Document And Entity Information
Document And Entity Information | 3 Months Ended |
Mar. 31, 2024 | |
Document And Entity Information | |
Document Type | S-1 |
Entity Registrant Name | SOLIGENIX, INC. |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Central Index Key | 0000812796 |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets | Mar. 31, 2024 USD ($) | |
Current assets: | ||
Cash and cash equivalents | $ 7,091,548 | |
Contracts and grants receivable | 117,029 | |
Research and development incentives receivable, current | 25,253 | |
Deferred issuance cost | 132,681 | |
Prepaid expenses and other current assets | 451,876 | |
Total current assets | 7,818,387 | |
Security deposit | 22,777 | |
Office furniture and equipment, net | 10,339 | |
Right-of-use lease assets | 200,569 | |
Research and development incentives receivable, net of current portion | 6,313 | |
Total assets | 8,058,385 | |
Current liabilities: | ||
Accounts payable | 1,436,728 | |
Accrued expenses | 2,602,665 | |
Accrued compensation | 50,216 | |
Lease liabilities, current | 125,143 | |
Convertible debt | 2,996,136 | |
Total current liabilities | 7,210,888 | |
Non-current liabilities: | ||
Lease liabilities, net of current portion | 79,125 | |
Total liabilities | 7,290,013 | |
Commitments and contingencies (Note 6) | ||
Shareholders' equity: | ||
Preferred stock, 350,000 shares authorized; none issued or outstanding at March 31, 2024 and December 31, 2023, respectively | ||
Common stock, $.001 par value; 75,000,000 shares authorized; 657,900 and 648,761 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 658 | [1] |
Additional paid-in capital | 228,363,074 | [1] |
Accumulated other comprehensive income | 24,143 | |
Accumulated deficit | (227,619,503) | |
Total shareholders' equity | 768,372 | |
Total liabilities and shareholders' equity | $ 8,058,385 | |
[1]Adjusted to reflect the reverse stock split of one-for- sixteen |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) | Jun. 05, 2024 | Mar. 31, 2024 $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares |
Accumulated depreciation | $ | $ 121,320 | $ 114,766 | ||
Debt discount, current | $ | $ 0 | $ 102,309 | ||
Preferred stock, shares authorized | 350,000 | 350,000 | 300,000 | |
Preferred stock, shares issued | 0 | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | 0 | |
Common stock, par value (per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares authorized | 75,000,000 | 75,000,000 | 75,000,000 | |
Common stock, shares issued | 657,900 | 648,761 | ||
Common stock, shares outstanding | 657,900 | 648,761 | 181,898 | |
Subsequent Event | ||||
Reverse stock spilt effective from June 5, 2024 | 0.625 | |||
Series D Preferred Stock | ||||
Temporary equity per share | $ / shares | $ 0.001 | $ 0.001 | ||
Temporary equity authorized | 0 | 50,000 | ||
Temporary equity Issued | 0 | 0 | ||
Temporary equity Outstanding | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | ||
Total revenues | $ 117,029 | $ 257,178 | $ 839,359 | $ 948,911 | |
Cost of revenues | (117,029) | (226,040) | (742,048) | (550,822) | |
Gross profit | 31,138 | 97,311 | 398,089 | ||
Operating expenses: | |||||
Research and development | 1,095,040 | 946,451 | 3,312,699 | 7,944,089 | |
General and administrative | 1,022,051 | 1,235,376 | 4,482,552 | 6,692,904 | |
Total operating expenses | 2,117,091 | 2,181,827 | 7,795,251 | 14,636,993 | |
Loss from operations | (2,117,091) | (2,150,689) | (7,697,940) | (14,238,904) | |
Other income (expense): | |||||
Foreign currency transaction gain (loss) | 1,209 | (366) | 1,483 | (30,549) | |
Interest income (expense), net | 28,842 | (103,568) | (49,129) | (822,611) | |
Research and development incentives | 6,331 | 6,448 | 23,784 | 132,869 | |
CARES Act Employee Retention Credit | 120,771 | ||||
Other income | 40,869 | 43,223 | 5,921 | ||
Loss on extinguishment of debt | (393,791) | ||||
Change in fair value of convertible debt | 165,382 | 43,066 | |||
Total other income (expense) | 201,764 | (56,617) | (210,593) | (714,370) | |
Net loss before income taxes | (1,915,327) | (2,207,306) | (7,908,533) | (14,953,274) | |
Income tax benefit | 1,161,197 | 1,767,803 | 1,154,935 | ||
Net loss applicable to common stockholders | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) | |
Basic net loss per share (in Dollars per share) | [1] | $ (2.42) | $ (5.74) | $ (12.66) | $ (76.84) |
Diluted net loss per share (in Dollars per share) | [1] | $ (2.42) | $ (5.74) | $ (0.79) | $ (4.81) |
Basic weighted average common shares outstanding (in Shares) | [1] | 790,239 | 182,296 | 484,995 | 179,565 |
Diluted weighted average common shares outstanding (in Shares) | [1] | 790,239 | 182,296 | 7,758,036 | 2,871,345 |
Licensing revenue | |||||
Total revenues | $ 250,000 | ||||
Grant revenue | |||||
Total revenues | $ 117,029 | $ 257,178 | $ 839,359 | $ 698,911 | |
[1]Adjusted to reflect the reverse stock split of one-for- sixteen |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Parenthetical) | Jun. 05, 2024 |
Subsequent Event | |
Reverse stock spilt effective from June 5, 2024 | 0.625 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 1,900 | (12,153) | (2,504) | (17,195) |
Comprehensive loss | $ (1,913,427) | $ (1,058,262) | $ (6,143,234) | $ (13,815,534) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Shareholders' Equity/(Deficit) - USD ($) | Preferred Stock Series D Preferred Stock | Common Stock B Riley Sales Agreement [Member] | Common Stock Public Offering | Common Stock | Additional Paid-In Capital B Riley Sales Agreement [Member] | Additional Paid-In Capital Series D Preferred Stock | Additional Paid-In Capital Public Offering | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | B Riley Sales Agreement [Member] | Series D Preferred Stock | Public Offering | Total |
Balance at Dec. 31, 2021 | $ 179 | $ 216,445,584 | $ 41,942 | $ (205,765,107) | $ 10,722,598 | |||||||||
Balance (in shares) at Dec. 31, 2021 | 178,744 | |||||||||||||
Balance at Dec. 31, 2021 | $ 0 | |||||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 1 | $ 79,353 | $ 79,354 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 539 | |||||||||||||
Issuance costs | (2,593) | (2,593) | ||||||||||||
Declaration of Series D preferred stock | 43 | |||||||||||||
Declaration of Series D preferred stock | $ (43) | $ (43) | ||||||||||||
Fractional shares issued in reverse stock split (Shares) | 1,222 | |||||||||||||
Fractional shares issued in reverse stock split | $ 1 | (1) | ||||||||||||
Issuance of common stock to vendors | $ 1 | 212,002 | 212,003 | |||||||||||
Issuance of common stock to vendors (in shares) | 1,393 | |||||||||||||
Share-based compensation expense | 333,389 | 333,389 | ||||||||||||
Foreign currency translation adjustment | (17,195) | (17,195) | ||||||||||||
Net loss | (13,798,339) | (13,798,339) | ||||||||||||
Balance at Dec. 31, 2022 | $ 182 | 217,067,691 | 24,747 | (219,563,446) | (2,470,826) | |||||||||
Balance (in Shares) at Dec. 31, 2022 | 181,898 | |||||||||||||
Balance at Dec. 31, 2022 | 43 | 43 | ||||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 1 | 70,729 | 70,730 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 1,329 | |||||||||||||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | (2,341) | (2,341) | ||||||||||||
Declaration of Series D preferred stock | (43) | |||||||||||||
Share-based compensation expense | 73,634 | 73,634 | ||||||||||||
Foreign currency translation adjustment | (12,153) | (12,153) | ||||||||||||
Net loss | (1,046,109) | (1,046,109) | ||||||||||||
Balance at Mar. 31, 2023 | $ 183 | 217,209,713 | 12,594 | (220,609,555) | (3,387,065) | |||||||||
Balance (in Shares) at Mar. 31, 2023 | 183,227 | |||||||||||||
Balance at Dec. 31, 2022 | $ 182 | 217,067,691 | 24,747 | (219,563,446) | (2,470,826) | |||||||||
Balance (in shares) at Dec. 31, 2022 | 181,898 | |||||||||||||
Balance at Dec. 31, 2022 | 43 | 43 | ||||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 53 | 3,091,409 | 3,091,462 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 53,202 | |||||||||||||
Issuance costs | $ (113,217) | $ (834,061) | $ (113,217) | $ (834,061) | ||||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering | $ 144 | $ 8,495,673 | $ 8,495,817 | |||||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering (in shares) | 143,844 | |||||||||||||
Declaration of Series D preferred stock | (43) | |||||||||||||
Issuance of common stock to vendors | $ 3 | 72,997 | 73,000 | |||||||||||
Issuance of common stock to vendors (in shares) | 3,125 | |||||||||||||
Issuance of common stock associated with conversion of debt | $ 265 | 3,034 | 3,299 | |||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 264,714 | |||||||||||||
Issuance of common stock for unexercised purchase option | $ 2 | 49,998 | 50,000 | |||||||||||
Issuance of common stock for unexercised purchase option (in shares) | 1,978 | |||||||||||||
Share-based compensation expense | 370,182 | 370,182 | ||||||||||||
Foreign currency translation adjustment | (2,504) | (2,504) | ||||||||||||
Net loss | (6,140,730) | (6,140,730) | ||||||||||||
Balance at Dec. 31, 2023 | $ 649 | 228,203,706 | 22,243 | (225,704,176) | 2,522,422 | |||||||||
Balance (in Shares) at Dec. 31, 2023 | 648,761 | |||||||||||||
Balance at Dec. 31, 2023 | $ 0 | |||||||||||||
Issuance of common stock associated with conversion of debt | $ 9 | 99,407 | 99,416 | |||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 9,139 | |||||||||||||
Share-based compensation expense | 59,961 | 59,961 | ||||||||||||
Foreign currency translation adjustment | 1,900 | 1,900 | ||||||||||||
Net loss | (1,915,327) | (1,915,327) | ||||||||||||
Balance at Mar. 31, 2024 | $ 658 | $ 228,363,074 | $ 24,143 | $ (227,619,503) | $ 768,372 | |||||||||
Balance (in Shares) at Mar. 31, 2024 | 657,900 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||||
Net loss | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Amortization and depreciation | 1,588 | 1,785 | 6,554 | 24,562 |
Non-cash lease expense | 29,265 | 26,936 | 111,153 | 112,714 |
Share-based compensation | 59,961 | 73,634 | 370,182 | 333,389 |
Issuance of common stock to vendors for services | 73,000 | 212,003 | ||
Issuance of common stock for unexercised purchase option | 50,000 | |||
Loss on extinguishment of debt | 393,791 | |||
Change in fair value of convertible debt | (165,382) | (43,066) | ||
Amortization of deferred issuance costs associated with convertible debt | 10,242 | 12,518 | 41,538 | |
Change in operating assets and liabilities: | ||||
Contracts and grants receivable | 54,225 | (102,878) | (56,124) | 23,759 |
Prepaid expenses and other current assets | 414,138 | 60,894 | (591,805) | 8,694 |
Research and development incentives receivable | 17,379 | 98,456 | 90,016 | 73,374 |
Operating lease liability | (29,359) | (26,256) | (108,948) | (111,122) |
Accounts payable and accrued expenses | 391,929 | (970,757) | (2,685,073) | 396,651 |
Accrued compensation | (200,899) | (292,200) | (85,577) | 33,756 |
Net cash used in operating activities | (1,342,482) | (2,166,253) | (8,604,109) | (12,649,021) |
Investing activities: | ||||
Purchases of office furniture and equipment | (13,073) | |||
Net cash used in investing activities | (13,073) | |||
Financing activities: | ||||
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | 70,730 | 3,091,462 | 79,354 | |
Proceeds from issuance of common stock and pre-funded warrants pursuant to public offering | 8,495,817 | |||
Convertible debt repayments | (1,000,000) | (7,000,000) | ||
Net cash used in financing activities | (8,992) | (931,558) | 3,663,506 | 76,821 |
Effect of exchange rate on cash and cash equivalents | (3,136) | 4,046 | 27,146 | (99,009) |
Net decrease in cash and cash equivalents | (1,354,610) | (3,093,765) | (4,913,457) | (12,684,282) |
Cash and cash equivalents at beginning of period | 8,446,158 | 13,359,615 | 13,359,615 | 26,043,897 |
Cash and cash equivalents at end of period | 7,091,548 | 10,265,850 | 8,446,158 | 13,359,615 |
Supplemental information: | ||||
Cash paid for state income taxes | 17,965 | 2,110 | 20,730 | 16,043 |
Cash paid for interest | 64,047 | 213,490 | 552,058 | 857,411 |
Cash paid for lease liabilities: | ||||
Operating lease | 34,100 | 33,325 | 133,817 | 133,300 |
Non-cash investing and financing activities: | ||||
Right-of-use assets and lease liabilities recorded | 347,546 | |||
Pontifax conversion of portion of debt principal into common stock | 99,416 | |||
Deferred issuance cost reclassified to additional paid-in capital | 53 | 20,208 | 60 | |
Declaration of Series D preferred stock for stock dividend | 43 | |||
Redemption liability for Series D preferred stock | 43 | 43 | ||
Public offering costs included in accounts payable | 123,689 | |||
B. Riley Sales Agreement | ||||
Financing activities: | ||||
Stock issuance costs associated | $ (2,288) | (93,011) | $ (2,533) | |
Public Offering | ||||
Financing activities: | ||||
Stock issuance costs associated | $ (8,992) | (834,061) | ||
Pre-funded warrants | ||||
Financing activities: | ||||
Proceeds from the exercise of pre-funded warrants | $ 3,299 |
Nature of Business
Nature of Business | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Nature of Business | ||
Nature of Business | Note 1. Nature of Business Basis of Presentation Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions. The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease, the Company is targeting to begin patient enrollment by Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease. The Company’s Public Health Solutions business segment includes development programs for RiVax ® ® The Company primarily generates revenues under government grants and contracts. The Company was awarded a subcontract that originally provided for approximately $1.1 million from a U.S. Food and Drug Administration (“FDA”) Orphan Products Development grant over four years The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability. Results for the three months ended March 31, 2024 are not necessarily indicative of results that may be expected for the full year. Liquidity In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. As of March 31, 2024, the Company had an accumulated deficit of $227,619,503. During the three months ended March 31, 2024, the Company incurred a net loss of $1,915,327 and used $1,342,482 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due through the first quarter of 2025. The Company does not have sufficient cash and cash equivalents as of the date of filing this Quarterly Report on Form 10-Q to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company plans to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, securing additional proceeds available from the sale of shares of the common stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Pontifax Medison Finance (“Pontifax”) to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce the Company’s debt repayments; however, none of these alternatives are committed at this time. There can be no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to it to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that it will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce the Company’s ability to access capital, which could negatively affect its liquidity and ability to continue as a going concern. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations. The accompanying 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, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. As of March 31, 2024, the Company had cash and cash equivalents of $7,091,548 as compared to $8,446,158 as of December 31, 2023, representing a decrease of $1,354,610 or 16%. As of March 31, 2024, the Company had working capital of $607,499 as compared to working capital of $3,355,212 as of December 31, 2023, representing a decrease in working capital of $2,747,713 or 82%. The decrease in cash and cash equivalents was primarily related to cash used in operating activities during the three months ended March 31, 2024. The decrease in working capital is primarily the result of the reclassification of approximately $1 million of the Company’s convertible debt balance from a non-current liability as of December 31, 2023 to a current liability as of March 31, 2024 (resulting from the amendment to the loan and security agreement with Pontifax – see Note 4), and cash used in operating activities during the three months ended March 31, 2024. Management’s business strategy can be outlined as follows: ● Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3 FLASH study, initiate the FLASH2 study, while at the same time, continuing discussions with the FDA on potential modifications to the development path to adequately address their feedback. ● Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. ● Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be required to support a marketing authorization; design a second study and attempt to identify a potential partner(s) to continue this development program. ● Expanding development of dusquetide under the research name SGX945 into Behçet’s Disease with the conduct of a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with United States (“U.S.”) government or non-governmental organization funding support. ● Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies. ● Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. The Company’s plans with respect to its liquidity management include, but are not limited to, the following: ● The Company has up to approximately $673,000 in active government grant funding still available as of March 31, 2024 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding. ● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. ● The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available. ● The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions. ● The Company completed a public offering on April 22, 2024 of 204,694 shares of its common stock, pre-funded warrants to purchase 537,500 shares of its common stock and common warrants to purchase up to 742,194 shares of its common stock at a combined public offering price of $6.40 . The pre-funded warrants have an exercise price of $0.02 . The common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses ( $4.3 million, net). The Company plans to use the proceeds for further support of its programs, as well as for working capital. See Note 8. ● The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing. Nasdaq Capital Market Listing Requirements On June 23, 2023, the Company received a letter from the staff (the “Staff”) of the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between May 9, 2023 through June 22, 2023, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company would be provided with a compliance period of 180 calendar days, or until December 20, 2023, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). The Company was unable to regain compliance prior to the expiration of the 180-day period. On December 21, 2023, the Company received another written notice (the “Notice”) from the Staff stating that the Company had not complied with the minimum bid price requirement and was not eligible for a second 180-day period because the Company did not comply with the $5,000,000 minimum stockholders’ equity initial listing requirement for Nasdaq. As a result, the Notice indicated that the Company’s common stock would be suspended from trading on Nasdaq unless the Company requested a hearing before the Nasdaq Hearings Panel by December 28, 2023. On March 26, 2024, the Company had an oral hearing with a Nasdaq Hearings Panel to appeal the Staff’s delisting determination, which stayed the trading suspension of the Common Stock pending a final written decision by the Nasdaq Hearings Panel and expiration of any additional extension period granted by the panel following the hearing. In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the compliance period. | Soligenix, Inc. and Subsidiaries Notes to Consolidated Financial Statements Note 1. Nature of Business Basis of Presentation Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions. The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (“PDT”) utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the Phase 3 FLASH (Fluorescent Light And Synthetic Hypericin) study, regulatory approval is being pursued in the United States (“U.S.”) and Europe. Following submission of a new drug application (“NDA”) for HyBryte™ in the treatment of CTCL in December 2022, the Company received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) in February 2023. In April 2023, the Company had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards U.S. marketing approval and commercialization. In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 pivotal study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, the Company is collaboratively engaging in active discussions with both the FDA and the European Medicines Agency (“EMA”) in order to define the protocol and evaluate the feasibility of conducting the additional Phase 3 clinical trial evaluating HyBryte™ in the treatment of CTCL in support of potential marketing approval. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease. The Company’s Public Health Solutions business segment includes development programs for RiVax ® ® The Company primarily generates revenues under government grants and contracts principally from the National Institutes of Health (“NIH”). The Company was awarded a subcontract that originally provided The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability. Liquidity In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of December 31, 2023, the Company had an accumulated deficit of $225,704,176 and working capital of $3,355,212. During the year ended December 31, 2023, the Company incurred a net loss of $6,140,730 and used $8,604,109 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due into the fourth quarter of 2024. The Company does not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company plans to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, securing additional proceeds available from the sale of shares of the common stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Pontifax to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce the Company’s debt repayments; however, none of these alternatives are committed at this time. There can be no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to it to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that it will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce the Company’s ability to access capital, which could negatively affect its liquidity and ability to continue as a going concern. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations. The accompanying 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, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. As of December 31, 2023, the Company had cash and cash equivalents of $8,446,158 as compared to $13,359,615 as of December 31, 2022, representing a decrease of $4,913,457 or 37%. As of December 31, 2023, the Company had working capital of $3,355,212 as compared to a working capital deficit of ($2,663,721) as of December 31, 2022, representing an increase of $6,018,933 or 226%. The decrease in cash and cash equivalents was primarily related to cash used in operating activities. The increase in working capital is primarily the result of the net proceeds received from financing activities partially offset by the immediate paydown of $5 million of outstanding debt principal balance and any accrued interest resulting from the amendment to the convertible debt financing agreement with Pontifax during the year ended December 31, 2023. Management’s business strategy can be outlined as follows: ● Following positive primary endpoint results for the Phase 3 FLASH (Florescent Light Activated Synthetic Hypericin) clinical trial of HyBryte ™ in CTCL as well as further statistically significant improvement in response rates with longer treatment (18 weeks compared to 12 and 6 weeks of treatment), collaboratively engage in discussions with both the FDA and the EMA in order to define the protocol and evaluate the feasibility of conducting a second clinical study in order to advance HyBryte ™ towards U.S. marketing approval and commercialization while continuing to explore potential marketing approval and partnership in Europe. ● Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. ● Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be required to support a marketing authorization; design a second study and attempt to identify a potential partner(s) to continue this development program. ● Expanding development of dusquetide under the research name SGX945 into Beh ç et ’ s Disease with the conduct of a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with U.S. government or non-governmental organization funding support. ● Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies. ● Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. The Company’s plans with respect to its liquidity management include, but are not limited to, the following: ● The Company has up to approximately $844,000 in active government grant funding still available as of December 31, 2023 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding. ● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. ● The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available. ● The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions. ● The Company completed a public offering of 143,844 shares of its common stock, pre-funded warrants to purchase 264,813 shares of its common stock and common warrants to purchase up to 408,656 shares of its common stock at a combined public offering price of $20.80 . The pre-funded warrants had an exercise price of $0.001 . The common warrants have an exercise price of $24.00 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering was approximately $8.5 million before deducting commissions and other estimated offering expenses. The Company plans to use the proceeds for further support of its programs, as well as for working capital; and ● The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that it can consummate such a transaction, or consummate a transaction at favorable pricing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies | ||
