Financial Information - CONSOLIDATED STATEMENTS OF INCOME (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | |||||||
Net loss attributable to common shareholders | $ (6,082) | $ (5,498) | $ (5,854) | $ (5,146) | $ (11,353) | $ (17,435) | $ (13,930) |
Common Stock | |||||||
Operating expenses: | |||||||
Net loss attributable to common shareholders | $ (4,144) | $ (4,399) | $ (8,544) | ||||
Net Loss per Common Share | |||||||
Net loss per share - basic | $ (0.48) | $ (0.44) | $ (0.47) | $ (0.43) | $ (0.90) | $ (1.39) | $ (1.30) |
Net loss per share - diluted | (0.48) | $ (0.44) | $ (0.47) | (0.43) | $ (0.90) | (1.39) | (1.30) |
Redeemable Common Stock | |||||||
Operating expenses: | |||||||
Net loss attributable to common shareholders | $ (1,354) | $ (1,455) | $ (2,809) | ||||
Net Loss per Common Share | |||||||
Net loss per share - basic | (0.48) | $ (0.44) | $ (0.47) | (0.38) | $ (0.90) | (1.39) | (1.10) |
Net loss per share - diluted | $ (0.48) | $ (0.44) | $ (0.47) | $ (0.38) | $ (0.90) | $ (1.39) | $ (1.10) |
As previously reported | |||||||
Operating expenses: | |||||||
Net loss attributable to common shareholders | $ (5,498) | $ (5,854) | $ (11,353) | ||||
As previously reported | Common Stock | |||||||
Net Loss per Common Share | |||||||
Net loss per share - basic | $ (0.44) | $ (0.47) | $ (0.91) | ||||
Net loss per share - diluted | (0.44) | (0.47) | (0.91) | ||||
Adjustments | Redeemable Common Stock | |||||||
Net Loss per Common Share | |||||||
Net loss per share - basic | (0.44) | (0.47) | (0.90) | ||||
Net loss per share - diluted | $ (0.44) | $ (0.47) | $ (0.90) |
Restatement of Prior Financia_6
Restatement of Prior Financial Information - CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||||
Jun. 30, 2023 | Jun. 30, 2022 | Sep. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | $ 453 | |||||||
Total stockholders' equity | $ 6,671 | 29,532 | $ 4,297 | $ 10,578 | $ 15,939 | $ 22,497 | $ 33,840 | $ 37,693 |
Common Stock | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | 1 | |||||||
Total stockholders' equity | 10 | 10 | 12 | 9 | 9 | 9 | 10 | 10 |
Additional Paid-in Capital | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | 1,104 | 453 | ||||||
Total stockholders' equity | 424,737 | 424,010 | 428,464 | 423,324 | 422,973 | 422,542 | 423,290 | 422,960 |
Accumulated Other Comprehensive Loss | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | (1,097) | (1,276) | (1,168) | (1,224) | (1,316) | (1,746) | (823) | (748) |
Accumulated Deficit | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | (416,979) | (393,212) | $ (423,011) | (411,531) | (405,727) | $ (398,308) | $ (388,637) | $ (384,529) |
As previously reported | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | 5,136 | 10,148 | ||||||
As previously reported | Common Stock | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | 9 | |||||||
As previously reported | Additional Paid-in Capital | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | 423,633 | |||||||
As previously reported | Accumulated Deficit | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | $ (417,409) | (411,961) | (406,157) | |||||
Adjustments | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | 1,535 | 430 | ||||||
Adjustments | Common Stock | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | 1 | |||||||
Total stockholders' equity | 1 | |||||||
Adjustments | Additional Paid-in Capital | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Issue of common stock on At Market Issuance sales agreement, net of expenses | 1,104 | |||||||
Total stockholders' equity | 1,104 | |||||||
Adjustments | Accumulated Deficit | ||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||||
Total stockholders' equity | $ 430 | $ 430 | $ 430 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2024 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Line Items] | ||||||
Cash and cash equivalents | $ 5,944 | $ 18,345 | ||||
Research and development tax credits | $ 3,100 | |||||
Tax on other comprehensive income (loss) | 0 | |||||
