Document And Entity Information
Document And Entity Information | 3 Months Ended |
Mar. 31, 2024 | |
Document Information [Line Items] | |
Document Type | S-1/A |
Entity Registrant Name | CERVOMED INC. |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 30-0645032 |
Entity Address, Address Line One | 20 Park Plaza, Suite 424 |
Entity Address, City or Town | Boston |
Entity Address, State or Province | MA |
Entity Address, Postal Zip Code | 02116 |
City Area Code | 617 |
Local Phone Number | 744-4400 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Amendment Description | The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine. |
Entity Central Index Key | 0001053691 |
Amendment Flag | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 7,792,846 | $ 4,093,579 |
Prepaid expenses and other current assets | 1,256,501 | 64,127 |
Grant receivable | 915,404 | 0 |
Total current assets | 9,964,751 | 4,157,706 |
Other assets | 7,770 | 0 |
Total assets | 9,972,521 | 4,157,706 |
Accounts payable | 662,471 | 97,302 |
Accrued expenses and other current liabilities | 1,933,276 | 644,252 |
Convertible Notes | 0 | 12,414,000 |
Total liabilities | 2,595,747 | 13,155,554 |
Convertible preferred stock: | ||
Convertible preferred stock | 0 | 24,287,211 |
Stockholders’ Equity (Deficit): | ||
Common stock, $0.001 par value: 1,000,000,000 shares authorized, 5,674,354 and 518,140 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 5,674 | 518 |
Additional paid-in capital | 61,811,889 | 18,983,339 |
Accumulated deficit | (54,440,789) | (52,268,916) |
Total stockholders' equity (deficit) | 7,376,774 | (33,285,059) |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | 9,972,521 | 4,157,706 |
Series Preferred Stock [Member] | ||
Convertible preferred stock: | ||
Convertible preferred stock | 0 | 0 |
Series A-1 Preferred Stock [Member] | ||
Convertible preferred stock: | ||
Convertible preferred stock | 0 | 246,849 |
Series A-2 Preferred Stock [Member] | ||
Convertible preferred stock: | ||
Convertible preferred stock | 0 | 4,173,267 |
Series B Preferred Stock [Member] | ||
Convertible preferred stock: | ||
Convertible preferred stock | $ 0 | $ 19,867,095 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | |
Preferred Stock, Shares Authorized (in shares) | 30,000,000 | |
Preferred Stock, Shares Outstanding (in shares) | 0 | |
Preferred Stock, Shares Issued (in shares) | 0 | |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized (in shares) | 1,000,000,000 | 4,163,600 |
Common Stock, Shares Authorized (in shares) | 1,000,000,000 | 4,163,600 |
Common Stock, Shares, Outstanding (in shares) | 5,674,520 | 518,140 |
Series Preferred Stock [Member] | ||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized (in shares) | 30,000,000 | 0 |
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 |
Preferred Stock, Shares Issued (in shares) | 0 | |
Series A-1 Preferred Stock [Member] | ||
Temporary Equity, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Temporary Equity, Shares Authorized (in shares) | 0 | 1,960,600 |
Temporary Equity, Shares Outstanding (in shares) | 0 | 1,960,600 |
Temporary Equity, Shares Issued (in shares) | 0 | 1,960,600 |
Series A-2 Preferred Stock [Member] | ||
Temporary Equity, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Temporary Equity, Shares Authorized (in shares) | 0 | 335,711 |
Temporary Equity, Shares Outstanding (in shares) | 0 | 335,711 |
Temporary Equity, Shares Issued (in shares) | 0 | 335,711 |
Series B Preferred Stock [Member] | ||
Temporary Equity, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Temporary Equity, Shares Authorized (in shares) | 0 | 1,034,890 |
Temporary Equity, Shares Outstanding (in shares) | 0 | 1,034,890 |
Temporary Equity, Shares Issued (in shares) | 0 | 1,034,890 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Grant revenue | $ 7,144,872 | $ 0 |
Operating expenses: | ||
Research and development | 8,438,499 | 1,336,469 |
General and administrative | 6,519,268 | 2,139,065 |
Total operating expenses | 14,957,767 | 3,475,534 |
Loss from operations | (7,812,895) | (3,475,534) |
Other income (expense): | ||
Other income (expense) | 5,421,592 | (2,389,152) |
Interest income | 219,430 | 62,226 |
Interest expense | 0 | (587) |
Total other income (expense) | 5,641,022 | (2,327,513) |
Net income (loss) | $ (2,171,873) | $ (5,803,047) |
Earnings Per Share [Abstract] | ||
Net income (loss) per share of common stock - basic (in dollars per share) | $ (0.82) | $ (11.2) |
Weighted average shares outstanding - basic (in shares) | 2,661,416 | 518,140 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) | Series A-1 Preferred Stock [Member] Preferred Stock [Member] | Series A-1 Preferred Stock [Member] | Series A-2 Preferred Stock [Member] Preferred Stock [Member] | Series A-2 Preferred Stock [Member] | Series B Preferred Stock [Member] Preferred Stock [Member] | Series B Preferred Stock [Member] | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 1,960,600 | 335,711 | 1,034,890 | ||||||||
Balance at Dec. 31, 2021 | $ 246,849 | $ 4,173,267 | $ 19,867,095 | ||||||||
Balance (in shares) at Dec. 31, 2021 | 518,140 | ||||||||||
Balance at Dec. 31, 2021 | $ 518 | $ 18,521,988 | $ (46,465,869) | $ (27,943,363) | |||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 333,835 | 0 | 333,835 | ||||
Contributed capital in lieu of executive compensation | 0 | 0 | 0 | 0 | 127,516 | 0 | 127,516 | ||||
Net loss | (5,803,047) | (5,803,047) | |||||||||
Conversion of preferred stock to common stock | 0 | ||||||||||
Stock-based compensation expense, including vesting of RSUs | $ 0 | $ 0 | $ 0 | $ 0 | 333,835 | 0 | $ 333,835 | ||||
Issuance of common stock from exercises of stock options (in shares) | 0 | ||||||||||
Balance (in shares) at Dec. 31, 2022 | 1,960,600 | 1,960,600 | 335,711 | 335,711 | 1,034,890 | 1,034,890 | |||||
Balance at Dec. 31, 2022 | $ 246,849 | $ 4,173,267 | $ 19,867,095 | ||||||||
Balance (in shares) at Dec. 31, 2022 | 3,331,201 | 518,140 | |||||||||
Balance at Dec. 31, 2022 | $ 24,287,211 | $ 518 | 18,983,339 | (52,268,916) | $ (33,285,059) | ||||||
Stock-based compensation expense | 0 | 0 | 71,240 | 0 | 71,240 | ||||||
Net loss | 0 | 0 | 0 | (534,336) | (534,336) | ||||||
Stock-based compensation expense, including vesting of RSUs | $ 0 | $ 0 | 71,240 | 0 | 71,240 | ||||||
Balance (in shares) at Mar. 31, 2023 | 3,331,201 | 518,140 | |||||||||
Balance at Mar. 31, 2023 | $ 24,287,211 | $ 518 | 19,054,579 | (52,803,252) | (33,748,155) | ||||||
Balance (in shares) at Dec. 31, 2022 | 1,960,600 | 1,960,600 | 335,711 | 335,711 | 1,034,890 | 1,034,890 | |||||
Balance at Dec. 31, 2022 | $ 246,849 | $ 4,173,267 | $ 19,867,095 | ||||||||
Balance (in shares) at Dec. 31, 2022 | 3,331,201 | 518,140 | |||||||||
Balance at Dec. 31, 2022 | $ 24,287,211 | $ 518 | 18,983,339 | (52,268,916) | (33,285,059) | ||||||
Stock-based compensation expense | 0 | 0 | 0 | 0 | 407,632 | 0 | 407,632 | ||||
Net loss | $ 0 | $ 0 | $ 0 | $ 0 | 0 | (2,171,873) | (2,171,873) | ||||
Conversion of preferred stock to common stock (in shares) | (1,960,600) | (335,711) | (1,034,890) | ||||||||
Conversion of preferred stock to common stock | $ (246,849) | $ (4,173,267) | $ (19,867,095) | ||||||||
Conversion of preferred stock to common stock (in shares) | 2,936,566 | ||||||||||
Conversion of preferred stock to common stock | $ 2,937 | 24,284,274 | 0 | 24,287,211 | |||||||
Issuance of common stock upon settlement of convertible promissory note (in shares) | 0 | 0 | 0 | 795,905 | |||||||
Issuance of common stock upon settlement of convertible promissory note | $ 0 | $ 0 | $ 0 | $ 796 | 6,988,953 | 0 | 6,989,749 | ||||
Issuance of common stock to Diffusion stockholders in reverse recapitalization, net of issuance costs | $ 0 | $ 0 | $ 0 | $ 1,360 | 10,337,754 | $ 10,339,114 | |||||
Issuance of common stock to Diffusion stockholders in reverse recapitalization, net of issuance costs (in shares) | 1,360,244 | 1,360,244 | |||||||||
Sale of common stock (in shares) | 0 | 0 | 0 | 63,422 | |||||||
Sale of common stock | $ 0 | $ 0 | $ 0 | $ 63 | 809,937 | 0 | $ 810,000 | ||||
Stock-based compensation expense, including vesting of RSUs | $ 0 | $ 0 | $ 0 | $ 0 | 407,632 | 0 | $ 407,632 | ||||
Stock-based compensation expense, including vesting of RSUs (in shares) | 77 | ||||||||||
Issuance of common stock from exercises of stock options (in shares) | 0 | 0 | 0 | 359 | 359 | ||||||
Issuance of common stock from exercises of stock options | $ 0 | $ 0 | $ 0 | $ 0 | 0 | 0 | $ 0 | ||||
Repurchase of common stock from net settled stock option (in shares) | 0 | 0 | 0 | (193) | |||||||
Repurchase of common stock from net settled stock option | $ 0 | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | ||||
Balance (in shares) at Dec. 31, 2023 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
Balance at Dec. 31, 2023 | $ 0 | $ 0 | $ 0 | ||||||||
Balance (in shares) at Dec. 31, 2023 | 0 | 5,674,520 | |||||||||
Balance at Dec. 31, 2023 | $ 0 | $ 5,674 | 61,811,889 | (54,440,789) | 7,376,774 | ||||||
Stock-based compensation expense | 0 | 0 | 218,215 | 0 | 218,215 | ||||||
Contributed capital in lieu of executive compensation | 0 | 0 | 255,724 | 0 | 255,724 | ||||||
Net loss | 0 | 0 | 0 | (2,514,335) | (2,514,335) | ||||||
Stock-based compensation expense, including vesting of RSUs | $ 0 | $ 0 | 218,215 | 0 | 218,215 | ||||||
Balance (in shares) at Mar. 31, 2024 | 0 | 6,170,479 | |||||||||
Balance at Mar. 31, 2024 | $ 0 | $ 6,170 | $ 62,285,332 | $ (56,955,124) | $ 5,336,378 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (2,171,873) | $ (5,803,047) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 407,632 | 333,835 |
Capital in lieu of executive compensation | 0 | 127,516 |
Change in fair value of convertible debt | 5,424,251 | (2,389,000) |
us-gaap_IncreaseDecreaseInOperatingCapitalAbstract | ||
Prepaid expenses, deposits and other assets | (1,200,144) | 85,104 |
Grant receivable | (915,404) | 0 |
Accounts payable | 565,169 | 79,154 |
Acccrued expenses and other liabilities | 1,289,024 | 215,679 |
Net cash used in operating activities | (7,449,847) | (2,572,759) |
Net assets assumed in connection with reverse recapitalization | 11,887,757 | 0 |
Proceeds from sale of common stock | 810,000 | 0 |
Payment of reverse recapitalization costs | (1,548,643) | 0 |
Net cash provided by financing activities | 11,149,114 | 0 |
Net increase (decrease) in cash and cash equivalents | 3,699,267 | (2,572,759) |
Cash and cash equivalents at beginning of year | 4,093,579 | 6,666,338 |
Cash and cash equivalents at end of year | 7,792,846 | 4,093,579 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Conversion of preferred stock to common stock | 24,287,211 | 0 |
Conversion of Debt into Common Stock [Member] | ||
Supplemental disclosure of non-cash investing and financing activities: | ||
Conversion of Convertible Notes | $ 6,989,749 | $ 0 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 6,369,172 | $ 7,792,846 |
Deferred offering costs | 247,671 | 0 |
Prepaid expenses and other current assets | 1,348,679 | 1,256,501 |
Grant receivable | 0 | 915,404 |
Total current assets | 7,965,522 | 9,964,751 |
Other assets | 31,926 | 7,770 |
Total assets | 7,997,448 | 9,972,521 |
Current liabilities: | ||
Accounts payable | 679,739 | 662,471 |
Deferred grant revenue | 572,475 | 0 |
Accrued expenses and other current liabilities | 1,408,856 | 1,933,276 |
Total liabilities | 2,661,070 | 2,595,747 |
Commitments and Contingencies | ||
Stockholders’ Equity (Deficit): | ||
Series A preferred stock $0.001 par value; 30,000,000 authorized at March 31, 2024 and December 31, 2023, 0 shares issued and outstanding at March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock, $0.001 par value: 1,000,000,000 shares authorized, 5,674,354 and 518,140 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 6,170 | 5,674 |
Additional paid-in capital | 62,285,332 | 61,811,889 |
Accumulated deficit | (56,955,124) | (54,440,789) |
Total stockholders' equity (deficit) | 5,336,378 | 7,376,774 |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ 7,997,448 | $ 9,972,521 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized (in shares) | 30,000,000 | 30,000,000 |
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 |
Preferred Stock, Shares Issued (in shares) | 0 | 0 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common Stock, Shares, Issued (in shares) | 6,170,479 | 5,674,520 |
Common Stock, Shares, Outstanding (in shares) | 6,170,479 | 5,674,520 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Grant revenue | $ 2,347,250 | $ 1,407,868 | $ 7,144,872 | $ 0 |
Operating expenses: | ||||
Research and development | 2,814,258 | 1,833,274 | 8,438,499 | 1,336,469 |
General and administrative | 2,127,930 | 1,000,913 | 6,519,268 | 2,139,065 |
Total operating expenses | 4,942,188 | 2,834,187 | 14,957,767 | 3,475,534 |
Loss from operations | (2,594,938) | (1,426,319) | (7,812,895) | (3,475,534) |
Other income (expense): | ||||
Other income (expense) | (30) | 856,579 | 5,421,592 | (2,389,152) |
Interest income | 80,633 | 35,404 | 219,430 | 62,226 |
Total other income (expense) | 80,603 | 891,983 | 5,641,022 | (2,327,513) |
Net income (loss) | $ (2,514,335) | $ (534,336) | $ (2,171,873) | $ (5,803,047) |
Earnings Per Share [Abstract] | ||||
Net income (loss) per share of common stock - basic (in dollars per share) | $ (0.41) | $ (1.03) | $ (0.82) | $ (11.2) |
Weighted average shares outstanding - basic (in shares) | 6,170,501 | 518,140 | 2,661,416 | 518,140 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Deficit (Unaudited) - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 518,140 | ||||
Balance at Dec. 31, 2021 | $ 518 | $ 18,521,988 | $ (46,465,869) | $ (27,943,363) | |
Stock-based compensation expense | 0 | 333,835 | 0 | 333,835 | |
Net loss | (5,803,047) | (5,803,047) | |||
Contributed capital in lieu of executive compensation | $ 0 | 127,516 | 0 | 127,516 | |
Net loss | (5,803,047) | (5,803,047) | |||
Balance (in shares) at Dec. 31, 2022 | 3,331,201 | 518,140 | |||
Balance at Dec. 31, 2022 | $ 24,287,211 | $ 518 | 18,983,339 | (52,268,916) | (33,285,059) |
Stock-based compensation expense | 0 | 0 | 71,240 | 0 | 71,240 |
Net loss | 0 | 0 | 0 | (534,336) | (534,336) |
Net loss | $ 0 | $ 0 | 0 | (534,336) | (534,336) |
Balance (in shares) at Mar. 31, 2023 | 3,331,201 | 518,140 | |||
Balance at Mar. 31, 2023 | $ 24,287,211 | $ 518 | 19,054,579 | (52,803,252) | (33,748,155) |
Balance (in shares) at Dec. 31, 2022 | 3,331,201 | 518,140 | |||
Balance at Dec. 31, 2022 | $ 24,287,211 | $ 518 | 18,983,339 | (52,268,916) | (33,285,059) |
Stock-based compensation expense | 0 | 407,632 | 0 | 407,632 | |
Net loss | 0 | 0 | (2,171,873) | (2,171,873) | |
Net loss | $ 0 | 0 | (2,171,873) | (2,171,873) | |
Balance (in shares) at Dec. 31, 2023 | 0 | 5,674,520 | |||
Balance at Dec. 31, 2023 | $ 0 | $ 5,674 | 61,811,889 | (54,440,789) | 7,376,774 |
Stock-based compensation expense | 0 | 0 | 218,215 | 0 | 218,215 |
Net loss | 0 | 0 | 0 | (2,514,335) | (2,514,335) |
Contributed capital in lieu of executive compensation | 0 | 0 | 255,724 | 0 | 255,724 |
Cashless exercise of prefunded warrants | 0 | $ 496 | (496) | 0 | 0 |
Cashless exercise of prefunded warrants (in shares) | 495,959 | ||||
Net loss | $ 0 | $ 0 | 0 | (2,514,335) | (2,514,335) |
Balance (in shares) at Mar. 31, 2024 | 0 | 6,170,479 | |||
Balance at Mar. 31, 2024 | $ 0 | $ 6,170 | $ 62,285,332 | $ (56,955,124) | $ 5,336,378 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (2,514,335) | $ (534,336) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 218,215 | 71,240 |
Changes in fair value of convertible debt | 0 | (858,000) |
us-gaap_IncreaseDecreaseInDeferredCharges | 0 | 638,018 |
Prepaid expenses, deposits and other assets | (116,334) | (629,713) |
Accounts payable | (230,403) | 240,257 |
Acccrued expenses and other liabilities | (268,696) | 364,807 |
Grant receivable | 915,404 | |
Deferred grant revenue | 572,475 | 501,821 |
Net cash used in operating activities | (1,423,674) | (1,481,942) |
Net increase (decrease) in cash and cash equivalents | (1,423,674) | (1,481,942) |
Cash and cash equivalents at beginning of year | 7,792,846 | 4,093,579 |
Cash and cash equivalents at end of year | 6,369,172 | 2,611,637 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Deferred offering costs in accounts payable and accrued expenses | 247,671 | 0 |
Stock options granted in lieu of cash bonus | 255,724 | 0 |
Cashless exercise of prefunded warrants | $ 496 | $ 0 |
Note 1 - The Company and Descri
Note 1 - The Company and Description of Business | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Nature of Operations [Text Block] | 1. The Company and Description of Business The Company is a corporation organized under the laws of the state of Delaware and headquartered in Boston, Massachusetts. The Company is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently focused on the development of its lead drug candidate, neflamapimod, an investigational, orally administered, small molecule brain penetrant that inhibits p38α in the neurons (nerve cells) within the brains of people with neurodegenerative diseases. Neflamapimod has the potential to treat and improve synaptic dysfunction, the reversible aspect of the underlying disease processes in DLB and certain other major neurological disorders, and is currently being evaluated in the Company's ongoing RewinD-LB Trial, a Phase 2b study in patients with DLB funded by a $21.0 million grant from the NIA. | 1. The Company and Description of Business The Company is a corporation organized under the laws of the state of Delaware and headquartered in Boston, Massachusetts. The Company is a biotechnology company developing treatments for age-related neurologic disorders. The Company is currently developing its product candidate neflamapimod, an investigational orally administered small molecule brain penetrant that inhibits p38α. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in DLB and certain other major neurological disorders and is currently being evaluated in a Phase 2b study in patients with DLB. On March 30, 2023, Diffusion Pharmaceuticals Inc. (“Diffusion”), Dawn Merger Inc., a wholly-owned subsidiary of Diffusion (“Merger Sub”) and EIP Pharma, Inc. (“EIP”) entered into the Merger Agreement (Note 4), pursuant to which, at the Effective Time, Merger Sub merged with and into EIP, with EIP surviving the Merger as a wholly-owned subsidiary of the Company. In connection with the Merger, on August 16, 2023, the Company changed its corporate name from “Diffusion Pharmaceuticals Inc.” to “CervoMed Inc.” On August 16, 2023, Diffusion approved a one-for-1.5 reverse stock split which was consummated for historical Diffusion shares in connection with the Merger. In addition, upon consummation of the Merger, all historical EIP shares were adjusted using an exchange ratio of 0.1151. All information in the accompanying consolidated financial statements and notes thereto regarding share amounts of common stock, price per share of common stock and the conversion factor for preferred stock into common stock has been adjusted to reflect the application of the reverse stock split and the exchange ratio on a retroactive basis. All shares of EIP common stock outstanding immediately prior to the Effective Time, after giving effect to the conversion of EIP preferred stock and the Convertible Notes (and excluding shares held as treasury stock by EIP, shares held or owned by the Company and any dissenting shares), converted into the right to receive, in the aggregate, 4,314,033 shares of the Company’s common stock and prefunded warrants to purchase 495,995 shares of common stock, based on an exchange ratio of 0.1151. |
Note 2 - Liquidity and Capital
Note 2 - Liquidity and Capital Resources | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Liquidity Disclosure [Text Block] | 2. Liquidity and Capital Resources The Company has generated negative cash flows from operations and, as of March 31, 2024, had an accumulated deficit of approximately $57.0 million. Based on its current operating plan, the Company believes its existing cash and cash equivalents on hand as of March 31, 2024, along with the remaining funds to be received from the NIA grant and the upfront proceeds received from the 2024 Private Placement on April 1, 2024, will enable the Company to fund its operating expenses and capital expenditure requirements for at least twelve months from the issuance of these unaudited condensed consolidated interim financial statements. The Company has based this estimate on assumptions that may prove to be wrong, and it could utilize its available capital resources sooner than it currently expects. The Company will continue to require additional financing to advance its current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. The Company intends to continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms, or at all. If the Company does raise additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the Company's stockholders’ rights. If the Company raises additional capital through a debt financing, it may be subject to covenants limiting or restricting the Company's ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on the Company's financial condition and on its ability to pursue its business plans and strategies. If the Company is unable to raise sufficient capital when needed, it will need to delay, reduce or terminate planned activities to reduce costs, including development or commercialization activities for neflamapimod. The Company might also be required to seek funds through arrangements with third parties that require it to relinquish certain of its rights to neflamapimod or otherwise agree to terms unfavorable to the Company. On April 1, 2024, pursuant to and in accordance with the terms of a securities purchase agreement with certain purchasers named therein, the Company completed the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one Operations of the Company are subject to certain additional risks and uncertainties as well, and any one or more of these factors could materially affect the Company’s financial condition, future operations and liquidity needs. Many of these risks and uncertainties are outside of the Company’s control, including internal and external factors that may affect the success or failure of the Company’s research and development efforts, the length of time and cost of developing and commercializing the Company’s current or future product candidates, whether and when any such product candidates become approved drugs, and how significant a drug’s market share will be, if approved, among others. | 2. Liquidity and Capital Resources The Company has generated negative cash flows from operations and, as of December 31, 2023, had an accumulated deficit of approximately $54.4 million. In January 2023, the Company was awarded a $21.0 million grant from the NIA to support its ongoing RewinD-LB Trial, which is expected to be received over a three-year The Company will continue to require additional financing to advance current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. The Company expects that its existing cash and cash equivalents as of December 31, 2023, along with the remaining funds expected to be received from the NIA Grant, will not be sufficient to enable it to fund its operating expenses and capital expenditure requirements, and continue as a going concern for at least twelve months following the issuance of these consolidated financial statements. The Company will continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, grants, licenses and other similar arrangements. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Without additional funding, the Company would be forced to delay, reduce or eliminate its research and development programs. Accordingly, since the financing discussed below has not been completed, substantial doubt exists about the Company’s ability to continue as a going concern within one year after the date these financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. On March 28, 2024, the Company entered into a securities purchase agreement with certain purchasers named therein related to the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one |
Note 3 - Summary of Significant