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Principles of Consolidation The condensed consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. Impairment of Long-Lived Assets Office furniture and equipment and right of use assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the three months ended March 31, 2024 and 2023. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the condensed consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the condensed consolidated balance sheet as of March 31, 2024 for the convertible debt is its fair value - see Note 4. The principal amount of the convertible debt was $2,900,585 at March 31, 2024 and the fair value was $2,996,136. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to March 31, 2024 is as follows: Balance Conversion Adjustment to Balance December 31, 2023 January 3, 2024 fair value March 31, 2024 Convertible debt at fair value $ 3,260,934 $ (99,416) $ (165,382) $ 2,996,136 Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year three years three months From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. There were no options issued during the three months ended March 31, 2024 and 2023. Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company did not recognize an income tax benefit during the three months ended March 31, 2024. The Company recognized $1,161,197 of income tax benefit, net of transaction costs from the sale of its 2021 NOL carryforwards during the three months ended March 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for the three months ended March 31, 2024 and 2023. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at March 31, 2024 or December 31, 2023. Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the three months ended March 31, 2024, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: As of March 31, 2024 2023 Common stock purchase warrants 408,640 — Stock options 56,568 11,946 Convertible debt 335,716 105,746 Total 800,924 117,692 The weighted average exercise prices of the Company’s warrants and stock options outstanding at March 31, 2024 were $24.00 and $87.15 per share, respectively. The weighted average exercise prices of the Company’s stock options outstanding at March 31, 2023 was $435.32 per share. The weighted average conversion price of the Company’s convertible debt at March 31, 2024 and 2023 was $138.24 and $453.92 per share, respectively. Use of Estimates and Assumptions The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. (“GAAP”) requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. | Note 2. Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Contracts and Grants Receivable In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326) Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. Impairment of Long-Lived Assets Office furniture and equipment, right of use assets and website development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 2023 and 2022. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, to the Company on December 31, 2023 and 2022. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the consolidated balance sheet as of December 31, 2023 for the convertible debt is its fair value – see Note 5. The principal amount of the convertible debt was $3,000,000 at December 31, 2023 and the fair value was approximately $3,260,934. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to December 31, 2023 is as follows: Balance Adjustment to Balance December 31, 2022 Issued fair value December 31, 2023 Convertible debt at fair value $ — $ 3,304,000 $ (43,066) $ 3,260,934 Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the years ended December 31, 2023 and 2022 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of four years ; ● volatility of 94% - 110% for 2023 and 84% - 87% for 2022; and ● risk-free interest rates ranging from 3.48% to 4.35% in 2023 and ranging from 1.12% to 4.51% in 2022. The fair value of each option grant made during 2023 and 2022 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. The expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for forfeitures as they are incurred. Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company sold 2022, 2021 and 2020 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $1,767,803 and $1,154,935 during the years ended December 31, 2023 and 2022, respectively. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2023 and 2022. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2023 or 2022. Research and Development Incentive Income and Receivable The Company recognizes other income from UK research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income. The research and development incentive receivable represents an amount due in connection with the above-described tax relief program. The Company has recorded a research and development incentive receivable of approximately $49,000 and $128,000 as of December 31, 2023 and 2022, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to December 31, 2023: Current Long-Term Total Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 UK research and development incentives, transfer 24,114 (24,114) — UK research and development incentives — 24,897 24,897 Adjustments to 2021 and 2022 incentives earned (1,113) — (1,113) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 1,117 571 1,688 Balance at December 31, 2023 $ 23,894 $ 25,468 $ 49,362 Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the year ended December 31, 2023, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: December 31, December 31, 2023 2022 Common stock purchase warrants 408,640 42 Stock options 56,609 11,946 Convertible debt 273,973 30,865 Total 739,222 42,853 Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Accrued Expenses
Accrued Expenses | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Accrued Expenses | ||
Accrued Expenses | Note 3. Accrued Expenses The following is a summary of the Company’s accrued expenses: March 31, December 31, 2024 2023 Clinical trial expenses $ 2,070,955 $ 1,993,784 Other 531,710 424,218 Total $ 2,602,665 $ 2,418,002 | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: December 31, 2023 2022 Clinical trial expenses $ 1,993,784 $ 1,884,117 Other 424,218 423,629 Total $ 2,418,002 $ 2,307,746 |
Debt
Debt | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Debt | ||
Debt | Note 4. Debt In December 2020, the Company entered into a $20 million convertible debt financing agreement with Pontifax. Under the terms of the agreement with Pontifax, the Company had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years Upon the closing of this transaction, the Company borrowed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the new drug application for HyBryte™, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively. On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement dated December 15, 2020 with Pontifax. The amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the amendment reduced the conversion price with respect to the remaining principal amount under the agreement to (i) 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares of the Company’s common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon conversion in excess of the first 36,790 shares so issued. The remaining terms of the agreement remain in effect without modification. On January, 3, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 9,139 shares of the Company’s common stock at $10.88 per share, reducing the remaining principal balance by $99,416. Pontifax may elect to convert the remaining outstanding loan drawn under the first tranche into additional shares of the Company’s common stock at any time prior to repayment. The Company also has the ability to force the conversion of the loan into shares of its common stock, subject to certain conditions. The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. The Company concluded that the amended debt instrument has an embedded derivative that requires bifurcation pursuant to ASC 815-15-25-1 and qualifies for the fair value option in accordance with ASC 815-15-25-4 through ASC 815-15-25-6. The Company elected to account for the amended convertible debt using the fair value option, which requires the Company to record changes in fair value as a component of other income or expense. The fair value of the convertible debt as of March 31, 2024 was $2,996,136, which resulted in the recognition of $165,382 of other income from the change in the fair value of the convertible debt on the Company’s accompanying condensed consolidated statements of operations during the three months ended March 31, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method. The key assumptions used in the Monte Carlo valuations were as follows: Assumptions 12/31/2023 3/31/2024 Stock price $ 0.76 $ 0.60 Volatility 141.90% 148.80% Discount rate 13.62% 16.16% Risk-free rate 4.65% 5.03% Interest expense incurred during the three months ended March 31, 2024 and 2023 was $61,239 and $187,964, respectively. Interest expense paid during the three months ended March 31, 2024 and 2023 was $64,047 and $213,490, respectively. Annual principal and interest payments due as of March 31, 2024 in accordance with the amended terms of the Pontifax loan agreement, including the January 3, 2024 conversion and assuming no further conversions are as follows: Year Principal Interest Total Remainder of 2024 $ 2,250,000 $ 198,305 $ 2,448,305 2025 650,585 13,889 664,474 Total $ 2,900,585 $ 212,194 $ 3,112,779 | Note 5. Debt In December 2020, the Company entered into a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing (“Pontifax”), the healthcare-dedicated venture and debt fund of the Pontifax life science funds. Under the terms of the agreement with Pontifax, the Company had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years with a fixed interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal is to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The agreement is secured by a lien covering substantially all of the Company’s assets, other than intellectual property. Upon the closing of this transaction, the Company accessed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the HyBryte™ NDA, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively. On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement dated December 15, 2020 with Pontifax. The amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the amendment reduced the conversion price with respect to the remaining principal amount under the agreement to (i) 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares of the Company’s common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon conversion in excess of the first 36,790 shares so issued. The remaining terms of the agreement remain in effect without modification. The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. The Company concluded that the amended debt instrument has an embedded derivative that requires bifurcation pursuant to ASC 815-15-25-1 and qualifies for the fair value option in accordance with ASC 815-15-25-4 through ASC 815-15-25-6. The Company elected to account for the amended convertible debt using the fair value option, which requires the Company to record changes in fair value as a component of other income or expense. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt was estimated using the Monte Carlo valuation method. Assumptions 4/19/2023 9/30/2023 12/31/2023 Stock price $ 1.72 $ 0.56 $ 0.76 Volatility 75.20% 110.50% 141.90% Discount rate 16.28% 14.84% 13.62% Risk-free rate 4.27% 5.24% 4.65% Interest expense incurred during the years ended December 31, 2023 and 2022 was $402,615 and $847,000, respectively. Interest expense paid during the years ended December 31, 2023 and 2022 was $552,058 and $857,411, respectively. Pontifax may elect to convert the outstanding loan drawn into shares of the Company’s common stock at any time prior to repayment. There was $3,000,000 of principal and $63,351 of accrued interest outstanding as of December 31, 2023.The Convertible Notes were convertible at (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares issuable upon conversion as of December 31, 2023 and (ii) $27.20 with respect to all shares issuable upon conversion in excess of the first 36,790 shares issued upon conversion as of December 31, 2023. The Company also has the ability to force the conversion of the loan into shares of the Company’s common stock at the same conversion price, subject to certain conditions. Annual principal and interest payments due, according to the agreement’s contractual terms, assuming no conversion is as follows: Year Principal Interest Total 2024 $ 2,250,000 $ 270,808 $ 2,520,808 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 286,820 $ 3,286,820 |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Shareholders' Equity | ||
Shareholders' Equity | Note 5. Shareholders’ Equity Common Stock The following items represent transactions in the Company’s common stock for the three months ended March 31, 2024: ● The Company issued Pontifax 9,139 shares of fully vested common stock pursuant to conversion of a portion of the convertible debt principal balance at a conversion price of $10.88 per share on January 3, 2024, the date of issuance. The conversion price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice. The issuance of the Company’s common stock in connection with the convertible debt financing agreement as described above was exempt under Section 3(a)(9) of the Securities Act of 1933, as amended. | Note 7. Shareholders’ Equity (Deficit) Preferred Stock The Company has 350,000 shares of preferred stock authorized, of which 50,000 were designated as Series D preferred stock during the year ended December 31, 2023. Series D Preferred Stock On December 21, 2022, the Board of Directors of the Company declared a dividend for the stockholders of record on January 3, 2023. The dividend consists of one one-thousandth General; Transferability - Series D preferred stock shares will be in book-entry form without certificates. Transfers can only happen alongside common stock transfers, with 1/1,000th Voting Rights - Each Series D preferred stock share gives the holder 1,000,000 votes. If a shareholder owns a fraction of a share, they will have a proportional number of votes. Series D preferred stock and common stock shares only vote together on two specific matters: 1. Any plan to change the Company's Certificate of Incorporation for a reverse stock split. 2. Any plan to delay a stockholders' meeting to vote on a reverse stock split (the "Adjournment Proposal"). When voting on the reverse stock split or the Adjournment Proposal, each Series D preferred stock share (or fraction of a share) will vote the same way as the common stock share it was issued from. Dividend Rights - The holders of Series D preferred stock will not be entitled to receive dividends of any kind. Liquidation Preference - If the Company undergoes liquidation, dissolution, or winding up, Series D preferred stock has priority over common stock for asset distribution. In such a situation, Series D preferred stockholders will receive a cash payment of $0.001 per share before any distribution is made to common stockholders. Redemption - If Series D preferred stockholders do not attend or vote by proxy at a meeting for the reverse stock split and Adjournment Proposal, their shares will be automatically redeemed by the Company. If any Series D preferred stock remains after this redemption, it can be redeemed in one of two ways: 1. The Board decides to redeem the shares at a time and date of their choosing. 2. The shares will be automatically redeemed when the Company's stockholders approve the reverse stock split during a meeting for this purpose. When Series D preferred stock is redeemed, stockholders receive a cash payment based on the number of shares they own. For every 100 whole shares redeemed, the stockholder will get $0.10 in cash. The Series D preferred stock shares were classified as mezzanine equity as of December 31, 2022 since they were not mandatorily redeemable but were redeemable based on an event not entirely controlled by the Company. All Series D preferred stock were redeemed in conjunction with the special meeting of the shareholders’ on February 8, 2023. Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2023: ● The Company issued a vendor 3 ,125 shares of fully vested common stock with a fair value based on a closing price of $23.36 per share on April 27, 2023, the date of issuance. ● The Company sold 53,202 shares of common stock pursuant to the At Market Issuance Sales Agreement (“B. Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”) at a weighted average price of $58.08 per share. ● The Company issued 1,978 shares of fully vested common stock pursuant to an exclusive option agreement at $25.28 per share on May 2, 2023. The share price was calculated using the average closing price of the common stock for the ten days immediately preceding April 27, 2023, the effective date of the option agreement . ● The Company sold 143,844 shares of common stock and 264,813 pre-funded warrants pursuant to the May 2023 public offering for $20.80 per share on May 9, 2023. ● The Company issued 126,438 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 9, 2023. ● The Company issued 58,625 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 10, 2023. ● The Company issued 21,125 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 22, 2023. ● The Company issued 25,001 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on June 8, 2023. ● The Company issued 33,525 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on September 6, 2023. The following items represent transactions in the Company’s common stock for the year ended December 31, 2022: ● The Company issued a vendor 337 shares of fully vested common stock with a fair value of $148.80 per share on February 7, 2022. ● The Company issued a vendor 401 shares of fully vested common stock with a fair value of $124.80 per share on May 6, 2022. ● The Company issued a vendor 229 shares of fully vested common stock with a fair value of $218.40 per share on August 5, 2022. ● The Company issued a vendor 105 shares of fully vested common stock with a fair value of $115.20 per share on October 4, 2022. ● The Company issued a vendor 321 shares of fully vested common stock with a fair value of $156.00 per share on November 7, 2022. ● The Company issued 539 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $148.64 per share. All issuances of the Company’s common stock for the years ended December 31, 2023 and 2022 described above, other than shares issued to vendors or issued pursuant to the exclusive option agreement, were registered on a Registration Statement on Form S-8 (SEC File No. 333-208515), a Registration Statement on Form S-1 (333-271049) and a Registration Statement on Form S-3 (SEC File No. 333-239928). The certificates evidencing unregistered shares reflect a Securities Act of 1933, as amended, restrictive legend. The issuances of the Company’s common stock to vendors and pursuant to the exclusive option agreement as described above were exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about the Company or had adequate access to information about the Company. The vendors represented to the Company that the vendors are not “consultants” for purposes of Nasdaq Listing Rule 5635(c). B. Riley At Market Issuance Sales Agreement On August 11, 2017, the Company entered into the B. Riley Sales Agreement to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program under which B. Riley acts as sales agent. Under the B. Riley Sales Agreement, the Company set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The B. Riley Sales Agreement provided that B. Riley was entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the B. Riley Sale Agreement. The B. Riley Sales Agreement has expired. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Commitments and Contingencies. | ||
Commitments and Contingencies | Note 6. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $230,000 as of March 31, 2024 over the next five years for several licensing agreements with partners and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to approximately $13.2 million, royalties on net sales of covered products ranging from 2% to 3% sub-license Investigational New Drug (“IND”) milestones on covered products of up to approximately $200,000, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. The Company currently leases office space which serves as the Company’s corporate headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended to October 2025. The current rent of $11,367 per month will be maintained until November 2024 when it will be increased to $11,625 per month where it will remain until expiration. In September 2014, the Company entered into an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 771 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to GAAP. In March 2020, the Company issued 8,151 shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the purchase agreement. Provided the sole remaining future success-oriented milestone of FDA approval is attained, the Company will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of March 31, 2024, no other milestone or royalty payments have been paid or accrued. As a result of the above agreements, the Company has the following contractual obligations: Research and Property and Year Development Other Leases Total April 1 through December 31, 2024 $ 46,000 $ 102,817 $ 148,817 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 219,067 $ 449,067 Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. | Note 10. Commitments and Contingencies The Company has commitments of approximately $230,000 as of December 31, 2023 over the next five years for several licensing agreements with partners and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to approximately $13.2 million, royalties on net sales of covered products ranging from 2% to 3%, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey. This office space currently serves as the Company’s corporate headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended from November 2022 to October 2025. The current rent is approximately $11,367 per month and will remain so through October 2024. The rent for the lease period starting November 2024 is approximately $11,625 per month. On September 3, 2014, the Company entered into an asset purchase agreement with Hy Biopharma, Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 12,328 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the U.S. In March 2020, the Company issued 130,413 fully vested shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued to Hy Biopharma was calculated using an effective price of $38.40 per share, based upon a formula set forth in the purchase agreement. Provided the sole remaining future success-oriented milestone of FDA approval is attained, the Company will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of December 31, 2023, no other milestone or royalty payments have been paid or accrued. In January 2020, the Company’s Board of Directors authorized the amendment of Dr. Schaber’s employment agreement to increase the number of shares of the Company’s common stock from 334 to 33,334 issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by its Board of Directors whereby, directly or indirectly, a majority of its capital stock or a majority of its assets are transferred from the Company and/or its stockholders to a third party. As a result of the above agreements, the Company has future contractual obligations over the next five years as follows: Research and Property and Year Development Other Leases Total 2024 $ 46,000 $ 136,917 $ 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 253,167 $ 483,167 Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. COVID-19 Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites. COVID-19 affected the Company’s operations but did not have a material impact on the Company’s business, operating results, financial condition or cash flows as of and for the year ended December 31, 2023. The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus. |
Operating Segments
Operating Segments | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Operating Segments | ||
Operating Segments | Note 7. Operating Segments The Company maintains two active operating segments: Specialized BioTherapeutics and Public Health Solutions. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments. Three Months Ended March 31, 2024 2023 Revenues Specialized BioTherapeutics $ 117,029 $ 155,365 Public Health Solutions — 101,813 Total $ 117,029 $ 257,178 Income (loss) from Operations Specialized BioTherapeutics $ (860,604) $ (910,377) Public Health Solutions (45,997) 427 Corporate (1,210,490) (1,240,739) Total $ (2,117,091) $ (2,150,689) Amortization and Depreciation Expense Specialized BioTherapeutics $ 953 $ 1,071 Public Health Solutions 159 178 Corporate 476 536 Total $ 1,588 $ 1,785 Other (Expense) Income, Net Specialized BioTherapeutics $ 7,540 $ 6,082 Corporate 194,224 (62,699) Total $ 201,764 $ (56,617) Share-Based Compensation Specialized BioTherapeutics $ 20,672 $ 27,427 Public Health Solutions 588 994 Corporate 38,701 45,213 Total $ 59,961 $ 73,634 As of As of March 31, December 31, 2024 2023 Identifiable Assets Specialized BioTherapeutics $ 301,709 $ 272,099 Public Health Solutions 120,475 3,976 Corporate 7,636,201 9,521,251 Total $ 8,058,385 $ 9,797,326 | Note 11. Operating Segments The Company maintains two active operating segments: Specialized BioTherapeutics and Public Health Solutions. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments. For the Years Ended December 31, 2023 2022 Revenues Specialized BioTherapeutics $ 395,124 $ 31,929 Public Health Solutions 444,235 916,982 Total $ 839,359 $ 948,911 Income (loss) from Operations Specialized BioTherapeutics $ (2,812,303) $ (7,614,988) Public Health Solutions (36,531) 26,612 Corporate (4,849,106) (6,650,528) Total $ (7,697,940) $ (14,238,904) Amortization and Depreciation Expense Specialized BioTherapeutics $ 3,932 $ 10,087 Public Health Solutions 655 1,681 Corporate 1,967 12,794 Total $ 6,554 $ 24,562 Other (Expense) Income, Net Specialized BioTherapeutics $ 25,267 $ 102,320 Corporate (235,860) (816,690) Total $ (210,593) $ (714,370) Share-Based Compensation Specialized BioTherapeutics $ 145,683 $ 138,075 Public Health Solutions 4,782 4,804 Corporate 219,717 190,510 Total $ 370,182 $ 333,389 As of December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 272,099 $ 103,742 Public Health Solutions 3,976 121,290 Corporate 9,521,251 14,054,685 Total $ 9,797,326 $ 14,279,717 |
Subsequent Events
Subsequent Events | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Subsequent Events | ||
Subsequent Events | Note 8. Subsequent Events Pontifax Conversion of Convertible Debt On April 15, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 27,651 shares of the Company’s common stock at $5.60 per share, reducing the remaining principal balance by $154,840. Pontifax may elect to convert the remaining outstanding loan drawn under the first tranche into additional shares of the Company’s common stock at any time prior to repayment. The Company also has the ability to force the conversion of the loan into shares of its common stock, subject to certain conditions. $ 4.75 million Public Offering On April 22, 2024, the Company completed a public offering of (i) 204,694 shares of the Company’s common stock, (ii) pre-funded warrants to purchase 537,500 shares of the Company’s common stock and (iii) common warrants to purchase 742,194 shares of the Company’s common stock. The shares of common stock, or pre-funded warrants in lieu thereof, and the common warrants, were sold in units, with each unit consisting of one share of common stock or one pre-funded warrant in lieu thereof and one common warrant. Each unit comprised of common stock and common warrants was sold at a per unit price of $6.40. Each unit comprised of pre-funded warrants and common warrants was sold at a per unit price of $6.38, which represents the same per unit price less the $0.02 per share exercise price of the pre-funded warrants. The common warrants are exercisable at a price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses payable by the Company ($4.3 million, net). | Note 12. Subsequent Event Convertible Debt Financing Agreement On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement with Pontifax (See Note 5). The amendment reduced the conversion price with respect to the remaining principal amount outstanding under the agreement. The conversion price was amended to be (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 3 6,790 shares of our common stock issuable upon conversion and (ii) $27.20 with respect to all shares of our common stock issuable upon conversion in excess of the first 3 6,790 shares so issued. Conversion of Promissory Notes On January 3, 2024, the Company issued an aggregate of 9,139 shares of common stock to two lenders upon conversion of approximately $100,000 of principal under promissory notes at a conversion price of $10.88 per share. Remaining Convertible Debt As of March 8, 2024, $2,900,585 of principal and $45,840 of accrued interest remain outstanding under the agreement. The conversion price for the remaining principal amount as of March 8, 2024 is (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 27,651 shares of common stock issuable upon conversion and (ii) $27.40 with respect to all shares issuable upon conversion in excess of the first 27,651 shares so issued. |