Reclassifications out of other comprehensive income (loss) | 0 | $ 0 | ||||
Total Assets | 12,497 | $ 16,991 | $ 22,609 | 28,050 | ||
Accumulated deficit | $ 423,011 | 416,979 | 411,531 | $ 405,727 | ||
Revision of Prior Period, Error Correction, Adjustment [Member] | ||||||
Accounting Policies [Line Items] | ||||||
Total Assets | 549 | 549 | ||||
Accumulated deficit | $ (430) | $ (430) |
Revenue (Narrative) (Details)
Revenue (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue [Abstract] | ||||
Revenue | $ 16,000 | $ 0 | $ 389,000 | $ 0 |
Net Loss per Common Share (Basi
Net Loss per Common Share (Basic and Diluted Net Loss Per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | |||||||||
Net loss | $ (6,032) | $ (5,448) | $ (5,804) | $ (5,096) | $ (4,575) | $ (4,108) | $ (11,252) | $ (17,284) | $ (13,779) |
Dividend on convertible exchangeable preferred shares | (50) | (50) | (50) | (50) | (101) | (151) | (151) | ||
Net loss attributable to common shareholders | (6,082) | (5,498) | (5,854) | (5,146) | (11,353) | (17,435) | (13,930) | ||
Remaining undistributed loss | (6,082) | (5,498) | (5,854) | $ (5,248) | (11,353) | (17,435) | $ (14,065) | ||
Redeemable common shareholders | |||||||||
Numerator: | |||||||||
Net loss attributable to common shareholders | (1,354) | (1,455) | (2,809) | ||||||
Remaining undistributed loss | $ (356) | $ (1,354) | $ (1,455) | $ (2,809) | $ (3,198) | ||||
Denominator: | |||||||||
Weighted average common shares outstanding basic | 740,379 | 3,090,477 | 3,117,100 | 2,376,721 | 3,107,715 | 2,307,279 | 809,821 | ||
Weighted average common shares outstanding diluted | 740,379 | 3,090,477 | 3,117,100 | 10,013,317 | 3,107,715 | 2,307,279 | 809,821 | ||
Net loss per share - basic | $ (0.48) | $ (0.44) | $ (0.47) | $ (0.38) | $ (0.90) | $ (1.39) | $ (1.10) | ||
Undistributed loss per share - basic | (0.48) | (0.44) | (0.47) | (0.42) | (0.90) | (1.39) | (1.27) | ||
Net loss per share - diluted | (0.48) | (0.44) | (0.47) | (0.38) | (0.90) | (1.39) | (1.10) | ||
Undistributed loss per share - diluted | $ (0.48) | $ (0.44) | $ (0.47) | $ (1.30) | $ (0.90) | $ (1.39) | $ (1.27) | ||
Common Stock | |||||||||
Numerator: | |||||||||
Net loss attributable to common shareholders | $ (4,144) | $ (4,399) | $ (8,544) | ||||||
Remaining undistributed loss | $ (5,726) | $ (4,144) | $ (4,399) | $ (8,544) | $ (14,237) | ||||
Denominator: | |||||||||
Weighted average common shares outstanding basic | 11,902,443 | 9,461,317 | 9,422,089 | 9,937,958 | 9,441,811 | 10,271,036 | 10,013,317 | ||
Weighted average common shares outstanding diluted | 11,902,443 | 9,461,317 | 9,422,089 | 9,937,958 | 9,441,811 | 10,271,036 | 2,376,721 | ||
Net loss per share - basic | $ (0.48) | $ (0.44) | $ (0.47) | $ (0.43) | $ (0.90) | $ (1.39) | $ (1.30) | ||
Undistributed loss per share - basic | (0.48) | (0.44) | (0.47) | (0.43) | (0.90) | (1.39) | (1.30) | ||
Net loss per share - diluted | (0.48) | (0.44) | (0.47) | (0.43) | (0.90) | (1.39) | (1.30) | ||
Undistributed loss per share - diluted | $ (0.48) | $ (0.44) | $ (0.47) | $ (0.43) | $ (0.90) | $ (1.39) | $ (0.42) |
Net Loss per Common Share - Sch
Net Loss per Common Share - Schedule of Company's Potential Anti Dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 7,133,449 | 6,185,535 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 2,181,689 | 1,618,089 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 521,971 | 137,657 |
6% convertible exchangeable preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 85 | 85 |
Preferred stock, dividend rate (in percent) | 6% | |
Series A Convertible Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 6,600 | 6,600 |
Series B Convertible Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 1,188,725 | 1,188,725 |
Common Stock Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares excluded from calculation | 3,234,379 | 3,234,379 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $ 2,527 | $ 4,664 |
Prepayments and VAT receivable | 692 | 976 |
Other current assets | 1,950 | 426 |
Prepaid expenses and other current assets | 5,169 | $ 6,066 |