Note 3 - Summary of Significant Accounting Policies | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | 3. Summary of Significant Accounting Policies Basis of presentation The unaudited condensed consolidated interim financial statements have been prepared in conformity with US GAAP as defined by the FASB. Unaudited condensed consolidated interim financial statements The accompanying unaudited condensed consolidated interim financial statements have been prepared by the Company in accordance with US GAAP for interim information and pursuant to the rules and regulations of the SEC. Accordingly, certain information and footnote disclosures normally included in unaudited condensed consolidated interim financial statements prepared in accordance with US GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and related notes for the year ended December 31, 2023, filed as part of the Company's Annual Report on Form 10-K. The unaudited condensed consolidated interim financial statements have been prepared on the same basis as the audited consolidated financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods. The results of operations for any interim period are not necessarily indicative of the results to be expected for the full fiscal year. Consolidation The unaudited condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of estimates The preparation of unaudited condensed consolidated interim financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, grant revenue, expenses, and related disclosures. On an ongoing basis, the Company’s management evaluates its estimates, including estimates related to money market accounts, clinical trial accruals, stock-based compensation expense, grant revenue, convertible notes, and expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ significantly from those estimates or assumptions. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains its cash and cash equivalent balances with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance-sheet risk of loss. The Company has not experienced any losses in such accounts. Cash and Cash Equivalents The Company considers all highly-liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents, which consist of amounts invested in money market funds, are stated at fair value. There are no unrealized gains or losses on the money market funds for the period ended March 31, 2024. Equity issuance costs The Company capitalizes costs directly associated with equity financings as deferred offering costs on its unaudited condensed consolidated balance sheet. These costs remain capitalized until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. As of March 31, 2024, there were $0.2 million of deferred offering costs related to the 2024 Private Placement. Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash, accounts payable, previously outstanding convertible notes and accrued liabilities. The Company’s cash, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company determined the fair value of its previously outstanding convertible notes as described in Note 7. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The following table presents the Company’s assets that are measured at fair value on a recurring basis: March 31, 2024 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 3,729,954 $ — $ — Total assets measured at fair value $ 3,729,954 $ — $ — December 31, 2023 Assets Cash equivalents (money market accounts) $ 7,792,846 $ — $ — Total assets measured at fair value $ 7,792,846 $ — $ — The following table presents a roll-forward of the fair value of the Convertible Notes (Note 7) for which fair value is determined by Level 3 inputs: Three Months Ended March 31, 2023 Beginning balance $ 12,414,000 Fair value adjustment (858,000 ) Ending balance $ 11,556,000 Valuation techniques used to measure fair value maximize the use of relevant observable inputs and minimize the use of unobservable inputs (Note 7). The Convertible Notes are classified within Level 3 of the fair value hierarchy because the fair value measurement is based, in part, on significant inputs not observed in the market. There were no transfers among Level 1, Level 2 or Level 3 categories in the three months ended March 31, 2024 or March 31, 2023. The fair value of the 2020 Notes and the 2021 Notes, and collectively the Convertible Notes (Note 7) as of March 31, 2023 were estimated as the combination of a zero-coupon bond and a call option. The combined values for each of the 2020 Notes and the 2021 Notes as of March 31, 2023 were then weighted by the probability of completing a financing or reverse merger. This approach resulted in the classification of the 2020 Notes and the 2021 Notes as of March 31, 2023 as Level 3 of the fair value hierarchy. The assumptions utilized to value the 2020 Notes and the 2021 Notes as of March 31, 2023 were an estimated term of 0.69 years, volatility of 75.0% and a market yield of 55.3%. The measurement of fair value incorporates expected future cash flows associated with interest payments; as such, there was no separate accrual for interest accrued but not yet paid. Leases In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which establishes an ROU model. That requires a lessee to recognize an ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and expense recognition in the statement of operations as well as the reduction of the ROU asset. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply (i) the practical expedient, which allows us to not separate lease and non-lease components, for new leases and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has elected to combine lease and non-lease components as a single component. Operating leases will be recognized on the unaudited interim condensed consolidated balance sheet as ROU assets, lease liabilities, current and lease liabilities, non-current. Fixed rent payments are included in the calculation of the lease balances, while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. Research and Development Research and development costs are expensed as incurred and consist primarily of new product development. Research and development costs include salaries and benefits, consultants’ fees, process development costs and stock-based compensation, as well as fees paid to third parties that conduct certain research and development activities on the Company’s behalf. A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers. The Company records accrued expenses for estimated preclinical study and clinical trial expenses. Estimates are based on the services performed pursuant to contracts with research institutions, contract research organizations in connection with clinical studies, investigative sites in connection with clinical studies, vendors in connection with preclinical development activities, and contract manufacturing organizations in connection with the production of materials for clinical trials. Further, the Company accrues expenses related to clinical trials based on the level of subject enrollment and activity according to the related agreement. The Company monitors subject enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development. If the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ from estimates. To date, the Company has not experienced significant changes in its estimates of preclinical studies and clinical trial accruals. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the unaudited interim condensed consolidated statement of operations. Stock-based Compensation Stock-based compensation for employee and non-employee awards is measured on the grant date based on the fair value of the award and recognized on a straight-line basis over the requisite service period. The fair value of stock options to purchase common stock are measured using the Black-Scholes option pricing model. The Company accounts for forfeitures as they occur. The fair value of stock options is determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Rate zero Revenue Recognition The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. The Company recognizes funding received as grant revenue for the NIA Grant, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these contracts are central to its ongoing operations. Revenue is recognized as the qualifying expenses related to the contracts are incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s unaudited interim condensed consolidated balance sheets as accounts receivable. Amounts received in advance of services rendered are recorded as deferred grant revenue on the Company's unaudited interim condensed consolidated balance sheet. The related costs incurred by the Company are included in research and development expense in the Company’s unaudited interim condensed consolidated statements of operations. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the unaudited condensed consolidated interim financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to recover or settle. The effect of a change in tax rates on deferred tax assets and liabilities is recognized on the statement of operations for the period that includes the enactment date. The deferred tax assets are recognized to the extent the Company believes that these assets are more likely than not to be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company records uncertain tax positions using a two-step process. First, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position. Second, for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits on the interest expense line and other expense line, respectively, in the accompanying statements of operations. Accrued interest and penalties are included on the related liability lines in the unaudited interim condensed consolidated balance sheet. Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period (and potential shares of common stock that are exercisable for little or no consideration). Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: March 31, 2024 2023 Convertible preferred stock — 3,331,201 Common stock warrants 102,462 43,621 Stock options 519,257 114,525 621,719 3,489,347 Segments The Company has one Recently Issued But Not Yet Adopted Accounting Pronouncements In January 2021, the FASB issued ASU No. 2021-01 “Reference Rate Reform (Topic 848): Scope” (“ASU 2021-01”), which was effective immediately and permits entities to elect certain optional expedients and exceptions when accounting for derivatives and certain hedging relationships affected by changes in interest rates and the transition. Additionally, ASU 2022-06 “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848” defers the sunset date of ASC 848 from December 31, 2022 to December 31, 2024. The new guidance is effective for fiscal years beginning after December 31, 2024. The Company does not currently believe that this transition from LIBOR will have a material impact on its financial statements. In November 2023, the FASB issued ASU No. 2023-07 "Segment Reporting - Improvements to Reportable Segment Disclosures" (“ASU 2023-07”), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The guidance is effective for all public companies for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company expects the new guidance will have an immaterial impact on its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): “Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU No. 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures. | 3. Summary of Significant Accounting Policies Basis of presentation The consolidated financial statements have been prepared in conformity with US GAAP as defined by the FASB. Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, grant revenue, expenses, and related disclosures. On an ongoing basis, the Company’s management evaluates its estimates, including estimates related to money market accounts, clinical trial accruals, stock-based compensation expense, grant revenue, Convertible Notes, and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ significantly from those estimates or assumptions. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains its cash and cash equivalent balances with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance-sheet risk of loss. The Company has not experienced any losses in such accounts. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents, which consist of amounts invested in money market funds, are stated at fair value. There are no unrealized gains or losses on the money market funds for the years ended December 31, 2023 and 2022. Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash and cash equivalents, accounts payable, previously outstanding Convertible Notes and accrued liabilities. The Company’s cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company determined the fair value of the Convertible Notes as described in Note 9. In connection with the consummation of the Merger (Note 4) on August 16, 2023, the Convertible Notes were converted into EIP Common Stock which was subsequently converted into the right to exchange such shares of EIP Common Stock for shares of the Company’s common stock. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 Level 2 Level 3 The following table presents the Company’s assets that are measured at fair value on a recurring basis: December 31, 2023 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 7,792,846 $ - $ - Total assets measured at fair value $ 7,792,846 $ - $ - December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 4,093,579 $ - $ - Total assets measured at fair value $ 4,093,579 $ - $ - Liabilities Convertible Notes $ - $ - $ 12,414,000 Total liabilities measured at fair value $ - $ - $ 12,414,000 The following table presents a roll-forward of the fair value of the Convertible Notes (Note 9) for which fair value is determined by Level 3 inputs: Year Ended December 31, 2023 December 31, 2022 Beginning balance $ 12,414,000 $ 10,025,000 Fair value adjustment (5,424,251 ) 2,389,000 Reclassification to additional paid in capital upon conversion (6,989,749 ) - Ending balance $ - $ 12,414,000 Valuation techniques used to measure fair value maximize the use of relevant observable inputs and minimize the use of unobservable inputs (Note 9). The Company’s Convertible Notes are classified within Level 3 of the fair value hierarchy because the fair value measurement is based, in part, on significant inputs not observed in the market. There were no transfers among Level 1, Level 2 or Level 3 categories in the years ended December 31, 2023 or 2022. The fair value of the 2020 Notes and the 2021 Notes, and collectively the Convertible Notes (Note 9) as of December 31, 2022 were estimated as the combination of a zero-coupon bond and a call option. The combined values for each of the 2020 Notes and the 2021 Notes as of December 31, 2022 were then weighted by the probability of completing a financing or reverse merger. This approach resulted in the classification of the 2020 Notes and the 2021 Notes as of December 31, 2022 as Level 3 of the fair value hierarchy. The assumptions utilized to value the 2020 Notes and the 2021 Notes as of December 31, 2022 were an estimated term of 0.94 years, volatility of 80.0% and a market yield of 55.2%. The measurement of fair value incorporates expected future cash flows associated with interest payments; as such, there is no separate accrual for interest accrued but not yet paid. Leases In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which establishes a ROU model. That requires a lessee to recognize an ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations as well as the reduction of the ROU asset. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply (i) the practical expedient, which allows us to not separate lease and non-lease components, for new leases and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has elected to combine lease and non-lease components as a single component. Operating leases will be recognized on the consolidated balance sheet as ROU assets, lease liabilities current and lease liabilities non-current. Fixed rent payments are included in the calculation of the lease balances, while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. Research and Development Research and development costs are expensed as incurred and consist primarily of new product development. Research and development costs include salaries and benefits, consultants’ fees, process development costs and stock-based compensation, as well as fees paid to third parties that conduct certain research and development activities on the Company’s behalf. A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers. The Company records accrued expenses for estimated preclinical study and clinical trial expenses. Estimates are based on the services performed pursuant to contracts with research institutions, contract research organizations in connection with clinical studies, investigative sites in connection with clinical studies, vendors in connection with preclinical development activities, and contract manufacturing organizations in connection with the production of materials for clinical trials. Further, the Company accrues expenses related to clinical trials based on the level of subject enrollment and activity according to the related agreement. The Company monitors subject enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development. If the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ from estimates. To date, the Company has not experienced significant changes in its estimates of preclinical studies and clinical trial accruals. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the consolidated statements of operations. Stock-based Compensation Stock-based compensation for employee and non-employee awards is measured on the grant date based on the fair value of the award and recognized on a straight-line basis over the requisite service period. The fair value of stock options to purchase common stock are measured using the Black-Scholes option pricing model. The Company accounts for forfeitures as they occur. The fair value of stock options is determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Rate zero Grant Revenue Recognition The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. The Company recognizes funding received as grant revenue for the Company’s grant from the NIA, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these contracts are central to its ongoing operations. Revenue is recognized as the qualifying expenses related to the contracts are incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s consolidated balance sheets as accounts receivable. Funding received in advance of services rendered are recorded in the Company’s consolidated balance sheets as deferred grant revenue. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to recover or settle. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income for the period that includes the enactment date. The deferred tax assets are recognized to the extent the Company believes that these assets are more likely than not to be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company records uncertain tax positions using a two-step process. First, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position. Second, for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits on the interest expense line and other expense line, respectively, in the accompanying statements of operations. Accrued interest and penalties are included on the related liability lines in the consolidated balance sheets. Net L oss P er S hare Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period (and potential shares of common stock that are exercisable for little or no consideration). Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The pre-funded warrants to purchase common stock issued in connection with the Merger are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is non-substantive and is virtually assured. The pre-funded warrants are more fully described in Note 11. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: December 31, 2023 2022 Preferred Series A-1 - 1,960,600 Preferred Series A-2 - 335,711 Preferred Series B - 1,034,890 Warrants 598,457 43,618 Stock options 349,384 114,516 Total 947,841 3,489,335 Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. Recently Issued But Not Yet Adopted Accounting Pronouncements In January 2021, the FASB issued ASU No. 2021-01 “Reference Rate Reform (Topic 848): Scope” (“ASU 2021-01”), which was effective immediately and permits entities to elect certain optional expedients and exceptions when accounting for derivatives and certain hedging relationships affected by changes in interest rates and the transition. Additionally, ASU 2022-06 “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848” defers the sunset date of ASC 848 from December 31, 2022 to December 31, 2024. The new guidance is effective for fiscal years beginning after December 31, 2024. The Company does not currently believe that this transition from LIBOR will have a material impact on its financial statements. In November 2023, the FASB issued ASU No. 2023-07 "Segment Reporting - Improvements to Reportable Segment Disclosures" (“ASU 2023-07”), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The guidance is effective for the Company beginning in the year ended December 31, 2025, with early adoption permitted. The Company expects the new guidance will have an immaterial impact on its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): “Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU No. 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures. |
Note 4 - Merger
Note 4 - Merger | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Business Combination Disclosure [Text Block] | 4. Merger On August 16, 2023, the Company completed the Merger of EIP and Merger Sub as discussed in Note 1. For financial reporting purposes, EIP was determined to be the accounting acquirer based upon the terms of the Merger and other factors, including: (i) EIP securityholders immediately prior to the Merger owning approximately 76% of the Company immediately following the Merger, (ii) EIP appointing the majority (five of seven) of the Company’s Board immediately following the Merger and (iii) former EIP management holding the majority of key positions of management, including the Chief Executive Officer and Chairman of the Board positions, immediately following the Merger. The Merger was also accounted for as a reverse recapitalization under US GAAP because the primary assets of the Company immediately prior to the Merger were cash and cash equivalents. Accordingly, (i) for all periods prior to the Merger, EIP’s historical financial statements and results of operations replace and are deemed to be the Company’s financial statements and results of operations for such periods, (ii) the Merger was treated as the equivalent of EIP issuing shares of common stock to the holders of the Company's common stock immediately prior to the Merger as consideration to acquire the net assets of the Company, and (iii) the net assets of the Company as of immediately prior to the Merger were recorded at their acquisition-date fair value in the consolidated financial statements of EIP. Immediately after the Merger, there were approximately 5,674,277 shares of the Company’s common stock outstanding. The following table shows the net assets acquired in the Merger: August 16, 2023 Cash and cash equivalents $ 12,705,140 Prepaid and other assets 406,488 Accounts payable and accrued expenses (1,223,871 ) Total net assets assumed 11,887,757 Minus: Transaction costs (1,548,643 ) Total net assets assumed minus transaction costs $ 10,339,114 |
Note 5 - Significant Agreements
Note 5 - Significant Agreements and Contracts | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Collaborative Arrangement Disclosure [Text Block] | 4. Significant Agreements and Contracts Vertex Option and License Agreement In August 2012, the Company entered the Vertex Agreement, as amended, to acquire an exclusive license to develop and commercialize a drug candidate “VX-745” from Vertex. In August 2014, the Company exercised its option to acquire the license and paid an option fee of $100,000, which was expensed as incurred as a component of research and development expense. The Vertex Agreement granted the Company the exclusive worldwide use of VX-745 in the field of diagnosis, treatment and prevention of Alzheimer’s disease and related central nervous system disorders in humans. As part of the Vertex Agreement, the Company is obligated to make certain payments totaling up to approximately $117.0 million upon achievement of certain regulatory and sales milestones, and royalties on net sales of products on indications covered by the Vertex Agreement. The first expected milestone events concern filing of an NDA, with the FDA for marketing approval of neflamapimod, in the U.S., or a similar filing for a non-U.S. major market, as specified in the Vertex Agreement, and such royalties will be on a sliding scale of percentages of net sales in the low- to mid-teens, depending on the amount of net sales in the applicable years. The Company is also obligated to make a milestone payment to Vertex upon net sales reaching a certain specified amount in any 12-month period. The Vertex Agreement states that royalties will be reduced by 50% during any portion of the royalty term when there is no valid claim of an issued patent within specified patent rights covering the licensed product. The Company also has the right to deduct, on a country by country basis, from royalties otherwise payable to Vertex under the terms of the Vertex Agreement, 50% of all royalties, upfront fees, milestones and other payments paid by the Company or any of the Company’s affiliates or sublicensees to third parties under licenses that are necessary for the development, manufacture, sale or use of a licensed product, provided that in no event will the royalty payable to Vertex be reduced to less than 50% of the rates specified in the Vertex Agreement, subject to certain adjustments specified therein. The Company has made a total of $100,000 in payments to Vertex related to the Vertex Agreement. No payments were made during the three months ended March 31, 2024 and 2023. National Institute of Aging Grant In January 2023, the Company was awarded a $21.0 million grant from the NIA to support a Phase 2b study of neflamapimod in DLB. The grant monies are expected to be received over a period of three years including $6.7 million in 2023, $8.1 million in 2024 and $6.2 million in 2025. The total revenue recognized from the NIA Grant was $2.3 million and $1.4 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, aggregate total cash funding of $10.1 million has been received from the NIA Grant, resulting in approximately $10.9 million in funding remaining. The Company received access to the current year 2 (i.e., the year ending December 31, 2024) funding in the amount of $7.3 million in February 2024. This amount was 90% of the full year 2 amount provided for in the NIA Grant due to then-current NIA policy as a result of the U.S. government being funded at such time on the basis of a continuing resolution. Consolidated appropriations acts were signed into law in March 2024, and the Company expects to receive the remaining 10% of the year 2 amount by June 30, 2024. | 5. Significant Agreements and Contracts Vertex Option and License Agreement In August 2012, the Company entered the Vertex Agreement, as amended, to acquire an exclusive license to develop and commercialize a drug candidate “VX-745” from Vertex. In August 2014, the Company exercised its option to acquire the license and paid an option fee of $100,000, which was expensed as incurred as a component of research and development expense. The Vertex Agreement granted the Company the exclusive worldwide use of VX-745 in the field of diagnosis, treatment and prevention of Alzheimer’s disease and related central nervous system disorders in humans. As part of the Vertex Agreement, the Company is obligated to make certain payments totaling up to approximately $117.0 million upon achievement of certain regulatory and sales milestones, and royalties on net sales of products on indications covered by the Vertex Agreement. The first expected milestone events concern filing of an NDA, with the FDA for marketing approval of neflamapimod, in the U.S., or a similar filing for a non-U.S. major market, as specified in the Vertex Agreement, and such royalties will be on a sliding scale of percentages of net sales in the low- to mid-teens, depending on the amount of net sales in the applicable years. The Company is also obligated to make a milestone payment to Vertex upon net sales reaching a certain specified amount in any 12-month period. The Vertex Agreement states that royalties will be reduced by 50% during any portion of the royalty term when there is no valid claim of an issued patent within specified patent rights covering the licensed product. The Company also has the right to deduct, on a country by country basis, from royalties otherwise payable to Vertex under the terms of the Vertex Agreement, 50% of all royalties, upfront fees, milestones and other payments paid by the Company or any of the Company’s affiliates or sublicensees to third parties under licenses that are necessary for the development, manufacture, sale or use of a licensed product, provided that in no event will the royalty payable to Vertex be reduced to less than 50% of the rates specified in the Vertex Agreement, subject to certain adjustments specified therein. The Company has made a total of $100,000 in payments to Vertex related to the Vertex Agreement. No National Institute of Aging Grant In January 2023, the Company was awarded a $21.0 million grant from the NIA to support a Phase 2b study of neflamapimod in dementia with Lewy bodies. The grant monies are expected to be received over a period of three years including $6.7 million in 2023, $8.1 million in 2024 and $6.2 million in 2025. The total revenue recognized from the NIA Grant was $7.1 million year ended December 31, 2023. As of December 31, 2023, total cash funding of $6.2 million has been received from the NIA Grant, resulting in approximately $15.8 million in funding remaining. In addition, $0.9 million has been recorded as a receivable in the consolidated balance sheet at December 31, 2023, which was received subsequent to December 31, 2023. The Company received access to the current year 2 (i.e., the year ending December 31, 2024) funding in the amount of $7.3 million in February 2024. This amount was 90% of the full year 2 amount provided for in the NIA Grant due to current NIA policy as a result of the U.S. government currently being funded on the basis of a continuing resolution (the “Continuing Resolution”). |