Reverse Stock Split
Reverse Stock Split | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Shareholders' Equity | ||
Reverse Stock Split | Note 9. Reverse Stock Split On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-sixteen, whereby every sixteen | Note 13. Reverse Stock Split On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for- sixteen |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies | ||
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. | Principles of Consolidation The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. |
Operating Segments | Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. | Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. |
Contracts and Grants Receivable | Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. | Contracts and Grants Receivable In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326) Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Office furniture and equipment and right of use assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the three months ended March 31, 2024 and 2023. | Impairment of Long-Lived Assets Office furniture and equipment, right of use assets and website development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 2023 and 2022. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the condensed consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the condensed consolidated balance sheet as of March 31, 2024 for the convertible debt is its fair value - see Note 4. The principal amount of the convertible debt was $2,900,585 at March 31, 2024 and the fair value was $2,996,136. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to March 31, 2024 is as follows: Balance Conversion Adjustment to Balance December 31, 2023 January 3, 2024 fair value March 31, 2024 Convertible debt at fair value $ 3,260,934 $ (99,416) $ (165,382) $ 2,996,136 | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, to the Company on December 31, 2023 and 2022. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the consolidated balance sheet as of December 31, 2023 for the convertible debt is its fair value – see Note 5. The principal amount of the convertible debt was $3,000,000 at December 31, 2023 and the fair value was approximately $3,260,934. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to December 31, 2023 is as follows: Balance Adjustment to Balance December 31, 2022 Issued fair value December 31, 2023 Convertible debt at fair value $ — $ 3,304,000 $ (43,066) $ 3,260,934 |
Deferred Issuance Costs | Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. | Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. |
Revenue Recognition | Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. | Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development | Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development |
Share-Based Compensation | Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year three years three months From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. There were no options issued during the three months ended March 31, 2024 and 2023. | Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the years ended December 31, 2023 and 2022 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of four years ; ● volatility of 94% - 110% for 2023 and 84% - 87% for 2022; and ● risk-free interest rates ranging from 3.48% to 4.35% in 2023 and ranging from 1.12% to 4.51% in 2022. The fair value of each option grant made during 2023 and 2022 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. The expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for forfeitures as they are incurred. |
Foreign Currency Transactions and Translation | Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters | Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company did not recognize an income tax benefit during the three months ended March 31, 2024. The Company recognized $1,161,197 of income tax benefit, net of transaction costs from the sale of its 2021 NOL carryforwards during the three months ended March 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for the three months ended March 31, 2024 and 2023. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at March 31, 2024 or December 31, 2023. | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company sold 2022, 2021 and 2020 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $1,767,803 and $1,154,935 during the years ended December 31, 2023 and 2022, respectively. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2023 and 2022. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2023 or 2022. |
Research and Development Incentive Income and Receivable | Research and Development Incentive Income and Receivable The Company recognizes other income from UK research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income. The research and development incentive receivable represents an amount due in connection with the above-described tax relief program. The Company has recorded a research and development incentive receivable of approximately $49,000 and $128,000 as of December 31, 2023 and 2022, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to December 31, 2023: Current Long-Term Total Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 UK research and development incentives, transfer 24,114 (24,114) — UK research and development incentives — 24,897 24,897 Adjustments to 2021 and 2022 incentives earned (1,113) — (1,113) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 1,117 571 1,688 Balance at December 31, 2023 $ 23,894 $ 25,468 $ 49,362 | |
Loss Per Share | Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the three months ended March 31, 2024, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: As of March 31, 2024 2023 Common stock purchase warrants 408,640 — Stock options 56,568 11,946 Convertible debt 335,716 105,746 Total 800,924 117,692 The weighted average exercise prices of the Company’s warrants and stock options outstanding at March 31, 2024 were $24.00 and $87.15 per share, respectively. The weighted average exercise prices of the Company’s stock options outstanding at March 31, 2023 was $435.32 per share. The weighted average conversion price of the Company’s convertible debt at March 31, 2024 and 2023 was $138.24 and $453.92 per share, respectively. | Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the year ended December 31, 2023, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: December 31, December 31, 2023 2022 Common stock purchase warrants 408,640 42 Stock options 56,609 11,946 Convertible debt 273,973 30,865 Total 739,222 42,853 |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. (“GAAP”) requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. | Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies | ||
Schedule of carrying value of convertible debt | A roll forward of the carrying value of the convertible debt to March 31, 2024 is as follows: Balance Conversion Adjustment to Balance December 31, 2023 January 3, 2024 fair value March 31, 2024 Convertible debt at fair value $ 3,260,934 $ (99,416) $ (165,382) $ 2,996,136 | Balance Adjustment to Balance December 31, 2022 Issued fair value December 31, 2023 Convertible debt at fair value $ — $ 3,304,000 $ (43,066) $ 3,260,934 |
Schedule of United Kingdom research and development incentives receivable | Current Long-Term Total Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 UK research and development incentives, transfer 24,114 (24,114) — UK research and development incentives — 24,897 24,897 Adjustments to 2021 and 2022 incentives earned (1,113) — (1,113) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 1,117 571 1,688 Balance at December 31, 2023 $ 23,894 $ 25,468 $ 49,362 | |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of March 31, 2024 2023 Common stock purchase warrants 408,640 — Stock options 56,568 11,946 Convertible debt 335,716 105,746 Total 800,924 117,692 | December 31, December 31, 2023 2022 Common stock purchase warrants 408,640 42 Stock options 56,609 11,946 Convertible debt 273,973 30,865 Total 739,222 42,853 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Accrued Expenses | ||
Schedule of accrued expenses | March 31, December 31, 2024 2023 Clinical trial expenses $ 2,070,955 $ 1,993,784 Other 531,710 424,218 Total $ 2,602,665 $ 2,418,002 | December 31, 2023 2022 Clinical trial expenses $ 1,993,784 $ 1,884,117 Other 424,218 423,629 Total $ 2,418,002 $ 2,307,746 |
Debt (Tables)
Debt (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Debt | ||
Schedule of debt assumptions | Assumptions 12/31/2023 3/31/2024 Stock price $ 0.76 $ 0.60 Volatility 141.90% 148.80% Discount rate 13.62% 16.16% Risk-free rate 4.65% 5.03% | Assumptions 4/19/2023 9/30/2023 12/31/2023 Stock price $ 1.72 $ 0.56 $ 0.76 Volatility 75.20% 110.50% 141.90% Discount rate 16.28% 14.84% 13.62% Risk-free rate 4.27% 5.24% 4.65% |
Schedule of annual principle and interest payments due | Year Principal Interest Total Remainder of 2024 $ 2,250,000 $ 198,305 $ 2,448,305 2025 650,585 13,889 664,474 Total $ 2,900,585 $ 212,194 $ 3,112,779 | Year Principal Interest Total 2024 $ 2,250,000 $ 270,808 $ 2,520,808 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 286,820 $ 3,286,820 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Commitments and Contingencies. | ||
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total April 1 through December 31, 2024 $ 46,000 $ 102,817 $ 148,817 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 219,067 $ 449,067 | Research and Property and Year Development Other Leases Total 2024 $ 46,000 $ 136,917 $ 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 253,167 $ 483,167 |
Operating Segments (Tables)
Operating Segments (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Operating Segments | ||
Schedule of operating segments | Three Months Ended March 31, 2024 2023 Revenues Specialized BioTherapeutics $ 117,029 $ 155,365 Public Health Solutions — 101,813 Total $ 117,029 $ 257,178 Income (loss) from Operations Specialized BioTherapeutics $ (860,604) $ (910,377) Public Health Solutions (45,997) 427 Corporate (1,210,490) (1,240,739) Total $ (2,117,091) $ (2,150,689) Amortization and Depreciation Expense Specialized BioTherapeutics $ 953 $ 1,071 Public Health Solutions 159 178 Corporate 476 536 Total $ 1,588 $ 1,785 Other (Expense) Income, Net Specialized BioTherapeutics $ 7,540 $ 6,082 Corporate 194,224 (62,699) Total $ 201,764 $ (56,617) Share-Based Compensation Specialized BioTherapeutics $ 20,672 $ 27,427 Public Health Solutions 588 994 Corporate 38,701 45,213 Total $ 59,961 $ 73,634 As of As of March 31, December 31, 2024 2023 Identifiable Assets Specialized BioTherapeutics $ 301,709 $ 272,099 Public Health Solutions 120,475 3,976 Corporate 7,636,201 9,521,251 Total $ 8,058,385 $ 9,797,326 | For the Years Ended December 31, 2023 2022 Revenues Specialized BioTherapeutics $ 395,124 $ 31,929 Public Health Solutions 444,235 916,982 Total $ 839,359 $ 948,911 Income (loss) from Operations Specialized BioTherapeutics $ (2,812,303) $ (7,614,988) Public Health Solutions (36,531) 26,612 Corporate (4,849,106) (6,650,528) Total $ (7,697,940) $ (14,238,904) Amortization and Depreciation Expense Specialized BioTherapeutics $ 3,932 $ 10,087 Public Health Solutions 655 1,681 Corporate 1,967 12,794 Total $ 6,554 $ 24,562 Other (Expense) Income, Net Specialized BioTherapeutics $ 25,267 $ 102,320 Corporate (235,860) (816,690) Total $ (210,593) $ (714,370) Share-Based Compensation Specialized BioTherapeutics $ 145,683 $ 138,075 Public Health Solutions 4,782 4,804 Corporate 219,717 190,510 Total $ 370,182 $ 333,389 As of December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 272,099 $ 103,742 Public Health Solutions 3,976 121,290 Corporate 9,521,251 14,054,685 Total $ 9,797,326 $ 14,279,717 |
Nature of Business (Details)
Nature of Business (Details) | 3 Months Ended | 12 Months Ended | |||||||||||||||
Jun. 05, 2024 | Apr. 22, 2024 USD ($) $ / shares shares | Jan. 03, 2024 USD ($) $ / shares shares | May 09, 2023 USD ($) $ / shares shares | May 02, 2023 $ / shares shares | Apr. 27, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | May 06, 2022 shares | Apr. 27, 2022 shares | Feb. 07, 2022 shares | Mar. 31, 2024 USD ($) segment shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) segment shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Nature of business: | |||||||||||||||||
Number of operating segments | segment | 2 | 2 | |||||||||||||||
Collaborative Arrangement, Revenue Not from Contract with Customer, Statement of Income or Comprehensive Income [Extensible Enumeration] | Revenues | ||||||||||||||||
Net loss | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) | |||||||||||||
Net cash used in operating activities | (1,342,482) | (2,166,253) | (8,604,109) | (12,649,021) | |||||||||||||
Reclassification of Convertible Debt From Non-Current to current Liability | 1,000,000 | ||||||||||||||||
Number of shares sold | 70,730 | ||||||||||||||||
Cash and cash equivalents | 7,091,548 | 10,265,850 | 8,446,158 | 13,359,615 | $ 26,043,897 | ||||||||||||
Net decrease in cash | $ 1,354,610 | 3,093,765 | $ 4,913,457 | 12,684,282 | |||||||||||||
Percentage change in cash and cash equivalent | 16% | 37% | |||||||||||||||
Accumulated deficit | $ 227,619,503 | $ 225,704,176 | 219,563,446 | ||||||||||||||
Working capital | 607,499 | $ 3,355,212 | (2,663,721) | ||||||||||||||
Working capital increase, decrease | $ (2,747,713) | $ 6,018,933 | |||||||||||||||
Working capital increase (decrease) as a percent | 82% | 226% | |||||||||||||||
Common Stock, Shares, Issued | shares | 657,900 | 648,761 | |||||||||||||||
Number of shares issued | shares | 3 | 321 | 105 | 229 | 401 | 3 | 337 | ||||||||||
Repayment of debt principal | 1,000,000 | $ 7,000,000 | |||||||||||||||
Consideration paid recorded in general and administrative expense | $ 1,022,051 | 1,235,376 | 4,482,552 | $ 6,692,904 | |||||||||||||
Issuance of common stock for unexercised purchase option | 50,000 | ||||||||||||||||
Pontifax [Member] | |||||||||||||||||
Nature of business: | |||||||||||||||||
Repayment of debt principal | $ 5,000,000 | ||||||||||||||||
Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Total gross proceeds | $ 8,500,000 | ||||||||||||||||
Shares issued price per share | $ / shares | $ 20.80 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Common Stock | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares sold | $ 1 | ||||||||||||||||
Issuance of common stock for unexercised purchase option (in shares) | shares | 1,978 | ||||||||||||||||
Issuance of common stock for unexercised purchase option | $ 2 | ||||||||||||||||
Common Stock | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Shares issued price per share | $ / shares | $ 20.80 | ||||||||||||||||
Number of shares issued | shares | 143,844 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 24 | ||||||||||||||||
Subsequent Event | |||||||||||||||||
Nature of business: | |||||||||||||||||
Shares issued price per share | $ / shares | $ 6.40 | ||||||||||||||||
Reverse stock spilt effective from June 5, 2024 | 0.625 | ||||||||||||||||
Subsequent Event | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Total gross proceeds | $ 4,750,000 | ||||||||||||||||
Shares issued price per share | $ / shares | $ 6.40 | ||||||||||||||||
Number of shares issued | shares | 143,844 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.02 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Net proceeds | $ 4,300,000 | ||||||||||||||||
Subsequent Event | Common Stock | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares issued | shares | 204,694 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 6.40 | ||||||||||||||||
Pre-funded warrants | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 264,813 | ||||||||||||||||
Pre-funded warrants | Subsequent Event | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 537,500 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.02 | ||||||||||||||||
Common warrants | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 408,656 | ||||||||||||||||
Common warrants | Subsequent Event | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 742,194 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 6.40 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Convertible Debt | |||||||||||||||||
Nature of business: | |||||||||||||||||
Total gross proceeds | $ 100,000 | ||||||||||||||||
Shares issued price per share | $ / shares | $ 10.88 | ||||||||||||||||
Number of shares issued | shares | 9,139 | ||||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||||
CiVax | |||||||||||||||||
Nature of business: | |||||||||||||||||
Revenue from collaborative arrangement | $ 1,500,000 | ||||||||||||||||
Term (in years) | 2 years | ||||||||||||||||
HyBryte | |||||||||||||||||
Nature of business: | |||||||||||||||||
Revenue from collaborative arrangement | $ 1,100,000 | $ 1,100,000 | |||||||||||||||
Term (in years) | 4 years | 4 years | |||||||||||||||
NIH | |||||||||||||||||
Nature of business: | |||||||||||||||||
Government grant funding | $ 673,000,000,000 | $ 844,000 | |||||||||||||||
Exclusive option agreement | Common Stock | |||||||||||||||||
Nature of business: | |||||||||||||||||
Shares issued price per share | $ / shares | $ 25.28 | ||||||||||||||||
Number of shares issued | shares | 1,978 | ||||||||||||||||
B Riley Sales Agreement [Member] | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares sold | 3,091,462 | 79,354 | |||||||||||||||
B Riley Sales Agreement [Member] | Common Stock | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares sold | $ 53 | $ 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2024 USD ($) segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) segment shares | Dec. 31, 2022 USD ($) shares | Apr. 19, 2023 USD ($) | Dec. 31, 2020 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Allowance for doubtful accounts | $ 0 | |||||
Number of operating segments | segment | 2 | 2 | ||||
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 | $ 0 | ||
Requisite period (in years) | 3 years | 3 years | ||||
Expiration period | 10 years | 10 years | ||||
Option vesting rights | 25% | 25% | ||||
Dividend yield | 0% | 0% | ||||
Expected life | 4 years | |||||
Volatility rate minimum | 94% | 84% | ||||
Volatility rate maximum | 110% | 87% | ||||
Risk free interest rate, minimum | 3.48% | 1.12% | ||||
Risk free interest rate, maximum | 4.35% | 4.51% | ||||
Foreign currency transaction gain (loss) | $ 1,209 | (366) | $ (1,483) | $ 30,549 | ||
Income tax benefit | (1,161,197) | (1,767,803) | (1,154,935) | |||
Net Operating Loss Carryforwards Sold | 606,606 | |||||
Interest and penalties | 0 | $ 0 | 0 | 0 | ||
Unrecognized Tax Benefits | 0 | $ 0 | $ 0 | |||
Number of options issued | shares | 45,715 | 3,497 | ||||
Convertible debt fair value | 2,996,136 | $ 3,260,934 | ||||
Convertible Debt | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Debt instrument, face amount | 2,900,585 | 3,000,000 | $ 20,000,000 | |||
Convertible debt fair value | $ 2,996,136 | $ 3,260,934 | $ 3,304,000 | |||
Warrants | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
DO NOT USE FOR WARRANTS Expired (in shares) | shares | (42) | (13,826) | ||||
Number of options issued | shares | 673,445 | |||||
Termination benefits | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Expiration period | 3 months | 3 months | ||||
Directors | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Requisite period (in years) | 1 year | 1 year |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Carrying Value of Convertible Debt (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Jan. 03, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Debt instruments | ||||
Convertible debt repayments | $ (1,000,000) | $ (7,000,000) | ||
Adjustment to fair value | $ (165,382) | (43,066) | ||
Convertible Debt | ||||
Debt instruments | ||||
Convertible debt at fair value as of December 31, 2022 | 3,260,934 | $ 0 | 0 | |
Issued | 3,304,000 | |||
Convertible debt repayments | $ (99,416) | |||
Adjustment to fair value | (165,382) | (43,066) | ||
Convertible debt at fair value as of September 30, 2023 | $ 2,996,136 | $ 3,260,934 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Loss per share, Warrants and Options expirations (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 800,924 | 117,692 | 739,222 | 42,853 | |
Weighted average exercise price, outstanding warrants | $ 24 | ||||
Weighted average exercise price, outstanding options | 87.15 | $ 435.32 | $ 90.58 | $ 435.32 | $ 593.92 |
Weighted Average | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Conversion price | $ 138.24 | $ 453.92 | |||
Common stock purchase warrants | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 408,640 | 408,640 | 42 | ||
Stock options | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 56,568 | 11,946 | 56,609 | 11,946 | |
Convertible debt | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 335,716 | 105,746 | 273,973 | 30,865 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses | |||
Clinical trail expenses | $ 2,070,955 | $ 1,993,784 | $ 1,884,117 |
Other | 531,710 | 424,218 | 423,629 |
Total | $ 2,602,665 | $ 2,418,002 | $ 2,307,746 |
Debt (Details)
Debt (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||
Mar. 08, 2024 USD ($) | Jan. 03, 2024 USD ($) $ / shares | Apr. 19, 2023 USD ($) $ / shares | Apr. 18, 2023 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Apr. 27, 2023 $ / shares | Nov. 07, 2022 $ / shares | Oct. 04, 2022 $ / shares | Aug. 04, 2022 $ / shares | May 07, 2022 $ / shares | Feb. 07, 2022 $ / shares | |
Debt instruments | |||||||||||||||
Outstanding principal | $ 1,010,934 | $ 0 | |||||||||||||
Fair value per share | $ / shares | $ 23.36 | $ 156 | $ 115.20 | $ 218.40 | $ 124.80 | $ 148.80 | |||||||||
Repayment of debt principal | $ 1,000,000 | 7,000,000 | |||||||||||||
Convertible debt fair value | $ 2,996,136 | 3,260,934 | |||||||||||||
Change in fair value of convertible debt | (165,382) | (43,066) | |||||||||||||
Loss on extinguishment of debt | (393,791) | ||||||||||||||
Pontifax | |||||||||||||||
Debt instruments | |||||||||||||||
Debt instrument, face amount | 3,000,000 | ||||||||||||||
Accrued interest expense | $ 63,351 | ||||||||||||||
Pontifax | First 588,599 shares of common stock issuable upon conversion | |||||||||||||||
Debt instruments | |||||||||||||||
Shares of common stock issuable upon conversion | 36,790 | ||||||||||||||
Convertible Debt | |||||||||||||||
Debt instruments | |||||||||||||||
Debt instrument, face amount | $ 20,000,000 | 2,900,585 | $ 3,000,000 | ||||||||||||
Number of tranches | three | ||||||||||||||
Interest-only period | 2 years | ||||||||||||||
Interest rate percentage | 8.47% | ||||||||||||||
Unused line of credit fee, as a percent | 1% | ||||||||||||||
Outstanding principal periodic payment | $ 1,000,000 | ||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||
Convertible debt fair value | $ 3,304,000 | 2,996,136 | 3,260,934 | ||||||||||||
Change in fair value of convertible debt | (165,382) | (43,066) | |||||||||||||
Interest expense | 61,239 | 187,964 | 402,615 | 847,000 | |||||||||||
Interest paid | $ 64,047 | $ 213,490 | 552,058 | $ 857,411 | |||||||||||
Loss on extinguishment of debt | $ 394,000 | ||||||||||||||
Convertible Debt | Maximum | |||||||||||||||
Debt instruments | |||||||||||||||
Debt instrument, face amount | 20,000,000 | ||||||||||||||
Convertible Debt | First Tranche [Member] | |||||||||||||||
Debt instruments | |||||||||||||||
Convertible note | 10,000,000 | ||||||||||||||
Convertible Debt | Second Tranche [Member] | |||||||||||||||
Debt instruments | |||||||||||||||
Convertible note | 5,000,000 | ||||||||||||||
Convertible Debt | Third Tranche [Member] | |||||||||||||||
Debt instruments | |||||||||||||||
Convertible note | $ 5,000,000 | ||||||||||||||
Convertible Debt | Pontifax | |||||||||||||||
Debt instruments | |||||||||||||||
Outstanding principal periodic payment | 750,000 | $ 1,000,000 | |||||||||||||
Amount repaid | 5,000,000 | ||||||||||||||
Outstanding principal | $ 3,000,000 | ||||||||||||||
Shares of common stock issuable upon conversion | 27,651 | 9 | 3 | ||||||||||||
Fair value per share | $ / shares | $ 10.88 | ||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||
Percent Of Closing Price Of Common Stock For Conversion Price Per Share | 90% | ||||||||||||||
Convertible Debt | Pontifax | First 588,599 shares of common stock issuable upon conversion | |||||||||||||||
Debt instruments | |||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | ||||||||||||||
Shares of common stock issuable upon conversion | 3 | 3 | |||||||||||||
Reduction in conversion price | $ / shares | $ 27.20 |
Debt - Assumptions (Details)
Debt - Assumptions (Details) | Mar. 31, 2024 $ / shares | Dec. 31, 2023 $ / shares | Sep. 30, 2023 $ / shares | Apr. 19, 2023 $ / shares |
Measurement Input, Share Price [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 0.60 | 0.76 | 0.56 | 1.72 |
Measurement Input, Price Volatility [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 1.4880 | 1.4190 | 1.1050 | 0.7520 |
Measurement Input, Discount Rate [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 0.1616 | 0.1362 | 0.1484 | 0.1628 |
Measurement Input, Risk Free Interest Rate [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 0.0503 | 0.0465 | 0.0524 | 0.0427 |
Debt - Payments due (Details)
Debt - Payments due (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Debt instruments | ||
Remainder of 2024 | $ 2,448,305 | |
2025 | 664,474 | $ 2,520,808 |
2025 | 766,012 | |
Total | 3,112,779 | 3,286,820 |
Principal [Member] | ||
Debt instruments | ||
Remainder of 2024 | 2,250,000 | |
2025 | 650,585 | 2,250,000 |
2025 | 750,000 | |
Total | 2,900,585 | 3,000,000 |
Interest [Member] | ||
Debt instruments | ||
Remainder of 2024 | 198,305 | |
2025 | 13,889 | 270,808 |
2025 | 16,012 | |
Total | $ 212,194 | $ 286,820 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) | 3 Months Ended | 12 Months Ended | ||||||||||||||||
Jan. 03, 2024 $ / shares shares | Sep. 06, 2023 $ / shares shares | Jun. 08, 2023 $ / shares shares | May 22, 2023 $ / shares shares | May 10, 2023 $ / shares shares | May 09, 2023 $ / shares shares | Apr. 27, 2023 $ / shares | Dec. 21, 2022 $ / shares | Aug. 11, 2017 | Mar. 31, 2024 shares | Dec. 31, 2023 Vote $ / shares shares | Dec. 31, 2022 $ / shares shares | Nov. 07, 2022 $ / shares | Oct. 04, 2022 $ / shares | Aug. 04, 2022 $ / shares | May 07, 2022 $ / shares | Feb. 07, 2022 $ / shares | Dec. 31, 2021 shares | |