Clinical trial deposits, current | $ 1,600 |
Non-Current Assets (Details)
Non-Current Assets (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Non-Current Assets [Abstract] | |
Clinical trial deposits held by a contract research organization | $ 1.3 |
Accrued and Other Liabilities -
Accrued and Other Liabilities - Schedule of accrued and other current liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued and Other Current Liabilities [Abstract] | ||||
Accrued research and development | $ 5,866 | $ 3,611 | ||
Accrued legal and professional fees | 355 | 333 | ||
Other current liabilities | 356 | 1,006 | ||
Accrued and other current liabilities | $ 6,577 | $ 4,696 | $ 4,948 | $ 4,950 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating lease expense | $ 55,982 | $ 46,699 |
Operating lease, payments | $ 55,245 | $ 46,489 |
Discount rate lease liability | 12% | |
Berkeley Heights facility | ||
Remaining lease term | 1 year 9 months 18 days | |
Dundee facility | ||
Operating lease expense | $ 7,902 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Operating Lease Obligation | |
2023 | $ 19 |
2024 | 66 |
2025 | 38 |
Thereafter | 0 |
Lease payments, Total | $ 123 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation costs before income taxes | $ 390 | $ 389 | $ 1,151 | $ 1,119 |
General and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation costs before income taxes | 279 | 255 | 801 | 724 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation costs before income taxes | $ 111 | $ 134 | $ 350 | $ 396 |
Stock Based Compensation - Narr
Stock Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jun. 13, 2023 | Jun. 30, 2023 | Jan. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Jun. 14, 2022 | Oct. 31, 2020 | |
Stock-based compensation | ||||||||||
Common stock, shares issued | 12,642,822 | 12,642,822 | 9,422,089 | |||||||
Options exercised (in shares) | 0 | 0 | ||||||||
Stock-based compensation costs before income taxes | $ 390 | $ 389 | $ 1,151 | $ 1,119 | ||||||
Stock options | ||||||||||
Stock-based compensation | ||||||||||
Options granted (in shares) | 650,128 | 522,337 | ||||||||
Stock options | Options Vesting On Third Anniversary Of Grant [Member] | ||||||||||
Stock-based compensation | ||||||||||
Stock awards vesting period | 3 years | |||||||||
Options granted (in shares) | 384,500 | |||||||||
Stock options | Minimum | ||||||||||
Stock-based compensation | ||||||||||
Options granted, grant date fair value | $ 0.42 | $ 0.83 | ||||||||
Stock options | Maximum | ||||||||||
Stock-based compensation | ||||||||||
Options granted, grant date fair value | $ 0.73 | $ 2.90 | ||||||||
Restricted Stock Units (RSUs) | ||||||||||
Stock-based compensation | ||||||||||
Stock awards vesting period | 3 years | |||||||||
Options granted, grant date fair value | $ 0.59 | |||||||||
Restricted Stock Units, Granted | 127,314 | 257,000 | 118,665 | |||||||
Restricted Stock Units outstanding/unvested | 521,971 | 521,971 | ||||||||
Restricted stock units, grant date fair value | $ 0.90 | $ 1.08 | $ 1.08 | $ 1.11 | ||||||
Modified Stock Options And Restricted Stock Units [Member] | ||||||||||
Stock-based compensation | ||||||||||
Restricted Stock Units, Granted | 384,314 | |||||||||
2018 Equity Incentive Plan (the "2018 Plan") [Member] | ||||||||||
Stock-based compensation | ||||||||||
Number of shares reserved for issuance | 336,984 | |||||||||
Life of stock option awards granted | 10 years | |||||||||
Number of authorized shares | 900,000 | 500,000 | ||||||||
2018 Equity Incentive Plan (the "2018 Plan") [Member] | Minimum | ||||||||||
Stock-based compensation | ||||||||||
Stock awards vesting period | 1 year | |||||||||
2018 Equity Incentive Plan (the "2018 Plan") [Member] | Maximum | ||||||||||
Stock-based compensation | ||||||||||
Stock awards vesting period | 4 years | |||||||||
Inducement Equity Incentive Plan 2020 [Member] | ||||||||||
Stock-based compensation | ||||||||||
Number of shares reserved for issuance | 80,000 | 80,000 | ||||||||
Common stock, shares issued | 120,000 | 120,000 | ||||||||