Note 6 - Prepaid Expenses and O
Note 6 - Prepaid Expenses and Other Current Assets | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Prepaid Expenses and Other Current Assets [Text Block] | 5. Prepaid Expenses Prepaid expenses consisted of the following: March 31, 2024 December 31, 2023 Clinical expenses $ 952,574 $ 711,362 Insurance 265,944 436,859 Professional services 21,917 37,917 Dues and memberships 77,599 — Other 30,645 70,363 Total $ 1,348,679 $ 1,256,501 | 6. Prepaid Expenses Prepaid expenses consisted of the following: December 31, 2023 2022 Prepaid clinical expenses $ 711,362 $ - Insurance 436,859 9,937 Rent - 2,455 Prepaid professional services 37,917 - Other 70,363 51,735 Total $ 1,256,501 $ 64,127 |
Note 7 - Accrued Expenses and O
Note 7 - Accrued Expenses and Other Current Liabilities | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: March 31, 2024 December 31, 2023 Employee compensation costs $ 264,237 $ 1,026,054 Clinical development costs 253,883 389,045 Professional fees 772,074 309,062 State franchise and excise tax 54,856 120,456 Other 63,806 88,659 Total $ 1,408,856 $ 1,933,276 | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: December 31, 2023 2022 Employee compensation costs $ 1,026,054 $ 364,070 Clinical development costs 389,045 23,185 Professional fees 309,062 206,675 State franchise and excise tax 120,456 - Other 88,659 50,322 Total $ 1,933,276 $ 644,252 |
Note 8 - Line of Credit
Note 8 - Line of Credit | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 8. Line of Credit The Company established a line of credit with a lender during the year ended December 31, 2020 in the amount of $2.5 million with a variable interest rate of 1.75% over the 30-day LIBOR (7.22% and 6.08% at December 31, 2023 and December 31, 2022, respectively). The line is secured by the personal assets of the Company’s Chief Executive Officer and the former Chair of the Board. No no |
Note 9 - Convertible Notes
Note 9 - Convertible Notes | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Long-Term Debt [Text Block] | 7. Convertible Notes In December 2020, EIP issued the 2020 Notes to predominantly related party investors for proceeds of $5.1 million. In December 2021, EIP issued the 2021 Notes to predominantly related party investors for proceeds of $6.0 million. Upon completion of the Merger in August 2023, all EIP Convertible Notes outstanding were converted into common stock and in certain cases pre-funded warrants. As of March 31, 2024 and December 31, 2023, the Convertible Notes were no longer outstanding. Upon issuance, the Company elected the fair value option for the Convertible Notes in accordance with ASC 825, “Financial Instruments,” pursuant to which the entire instrument, including interest expense, is measured at fair value with the initial change in fair value deemed to be a capital contribution and any subsequent changes in fair value being recorded to other income (expense) on the consolidated statements of operations. During the three months ended March 31, 2024 there were no fair value adjustments recognized as the Convertible Notes were no longer outstanding. The fair value adjustment recognized in other income (expense) was $0.9 million for the three months ended March 31, 2023. | 9. Convertible Notes In December 2020, EIP issued the 2020 Notes to predominantly related party investors for proceeds of $5.1 million. In December 2021, EIP issued the 2021 Notes to predominantly related party investors for proceeds of $6.0 million. Upon issuance, the Company elected the fair value option for the Convertible Notes in accordance with ASC 825, “Financial Instruments,” pursuant to which the entire instrument, including interest expense, is measured at fair value with the initial change in fair value deemed to be a capital contribution and any subsequent changes in fair value being recorded to other income (expense) on the consolidated statement of operations. The fair value adjustments recognized in other income (expense) were $5.4million and $(2.4)million for the years ended December 31, 2023 and 2022, respectively. In April 2022, the Company entered into the 2022 Notes Amendment with the noteholders for the 2020 Notes (the “Amendment”). In accordance with the Amendment, the maturity of the 2020 Notes was extended from June 2022 to December 2023, the interest rate was modified so interest accrued at 5% through the original maturity of June 2022 and at 0% thereafter, the conversion discount was increased from 20% to 30%, and a conversion price limit of $3.00 was established, as discussed further below. Expenses associated with the amendment were de minimis The Company concluded the 2022 Notes Amendment qualified as a troubled debt restructuring, in accordance with FASB ASC 470, Debt, as the noteholders for the 2020 Notes, for economic reasons related to the Company’s financial difficulties, granted concessions to the Company. The Company concluded no gain or loss, and no adjustment to, or reclassification of, the carrying value of the 2020 Notes were considered necessary as a result of the 2022 Notes Amendment. In addition, the Company concluded there was no other financial statement impact as a result of the 2022 Notes Amendment, as any prospective change would be related to interest and, as a result of the amendment, the interest rate decreased to 0% following the original maturity of June 2022. In June 2023, EIP entered into the 2023 Notes Amendment which amended the conversion price of the Convertible Notes to $1.47 per share of EIP Common Stock upon effectiveness of the Merger with the Diffusion or a 30% conversion discount upon the occurrence of any other reverse merger. Further, the 2023 Notes Amendment provided that if the Merger with the Company resulted in a holder of these notes beneficially owning more than 9.99% of the outstanding voting stock of the Company, then, the holder of these notes shall be granted pre-funded warrants in lieu of the Company’s common stock for the conversion of any principal and accrued but unpaid interest in excess of such threshold. The exercise price of one share of the Company’s common stock under this pre-funded warrant is equal to $0.001 (Note 11). The 2023 Notes Amendment qualified as a modification in accordance with FASB ASC 470 Debt As a result of the Merger (Note 4), pursuant to the terms thereof, the Convertible Notes converted into shares of EIP Common Stock which were subsequently converted into the right to exchange such shares for 897,272 shares of the Company’s common stock and, in certain cases, pre-funded warrants to purchase the Company’s common stock. Accordingly, the Convertible Notes were adjusted to fair value prior to conversion by multiplying the trading price of the Company’s common stock at the date of the Effective Time and the 795,905 common shares and 101,367 pre-funded warrants issued upon conversion. The Company recorded a gain on the fair value adjustment of the Convertible Notes of $5.4 million for year ended December 31, 2023 and recorded $7.0 million to additional paid in capital for the issuance of common stock upon settlement of the Convertible Notes. |
Note 10 - Commitments and Conti
Note 10 - Commitments and Contingencies | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Commitments and Contingencies Disclosure [Text Block] | 8. Commitments and Contingencies Operating Leases The Company has a short-term lease for office space in Boston, Massachusetts and previously had a short-term agreement to utilize membership-based co-working space in Charlottesville, Virginia, the latter of which was terminated during the first quarter of 2024. Lease expense was approximately $9,492 and $7,666 for the three months ended March 31, 2024 and 2023, respectively. The Company is obligated to make de minimis lease payments under the Boston lease as of March 31, 2024 through the remaining lease term of August 31, 2024. Research and Development Arrangements In the course of normal business operations, the Company would enter into agreements with universities and CROs to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to CROs represented a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash. Defined Contribution Retirement Plan The Company has established its 401(k) Plan, which covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k) Plan up to 90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of de minimis amounts for the three months ended March 31, 2024 and 2023. Legal Proceedings On August 7, 2014, a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the former Chief Executive Officer of the Company’s legal predecessor under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case No. BC553996). The complaint asserts various causes of action, including, among other things, promissory fraud, negligent misrepresentation, breach of contract, breach of employment agreement, breach of the covenant of good faith and fair dealing, violations of the California Labor Code and common counts. The plaintiff is seeking, among other things, compensatory damages in an undetermined amount, punitive damages, accrued interest and an award of attorneys’ fees and costs. On December 30, 2014, the Company filed a petition to compel arbitration and a motion to stay the action. On April 1, 2015, the plaintiff filed a petition in opposition to the Company’s petition to compel arbitration and a motion to stay the action. After a related hearing on April 14, 2015, the court granted the Company’s petition to compel arbitration and a motion to stay the action. On January 8, 2016, the plaintiff filed an arbitration demand with the American Arbitration Association. On November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the court found sufficient grounds not to dismiss the case and an arbitration hearing was scheduled, originally for November 2020 but later postponed due to the COVID-19 pandemic and related restrictions on gatherings in the State of California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration in connection with the plaintiff filing for personal bankruptcy protection. On October 22, 2021, following a determination by the bankruptcy trustee not to pursue the claims and release them back to the plaintiff, the parties entered into a stipulation to abandon arbitration and return the matter to state court. A case management conference was held on February 23, 2022 at which an initial trial date of May 24, 2023 was set, and the parties have agreed to stipulate to mediation in advance of the trial. On October 20, 2022, the parties filed a joint stipulation to continue the trial and certain deadlines related to the mediation in order to allow plaintiff’s counsel to continue to seek treatment for an ongoing medical issue. On November 1, 2022, based on the parties joint stipulation, the court entered an order continuing the trial date to October 25, 2023, on October 6, 2023, the court entered an order further continuing the trial date to April 24, 2024, and on March 3, 2024, based on an additional joint stipulation of the parties, the court entered an order continuing the trial date to October 23, 2024. The Company believes that is has meritorious defenses to the claims alleged in this matter and is defending itself vigorously. However, at this stage, the Company is unable to predict the outcome and possible loss or range of loss, if any, associated with its resolution or any potential effect the matter may have on the Company’s financial position. Depending on the outcome or resolution of this matter, it could have a material effect on the Company’s financial position, results of operations and cash flows. | 10. Commitments and Contingencies Operating Leases The Company has a short-term agreement to utilize membership-based co-working space in Charlottesville, Virginia and a short-term lease for office space in Boston, Massachusetts. Rent expense was approximately $34,000 and $45,000 for the years ended December 31, 2023 and 2022, respectively. Research and Development Arrangements In the course of normal business operations, the Company would enter into agreements with universities and CROs to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to CROs represented a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash. Defined Contribution Retirement Plan The Company has established its 401(k) Plan, which covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k) Plan up to 90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of de minimis Legal Proceedings On August 7, 2014, a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the former Chief Executive Officer of the Company’s legal predecessor under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case No. BC553996). The complaint asserts various causes of action, including, among other things, promissory fraud, negligent misrepresentation, breach of contract, breach of employment agreement, breach of the covenant of good faith and fair dealing, violations of the California Labor Code and common counts. The plaintiff is seeking, among other things, compensatory damages in an undetermined amount, punitive damages, accrued interest and an award of attorneys’ fees and costs. On December 30, 2014, the Company filed a petition to compel arbitration and a motion to stay the action. On April 1, 2015, the plaintiff filed a petition in opposition to the Company’s petition to compel arbitration and a motion to stay the action. After a related hearing on April 14, 2015, the court granted the Company’s petition to compel arbitration and a motion to stay the action. On January 8, 2016, the plaintiff filed an arbitration demand with the American Arbitration Association. On November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the court found sufficient grounds not to dismiss the case and an arbitration hearing was scheduled, originally for November 2020 but later postponed due to the COVID-19 pandemic and related restrictions on gatherings in the State of California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration in connection with the plaintiff filing for personal bankruptcy protection. On October 22, 2021, following a determination by the bankruptcy trustee not to pursue the claims and release them back to the plaintiff, the parties entered into a stipulation to abandon arbitration and return the matter to state court. A case management conference was held on February 23, 2022 at which an initial trial date of May 24, 2023 was set, and the parties have agreed to stipulate to mediation in advance of the trial. On October 20, 2022, the parties filed a joint stipulation to continue the trial and certain deadlines related to the mediation in order to allow plaintiff’s counsel to continue to seek treatment for an ongoing medical issue. On November 1, 2022, based on the parties joint stipulation, the court entered an order continuing the trial date to October 25, 2023, on October 6, 2023, the court entered an order further continuing the trial date to April 24, 2024 , and on March 3, 2024, based on an additional joint stipulation of the parties, the court entered an order continuing the trial date to October 23, 2024. The Company believes that is has meritorious defenses to the claims alleged in this matter and is defending itself vigorously. However, at this stage, the Company is unable to predict the outcome and possible loss or range of loss, if any, associated with its resolution or any potential effect the matter may have on the Company’s financial position. Depending on the outcome or resolution of this matter, it could have a material effect on the Company’s financial position, results of operations and cash flows. |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity (Deficit) and Common Stock Warrants | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Equity [Text Block] | 9. Stockholders' Equity and Common Stock Warrants In July 2023, EIP sold 63,422 shares of common stock at $12.78 per share (as adjusted for the Exchange Ratio) for net proceeds of approximately $0.8 million. Warrants As of March 31, 2024, the Company had the following warrants outstanding to acquire shares of its common stock: Outstanding Range of exercise price per share Expiration dates Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $ 19.81 4/1/2028 102,462 On February 26, 2024, following the effectiveness of an amendment eliminating certain beneficial ownership limitations set forth therein, the Company’s previously outstanding 495,995 pre-funded warrants, which were issued in connection with the closing of the Merger, were exercised in full by the holder thereof pursuant to a cashless exercise provision of the pre-funded warrants. Upon exercise, 36 shares of common stock were withheld in lieu of a cash payment of the exercise price and the holder was issued 495,959 shares of common stock. The Company is party to the 2022 Sales Agreement with BTIG. The 2022 Sales Agreement is an "at-the-market" sales agreement pursuant to which the Company may, from time to time and through BTIG as the Company’s agent, sell up to an aggregate of $20.0 million in shares of common stock by any permissible method deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. As of the date of this Quarterly Report, however, the Company has not sold any shares pursuant to the 2022 Sales Agreement. | 11. Stockholders Equity (Deficit) and Common Stock Warrants On August 16, 2023 in connection with the closing of the Merger, the following is reflected on the consolidated financial statements of convertible preferred stock and stockholders’ equity (deficit) for the year ended December 31, 2023: (i) the issuance of 795,905 shares of common stock and 101,367 pre-funded warrants upon the settlement of the Convertible Notes, (ii) the conversion of 3,331,201 shares of convertible preferred stock into 2,936,566 shares of common stock and 394,628 prefunded warrants, and (iii) the issuance of 1,360,244 shares of common stock to Diffusion stockholders as consideration for the Merger. In July 2023, EIP sold 63,422 shares of common stock at $12.78 per share (as adjusted for the Exchange Ratio) for net proceeds of approximately $0.8 million. Warrants As of December 31, 2023, the Company had the following warrants outstanding to acquire shares of its common stock: Warrants Exercise Outstanding Price Expiration Date Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $19.81 April 2028 Pre-funded warrants issued related to closing of reverse recapitalization 495,995 $0.001 None 598,457 Upon completion of the Merger, the Convertible Notes and outstanding shares of EIP preferred stock converted into shares of EIP Common Stock which were subsequently converted into the right to exchange such shares for shares of the Company’s common stock or, in certain cases, pre-funded warrants to purchase the Company’s common stock. All of the warrants are equity-classified because they are indexed to the Company’s own shares and meet the criteria to be classified as an equity instrument. The Company is party to the 2022 Sales Agreement with BTIG. The 2022 Sales Agreement is an "at-the-market" sales agreement pursuant to which the Company may, from time to time and through BTIG as the Company’s agent, sell up to an aggregate of $20.0 million in shares of common stock by any permissible method deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. As of the date of this Annual Report, however, the Company has not sold any shares pursuant to the 2022 Sales Agreement. |
Note 12 - Stock-based Compensat
Note 12 - Stock-based Compensation | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Share-Based Payment Arrangement [Text Block] | 10. Stock-Based Compensation Stock 2015 Equity Plan The 2015 Equity Plan provides for increases to the number of shares reserved for issuance thereunder each January 1 equal to 4.0% of the total shares of the Company’s common stock outstanding as of the immediately preceding December 31, unless a lesser amount is stipulated by the Compensation Committee of the Board. As of March 31, 2024, there were 37,678 shares available for future issuance under the 2015 Equity Plan. 2018 Employee, Director and Consultant Equity Incentive Plan On March 28, 2018, EIP adopted the 2018 Plan, which was assumed by the Company pursuant to and in accordance with the terms of the Merger Agreement. Under the 2018 Plan, the Company may issue incentive stock options, non-qualified stock options, stock grants, and other stock-based awards to employees, directors, and consultants, as specified in the 2018 Plan and subject to applicable SEC and Nasdaq rules and regulations. The Board has the authority to determine to whom options or stock will be granted, the number of shares, the term, and the exercise price. Options granted under the 2018 Plan have a term of up to ten four-year one-year no The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations: Three Months Ended March 31, 2024 2023 Research and development $ 63,797 $ 40,126 General and administrative 154,418 31,114 Total stock-based compensation expense $ 218,215 $ 71,240 The following table summarizes the activity related to all stock option grants for the three months ended March 31, 2024: Number of Options Weighted average exercise price per share Weighted average remaining contractual life (in years) Aggregate intrinsic value Balance at January 1, 2024 349,374 $ 51.15 Granted 169,934 9.52 Expired (51 ) 28,897.06 Outstanding at March 31, 2024 519,257 $ 34.69 8.5 — Exercisable at March 31, 2024 192,004 $ 79.03 6.7 — The Black-Scholes option pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions: Three Months Ended March 31, 2024 Expected term (in years) 5.74 - 5.76 Risk-free interest rate 4.06 - 4.14 % Expected volatility 79.13 - 79.31 % Dividend yield — There were no At March 31, 2024, there was $1.7 million of unrecognized compensation expense that will be recognized over a weighted-average period of 2.3 years. During the three months ended March 31, 2024 the Company granted 39,721 options in lieu of 2023 executive bonus compensation. | 12. Stock-Based Compensation 2015 Equity Plan The 2015 Equity Plan provides for increases to the number of shares reserved for issuance thereunder each January 1 equal to 4.0% of the total shares of the Company’s common stock outstanding as of the immediately preceding December 31, unless a lesser amount is stipulated by the Compensation Committee of the Company’s Board of Directors. As of December 31, 2023, there were 12,580 shares available for future issuance under the 2015 Equity Plan. On January 1, 2024, the number of shares available for future issuance under the 2015 Equity Plan increased by 226,981. 2018 Employee, Director and Consultant Equity Incentive Plan On March 28, 2018, EIP adopted the 2018 Plan, which was assumed by the Company pursuant to and in accordance with the terms of the Merger Agreement. Under the 2018 Plan, the Company may issue incentive stock options, non-qualified stock options, stock grants, and other stock-based awards to employees, directors, and consultants, as specified in the 2018 Plan and subject to applicable SEC and Nasdaq rules and regulations. The Board of Directors has the authority to determine to whom options or stock will be granted, the number of shares, the term, and the exercise price. Options granted under the 2018 Plan have a term of up to ten four-year one-year no The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations: Year Ended December 31, 2023 2022 Research and development $ 143,685 $ 174,710 General and administrative 263,947 159,125 Total stock-based compensation expense $ 407,632 $ 333,835 The following table summarizes the activity related to all stock option grants for the year ended December 31, 2023: Number of Options Weighted average exercise price per share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Balance at January 1, 2023 114,516 $ 25.98 6.72 Options assumed in the merger 52,574 $ 313.67 Granted 198,600 $ 5.95 Cancelled (15,957 ) $ 180.80 Exercised (359 ) $ 5.33 Outstanding at December 31, 2023 349,374 $ 51.15 8.12 $ 358,340 Exercisable at December 31, 2023 157,301 $ 103.67 6.35 $ 39,820 The Black-Scholes option-pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions: December 31, 2023 2022 Expected term (in years) 5.75 6.00 Risk-free interest rate 3.9% - 4.5% 1.9 % Expected volatility 81.7% - 83.3% 80.3 % Dividend yield 0.0% 0.0 % During the year ended December 31, 2023, 359 shares underlying options were exercised, of which 193 were withheld as consideration for the exercise price of such shares pursuant to the cashless exercise provision of the related option award agreement. No Contributed Capital in lieu of Executive Compensation In 2022, the former Chair of the Board and the Chief Executive Officer offered to forego, without repayment, certain compensation to ensure the Company had enough resources to maintain operations until the financial funding was completed. The amount of $0.1 million for the year ended December 31, 2022, which is recorded as contributed capital in lieu of executive compensation in additional paid-in capital, will not be paid in cash, debt or equity in the future. No |