Class of Stock [Line Items] | ||||||||||||||||||
Fair value per share | $ 23.36 | $ 156 | $ 115.20 | $ 218.40 | $ 124.80 | $ 148.80 | ||||||||||||
Shares issues (in shares) | shares | 56,609 | 11,946 | 8,719 | |||||||||||||||
Weighted average price per share (in Dollars per share) | $ 10.45 | $ 141.61 | ||||||||||||||||
B Riley Sales Agreement [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Threshold percentage of compensation from gross proceeds | 3% | |||||||||||||||||
Shares issues (in shares) | shares | 539 | |||||||||||||||||
Weighted average price per share (in Dollars per share) | $ 148.64 | |||||||||||||||||
Pre-funded warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants Issued | shares | 264,813 | |||||||||||||||||
Series D Preferred Stock | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Series D preferred stock dividend ratio for each common stock transferred | 0.001 | |||||||||||||||||
Temporary equity per share | $ 0.001 | |||||||||||||||||
Series D preferred stock share transferred ratio for each common stock transferred | 0.001 | |||||||||||||||||
Number of votes per Series D preferred stock | Vote | 1,000,000 | |||||||||||||||||
Liquidation, cash payment per share | $ 0.001 | |||||||||||||||||
Threshold number of shares redeemed | shares | 100 | |||||||||||||||||
Redemption price per share | $ 0.10 | |||||||||||||||||
Convertible Debt | Pontifax | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Fair value per share | $ 10.88 | |||||||||||||||||
Common Stock | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares issued on exercise of warrants | shares | 9,139 | 264,714 | ||||||||||||||||
Shares issues (in shares) | shares | 53,202 | |||||||||||||||||
Weighted average price per share (in Dollars per share) | $ 58.08 | |||||||||||||||||
Common Stock | Exclusive option agreement | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Period considered for average closing price | 10 days | |||||||||||||||||
Common Stock | Pre-funded warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares issued on exercise of warrants | shares | 33,525 | 25,001 | 21,125 | 58,625 | 126,438 | |||||||||||||
Exercise price of warrants | $ 0.02 | $ 0.02 | $ 0.02 | $ 0.02 | $ 0.02 | |||||||||||||
Common Stock | Convertible Debt | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | |||||||||||||||||
Common Stock | Convertible Debt | Pontifax | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares issued on exercise of warrants | shares | 9,139 | |||||||||||||||||
Fair value per share | $ 10.88 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||
Apr. 27, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | May 06, 2022 shares | Apr. 27, 2022 shares | Feb. 07, 2022 shares | Mar. 01, 2020 $ / shares shares | Sep. 03, 2014 USD ($) shares | Mar. 31, 2020 $ / shares shares | Jan. 31, 2020 USD ($) | Sep. 30, 2014 USD ($) shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) m² | Jun. 21, 2022 USD ($) | |
Other Commitments [Line Items] | |||||||||||||||
Contractual obligation | $ 449,067 | $ 483,167 | |||||||||||||
Maximum payment for commitment milestones | 13,200,000 | 13,200,000 | |||||||||||||
Sub license milestones payments on covered products | $ 200,000 | ||||||||||||||
Employee Retention Credit, CARES ACT | $ 120,771 | ||||||||||||||
Percentage of sub license income on royalties | 15% | 15% | |||||||||||||
Office space in square feet | m² | 6,200 | ||||||||||||||
Lease rent per month | $ 11,367 | ||||||||||||||
Fair value of shares issued in connection with asset purchase | $ 50,000 | ||||||||||||||
Issuance of common stock | shares | 3 | 321 | 105 | 229 | 401 | 3 | 337 | ||||||||
For Period Till November 2023 [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Lease rent per month | 11,367 | ||||||||||||||
From Period Till November 2024 [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Lease rent per month | $ 11,625 | ||||||||||||||
Research and Development Arrangement [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Contractual obligation | $ 230,000 | $ 230,000 | |||||||||||||
Asset Purchase Agreement [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Cash paid to acquire intangible asset | $ 275,000 | $ 275,000 | |||||||||||||
Issuance of shares for assets (in shares) | shares | 12,328 | 771 | |||||||||||||
Fair value of shares issued in connection with asset purchase | $ 3,750,000 | $ 3,750,000 | |||||||||||||
Issuance of common stock | shares | 8,151 | 130,413 | |||||||||||||
Effective price per share (in dollars per share) | $ / shares | $ 614.40 | $ 38.40 | |||||||||||||
Ownership of company outstanding | 19.90% | 19.90% | |||||||||||||
Minimum | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Percentage for royalties | 2% | 2% | |||||||||||||
Percentage of global net sales royalties on covered products | 1.50% | 1.50% | |||||||||||||
Authorized shares to be issued | $ 334 | ||||||||||||||
Maximum | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Percentage for royalties | 3% | 3% | |||||||||||||
Percentage of global net sales royalties on covered products | 2.50% | 2.50% | |||||||||||||
Authorized shares to be issued | $ 33,334 | ||||||||||||||
Maximum | Asset Purchase Agreement [Member] | Scenario, Plan [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Contingent consideration | $ 5,000,000 | $ 5,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Maturity (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
April 1 through December 31, 2024 | $ 148,817 | |
2025 | 162,250 | $ 182,917 |
2026 | 46,000 | 162,250 |
2027 | 46,000 | 46,000 |
2028 | 46,000 | 46,000 |
Total | 449,067 | 483,167 |
Research and Development Arrangement [Member] | ||
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
April 1 through December 31, 2024 | 46,000 | |
2025 | 46,000 | 46,000 |
2026 | 46,000 | 46,000 |
2027 | 46,000 | 46,000 |
2028 | 46,000 | 46,000 |
Total | 230,000 | 230,000 |
Lease Agreements [Member] | ||
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
April 1 through December 31, 2024 | 102,817 | |
2025 | 116,250 | 136,917 |
2026 | 116,250 | |
Total | $ 219,067 | $ 253,167 |
Operating Segments (Details)
Operating Segments (Details) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 USD ($) segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Segment reporting | ||||
Revenues | $ 117,029 | $ 257,178 | $ 839,359 | $ 948,911 |
Income (loss) from Operations | (2,117,091) | (2,150,689) | (7,697,940) | (14,238,904) |
Amortization and Depreciation Expense | 1,588 | 1,785 | 6,554 | 24,562 |
Other (Expense) Income, Net | 201,764 | (56,617) | (210,593) | (714,370) |
Share-Based Compensation | 59,961 | 73,634 | 370,182 | 333,389 |
Identifiable Assets | $ 8,058,385 | $ 9,797,326 | 14,279,717 | |
Number of operating segments | segment | 2 | 2 | ||
Operating Segments [Member] | Specialized BioTherapeutics [Member] | ||||
Segment reporting | ||||
Revenues | $ 117,029 | 155,365 | $ 395,124 | 31,929 |
Income (loss) from Operations | (860,604) | (910,377) | (2,812,303) | (7,614,988) |
Amortization and Depreciation Expense | 953 | 1,071 | 3,932 | 10,087 |
Other (Expense) Income, Net | 7,540 | 6,082 | 25,267 | 102,320 |
Share-Based Compensation | 20,672 | 27,427 | 145,683 | 138,075 |
Identifiable Assets | 301,709 | 272,099 | 103,742 | |
Operating Segments [Member] | Public Health Solutions [Member] | ||||
Segment reporting | ||||
Revenues | 101,813 | 444,235 | 916,982 | |
Income (loss) from Operations | (45,997) | 427 | (36,531) | 26,612 |
Amortization and Depreciation Expense | 159 | 178 | 655 | 1,681 |
Share-Based Compensation | 588 | 994 | 4,782 | 4,804 |
Identifiable Assets | 120,475 | 3,976 | 121,290 | |
Corporate [Member] | ||||
Segment reporting | ||||
Income (loss) from Operations | (1,210,490) | (1,240,739) | (4,849,106) | (6,650,528) |
Amortization and Depreciation Expense | 476 | 536 | 1,967 | 12,794 |
Other (Expense) Income, Net | 194,224 | (62,699) | (235,860) | (816,690) |
Share-Based Compensation | 38,701 | $ 45,213 | 219,717 | 190,510 |
Identifiable Assets | $ 7,636,201 | $ 9,521,251 | $ 14,054,685 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||||||||
Apr. 22, 2024 | Apr. 15, 2024 | Mar. 08, 2024 | Jan. 03, 2024 | May 09, 2023 | Apr. 27, 2023 | Nov. 07, 2022 | Oct. 04, 2022 | Aug. 05, 2022 | May 06, 2022 | Apr. 27, 2022 | Feb. 07, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Aug. 04, 2022 | May 07, 2022 | |
Subsequent Event | |||||||||||||||||
Fair value per share | $ 23.36 | $ 156 | $ 115.20 | $ 148.80 | $ 218.40 | $ 124.80 | |||||||||||
Repayment of debt principal | $ 1,000,000 | $ 7,000,000 | |||||||||||||||
Number of shares issued | 3 | 321 | 105 | 229 | 401 | 3 | 337 | ||||||||||
Common Stock | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 9,139 | 264,714 | |||||||||||||||
Public Offering | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Shares issued price per share | $ 20.80 | ||||||||||||||||
Exercise price of warrants | $ 0.001 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Public Offering | Pre-funded warrants | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of common warrants to purchase shares issued | 264,813 | ||||||||||||||||
Public Offering | Common warrants | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of common warrants to purchase shares issued | 408,656 | ||||||||||||||||
Public Offering | Common Stock | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of shares issued | 143,844 | ||||||||||||||||
Shares issued price per share | $ 20.80 | ||||||||||||||||
Exercise price of warrants | $ 24 | ||||||||||||||||
Convertible Debt | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||||
Number of shares issued | 9,139 | ||||||||||||||||
Shares issued price per share | $ 10.88 | ||||||||||||||||
Convertible Debt | Pontifax | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Fair value per share | $ 10.88 | ||||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||||
Convertible Debt | Pontifax | Common Stock | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 9,139 | ||||||||||||||||
Fair value per share | $ 10.88 | ||||||||||||||||
Subsequent Event | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Shares issued price per share | $ 6.40 | ||||||||||||||||
Subsequent Event | Public Offering | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of shares issued | 143,844 | ||||||||||||||||
Shares issued price per share | 6.40 | ||||||||||||||||
Exercise price of warrants | 0.02 | ||||||||||||||||
Price per unit | $ 6.38 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Total gross proceeds | $ 4,750,000 | ||||||||||||||||
Net proceeds | $ 4,300,000 | ||||||||||||||||
Subsequent Event | Public Offering | Pre-funded warrants | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of common warrants to purchase shares issued | 537,500 | ||||||||||||||||
Number of shares in an unit | 1 | ||||||||||||||||
Exercise price of warrants | $ 0.02 | ||||||||||||||||
Subsequent Event | Public Offering | Common warrants | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of common warrants to purchase shares issued | 742,194 | ||||||||||||||||
Number of warrants in an unit | 1 | ||||||||||||||||
Exercise price of warrants | $ 6.40 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Subsequent Event | Public Offering | Common Stock | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Number of shares issued | 204,694 | ||||||||||||||||
Number of shares in an unit | 1 | ||||||||||||||||
Exercise price of warrants | $ 6.40 | ||||||||||||||||
Subsequent Event | Convertible Debt | Pontifax | |||||||||||||||||
Subsequent Event | |||||||||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 27,651 | ||||||||||||||||
Fair value per share | $ 5.60 | ||||||||||||||||
Repayment of debt principal | $ 154,840 | ||||||||||||||||
Shares issued price per share | $ 27.40 | ||||||||||||||||
Interest outstanding | $ 45,840 |
Reverse Stock Split (Details)
Reverse Stock Split (Details) | Jun. 05, 2024 |
Subsequent Event | |
Reverse stock spilt effective from June 5, 2024 | 0.625 |
Condensed Consolidated Balanc_3
Condensed Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 | |
Current assets: | |||
Cash and cash equivalents | $ 8,446,158 | $ 13,359,615 | |
Contracts and grants receivable | 115,130 | ||
Unbilled revenue | 171,254 | ||
Research and development incentives receivable, current | 23,894 | 104,198 | |
Prepaid expenses and other current assets | 866,014 | 274,209 | |
Total current assets | 9,507,320 | 13,853,152 | |
Security deposit | 22,777 | 22,777 | |
Office furniture and equipment, net | 11,927 | 18,481 | |
Deferred issuance cost | 20,206 | ||
Right-of-use lease assets | 229,834 | 340,987 | |
Research and development incentives receivable, net of current portion | 25,468 | 24,114 | |
Total assets | 9,797,326 | 14,279,717 | |
Current liabilities: | |||
Accounts payable | 1,111,226 | 3,865,796 | |
Accrued expenses | 2,418,002 | 2,307,746 | |
Accrued compensation | 251,115 | 336,692 | |
Lease liabilities, current | 121,765 | 108,948 | |
Convertible debt | 2,250,000 | 9,897,691 | |
Total current liabilities | 6,152,108 | 16,516,873 | |
Non-current liabilities: | |||
Convertible debt | 1,010,934 | 0 | |
Lease liabilities, net of current portion | 111,862 | 233,627 | |
Total liabilities | 7,274,904 | 16,750,500 | |
Commitments and contingencies (Note 6) | |||
Shareholders' equity: | |||
Preferred stock, 350,000 shares authorized; none issued or outstanding at March 31, 2024 and December 31, 2023, respectively | |||
Common stock, $.001 par value; 75,000,000 shares authorized; 648,761 and 183,227 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | [1] | 649 | 182 |
Additional paid-in capital | [1] | 228,203,706 | 217,067,691 |
Accumulated other comprehensive income | 22,243 | 24,747 | |
Accumulated deficit | (225,704,176) | (219,563,446) | |
Total shareholders' equity | 2,522,422 | (2,470,826) | |
Total liabilities and shareholders' equity | $ 9,797,326 | $ 14,279,717 | |
[1]Adjusted to reflect the reverse stock split of one-for- sixteen |
Condensed Consolidated Balanc_4
Condensed Consolidated Balance Sheets (Parenthetical) | Jun. 05, 2024 | Mar. 31, 2024 $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares |
Accumulated depreciation | $ | $ 121,320 | $ 114,766 | ||
Debt discount, current | $ | $ 0 | $ 102,309 | ||
Preferred stock, shares authorized | 350,000 | 350,000 | 300,000 | |
Preferred stock, shares issued | 0 | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | 0 | |
Common stock, par value (per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares authorized | 75,000,000 | 75,000,000 | 75,000,000 | |
Common stock, shares issued | 657,900 | 648,761 | ||
Common stock, shares outstanding | 657,900 | 648,761 | 181,898 | |
Subsequent Event | ||||
Reverse stock spilt effective from June 5, 2024 | 0.625 | |||
Series D Preferred Stock | ||||
Temporary equity per share | $ / shares | $ 0.001 | $ 0.001 | ||
Temporary equity authorized | 0 | 50,000 | ||
Temporary equity Issued | 0 | 0 | ||
Temporary equity Outstanding | 0 | 0 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | ||
Total revenues | $ 117,029 | $ 257,178 | $ 839,359 | $ 948,911 | |
Cost of revenues | (117,029) | (226,040) | (742,048) | (550,822) | |
Gross profit | 31,138 | 97,311 | 398,089 | ||
Operating expenses: | |||||
Research and development | 1,095,040 | 946,451 | 3,312,699 | 7,944,089 | |
General and administrative | 1,022,051 | 1,235,376 | 4,482,552 | 6,692,904 | |
Total operating expenses | 2,117,091 | 2,181,827 | 7,795,251 | 14,636,993 | |
Loss from operations | (2,117,091) | (2,150,689) | (7,697,940) | (14,238,904) | |
Other income (expense): | |||||
Foreign currency transaction gain (loss) | 1,209 | (366) | 1,483 | (30,549) | |
Interest income (expense), net | 28,842 | (103,568) | (49,129) | (822,611) | |
Research and development incentives | 6,331 | 6,448 | 23,784 | 132,869 | |
CARES Act Employee Retention Credit | 120,771 | ||||
Other income | 40,869 | 43,223 | 5,921 | ||
Loss on extinguishment of debt | (393,791) | ||||
Change in fair value of convertible debt | 165,382 | 43,066 | |||
Total other income (expense) | 201,764 | (56,617) | (210,593) | (714,370) | |
Net loss before income taxes | (1,915,327) | (2,207,306) | (7,908,533) | (14,953,274) | |
Income tax benefit | 1,161,197 | 1,767,803 | 1,154,935 | ||
Net loss applicable to common stockholders | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) | |
Basic net loss per share (in Dollars per share) | [1] | $ (2.42) | $ (5.74) | $ (12.66) | $ (76.84) |
Diluted net loss per share (in Dollars per share) | [1] | $ (2.42) | $ (5.74) | $ (0.79) | $ (4.81) |
Basic weighted average common shares outstanding (in Shares) | [1] | 790,239 | 182,296 | 484,995 | 179,565 |
Diluted weighted average common shares outstanding (in Shares) | [1] | 790,239 | 182,296 | 7,758,036 | 2,871,345 |
Licensing revenue | |||||
Total revenues | $ 250,000 | ||||
Grant revenue | |||||
Total revenues | $ 117,029 | $ 257,178 | $ 839,359 | $ 698,911 | |
[1]Adjusted to reflect the reverse stock split of one-for- sixteen |
Condensed Consolidated Statem_7
Condensed Consolidated Statements of Operations (Parenthetical) | Jun. 05, 2024 |
Subsequent Event | |
Reverse stock spilt effective from June 5, 2024 | 0.625 |
Condensed Consolidated Statem_8
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | 1,900 | (12,153) | (2,504) | (17,195) |
Comprehensive loss | $ (1,913,427) | $ (1,058,262) | $ (6,143,234) | $ (13,815,534) |
Condensed Consolidated Statem_9
Condensed Consolidated Statements of Changes in Shareholders' Equity/(Deficit) - USD ($) | Preferred Stock Series D Preferred Stock | Common Stock B Riley Sales Agreement [Member] | Common Stock Public Offering | Common Stock | Additional Paid-In Capital B Riley Sales Agreement [Member] | Additional Paid-In Capital Series D Preferred Stock | Additional Paid-In Capital Public Offering | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | B Riley Sales Agreement [Member] | Series D Preferred Stock | Public Offering | Total |
Balance at Dec. 31, 2021 | $ 179 | $ 216,445,584 | $ 41,942 | $ (205,765,107) | $ 10,722,598 | |||||||||
Balance (in shares) at Dec. 31, 2021 | 178,744 | |||||||||||||
Balance at Dec. 31, 2021 | $ 0 | |||||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 1 | $ 79,353 | $ 79,354 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 539 | |||||||||||||
Issuance costs | (2,593) | (2,593) | ||||||||||||
Declaration of Series D preferred stock | 43 | |||||||||||||
Declaration of Series D preferred stock | $ (43) | $ (43) | ||||||||||||
Fractional shares issued in reverse stock split (Shares) | 1,222 | |||||||||||||
Fractional shares issued in reverse stock split | $ 1 | (1) | ||||||||||||
Issuance of common stock to vendors | $ 1 | 212,002 | 212,003 | |||||||||||
Issuance of common stock to vendors (in shares) | 1,393 | |||||||||||||
Share-based compensation expense | 333,389 | 333,389 | ||||||||||||
Foreign currency translation adjustment | (17,195) | (17,195) | ||||||||||||
Net loss | (13,798,339) | (13,798,339) | ||||||||||||
Balance at Dec. 31, 2022 | $ 182 | 217,067,691 | 24,747 | (219,563,446) | (2,470,826) | |||||||||
Balance (in Shares) at Dec. 31, 2022 | 181,898 | |||||||||||||
Balance at Dec. 31, 2022 | 43 | 43 | ||||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 1 | 70,729 | 70,730 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 1,329 | |||||||||||||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | (2,341) | (2,341) | ||||||||||||
Declaration of Series D preferred stock | (43) | |||||||||||||
Share-based compensation expense | 73,634 | 73,634 | ||||||||||||
Foreign currency translation adjustment | (12,153) | (12,153) | ||||||||||||
Net loss | (1,046,109) | (1,046,109) | ||||||||||||
Balance at Mar. 31, 2023 | $ 183 | 217,209,713 | 12,594 | (220,609,555) | (3,387,065) | |||||||||
Balance (in Shares) at Mar. 31, 2023 | 183,227 | |||||||||||||
Balance at Dec. 31, 2022 | $ 182 | 217,067,691 | 24,747 | (219,563,446) | (2,470,826) | |||||||||
Balance (in shares) at Dec. 31, 2022 | 181,898 | |||||||||||||
Balance at Dec. 31, 2022 | 43 | 43 | ||||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 53 | 3,091,409 | 3,091,462 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 53,202 | |||||||||||||
Issuance costs | $ (113,217) | $ (834,061) | $ (113,217) | $ (834,061) | ||||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering | $ 144 | $ 8,495,673 | $ 8,495,817 | |||||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering (in shares) | 143,844 | |||||||||||||
Declaration of Series D preferred stock | (43) | |||||||||||||
Issuance of common stock to vendors | $ 3 | 72,997 | 73,000 | |||||||||||
Issuance of common stock to vendors (in shares) | 3,125 | |||||||||||||
Issuance of common stock associated with conversion of debt | $ 265 | 3,034 | 3,299 | |||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 264,714 | |||||||||||||
Issuance of common stock for unexercised purchase option | $ 2 | 49,998 | 50,000 | |||||||||||
Issuance of common stock for unexercised purchase option (in shares) | 1,978 | |||||||||||||
Share-based compensation expense | 370,182 | 370,182 | ||||||||||||
Foreign currency translation adjustment | (2,504) | (2,504) | ||||||||||||
Net loss | (6,140,730) | (6,140,730) | ||||||||||||
Balance at Dec. 31, 2023 | $ 649 | 228,203,706 | 22,243 | (225,704,176) | 2,522,422 | |||||||||
Balance (in Shares) at Dec. 31, 2023 | 648,761 | |||||||||||||
Balance at Dec. 31, 2023 | $ 0 | |||||||||||||
Issuance of common stock associated with conversion of debt | $ 9 | 99,407 | 99,416 | |||||||||||
Issuance of common stock associated with conversion of debt (in shares) | 9,139 | |||||||||||||
Share-based compensation expense | 59,961 | 59,961 | ||||||||||||
Foreign currency translation adjustment | 1,900 | 1,900 | ||||||||||||
Net loss | (1,915,327) | (1,915,327) | ||||||||||||
Balance at Mar. 31, 2024 | $ 658 | $ 228,363,074 | $ 24,143 | $ (227,619,503) | $ 768,372 | |||||||||
Balance (in Shares) at Mar. 31, 2024 | 657,900 |
Condensed Consolidated State_10
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||||
Net loss | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Amortization and depreciation | 1,588 | 1,785 | 6,554 | 24,562 |
Non-cash lease expense | 29,265 | 26,936 | 111,153 | 112,714 |
Share-based compensation | 59,961 | 73,634 | 370,182 | 333,389 |
Issuance of common stock to vendors for services | 73,000 | 212,003 | ||
Issuance of common stock for unexercised purchase option | 50,000 | |||
Loss on extinguishment of debt | 393,791 | |||
Change in fair value of convertible debt | (165,382) | (43,066) | ||
Amortization of deferred issuance costs associated with convertible debt | 10,242 | 12,518 | 41,538 | |
Change in operating assets and liabilities: | ||||
Contracts and grants receivable | 54,225 | (102,878) | (56,124) | 23,759 |
Prepaid expenses and other current assets | 414,138 | 60,894 | (591,805) | 8,694 |
Research and development incentives receivable | 17,379 | 98,456 | 90,016 | 73,374 |
Operating lease liability | (29,359) | (26,256) | (108,948) | (111,122) |
Accounts payable and accrued expenses | 391,929 | (970,757) | (2,685,073) | 396,651 |
Accrued compensation | (200,899) | (292,200) | (85,577) | 33,756 |
Net cash used in operating activities | (1,342,482) | (2,166,253) | (8,604,109) | (12,649,021) |
Investing activities: | ||||
Purchases of office furniture and equipment | (13,073) | |||
Net cash used in investing activities | (13,073) | |||
Financing activities: | ||||
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | 70,730 | 3,091,462 | 79,354 | |
Proceeds from issuance of common stock and pre-funded warrants pursuant to public offering | 8,495,817 | |||
Convertible debt repayments | (1,000,000) | (7,000,000) | ||
Net cash used in financing activities | (8,992) | (931,558) | 3,663,506 | 76,821 |
Effect of exchange rate on cash and cash equivalents | (3,136) | 4,046 | 27,146 | (99,009) |
Net decrease in cash and cash equivalents | (1,354,610) | (3,093,765) | (4,913,457) | (12,684,282) |
Cash and cash equivalents at beginning of period | 8,446,158 | 13,359,615 | 13,359,615 | 26,043,897 |
Cash and cash equivalents at end of period | 7,091,548 | 10,265,850 | 8,446,158 | 13,359,615 |
Supplemental information: | ||||
Cash paid for state income taxes | 17,965 | 2,110 | 20,730 | 16,043 |
Cash paid for interest | 64,047 | 213,490 | 552,058 | 857,411 |
Cash paid for lease liabilities: | ||||
Operating lease | 34,100 | 33,325 | 133,817 | 133,300 |
Non-cash investing and financing activities: | ||||
Right-of-use assets and lease liabilities recorded | 347,546 | |||
Pontifax conversion of portion of debt principal into common stock | 99,416 | |||
Deferred issuance cost reclassified to additional paid-in capital | 53 | 20,208 | 60 | |
Declaration of Series D preferred stock for stock dividend | 43 | |||
Redemption liability for Series D preferred stock | 43 | 43 | ||
Public offering costs included in accounts payable | 123,689 | |||
B. Riley Sales Agreement | ||||
Financing activities: | ||||
Stock issuance costs associated | $ (2,288) | (93,011) | $ (2,533) | |
Public Offering | ||||
Financing activities: | ||||
Stock issuance costs associated | $ (8,992) | (834,061) | ||
Pre-funded warrants | ||||
Financing activities: | ||||
Proceeds from the exercise of pre-funded warrants | $ 3,299 |
Nature of Business_2
Nature of Business | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Nature of Business | ||