Inducement Equity Incentive Plan 2020 [Member] | Minimum | ||||||||||
Stock-based compensation | ||||||||||
Number of authorized shares | 200,000 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Fair Value of the Stock Options Granted (Details) - Stock options | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected dividend yield over expected term | 0% | 0% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (years) | 5 years | 5 years |
Risk free interest rate | 3.66% | 1.37% |
Volatility | 89% | 86% |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (years) | 6 years | 6 years |
Risk free interest rate | 4.05% | 3.605% |
Volatility | 92% | 93% |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Share Option Activity (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Number of Options Outstanding | |||
Exercised (in shares) | 0 | 0 | |
Stock options | |||
Number of Options Outstanding | |||
Options outstanding | 1,610,590 | ||
Granted | 650,128 | 522,337 | |
Cancelled/forfeited | (79,030) | ||
Options outstanding | 2,181,688 | 1,610,590 | |
Unvested | 994,421 | ||
Vested and exercisable | 1,187,267 | ||
Weighted Average Exercise Price Per Share | |||
Options outstanding | $ 5.85 | ||
Granted | 0.59 | ||
Cancelled/forfeited (in dollars per share) | 15.47 | ||
Options outstanding | 3.93 | $ 5.85 | |
Unvested | 1.59 | ||
Vested and exercisable | $ 5.89 | ||
Weighted Average Remaining Contractual Term (Years) | |||
Options outstanding | 8 years 2 months 15 days | 8 years 4 months 2 days | |
Unvested | 9 years 2 months 12 days | ||
Vested and exercisable | 7 years 4 months 17 days |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) - $ / shares | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2023 | Jan. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Number of Options Outstanding | ||||
Granted | 127,314 | 257,000 | 118,665 | |
Restricted Stock Units outstanding/unvested | 521,971 | |||
Unvested | 400,927 | |||
Vested and exercisable | 121,044 | |||
Weighted Average Grant Date Value Per Share | ||||
Restricted stock units, grant date fair value | $ 0.90 | $ 1.08 | $ 1.11 | |
Unvested, Weighted Average Grant Date Value Per Share | 0.82 | |||
Vested and exercisable | $ 1.95 | |||
Weighted Average Remaining Term | ||||
Restricted stock units, Weighted average remaining term | 9 years 2 months 15 days | |||
Unvested | 9 years 5 months 12 days | |||
Vested and exercisable | 8 years 5 months 1 day | |||
Stock awards vesting period | 3 years | |||
Employees | ||||
Weighted Average Remaining Term | ||||
Stock awards vesting period | 3 years |
Stockholders Equity - Narrative
Stockholders Equity - Narrative (Details) - USD ($) | 1 Months Ended | 8 Months Ended | 9 Months Ended | 12 Months Ended | 13 Months Ended | |||||
Aug. 12, 2022 | Aug. 12, 2021 | Dec. 31, 2020 | Jul. 31, 2017 | Aug. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2017 | Aug. 31, 2022 | |
Class of Stock [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Common stock, shares issued | 12,642,822 | 9,422,089 | ||||||||
July 2017 - Underwritten Public Offering [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants, exercise price per share | $ 40 | |||||||||
Percentage Of Outstanding Common Stock | 4.99% | |||||||||
Outstanding common stock at election of purchaser | 9.99% | |||||||||
Warrants outstanding | 374,525 | |||||||||
Warrants exercised | 0 | 0 | ||||||||
Cantor Fitzgerald & Co. [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Aggregate offering price | $ 10,000,000 | |||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,721,187 | $ 4,494,496 | $ 7,600,000 | |||||||
Number of share sold under the sales agreement | 3,117,100 | 1,987,100 | 3,281,067 | |||||||
Acorn Bioventures, LP [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants to purchase shares | 669,854 | |||||||||
Warrant outstanding Term | 5 years | |||||||||
Warrants, exercise price per share | $ 4.13 | |||||||||
Warrants exercised | 0 | 0 | ||||||||