Note 13 - Income Taxes
Note 13 - Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 13. Income Taxes A reconciliation of income tax benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements as of December 31, 2023 and 2022: Rate reconciliation: 2023 2022 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit 6.3 % 8.0 % Change in convertible debt 52.8 % -8.6 % Research & Development credit 17.1 % 1.2 % Change in valuation allowance -95.9 % -15.8 % Share-based compensation -1.0 % 0.0 % Other -0.3 % -5.8 % Total provision 0.0 % 0.0 % Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates in effect for years in which differences are expected to reverse. Significant components of the Company's deferred tax assets for federal income taxes as of December 31, 2023 and December 31, 2022 consisted of the following: 2023 2022 Deferred tax assets: Net operating loss $ 10,495,881 $ 10,977,455 Research and development credits 708,443 354,283 Capitalized research expenditures 2,271,853 259,749 Stock-based compensation 567,473 514,654 Reserves and accruals - 105,399 Intangibles 223,548 262,872 Gross deferred tax assets 14,267,198 12,474,412 Less valuation allowance (14,100,543 ) (12,474,412 ) Total deferred tax assets 166,655 - Deferred tax liabilities: Prepaids $ (166,655 ) $ - Gross deferred tax liabilities (166,655 ) - Deferred tax assets, net $ - $ - The Company does not In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred assets will be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Evaluating the need for a valuation allowance for deferred tax assets often requires judgment and analysis of all the positive and negative evidence available, including cumulative losses in recent years and projected future taxable income, to determine whether all or some portion of the deferred tax assets will not be realized. As of December 31, 2023, the Company has utilized a full valuation allowance to offset the net deferred tax assets as the Company believes it is not more likely than not that the net deferred tax assets will be fully realizable. The valuation allowance increased by $1.6 million during the year ended December 31, 2023. As of December 31, 2023, the Company had NOL carryforwards of approximately $38.9 million and $37.0 million for federal and state tax purposes, respectively. Federal NOL carryforwards will not expire and state NOL carryforwards will begin to expire in 2038, if not utilized. The TCJA enacted on December 22, 2017 limits a taxpayer’s ability to utilize NOL deduction in a year to 80% taxable income for federal net operating losses arising in tax years beginning after 2017, however, federal NOLs post 2017, are now indefinite lived. As of December 31, 2023, the Company also had federal and state research credit carryforwards of $0.6 million and $0.1 million, respectively. The federal and state research credits will begin to expire in 2038 and 2034, respectively. Generally, utilization of the NOL carryforwards and credits may be subject to an annual limitation due to the ownership change limitations provided by Section 382 of the Code, which provides for limitations on NOL carryforwards and certain built-in losses following ownership changes, and Section 383 of the Code, which provides for special limitations on certain excess credits, as well as similar state provisions. Accordingly, the Company’s ability to utilize NOL carryforwards may be limited as the result of such an “ownership change.” A formal Section 382 study was performed through December 31, 2023 which resulted concluded there have been no historical section 382 ownership changes, thus the NOL carryforwards are not be subject to an annual limitation. With respect to Diffusion, the Company deems the historical Diffusion tax attributes (NOLs/Credits) are unusable due to the IRC Section 382 limitation. ASC 740-10-25 states that a “write off might be appropriate if there is only a remote likelihood that the entity will utilize the carryforward (i.e. NOL), it is acceptable for the entity to write off the deferred tax assets against the valuation allowance, thereby eliminating the need to disclose the gross amounts. As such, the Company has written off these attributes. The Company files federal and state income tax returns in jurisdictions with varying statutes of limitations. Due to its NOL carryforwards, the Company’s income tax returns generally remain subject to examination by federal and state tax authorities. The Company is currently not subject to any income tax audits by federal or state taxing authorities. The statute of limitations for tax liabilities for all years remains open. The Company uses the “more likely than not” criterion for recognizing the income tax benefit of uncertain income tax positions and establishing measurement criteria for income tax benefits. The Company has evaluated the impact of these positions and believes that its income tax filing positions and deductions will be sustained upon examination. Accordingly, no reserves for uncertain income tax positions or related accruals for interest and penalties have been recorded as of December 31, 2023 and 2022. |
Note 14 - Subsequent Events
Note 14 - Subsequent Events | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Subsequent Events [Text Block] | 12. Subsequent Events 2024 Private Placement On April 1, 2024, pursuant to and in accordance with the terms of a securities purchase agreement with certain purchasers named therein, the Company completed the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one | 14. Subsequent Events 2024 Private Placement On March 28, 2024, the Company entered into a securities purchase agreement with certain purchasers named therein related to the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one Pre-Funded Warrant Amendment and Exercise On February 26, 2024, following the effectiveness of an amendment eliminating certain beneficial ownership limitations set forth therein, the Company’s previously outstanding pre-funded warrant was exercised in full by the holder thereof pursuant to the cashless exercise provision in Section 2(c) of the pre-funded warrant. Upon exercise, 36 shares were withheld in lieu of a cash payment of the exercise price and the holder was issued 495,959 shares of common stock. |
Note 1 - The Company and Desc_2
Note 1 - The Company and Description of Business (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Nature of Operations [Text Block] | 1. The Company and Description of Business The Company is a corporation organized under the laws of the state of Delaware and headquartered in Boston, Massachusetts. The Company is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently focused on the development of its lead drug candidate, neflamapimod, an investigational, orally administered, small molecule brain penetrant that inhibits p38α in the neurons (nerve cells) within the brains of people with neurodegenerative diseases. Neflamapimod has the potential to treat and improve synaptic dysfunction, the reversible aspect of the underlying disease processes in DLB and certain other major neurological disorders, and is currently being evaluated in the Company's ongoing RewinD-LB Trial, a Phase 2b study in patients with DLB funded by a $21.0 million grant from the NIA. | 1. The Company and Description of Business The Company is a corporation organized under the laws of the state of Delaware and headquartered in Boston, Massachusetts. The Company is a biotechnology company developing treatments for age-related neurologic disorders. The Company is currently developing its product candidate neflamapimod, an investigational orally administered small molecule brain penetrant that inhibits p38α. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in DLB and certain other major neurological disorders and is currently being evaluated in a Phase 2b study in patients with DLB. On March 30, 2023, Diffusion Pharmaceuticals Inc. (“Diffusion”), Dawn Merger Inc., a wholly-owned subsidiary of Diffusion (“Merger Sub”) and EIP Pharma, Inc. (“EIP”) entered into the Merger Agreement (Note 4), pursuant to which, at the Effective Time, Merger Sub merged with and into EIP, with EIP surviving the Merger as a wholly-owned subsidiary of the Company. In connection with the Merger, on August 16, 2023, the Company changed its corporate name from “Diffusion Pharmaceuticals Inc.” to “CervoMed Inc.” On August 16, 2023, Diffusion approved a one-for-1.5 reverse stock split which was consummated for historical Diffusion shares in connection with the Merger. In addition, upon consummation of the Merger, all historical EIP shares were adjusted using an exchange ratio of 0.1151. All information in the accompanying consolidated financial statements and notes thereto regarding share amounts of common stock, price per share of common stock and the conversion factor for preferred stock into common stock has been adjusted to reflect the application of the reverse stock split and the exchange ratio on a retroactive basis. All shares of EIP common stock outstanding immediately prior to the Effective Time, after giving effect to the conversion of EIP preferred stock and the Convertible Notes (and excluding shares held as treasury stock by EIP, shares held or owned by the Company and any dissenting shares), converted into the right to receive, in the aggregate, 4,314,033 shares of the Company’s common stock and prefunded warrants to purchase 495,995 shares of common stock, based on an exchange ratio of 0.1151. |
Note 2 - Liquidity and Capita_2
Note 2 - Liquidity and Capital Resources (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Liquidity Disclosure [Text Block] | 2. Liquidity and Capital Resources The Company has generated negative cash flows from operations and, as of March 31, 2024, had an accumulated deficit of approximately $57.0 million. Based on its current operating plan, the Company believes its existing cash and cash equivalents on hand as of March 31, 2024, along with the remaining funds to be received from the NIA grant and the upfront proceeds received from the 2024 Private Placement on April 1, 2024, will enable the Company to fund its operating expenses and capital expenditure requirements for at least twelve months from the issuance of these unaudited condensed consolidated interim financial statements. The Company has based this estimate on assumptions that may prove to be wrong, and it could utilize its available capital resources sooner than it currently expects. The Company will continue to require additional financing to advance its current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. The Company intends to continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms, or at all. If the Company does raise additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the Company's stockholders’ rights. If the Company raises additional capital through a debt financing, it may be subject to covenants limiting or restricting the Company's ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on the Company's financial condition and on its ability to pursue its business plans and strategies. If the Company is unable to raise sufficient capital when needed, it will need to delay, reduce or terminate planned activities to reduce costs, including development or commercialization activities for neflamapimod. The Company might also be required to seek funds through arrangements with third parties that require it to relinquish certain of its rights to neflamapimod or otherwise agree to terms unfavorable to the Company. On April 1, 2024, pursuant to and in accordance with the terms of a securities purchase agreement with certain purchasers named therein, the Company completed the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one Operations of the Company are subject to certain additional risks and uncertainties as well, and any one or more of these factors could materially affect the Company’s financial condition, future operations and liquidity needs. Many of these risks and uncertainties are outside of the Company’s control, including internal and external factors that may affect the success or failure of the Company’s research and development efforts, the length of time and cost of developing and commercializing the Company’s current or future product candidates, whether and when any such product candidates become approved drugs, and how significant a drug’s market share will be, if approved, among others. | 2. Liquidity and Capital Resources The Company has generated negative cash flows from operations and, as of December 31, 2023, had an accumulated deficit of approximately $54.4 million. In January 2023, the Company was awarded a $21.0 million grant from the NIA to support its ongoing RewinD-LB Trial, which is expected to be received over a three-year The Company will continue to require additional financing to advance current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. The Company expects that its existing cash and cash equivalents as of December 31, 2023, along with the remaining funds expected to be received from the NIA Grant, will not be sufficient to enable it to fund its operating expenses and capital expenditure requirements, and continue as a going concern for at least twelve months following the issuance of these consolidated financial statements. The Company will continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, grants, licenses and other similar arrangements. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Without additional funding, the Company would be forced to delay, reduce or eliminate its research and development programs. Accordingly, since the financing discussed below has not been completed, substantial doubt exists about the Company’s ability to continue as a going concern within one year after the date these financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. On March 28, 2024, the Company entered into a securities purchase agreement with certain purchasers named therein related to the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one |
Note 3 - Summary of Significa_2
Note 3 - Summary of Significant Accounting Policies (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | 3. Summary of Significant Accounting Policies Basis of presentation The unaudited condensed consolidated interim financial statements have been prepared in conformity with US GAAP as defined by the FASB. Unaudited condensed consolidated interim financial statements The accompanying unaudited condensed consolidated interim financial statements have been prepared by the Company in accordance with US GAAP for interim information and pursuant to the rules and regulations of the SEC. Accordingly, certain information and footnote disclosures normally included in unaudited condensed consolidated interim financial statements prepared in accordance with US GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and related notes for the year ended December 31, 2023, filed as part of the Company's Annual Report on Form 10-K. The unaudited condensed consolidated interim financial statements have been prepared on the same basis as the audited consolidated financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods. The results of operations for any interim period are not necessarily indicative of the results to be expected for the full fiscal year. Consolidation The unaudited condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of estimates The preparation of unaudited condensed consolidated interim financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, grant revenue, expenses, and related disclosures. On an ongoing basis, the Company’s management evaluates its estimates, including estimates related to money market accounts, clinical trial accruals, stock-based compensation expense, grant revenue, convertible notes, and expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ significantly from those estimates or assumptions. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains its cash and cash equivalent balances with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance-sheet risk of loss. The Company has not experienced any losses in such accounts. Cash and Cash Equivalents The Company considers all highly-liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents, which consist of amounts invested in money market funds, are stated at fair value. There are no unrealized gains or losses on the money market funds for the period ended March 31, 2024. Equity issuance costs The Company capitalizes costs directly associated with equity financings as deferred offering costs on its unaudited condensed consolidated balance sheet. These costs remain capitalized until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. As of March 31, 2024, there were $0.2 million of deferred offering costs related to the 2024 Private Placement. Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash, accounts payable, previously outstanding convertible notes and accrued liabilities. The Company’s cash, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company determined the fair value of its previously outstanding convertible notes as described in Note 7. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The following table presents the Company’s assets that are measured at fair value on a recurring basis: March 31, 2024 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 3,729,954 $ — $ — Total assets measured at fair value $ 3,729,954 $ — $ — December 31, 2023 Assets Cash equivalents (money market accounts) $ 7,792,846 $ — $ — Total assets measured at fair value $ 7,792,846 $ — $ — The following table presents a roll-forward of the fair value of the Convertible Notes (Note 7) for which fair value is determined by Level 3 inputs: Three Months Ended March 31, 2023 Beginning balance $ 12,414,000 Fair value adjustment (858,000 ) Ending balance $ 11,556,000 Valuation techniques used to measure fair value maximize the use of relevant observable inputs and minimize the use of unobservable inputs (Note 7). The Convertible Notes are classified within Level 3 of the fair value hierarchy because the fair value measurement is based, in part, on significant inputs not observed in the market. There were no transfers among Level 1, Level 2 or Level 3 categories in the three months ended March 31, 2024 or March 31, 2023. The fair value of the 2020 Notes and the 2021 Notes, and collectively the Convertible Notes (Note 7) as of March 31, 2023 were estimated as the combination of a zero-coupon bond and a call option. The combined values for each of the 2020 Notes and the 2021 Notes as of March 31, 2023 were then weighted by the probability of completing a financing or reverse merger. This approach resulted in the classification of the 2020 Notes and the 2021 Notes as of March 31, 2023 as Level 3 of the fair value hierarchy. The assumptions utilized to value the 2020 Notes and the 2021 Notes as of March 31, 2023 were an estimated term of 0.69 years, volatility of 75.0% and a market yield of 55.3%. The measurement of fair value incorporates expected future cash flows associated with interest payments; as such, there was no separate accrual for interest accrued but not yet paid. Leases In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which establishes an ROU model. That requires a lessee to recognize an ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and expense recognition in the statement of operations as well as the reduction of the ROU asset. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply (i) the practical expedient, which allows us to not separate lease and non-lease components, for new leases and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has elected to combine lease and non-lease components as a single component. Operating leases will be recognized on the unaudited interim condensed consolidated balance sheet as ROU assets, lease liabilities, current and lease liabilities, non-current. Fixed rent payments are included in the calculation of the lease balances, while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. Research and Development Research and development costs are expensed as incurred and consist primarily of new product development. Research and development costs include salaries and benefits, consultants’ fees, process development costs and stock-based compensation, as well as fees paid to third parties that conduct certain research and development activities on the Company’s behalf. A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers. The Company records accrued expenses for estimated preclinical study and clinical trial expenses. Estimates are based on the services performed pursuant to contracts with research institutions, contract research organizations in connection with clinical studies, investigative sites in connection with clinical studies, vendors in connection with preclinical development activities, and contract manufacturing organizations in connection with the production of materials for clinical trials. Further, the Company accrues expenses related to clinical trials based on the level of subject enrollment and activity according to the related agreement. The Company monitors subject enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development. If the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ from estimates. To date, the Company has not experienced significant changes in its estimates of preclinical studies and clinical trial accruals. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the unaudited interim condensed consolidated statement of operations. Stock-based Compensation Stock-based compensation for employee and non-employee awards is measured on the grant date based on the fair value of the award and recognized on a straight-line basis over the requisite service period. The fair value of stock options to purchase common stock are measured using the Black-Scholes option pricing model. The Company accounts for forfeitures as they occur. The fair value of stock options is determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Rate zero Revenue Recognition The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. The Company recognizes funding received as grant revenue for the NIA Grant, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these contracts are central to its ongoing operations. Revenue is recognized as the qualifying expenses related to the contracts are incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s unaudited interim condensed consolidated balance sheets as accounts receivable. Amounts received in advance of services rendered are recorded as deferred grant revenue on the Company's unaudited interim condensed consolidated balance sheet. The related costs incurred by the Company are included in research and development expense in the Company’s unaudited interim condensed consolidated statements of operations. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the unaudited condensed consolidated interim financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to recover or settle. The effect of a change in tax rates on deferred tax assets and liabilities is recognized on the statement of operations for the period that includes the enactment date. The deferred tax assets are recognized to the extent the Company believes that these assets are more likely than not to be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company records uncertain tax positions using a two-step process. First, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position. Second, for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits on the interest expense line and other expense line, respectively, in the accompanying statements of operations. Accrued interest and penalties are included on the related liability lines in the unaudited interim condensed consolidated balance sheet. Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period (and potential shares of common stock that are exercisable for little or no consideration). Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: March 31, 2024 2023 Convertible preferred stock — 3,331,201 Common stock warrants 102,462 43,621 Stock options 519,257 114,525 621,719 3,489,347 Segments The Company has one Recently Issued But Not Yet Adopted Accounting Pronouncements In January 2021, the FASB issued ASU No. 2021-01 “Reference Rate Reform (Topic 848): Scope” (“ASU 2021-01”), which was effective immediately and permits entities to elect certain optional expedients and exceptions when accounting for derivatives and certain hedging relationships affected by changes in interest rates and the transition. Additionally, ASU 2022-06 “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848” defers the sunset date of ASC 848 from December 31, 2022 to December 31, 2024. The new guidance is effective for fiscal years beginning after December 31, 2024. The Company does not currently believe that this transition from LIBOR will have a material impact on its financial statements. In November 2023, the FASB issued ASU No. 2023-07 "Segment Reporting - Improvements to Reportable Segment Disclosures" (“ASU 2023-07”), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The guidance is effective for all public companies for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company expects the new guidance will have an immaterial impact on its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): “Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU No. 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures. | 3. Summary of Significant Accounting Policies Basis of presentation The consolidated financial statements have been prepared in conformity with US GAAP as defined by the FASB. Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, grant revenue, expenses, and related disclosures. On an ongoing basis, the Company’s management evaluates its estimates, including estimates related to money market accounts, clinical trial accruals, stock-based compensation expense, grant revenue, Convertible Notes, and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ significantly from those estimates or assumptions. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains its cash and cash equivalent balances with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance-sheet risk of loss. The Company has not experienced any losses in such accounts. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents, which consist of amounts invested in money market funds, are stated at fair value. There are no unrealized gains or losses on the money market funds for the years ended December 31, 2023 and 2022. Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash and cash equivalents, accounts payable, previously outstanding Convertible Notes and accrued liabilities. The Company’s cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company determined the fair value of the Convertible Notes as described in Note 9. In connection with the consummation of the Merger (Note 4) on August 16, 2023, the Convertible Notes were converted into EIP Common Stock which was subsequently converted into the right to exchange such shares of EIP Common Stock for shares of the Company’s common stock. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 Level 2 Level 3 The following table presents the Company’s assets that are measured at fair value on a recurring basis: December 31, 2023 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 7,792,846 $ - $ - Total assets measured at fair value $ 7,792,846 $ - $ - December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 4,093,579 $ - $ - Total assets measured at fair value $ 4,093,579 $ - $ - Liabilities Convertible Notes $ - $ - $ 12,414,000 Total liabilities measured at fair value $ - $ - $ 12,414,000 The following table presents a roll-forward of the fair value of the Convertible Notes (Note 9) for which fair value is determined by Level 3 inputs: Year Ended December 31, 2023 December 31, 2022 Beginning balance $ 12,414,000 $ 10,025,000 Fair value adjustment (5,424,251 ) 2,389,000 Reclassification to additional paid in capital upon conversion (6,989,749 ) - Ending balance $ - $ 12,414,000 Valuation techniques used to measure fair value maximize the use of relevant observable inputs and minimize the use of unobservable inputs (Note 9). The Company’s Convertible Notes are classified within Level 3 of the fair value hierarchy because the fair value measurement is based, in part, on significant inputs not observed in the market. There were no transfers among Level 1, Level 2 or Level 3 categories in the years ended December 31, 2023 or 2022. The fair value of the 2020 Notes and the 2021 Notes, and collectively the Convertible Notes (Note 9) as of December 31, 2022 were estimated as the combination of a zero-coupon bond and a call option. The combined values for each of the 2020 Notes and the 2021 Notes as of December 31, 2022 were then weighted by the probability of completing a financing or reverse merger. This approach resulted in the classification of the 2020 Notes and the 2021 Notes as of December 31, 2022 as Level 3 of the fair value hierarchy. The assumptions utilized to value the 2020 Notes and the 2021 Notes as of December 31, 2022 were an estimated term of 0.94 years, volatility of 80.0% and a market yield of 55.2%. The measurement of fair value incorporates expected future cash flows associated with interest payments; as such, there is no separate accrual for interest accrued but not yet paid. Leases In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which establishes a ROU model. That requires a lessee to recognize an ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations as well as the reduction of the ROU asset. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply (i) the practical expedient, which allows us to not separate lease and non-lease components, for new leases and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has elected to combine lease and non-lease components as a single component. Operating leases will be recognized on the consolidated balance sheet as ROU assets, lease liabilities current and lease liabilities non-current. Fixed rent payments are included in the calculation of the lease balances, while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. Research and Development Research and development costs are expensed as incurred and consist primarily of new product development. Research and development costs include salaries and benefits, consultants’ fees, process development costs and stock-based compensation, as well as fees paid to third parties that conduct certain research and development activities on the Company’s behalf. A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers. The Company records accrued expenses for estimated preclinical study and clinical trial expenses. Estimates are based on the services performed pursuant to contracts with research institutions, contract research organizations in connection with clinical studies, investigative sites in connection with clinical studies, vendors in connection with preclinical development activities, and contract manufacturing organizations in connection with the production of materials for clinical trials. Further, the Company accrues expenses related to clinical trials based on the level of subject enrollment and activity according to the related agreement. The Company monitors subject enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development. If the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ from estimates. To date, the Company has not experienced significant changes in its estimates of preclinical studies and clinical trial accruals. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the consolidated statements of operations. Stock-based Compensation Stock-based compensation for employee and non-employee awards is measured on the grant date based on the fair value of the award and recognized on a straight-line basis over the requisite service period. The fair value of stock options to purchase common stock are measured using the Black-Scholes option pricing model. The Company accounts for forfeitures as they occur. The fair value of stock options is determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Rate zero Grant Revenue Recognition The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. The Company recognizes funding received as grant revenue for the Company’s grant from the NIA, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these contracts are central to its ongoing operations. Revenue is recognized as the qualifying expenses related to the contracts are incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s consolidated balance sheets as accounts receivable. Funding received in advance of services rendered are recorded in the Company’s consolidated balance sheets as deferred grant revenue. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to recover or settle. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income for the period that includes the enactment date. The deferred tax assets are recognized to the extent the Company believes that these assets are more likely than not to be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company records uncertain tax positions using a two-step process. First, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position. Second, for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits on the interest expense line and other expense line, respectively, in the accompanying statements of operations. Accrued interest and penalties are included on the related liability lines in the consolidated balance sheets. Net L oss P er S hare Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period (and potential shares of common stock that are exercisable for little or no consideration). Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The pre-funded warrants to purchase common stock issued in connection with the Merger are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is non-substantive and is virtually assured. The pre-funded warrants are more fully described in Note 11. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: December 31, 2023 2022 Preferred Series A-1 - 1,960,600 Preferred Series A-2 - 335,711 Preferred Series B - 1,034,890 Warrants 598,457 43,618 Stock options 349,384 114,516 Total 947,841 3,489,335 Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. Recently Issued But Not Yet Adopted Accounting Pronouncements In January 2021, the FASB issued ASU No. 2021-01 “Reference Rate Reform (Topic 848): Scope” (“ASU 2021-01”), which was effective immediately and permits entities to elect certain optional expedients and exceptions when accounting for derivatives and certain hedging relationships affected by changes in interest rates and the transition. Additionally, ASU 2022-06 “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848” defers the sunset date of ASC 848 from December 31, 2022 to December 31, 2024. The new guidance is effective for fiscal years beginning after December 31, 2024. The Company does not currently believe that this transition from LIBOR will have a material impact on its financial statements. In November 2023, the FASB issued ASU No. 2023-07 "Segment Reporting - Improvements to Reportable Segment Disclosures" (“ASU 2023-07”), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The guidance is effective for the Company beginning in the year ended December 31, 2025, with early adoption permitted. The Company expects the new guidance will have an immaterial impact on its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): “Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU No. 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures. |
Note 4 - Significant Agreements
Note 4 - Significant Agreements and Contracts (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Collaborative Arrangement Disclosure [Text Block] | 4. Significant Agreements and Contracts Vertex Option and License Agreement In August 2012, the Company entered the Vertex Agreement, as amended, to acquire an exclusive license to develop and commercialize a drug candidate “VX-745” from Vertex. In August 2014, the Company exercised its option to acquire the license and paid an option fee of $100,000, which was expensed as incurred as a component of research and development expense. The Vertex Agreement granted the Company the exclusive worldwide use of VX-745 in the field of diagnosis, treatment and prevention of Alzheimer’s disease and related central nervous system disorders in humans. As part of the Vertex Agreement, the Company is obligated to make certain payments totaling up to approximately $117.0 million upon achievement of certain regulatory and sales milestones, and royalties on net sales of products on indications covered by the Vertex Agreement. The first expected milestone events concern filing of an NDA, with the FDA for marketing approval of neflamapimod, in the U.S., or a similar filing for a non-U.S. major market, as specified in the Vertex Agreement, and such royalties will be on a sliding scale of percentages of net sales in the low- to mid-teens, depending on the amount of net sales in the applicable years. The Company is also obligated to make a milestone payment to Vertex upon net sales reaching a certain specified amount in any 12-month period. The Vertex Agreement states that royalties will be reduced by 50% during any portion of the royalty term when there is no valid claim of an issued patent within specified patent rights covering the licensed product. The Company also has the right to deduct, on a country by country basis, from royalties otherwise payable to Vertex under the terms of the Vertex Agreement, 50% of all royalties, upfront fees, milestones and other payments paid by the Company or any of the Company’s affiliates or sublicensees to third parties under licenses that are necessary for the development, manufacture, sale or use of a licensed product, provided that in no event will the royalty payable to Vertex be reduced to less than 50% of the rates specified in the Vertex Agreement, subject to certain adjustments specified therein. The Company has made a total of $100,000 in payments to Vertex related to the Vertex Agreement. No payments were made during the three months ended March 31, 2024 and 2023. National Institute of Aging Grant In January 2023, the Company was awarded a $21.0 million grant from the NIA to support a Phase 2b study of neflamapimod in DLB. The grant monies are expected to be received over a period of three years including $6.7 million in 2023, $8.1 million in 2024 and $6.2 million in 2025. The total revenue recognized from the NIA Grant was $2.3 million and $1.4 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, aggregate total cash funding of $10.1 million has been received from the NIA Grant, resulting in approximately $10.9 million in funding remaining. The Company received access to the current year 2 (i.e., the year ending December 31, 2024) funding in the amount of $7.3 million in February 2024. This amount was 90% of the full year 2 amount provided for in the NIA Grant due to then-current NIA policy as a result of the U.S. government being funded at such time on the basis of a continuing resolution. Consolidated appropriations acts were signed into law in March 2024, and the Company expects to receive the remaining 10% of the year 2 amount by June 30, 2024. | 5. Significant Agreements and Contracts Vertex Option and License Agreement In August 2012, the Company entered the Vertex Agreement, as amended, to acquire an exclusive license to develop and commercialize a drug candidate “VX-745” from Vertex. In August 2014, the Company exercised its option to acquire the license and paid an option fee of $100,000, which was expensed as incurred as a component of research and development expense. The Vertex Agreement granted the Company the exclusive worldwide use of VX-745 in the field of diagnosis, treatment and prevention of Alzheimer’s disease and related central nervous system disorders in humans. As part of the Vertex Agreement, the Company is obligated to make certain payments totaling up to approximately $117.0 million upon achievement of certain regulatory and sales milestones, and royalties on net sales of products on indications covered by the Vertex Agreement. The first expected milestone events concern filing of an NDA, with the FDA for marketing approval of neflamapimod, in the U.S., or a similar filing for a non-U.S. major market, as specified in the Vertex Agreement, and such royalties will be on a sliding scale of percentages of net sales in the low- to mid-teens, depending on the amount of net sales in the applicable years. The Company is also obligated to make a milestone payment to Vertex upon net sales reaching a certain specified amount in any 12-month period. The Vertex Agreement states that royalties will be reduced by 50% during any portion of the royalty term when there is no valid claim of an issued patent within specified patent rights covering the licensed product. The Company also has the right to deduct, on a country by country basis, from royalties otherwise payable to Vertex under the terms of the Vertex Agreement, 50% of all royalties, upfront fees, milestones and other payments paid by the Company or any of the Company’s affiliates or sublicensees to third parties under licenses that are necessary for the development, manufacture, sale or use of a licensed product, provided that in no event will the royalty payable to Vertex be reduced to less than 50% of the rates specified in the Vertex Agreement, subject to certain adjustments specified therein. The Company has made a total of $100,000 in payments to Vertex related to the Vertex Agreement. No National Institute of Aging Grant In January 2023, the Company was awarded a $21.0 million grant from the NIA to support a Phase 2b study of neflamapimod in dementia with Lewy bodies. The grant monies are expected to be received over a period of three years including $6.7 million in 2023, $8.1 million in 2024 and $6.2 million in 2025. The total revenue recognized from the NIA Grant was $7.1 million year ended December 31, 2023. As of December 31, 2023, total cash funding of $6.2 million has been received from the NIA Grant, resulting in approximately $15.8 million in funding remaining. In addition, $0.9 million has been recorded as a receivable in the consolidated balance sheet at December 31, 2023, which was received subsequent to December 31, 2023. The Company received access to the current year 2 (i.e., the year ending December 31, 2024) funding in the amount of $7.3 million in February 2024. This amount was 90% of the full year 2 amount provided for in the NIA Grant due to current NIA policy as a result of the U.S. government currently being funded on the basis of a continuing resolution (the “Continuing Resolution”). |
Note 5 - Prepaid Expenses and O
Note 5 - Prepaid Expenses and Other Current Assets (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Prepaid Expenses and Other Current Assets [Text Block] | 5. Prepaid Expenses Prepaid expenses consisted of the following: March 31, 2024 December 31, 2023 Clinical expenses $ 952,574 $ 711,362 Insurance 265,944 436,859 Professional services 21,917 37,917 Dues and memberships 77,599 — Other 30,645 70,363 Total $ 1,348,679 $ 1,256,501 | 6. Prepaid Expenses Prepaid expenses consisted of the following: December 31, 2023 2022 Prepaid clinical expenses $ 711,362 $ - Insurance 436,859 9,937 Rent - 2,455 Prepaid professional services 37,917 - Other 70,363 51,735 Total $ 1,256,501 $ 64,127 |
Note 6 - Accrued Expenses and O
Note 6 - Accrued Expenses and Other Current Liabilities (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: March 31, 2024 December 31, 2023 Employee compensation costs $ 264,237 $ 1,026,054 Clinical development costs 253,883 389,045 Professional fees 772,074 309,062 State franchise and excise tax 54,856 120,456 Other 63,806 88,659 Total $ 1,408,856 $ 1,933,276 | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: December 31, 2023 2022 Employee compensation costs $ 1,026,054 $ 364,070 Clinical development costs 389,045 23,185 Professional fees 309,062 206,675 State franchise and excise tax 120,456 - Other 88,659 50,322 Total $ 1,933,276 $ 644,252 |
Note 7 - Convertible Notes (10-
Note 7 - Convertible Notes (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Long-Term Debt [Text Block] | 7. Convertible Notes In December 2020, EIP issued the 2020 Notes to predominantly related party investors for proceeds of $5.1 million. In December 2021, EIP issued the 2021 Notes to predominantly related party investors for proceeds of $6.0 million. Upon completion of the Merger in August 2023, all EIP Convertible Notes outstanding were converted into common stock and in certain cases pre-funded warrants. As of March 31, 2024 and December 31, 2023, the Convertible Notes were no longer outstanding. Upon issuance, the Company elected the fair value option for the Convertible Notes in accordance with ASC 825, “Financial Instruments,” pursuant to which the entire instrument, including interest expense, is measured at fair value with the initial change in fair value deemed to be a capital contribution and any subsequent changes in fair value being recorded to other income (expense) on the consolidated statements of operations. During the three months ended March 31, 2024 there were no fair value adjustments recognized as the Convertible Notes were no longer outstanding. The fair value adjustment recognized in other income (expense) was $0.9 million for the three months ended March 31, 2023. | 9. Convertible Notes In December 2020, EIP issued the 2020 Notes to predominantly related party investors for proceeds of $5.1 million. In December 2021, EIP issued the 2021 Notes to predominantly related party investors for proceeds of $6.0 million. Upon issuance, the Company elected the fair value option for the Convertible Notes in accordance with ASC 825, “Financial Instruments,” pursuant to which the entire instrument, including interest expense, is measured at fair value with the initial change in fair value deemed to be a capital contribution and any subsequent changes in fair value being recorded to other income (expense) on the consolidated statement of operations. The fair value adjustments recognized in other income (expense) were $5.4million and $(2.4)million for the years ended December 31, 2023 and 2022, respectively. In April 2022, the Company entered into the 2022 Notes Amendment with the noteholders for the 2020 Notes (the “Amendment”). In accordance with the Amendment, the maturity of the 2020 Notes was extended from June 2022 to December 2023, the interest rate was modified so interest accrued at 5% through the original maturity of June 2022 and at 0% thereafter, the conversion discount was increased from 20% to 30%, and a conversion price limit of $3.00 was established, as discussed further below. Expenses associated with the amendment were de minimis The Company concluded the 2022 Notes Amendment qualified as a troubled debt restructuring, in accordance with FASB ASC 470, Debt, as the noteholders for the 2020 Notes, for economic reasons related to the Company’s financial difficulties, granted concessions to the Company. The Company concluded no gain or loss, and no adjustment to, or reclassification of, the carrying value of the 2020 Notes were considered necessary as a result of the 2022 Notes Amendment. In addition, the Company concluded there was no other financial statement impact as a result of the 2022 Notes Amendment, as any prospective change would be related to interest and, as a result of the amendment, the interest rate decreased to 0% following the original maturity of June 2022. In June 2023, EIP entered into the 2023 Notes Amendment which amended the conversion price of the Convertible Notes to $1.47 per share of EIP Common Stock upon effectiveness of the Merger with the Diffusion or a 30% conversion discount upon the occurrence of any other reverse merger. Further, the 2023 Notes Amendment provided that if the Merger with the Company resulted in a holder of these notes beneficially owning more than 9.99% of the outstanding voting stock of the Company, then, the holder of these notes shall be granted pre-funded warrants in lieu of the Company’s common stock for the conversion of any principal and accrued but unpaid interest in excess of such threshold. The exercise price of one share of the Company’s common stock under this pre-funded warrant is equal to $0.001 (Note 11). The 2023 Notes Amendment qualified as a modification in accordance with FASB ASC 470 Debt As a result of the Merger (Note 4), pursuant to the terms thereof, the Convertible Notes converted into shares of EIP Common Stock which were subsequently converted into the right to exchange such shares for 897,272 shares of the Company’s common stock and, in certain cases, pre-funded warrants to purchase the Company’s common stock. Accordingly, the Convertible Notes were adjusted to fair value prior to conversion by multiplying the trading price of the Company’s common stock at the date of the Effective Time and the 795,905 common shares and 101,367 pre-funded warrants issued upon conversion. The Company recorded a gain on the fair value adjustment of the Convertible Notes of $5.4 million for year ended December 31, 2023 and recorded $7.0 million to additional paid in capital for the issuance of common stock upon settlement of the Convertible Notes. |
Note 8 - Commitments and Contin