Nature of Business | Note 1. Nature of Business Basis of Presentation Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions. The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease, the Company is targeting to begin patient enrollment by Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease. The Company’s Public Health Solutions business segment includes development programs for RiVax ® ® The Company primarily generates revenues under government grants and contracts. The Company was awarded a subcontract that originally provided for approximately $1.1 million from a U.S. Food and Drug Administration (“FDA”) Orphan Products Development grant over four years The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability. Results for the three months ended March 31, 2024 are not necessarily indicative of results that may be expected for the full year. Liquidity In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. As of March 31, 2024, the Company had an accumulated deficit of $227,619,503. During the three months ended March 31, 2024, the Company incurred a net loss of $1,915,327 and used $1,342,482 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due through the first quarter of 2025. The Company does not have sufficient cash and cash equivalents as of the date of filing this Quarterly Report on Form 10-Q to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company plans to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, securing additional proceeds available from the sale of shares of the common stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Pontifax Medison Finance (“Pontifax”) to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce the Company’s debt repayments; however, none of these alternatives are committed at this time. There can be no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to it to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that it will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce the Company’s ability to access capital, which could negatively affect its liquidity and ability to continue as a going concern. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations. The accompanying 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, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. As of March 31, 2024, the Company had cash and cash equivalents of $7,091,548 as compared to $8,446,158 as of December 31, 2023, representing a decrease of $1,354,610 or 16%. As of March 31, 2024, the Company had working capital of $607,499 as compared to working capital of $3,355,212 as of December 31, 2023, representing a decrease in working capital of $2,747,713 or 82%. The decrease in cash and cash equivalents was primarily related to cash used in operating activities during the three months ended March 31, 2024. The decrease in working capital is primarily the result of the reclassification of approximately $1 million of the Company’s convertible debt balance from a non-current liability as of December 31, 2023 to a current liability as of March 31, 2024 (resulting from the amendment to the loan and security agreement with Pontifax – see Note 4), and cash used in operating activities during the three months ended March 31, 2024. Management’s business strategy can be outlined as follows: ● Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3 FLASH study, initiate the FLASH2 study, while at the same time, continuing discussions with the FDA on potential modifications to the development path to adequately address their feedback. ● Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. ● Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be required to support a marketing authorization; design a second study and attempt to identify a potential partner(s) to continue this development program. ● Expanding development of dusquetide under the research name SGX945 into Behçet’s Disease with the conduct of a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with United States (“U.S.”) government or non-governmental organization funding support. ● Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies. ● Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. The Company’s plans with respect to its liquidity management include, but are not limited to, the following: ● The Company has up to approximately $673,000 in active government grant funding still available as of March 31, 2024 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding. ● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. ● The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available. ● The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions. ● The Company completed a public offering on April 22, 2024 of 204,694 shares of its common stock, pre-funded warrants to purchase 537,500 shares of its common stock and common warrants to purchase up to 742,194 shares of its common stock at a combined public offering price of $6.40 . The pre-funded warrants have an exercise price of $0.02 . The common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses ( $4.3 million, net). The Company plans to use the proceeds for further support of its programs, as well as for working capital. See Note 8. ● The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing. Nasdaq Capital Market Listing Requirements On June 23, 2023, the Company received a letter from the staff (the “Staff”) of the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock for the 30 consecutive business day period between May 9, 2023 through June 22, 2023, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that the Company would be provided with a compliance period of 180 calendar days, or until December 20, 2023, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). The Company was unable to regain compliance prior to the expiration of the 180-day period. On December 21, 2023, the Company received another written notice (the “Notice”) from the Staff stating that the Company had not complied with the minimum bid price requirement and was not eligible for a second 180-day period because the Company did not comply with the $5,000,000 minimum stockholders’ equity initial listing requirement for Nasdaq. As a result, the Notice indicated that the Company’s common stock would be suspended from trading on Nasdaq unless the Company requested a hearing before the Nasdaq Hearings Panel by December 28, 2023. On March 26, 2024, the Company had an oral hearing with a Nasdaq Hearings Panel to appeal the Staff’s delisting determination, which stayed the trading suspension of the Common Stock pending a final written decision by the Nasdaq Hearings Panel and expiration of any additional extension period granted by the panel following the hearing. In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the compliance period. | Soligenix, Inc. and Subsidiaries Notes to Consolidated Financial Statements Note 1. Nature of Business Basis of Presentation Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions. The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (“PDT”) utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the Phase 3 FLASH (Fluorescent Light And Synthetic Hypericin) study, regulatory approval is being pursued in the United States (“U.S.”) and Europe. Following submission of a new drug application (“NDA”) for HyBryte™ in the treatment of CTCL in December 2022, the Company received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) in February 2023. In April 2023, the Company had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards U.S. marketing approval and commercialization. In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 pivotal study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, the Company is collaboratively engaging in active discussions with both the FDA and the European Medicines Agency (“EMA”) in order to define the protocol and evaluate the feasibility of conducting the additional Phase 3 clinical trial evaluating HyBryte™ in the treatment of CTCL in support of potential marketing approval. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease. The Company’s Public Health Solutions business segment includes development programs for RiVax ® ® The Company primarily generates revenues under government grants and contracts principally from the National Institutes of Health (“NIH”). The Company was awarded a subcontract that originally provided The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability. Liquidity In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of December 31, 2023, the Company had an accumulated deficit of $225,704,176 and working capital of $3,355,212. During the year ended December 31, 2023, the Company incurred a net loss of $6,140,730 and used $8,604,109 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due into the fourth quarter of 2024. The Company does not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company plans to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, securing additional proceeds available from the sale of shares of the common stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Pontifax to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce the Company’s debt repayments; however, none of these alternatives are committed at this time. There can be no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to it to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that it will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce the Company’s ability to access capital, which could negatively affect its liquidity and ability to continue as a going concern. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations. The accompanying 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, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. As of December 31, 2023, the Company had cash and cash equivalents of $8,446,158 as compared to $13,359,615 as of December 31, 2022, representing a decrease of $4,913,457 or 37%. As of December 31, 2023, the Company had working capital of $3,355,212 as compared to a working capital deficit of ($2,663,721) as of December 31, 2022, representing an increase of $6,018,933 or 226%. The decrease in cash and cash equivalents was primarily related to cash used in operating activities. The increase in working capital is primarily the result of the net proceeds received from financing activities partially offset by the immediate paydown of $5 million of outstanding debt principal balance and any accrued interest resulting from the amendment to the convertible debt financing agreement with Pontifax during the year ended December 31, 2023. Management’s business strategy can be outlined as follows: ● Following positive primary endpoint results for the Phase 3 FLASH (Florescent Light Activated Synthetic Hypericin) clinical trial of HyBryte ™ in CTCL as well as further statistically significant improvement in response rates with longer treatment (18 weeks compared to 12 and 6 weeks of treatment), collaboratively engage in discussions with both the FDA and the EMA in order to define the protocol and evaluate the feasibility of conducting a second clinical study in order to advance HyBryte ™ towards U.S. marketing approval and commercialization while continuing to explore potential marketing approval and partnership in Europe. ● Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. ● Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be required to support a marketing authorization; design a second study and attempt to identify a potential partner(s) to continue this development program. ● Expanding development of dusquetide under the research name SGX945 into Beh ç et ’ s Disease with the conduct of a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with U.S. government or non-governmental organization funding support. ● Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies. ● Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. The Company’s plans with respect to its liquidity management include, but are not limited to, the following: ● The Company has up to approximately $844,000 in active government grant funding still available as of December 31, 2023 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding. ● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. ● The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available. ● The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions. ● The Company completed a public offering of 143,844 shares of its common stock, pre-funded warrants to purchase 264,813 shares of its common stock and common warrants to purchase up to 408,656 shares of its common stock at a combined public offering price of $20.80 . The pre-funded warrants had an exercise price of $0.001 . The common warrants have an exercise price of $24.00 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering was approximately $8.5 million before deducting commissions and other estimated offering expenses. The Company plans to use the proceeds for further support of its programs, as well as for working capital; and ● The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that it can consummate such a transaction, or consummate a transaction at favorable pricing. |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies | ||
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Principles of Consolidation The condensed consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. Impairment of Long-Lived Assets Office furniture and equipment and right of use assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the three months ended March 31, 2024 and 2023. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the condensed consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the condensed consolidated balance sheet as of March 31, 2024 for the convertible debt is its fair value - see Note 4. The principal amount of the convertible debt was $2,900,585 at March 31, 2024 and the fair value was $2,996,136. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to March 31, 2024 is as follows: Balance Conversion Adjustment to Balance December 31, 2023 January 3, 2024 fair value March 31, 2024 Convertible debt at fair value $ 3,260,934 $ (99,416) $ (165,382) $ 2,996,136 Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year three years three months From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. There were no options issued during the three months ended March 31, 2024 and 2023. Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company did not recognize an income tax benefit during the three months ended March 31, 2024. The Company recognized $1,161,197 of income tax benefit, net of transaction costs from the sale of its 2021 NOL carryforwards during the three months ended March 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for the three months ended March 31, 2024 and 2023. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at March 31, 2024 or December 31, 2023. Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the three months ended March 31, 2024, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: As of March 31, 2024 2023 Common stock purchase warrants 408,640 — Stock options 56,568 11,946 Convertible debt 335,716 105,746 Total 800,924 117,692 The weighted average exercise prices of the Company’s warrants and stock options outstanding at March 31, 2024 were $24.00 and $87.15 per share, respectively. The weighted average exercise prices of the Company’s stock options outstanding at March 31, 2023 was $435.32 per share. The weighted average conversion price of the Company’s convertible debt at March 31, 2024 and 2023 was $138.24 and $453.92 per share, respectively. Use of Estimates and Assumptions The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. (“GAAP”) requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. | Note 2. Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Contracts and Grants Receivable In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326) Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. Impairment of Long-Lived Assets Office furniture and equipment, right of use assets and website development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 2023 and 2022. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, to the Company on December 31, 2023 and 2022. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the consolidated balance sheet as of December 31, 2023 for the convertible debt is its fair value – see Note 5. The principal amount of the convertible debt was $3,000,000 at December 31, 2023 and the fair value was approximately $3,260,934. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to December 31, 2023 is as follows: Balance Adjustment to Balance December 31, 2022 Issued fair value December 31, 2023 Convertible debt at fair value $ — $ 3,304,000 $ (43,066) $ 3,260,934 Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the years ended December 31, 2023 and 2022 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of four years ; ● volatility of 94% - 110% for 2023 and 84% - 87% for 2022; and ● risk-free interest rates ranging from 3.48% to 4.35% in 2023 and ranging from 1.12% to 4.51% in 2022. The fair value of each option grant made during 2023 and 2022 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. The expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for forfeitures as they are incurred. Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company sold 2022, 2021 and 2020 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $1,767,803 and $1,154,935 during the years ended December 31, 2023 and 2022, respectively. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2023 and 2022. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2023 or 2022. Research and Development Incentive Income and Receivable The Company recognizes other income from UK research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income. The research and development incentive receivable represents an amount due in connection with the above-described tax relief program. The Company has recorded a research and development incentive receivable of approximately $49,000 and $128,000 as of December 31, 2023 and 2022, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to December 31, 2023: Current Long-Term Total Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 UK research and development incentives, transfer 24,114 (24,114) — UK research and development incentives — 24,897 24,897 Adjustments to 2021 and 2022 incentives earned (1,113) — (1,113) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 1,117 571 1,688 Balance at December 31, 2023 $ 23,894 $ 25,468 $ 49,362 Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the year ended December 31, 2023, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: December 31, December 31, 2023 2022 Common stock purchase warrants 408,640 42 Stock options 56,609 11,946 Convertible debt 273,973 30,865 Total 739,222 42,853 Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | Note 3. Leases The Company classifies a lease for its office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey as an operating lease, and recorded a related right-of-use lease asset and lease liability accordingly. Pursuant to an amendment executed on June 21, 2022, the lease has been extended to October 2025. The current rent of $11,367 per month will be maintained until November 2024 when it will be increased to $11,625 where it will remain until expiration. As of December 31, 2023 and 2022, the Company’s consolidated balance sheets included a right-of-use lease asset of $229,834 and $340,987 for the office space, respectively. The Company’s consolidated balance sheets as of December 31, 2023 and 2022 included corresponding lease liabilities of $233,627 and $342,575 for the office space, respectively. The following represents a reconciliation of contractual lease cash flows to the right-of-use lease asset and liability recognized in the financial statements: Operating Lease Contractual cash payments for the remaining lease term as of December 31, 2023 2024 $ 136,917 2025 116,250 Less implied interest 19,540 Total $ 233,627 Discount rate applied 8.47 % Remaining lease term (months) as of December 31, 2023 22 Right-of-use lease asset: Right-of-use lease asset, January 1, 2022 $ 106,155 New lease extension June 21, 2022 347,546 Less: reduction/amortization 112,714 Right-of-use lease asset, December 31, 2022 340,987 Less: reduction/amortization 111,153 Right-of-use lease asset, December 31, 2023 $ 229,834 Lease liability: Lease liability, January 1, 2022 $ 106,151 New lease extension June 21, 2022 347,546 Less: repayments 111,122 Lease liability, December 31, 2022 342,575 Less: repayments 108,948 Lease liability, December 31, 2023 $ 233,627 Lease expense for the year ended December 31, 2022: Lease expense $ 134,892 Total $ 134,892 Lease expense for the year ended December 31, 2023: Lease expense $ 136,022 Total $ 136,022 |
Accrued Expenses_2
Accrued Expenses | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Accrued Expenses | ||
Accrued Expenses | Note 3. Accrued Expenses The following is a summary of the Company’s accrued expenses: March 31, December 31, 2024 2023 Clinical trial expenses $ 2,070,955 $ 1,993,784 Other 531,710 424,218 Total $ 2,602,665 $ 2,418,002 | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: December 31, 2023 2022 Clinical trial expenses $ 1,993,784 $ 1,884,117 Other 424,218 423,629 Total $ 2,418,002 $ 2,307,746 |
Debt_2
Debt | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Debt | ||
Debt | Note 4. Debt In December 2020, the Company entered into a $20 million convertible debt financing agreement with Pontifax. Under the terms of the agreement with Pontifax, the Company had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years Upon the closing of this transaction, the Company borrowed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the new drug application for HyBryte™, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively. On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement dated December 15, 2020 with Pontifax. The amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the amendment reduced the conversion price with respect to the remaining principal amount under the agreement to (i) 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares of the Company’s common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon conversion in excess of the first 36,790 shares so issued. The remaining terms of the agreement remain in effect without modification. On January, 3, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 9,139 shares of the Company’s common stock at $10.88 per share, reducing the remaining principal balance by $99,416. Pontifax may elect to convert the remaining outstanding loan drawn under the first tranche into additional shares of the Company’s common stock at any time prior to repayment. The Company also has the ability to force the conversion of the loan into shares of its common stock, subject to certain conditions. The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. The Company concluded that the amended debt instrument has an embedded derivative that requires bifurcation pursuant to ASC 815-15-25-1 and qualifies for the fair value option in accordance with ASC 815-15-25-4 through ASC 815-15-25-6. The Company elected to account for the amended convertible debt using the fair value option, which requires the Company to record changes in fair value as a component of other income or expense. The fair value of the convertible debt as of March 31, 2024 was $2,996,136, which resulted in the recognition of $165,382 of other income from the change in the fair value of the convertible debt on the Company’s accompanying condensed consolidated statements of operations during the three months ended March 31, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method. The key assumptions used in the Monte Carlo valuations were as follows: Assumptions 12/31/2023 3/31/2024 Stock price $ 0.76 $ 0.60 Volatility 141.90% 148.80% Discount rate 13.62% 16.16% Risk-free rate 4.65% 5.03% Interest expense incurred during the three months ended March 31, 2024 and 2023 was $61,239 and $187,964, respectively. Interest expense paid during the three months ended March 31, 2024 and 2023 was $64,047 and $213,490, respectively. Annual principal and interest payments due as of March 31, 2024 in accordance with the amended terms of the Pontifax loan agreement, including the January 3, 2024 conversion and assuming no further conversions are as follows: Year Principal Interest Total Remainder of 2024 $ 2,250,000 $ 198,305 $ 2,448,305 2025 650,585 13,889 664,474 Total $ 2,900,585 $ 212,194 $ 3,112,779 | Note 5. Debt In December 2020, the Company entered into a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing (“Pontifax”), the healthcare-dedicated venture and debt fund of the Pontifax life science funds. Under the terms of the agreement with Pontifax, the Company had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years with a fixed interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal is to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The agreement is secured by a lien covering substantially all of the Company’s assets, other than intellectual property. Upon the closing of this transaction, the Company accessed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the HyBryte™ NDA, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively. On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement dated December 15, 2020 with Pontifax. The amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the amendment reduced the conversion price with respect to the remaining principal amount under the agreement to (i) 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares of the Company’s common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon conversion in excess of the first 36,790 shares so issued. The remaining terms of the agreement remain in effect without modification. The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. The Company concluded that the amended debt instrument has an embedded derivative that requires bifurcation pursuant to ASC 815-15-25-1 and qualifies for the fair value option in accordance with ASC 815-15-25-4 through ASC 815-15-25-6. The Company elected to account for the amended convertible debt using the fair value option, which requires the Company to record changes in fair value as a component of other income or expense. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt was estimated using the Monte Carlo valuation method. Assumptions 4/19/2023 9/30/2023 12/31/2023 Stock price $ 1.72 $ 0.56 $ 0.76 Volatility 75.20% 110.50% 141.90% Discount rate 16.28% 14.84% 13.62% Risk-free rate 4.27% 5.24% 4.65% Interest expense incurred during the years ended December 31, 2023 and 2022 was $402,615 and $847,000, respectively. Interest expense paid during the years ended December 31, 2023 and 2022 was $552,058 and $857,411, respectively. Pontifax may elect to convert the outstanding loan drawn into shares of the Company’s common stock at any time prior to repayment. There was $3,000,000 of principal and $63,351 of accrued interest outstanding as of December 31, 2023.The Convertible Notes were convertible at (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares issuable upon conversion as of December 31, 2023 and (ii) $27.20 with respect to all shares issuable upon conversion in excess of the first 36,790 shares issued upon conversion as of December 31, 2023. The Company also has the ability to force the conversion of the loan into shares of the Company’s common stock at the same conversion price, subject to certain conditions. Annual principal and interest payments due, according to the agreement’s contractual terms, assuming no conversion is as follows: Year Principal Interest Total 2024 $ 2,250,000 $ 270,808 $ 2,520,808 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 286,820 $ 3,286,820 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | Note 6. Income Taxes The income tax benefit consisted of the following for the years ended December 31, 2023 and 2022: 2023 2022 Federal $ — $ — Foreign — — State & Local (1,767,803) (1,154,935) Income tax benefit $ (1,767,803) $ (1,154,935) The significant components of the Company’s deferred tax assets and liabilities at December 31, 2023 and 2022 are as follows: 2023 2022 Net operating loss carry forwards $ 27,522,000 $ 27,252,000 Orphan drug and research and development credit carry forwards 8,921,000 8,837,000 Equity based compensation 246,000 285,000 Intangibles 1,409,000 1,696,000 Capitalized research and development (Section 174) 2,311,000 1,832,000 Lease liability 66,000 96,000 Other (12,000) — Total 40,463,000 39,998,000 Valuation allowance (40,398,000) (39,902,000) Net deferred tax assets 65,000 96,000 Right of use asset (65,000) (96,000) Total gross deferred tax liabilities (65,000) (96,000) Net deferred tax assets $ — $ — The Company had gross NOLs at December 31, 2023 of approximately $123.0 million for federal tax purposes, approximately $12.9 million for state tax purposes and approximately $3.7 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8.9 million of various tax credits which credit the Company may be able to utilize its NOLs to reduce future federal and state income tax liabilities. However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382 limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. In addition, the NOL carryforwards are subject to examination by the taxing authority and could be adjusted or disallowed due to such exams. Although the Company has not undergone an IRC Section 382 analysis, it is likely that the utilization of the NOLs may be substantially limited. The Company and one or more of its subsidiaries files income tax returns in the U.S. federal jurisdiction, and various state and local jurisdictions. During the years ended December 31, 2023 and 2022 in accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carry forwards, resulting in the recognition of $1,767,803 and $1,154,935, respectively, of income tax benefit, net of transaction costs. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. There can be no assurance as to the continuation or magnitude of this program in the future. The Tax Cuts and Jobs Act of 2017 (“TCJA”) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize over five years for U.S. activities and 15 years for non-U.S. activities using a mid-year convention. Therefore, the capitalization of research and development costs in accordance with IRC 174 resulted in a deferred tax asset of $2,310,677. Reconciliations of the difference between income tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended December 31, 2023 and 2022 were as follows: 2023 2022 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (21.6) (2.4) Foreign tax rate difference 0.1 0.2 Orphan drug and research and development credits (2.0) (3.9) Permanent differences 0.9 3.1 Foreign NOL adjustments 0.7 0.4 Expiration of tax attributes 14.2 9.1 Change in valuation allowance 6.3 6.8 Income tax benefit (22.4) % (7.7) % Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2023, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination could apply from 2011, the earliest year with a net operating loss carryover, because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the years ended December 31, 2023 and 2022. |