Co-Placement Agents [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Warrants, exercise price per share | $ 5 | |||||||||
Number of common shares called by each warrant | 1 | |||||||||
Warrant Exercises (in shares) | 0 | 0 | ||||||||
Warrants outstanding | 2,190,000 | |||||||||
Fractional shares issued | 0 | |||||||||
Co-Placement Agents [Member] | Common Stock Warrants | ||||||||||
Class of Stock [Line Items] | ||||||||||
Percentage Of Outstanding Common Stock | 4.99% | |||||||||
Outstanding common stock at election of purchaser | 9.99% | |||||||||
Notice period from the holder to increase the percentage of ownership of outstanding common stock after exercise of warrants | 61 days | |||||||||
Series B Convertible Preferred Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Preferred stock, shares issued | 237,745 | 237,745 | 237,745 | |||||||
Preferred stock, shares outstanding | 237,745 | 237,745 | ||||||||
Outstanding common stock at election of purchaser | 9.99% | |||||||||
Number of shares converted | 5 | |||||||||
Series A Convertible Preferred Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Measurement period of consecutive trading days used in determining whether specified triggers are met which would allow the entity to require the conversion of all or part of outstanding preferred stock | 30 days | |||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Number of common shares issued upon conversion | 215,200 | |||||||||
Effective Conversion price per share | $ 40 | |||||||||
Preferred stock, shares issued | 8,872 | 264 | 264 | |||||||
Preferred stock, shares outstanding | 264 | 264 | ||||||||
Number of shares converted | 6,600 | 8,608 | ||||||||
Price per share used to determine number of shares of common stock | $ 1,000 | |||||||||
Percentage of blocker provision | 4.99% | |||||||||
Conversion percentage | 9.99% | |||||||||
Series A Convertible Preferred Stock | Minimum | ||||||||||
Class of Stock [Line Items] | ||||||||||
Percentage by which the weighted average price of common stock during the measurement period exceeds the initial conversion price which triggers the right of the entity to cause all or part of the outstanding preferred stock to be converted | 300% | |||||||||
Threshold amount of daily trading volume on each trading day during the measurement period which triggers the right of the entity to cause all or part of the outstanding preferred stock to be converted | $ 500,000 | |||||||||
6% convertible exchangeable preferred stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Share issue price per share | $ 10 | |||||||||
Preferred stock, shares issued | 335,273 | 335,273 | ||||||||
Preferred stock, shares outstanding | 335,273 | 335,273 | ||||||||
Dividend rate on convertible exchangeable preferred stock (in percent) | 6% | 6% | ||||||||
Accrued and unpaid dividends | $ 50,291 | |||||||||
Convertible Preferred Stock, Terms of Conversion | The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $59,220, which is 150% of the conversion price of the 6% Preferred Stock, for at least 20 trading days during any 30 day trading period, ending within five trading days prior to notice of automatic conversion. | |||||||||
Redemption price per share (in dollars per share) | $ 10 | |||||||||
Debt principal amount per share, basis for exchange (in dollars per share) | $ 10 | |||||||||
Debt Instrument, Term | 25 years | |||||||||
Liquidation preference (in dollars per share) | $ 10 |
Subsequent Events - Narrative (
Subsequent Events - Narrative (Details) - 6% convertible exchangeable preferred stock - $ / shares | 9 Months Ended | 12 Months Ended | |||
Nov. 01, 2023 | Oct. 20, 2023 | Sep. 06, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | |||||
Dividend declared, date | Sep. 06, 2023 | ||||
Preferred stock dividend declared, amount per share | $ 0.15 | ||||
Preferred stock, dividend rate (in percent) | 6% | 6% | |||
Subsequent event | |||||
Subsequent Event [Line Items] | |||||
Dividends payable, date to be paid | Nov. 01, 2023 | ||||
Dividend, record date | Oct. 20, 2023 | ||||
Preferred stock, dividends per share, cash paid | $ 0.15 |