Note 8 - Commitments and Contingencies (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Commitments and Contingencies Disclosure [Text Block] | 8. Commitments and Contingencies Operating Leases The Company has a short-term lease for office space in Boston, Massachusetts and previously had a short-term agreement to utilize membership-based co-working space in Charlottesville, Virginia, the latter of which was terminated during the first quarter of 2024. Lease expense was approximately $9,492 and $7,666 for the three months ended March 31, 2024 and 2023, respectively. The Company is obligated to make de minimis lease payments under the Boston lease as of March 31, 2024 through the remaining lease term of August 31, 2024. Research and Development Arrangements In the course of normal business operations, the Company would enter into agreements with universities and CROs to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to CROs represented a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash. Defined Contribution Retirement Plan The Company has established its 401(k) Plan, which covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k) Plan up to 90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of de minimis amounts for the three months ended March 31, 2024 and 2023. Legal Proceedings On August 7, 2014, a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the former Chief Executive Officer of the Company’s legal predecessor under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case No. BC553996). The complaint asserts various causes of action, including, among other things, promissory fraud, negligent misrepresentation, breach of contract, breach of employment agreement, breach of the covenant of good faith and fair dealing, violations of the California Labor Code and common counts. The plaintiff is seeking, among other things, compensatory damages in an undetermined amount, punitive damages, accrued interest and an award of attorneys’ fees and costs. On December 30, 2014, the Company filed a petition to compel arbitration and a motion to stay the action. On April 1, 2015, the plaintiff filed a petition in opposition to the Company’s petition to compel arbitration and a motion to stay the action. After a related hearing on April 14, 2015, the court granted the Company’s petition to compel arbitration and a motion to stay the action. On January 8, 2016, the plaintiff filed an arbitration demand with the American Arbitration Association. On November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the court found sufficient grounds not to dismiss the case and an arbitration hearing was scheduled, originally for November 2020 but later postponed due to the COVID-19 pandemic and related restrictions on gatherings in the State of California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration in connection with the plaintiff filing for personal bankruptcy protection. On October 22, 2021, following a determination by the bankruptcy trustee not to pursue the claims and release them back to the plaintiff, the parties entered into a stipulation to abandon arbitration and return the matter to state court. A case management conference was held on February 23, 2022 at which an initial trial date of May 24, 2023 was set, and the parties have agreed to stipulate to mediation in advance of the trial. On October 20, 2022, the parties filed a joint stipulation to continue the trial and certain deadlines related to the mediation in order to allow plaintiff’s counsel to continue to seek treatment for an ongoing medical issue. On November 1, 2022, based on the parties joint stipulation, the court entered an order continuing the trial date to October 25, 2023, on October 6, 2023, the court entered an order further continuing the trial date to April 24, 2024, and on March 3, 2024, based on an additional joint stipulation of the parties, the court entered an order continuing the trial date to October 23, 2024. The Company believes that is has meritorious defenses to the claims alleged in this matter and is defending itself vigorously. However, at this stage, the Company is unable to predict the outcome and possible loss or range of loss, if any, associated with its resolution or any potential effect the matter may have on the Company’s financial position. Depending on the outcome or resolution of this matter, it could have a material effect on the Company’s financial position, results of operations and cash flows. | 10. Commitments and Contingencies Operating Leases The Company has a short-term agreement to utilize membership-based co-working space in Charlottesville, Virginia and a short-term lease for office space in Boston, Massachusetts. Rent expense was approximately $34,000 and $45,000 for the years ended December 31, 2023 and 2022, respectively. Research and Development Arrangements In the course of normal business operations, the Company would enter into agreements with universities and CROs to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to CROs represented a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of cash. Defined Contribution Retirement Plan The Company has established its 401(k) Plan, which covers all employees who qualify under the terms of the plan. Eligible employees may elect to contribute to the 401(k) Plan up to 90% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of de minimis Legal Proceedings On August 7, 2014, a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the former Chief Executive Officer of the Company’s legal predecessor under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case No. BC553996). The complaint asserts various causes of action, including, among other things, promissory fraud, negligent misrepresentation, breach of contract, breach of employment agreement, breach of the covenant of good faith and fair dealing, violations of the California Labor Code and common counts. The plaintiff is seeking, among other things, compensatory damages in an undetermined amount, punitive damages, accrued interest and an award of attorneys’ fees and costs. On December 30, 2014, the Company filed a petition to compel arbitration and a motion to stay the action. On April 1, 2015, the plaintiff filed a petition in opposition to the Company’s petition to compel arbitration and a motion to stay the action. After a related hearing on April 14, 2015, the court granted the Company’s petition to compel arbitration and a motion to stay the action. On January 8, 2016, the plaintiff filed an arbitration demand with the American Arbitration Association. On November 19, 2018 at an Order to Show Cause Re Dismissal Hearing, the court found sufficient grounds not to dismiss the case and an arbitration hearing was scheduled, originally for November 2020 but later postponed due to the COVID-19 pandemic and related restrictions on gatherings in the State of California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration in connection with the plaintiff filing for personal bankruptcy protection. On October 22, 2021, following a determination by the bankruptcy trustee not to pursue the claims and release them back to the plaintiff, the parties entered into a stipulation to abandon arbitration and return the matter to state court. A case management conference was held on February 23, 2022 at which an initial trial date of May 24, 2023 was set, and the parties have agreed to stipulate to mediation in advance of the trial. On October 20, 2022, the parties filed a joint stipulation to continue the trial and certain deadlines related to the mediation in order to allow plaintiff’s counsel to continue to seek treatment for an ongoing medical issue. On November 1, 2022, based on the parties joint stipulation, the court entered an order continuing the trial date to October 25, 2023, on October 6, 2023, the court entered an order further continuing the trial date to April 24, 2024 , and on March 3, 2024, based on an additional joint stipulation of the parties, the court entered an order continuing the trial date to October 23, 2024. The Company believes that is has meritorious defenses to the claims alleged in this matter and is defending itself vigorously. However, at this stage, the Company is unable to predict the outcome and possible loss or range of loss, if any, associated with its resolution or any potential effect the matter may have on the Company’s financial position. Depending on the outcome or resolution of this matter, it could have a material effect on the Company’s financial position, results of operations and cash flows. |
Note 9 - Stockholders' Equity a
Note 9 - Stockholders' Equity and Common Stock Warrants (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Equity [Text Block] | 9. Stockholders' Equity and Common Stock Warrants In July 2023, EIP sold 63,422 shares of common stock at $12.78 per share (as adjusted for the Exchange Ratio) for net proceeds of approximately $0.8 million. Warrants As of March 31, 2024, the Company had the following warrants outstanding to acquire shares of its common stock: Outstanding Range of exercise price per share Expiration dates Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $ 19.81 4/1/2028 102,462 On February 26, 2024, following the effectiveness of an amendment eliminating certain beneficial ownership limitations set forth therein, the Company’s previously outstanding 495,995 pre-funded warrants, which were issued in connection with the closing of the Merger, were exercised in full by the holder thereof pursuant to a cashless exercise provision of the pre-funded warrants. Upon exercise, 36 shares of common stock were withheld in lieu of a cash payment of the exercise price and the holder was issued 495,959 shares of common stock. The Company is party to the 2022 Sales Agreement with BTIG. The 2022 Sales Agreement is an "at-the-market" sales agreement pursuant to which the Company may, from time to time and through BTIG as the Company’s agent, sell up to an aggregate of $20.0 million in shares of common stock by any permissible method deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. As of the date of this Quarterly Report, however, the Company has not sold any shares pursuant to the 2022 Sales Agreement. | 11. Stockholders Equity (Deficit) and Common Stock Warrants On August 16, 2023 in connection with the closing of the Merger, the following is reflected on the consolidated financial statements of convertible preferred stock and stockholders’ equity (deficit) for the year ended December 31, 2023: (i) the issuance of 795,905 shares of common stock and 101,367 pre-funded warrants upon the settlement of the Convertible Notes, (ii) the conversion of 3,331,201 shares of convertible preferred stock into 2,936,566 shares of common stock and 394,628 prefunded warrants, and (iii) the issuance of 1,360,244 shares of common stock to Diffusion stockholders as consideration for the Merger. In July 2023, EIP sold 63,422 shares of common stock at $12.78 per share (as adjusted for the Exchange Ratio) for net proceeds of approximately $0.8 million. Warrants As of December 31, 2023, the Company had the following warrants outstanding to acquire shares of its common stock: Warrants Exercise Outstanding Price Expiration Date Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $19.81 April 2028 Pre-funded warrants issued related to closing of reverse recapitalization 495,995 $0.001 None 598,457 Upon completion of the Merger, the Convertible Notes and outstanding shares of EIP preferred stock converted into shares of EIP Common Stock which were subsequently converted into the right to exchange such shares for shares of the Company’s common stock or, in certain cases, pre-funded warrants to purchase the Company’s common stock. All of the warrants are equity-classified because they are indexed to the Company’s own shares and meet the criteria to be classified as an equity instrument. The Company is party to the 2022 Sales Agreement with BTIG. The 2022 Sales Agreement is an "at-the-market" sales agreement pursuant to which the Company may, from time to time and through BTIG as the Company’s agent, sell up to an aggregate of $20.0 million in shares of common stock by any permissible method deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. As of the date of this Annual Report, however, the Company has not sold any shares pursuant to the 2022 Sales Agreement. |
Note 10 - Stock-based Compensat
Note 10 - Stock-based Compensation (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Share-Based Payment Arrangement [Text Block] | 10. Stock-Based Compensation Stock 2015 Equity Plan The 2015 Equity Plan provides for increases to the number of shares reserved for issuance thereunder each January 1 equal to 4.0% of the total shares of the Company’s common stock outstanding as of the immediately preceding December 31, unless a lesser amount is stipulated by the Compensation Committee of the Board. As of March 31, 2024, there were 37,678 shares available for future issuance under the 2015 Equity Plan. 2018 Employee, Director and Consultant Equity Incentive Plan On March 28, 2018, EIP adopted the 2018 Plan, which was assumed by the Company pursuant to and in accordance with the terms of the Merger Agreement. Under the 2018 Plan, the Company may issue incentive stock options, non-qualified stock options, stock grants, and other stock-based awards to employees, directors, and consultants, as specified in the 2018 Plan and subject to applicable SEC and Nasdaq rules and regulations. The Board has the authority to determine to whom options or stock will be granted, the number of shares, the term, and the exercise price. Options granted under the 2018 Plan have a term of up to ten four-year one-year no The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations: Three Months Ended March 31, 2024 2023 Research and development $ 63,797 $ 40,126 General and administrative 154,418 31,114 Total stock-based compensation expense $ 218,215 $ 71,240 The following table summarizes the activity related to all stock option grants for the three months ended March 31, 2024: Number of Options Weighted average exercise price per share Weighted average remaining contractual life (in years) Aggregate intrinsic value Balance at January 1, 2024 349,374 $ 51.15 Granted 169,934 9.52 Expired (51 ) 28,897.06 Outstanding at March 31, 2024 519,257 $ 34.69 8.5 — Exercisable at March 31, 2024 192,004 $ 79.03 6.7 — The Black-Scholes option pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions: Three Months Ended March 31, 2024 Expected term (in years) 5.74 - 5.76 Risk-free interest rate 4.06 - 4.14 % Expected volatility 79.13 - 79.31 % Dividend yield — There were no At March 31, 2024, there was $1.7 million of unrecognized compensation expense that will be recognized over a weighted-average period of 2.3 years. During the three months ended March 31, 2024 the Company granted 39,721 options in lieu of 2023 executive bonus compensation. | 12. Stock-Based Compensation 2015 Equity Plan The 2015 Equity Plan provides for increases to the number of shares reserved for issuance thereunder each January 1 equal to 4.0% of the total shares of the Company’s common stock outstanding as of the immediately preceding December 31, unless a lesser amount is stipulated by the Compensation Committee of the Company’s Board of Directors. As of December 31, 2023, there were 12,580 shares available for future issuance under the 2015 Equity Plan. On January 1, 2024, the number of shares available for future issuance under the 2015 Equity Plan increased by 226,981. 2018 Employee, Director and Consultant Equity Incentive Plan On March 28, 2018, EIP adopted the 2018 Plan, which was assumed by the Company pursuant to and in accordance with the terms of the Merger Agreement. Under the 2018 Plan, the Company may issue incentive stock options, non-qualified stock options, stock grants, and other stock-based awards to employees, directors, and consultants, as specified in the 2018 Plan and subject to applicable SEC and Nasdaq rules and regulations. The Board of Directors has the authority to determine to whom options or stock will be granted, the number of shares, the term, and the exercise price. Options granted under the 2018 Plan have a term of up to ten four-year one-year no The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations: Year Ended December 31, 2023 2022 Research and development $ 143,685 $ 174,710 General and administrative 263,947 159,125 Total stock-based compensation expense $ 407,632 $ 333,835 The following table summarizes the activity related to all stock option grants for the year ended December 31, 2023: Number of Options Weighted average exercise price per share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Balance at January 1, 2023 114,516 $ 25.98 6.72 Options assumed in the merger 52,574 $ 313.67 Granted 198,600 $ 5.95 Cancelled (15,957 ) $ 180.80 Exercised (359 ) $ 5.33 Outstanding at December 31, 2023 349,374 $ 51.15 8.12 $ 358,340 Exercisable at December 31, 2023 157,301 $ 103.67 6.35 $ 39,820 The Black-Scholes option-pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions: December 31, 2023 2022 Expected term (in years) 5.75 6.00 Risk-free interest rate 3.9% - 4.5% 1.9 % Expected volatility 81.7% - 83.3% 80.3 % Dividend yield 0.0% 0.0 % During the year ended December 31, 2023, 359 shares underlying options were exercised, of which 193 were withheld as consideration for the exercise price of such shares pursuant to the cashless exercise provision of the related option award agreement. No Contributed Capital in lieu of Executive Compensation In 2022, the former Chair of the Board and the Chief Executive Officer offered to forego, without repayment, certain compensation to ensure the Company had enough resources to maintain operations until the financial funding was completed. The amount of $0.1 million for the year ended December 31, 2022, which is recorded as contributed capital in lieu of executive compensation in additional paid-in capital, will not be paid in cash, debt or equity in the future. No |
Note 11 - Restatement of Previo
Note 11 - Restatement of Previously Issued (Unaudited) Interim Financial Statements (10-Q) | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Error Correction [Text Block] | Note 11. Restatement of Previously Issued (Unaudited) Interim Financial Statements While undergoing a review of its unaudited condensed consolidated interim financial statements, the Company determined it had incorrectly expensed costs directly associated with the Merger during various periods in 2023. Fees such as accounting and legal related to the Merger should have been capitalized and net against proceeds of the Merger. This impacted previously reported amounts for deferred offering costs and general and administrative expense, among other line items in the unaudited condensed consolidated interim financial statements as of and for the three months ended March 31, 2023. The following tables set forth the effects of the error corrections on affected items within the Company’s previously reported unaudited interim condensed consolidated balance sheet as of the periods indicated had the adjustments been made in the corresponding quarter: March 31, 2023 As reported Adjusted As restated Deferred offering costs $ - $ 638,018 $ 638,018 Accumulated deficit $ (53,441,270 ) $ 638,018 $ (52,803,252 ) Total assets $ 3,305,477 $ 638,018 $ 3,943,495 Total liabilities, convertible preferred stock and stockholder’s equity (deficit) $ 3,305,477 $ 638,018 $ 3,943,495 Total stockholders’ equity (deficit) $ (34,386,173 ) $ 638,018 $ (33,748,155 ) The following tables set forth the effects of the error corrections on affected items within the Company’s previously reported unaudited interim condensed statements of operations for the periods indicated had the adjustments been made in the corresponding quarters: Three Months Ended March 31, 2023 As reported Adjusted As restated General and administrative expense $ 1,638,931 $ (638,018 ) $ 1,000,913 Total operating expenses $ 3,472,205 $ (638,018 ) $ 2,834,187 Loss from operations $ (2,064,337 ) $ 638,018 $ (1,426,319 ) Net loss $ (1,172,354 ) $ 638,018 $ (534,336 ) Net loss per share of common stock, basic and diluted $ (2.26 ) $ 1.23 $ (1.03 ) |
Note 12 - Subsequent Events (10
Note 12 - Subsequent Events (10-Q) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes to Financial Statements | ||
Subsequent Events [Text Block] | 12. Subsequent Events 2024 Private Placement On April 1, 2024, pursuant to and in accordance with the terms of a securities purchase agreement with certain purchasers named therein, the Company completed the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one | 14. Subsequent Events 2024 Private Placement On March 28, 2024, the Company entered into a securities purchase agreement with certain purchasers named therein related to the private placement of an aggregate of 2,532,285 units, each comprised of (i) (A) one one one Pre-Funded Warrant Amendment and Exercise On February 26, 2024, following the effectiveness of an amendment eliminating certain beneficial ownership limitations set forth therein, the Company’s previously outstanding pre-funded warrant was exercised in full by the holder thereof pursuant to the cashless exercise provision in Section 2(c) of the pre-funded warrant. Upon exercise, 36 shares were withheld in lieu of a cash payment of the exercise price and the holder was issued 495,959 shares of common stock. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of presentation The consolidated financial statements have been prepared in conformity with US GAAP as defined by the FASB. |
Consolidation, Policy [Policy Text Block] | Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, grant revenue, expenses, and related disclosures. On an ongoing basis, the Company’s management evaluates its estimates, including estimates related to money market accounts, clinical trial accruals, stock-based compensation expense, grant revenue, Convertible Notes, and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ significantly from those estimates or assumptions. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company maintains its cash and cash equivalent balances with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance-sheet risk of loss. The Company has not experienced any losses in such accounts. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents, which consist of amounts invested in money market funds, are stated at fair value. There are no unrealized gains or losses on the money market funds for the years ended December 31, 2023 and 2022. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company’s financial instruments consist primarily of cash and cash equivalents, accounts payable, previously outstanding Convertible Notes and accrued liabilities. The Company’s cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company determined the fair value of the Convertible Notes as described in Note 9. In connection with the consummation of the Merger (Note 4) on August 16, 2023, the Convertible Notes were converted into EIP Common Stock which was subsequently converted into the right to exchange such shares of EIP Common Stock for shares of the Company’s common stock. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 Level 2 Level 3 The following table presents the Company’s assets that are measured at fair value on a recurring basis: December 31, 2023 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 7,792,846 $ - $ - Total assets measured at fair value $ 7,792,846 $ - $ - December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 4,093,579 $ - $ - Total assets measured at fair value $ 4,093,579 $ - $ - Liabilities Convertible Notes $ - $ - $ 12,414,000 Total liabilities measured at fair value $ - $ - $ 12,414,000 The following table presents a roll-forward of the fair value of the Convertible Notes (Note 9) for which fair value is determined by Level 3 inputs: Year Ended December 31, 2023 December 31, 2022 Beginning balance $ 12,414,000 $ 10,025,000 Fair value adjustment (5,424,251 ) 2,389,000 Reclassification to additional paid in capital upon conversion (6,989,749 ) - Ending balance $ - $ 12,414,000 Valuation techniques used to measure fair value maximize the use of relevant observable inputs and minimize the use of unobservable inputs (Note 9). The Company’s Convertible Notes are classified within Level 3 of the fair value hierarchy because the fair value measurement is based, in part, on significant inputs not observed in the market. There were no transfers among Level 1, Level 2 or Level 3 categories in the years ended December 31, 2023 or 2022. The fair value of the 2020 Notes and the 2021 Notes, and collectively the Convertible Notes (Note 9) as of December 31, 2022 were estimated as the combination of a zero-coupon bond and a call option. The combined values for each of the 2020 Notes and the 2021 Notes as of December 31, 2022 were then weighted by the probability of completing a financing or reverse merger. This approach resulted in the classification of the 2020 Notes and the 2021 Notes as of December 31, 2022 as Level 3 of the fair value hierarchy. The assumptions utilized to value the 2020 Notes and the 2021 Notes as of December 31, 2022 were an estimated term of 0.94 years, volatility of 80.0% and a market yield of 55.2%. The measurement of fair value incorporates expected future cash flows associated with interest payments; as such, there is no separate accrual for interest accrued but not yet paid. |
Lessee, Leases [Policy Text Block] | Leases In February 2016, the FASB issued ASU No. 2016-02, “Leases”, which establishes a ROU model. That requires a lessee to recognize an ROU asset and corresponding lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations as well as the reduction of the ROU asset. The new standard provides a number of optional practical expedients in transition. The Company has elected to apply (i) the practical expedient, which allows us to not separate lease and non-lease components, for new leases and (ii) the short-term lease exemption for all leases with an original term of less than 12 months, for purposes of applying the recognition and measurements requirements in the new standard. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company will utilize the incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has elected to combine lease and non-lease components as a single component. Operating leases will be recognized on the consolidated balance sheet as ROU assets, lease liabilities current and lease liabilities non-current. Fixed rent payments are included in the calculation of the lease balances, while variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected term on a straight-line basis. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Research and development costs are expensed as incurred and consist primarily of new product development. Research and development costs include salaries and benefits, consultants’ fees, process development costs and stock-based compensation, as well as fees paid to third parties that conduct certain research and development activities on the Company’s behalf. A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers. The Company records accrued expenses for estimated preclinical study and clinical trial expenses. Estimates are based on the services performed pursuant to contracts with research institutions, contract research organizations in connection with clinical studies, investigative sites in connection with clinical studies, vendors in connection with preclinical development activities, and contract manufacturing organizations in connection with the production of materials for clinical trials. Further, the Company accrues expenses related to clinical trials based on the level of subject enrollment and activity according to the related agreement. The Company monitors subject enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development. If the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ from estimates. To date, the Company has not experienced significant changes in its estimates of preclinical studies and clinical trial accruals. |
Legal Costs, Policy [Policy Text Block] | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the consolidated statements of operations. |
Share-Based Payment Arrangement [Policy Text Block] | Stock-based Compensation Stock-based compensation for employee and non-employee awards is measured on the grant date based on the fair value of the award and recognized on a straight-line basis over the requisite service period. The fair value of stock options to purchase common stock are measured using the Black-Scholes option pricing model. The Company accounts for forfeitures as they occur. The fair value of stock options is determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management. Expected Term Expected Volatility Risk-Free Interest Rate Expected Dividend Rate zero |