Shareholders' Equity_2
Shareholders' Equity | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Shareholders' Equity | ||
Shareholders' Equity | Note 5. Shareholders’ Equity Common Stock The following items represent transactions in the Company’s common stock for the three months ended March 31, 2024: ● The Company issued Pontifax 9,139 shares of fully vested common stock pursuant to conversion of a portion of the convertible debt principal balance at a conversion price of $10.88 per share on January 3, 2024, the date of issuance. The conversion price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice. The issuance of the Company’s common stock in connection with the convertible debt financing agreement as described above was exempt under Section 3(a)(9) of the Securities Act of 1933, as amended. | Note 7. Shareholders’ Equity (Deficit) Preferred Stock The Company has 350,000 shares of preferred stock authorized, of which 50,000 were designated as Series D preferred stock during the year ended December 31, 2023. Series D Preferred Stock On December 21, 2022, the Board of Directors of the Company declared a dividend for the stockholders of record on January 3, 2023. The dividend consists of one one-thousandth General; Transferability - Series D preferred stock shares will be in book-entry form without certificates. Transfers can only happen alongside common stock transfers, with 1/1,000th Voting Rights - Each Series D preferred stock share gives the holder 1,000,000 votes. If a shareholder owns a fraction of a share, they will have a proportional number of votes. Series D preferred stock and common stock shares only vote together on two specific matters: 1. Any plan to change the Company's Certificate of Incorporation for a reverse stock split. 2. Any plan to delay a stockholders' meeting to vote on a reverse stock split (the "Adjournment Proposal"). When voting on the reverse stock split or the Adjournment Proposal, each Series D preferred stock share (or fraction of a share) will vote the same way as the common stock share it was issued from. Dividend Rights - The holders of Series D preferred stock will not be entitled to receive dividends of any kind. Liquidation Preference - If the Company undergoes liquidation, dissolution, or winding up, Series D preferred stock has priority over common stock for asset distribution. In such a situation, Series D preferred stockholders will receive a cash payment of $0.001 per share before any distribution is made to common stockholders. Redemption - If Series D preferred stockholders do not attend or vote by proxy at a meeting for the reverse stock split and Adjournment Proposal, their shares will be automatically redeemed by the Company. If any Series D preferred stock remains after this redemption, it can be redeemed in one of two ways: 1. The Board decides to redeem the shares at a time and date of their choosing. 2. The shares will be automatically redeemed when the Company's stockholders approve the reverse stock split during a meeting for this purpose. When Series D preferred stock is redeemed, stockholders receive a cash payment based on the number of shares they own. For every 100 whole shares redeemed, the stockholder will get $0.10 in cash. The Series D preferred stock shares were classified as mezzanine equity as of December 31, 2022 since they were not mandatorily redeemable but were redeemable based on an event not entirely controlled by the Company. All Series D preferred stock were redeemed in conjunction with the special meeting of the shareholders’ on February 8, 2023. Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2023: ● The Company issued a vendor 3 ,125 shares of fully vested common stock with a fair value based on a closing price of $23.36 per share on April 27, 2023, the date of issuance. ● The Company sold 53,202 shares of common stock pursuant to the At Market Issuance Sales Agreement (“B. Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”) at a weighted average price of $58.08 per share. ● The Company issued 1,978 shares of fully vested common stock pursuant to an exclusive option agreement at $25.28 per share on May 2, 2023. The share price was calculated using the average closing price of the common stock for the ten days immediately preceding April 27, 2023, the effective date of the option agreement . ● The Company sold 143,844 shares of common stock and 264,813 pre-funded warrants pursuant to the May 2023 public offering for $20.80 per share on May 9, 2023. ● The Company issued 126,438 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 9, 2023. ● The Company issued 58,625 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 10, 2023. ● The Company issued 21,125 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 22, 2023. ● The Company issued 25,001 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on June 8, 2023. ● The Company issued 33,525 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on September 6, 2023. The following items represent transactions in the Company’s common stock for the year ended December 31, 2022: ● The Company issued a vendor 337 shares of fully vested common stock with a fair value of $148.80 per share on February 7, 2022. ● The Company issued a vendor 401 shares of fully vested common stock with a fair value of $124.80 per share on May 6, 2022. ● The Company issued a vendor 229 shares of fully vested common stock with a fair value of $218.40 per share on August 5, 2022. ● The Company issued a vendor 105 shares of fully vested common stock with a fair value of $115.20 per share on October 4, 2022. ● The Company issued a vendor 321 shares of fully vested common stock with a fair value of $156.00 per share on November 7, 2022. ● The Company issued 539 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $148.64 per share. All issuances of the Company’s common stock for the years ended December 31, 2023 and 2022 described above, other than shares issued to vendors or issued pursuant to the exclusive option agreement, were registered on a Registration Statement on Form S-8 (SEC File No. 333-208515), a Registration Statement on Form S-1 (333-271049) and a Registration Statement on Form S-3 (SEC File No. 333-239928). The certificates evidencing unregistered shares reflect a Securities Act of 1933, as amended, restrictive legend. The issuances of the Company’s common stock to vendors and pursuant to the exclusive option agreement as described above were exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about the Company or had adequate access to information about the Company. The vendors represented to the Company that the vendors are not “consultants” for purposes of Nasdaq Listing Rule 5635(c). B. Riley At Market Issuance Sales Agreement On August 11, 2017, the Company entered into the B. Riley Sales Agreement to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program under which B. Riley acts as sales agent. Under the B. Riley Sales Agreement, the Company set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The B. Riley Sales Agreement provided that B. Riley was entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the B. Riley Sale Agreement. The B. Riley Sales Agreement has expired. |
Stock Option Plans and Warrants
Stock Option Plans and Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2023 | |
Stock Option Plans and Warrants to Purchase Common Stock | |
Stock Option Plans and Warrants to Purchase Common Stock | Note 8. Stock Option Plans and Warrants to Purchase Common Stock Stock Option Plans The Amended and Restated 2005 Equity Incentive Plan (“2005 Plan”) was replaced by the 2015 Plan, which was approved in June 2015. No securities are available for future issuance under the 2005 Plan. In September 2022, the stockholders approved an amendment to the 2015 Plan to increase the maximum number of shares of common stock available for issuance under the plan by 4,000,000 shares. As of December 31, 2023, there are 5,943,590 shares currently available for grants under the 2015 Plan. The plan is divided into four separate equity programs: 1) the Discretionary Option Grant Program, under which eligible persons may, at the discretion of the Plan Administrator, be granted options to purchase shares of common stock, 2) the Salary Investment Option Grant Program, under which eligible employees may elect to have a portion of their base salary invested each year in options to purchase shares of common stock, 3) the Automatic Option Grant Program, under which eligible nonemployee Board members will automatically receive options at periodic intervals to purchase shares of common stock, and 4) the Director Fee Option Grant Program, under which non-employee Board members may elect to have all, or any portion, of their annual retainer fee otherwise payable in cash applied to a special option grant. Shares available for grant under the 2015 Plan were as follows: Shares available for grant at January 1, 2023 5,988,368 Options granted (45,715) Options forfeited 937 Options exercised — Shares available for grant at December 31, 2023 5,943,590 Activity under the 2005 Plan and the 2015 Plan for the years ended December 31, 2023 and 2022 Weighted Average Exercise Options Price Balance outstanding at December 31, 2021 8,719 $ 593.92 Granted 3,497 141.61 Forfeited (236) 1,727.66 Cancelled (34) 187.20 Exercised — — Balance outstanding at December 31, 2022 11,946 $ 435.32 Granted 45,715 10.45 Forfeited (1,052) 533.80 Cancelled — — Exercised — — Balance outstanding at December 31, 2023 56,609 $ 90.58 As of December 31, 2023, there were 19,187 options exercisable with a weighted average exercise price of $236.90 and a weighted average remaining contractual term of 7.99 years. As of December 31, 2023, there were 56,609 options outstanding with a weighted average remaining term of 9.25 years. Options outstanding as of December 31, 2023 had no intrinsic value. The Company awarded 45,715 and 3,474 stock options during the years ended December 31, 2023 and 2022, respectively, which had a weighted average grant date fair value per share of $8.05 and $89.10, respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2023 was: Weighted Average Remaining Contractual Outstanding Exercisable Price Range Life in Years Options Options $9.44 - $540.00 9.31 56,182 18,760 $1,776.00 – 5,256.00 1.52 427 427 Total 9.25 56,609 19,187 The Company’s share-based compensation expense for the years ended December 31, 2023 and 2022 was recognized as follows: Share-based compensation 2023 2022 Research and development $ 150,466 $ 142,879 General and administrative 219,716 190,510 Total $ 370,182 $ 333,389 At December 31, 2023, the total compensation cost for stock options not yet recognized was approximately $421,000 and will be expensed over the next three years. Warrants to Purchase Common Stock Warrant activity for the years ended December 31, 2023 and 2022 was as follows: Weighted Average Exercise Warrants Price Balance at December 31, 2021 13,868 $ 540.68 Granted — — Exercised — — Expired (13,826) 540.90 Balance at December 31, 2022 42 $ 468.00 Granted 673,445 14.56 Exercised (264,815) 0.02 Expired (42) 468.00 Balance at December 31, 2023 408,640 $ 24.00 The remaining life, by grant date, for outstanding warrants at December 31, 2023 was: Remaining Exercise Contractual Outstanding Exercisable Grant Date Price Life in Years Warrants Warrants May 09, 2023 $ 24.00 4.36 408,640 408,640 |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2023 | |
Concentrations | |
Concentrations | Note 9. Concentrations At December 31, 2023 and 2022, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”) and the Federal Deposit Insurance Corporation (“FDIC”). Currently, the Company is covered up to $250,000 by the SIPC and FDIC and at times maintains cash balances in excess of the SIPC and FDIC coverages. |
Commitments and Contingencies_3
Commitments and Contingencies | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Commitments and Contingencies. | ||
Commitments and Contingencies | Note 6. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $230,000 as of March 31, 2024 over the next five years for several licensing agreements with partners and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to approximately $13.2 million, royalties on net sales of covered products ranging from 2% to 3% sub-license Investigational New Drug (“IND”) milestones on covered products of up to approximately $200,000, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. The Company currently leases office space which serves as the Company’s corporate headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended to October 2025. The current rent of $11,367 per month will be maintained until November 2024 when it will be increased to $11,625 per month where it will remain until expiration. In September 2014, the Company entered into an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 771 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to GAAP. In March 2020, the Company issued 8,151 shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the purchase agreement. Provided the sole remaining future success-oriented milestone of FDA approval is attained, the Company will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of March 31, 2024, no other milestone or royalty payments have been paid or accrued. As a result of the above agreements, the Company has the following contractual obligations: Research and Property and Year Development Other Leases Total April 1 through December 31, 2024 $ 46,000 $ 102,817 $ 148,817 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 219,067 $ 449,067 Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. | Note 10. Commitments and Contingencies The Company has commitments of approximately $230,000 as of December 31, 2023 over the next five years for several licensing agreements with partners and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to approximately $13.2 million, royalties on net sales of covered products ranging from 2% to 3%, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur. The Company currently leases approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey. This office space currently serves as the Company’s corporate headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment on June 21, 2022, the lease has been extended from November 2022 to October 2025. The current rent is approximately $11,367 per month and will remain so through October 2024. The rent for the lease period starting November 2024 is approximately $11,625 per month. On September 3, 2014, the Company entered into an asset purchase agreement with Hy Biopharma, Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 12,328 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the U.S. In March 2020, the Company issued 130,413 fully vested shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued to Hy Biopharma was calculated using an effective price of $38.40 per share, based upon a formula set forth in the purchase agreement. Provided the sole remaining future success-oriented milestone of FDA approval is attained, the Company will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of December 31, 2023, no other milestone or royalty payments have been paid or accrued. In January 2020, the Company’s Board of Directors authorized the amendment of Dr. Schaber’s employment agreement to increase the number of shares of the Company’s common stock from 334 to 33,334 issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by its Board of Directors whereby, directly or indirectly, a majority of its capital stock or a majority of its assets are transferred from the Company and/or its stockholders to a third party. As a result of the above agreements, the Company has future contractual obligations over the next five years as follows: Research and Property and Year Development Other Leases Total 2024 $ 46,000 $ 136,917 $ 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 253,167 $ 483,167 Contingencies The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable. COVID-19 Based on the current outbreak of SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites. COVID-19 affected the Company’s operations but did not have a material impact on the Company’s business, operating results, financial condition or cash flows as of and for the year ended December 31, 2023. The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus. |
Operating Segments_2
Operating Segments | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Operating Segments | ||
Operating Segments | Note 7. Operating Segments The Company maintains two active operating segments: Specialized BioTherapeutics and Public Health Solutions. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments. Three Months Ended March 31, 2024 2023 Revenues Specialized BioTherapeutics $ 117,029 $ 155,365 Public Health Solutions — 101,813 Total $ 117,029 $ 257,178 Income (loss) from Operations Specialized BioTherapeutics $ (860,604) $ (910,377) Public Health Solutions (45,997) 427 Corporate (1,210,490) (1,240,739) Total $ (2,117,091) $ (2,150,689) Amortization and Depreciation Expense Specialized BioTherapeutics $ 953 $ 1,071 Public Health Solutions 159 178 Corporate 476 536 Total $ 1,588 $ 1,785 Other (Expense) Income, Net Specialized BioTherapeutics $ 7,540 $ 6,082 Corporate 194,224 (62,699) Total $ 201,764 $ (56,617) Share-Based Compensation Specialized BioTherapeutics $ 20,672 $ 27,427 Public Health Solutions 588 994 Corporate 38,701 45,213 Total $ 59,961 $ 73,634 As of As of March 31, December 31, 2024 2023 Identifiable Assets Specialized BioTherapeutics $ 301,709 $ 272,099 Public Health Solutions 120,475 3,976 Corporate 7,636,201 9,521,251 Total $ 8,058,385 $ 9,797,326 | Note 11. Operating Segments The Company maintains two active operating segments: Specialized BioTherapeutics and Public Health Solutions. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments. For the Years Ended December 31, 2023 2022 Revenues Specialized BioTherapeutics $ 395,124 $ 31,929 Public Health Solutions 444,235 916,982 Total $ 839,359 $ 948,911 Income (loss) from Operations Specialized BioTherapeutics $ (2,812,303) $ (7,614,988) Public Health Solutions (36,531) 26,612 Corporate (4,849,106) (6,650,528) Total $ (7,697,940) $ (14,238,904) Amortization and Depreciation Expense Specialized BioTherapeutics $ 3,932 $ 10,087 Public Health Solutions 655 1,681 Corporate 1,967 12,794 Total $ 6,554 $ 24,562 Other (Expense) Income, Net Specialized BioTherapeutics $ 25,267 $ 102,320 Corporate (235,860) (816,690) Total $ (210,593) $ (714,370) Share-Based Compensation Specialized BioTherapeutics $ 145,683 $ 138,075 Public Health Solutions 4,782 4,804 Corporate 219,717 190,510 Total $ 370,182 $ 333,389 As of December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 272,099 $ 103,742 Public Health Solutions 3,976 121,290 Corporate 9,521,251 14,054,685 Total $ 9,797,326 $ 14,279,717 |
Subsequent Events_2
Subsequent Events | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Subsequent Events | ||
Subsequent Events | Note 8. Subsequent Events Pontifax Conversion of Convertible Debt On April 15, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 27,651 shares of the Company’s common stock at $5.60 per share, reducing the remaining principal balance by $154,840. Pontifax may elect to convert the remaining outstanding loan drawn under the first tranche into additional shares of the Company’s common stock at any time prior to repayment. The Company also has the ability to force the conversion of the loan into shares of its common stock, subject to certain conditions. $ 4.75 million Public Offering On April 22, 2024, the Company completed a public offering of (i) 204,694 shares of the Company’s common stock, (ii) pre-funded warrants to purchase 537,500 shares of the Company’s common stock and (iii) common warrants to purchase 742,194 shares of the Company’s common stock. The shares of common stock, or pre-funded warrants in lieu thereof, and the common warrants, were sold in units, with each unit consisting of one share of common stock or one pre-funded warrant in lieu thereof and one common warrant. Each unit comprised of common stock and common warrants was sold at a per unit price of $6.40. Each unit comprised of pre-funded warrants and common warrants was sold at a per unit price of $6.38, which represents the same per unit price less the $0.02 per share exercise price of the pre-funded warrants. The common warrants are exercisable at a price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses payable by the Company ($4.3 million, net). | Note 12. Subsequent Event Convertible Debt Financing Agreement On April 19, 2023, the Company entered into an amendment to the convertible debt financing agreement with Pontifax (See Note 5). The amendment reduced the conversion price with respect to the remaining principal amount outstanding under the agreement. The conversion price was amended to be (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 3 6,790 shares of our common stock issuable upon conversion and (ii) $27.20 with respect to all shares of our common stock issuable upon conversion in excess of the first 3 6,790 shares so issued. Conversion of Promissory Notes On January 3, 2024, the Company issued an aggregate of 9,139 shares of common stock to two lenders upon conversion of approximately $100,000 of principal under promissory notes at a conversion price of $10.88 per share. Remaining Convertible Debt As of March 8, 2024, $2,900,585 of principal and $45,840 of accrued interest remain outstanding under the agreement. The conversion price for the remaining principal amount as of March 8, 2024 is (i) 90% of the closing price of our common stock on the day before the delivery of the conversion notice with respect to the first 27,651 shares of common stock issuable upon conversion and (ii) $27.40 with respect to all shares issuable upon conversion in excess of the first 27,651 shares so issued. |
Reverse Stock Split_2
Reverse Stock Split | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Shareholders' Equity | ||
Reverse Stock Split | Note 9. Reverse Stock Split On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-sixteen, whereby every sixteen | Note 13. Reverse Stock Split On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for- sixteen |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Policies) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies | ||
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. | Principles of Consolidation The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation. |
Operating Segments | Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. | Operating Segments Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. |
Contracts and Grants Receivable | Contracts and Grants Receivable Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. | Contracts and Grants Receivable In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326) Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Office furniture and equipment and right of use assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the three months ended March 31, 2024 and 2023. | Impairment of Long-Lived Assets Office furniture and equipment, right of use assets and website development costs with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment. The Company did not record any impairment of long-lived assets for the years ended December 31, 2023 and 2022. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the condensed consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the condensed consolidated balance sheet as of March 31, 2024 for the convertible debt is its fair value - see Note 4. The principal amount of the convertible debt was $2,900,585 at March 31, 2024 and the fair value was $2,996,136. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to March 31, 2024 is as follows: Balance Conversion Adjustment to Balance December 31, 2023 January 3, 2024 fair value March 31, 2024 Convertible debt at fair value $ 3,260,934 $ (99,416) $ (165,382) $ 2,996,136 | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, to the Company on December 31, 2023 and 2022. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments. FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments. The carrying amount reported in the consolidated balance sheet as of December 31, 2023 for the convertible debt is its fair value – see Note 5. The principal amount of the convertible debt was $3,000,000 at December 31, 2023 and the fair value was approximately $3,260,934. The fair value of the debt was estimated using the Monte Carlo valuation method, which utilizes certain unobservable inputs. As a result, the fair value estimate represents a Level 3 measurement. A roll forward of the carrying value of the convertible debt to December 31, 2023 is as follows: Balance Adjustment to Balance December 31, 2022 Issued fair value December 31, 2023 Convertible debt at fair value $ — $ 3,304,000 $ (43,066) $ 3,260,934 |
Deferred Issuance Costs | Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. | Deferred Issuance Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance. |
Revenue Recognition | Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. | Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development | Research and Development Costs Research and development costs are charged to expense when incurred in accordance with FASB ASC 730, Research and Development |