Revenue [Policy Text Block] | Grant Revenue Recognition The Company generates revenue from government contracts that reimburse the Company for certain allowable costs for funded projects. The Company recognizes funding received as grant revenue for the Company’s grant from the NIA, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these contracts are central to its ongoing operations. Revenue is recognized as the qualifying expenses related to the contracts are incurred. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded in the Company’s consolidated balance sheets as accounts receivable. Funding received in advance of services rendered are recorded in the Company’s consolidated balance sheets as deferred grant revenue. The related costs incurred by the Company are included in research and development expense in the Company’s consolidated statements of operations. |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to recover or settle. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income for the period that includes the enactment date. The deferred tax assets are recognized to the extent the Company believes that these assets are more likely than not to be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net deferred tax assets have been fully offset by a valuation allowance. The Company records uncertain tax positions using a two-step process. First, the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position. Second, for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties, if any, related to unrecognized tax benefits on the interest expense line and other expense line, respectively, in the accompanying statements of operations. Accrued interest and penalties are included on the related liability lines in the consolidated balance sheets. |
Earnings Per Share, Policy [Policy Text Block] | Net L oss P er S hare Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period (and potential shares of common stock that are exercisable for little or no consideration). Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The pre-funded warrants to purchase common stock issued in connection with the Merger are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is non-substantive and is virtually assured. The pre-funded warrants are more fully described in Note 11. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: December 31, 2023 2022 Preferred Series A-1 - 1,960,600 Preferred Series A-2 - 335,711 Preferred Series B - 1,034,890 Warrants 598,457 43,618 Stock options 349,384 114,516 Total 947,841 3,489,335 |
Segment Reporting, Policy [Policy Text Block] | Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued But Not Yet Adopted Accounting Pronouncements In January 2021, the FASB issued ASU No. 2021-01 “Reference Rate Reform (Topic 848): Scope” (“ASU 2021-01”), which was effective immediately and permits entities to elect certain optional expedients and exceptions when accounting for derivatives and certain hedging relationships affected by changes in interest rates and the transition. Additionally, ASU 2022-06 “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848” defers the sunset date of ASC 848 from December 31, 2022 to December 31, 2024. The new guidance is effective for fiscal years beginning after December 31, 2024. The Company does not currently believe that this transition from LIBOR will have a material impact on its financial statements. In November 2023, the FASB issued ASU No. 2023-07 "Segment Reporting - Improvements to Reportable Segment Disclosures" (“ASU 2023-07”), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. The guidance is effective for the Company beginning in the year ended December 31, 2025, with early adoption permitted. The Company expects the new guidance will have an immaterial impact on its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): “Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU No. 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated financial statements and disclosures. |
Note 3 - Summary of Significa_3
Note 3 - Summary of Significant Accounting Policies (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | March 31, 2024 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 3,729,954 $ — $ — Total assets measured at fair value $ 3,729,954 $ — $ — December 31, 2023 Assets Cash equivalents (money market accounts) $ 7,792,846 $ — $ — Total assets measured at fair value $ 7,792,846 $ — $ — | December 31, 2023 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 7,792,846 $ - $ - Total assets measured at fair value $ 7,792,846 $ - $ - December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 4,093,579 $ - $ - Total assets measured at fair value $ 4,093,579 $ - $ - Liabilities Convertible Notes $ - $ - $ 12,414,000 Total liabilities measured at fair value $ - $ - $ 12,414,000 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three Months Ended March 31, 2023 Beginning balance $ 12,414,000 Fair value adjustment (858,000 ) Ending balance $ 11,556,000 | Year Ended December 31, 2023 December 31, 2022 Beginning balance $ 12,414,000 $ 10,025,000 Fair value adjustment (5,424,251 ) 2,389,000 Reclassification to additional paid in capital upon conversion (6,989,749 ) - Ending balance $ - $ 12,414,000 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | March 31, 2024 2023 Convertible preferred stock — 3,331,201 Common stock warrants 102,462 43,621 Stock options 519,257 114,525 621,719 3,489,347 | December 31, 2023 2022 Preferred Series A-1 - 1,960,600 Preferred Series A-2 - 335,711 Preferred Series B - 1,034,890 Warrants 598,457 43,618 Stock options 349,384 114,516 Total 947,841 3,489,335 |
Note 4 - Merger (Tables)
Note 4 - Merger (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Business Acquisitions, by Acquisition [Table Text Block] | August 16, 2023 Cash and cash equivalents $ 12,705,140 Prepaid and other assets 406,488 Accounts payable and accrued expenses (1,223,871 ) Total net assets assumed 11,887,757 Minus: Transaction costs (1,548,643 ) Total net assets assumed minus transaction costs $ 10,339,114 |
Note 6 - Prepaid Expenses and_2
Note 6 - Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | March 31, 2024 December 31, 2023 Clinical expenses $ 952,574 $ 711,362 Insurance 265,944 436,859 Professional services 21,917 37,917 Dues and memberships 77,599 — Other 30,645 70,363 Total $ 1,348,679 $ 1,256,501 | December 31, 2023 2022 Prepaid clinical expenses $ 711,362 $ - Insurance 436,859 9,937 Rent - 2,455 Prepaid professional services 37,917 - Other 70,363 51,735 Total $ 1,256,501 $ 64,127 |
Note 7 - Accrued Expenses and_2
Note 7 - Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Other Current Liabilities [Table Text Block] | March 31, 2024 December 31, 2023 Employee compensation costs $ 264,237 $ 1,026,054 Clinical development costs 253,883 389,045 Professional fees 772,074 309,062 State franchise and excise tax 54,856 120,456 Other 63,806 88,659 Total $ 1,408,856 $ 1,933,276 | December 31, 2023 2022 Employee compensation costs $ 1,026,054 $ 364,070 Clinical development costs 389,045 23,185 Professional fees 309,062 206,675 State franchise and excise tax 120,456 - Other 88,659 50,322 Total $ 1,933,276 $ 644,252 |
Note 11 - Stockholders' Equit_2
Note 11 - Stockholders' Equity (Deficit) and Common Stock Warrants (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Outstanding Range of exercise price per share Expiration dates Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $ 19.81 4/1/2028 102,462 | Warrants Exercise Outstanding Price Expiration Date Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $19.81 April 2028 Pre-funded warrants issued related to closing of reverse recapitalization 495,995 $0.001 None 598,457 |
Note 12 - Stock-based Compens_2
Note 12 - Stock-based Compensation (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended March 31, 2024 2023 Research and development $ 63,797 $ 40,126 General and administrative 154,418 31,114 Total stock-based compensation expense $ 218,215 $ 71,240 | Year Ended December 31, 2023 2022 Research and development $ 143,685 $ 174,710 General and administrative 263,947 159,125 Total stock-based compensation expense $ 407,632 $ 333,835 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number of Options Weighted average exercise price per share Weighted average remaining contractual life (in years) Aggregate intrinsic value Balance at January 1, 2024 349,374 $ 51.15 Granted 169,934 9.52 Expired (51 ) 28,897.06 Outstanding at March 31, 2024 519,257 $ 34.69 8.5 — Exercisable at March 31, 2024 192,004 $ 79.03 6.7 — | Number of Options Weighted average exercise price per share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Balance at January 1, 2023 114,516 $ 25.98 6.72 Options assumed in the merger 52,574 $ 313.67 Granted 198,600 $ 5.95 Cancelled (15,957 ) $ 180.80 Exercised (359 ) $ 5.33 Outstanding at December 31, 2023 349,374 $ 51.15 8.12 $ 358,340 Exercisable at December 31, 2023 157,301 $ 103.67 6.35 $ 39,820 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Months Ended March 31, 2024 Expected term (in years) 5.74 - 5.76 Risk-free interest rate 4.06 - 4.14 % Expected volatility 79.13 - 79.31 % Dividend yield — | December 31, 2023 2022 Expected term (in years) 5.75 6.00 Risk-free interest rate 3.9% - 4.5% 1.9 % Expected volatility 81.7% - 83.3% 80.3 % Dividend yield 0.0% 0.0 % |
Note 13 - Income Taxes (Tables)
Note 13 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Rate reconciliation: 2023 2022 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit 6.3 % 8.0 % Change in convertible debt 52.8 % -8.6 % Research & Development credit 17.1 % 1.2 % Change in valuation allowance -95.9 % -15.8 % Share-based compensation -1.0 % 0.0 % Other -0.3 % -5.8 % Total provision 0.0 % 0.0 % |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | 2023 2022 Deferred tax assets: Net operating loss $ 10,495,881 $ 10,977,455 Research and development credits 708,443 354,283 Capitalized research expenditures 2,271,853 259,749 Stock-based compensation 567,473 514,654 Reserves and accruals - 105,399 Intangibles 223,548 262,872 Gross deferred tax assets 14,267,198 12,474,412 Less valuation allowance (14,100,543 ) (12,474,412 ) Total deferred tax assets 166,655 - Deferred tax liabilities: Prepaids $ (166,655 ) $ - Gross deferred tax liabilities (166,655 ) - Deferred tax assets, net $ - $ - |
Note 3 - Summary of Significa_4
Note 3 - Summary of Significant Accounting Policies (10-Q) (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | March 31, 2024 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 3,729,954 $ — $ — Total assets measured at fair value $ 3,729,954 $ — $ — December 31, 2023 Assets Cash equivalents (money market accounts) $ 7,792,846 $ — $ — Total assets measured at fair value $ 7,792,846 $ — $ — | December 31, 2023 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 7,792,846 $ - $ - Total assets measured at fair value $ 7,792,846 $ - $ - December 31, 2022 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (money market accounts) $ 4,093,579 $ - $ - Total assets measured at fair value $ 4,093,579 $ - $ - Liabilities Convertible Notes $ - $ - $ 12,414,000 Total liabilities measured at fair value $ - $ - $ 12,414,000 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three Months Ended March 31, 2023 Beginning balance $ 12,414,000 Fair value adjustment (858,000 ) Ending balance $ 11,556,000 | Year Ended December 31, 2023 December 31, 2022 Beginning balance $ 12,414,000 $ 10,025,000 Fair value adjustment (5,424,251 ) 2,389,000 Reclassification to additional paid in capital upon conversion (6,989,749 ) - Ending balance $ - $ 12,414,000 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | March 31, 2024 2023 Convertible preferred stock — 3,331,201 Common stock warrants 102,462 43,621 Stock options 519,257 114,525 621,719 3,489,347 | December 31, 2023 2022 Preferred Series A-1 - 1,960,600 Preferred Series A-2 - 335,711 Preferred Series B - 1,034,890 Warrants 598,457 43,618 Stock options 349,384 114,516 Total 947,841 3,489,335 |
Note 5 - Prepaid Expenses and_2
Note 5 - Prepaid Expenses and Other Current Assets (10-Q) (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | March 31, 2024 December 31, 2023 Clinical expenses $ 952,574 $ 711,362 Insurance 265,944 436,859 Professional services 21,917 37,917 Dues and memberships 77,599 — Other 30,645 70,363 Total $ 1,348,679 $ 1,256,501 | December 31, 2023 2022 Prepaid clinical expenses $ 711,362 $ - Insurance 436,859 9,937 Rent - 2,455 Prepaid professional services 37,917 - Other 70,363 51,735 Total $ 1,256,501 $ 64,127 |
Note 6 - Accrued Expenses and_2
Note 6 - Accrued Expenses and Other Current Liabilities (10-Q) (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Other Current Liabilities [Table Text Block] | March 31, 2024 December 31, 2023 Employee compensation costs $ 264,237 $ 1,026,054 Clinical development costs 253,883 389,045 Professional fees 772,074 309,062 State franchise and excise tax 54,856 120,456 Other 63,806 88,659 Total $ 1,408,856 $ 1,933,276 | December 31, 2023 2022 Employee compensation costs $ 1,026,054 $ 364,070 Clinical development costs 389,045 23,185 Professional fees 309,062 206,675 State franchise and excise tax 120,456 - Other 88,659 50,322 Total $ 1,933,276 $ 644,252 |
Note 9 - Stockholders' Equity_2
Note 9 - Stockholders' Equity and Common Stock Warrants (10-Q) (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Outstanding Range of exercise price per share Expiration dates Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $ 19.81 4/1/2028 102,462 | Warrants Exercise Outstanding Price Expiration Date Historical Diffusion common stock warrants 58,844 $26.27 - $459.06 May 2024 through February 2026 Historical EIP common stock warrants 43,618 $19.81 April 2028 Pre-funded warrants issued related to closing of reverse recapitalization 495,995 $0.001 None 598,457 |
Note 10 - Stock-based Compens_2
Note 10 - Stock-based Compensation (10-Q) (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Notes Tables | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended March 31, 2024 2023 Research and development $ 63,797 $ 40,126 General and administrative 154,418 31,114 Total stock-based compensation expense $ 218,215 $ 71,240 | Year Ended December 31, 2023 2022 Research and development $ 143,685 $ 174,710 General and administrative 263,947 159,125 Total stock-based compensation expense $ 407,632 $ 333,835 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number of Options Weighted average exercise price per share Weighted average remaining contractual life (in years) Aggregate intrinsic value Balance at January 1, 2024 349,374 $ 51.15 Granted 169,934 9.52 Expired (51 ) 28,897.06 Outstanding at March 31, 2024 519,257 $ 34.69 8.5 — Exercisable at March 31, 2024 192,004 $ 79.03 6.7 — | Number of Options Weighted average exercise price per share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Balance at January 1, 2023 114,516 $ 25.98 6.72 Options assumed in the merger 52,574 $ 313.67 Granted 198,600 $ 5.95 Cancelled (15,957 ) $ 180.80 Exercised (359 ) $ 5.33 Outstanding at December 31, 2023 349,374 $ 51.15 8.12 $ 358,340 Exercisable at December 31, 2023 157,301 $ 103.67 6.35 $ 39,820 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Months Ended March 31, 2024 Expected term (in years) 5.74 - 5.76 Risk-free interest rate 4.06 - 4.14 % Expected volatility 79.13 - 79.31 % Dividend yield — | December 31, 2023 2022 Expected term (in years) 5.75 6.00 Risk-free interest rate 3.9% - 4.5% 1.9 % Expected volatility 81.7% - 83.3% 80.3 % Dividend yield 0.0% 0.0 % |
Note 11 - Restatement of Prev_2
Note 11 - Restatement of Previously Issued (Unaudited) Interim Financial Statements (10-Q) (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Notes Tables | |
Schedule of Error Corrections and Prior Period Adjustments [Table Text Block] | March 31, 2023 As reported Adjusted As restated Deferred offering costs $ - $ 638,018 $ 638,018 Accumulated deficit $ (53,441,270 ) $ 638,018 $ (52,803,252 ) Total assets $ 3,305,477 $ 638,018 $ 3,943,495 Total liabilities, convertible preferred stock and stockholder’s equity (deficit) $ 3,305,477 $ 638,018 $ 3,943,495 Total stockholders’ equity (deficit) $ (34,386,173 ) $ 638,018 $ (33,748,155 ) Three Months Ended March 31, 2023 As reported Adjusted As restated General and administrative expense $ 1,638,931 $ (638,018 ) $ 1,000,913 Total operating expenses $ 3,472,205 $ (638,018 ) $ 2,834,187 Loss from operations $ (2,064,337 ) $ 638,018 $ (1,426,319 ) Net loss $ (1,172,354 ) $ 638,018 $ (534,336 ) Net loss per share of common stock, basic and diluted $ (2.26 ) $ 1.23 $ (1.03 ) |
Note 1 - The Company and Desc_3
Note 1 - The Company and Description of Business (Details Textual) | Aug. 16, 2023 shares | Sep. 30, 2023 shares |
Pre-funded Warrants [Member] | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 495,995 | |
Merger Agreement [Member] | ||
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares | 4,314,033 | |
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 0.1151 | |
Reverse Stock Split [Member ] | ||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 1.5 |
Note 2 - Liquidity and Capita_3
Note 2 - Liquidity and Capital Resources (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Apr. 01, 2024 USD ($) shares | Apr. 01, 2024 USD ($) shares | Apr. 01, 2024 USN ($) shares | Aug. 16, 2023 USD ($) | Jul. 31, 2023 USD ($) | Jan. 31, 2023 USD ($) | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) | |
Retained Earnings (Accumulated Deficit) | $ | $ (56,955,124) | $ (54,440,789) | $ (52,268,916) | $ (52,803,252) | ||||||
Government Assistance, Transaction Duration | 3 years | |||||||||
Proceeds from Issuance of Common Stock | $ | $ 800,000 | $ 810,000 | $ 0 | |||||||
Prefunded Warrant [Member] | ||||||||||
Number of Warrants Per Unit | 1 | 1 | 1 | |||||||
Series A Warrant [Member] | ||||||||||
Number of Warrants Per Unit | 1 | 1 | 1 | |||||||
Private Placement [Member] | ||||||||||
Equity Offering, Number of Units Sold | 2,532,285 | 2,532,285 | ||||||||
Number of Shares Per Unit | 1 | 1 | 1 | |||||||
Proceeds From Issuance or Sale of Equity, Gross | $ 50 | $ 50,000,000 | ||||||||
Proceeds from Issuance or Sale of Equity | $ | $ 99.4 | |||||||||
Subsequent Event [Member] | Prefunded Warrant [Member] | ||||||||||
Number of Warrants Per Unit | 1 | 1 | 1 | |||||||
Subsequent Event [Member] | Series A Warrant [Member] | ||||||||||
Number of Warrants Per Unit | 1 | 1 | 1 | |||||||
Subsequent Event [Member] | Private Placement [Member] | ||||||||||
Equity Offering, Number of Units Sold | 2,532,285 | 2,532,285 | 2,532,285 | |||||||
Number of Shares Per Unit | 1 | 1 | 1 | |||||||
Proceeds From Issuance or Sale of Equity, Gross | $ | $ 50,000,000 | |||||||||
Proceeds from Issuance or Sale of Equity | $ | $ 99,400,000 | $ 99,400,000 | ||||||||
Merger Agreement [Member] | ||||||||||
Cash Acquired from Acquisition | $ | $ 12,700,000 | |||||||||
RewinD-LB Trial [Member] | ||||||||||
Government Assistance, Asset | $ | $ 21,000,000 |
Note 3 - Summary of Significa_5
Note 3 - Summary of Significant Accounting Policies (Details Textual) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 $ / shares | Jun. 30, 2023 $ / shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0% | 0% | |
Prefunded Warrant [Member] | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.001 | $ 0.001 | |
Convertible Debt [Member] | Measurement Input, Expected Term [Member] | |||
Debt Instrument, Measurement Input | 0.69 | 0.94 | |
Convertible Debt [Member] | Measurement Input, Price Volatility [Member] | |||
Debt Instrument, Measurement Input | 0.75 | 0.80 | |
Convertible Debt [Member] | Measurement Input, Cost to Sell [Member] | |||
Debt Instrument, Measurement Input | 0.553 | 0.552 |
Note 3 - Summary of Significa_6
Note 3 - Summary of Significant Accounting Policies - Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Inputs, Level 1 [Member] | |||
Cash equivalents (money market accounts) | $ 3,729,954 | $ 7,792,846 | $ 4,093,579 |
Total assets measured at fair value | 3,729,954 | 7,792,846 | 4,093,579 |
Convertible Notes | 0 | ||
Total liabilities measured at fair value | 0 | ||
Fair Value, Inputs, Level 2 [Member] | |||
Cash equivalents (money market accounts) | 0 | 0 | 0 |
Total assets measured at fair value | 0 | 0 | 0 |
Convertible Notes | 0 | ||
Total liabilities measured at fair value | 0 | ||
Fair Value, Inputs, Level 3 [Member] | |||
Cash equivalents (money market accounts) | $ 0 | 0 | 0 |
Total assets measured at fair value | $ 0 | 0 | |
Convertible Notes | 12,414,000 | ||
Total liabilities measured at fair value | $ 12,414,000 |
Note 3 - Summary of significa_7
Note 3 - Summary of significant Accounting Policies - Roll-forward of Convertible Notes (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Beginning balance | $ 12,414,000 | ||
Fair value adjustment | (858,000) | ||
Ending balance | 11,556,000 | $ 12,414,000 | |
Fair Value, Inputs, Level 3 [Member] | |||
Beginning balance | $ 0 | 12,414,000 | $ 10,025,000 |
Fair value adjustment | (5,424,251) | 2,389,000 | |
Reclassification to additional paid in capital upon conversion | (6,989,749) | 0 | |
Ending balance | $ 0 | $ 12,414,000 |
Note 3 - Summary of Significa_8
Note 3 - Summary of Significant Accounting Policies - Outstanding Dilutive Securities (Details) - shares | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Preferred Series A-1 (in shares) | 621,719 | 3,489,347 | 947,841 | 3,489,335 |
Series A-1 Preferred Stock [Member] | ||||
Preferred Series A-1 (in shares) | 0 | 1,960,600 | ||
Series A-2 Preferred Stock [Member] | ||||
Preferred Series A-1 (in shares) | 0 | 335,711 | ||
Series B Preferred Stock [Member] | ||||
Preferred Series A-1 (in shares) | 0 | 1,034,890 | ||
Warrant [Member] | ||||
Preferred Series A-1 (in shares) | 102,462 | 43,621 | 598,457 | 43,618 |
Share-Based Payment Arrangement, Option [Member] | ||||
Preferred Series A-1 (in shares) | 519,257 | 114,525 | 349,384 | 114,516 |
Note 4 - Merger (Details Textua
Note 4 - Merger (Details Textual) - shares | Mar. 31, 2024 | Dec. 31, 2023 | Aug. 16, 2023 | Dec. 31, 2022 |
Common Stock, Shares, Outstanding | 6,170,479 | 5,674,520 | 5,674,277 | 518,140 |
Merger Agreement [Member] | ||||
Business Acquisition, Percentage Stock Owned by Legacy Holders | 76% |
Note 4 - Merger - Details of Me
Note 4 - Merger - Details of Merger (Details) - Merger Agreement [Member] | Aug. 16, 2023 USD ($) |
Cash and cash equivalents | $ 12,705,140 |
Prepaid and other assets | 406,488 |
Accounts payable and accrued expenses | (1,223,871) |
Total net assets assumed | 11,887,757 |
Minus: Transaction costs | (1,548,643) |
Total net assets assumed minus transaction costs | $ 10,339,114 |
Note 5 - Significant Agreemen_2
Note 5 - Significant Agreements and Contracts (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Jan. 01, 2024 | Feb. 29, 2024 USD ($) | Feb. 29, 2024 USN ($) | Aug. 31, 2014 USD ($) | Jun. 30, 2024 | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2025 USD ($) | Dec. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jan. 31, 2023 USD ($) | Jan. 01, 2023 USN ($) | |
Research and Development Expense | $ 2,814,258 | $ 1,833,274 | $ 8,438,499 | $ 1,336,469 | |||||||||
Revenues | 2,347,250 | 1,407,868 | 7,144,872 | 0 | |||||||||
Deferred Revenue, Current | 572,475 | 0 | |||||||||||
Vertex Option and License Agreement [Member] | |||||||||||||
Research and Development Expense | $ 100,000 | ||||||||||||
Contractual Obligation | 117,000,000 | 117,000,000 | |||||||||||
Payments for License Agreement | $ 100,000 | 0 | $ 0 | ||||||||||
National Institute of Aging Grant [Member] | |||||||||||||
Government Assistance, Asset | $ 21,000,000 | $ 21 | |||||||||||
Government Assistance, Income, Increase (Decrease) | $ 7.3 | 6,700,000 | 6,700,000 | ||||||||||
Revenues | 2,300,000 | $ 1,400,000 | 7,100,000 | ||||||||||
Proceeds From Grants | 10,100,000 | 6,200,000 | |||||||||||
Grant Funding Remaining | $ 10,900,000 | 15,800,000 | |||||||||||
Deferred Revenue, Current | $ 900,000 | ||||||||||||
Grant Amount, Received, Parentage | 90% | 90% | |||||||||||
National Institute of Aging Grant [Member] | Subsequent Event [Member] | |||||||||||||
Government Assistance, Income, Increase (Decrease) | $ 7,300,000 | ||||||||||||
Grant Amount, Received, Parentage | 90% | ||||||||||||
National Institute of Aging Grant [Member] | Forecast [Member] | |||||||||||||
Government Assistance, Income, Increase (Decrease) | $ 6,200,000 | $ 8,100,000 | |||||||||||
Grant Amount, Received, Parentage | 10% |
Note 6 - Prepaid Expenses and_3
Note 6 - Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid clinical expenses | $ 952,574 | $ 711,362 | $ 0 |
Insurance | 265,944 | 436,859 | 9,937 |
Rent | 0 | 2,455 | |
Prepaid professional services | 21,917 | 37,917 | 0 |
Other | 30,645 | 70,363 | 51,735 |
Total | $ 1,348,679 | $ 1,256,501 | $ 64,127 |
Note 7 - Accrued Expenses and_3
Note 7 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Employee compensation costs | $ 264,237 | $ 1,026,054 | $ 364,070 |
Clinical development costs | 253,883 | 389,045 | 23,185 |
Professional fees | 772,074 | 309,062 | 206,675 |
State franchise and excise tax | 54,856 | 120,456 | 0 |
Other | 63,806 | 88,659 | 50,322 |
Total | $ 1,408,856 | $ 1,933,276 | $ 644,252 |
Note 8 - Line of Credit (Detail
Note 8 - Line of Credit (Details Textual) - Line of Credit [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | |
Line of Credit Facility, Maximum Borrowing Capacity | $ 2,500 | ||
Line of Credit Facility, Interest Rate at Period End | 7.22% | 6.08% | |
Long-Term Line of Credit | $ 0 | $ 0 | |
Debt Issuance Costs, Line of Credit Arrangements, Net | $ 0 | $ 0 | |
LIBOR [Member] | |||
Debt Instrument, Basis Spread on Variable Rate | 1.75% |
Note 9 - Convertible Notes (Det
Note 9 - Convertible Notes (Details Textual) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Aug. 16, 2023 shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) | Jun. 30, 2023 $ / shares | Jun. 30, 2022 | Apr. 01, 2022 $ / shares | |
Liabilities, Fair Value Adjustment | $ 0 | $ 858,000 | $ 5,424,251 | $ (2,389,000) | ||||||
Conversion of Debt into Common Stock [Member] | ||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 795,905 | 795,905 | ||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | shares | 101,367 | 101,367 | ||||||||
Prefunded Warrant [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.001 | $ 0.001 | ||||||||
Convertible Debt [Member] | ||||||||||
Liabilities, Fair Value Adjustment | $ 900,000 | $ 5,400,000 | $ (2,400,000) | |||||||