Share-Based Compensation | Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year three years three months From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. There were no options issued during the three months ended March 31, 2024 and 2023. | Share-Based Compensation Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten year life for as long as the individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board. From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the years ended December 31, 2023 and 2022 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of four years ; ● volatility of 94% - 110% for 2023 and 84% - 87% for 2022; and ● risk-free interest rates ranging from 3.48% to 4.35% in 2023 and ranging from 1.12% to 4.51% in 2022. The fair value of each option grant made during 2023 and 2022 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. The expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for forfeitures as they are incurred. |
Foreign Currency Transactions and Translation | Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters | Foreign Currency Transactions and Translation In 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company did not recognize an income tax benefit during the three months ended March 31, 2024. The Company recognized $1,161,197 of income tax benefit, net of transaction costs from the sale of its 2021 NOL carryforwards during the three months ended March 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for the three months ended March 31, 2024 and 2023. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at March 31, 2024 or December 31, 2023. | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company sold 2022, 2021 and 2020 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $1,767,803 and $1,154,935 during the years ended December 31, 2023 and 2022, respectively. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax related interest and penalties recorded for 2023 and 2022. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2023 or 2022. |
Research and Development Incentive Income and Receivable | Research and Development Incentive Income and Receivable The Company recognizes other income from UK research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue & Customs as long as specific eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the SME research and development tax relief program described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief program are recorded as a component of other income. The research and development incentive receivable represents an amount due in connection with the above-described tax relief program. The Company has recorded a research and development incentive receivable of approximately $49,000 and $128,000 as of December 31, 2023 and 2022, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to December 31, 2023: Current Long-Term Total Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 UK research and development incentives, transfer 24,114 (24,114) — UK research and development incentives — 24,897 24,897 Adjustments to 2021 and 2022 incentives earned (1,113) — (1,113) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 1,117 571 1,688 Balance at December 31, 2023 $ 23,894 $ 25,468 $ 49,362 | |
Loss Per Share | Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the three months ended March 31, 2024, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: As of March 31, 2024 2023 Common stock purchase warrants 408,640 — Stock options 56,568 11,946 Convertible debt 335,716 105,746 Total 800,924 117,692 The weighted average exercise prices of the Company’s warrants and stock options outstanding at March 31, 2024 were $24.00 and $87.15 per share, respectively. The weighted average exercise prices of the Company’s stock options outstanding at March 31, 2023 was $435.32 per share. The weighted average conversion price of the Company’s convertible debt at March 31, 2024 and 2023 was $138.24 and $453.92 per share, respectively. | Loss Per Share Basic earnings per share (“EPS”) excludes dilution and is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding for the year ended December 31, 2023, are common shares issuable upon the exercise of the pre-funded warrants associated with the May 2023 public offering, as these pre-funded warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. Since there is a significant number of options and warrants outstanding, fluctuations in the actual market price can have a variety of results for each period presented. The following table summarizes potentially dilutive adjustments to the number of common shares which were excluded from the diluted calculation because their effect would be anti-dilutive due to the losses in each period: December 31, December 31, 2023 2022 Common stock purchase warrants 408,640 42 Stock options 56,609 11,946 Convertible debt 273,973 30,865 Total 739,222 42,853 |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of financial statements in conformity with generally accepted accounting principles in the U.S. (“GAAP”) requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. | Use of Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Summary of Significant Accounting Policies | ||
Schedule of carrying value of convertible debt | A roll forward of the carrying value of the convertible debt to March 31, 2024 is as follows: Balance Conversion Adjustment to Balance December 31, 2023 January 3, 2024 fair value March 31, 2024 Convertible debt at fair value $ 3,260,934 $ (99,416) $ (165,382) $ 2,996,136 | Balance Adjustment to Balance December 31, 2022 Issued fair value December 31, 2023 Convertible debt at fair value $ — $ 3,304,000 $ (43,066) $ 3,260,934 |
Schedule of United Kingdom research and development incentives receivable | Current Long-Term Total Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 UK research and development incentives, transfer 24,114 (24,114) — UK research and development incentives — 24,897 24,897 Adjustments to 2021 and 2022 incentives earned (1,113) — (1,113) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 1,117 571 1,688 Balance at December 31, 2023 $ 23,894 $ 25,468 $ 49,362 | |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of March 31, 2024 2023 Common stock purchase warrants 408,640 — Stock options 56,568 11,946 Convertible debt 335,716 105,746 Total 800,924 117,692 | December 31, December 31, 2023 2022 Common stock purchase warrants 408,640 42 Stock options 56,609 11,946 Convertible debt 273,973 30,865 Total 739,222 42,853 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Schedule of lease expense | Operating Lease Contractual cash payments for the remaining lease term as of December 31, 2023 2024 $ 136,917 2025 116,250 Less implied interest 19,540 Total $ 233,627 Discount rate applied 8.47 % Remaining lease term (months) as of December 31, 2023 22 Right-of-use lease asset: Right-of-use lease asset, January 1, 2022 $ 106,155 New lease extension June 21, 2022 347,546 Less: reduction/amortization 112,714 Right-of-use lease asset, December 31, 2022 340,987 Less: reduction/amortization 111,153 Right-of-use lease asset, December 31, 2023 $ 229,834 Lease liability: Lease liability, January 1, 2022 $ 106,151 New lease extension June 21, 2022 347,546 Less: repayments 111,122 Lease liability, December 31, 2022 342,575 Less: repayments 108,948 Lease liability, December 31, 2023 $ 233,627 Lease expense for the year ended December 31, 2022: Lease expense $ 134,892 Total $ 134,892 Lease expense for the year ended December 31, 2023: Lease expense $ 136,022 Total $ 136,022 |
Accrued Expenses (Tables)_2
Accrued Expenses (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Accrued Expenses | ||
Schedule of accrued expenses | March 31, December 31, 2024 2023 Clinical trial expenses $ 2,070,955 $ 1,993,784 Other 531,710 424,218 Total $ 2,602,665 $ 2,418,002 | December 31, 2023 2022 Clinical trial expenses $ 1,993,784 $ 1,884,117 Other 424,218 423,629 Total $ 2,418,002 $ 2,307,746 |
Debt (Tables)_2
Debt (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Debt | ||
Schedule of debt assumptions | Assumptions 12/31/2023 3/31/2024 Stock price $ 0.76 $ 0.60 Volatility 141.90% 148.80% Discount rate 13.62% 16.16% Risk-free rate 4.65% 5.03% | Assumptions 4/19/2023 9/30/2023 12/31/2023 Stock price $ 1.72 $ 0.56 $ 0.76 Volatility 75.20% 110.50% 141.90% Discount rate 16.28% 14.84% 13.62% Risk-free rate 4.27% 5.24% 4.65% |
Schedule of annual principle and interest payments due | Year Principal Interest Total Remainder of 2024 $ 2,250,000 $ 198,305 $ 2,448,305 2025 650,585 13,889 664,474 Total $ 2,900,585 $ 212,194 $ 3,112,779 | Year Principal Interest Total 2024 $ 2,250,000 $ 270,808 $ 2,520,808 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 286,820 $ 3,286,820 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2023 2022 Federal $ — $ — Foreign — — State & Local (1,767,803) (1,154,935) Income tax benefit $ (1,767,803) $ (1,154,935) |
Schedule of deferred tax assets and liabilities | 2023 2022 Net operating loss carry forwards $ 27,522,000 $ 27,252,000 Orphan drug and research and development credit carry forwards 8,921,000 8,837,000 Equity based compensation 246,000 285,000 Intangibles 1,409,000 1,696,000 Capitalized research and development (Section 174) 2,311,000 1,832,000 Lease liability 66,000 96,000 Other (12,000) — Total 40,463,000 39,998,000 Valuation allowance (40,398,000) (39,902,000) Net deferred tax assets 65,000 96,000 Right of use asset (65,000) (96,000) Total gross deferred tax liabilities (65,000) (96,000) Net deferred tax assets $ — $ — |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2023 2022 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (21.6) (2.4) Foreign tax rate difference 0.1 0.2 Orphan drug and research and development credits (2.0) (3.9) Permanent differences 0.9 3.1 Foreign NOL adjustments 0.7 0.4 Expiration of tax attributes 14.2 9.1 Change in valuation allowance 6.3 6.8 Income tax benefit (22.4) % (7.7) % |
Stock Option Plans and Warran_2
Stock Option Plans and Warrants to Purchase Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Grant 2015 Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of shares available for grant under the 2015 plan | Shares available for grant at January 1, 2023 5,988,368 Options granted (45,715) Options forfeited 937 Options exercised — Shares available for grant at December 31, 2023 5,943,590 |
Stock options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of activity under the 2005 plan and the 2015 plan | Weighted Average Exercise Options Price Balance outstanding at December 31, 2021 8,719 $ 593.92 Granted 3,497 141.61 Forfeited (236) 1,727.66 Cancelled (34) 187.20 Exercised — — Balance outstanding at December 31, 2022 11,946 $ 435.32 Granted 45,715 10.45 Forfeited (1,052) 533.80 Cancelled — — Exercised — — Balance outstanding at December 31, 2023 56,609 $ 90.58 |
Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock | Weighted Average Remaining Contractual Outstanding Exercisable Price Range Life in Years Options Options $9.44 - $540.00 9.31 56,182 18,760 $1,776.00 – 5,256.00 1.52 427 427 Total 9.25 56,609 19,187 |
Share-based Payment Arrangement | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of share-based compensation expense | Share-based compensation 2023 2022 Research and development $ 150,466 $ 142,879 General and administrative 219,716 190,510 Total $ 370,182 $ 333,389 |
Warrants | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of warrant activity | Weighted Average Exercise Warrants Price Balance at December 31, 2021 13,868 $ 540.68 Granted — — Exercised — — Expired (13,826) 540.90 Balance at December 31, 2022 42 $ 468.00 Granted 673,445 14.56 Exercised (264,815) 0.02 Expired (42) 468.00 Balance at December 31, 2023 408,640 $ 24.00 |
Schedule of remaining life, by grant date, for outstanding warrants | Remaining Exercise Contractual Outstanding Exercisable Grant Date Price Life in Years Warrants Warrants May 09, 2023 $ 24.00 4.36 408,640 408,640 |
Commitments and Contingencies_4
Commitments and Contingencies (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Commitments and Contingencies. | ||
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total April 1 through December 31, 2024 $ 46,000 $ 102,817 $ 148,817 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 219,067 $ 449,067 | Research and Property and Year Development Other Leases Total 2024 $ 46,000 $ 136,917 $ 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 2028 46,000 — 46,000 Total $ 230,000 $ 253,167 $ 483,167 |
Operating Segments (Tables)_2
Operating Segments (Tables) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Operating Segments | ||
Schedule of operating segments | Three Months Ended March 31, 2024 2023 Revenues Specialized BioTherapeutics $ 117,029 $ 155,365 Public Health Solutions — 101,813 Total $ 117,029 $ 257,178 Income (loss) from Operations Specialized BioTherapeutics $ (860,604) $ (910,377) Public Health Solutions (45,997) 427 Corporate (1,210,490) (1,240,739) Total $ (2,117,091) $ (2,150,689) Amortization and Depreciation Expense Specialized BioTherapeutics $ 953 $ 1,071 Public Health Solutions 159 178 Corporate 476 536 Total $ 1,588 $ 1,785 Other (Expense) Income, Net Specialized BioTherapeutics $ 7,540 $ 6,082 Corporate 194,224 (62,699) Total $ 201,764 $ (56,617) Share-Based Compensation Specialized BioTherapeutics $ 20,672 $ 27,427 Public Health Solutions 588 994 Corporate 38,701 45,213 Total $ 59,961 $ 73,634 As of As of March 31, December 31, 2024 2023 Identifiable Assets Specialized BioTherapeutics $ 301,709 $ 272,099 Public Health Solutions 120,475 3,976 Corporate 7,636,201 9,521,251 Total $ 8,058,385 $ 9,797,326 | For the Years Ended December 31, 2023 2022 Revenues Specialized BioTherapeutics $ 395,124 $ 31,929 Public Health Solutions 444,235 916,982 Total $ 839,359 $ 948,911 Income (loss) from Operations Specialized BioTherapeutics $ (2,812,303) $ (7,614,988) Public Health Solutions (36,531) 26,612 Corporate (4,849,106) (6,650,528) Total $ (7,697,940) $ (14,238,904) Amortization and Depreciation Expense Specialized BioTherapeutics $ 3,932 $ 10,087 Public Health Solutions 655 1,681 Corporate 1,967 12,794 Total $ 6,554 $ 24,562 Other (Expense) Income, Net Specialized BioTherapeutics $ 25,267 $ 102,320 Corporate (235,860) (816,690) Total $ (210,593) $ (714,370) Share-Based Compensation Specialized BioTherapeutics $ 145,683 $ 138,075 Public Health Solutions 4,782 4,804 Corporate 219,717 190,510 Total $ 370,182 $ 333,389 As of December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 272,099 $ 103,742 Public Health Solutions 3,976 121,290 Corporate 9,521,251 14,054,685 Total $ 9,797,326 $ 14,279,717 |
Nature of Business (Details)_2
Nature of Business (Details) | 3 Months Ended | 12 Months Ended | |||||||||||||||
Jun. 05, 2024 | Apr. 22, 2024 USD ($) $ / shares shares | Jan. 03, 2024 USD ($) $ / shares shares | May 09, 2023 USD ($) $ / shares shares | May 02, 2023 $ / shares shares | Apr. 27, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | May 06, 2022 shares | Apr. 27, 2022 shares | Feb. 07, 2022 shares | Mar. 31, 2024 USD ($) segment shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) segment shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Nature of business: | |||||||||||||||||
Number of operating segments | segment | 2 | 2 | |||||||||||||||
Collaborative Arrangement, Revenue Not from Contract with Customer, Statement of Income or Comprehensive Income [Extensible Enumeration] | Revenues | ||||||||||||||||
Net loss | $ (1,915,327) | $ (1,046,109) | $ (6,140,730) | $ (13,798,339) | |||||||||||||
Net cash used in operating activities | (1,342,482) | (2,166,253) | (8,604,109) | (12,649,021) | |||||||||||||
Reclassification of Convertible Debt From Non-Current to current Liability | 1,000,000 | ||||||||||||||||
Number of shares sold | 70,730 | ||||||||||||||||
Cash and cash equivalents | 7,091,548 | 10,265,850 | 8,446,158 | 13,359,615 | $ 26,043,897 | ||||||||||||
Net decrease in cash | $ 1,354,610 | 3,093,765 | $ 4,913,457 | 12,684,282 | |||||||||||||
Percentage change in cash and cash equivalent | 16% | 37% | |||||||||||||||
Accumulated deficit | $ 227,619,503 | $ 225,704,176 | 219,563,446 | ||||||||||||||
Working capital | 607,499 | $ 3,355,212 | (2,663,721) | ||||||||||||||
Working capital increase, decrease | $ (2,747,713) | $ 6,018,933 | |||||||||||||||
Working capital increase (decrease) as a percent | 82% | 226% | |||||||||||||||
Common Stock, Shares, Issued | shares | 657,900 | 648,761 | |||||||||||||||
Number of shares issued | shares | 3 | 321 | 105 | 229 | 401 | 3 | 337 | ||||||||||
Repayment of debt principal | 1,000,000 | $ 7,000,000 | |||||||||||||||
Consideration paid recorded in general and administrative expense | $ 1,022,051 | 1,235,376 | 4,482,552 | $ 6,692,904 | |||||||||||||
Issuance of common stock for unexercised purchase option | 50,000 | ||||||||||||||||
Pontifax [Member] | |||||||||||||||||
Nature of business: | |||||||||||||||||
Repayment of debt principal | $ 5,000,000 | ||||||||||||||||
Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Total gross proceeds | $ 8,500,000 | ||||||||||||||||
Shares issued price per share | $ / shares | $ 20.80 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Common Stock | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares sold | $ 1 | ||||||||||||||||
Issuance of common stock for unexercised purchase option (in shares) | shares | 1,978 | ||||||||||||||||
Issuance of common stock for unexercised purchase option | $ 2 | ||||||||||||||||
Common Stock | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Shares issued price per share | $ / shares | $ 20.80 | ||||||||||||||||
Number of shares issued | shares | 143,844 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 24 | ||||||||||||||||
Subsequent Event | |||||||||||||||||
Nature of business: | |||||||||||||||||
Shares issued price per share | $ / shares | $ 6.40 | ||||||||||||||||
Reverse stock spilt effective from June 5, 2024 | 0.625 | ||||||||||||||||
Subsequent Event | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Total gross proceeds | $ 4,750,000 | ||||||||||||||||
Shares issued price per share | $ / shares | $ 6.40 | ||||||||||||||||
Number of shares issued | shares | 143,844 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.02 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Net proceeds | $ 4,300,000 | ||||||||||||||||
Subsequent Event | Common Stock | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares issued | shares | 204,694 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 6.40 | ||||||||||||||||
Pre-funded warrants | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 264,813 | ||||||||||||||||
Pre-funded warrants | Subsequent Event | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 537,500 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.02 | ||||||||||||||||
Common warrants | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 408,656 | ||||||||||||||||
Common warrants | Subsequent Event | Public Offering | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of common warrants to purchase shares issued | shares | 742,194 | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 6.40 | ||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||
Convertible Debt | |||||||||||||||||
Nature of business: | |||||||||||||||||
Total gross proceeds | $ 100,000 | ||||||||||||||||
Shares issued price per share | $ / shares | $ 10.88 | ||||||||||||||||
Number of shares issued | shares | 9,139 | ||||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||||
CiVax | |||||||||||||||||
Nature of business: | |||||||||||||||||
Revenue from collaborative arrangement | $ 1,500,000 | ||||||||||||||||
Term (in years) | 2 years | ||||||||||||||||
HyBryte | |||||||||||||||||
Nature of business: | |||||||||||||||||
Revenue from collaborative arrangement | $ 1,100,000 | $ 1,100,000 | |||||||||||||||
Term (in years) | 4 years | 4 years | |||||||||||||||
NIH | |||||||||||||||||
Nature of business: | |||||||||||||||||
Government grant funding | $ 673,000,000,000 | $ 844,000 | |||||||||||||||
Exclusive option agreement | Common Stock | |||||||||||||||||
Nature of business: | |||||||||||||||||
Shares issued price per share | $ / shares | $ 25.28 | ||||||||||||||||
Number of shares issued | shares | 1,978 | ||||||||||||||||
B Riley Sales Agreement [Member] | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares sold | 3,091,462 | 79,354 | |||||||||||||||
B Riley Sales Agreement [Member] | Common Stock | |||||||||||||||||
Nature of business: | |||||||||||||||||
Number of shares sold | $ 53 | $ 1 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2024 USD ($) segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) segment shares | Dec. 31, 2022 USD ($) shares | Apr. 19, 2023 USD ($) | Dec. 31, 2020 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Allowance for doubtful accounts | $ 0 | |||||
Number of operating segments | segment | 2 | 2 | ||||
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 | $ 0 | ||
Requisite period (in years) | 3 years | 3 years | ||||
Expiration period | 10 years | 10 years | ||||
Option vesting rights | 25% | 25% | ||||
Dividend yield | 0% | 0% | ||||
Expected life | 4 years | |||||
Volatility rate minimum | 94% | 84% | ||||
Volatility rate maximum | 110% | 87% | ||||
Risk free interest rate, minimum | 3.48% | 1.12% | ||||
Risk free interest rate, maximum | 4.35% | 4.51% | ||||
Foreign currency transaction gain (loss) | $ 1,209 | (366) | $ (1,483) | $ 30,549 | ||
Income tax benefit | (1,161,197) | (1,767,803) | (1,154,935) | |||
Net Operating Loss Carryforwards Sold | 606,606 | |||||
Interest and penalties | 0 | $ 0 | 0 | 0 | ||
Unrecognized Tax Benefits | 0 | $ 0 | $ 0 | |||
Number of options issued | shares | 45,715 | 3,497 | ||||
Convertible debt fair value | 2,996,136 | $ 3,260,934 | ||||
Convertible Debt | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Debt instrument, face amount | 2,900,585 | 3,000,000 | $ 20,000,000 | |||
Convertible debt fair value | $ 2,996,136 | $ 3,260,934 | $ 3,304,000 | |||
Warrants | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
DO NOT USE FOR WARRANTS Expired (in shares) | shares | (42) | (13,826) | ||||
Number of options issued | shares | 673,445 | |||||
Termination benefits | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Expiration period | 3 months | 3 months | ||||
Directors | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Requisite period (in years) | 1 year | 1 year |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Carrying Value of Convertible Debt (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Jan. 03, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Debt instruments | ||||
Convertible debt repayments | $ (1,000,000) | $ (7,000,000) | ||
Adjustment to fair value | $ (165,382) | (43,066) | ||
Convertible Debt | ||||
Debt instruments | ||||
Convertible debt at fair value as of December 31, 2022 | 3,260,934 | $ 0 | 0 | |
Issued | 3,304,000 | |||
Convertible debt repayments | $ (99,416) | |||
Adjustment to fair value | (165,382) | (43,066) | ||
Convertible debt at fair value as of September 30, 2023 | $ 2,996,136 | $ 3,260,934 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Research and Development Incentives (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Research and development incentive receivable, total | $ 49,000 | $ 128,000 |
Incentives receivable, Beginning balance | 128,312 | |
UK research and development incentives | 24,897 | |
Adjustments to 2021 and 2022 incentives earned | (1,113) | |
UK research and development incentives cash receipt | (104,422) | |
Foreign currency translation | 1,688 | |
Incentives receivable, Ending balance | 49,362 | |
Current Receivables | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Incentives receivable, Beginning balance | 104,198 | |
UK research and development incentives, transfer | 24,114 | |
Adjustments to 2021 and 2022 incentives earned | (1,113) | |
UK research and development incentives cash receipt | (104,422) | |
Foreign currency translation | 1,117 | |
Incentives receivable, Ending balance | 23,894 | |
Long Term Receivable | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Incentives receivable, Beginning balance | 24,114 | |
UK research and development incentives, transfer | (24,114) | |
UK research and development incentives | 24,897 | |
Foreign currency translation | 571 | |
Incentives receivable, Ending balance | $ 25,468 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Loss per share, Warrants and Options expirations (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 800,924 | 117,692 | 739,222 | 42,853 | |
Weighted average exercise price, outstanding warrants | $ 24 | ||||
Weighted average exercise price, outstanding options | 87.15 | $ 435.32 | $ 90.58 | $ 435.32 | $ 593.92 |
Pontifax | First 588,599 shares of common stock issuable upon conversion | Convertible Debt | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Conversion price | $ 27.20 | ||||
Weighted Average | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Conversion price | $ 138.24 | $ 453.92 | |||
Common stock purchase warrants | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 408,640 | 408,640 | 42 | ||
Stock options | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 56,568 | 11,946 | 56,609 | 11,946 | |
Convertible debt | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Securities excluded | 335,716 | 105,746 | 273,973 | 30,865 |
Leases (Details)
Leases (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 21, 2022 | Dec. 31, 2021 |
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,367 | ||||
Right-of-use asset, operating lease | $ 200,569 | $ 229,834 | $ 340,987 | $ 106,155 | |
Lease liability, operating | 233,627 | $ 342,575 | $ 106,151 | ||
For Period Till November 2023 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | 11,367 | ||||
From Period Till November 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,625 | ||||
From Period Till Lease Expiration 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,625 |
Leases - Reconciliation (Detail
Leases - Reconciliation (Details) - USD ($) | 12 Months Ended | ||
Jun. 21, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Contractual cash payments for the remaining lease term | |||
2024 | $ 136,917 | ||
2025 | 116,250 | ||
Less implied interest | 19,540 | ||
Total | $ 233,627 | ||
Operating Lease, Discount rate applied | 8.47% | ||
Remaining lease term (months) | 22 months | ||
Right-of-use lease asset: | |||
Right-of-use lease asset, Beginning balance | $ 340,987 | $ 106,155 | |
New lease extension | $ 347,546 | ||
Less: reduction/amortization | 111,153 | 112,714 | |
Right-of-use lease asset, Ending balance | 229,834 | 340,987 | |
Lease liability: | |||
Lease liability, Beginning | 342,575 | 106,151 | |
New lease extension | $ 347,546 | ||
Less: repayments | 108,948 | 111,122 | |
Lease liability, Ending | 233,627 | 342,575 | |
Lease expense | |||
Lease expense | $ 136,022 | $ 134,892 |
Accrued Expenses (Details)_2
Accrued Expenses (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses | |||
Clinical trail expenses | $ 2,070,955 | $ 1,993,784 | $ 1,884,117 |
Other | 531,710 | 424,218 | 423,629 |
Total | $ 2,602,665 | $ 2,418,002 | $ 2,307,746 |
Debt (Details)_2
Debt (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||
Mar. 08, 2024 USD ($) | Jan. 03, 2024 USD ($) $ / shares | Apr. 19, 2023 USD ($) $ / shares | Apr. 18, 2023 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Apr. 27, 2023 $ / shares | Nov. 07, 2022 $ / shares | Oct. 04, 2022 $ / shares | Aug. 04, 2022 $ / shares | May 07, 2022 $ / shares | Feb. 07, 2022 $ / shares | |
Debt instruments | |||||||||||||||
Outstanding principal | $ 1,010,934 | $ 0 | |||||||||||||
Fair value per share | $ / shares | $ 23.36 | $ 156 | $ 115.20 | $ 218.40 | $ 124.80 | $ 148.80 | |||||||||
Repayment of debt principal | $ 1,000,000 | 7,000,000 | |||||||||||||
Convertible debt fair value | $ 2,996,136 | 3,260,934 | |||||||||||||
Change in fair value of convertible debt | (165,382) | (43,066) | |||||||||||||
Loss on extinguishment of debt | (393,791) | ||||||||||||||
Pontifax | |||||||||||||||
Debt instruments | |||||||||||||||
Debt instrument, face amount | 3,000,000 | ||||||||||||||
Accrued interest expense | $ 63,351 | ||||||||||||||
Pontifax | First 588,599 shares of common stock issuable upon conversion | |||||||||||||||
Debt instruments | |||||||||||||||
Shares of common stock issuable upon conversion | 36,790 | ||||||||||||||
Convertible Debt | |||||||||||||||
Debt instruments | |||||||||||||||
Debt instrument, face amount | $ 20,000,000 | 2,900,585 | $ 3,000,000 | ||||||||||||
Number of tranches | three | ||||||||||||||
Interest-only period | 2 years | ||||||||||||||
Interest rate percentage | 8.47% | ||||||||||||||
Unused line of credit fee, as a percent | 1% | ||||||||||||||
Outstanding principal periodic payment | $ 1,000,000 | ||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||
Convertible debt fair value | $ 3,304,000 | 2,996,136 | 3,260,934 | ||||||||||||
Change in fair value of convertible debt | (165,382) | (43,066) | |||||||||||||
Interest expense | 61,239 | 187,964 | 402,615 | 847,000 | |||||||||||
Interest paid | $ 64,047 | $ 213,490 | 552,058 | $ 857,411 | |||||||||||
Loss on extinguishment of debt | $ 394,000 | ||||||||||||||
Convertible Debt | Maximum | |||||||||||||||
Debt instruments | |||||||||||||||
Debt instrument, face amount | 20,000,000 | ||||||||||||||
Convertible Debt | First Tranche [Member] | |||||||||||||||
Debt instruments | |||||||||||||||
Convertible note | 10,000,000 | ||||||||||||||
Convertible Debt | Second Tranche [Member] | |||||||||||||||
Debt instruments | |||||||||||||||
Convertible note | 5,000,000 | ||||||||||||||
Convertible Debt | Third Tranche [Member] | |||||||||||||||
Debt instruments | |||||||||||||||
Convertible note | $ 5,000,000 | ||||||||||||||
Convertible Debt | Pontifax | |||||||||||||||
Debt instruments | |||||||||||||||
Outstanding principal periodic payment | 750,000 | $ 1,000,000 | |||||||||||||
Amount repaid | 5,000,000 | ||||||||||||||
Outstanding principal | $ 3,000,000 | ||||||||||||||
Shares of common stock issuable upon conversion | 27,651 | 9 | 3 | ||||||||||||
Fair value per share | $ / shares | $ 10.88 | ||||||||||||||
Repayment of debt principal | $ 99,416 | ||||||||||||||
Percent Of Closing Price Of Common Stock For Conversion Price Per Share | 90% | ||||||||||||||
Convertible Debt | Pontifax | First 588,599 shares of common stock issuable upon conversion | |||||||||||||||
Debt instruments | |||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | ||||||||||||||
Shares of common stock issuable upon conversion | 3 | 3 | |||||||||||||
Reduction in conversion price | $ / shares | $ 27.20 |
Debt - Assumptions (Details)_2
Debt - Assumptions (Details) | Mar. 31, 2024 $ / shares | Dec. 31, 2023 $ / shares | Sep. 30, 2023 $ / shares | Apr. 19, 2023 $ / shares |
Measurement Input, Share Price [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 0.60 | 0.76 | 0.56 | 1.72 |
Measurement Input, Price Volatility [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 1.4880 | 1.4190 | 1.1050 | 0.7520 |
Measurement Input, Discount Rate [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 0.1616 | 0.1362 | 0.1484 | 0.1628 |
Measurement Input, Risk Free Interest Rate [Member] | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Debt Instrument, Measurement Input | 0.0503 | 0.0465 | 0.0524 | 0.0427 |
Debt - Payments due (Details)_2
Debt - Payments due (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Debt instruments | ||
Remainder of 2024 | $ 2,448,305 | |
2025 | 664,474 | $ 2,520,808 |
2025 | 766,012 | |
Total | 3,112,779 | 3,286,820 |
Principal [Member] | ||
Debt instruments | ||
Remainder of 2024 | 2,250,000 | |
2025 | 650,585 | 2,250,000 |
2025 | 750,000 | |
Total | 2,900,585 | 3,000,000 |
Interest [Member] | ||
Debt instruments | ||
Remainder of 2024 | 198,305 | |
2025 | 13,889 | 270,808 |
2025 | 16,012 | |
Total | $ 212,194 | $ 286,820 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
NOL for Federal tax | $ 123,000,000 | |
NOL for State tax | 12,900,000 | |
NOL for Foreign tax | 3,700,000 | |
Various tax credits, amount | 8,900,000 | |
NOL carryforwards | 1,767,803 | $ 1,154,935 |
Prepaid expenses | 606,606 | |
Interest or penalties accrued | $ 0 |
Income Taxes - Schedule of inco
Income Taxes - Schedule of income tax benefit (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes | |||
Federal | $ 0 | $ 0 | |
Foreign | 0 | 0 | |
State | (1,767,803) | (1,154,935) | |
Income Tax Expense (Benefit), Total | $ (1,161,197) | $ (1,767,803) | $ (1,154,935) |
Income Taxes - Schedule of defe
Income Taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Taxes | ||
Net operating loss carry forwards | $ 27,522,000 | $ 27,252,000 |
Orphan drug and research and development credit carry forwards | 8,921,000 | 8,837,000 |
Equity based compensation | 246,000 | 285,000 |
Intangibles | 1,409,000 | 1,696,000 |
Capitalized research and development (Section 174) | 2,310,677 | 1,832,000 |
Lease Liability | 66,000 | 96,000 |
Other | (12,000) | |
Deferred tax assets, gross | 40,463,000 | 39,998,000 |
Valuation allowance | (40,398,000) | (39,902,000) |
Net deferred tax assets | 65,000 | 96,000 |
ROU Assets | (65,000) | (96,000) |
Total gross deferred tax liabilities | (65,000) | (96,000) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of fede
Income Taxes - Schedule of federal and state statutory tax rates and the provision for income tax benefit (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
Federal tax at statutory rate | (21.00%) | (21.00%) |
State tax benefits, plus sale of NJ NOL, net of federal benefit | (21.60%) | (2.40%) |
Foreign tax rate difference | 0.10% | 0.20% |
Orphan drug and research and development credits | (2.00%) | (3.90%) |
Permanent differences | 0.90% | 3.10% |
Foreign NOL adjustments | 0.70% | 0.40% |
Expiration of tax attributes | 14.20% | 9.10% |
Change in valuation allowance | 6.30% | 6.80% |
Income tax benefit | (22.40%) | (7.70%) |
Shareholders' Equity (Details_2
Shareholders' Equity (Details) | 3 Months Ended | 12 Months Ended | ||||||||||||||||||||
Jan. 03, 2024 $ / shares shares | Sep. 06, 2023 shares | Jun. 08, 2023 shares | May 22, 2023 shares | May 10, 2023 shares | May 09, 2023 $ / shares shares | May 02, 2023 $ / shares shares | Apr. 27, 2023 $ / shares shares | Dec. 21, 2022 $ / shares | Nov. 07, 2022 $ / shares shares | Oct. 04, 2022 $ / shares shares | Aug. 05, 2022 shares | May 06, 2022 shares | Apr. 27, 2022 shares | Feb. 07, 2022 $ / shares shares | Aug. 11, 2017 | Mar. 31, 2024 shares | Dec. 31, 2023 Vote $ / shares shares | Dec. 31, 2022 $ / shares shares | Aug. 04, 2022 $ / shares | May 07, 2022 $ / shares | Dec. 31, 2021 shares | |
Class of Stock [Line Items] | ||||||||||||||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | 300,000 | |||||||||||||||||||
Preferred Stock, Shares Issued | 0 | 0 | 0 | |||||||||||||||||||
Fair value per share | $ / shares | $ 23.36 | $ 156 | $ 115.20 | $ 148.80 | $ 218.40 | $ 124.80 | ||||||||||||||||
Number of shares issued | 3 | 321 | 105 | 229 | 401 | 3 | 337 | |||||||||||||||
Shares issues (in shares) | 56,609 | 11,946 | 8,719 | |||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 10.45 | $ 141.61 | ||||||||||||||||||||
Maximum | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Preferred stock, shares authorized | 350,000 | |||||||||||||||||||||
B Riley Sales Agreement [Member] | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Threshold percentage of compensation from gross proceeds | 3% | |||||||||||||||||||||
Shares issues (in shares) | 539 | |||||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 148.64 | |||||||||||||||||||||
Pre-funded warrants | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Warrants Issued | 264,813 | |||||||||||||||||||||
Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 20.80 | |||||||||||||||||||||
Series D Preferred Stock | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Preferred Stock, Shares Issued | 50,000 | |||||||||||||||||||||
Series D preferred stock dividend ratio for each common stock transferred | 0.001 | |||||||||||||||||||||
Temporary equity per share | $ / shares | $ 0.001 | |||||||||||||||||||||
Series D preferred stock share transferred ratio for each common stock transferred | 0.001 | |||||||||||||||||||||
Number of votes per Series D preferred stock | Vote | 1,000,000 | |||||||||||||||||||||
Liquidation, cash payment per share | $ / shares | $ 0.001 | |||||||||||||||||||||
Threshold number of shares redeemed | 100 | |||||||||||||||||||||
Redemption price per share | $ / shares | $ 0.10 | |||||||||||||||||||||
Convertible Debt | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Number of shares issued | 9,139 | |||||||||||||||||||||
Shares issued price per share | $ / shares | $ 10.88 | |||||||||||||||||||||
Convertible Debt | Pontifax | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Fair value per share | $ / shares | $ 10.88 | |||||||||||||||||||||
Common Stock | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Number of shares issued on exercise of warrants | 9,139 | 264,714 | ||||||||||||||||||||
Shares issues (in shares) | 53,202 | |||||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 58.08 | |||||||||||||||||||||
Common Stock | Exclusive option agreement | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Number of shares issued | 1,978 | |||||||||||||||||||||
Period considered for average closing price | 10 days | |||||||||||||||||||||
Shares issued price per share | $ / shares | $ 25.28 | |||||||||||||||||||||
Common Stock | Pre-funded warrants | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Number of shares issued on exercise of warrants | 33,525 | 25,001 | 21,125 | 58,625 | 126,438 | |||||||||||||||||
Common Stock | Public Offering | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Number of shares issued | 143,844 | |||||||||||||||||||||
Shares issued price per share | $ / shares | $ 20.80 | |||||||||||||||||||||
Common Stock | Convertible Debt | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | |||||||||||||||||||||
Common Stock | Convertible Debt | Pontifax | ||||||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||||||
Number of shares issued on exercise of warrants | 9,139 | |||||||||||||||||||||
Fair value per share | $ / shares | $ 10.88 |
Stock Option Plans and Warran_3
Stock Option Plans and Warrants to Purchase Common Stock (Details) | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 shares | Dec. 31, 2023 USD ($) item $ / shares shares | Dec. 31, 2022 $ / shares shares | Dec. 31, 2021 shares | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | ||||
Number of equity programs | item | 4 | |||
Shares issues (in shares) | 56,609 | 11,946 | 8,719 | |
Total compensation cost (in Dollars) | $ | $ 421,000 | |||
Stock options | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | ||||
Shares issues (in shares) | 56,609 | |||
Stock options awarded | 45,715 | 3,474 | ||
Stock option expected year | 3 years | |||
Stock Option Plans [Member] | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | ||||
Weighted average exercise price (in Dollars per share) | $ / shares | $ 236.90 | |||
Exercisable, weighted average remaining contractual term | 7 years 11 months 26 days | |||
Weighted Average Remaining Term | 9 years 3 months | |||
Fair value per share (in Dollars per share) | $ / shares | $ 8 | $ 8 | ||
Grant 2015 Plan | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | ||||
Additional numbers of shares of common stock | 4,000,000 | |||
Shares available for grant | 5,943,590 | |||
Intrinsic value | $ | $ 0 | |||
Equity incentive | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | ||||
Future issuance | 0 |
Stock Option Plans and Warran_4
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of shares available for grant under the 2015 plan (Details) - Grant 2015 Plan | 12 Months Ended |
Dec. 31, 2023 shares | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of shares available for grant under the 2015 plan [Line Items] | |
Shares available for grant | 5,988,368 |
Options granted | (45,715) |
Options forfeited | 937 |
Shares available for grant | 5,943,590 |
Stock Option Plans and Warran_5
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of activity under the 2005 plan and the 2015 plan (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule of activity under the 2005 plan and the 2015 plan [Abstract] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | 11,946 | 8,719 |
Weighted Average Options Exercise Price outstanding beginning balance | $ 435.32 | $ 593.92 |
Number of options issued | 45,715 | 3,497 |
Weighted average price per share (in Dollars per share) | $ 10.45 | $ 141.61 |
Options Forfeited | (1,052) | (236) |
Options Cancelled | (34) | |
Weighted Average Options Exercise Price Cancelled | $ 187.20 | |
Weighted Average Options Exercise Price Forfeited | $ 533.80 | $ 1,727.66 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 56,609 | 11,946 |
Weighted Average Options Exercise Price outstanding ending balance | $ 90.58 | $ 435.32 |
Stock Option Plans and Warran_6
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock (Details) - Stock options | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Weighted Average Remaining Contractual Life in Years | 9 years 3 months |
Outstanding Options | 56,609 |
Exercisable Options | 19,187 |
$9.44 - $540.00 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Exercise price, lower limit | $ / shares | $ 9.44 |
Exercise price, upper limit | $ / shares | $ 540 |
Weighted Average Remaining Contractual Life in Years | 9 years 3 months 21 days |
Outstanding Options | 56,182 |
Exercisable Options | 18,760 |
$1,776.00 - 5,256.00 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of weighted-average exercise price, by price range, for outstanding options to purchase common stock [Line Items] | |
Exercise price, lower limit | $ / shares | $ 1,776 |
Exercise price, upper limit | $ / shares | $ 5,256 |
Weighted Average Remaining Contractual Life in Years | 1 year 6 months 7 days |
Outstanding Options | 427 |
Exercisable Options | 427 |
Stock Option Plans and Warran_7
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of share-based compensation expense (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||||
Share-Based Compensation | $ 59,961 | $ 73,634 | $ 370,182 | $ 333,389 |
Research and development [Member] | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||||
Share-Based Compensation | 150,466 | 142,879 | ||
General and administrative [Member] | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||||
Share-Based Compensation | $ 219,716 | $ 190,510 |
Stock Option Plans and Warran_8
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of warrant activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of warrant activity [Line Items] | ||
Warrants, Granted | 45,715 | 3,497 |
Weighted Average Exercise Price, Granted | $ 10.45 | $ 141.61 |
Warrants | ||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of warrant activity [Line Items] | ||
Warrants opening, Balance | 42 | 13,868 |
Weighted Average Exercise Price opening, Balance | $ 468 | $ 540.68 |
Warrants closing, Balance | 408,640 | 42 |
Weighted Average Exercise Price closing, Balance | $ 24 | $ 468 |
Warrants, Granted | 673,445 | |
Weighted Average Exercise Price, Granted | $ 14.56 | |
Exercise of common stock options (in shares) | (264,815) | |
Weighted Average Exercise Price, Exercised | $ 0.02 | |
DO NOT USE FOR WARRANTS Expired (in shares) | (42) | (13,826) |
Weighted Average Exercise Price, Expired | $ 468 | $ 540.90 |
Stock Option Plans and Warran_9
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of remaining life, by grant date, for outstanding warrants (Details) - 3/29/2018 [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price (in Dollars per share) | $ / shares | $ 24 |
Remaining Contractual Life in Years | 4 years 4 months 9 days |
Outstanding Warrants | 408,640 |
Exercisable Warrants | 408,640 |
Commitments and Contingencies_5
Commitments and Contingencies (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||
Apr. 27, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | May 06, 2022 shares | Apr. 27, 2022 shares | Feb. 07, 2022 shares | Mar. 01, 2020 $ / shares shares | Sep. 03, 2014 USD ($) shares | Mar. 31, 2020 $ / shares shares | Jan. 31, 2020 USD ($) | Sep. 30, 2014 USD ($) shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) m² | Jun. 21, 2022 USD ($) | |
Other Commitments [Line Items] | |||||||||||||||
Contractual obligation | $ 449,067 | $ 483,167 | |||||||||||||
Maximum payment for commitment milestones | 13,200,000 | 13,200,000 | |||||||||||||
Sub license milestones payments on covered products | $ 200,000 | ||||||||||||||
Employee Retention Credit, CARES ACT | $ 120,771 | ||||||||||||||
Percentage of sub license income on royalties | 15% | 15% | |||||||||||||
Office space in square feet | m² | 6,200 | ||||||||||||||
Lease rent per month | $ 11,367 | ||||||||||||||
Fair value of shares issued in connection with asset purchase | $ 50,000 | ||||||||||||||
Issuance of common stock | shares | 3 | 321 | 105 | 229 | 401 | 3 | 337 | ||||||||
For Period Till November 2023 [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Lease rent per month | 11,367 | ||||||||||||||
From Period Till November 2024 [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Lease rent per month | $ 11,625 | ||||||||||||||
Research and Development Arrangement [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Contractual obligation | $ 230,000 | $ 230,000 | |||||||||||||
Asset Purchase Agreement [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Cash paid to acquire intangible asset | $ 275,000 | $ 275,000 | |||||||||||||
Issuance of shares for assets (in shares) | shares | 12,328 | 771 | |||||||||||||
Fair value of shares issued in connection with asset purchase | $ 3,750,000 | $ 3,750,000 | |||||||||||||
Issuance of common stock | shares | 8,151 | 130,413 | |||||||||||||
Effective price per share (in dollars per share) | $ / shares | $ 614.40 | $ 38.40 | |||||||||||||
Ownership of company outstanding | 19.90% | 19.90% | |||||||||||||
Minimum | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Percentage for royalties | 2% | 2% | |||||||||||||
Percentage of global net sales royalties on covered products | 1.50% | 1.50% | |||||||||||||
Authorized shares to be issued | $ 334 | ||||||||||||||
Maximum | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Percentage for royalties | 3% | 3% | |||||||||||||
Percentage of global net sales royalties on covered products | 2.50% | 2.50% | |||||||||||||
Authorized shares to be issued | $ 33,334 | ||||||||||||||
Maximum | Asset Purchase Agreement [Member] | Scenario, Plan [Member] | |||||||||||||||
Other Commitments [Line Items] | |||||||||||||||
Contingent consideration | $ 5,000,000 | $ 5,000,000 |
Commitments and Contingencies_6
Commitments and Contingencies - Schedule of contractual obligation (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Long-term Purchase Commitment [Line Items] | ||
2025 | $ 162,250 | $ 182,917 |
2026 | 46,000 | 162,250 |
2027 | 46,000 | 46,000 |
2028 | 46,000 | 46,000 |
2027 | 46,000 | |
Total | 449,067 | 483,167 |
Research and Development Arrangement [Member] | ||
Long-term Purchase Commitment [Line Items] | ||
2025 | 46,000 | 46,000 |
2026 | 46,000 | 46,000 |
2027 | 46,000 | 46,000 |
2028 | 46,000 | 46,000 |
2027 | 46,000 | |
Total | 230,000 | 230,000 |
Lease Agreements [Member] | ||
Long-term Purchase Commitment [Line Items] | ||
2025 | 116,250 | 136,917 |
2026 | 116,250 | |
Total | $ 219,067 | $ 253,167 |
Operating Segments (Details)_2
Operating Segments (Details) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 USD ($) segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Segment reporting | ||||
Revenues | $ 117,029 | $ 257,178 | $ 839,359 | $ 948,911 |
Income (loss) from Operations | (2,117,091) | (2,150,689) | (7,697,940) | (14,238,904) |
Amortization and Depreciation Expense | 1,588 | 1,785 | 6,554 | 24,562 |
Other (Expense) Income, Net | 201,764 | (56,617) | (210,593) | (714,370) |
Share-Based Compensation | 59,961 | 73,634 | 370,182 | 333,389 |
Identifiable Assets | $ 8,058,385 | $ 9,797,326 | 14,279,717 | |
Number of operating segments | segment | 2 | 2 | ||
Operating Segments [Member] | Specialized BioTherapeutics [Member] | ||||
Segment reporting | ||||
Revenues | $ 117,029 | 155,365 | $ 395,124 | 31,929 |
Income (loss) from Operations | (860,604) | (910,377) | (2,812,303) | (7,614,988) |
Amortization and Depreciation Expense | 953 | 1,071 | 3,932 | 10,087 |
Other (Expense) Income, Net | 7,540 | 6,082 | 25,267 | 102,320 |
Share-Based Compensation | 20,672 | 27,427 | 145,683 | 138,075 |
Identifiable Assets | 301,709 | 272,099 | 103,742 | |
Operating Segments [Member] | Public Health Solutions [Member] | ||||
Segment reporting | ||||
Revenues | 101,813 | 444,235 | 916,982 | |
Income (loss) from Operations | (45,997) | 427 | (36,531) | 26,612 |
Amortization and Depreciation Expense | 159 | 178 | 655 | 1,681 |
Share-Based Compensation | 588 | 994 | 4,782 | 4,804 |
Identifiable Assets | 120,475 | 3,976 | 121,290 | |
Corporate [Member] | ||||
Segment reporting | ||||
Income (loss) from Operations | (1,210,490) | (1,240,739) | (4,849,106) | (6,650,528) |
Amortization and Depreciation Expense | 476 | 536 | 1,967 | 12,794 |
Other (Expense) Income, Net | 194,224 | (62,699) | (235,860) | (816,690) |
Share-Based Compensation | 38,701 | $ 45,213 | 219,717 | 190,510 |
Identifiable Assets | $ 7,636,201 | $ 9,521,251 | $ 14,054,685 |
Subsequent Events (Details)_2
Subsequent Events (Details) | 3 Months Ended | 12 Months Ended | |||||||||||||||||
Apr. 22, 2024 USD ($) $ / shares shares | Apr. 15, 2024 USD ($) $ / shares shares | Mar. 08, 2024 USD ($) $ / shares | Jan. 03, 2024 USD ($) $ / shares shares | May 09, 2023 $ / shares shares | Apr. 27, 2023 $ / shares shares | Apr. 19, 2023 USD ($) $ / shares | Nov. 07, 2022 $ / shares shares | Oct. 04, 2022 $ / shares shares | Aug. 05, 2022 shares | May 06, 2022 shares | Apr. 27, 2022 shares | Feb. 07, 2022 $ / shares shares | Mar. 31, 2024 shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | Aug. 04, 2022 $ / shares | May 07, 2022 $ / shares | |
Subsequent Event | |||||||||||||||||||
Fair value per share | $ 23.36 | $ 156 | $ 115.20 | $ 148.80 | $ 218.40 | $ 124.80 | |||||||||||||
Repayment of debt principal | $ | $ 1,000,000 | $ 7,000,000 | |||||||||||||||||
Number of shares issued | shares | 3 | 321 | 105 | 229 | 401 | 3 | 337 | ||||||||||||
Outstanding principal | $ | $ 1,010,934 | $ 0 | |||||||||||||||||
Common Stock | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Issuance of common stock associated with conversion of debt (in shares) | shares | 9,139 | 264,714 | |||||||||||||||||
Public Offering | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Shares issued price per share | $ 20.80 | ||||||||||||||||||
Exercise price of warrants | $ 0.001 | ||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||
Public Offering | Pre-funded warrants | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 264,813 | ||||||||||||||||||
Public Offering | Common warrants | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 408,656 | ||||||||||||||||||
Public Offering | Common Stock | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of shares issued | shares | 143,844 | ||||||||||||||||||
Shares issued price per share | $ 20.80 | ||||||||||||||||||
Exercise price of warrants | $ 24 | ||||||||||||||||||
Pontifax | First 588,599 shares of common stock issuable upon conversion | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Shares of common stock issuable upon conversion | $ | 36,790 | ||||||||||||||||||
Convertible Debt | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Repayment of debt principal | $ | $ 99,416 | ||||||||||||||||||
Number of shares issued | shares | 9,139 | ||||||||||||||||||
Shares issued price per share | $ 10.88 | ||||||||||||||||||
Convertible Debt | Common Stock | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | ||||||||||||||||||
Convertible Debt | Pontifax | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Fair value per share | $ 10.88 | ||||||||||||||||||
Repayment of debt principal | $ | $ 99,416 | ||||||||||||||||||
Shares of common stock issuable upon conversion | $ | 27,651 | 9 | 3 | ||||||||||||||||
Outstanding principal | $ | $ 3,000,000 | ||||||||||||||||||
Convertible Debt | Pontifax | First 588,599 shares of common stock issuable upon conversion | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Shares issued price per share | $ 27.20 | ||||||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | ||||||||||||||||||
Shares of common stock issuable upon conversion | $ | 3 | 3 | |||||||||||||||||
Convertible Debt | Pontifax | Common Stock | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Issuance of common stock associated with conversion of debt (in shares) | shares | 9,139 | ||||||||||||||||||
Fair value per share | $ 10.88 | ||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Shares issued price per share | $ 6.40 | ||||||||||||||||||
Subsequent Event | Public Offering | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of shares issued | shares | 143,844 | ||||||||||||||||||
Shares issued price per share | 6.40 | ||||||||||||||||||
Exercise price of warrants | 0.02 | ||||||||||||||||||
Price per unit | $ 6.38 | ||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||
Total gross proceeds | $ | $ 4,750,000 | ||||||||||||||||||
Net proceeds | $ | $ 4,300,000 | ||||||||||||||||||
Subsequent Event | Public Offering | Pre-funded warrants | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 537,500 | ||||||||||||||||||
Number of shares in an unit | shares | 1 | ||||||||||||||||||
Exercise price of warrants | $ 0.02 | ||||||||||||||||||
Subsequent Event | Public Offering | Common warrants | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 742,194 | ||||||||||||||||||
Number of warrants in an unit | shares | 1 | ||||||||||||||||||
Exercise price of warrants | $ 6.40 | ||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||
Subsequent Event | Public Offering | Common Stock | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Number of shares issued | shares | 204,694 | ||||||||||||||||||
Number of shares in an unit | shares | 1 | ||||||||||||||||||
Exercise price of warrants | $ 6.40 | ||||||||||||||||||
Subsequent Event | Convertible Debt | Pontifax | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Issuance of common stock associated with conversion of debt (in shares) | shares | 27,651 | ||||||||||||||||||
Fair value per share | $ 5.60 | ||||||||||||||||||
Repayment of debt principal | $ | $ 154,840 | ||||||||||||||||||
Shares issued price per share | $ 27.40 | ||||||||||||||||||
Interest outstanding | $ | $ 45,840 | ||||||||||||||||||
Reduction in conversion price as percentage of closing price of the common stock on the day before the delivery of the conversion notice | 90% | ||||||||||||||||||
Outstanding principal | $ | $ 2,900,585 |
Reverse Stock Split (Details)_2
Reverse Stock Split (Details) | Jun. 05, 2024 |
Subsequent Event | |
Reverse stock spilt effective from June 5, 2024 | 0.625 |