Debt Instrument, Convertible, Discount | 30% | |||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ / shares | $ 1.47 | |||||||||
Debt Instrument, Convertible, Maximum Beneficial Ownership | 9.99% | |||||||||
Payments of Debt Issuance Costs | 50,000 | |||||||||
Debt Instrument, Convertible, Number of Equity Instruments | 897,272 | |||||||||
Adjustments to Additional Paid in Capital, Convertible Debt with Conversion Feature | $ 7,000,000 | |||||||||
Convertible Debt [Member] | Minimum [Member] | ||||||||||
Debt Instrument, Convertible, Discount | 20% | |||||||||
Convertible Debt [Member] | Maximum [Member] | ||||||||||
Debt Instrument, Convertible, Discount | 30% | |||||||||
Convertible Debt Securities [Member] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 0% | 5% | ||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ / shares | $ 3 | |||||||||
The 2020 Notes [Member] | ||||||||||
Proceeds from Issuance of Long-Term Debt | $ 5,100,000 | |||||||||
The 2021 Notes [Member] | ||||||||||
Proceeds from Issuance of Long-Term Debt | $ 6,000,000 |
Note 10 - Commitments and Con_2
Note 10 - Commitments and Contingencies (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Lease, Expense | $ 9,492 | $ 7,666 | $ 34,000 | $ 45,000 |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 90% | 90% | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4% | 4% |
Note 11 - Stockholders' Equit_3
Note 11 - Stockholders' Equity (Deficit) and Common Stock Warrants (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Feb. 26, 2024 | Aug. 16, 2023 | Jul. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2024 | |
Class of Warrant or Right, Outstanding | 598,457 | 102,462 | ||||
Stock Issued During Period, Shares, Acquisitions | 1,360,244 | |||||
Stock Issued During Period, Shares, New Issues | 495,959 | 63,422 | ||||
Shares Issued, Price Per Share | $ 12.78 | |||||
Proceeds from Issuance of Common Stock | $ 800,000 | $ 810,000 | $ 0 | |||
Sales Agreement [Member] | ||||||
Share Sales Agreement, Maximum Amount | $ 20,000,000 | $ 20,000,000 | ||||
Pre-funded Warrants [Member] | ||||||
Class of Warrant or Right, Outstanding | 394,628 | |||||
Conversion of Preferred Stock into Common Stock [Member] | ||||||
Conversion of Stock, Shares Converted | 3,331,201 | |||||
Conversion of Stock, Shares Issued | 2,936,566 | |||||
Conversion of Debt into Common Stock [Member] | ||||||
Debt Conversion, Converted Instrument, Shares Issued | 795,905 | 795,905 | ||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 101,367 | 101,367 |
Note 11 - Stockholders' Equit_4
Note 11 - Stockholders' Equity (Deficit) and Common Stock Warrants - Warrants Outstanding to Acquire Shares of Its Common Stock (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 |
Warrants outstanding (in shares) | 102,462 | 598,457 | |
Historical Diffusion Common Stock Warrants [Member] | |||
Warrants outstanding (in shares) | 58,844 | 58,844 | |
Historical Diffusion Common Stock Warrants [Member] | Minimum [Member] | |||
Exercise price of warrants (in dollars per share) | $ 26.27 | $ 26.27 | |
Historical Diffusion Common Stock Warrants [Member] | Maximum [Member] | |||
Exercise price of warrants (in dollars per share) | $ 459.06 | $ 459.06 | |
Historical EIP Common Stock Warrants [Member] | |||
Warrants outstanding (in shares) | 43,618 | 43,618 | |
Exercise price of warrants (in dollars per share) | $ 19.81 | $ 19.81 | |
Prefunded Warrant [Member] | |||
Warrants outstanding (in shares) | 495,995 | ||
Exercise price of warrants (in dollars per share) | $ 0.001 | $ 0.001 |
Note 12 - Stock-based Compens_3
Note 12 - Stock-based Compensation (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 11 Months Ended | 12 Months Ended | |||
Feb. 26, 2024 | Mar. 31, 2024 | Dec. 13, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 359 | 0 | ||||
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation | 36 | 193 | ||||
Share-Based Payment Arrangement, Option [Member] | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 1,700 | $ 1,100 | ||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 3 months 18 days | 2 years 1 month 6 days | ||||
Restricted Stock Units (RSUs) [Member] | Director [Member] | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 0 | $ 100 | ||||
Equity Incentive Plan 2015 [Member] | ||||||
Percentage of Total Shares Eligible for Plan Reserve, On an Annual Basis | 4% | 4% | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 37,678 | 12,580 | 226,981 | |||
The 2018 Employee, Director and Consultant Equity Incentive Plan [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 0 | 0 | ||||
The 2018 Employee, Director and Consultant Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | 10 years | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 4 years | 4 years | ||||
The 2018 Employee, Director and Consultant Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 1 year | 1 year | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 25% | 25% |
Note 12 - Stock-based Compens_4
Note 12 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share based compensation expense | $ 218,215 | $ 71,240 | $ 407,632 | $ 333,835 |
Research and Development Expense [Member] | ||||
Share based compensation expense | 63,797 | 40,126 | 143,685 | 174,710 |
General and Administrative Expense [Member] | ||||
Share based compensation expense | $ 154,418 | $ 31,114 | $ 263,947 | $ 159,125 |
Note 12 - Stock-based Compens_5
Note 12 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Balance, number of shares (in shares) | 349,374 | 114,516 | ||
Balance, weighted average exercise price (in dollars per share) | $ 51.15 | $ 25.98 | ||
Balance, weighted average remaining contractual term (Year) | 8 years 6 months | 8 years 1 month 13 days | 6 years 8 months 19 days | |
Assumed, number of shares (in shares) | 52,574 | |||
Assumed, weighted average exercise price (in dollars per share) | $ 313.67 | |||
Granted, number of shares (in shares) | 169,934 | 0 | 198,600 | |
Granted, weighted average exercise price (in dollars per share) | $ 9.52 | $ 5.95 | ||
Cancelled, shares (in shares) | (51) | (15,957) | ||
Cancelled, weighted average exercise price per share (in dollars per share) | $ 28,897.06 | $ 180.8 | ||
Exercised, shares (in shares) | (359) | 0 | ||
Exercised, weighted average exercise price per share (in dollars per share) | $ 5.33 | |||
Outstanding, shares (in shares) | 519,257 | 349,374 | ||
Outstanding, weighted average exercise price per share (in dollars per share) | $ 34.69 | $ 51.15 | ||
Outstanding, aggregate intrinsic value | $ 0 | $ 358,340 | ||
Exercisable, shares (in shares) | 192,004 | 157,301 | ||
Exercisable, weighted average exercise price per share (in dollars per share) | $ 79.03 | $ 103.67 | ||
Exercisable, weighted average remaining contractual term (Year) | 6 years 8 months 12 days | 6 years 4 months 6 days | ||
Exercisable, aggregate intrinsic value | $ 0 | $ 39,820 |
Note 12 - Share-based Compensat
Note 12 - Share-based Compensation - Assumptions (Details) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Dividend yield | 0% | 0% | ||
Share-Based Payment Arrangement, Option [Member] | ||||
Expected term (in years) (Year) | 5 years 9 months | 6 years | ||
Risk-free interest rate | 1.90% | |||
Expected volatility | 80.30% | |||
Dividend yield | 0% | 0% | 0% | |
Share-Based Payment Arrangement, Option [Member] | Minimum [Member] | ||||
Expected term (in years) (Year) | 5 years 8 months 26 days | |||
Risk-free interest rate | 4.06% | 3.90% | ||
Expected volatility | 79.13% | 81.70% | ||
Share-Based Payment Arrangement, Option [Member] | Maximum [Member] | ||||
Expected term (in years) (Year) | 5 years 9 months 3 days | |||
Risk-free interest rate | 4.14% | 4.50% | ||
Expected volatility | 79.31% | 83.30% |
Note 13 - Income Taxes (Details
Note 13 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Unrecognized Tax Benefits | $ 0 | $ 0 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 1,600 | |
Domestic Tax Jurisdiction [Member] | ||
Operating Loss Carryforwards | 38,900 | |
Domestic Tax Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | 600 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards | 37,000 | |
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | $ 100 |
Note 13 - Income Taxes - Rate R
Note 13 - Income Taxes - Rate Reconciliation of Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Federal tax benefit at statutory rate | 21% | 21% |
State tax, net of federal benefit | 6.30% | 8% |
Change in convertible debt | 52.80% | (8.60%) |
Research & Development credit | 17.10% | 1.20% |
Change in valuation allowance | (95.90%) | (15.80%) |
Share-based compensation | (1.00%) | 0% |
Other | (0.30%) | (5.80%) |
Total provision | 0% | 0% |
Note 13 - Income Taxes - Deferr
Note 13 - Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Net operating loss | $ 10,495,881 | $ 10,977,455 |
Research and development credits | 708,443 | 354,283 |
Capitalized research expenditures | 2,271,853 | 259,749 |
Stock-based compensation | 567,473 | 514,654 |
Reserves and accruals | 0 | 105,399 |
Intangibles | 223,548 | 262,872 |
Gross deferred tax assets | 14,267,198 | 12,474,412 |
Less valuation allowance | (14,100,543) | (12,474,412) |
Total deferred tax assets | 166,655 | 0 |
Prepaids | (166,655) | 0 |
Gross deferred tax liabilities | (166,655) | 0 |
Deferred tax assets, net | $ 0 | $ 0 |
Note 14 - Subsequent Events (De
Note 14 - Subsequent Events (Details Textual) $ in Millions, $ in Millions | 1 Months Ended | 3 Months Ended | 11 Months Ended | ||||
Apr. 01, 2024 USD ($) shares | Apr. 01, 2024 USD ($) shares | Apr. 01, 2024 USN ($) shares | Feb. 26, 2024 shares | Jul. 31, 2023 shares | Mar. 31, 2024 USD ($) | Dec. 13, 2023 shares | |
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation | 36 | 193 | |||||
Stock Issued During Period, Shares, New Issues | 495,959 | 63,422 | |||||
Prefunded Warrant [Member] | |||||||
Number of Warrants Per Unit | 1 | 1 | 1 | ||||
Series A Warrant [Member] | |||||||
Number of Warrants Per Unit | 1 | 1 | 1 | ||||
Private Placement [Member] | |||||||
Equity Offering, Number of Units Sold | 2,532,285 | 2,532,285 | |||||
Number of Shares Per Unit | 1 | 1 | 1 | ||||
Proceeds From Issuance or Sale of Equity, Gross | $ 50 | $ 50 | |||||
Proceeds from Issuance or Sale of Equity | $ | $ 99.4 | ||||||
Subsequent Event [Member] | |||||||
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation | 36 | ||||||
Stock Issued During Period, Shares, New Issues | 495,959 | ||||||
Subsequent Event [Member] | Prefunded Warrant [Member] | |||||||
Number of Warrants Per Unit | 1 | 1 | 1 | ||||
Subsequent Event [Member] | Series A Warrant [Member] | |||||||
Number of Warrants Per Unit | 1 | 1 | 1 | ||||
Subsequent Event [Member] | Private Placement [Member] | |||||||
Equity Offering, Number of Units Sold | 2,532,285 | 2,532,285 | 2,532,285 | ||||
Number of Shares Per Unit | 1 | 1 | 1 | ||||
Proceeds From Issuance or Sale of Equity, Gross | $ | $ 50 | ||||||
Proceeds from Issuance or Sale of Equity | $ | $ 99.4 | $ 99.4 |
Note 1 - The Company and Desc_4
Note 1 - The Company and Description of Business (10-Q) (Details Textual) $ in Millions, $ in Millions | Jan. 31, 2023 USD ($) | Jan. 01, 2023 USN ($) |
National Institute of Aging Grant [Member] | ||
Government Assistance, Asset | $ 21 | $ 21 |
Note 2 - Liquidity and Capita_4
Note 2 - Liquidity and Capital Resources (10-Q) (Details Textual) $ in Millions | 3 Months Ended | ||||
Apr. 01, 2024 USN ($) shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Retained Earnings (Accumulated Deficit) | $ | $ (56,955,124) | $ (54,440,789) | $ (52,803,252) | $ (52,268,916) | |
Prefunded Warrant [Member] | |||||
Number of Warrants Per Unit | 1 | ||||
Series A Warrant [Member] | |||||
Number of Warrants Per Unit | 1 | ||||
Private Placement [Member] | |||||
Equity Offering, Number of Units Sold | 2,532,285 | ||||
Number of Shares Per Unit | 1 | ||||
Proceeds From Issuance or Sale of Equity, Gross | $ 50 | $ 50,000,000 | |||
Proceeds from Issuance or Sale of Equity | $ | $ 99.4 |
Note 3 - Summary of Significa_9
Note 3 - Summary of Significant Accounting Policies (10-Q) (Details Textual) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Mar. 31, 2023 USD ($) | |
Deferred Offering Costs | $ 247,671 | $ 0 | $ 638,018 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0% | 0% | |
Number of Operating Segments | 1 | ||
Convertible Debt [Member] | Measurement Input, Expected Term [Member] | |||
Debt Instrument, Measurement Input | 0.69 | 0.94 | |
Convertible Debt [Member] | Measurement Input, Price Volatility [Member] | |||
Debt Instrument, Measurement Input | 0.75 | 0.80 | |
Convertible Debt [Member] | Measurement Input, Cost to Sell [Member] | |||
Debt Instrument, Measurement Input | 0.553 | 0.552 | |
Private Placement [Member] | |||
Deferred Offering Costs | $ 200,000 |
Note 3 - Summary of Signific_10
Note 3 - Summary of Significant Accounting Policies - Assets Measured at Fair Value on Recurring Basis (10-Q) (Details) - Fair Value, Recurring [Member] - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Inputs, Level 1 [Member] | |||
Cash equivalents (money market accounts) | $ 3,729,954 | $ 7,792,846 | $ 4,093,579 |
Total assets measured at fair value | 3,729,954 | 7,792,846 | 4,093,579 |
Fair Value, Inputs, Level 2 [Member] | |||
Cash equivalents (money market accounts) | 0 | 0 | 0 |
Total assets measured at fair value | 0 | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | |||
Cash equivalents (money market accounts) | $ 0 | 0 | 0 |
Total assets measured at fair value | $ 0 | $ 0 |
Note 3 - Summary of signific_11
Note 3 - Summary of significant Accounting Policies - Roll-forward of Convertible Notes (10-Q) (Details) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Beginning balance | $ 12,414,000 |
Fair value adjustment | (858,000) |
Ending balance | $ 11,556,000 |
Note 3 - Summary of Signific_12
Note 3 - Summary of Significant Accounting Policies - Outstanding Dilutive Securities (10-Q) (Details) - shares | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Preferred Series A-1 (in shares) | 621,719 | 3,489,347 | 947,841 | 3,489,335 |
Convertible Preferred Stock [Member] | ||||
Preferred Series A-1 (in shares) | 0 | 3,331,201 | ||
Warrant [Member] | ||||
Preferred Series A-1 (in shares) | 102,462 | 43,621 | 598,457 | 43,618 |
Share-Based Payment Arrangement, Option [Member] | ||||
Preferred Series A-1 (in shares) | 519,257 | 114,525 | 349,384 | 114,516 |
Note 4 - Significant Agreemen_2
Note 4 - Significant Agreements and Contracts (10-Q) (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Feb. 29, 2024 USN ($) | Aug. 31, 2014 USD ($) | Jun. 30, 2024 | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2025 USD ($) | Dec. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jan. 31, 2023 USD ($) | Jan. 01, 2023 USN ($) | |
Research and Development Expense | $ 2,814,258 | $ 1,833,274 | $ 8,438,499 | $ 1,336,469 | |||||||
Revenues | 2,347,250 | 1,407,868 | 7,144,872 | 0 | |||||||
Vertex Option and License Agreement [Member] | |||||||||||
Research and Development Expense | $ 100,000 | ||||||||||
Contractual Obligation | 117,000,000 | 117,000,000 | |||||||||
Payments for License Agreement | $ 100,000 | 0 | $ 0 | ||||||||
National Institute of Aging Grant [Member] | |||||||||||
Government Assistance, Asset | $ 21,000,000 | $ 21 | |||||||||
Government Assistance, Income, Increase (Decrease) | $ 7.3 | 6,700,000 | 6,700,000 | ||||||||
Revenues | 2,300,000 | $ 1,400,000 | 7,100,000 | ||||||||
Proceeds From Grants | 10,100,000 | 6,200,000 | |||||||||
Grant Funding Remaining | $ 10,900,000 | $ 15,800,000 | |||||||||
Grant Amount, Received, Parentage | 90% | ||||||||||
National Institute of Aging Grant [Member] | Forecast [Member] | |||||||||||
Government Assistance, Income, Increase (Decrease) | $ 6,200,000 | $ 8,100,000 | |||||||||
Grant Amount, Received, Parentage | 10% |
Note 5 - Prepaid Expenses and_3
Note 5 - Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (10-Q) (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid clinical expenses | $ 952,574 | $ 711,362 | $ 0 |
Insurance | 265,944 | 436,859 | 9,937 |
Prepaid professional services | 21,917 | 37,917 | 0 |
Dues and memberships | 77,599 | 0 | |
Other | 30,645 | 70,363 | 51,735 |
Total | $ 1,348,679 | $ 1,256,501 | $ 64,127 |
Note 6 - Accrued Expenses and_3
Note 6 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses (10-Q) (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Employee compensation costs | $ 264,237 | $ 1,026,054 | $ 364,070 |
Clinical development costs | 253,883 | 389,045 | 23,185 |
Professional fees | 772,074 | 309,062 | 206,675 |
State franchise and excise tax | 54,856 | 120,456 | 0 |
Other | 63,806 | 88,659 | 50,322 |
Total | $ 1,408,856 | $ 1,933,276 | $ 644,252 |
Note 7 - Convertible Notes (1_2
Note 7 - Convertible Notes (10-Q) (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Liabilities, Fair Value Adjustment | $ 0 | $ 858,000 | $ 5,424,251 | $ (2,389,000) | ||
Convertible Debt [Member] | ||||||
Liabilities, Fair Value Adjustment | $ 900,000 | $ 5,400,000 | $ (2,400,000) | |||
The 2020 Notes [Member] | ||||||
Proceeds from Issuance of Long-Term Debt | $ 5,100,000 | |||||
The 2021 Notes [Member] | ||||||
Proceeds from Issuance of Long-Term Debt | $ 6,000,000 |
Note 8 - Commitments and Cont_2
Note 8 - Commitments and Contingencies (10-Q) (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Lease, Expense | $ 9,492 | $ 7,666 | $ 34,000 | $ 45,000 |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 90% | 90% | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4% | 4% |
Note 9 - Stockholders' Equity_3
Note 9 - Stockholders' Equity and Common Stock Warrants (10-Q) (Details Textual) - USD ($) | 1 Months Ended | 11 Months Ended | 12 Months Ended | ||
Feb. 26, 2024 | Jul. 31, 2023 | Dec. 13, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stock Issued During Period, Shares, New Issues | 495,959 | 63,422 | |||
Shares Issued, Price Per Share | $ 12.78 | ||||
Proceeds from Issuance of Common Stock | $ 800,000 | $ 810,000 | $ 0 | ||
Class of Warrant or Right, Exercised | 495,995 | ||||
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation | 36 | 193 | |||
Sales Agreement [Member] | |||||
Share Sales Agreement, Maximum Amount | $ 20,000,000 | $ 20,000,000 |
Note 9 - Stockholders' Equity_4
Note 9 - Stockholders' Equity and Common Stock Warrants - Warrants Outstanding to Acquire Shares of Its Common Stock (10-Q) (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Warrants outstanding (in shares) | 102,462 | 598,457 |
Historical Diffusion Common Stock Warrants [Member] | ||
Warrants outstanding (in shares) | 58,844 | 58,844 |
Historical Diffusion Common Stock Warrants [Member] | Minimum [Member] | ||
Exercise price of warrants (in dollars per share) | $ 26.27 | $ 26.27 |
Historical Diffusion Common Stock Warrants [Member] | Maximum [Member] | ||
Exercise price of warrants (in dollars per share) | $ 459.06 | $ 459.06 |
Historical EIP Common Stock Warrants [Member] | ||
Warrants outstanding (in shares) | 43,618 | 43,618 |
Exercise price of warrants (in dollars per share) | $ 19.81 | $ 19.81 |
Note 10 - Stock-based Compens_3
Note 10 - Stock-based Compensation (10-Q) (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Jan. 01, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 169,934 | 0 | 198,600 | |
Executive Officer [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 39,721 | |||
Share-Based Payment Arrangement, Option [Member] | ||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 1.7 | $ 1.1 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 3 months 18 days | 2 years 1 month 6 days | ||
Equity Incentive Plan 2015 [Member] | ||||
Percentage of Total Shares Eligible for Plan Reserve, On an Annual Basis | 4% | 4% | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 37,678 | 12,580 | 226,981 | |
The 2018 Employee, Director and Consultant Equity Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 0 | 0 | ||
The 2018 Employee, Director and Consultant Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | 10 years | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 4 years | 4 years | ||
The 2018 Employee, Director and Consultant Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 1 year | 1 year | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 25% | 25% |
Note 10 - Stock-based Compens_4
Note 10 - Stock-based Compensation - Stock-based Compensation Expense (10-Q) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share based compensation expense | $ 218,215 | $ 71,240 | $ 407,632 | $ 333,835 |
Research and Development Expense [Member] | ||||
Share based compensation expense | 63,797 | 40,126 | 143,685 | 174,710 |
General and Administrative Expense [Member] | ||||
Share based compensation expense | $ 154,418 | $ 31,114 | $ 263,947 | $ 159,125 |
Note 10 - Stock-based Compens_5
Note 10 - Stock-based Compensation - Stock Option Activity (10-Q) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Balance, number of shares (in shares) | 349,374 | 114,516 | ||
Balance, weighted average exercise price (in dollars per share) | $ 51.15 | $ 25.98 | ||
Granted, number of shares (in shares) | 169,934 | 0 | 198,600 | |
Granted, weighted average exercise price (in dollars per share) | $ 9.52 | $ 5.95 | ||
Cancelled, shares (in shares) | (51) | (15,957) | ||
Cancelled, weighted average exercise price per share (in dollars per share) | $ 28,897.06 | $ 180.8 | ||
Outstanding, shares (in shares) | 519,257 | 349,374 | ||
Outstanding, weighted average exercise price per share (in dollars per share) | $ 34.69 | $ 51.15 | ||
Balance, weighted average remaining contractual term (Year) | 8 years 6 months | 8 years 1 month 13 days | 6 years 8 months 19 days | |
Outstanding, aggregate intrinsic value | $ 0 | $ 358,340 | ||
Exercisable, shares (in shares) | 192,004 | 157,301 | ||
Exercisable, weighted average exercise price per share (in dollars per share) | $ 79.03 | $ 103.67 | ||
Exercisable, weighted average remaining contractual term (Year) | 6 years 8 months 12 days | 6 years 4 months 6 days | ||
Exercisable, aggregate intrinsic value | $ 0 | $ 39,820 |
Note 10 - Share-based Compensat
Note 10 - Share-based Compensation - Assumptions (10-Q) (Details) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Dividend yield | 0% | 0% | ||
Share-Based Payment Arrangement, Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term | 5 years 9 months | 6 years | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.90% | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 80.30% | |||
Dividend yield | 0% | 0% | 0% | |
Share-Based Payment Arrangement, Option [Member] | Minimum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term | 5 years 8 months 26 days | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 4.06% | 3.90% | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 79.13% | 81.70% | ||
Share-Based Payment Arrangement, Option [Member] | Maximum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term | 5 years 9 months 3 days | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 4.14% | 4.50% | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 79.31% | 83.30% |
Note 11 - Restatement of Prev_3
Note 11 - Restatement of Previously Issued (Unaudited) Interim Financial Statements - Schedule of Error Corrections (10-Q) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Deferred offering costs | $ 247,671 | $ 638,018 | $ 0 | |
General and administrative | 2,127,930 | 1,000,913 | 6,519,268 | $ 2,139,065 |
Accumulated deficit | (56,955,124) | (52,803,252) | (54,440,789) | (52,268,916) |
Total operating expenses | 4,942,188 | 2,834,187 | 14,957,767 | 3,475,534 |
Total assets | 7,997,448 | 3,943,495 | 9,972,521 | 4,157,706 |
Loss from operations | (2,594,938) | (1,426,319) | (7,812,895) | (3,475,534) |
Total liabilities, convertible preferred stock and stockholder’s deficit | 7,997,448 | 3,943,495 | 9,972,521 | 4,157,706 |
Net loss | (2,514,335) | (534,336) | (2,171,873) | (5,803,047) |
Total stockholders’ deficit | $ 5,336,378 | $ (33,748,155) | $ 7,376,774 | $ (33,285,059) |
Net income (loss) per share of common stock - basic (in dollars per share) | $ (0.41) | $ (1.03) | $ (0.82) | $ (11.2) |
Previously Reported [Member] | ||||
Deferred offering costs | $ 0 | |||
General and administrative | 1,638,931 | |||
Accumulated deficit | (53,441,270) | |||
Total operating expenses | 3,472,205 | |||
Total assets | 3,305,477 | |||
Loss from operations | (2,064,337) | |||
Total liabilities, convertible preferred stock and stockholder’s deficit | 3,305,477 | |||
Net loss | (1,172,354) | |||
Total stockholders’ deficit | $ (34,386,173) | |||
Net income (loss) per share of common stock - basic (in dollars per share) | $ (2.26) | |||
Revision of Prior Period, Error Correction, Adjustment [Member] | ||||
Deferred offering costs | $ 638,018 | |||
General and administrative | (638,018) | |||
Accumulated deficit | 638,018 | |||
Total operating expenses | (638,018) | |||
Total assets | 638,018 | |||
Loss from operations | 638,018 | |||
Total liabilities, convertible preferred stock and stockholder’s deficit | 638,018 | |||
Net loss | 638,018 | |||
Total stockholders’ deficit | $ 638,018 | |||
Net income (loss) per share of common stock - basic (in dollars per share) | $ 1.23 |
Note 12 - Subsequent Events (_2
Note 12 - Subsequent Events (10-Q) (Details Textual) $ in Millions, $ in Millions | 3 Months Ended | |||
Apr. 01, 2024 USD ($) shares | Apr. 01, 2024 USN ($) shares | Apr. 01, 2024 USD ($) shares | Mar. 31, 2024 USD ($) | |
Prefunded Warrant [Member] | ||||
Number of Warrants Per Unit | 1 | 1 | 1 | |
Series A Warrant [Member] | ||||
Number of Warrants Per Unit | 1 | 1 | 1 | |
Private Placement [Member] | ||||
Equity Offering, Number of Units Sold | 2,532,285 | 2,532,285 | ||
Number of Shares Per Unit | 1 | 1 | 1 | |
Proceeds From Issuance or Sale of Equity, Gross | $ 50 | $ 50 | ||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ | $ 3.5 | |||
Proceeds from Issuance or Sale of Equity | $ | $ 99.4 | |||
Subsequent Event [Member] | Prefunded Warrant [Member] | ||||
Number of Warrants Per Unit | 1 | 1 | 1 | |
Subsequent Event [Member] | Series A Warrant [Member] | ||||
Number of Warrants Per Unit | 1 | 1 | 1 | |
Subsequent Event [Member] | Private Placement [Member] | ||||
Equity Offering, Number of Units Sold | 2,532,285 | 2,532,285 | 2,532,285 | |
Number of Shares Per Unit | 1 | 1 | 1 | |
Proceeds From Issuance or Sale of Equity, Gross | $ | $ 50 | |||
Proceeds from Issuance or Sale of Equity | $ | $ 99.4 | $ 99.4 |